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PROFINAL XP 20 TAB

SKU: 02160216
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Weight:  kg

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Description

1. What is this preparation and what are the indications for its use?Provinal XP provides powerful pain relief thanks to its ingredients that relieve pain in many different ways.This medicine contains two active ingredients:Ibuprofen: It is a non-ste

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Product Description
1. What is this preparation and what are the indications for its use?
Provinal XP provides powerful pain relief thanks to its ingredients that relieve pain in many different ways.
 
This medicine contains two active ingredients:
Ibuprofen: It is a non-steroidal anti-inflammatory compound that has anti-inflammatory, anti-rheumatic, analgesic and fever-reducing properties.
Caffeine: It enhances the effect of ibuprofen and speeds up its onset.
 
Profinal XP is used for the rapid relief of pain in the following cases:
It is used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still"s disease), arthritis of the spine (ankylosing spondylitis), joint swelling, frozen shoulder, synovial bursitis, tendinitis tenosynovitis, lower back pain, sprains and strains.
Profinal XP is also used to treat other conditions associated with pain such as toothache, post-operative pain, menstrual pain and headaches, including migraines.
 
2. WHAT YOU NEED TO KNOW BEFORE USING THIS PRODUCT:
Risks to the heart and blood vessels:
Non-steroidal anti-inflammatory drugs may increase the risk of serious heart and blood vessel clots, myocardial infarction, and stroke, which can lead to death. This risk may increase if this medicine continues to be taken for a long time, and this risk may be greater in patients with or at risk of developing cardiovascular disease.
Non-steroidal anti-inflammatory drugs should not be used to treat pain that occurs before or after coronary artery bypass graft surgery.
Risks to the gut: Non-steroidal anti-inflammatory drugs may increase the risk of serious adverse effects on the gut including bleeding, ulcers, and perforation of the stomach or intestines, which can lead to death. These effects may occur at any time while taking this medicine without the appearance of any warning symptoms. Elderly patients are often more likely to experience these serious effects.
 
This medicine should not be taken in the following cases:
If you are allergic to any of the active ingredients or any of the other ingredients in Profinal XP (listed in section 6).
If you are pregnant or breast-feeding a baby.
If you currently have a peptic ulcer (stomach or duodenal ulcer) or stomach bleeding, or have previously had two or more episodes of peptic ulcer, or have previously suffered from stomach bleeding or perforation.
If you have a problem that increases your risk of bleeding.
If you have asthma or have ever had an allergic reaction or have ever had wheezing after taking ibuprofen, aspirin or any other anti-inflammatory pain medication.
If you have a heart disorder, medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risks may increase with higher doses and longer treatment periods.
The recommended dosage amount or prescribed treatment period should not be exceeded.
 
Please consult your physician and pharmacist about your treatment before taking Profinal XP if you:
You have heart problems including heart failure, angina (chest pain) or have ever had a heart attack, peripheral artery disease (poor circulation in the legs or feet caused by narrowed or blocked arteries) or have previously had heart operations.
you suffer from a type of stroke or think you may be at risk of these conditions (eg if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol levels or are a smoker).
 
Warnings and precautions:
Please tell your doctor or pharmacist before taking Profinal XP:
If you suffer from a liver or kidney disorder.
If you have systemic lupus erythematosus (sometimes called lupus) or a connective tissue disease (an autoimmune disease that affects connective tissue).
If you suffer from swelling or irritation inside the nose
Do you suffer from chickenpox or shingles?
When giving this medicine to children and adolescents. As dehydrated children and adolescents are at risk of kidney damage, other medicines should be taken concomitantly with Profinal XP.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
 
You should tell your doctor or pharmacist if you are taking any of the following medicines:
Anticoagulant medicines (thinners/anticoagulants such as aspirin/acetylsalicylic acid, warfarin, clodipine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
Oral diuretics.
Cardiac glycosides, eg digoxin, which is used to treat heart problems.
lithium;
Zidovudine (an antiviral medicine).
Steroids (medicines used to treat infections).
methotrexate (a medicine used to treat certain types of cancer and rheumatoid arthritis).
Medicines known as immunosuppressants eg ciclosporin and tacrolimus (medicines used to reduce the body"s immune system reactions).
Medicines known as selective serotonin reuptake inhibitors, which are medicines used to treat depression.
Antibiotics belonging to the quinolone group, for example, ciprofloxacin.
Aminoglycosides (a type of antibiotic)
Mifepristone.
Any other products containing ibuprofen, such as those that you can buy without a prescription.
Any other nonsteroidal anti-inflammatory drug, including aspirin.
Cholestyramine (a medicine used to lower cholesterol in the blood).
Medicines known as sulfonylureas, for example glibenclamide (used to treat diabetes).
voriconazole or fluconazole (antifungal medicines).
Ginkgo biloba herbal preparation (there is a chance of bleeding more easily if you take this medicine together with ibuprofen).
 
Pregnancy and breastfeeding:
You should avoid taking Profinal XP during pregnancy or breastfeeding.
Profinal XP should not be taken during the last 3 months of pregnancy and should be taken during the first 6 months of pregnancy only if recommended by your doctor.
 
Driving and using machines:
Profinal XP may cause dizziness or drowsiness.
You should avoid driving, operating machinery, or performing any tasks that require alertness if such effects occur.
 
Provinal XP with food, drink and alcohol:
It is recommended to take Profinal XP either with or after a meal or milk in order to minimize the negative effects on the gastrointestinal tract.
You should not drink alcohol or drink excessively caffeinated beverages.
 
3. What is the method of using this product?
You must always take Profinal XP strictly according to your physician"s instructions.
Please consult your physician or pharmacist if you are not sure how to take this medicine.
This medicine is for oral use only.
The dose listed below should not be exceeded.
 
Dosage:
The recommended dose is one tablet 3 times daily.
This medicine is not recommended for use by children under 12 years of age.
 
If you take Profinal XP at a higher dose than you should:
You should contact your doctor or go to the emergency department of the nearest hospital immediately, and take your tablets with you.
If you miss the missed dose, take the missed dose as soon as possible if you remember, unless it is almost time for the next dose. It is recommended to continue with the dosing schedule without taking the missed dose.
You should not double the dose to make up for the single dose that you may have missed.
If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.
 
4. Possible side effects:
Like all medicines, Profinal XP can cause side effects, but not everybody gets them.
 
Side effects caused by ibuprof:
You should stop taking Profinal XP Tablets and seek medical advice immediately, if you experience any of the following:
Signs of aseptic meningitis eg severe headache, high fever, stiff neck or inability to tolerate bright light.
 
Signs of gastrointestinal bleeding for example:
bloody stools;
Black stools.
Vomiting blood or vomit that contains dark-colored particles similar to coffee beans.
 
Please tell your treating doctor and stop taking Profinal XP if you experience any of the following:
Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling unwell and/or vomiting.
Unexplained wheezing, shortness of breath, rash, itching or bruising (may be symptoms of an allergic reaction).
Yellowing of the eyes and/or skin (jaundice).
Severe sore throat accompanied by a high fever (this may be a symptom of a condition known as agranulocytosis).
Blurred or disturbed vision (low vision) or seeing/hearing strange things (hallucinations).
Fluid retention eg swollen ankles (this could be a sign of kidney problems).
Severe rash spreading over large areas of the body (Stevens-Johnson syndrome and erythema multiforme, symptoms include severe rash, skin ulcers, including inside the mouth, nose and genitals, and peeling of the skin that may be accompanied by Symptoms such as pain, headache, and high body temperature).
Some medicines, for example ibuprofen, may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.
Some medicines, for example ibuprofen, may be used in exceptional cases with the occurrence of severe skin problems in patients with chickenpox and herpes zoster. Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely when taking ibuprofen.
Very rarely, ibuprofen may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Ibuprofen has also been shown to sometimes cause a worsening of Crohn"s disease or colitis symptoms.
 
Other side effects:
Common (affect up to 1 in 10 people):
rash.
Feeling dizzy or tired.
Stomach pain, indigestion, diarrhoea, feeling unwell, malaise, wind, constipation.
a headache.
If this occurs while you are taking this medicine, it is important not to take other medicines that are used to relieve pain at the same time as this medicine.
Black stools.
bloody stools;
hematemesis;
 
Uncommon (affect up to 1 in 100 people):
feeling sleepy;
feeling anxious
Numbness or tingling feeling like pins and needles.
difficulty sleeping
hives, itching
The body becomes sensitive to light.
Vision disturbance, hearing problems.
Hepatitis, yellowing of the skin or eyes, liver function disorder.
Kidney function disorder, nephritis, kidney failure.
sneezing, stuffy nose, itchy or runny nose (rhinitis).
Stomach or intestinal ulcer, perforation of the gastrointestinal wall.
Inflammation of the stomach lining.
Small bruises appear on the skin or inside the mouth, nose or ear.
Difficulty breathing, wheezing or coughing, asthma, or worsening of asthma.
ringing in the ears;
Feeling dizzy or dizzy.
Oral ulcers.
Serious allergic reactions that lead to swelling of the face or throat.
 
Rare (affects up to 1 in 1,000 people):
Feeling depressed or confused.
Fluid retention (edema).
A brain infection known as "non-bacterial meningitis".
vision loss;
Changes in the blood count, where the initial symptoms that indicate this occurs include:
High temperature, sore throat, mouth sores, flu-like symptoms, feeling very tired, nose and skin bleeding.
Low blood count (anaemia).
Serious allergic reactions that lead to difficulty breathing or dizziness.
Severe sore throat accompanied by a high temperature (agranulocytosis).
 
Very rare (affects up to 1 in 10,000 people):
liver failure;
heart failure;
Heart attack.
pancreatitis.
Skin problems (which may involve the inside of the mouth, nose or ears) eg Stevens-Johnson syndrome or toxic epidermal necrolysis and erythema multiforme.
Hypertension is not known (the frequency of its occurrence cannot be estimated from the available data).
Exacerbation of ulcerative colitis or Crohn"s disease (colitis).
 
Caffeine side effects:
Nausea, headache, insomnia were reported.
Excessive consumption of caffeinated beverages can cause headache, flushing and symptoms of anxiety neurosis.
Taking high doses causes insomnia, irritability and expulsion of contractions.
Caffeine increases the amount of stomach secretions, causing stomach ulcers.
Please tell your doctor or pharmacist if any side effects occur, including any side effects not mentioned in this leaflet.
 
To report any side effects:
National Center for Pharmacovigilance and Safety
Fax number: +966-11-205-7662
Please contact the National Center for Pharmacovigilance and Safety at: +966-11-2038222
Tel: 2340-2334-2354-2353-2356-2317
Toll Free: 8002490000
Website: www.sfda.gov.sa/npc 5
 
How to store the preparation:
Keep out of reach and sight of children.
Profinal XP should not be taken after the expiry date which is stated on the pack and strip.
Store at a temperature below 30ºC.
You should not take Profinal XP if you notice visible signs of damage.
Medicines should not be disposed of via waste water (wastewater) or household waste.
Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
 
pharmacy :
Online Pharmacy - Taj Al Dawaa Pharmacy.
 
Trade Name:
Profinal XP 400 mg Tablet 20pcs.
 
The scientific name:
Ibuprofen - caffeine.
 
Category:
Over-the-counter medications.
 
For more information about Profinal XP 400 mg 20 tablets, please visit the Saudi Food and Drug Authority website.
1. What is this preparation and what are the indications for its use?
Provinal XP provides powerful pain relief thanks to its ingredients that relieve pain in many different ways.
 
This medicine contains two active ingredients:
Ibuprofen: It is a non-steroidal anti-inflammatory compound that has anti-inflammatory, anti-rheumatic, analgesic and fever-reducing properties.
Caffeine: It enhances the effect of ibuprofen and speeds up its onset.
 
Profinal XP is used for the rapid relief of pain in the following cases:
It is used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still"s disease), arthritis of the spine (ankylosing spondylitis), joint swelling, frozen shoulder, synovial bursitis, tendinitis tenosynovitis, lower back pain, sprains and strains.
Profinal XP is also used to treat other conditions associated with pain such as toothache, post-operative pain, menstrual pain and headaches, including migraines.
 
2. WHAT YOU NEED TO KNOW BEFORE USING THIS PRODUCT:
Risks to the heart and blood vessels:
Non-steroidal anti-inflammatory drugs may increase the risk of serious heart and blood vessel clots, myocardial infarction, and stroke, which can lead to death. This risk may increase if this medicine continues to be taken for a long time, and this risk may be greater in patients with or at risk of developing cardiovascular disease.
Non-steroidal anti-inflammatory drugs should not be used to treat pain that occurs before or after coronary artery bypass graft surgery.
Risks to the gut: Non-steroidal anti-inflammatory drugs may increase the risk of serious adverse effects on the gut including bleeding, ulcers, and perforation of the stomach or intestines, which can lead to death. These effects may occur at any time while taking this medicine without the appearance of any warning symptoms. Elderly patients are often more likely to experience these serious effects.
 
This medicine should not be taken in the following cases:
If you are allergic to any of the active ingredients or any of the other ingredients in Profinal XP (listed in section 6).
If you are pregnant or breast-feeding a baby.
If you currently have a peptic ulcer (stomach or duodenal ulcer) or stomach bleeding, or have previously had two or more episodes of peptic ulcer, or have previously suffered from stomach bleeding or perforation.
If you have a problem that increases your risk of bleeding.
If you have asthma or have ever had an allergic reaction or have ever had wheezing after taking ibuprofen, aspirin or any other anti-inflammatory pain medication.
If you have a heart disorder, medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risks may increase with higher doses and longer treatment periods.
The recommended dosage amount or prescribed treatment period should not be exceeded.
 
Please consult your physician and pharmacist about your treatment before taking Profinal XP if you:
You have heart problems including heart failure, angina (chest pain) or have ever had a heart attack, peripheral artery disease (poor circulation in the legs or feet caused by narrowed or blocked arteries) or have previously had heart operations.
you suffer from a type of stroke or think you may be at risk of these conditions (eg if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol levels or are a smoker).
 
Warnings and precautions:
Please tell your doctor or pharmacist before taking Profinal XP:
If you suffer from a liver or kidney disorder.
If you have systemic lupus erythematosus (sometimes called lupus) or a connective tissue disease (an autoimmune disease that affects connective tissue).
If you suffer from swelling or irritation inside the nose
Do you suffer from chickenpox or shingles?
When giving this medicine to children and adolescents. As dehydrated children and adolescents are at risk of kidney damage, other medicines should be taken concomitantly with Profinal XP.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
 
You should tell your doctor or pharmacist if you are taking any of the following medicines:
Anticoagulant medicines (thinners/anticoagulants such as aspirin/acetylsalicylic acid, warfarin, clodipine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
Oral diuretics.
Cardiac glycosides, eg digoxin, which is used to treat heart problems.
lithium;
Zidovudine (an antiviral medicine).
Steroids (medicines used to treat infections).
methotrexate (a medicine used to treat certain types of cancer and rheumatoid arthritis).
Medicines known as immunosuppressants eg ciclosporin and tacrolimus (medicines used to reduce the body"s immune system reactions).
Medicines known as selective serotonin reuptake inhibitors, which are medicines used to treat depression.
Antibiotics belonging to the quinolone group, for example, ciprofloxacin.
Aminoglycosides (a type of antibiotic)
Mifepristone.
Any other products containing ibuprofen, such as those that you can buy without a prescription.
Any other nonsteroidal anti-inflammatory drug, including aspirin.
Cholestyramine (a medicine used to lower cholesterol in the blood).
Medicines known as sulfonylureas, for example glibenclamide (used to treat diabetes).
voriconazole or fluconazole (antifungal medicines).
Ginkgo biloba herbal preparation (there is a chance of bleeding more easily if you take this medicine together with ibuprofen).
 
Pregnancy and breastfeeding:
You should avoid taking Profinal XP during pregnancy or breastfeeding.
Profinal XP should not be taken during the last 3 months of pregnancy and should be taken during the first 6 months of pregnancy only if recommended by your doctor.
 
Driving and using machines:
Profinal XP may cause dizziness or drowsiness.
You should avoid driving, operating machinery, or performing any tasks that require alertness if such effects occur.
 
Provinal XP with food, drink and alcohol:
It is recommended to take Profinal XP either with or after a meal or milk in order to minimize the negative effects on the gastrointestinal tract.
You should not drink alcohol or drink excessively caffeinated beverages.
 
3. What is the method of using this product?
You must always take Profinal XP strictly according to your physician"s instructions.
Please consult your physician or pharmacist if you are not sure how to take this medicine.
This medicine is for oral use only.
The dose listed below should not be exceeded.
 
Dosage:
The recommended dose is one tablet 3 times daily.
This medicine is not recommended for use by children under 12 years of age.
 
If you take Profinal XP at a higher dose than you should:
You should contact your doctor or go to the emergency department of the nearest hospital immediately, and take your tablets with you.
If you miss the missed dose, take the missed dose as soon as possible if you remember, unless it is almost time for the next dose. It is recommended to continue with the dosing schedule without taking the missed dose.
You should not double the dose to make up for the single dose that you may have missed.
If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.
 
4. Possible side effects:
Like all medicines, Profinal XP can cause side effects, but not everybody gets them.
 
Side effects caused by ibuprof:
You should stop taking Profinal XP Tablets and seek medical advice immediately, if you experience any of the following:
Signs of aseptic meningitis eg severe headache, high fever, stiff neck or inability to tolerate bright light.
 
Signs of gastrointestinal bleeding for example:
bloody stools;
Black stools.
Vomiting blood or vomit that contains dark-colored particles similar to coffee beans.
 
Please tell your treating doctor and stop taking Profinal XP if you experience any of the following:
Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling unwell and/or vomiting.
Unexplained wheezing, shortness of breath, rash, itching or bruising (may be symptoms of an allergic reaction).
Yellowing of the eyes and/or skin (jaundice).
Severe sore throat accompanied by a high fever (this may be a symptom of a condition known as agranulocytosis).
Blurred or disturbed vision (low vision) or seeing/hearing strange things (hallucinations).
Fluid retention eg swollen ankles (this could be a sign of kidney problems).
Severe rash spreading over large areas of the body (Stevens-Johnson syndrome and erythema multiforme, symptoms include severe rash, skin ulcers, including inside the mouth, nose and genitals, and peeling of the skin that may be accompanied by Symptoms such as pain, headache, and high body temperature).
Some medicines, for example ibuprofen, may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.
Some medicines, for example ibuprofen, may be used in exceptional cases with the occurrence of severe skin problems in patients with chickenpox and herpes zoster. Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely when taking ibuprofen.
Very rarely, ibuprofen may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Ibuprofen has also been shown to sometimes cause a worsening of Crohn"s disease or colitis symptoms.
 
Other side effects:
Common (affect up to 1 in 10 people):
rash.
Feeling dizzy or tired.
Stomach pain, indigestion, diarrhoea, feeling unwell, malaise, wind, constipation.
a headache.
If this occurs while you are taking this medicine, it is important not to take other medicines that are used to relieve pain at the same time as this medicine.
Black stools.
bloody stools;
hematemesis;
 
Uncommon (affect up to 1 in 100 people):
feeling sleepy;
feeling anxious
Numbness or tingling feeling like pins and needles.
difficulty sleeping
hives, itching
The body becomes sensitive to light.
Vision disturbance, hearing problems.
Hepatitis, yellowing of the skin or eyes, liver function disorder.
Kidney function disorder, nephritis, kidney failure.
sneezing, stuffy nose, itchy or runny nose (rhinitis).
Stomach or intestinal ulcer, perforation of the gastrointestinal wall.
Inflammation of the stomach lining.
Small bruises appear on the skin or inside the mouth, nose or ear.
Difficulty breathing, wheezing or coughing, asthma, or worsening of asthma.
ringing in the ears;
Feeling dizzy or dizzy.
Oral ulcers.
Serious allergic reactions that lead to swelling of the face or throat.
 
Rare (affects up to 1 in 1,000 people):
Feeling depressed or confused.
Fluid retention (edema).
A brain infection known as "non-bacterial meningitis".
vision loss;
Changes in the blood count, where the initial symptoms that indicate this occurs include:
High temperature, sore throat, mouth sores, flu-like symptoms, feeling very tired, nose and skin bleeding.
Low blood count (anaemia).
Serious allergic reactions that lead to difficulty breathing or dizziness.
Severe sore throat accompanied by a high temperature (agranulocytosis).
 
Very rare (affects up to 1 in 10,000 people):
liver failure;
heart failure;
Heart attack.
pancreatitis.
Skin problems (which may involve the inside of the mouth, nose or ears) eg Stevens-Johnson syndrome or toxic epidermal necrolysis and erythema multiforme.
Hypertension is not known (the frequency of its occurrence cannot be estimated from the available data).
Exacerbation of ulcerative colitis or Crohn"s disease (colitis).
 
Caffeine side effects:
Nausea, headache, insomnia were reported.
Excessive consumption of caffeinated beverages can cause headache, flushing and symptoms of anxiety neurosis.
Taking high doses causes insomnia, irritability and expulsion of contractions.
Caffeine increases the amount of stomach secretions, causing stomach ulcers.
Please tell your doctor or pharmacist if any side effects occur, including any side effects not mentioned in this leaflet.
 
To report any side effects:
National Center for Pharmacovigilance and Safety
Fax number: +966-11-205-7662
Please contact the National Center for Pharmacovigilance and Safety at: +966-11-2038222
Tel: 2340-2334-2354-2353-2356-2317
Toll Free: 8002490000
Website: www.sfda.gov.sa/npc 5
 
How to store the preparation:
Keep out of reach and sight of children.
Profinal XP should not be taken after the expiry date which is stated on the pack and strip.
Store at a temperature below 30ºC.
You should not take Profinal XP if you notice visible signs of damage.
Medicines should not be disposed of via waste water (wastewater) or household waste.
Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
 
pharmacy :
Online Pharmacy - Taj Al Dawaa Pharmacy.
 
Trade Name:
Profinal XP 400 mg Tablet 20pcs.
 
The scientific name:
Ibuprofen - caffeine.
 
Category:
Over-the-counter medications.
 
For more information about Profinal XP 400 mg 20 tablets, please visit the Saudi Food and Drug Authority website.

About the product

1. What is this preparation and what are the indications for its use?
Provinal XP provides powerful pain relief thanks to its ingredients that relieve pain in many different ways.
 
This medicine contains two active ingredients:
Ibuprofen: It is a non-steroidal anti-inflammatory compound that has anti-inflammatory, anti-rheumatic, analgesic and fever-reducing properties.
Caffeine: It enhances the effect of ibuprofen and speeds up its onset.
 
Profinal XP is used for the rapid relief of pain in the following cases:
It is used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still"s disease), arthritis of the spine (ankylosing spondylitis), joint swelling, frozen shoulder, synovial bursitis, tendinitis tenosynovitis, lower back pain, sprains and strains.
Profinal XP is also used to treat other conditions associated with pain such as toothache, post-operative pain, menstrual pain and headaches, including migraines.
 
2. WHAT YOU NEED TO KNOW BEFORE USING THIS PRODUCT:
Risks to the heart and blood vessels:
Non-steroidal anti-inflammatory drugs may increase the risk of serious heart and blood vessel clots, myocardial infarction, and stroke, which can lead to death. This risk may increase if this medicine continues to be taken for a long time, and this risk may be greater in patients with or at risk of developing cardiovascular disease.
Non-steroidal anti-inflammatory drugs should not be used to treat pain that occurs before or after coronary artery bypass graft surgery.
Risks to the gut: Non-steroidal anti-inflammatory drugs may increase the risk of serious adverse effects on the gut including bleeding, ulcers, and perforation of the stomach or intestines, which can lead to death. These effects may occur at any time while taking this medicine without the appearance of any warning symptoms. Elderly patients are often more likely to experience these serious effects.
 
This medicine should not be taken in the following cases:
If you are allergic to any of the active ingredients or any of the other ingredients in Profinal XP (listed in section 6).
If you are pregnant or breast-feeding a baby.
If you currently have a peptic ulcer (stomach or duodenal ulcer) or stomach bleeding, or have previously had two or more episodes of peptic ulcer, or have previously suffered from stomach bleeding or perforation.
If you have a problem that increases your risk of bleeding.
If you have asthma or have ever had an allergic reaction or have ever had wheezing after taking ibuprofen, aspirin or any other anti-inflammatory pain medication.
If you have a heart disorder, medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risks may increase with higher doses and longer treatment periods.
The recommended dosage amount or prescribed treatment period should not be exceeded.
 
Please consult your physician and pharmacist about your treatment before taking Profinal XP if you:
You have heart problems including heart failure, angina (chest pain) or have ever had a heart attack, peripheral artery disease (poor circulation in the legs or feet caused by narrowed or blocked arteries) or have previously had heart operations.
you suffer from a type of stroke or think you may be at risk of these conditions (eg if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol levels or are a smoker).
 
Warnings and precautions:
Please tell your doctor or pharmacist before taking Profinal XP:
If you suffer from a liver or kidney disorder.
If you have systemic lupus erythematosus (sometimes called lupus) or a connective tissue disease (an autoimmune disease that affects connective tissue).
If you suffer from swelling or irritation inside the nose
Do you suffer from chickenpox or shingles?
When giving this medicine to children and adolescents. As dehydrated children and adolescents are at risk of kidney damage, other medicines should be taken concomitantly with Profinal XP.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
 
You should tell your doctor or pharmacist if you are taking any of the following medicines:
Anticoagulant medicines (thinners/anticoagulants such as aspirin/acetylsalicylic acid, warfarin, clodipine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
Oral diuretics.
Cardiac glycosides, eg digoxin, which is used to treat heart problems.
lithium;
Zidovudine (an antiviral medicine).
Steroids (medicines used to treat infections).
methotrexate (a medicine used to treat certain types of cancer and rheumatoid arthritis).
Medicines known as immunosuppressants eg ciclosporin and tacrolimus (medicines used to reduce the body"s immune system reactions).
Medicines known as selective serotonin reuptake inhibitors, which are medicines used to treat depression.
Antibiotics belonging to the quinolone group, for example, ciprofloxacin.
Aminoglycosides (a type of antibiotic)
Mifepristone.
Any other products containing ibuprofen, such as those that you can buy without a prescription.
Any other nonsteroidal anti-inflammatory drug, including aspirin.
Cholestyramine (a medicine used to lower cholesterol in the blood).
Medicines known as sulfonylureas, for example glibenclamide (used to treat diabetes).
voriconazole or fluconazole (antifungal medicines).
Ginkgo biloba herbal preparation (there is a chance of bleeding more easily if you take this medicine together with ibuprofen).
 
Pregnancy and breastfeeding:
You should avoid taking Profinal XP during pregnancy or breastfeeding.
Profinal XP should not be taken during the last 3 months of pregnancy and should be taken during the first 6 months of pregnancy only if recommended by your doctor.
 
Driving and using machines:
Profinal XP may cause dizziness or drowsiness.
You should avoid driving, operating machinery, or performing any tasks that require alertness if such effects occur.
 
Provinal XP with food, drink and alcohol:
It is recommended to take Profinal XP either with or after a meal or milk in order to minimize the negative effects on the gastrointestinal tract.
You should not drink alcohol or drink excessively caffeinated beverages.
 
3. What is the method of using this product?
You must always take Profinal XP strictly according to your physician"s instructions.
Please consult your physician or pharmacist if you are not sure how to take this medicine.
This medicine is for oral use only.
The dose listed below should not be exceeded.
 
Dosage:
The recommended dose is one tablet 3 times daily.
This medicine is not recommended for use by children under 12 years of age.
 
If you take Profinal XP at a higher dose than you should:
You should contact your doctor or go to the emergency department of the nearest hospital immediately, and take your tablets with you.
If you miss the missed dose, take the missed dose as soon as possible if you remember, unless it is almost time for the next dose. It is recommended to continue with the dosing schedule without taking the missed dose.
You should not double the dose to make up for the single dose that you may have missed.
If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.
 
4. Possible side effects:
Like all medicines, Profinal XP can cause side effects, but not everybody gets them.
 
Side effects caused by ibuprof:
You should stop taking Profinal XP Tablets and seek medical advice immediately, if you experience any of the following:
Signs of aseptic meningitis eg severe headache, high fever, stiff neck or inability to tolerate bright light.
 
Signs of gastrointestinal bleeding for example:
bloody stools;
Black stools.
Vomiting blood or vomit that contains dark-colored particles similar to coffee beans.
 
Please tell your treating doctor and stop taking Profinal XP if you experience any of the following:
Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling unwell and/or vomiting.
Unexplained wheezing, shortness of breath, rash, itching or bruising (may be symptoms of an allergic reaction).
Yellowing of the eyes and/or skin (jaundice).
Severe sore throat accompanied by a high fever (this may be a symptom of a condition known as agranulocytosis).
Blurred or disturbed vision (low vision) or seeing/hearing strange things (hallucinations).
Fluid retention eg swollen ankles (this could be a sign of kidney problems).
Severe rash spreading over large areas of the body (Stevens-Johnson syndrome and erythema multiforme, symptoms include severe rash, skin ulcers, including inside the mouth, nose and genitals, and peeling of the skin that may be accompanied by Symptoms such as pain, headache, and high body temperature).
Some medicines, for example ibuprofen, may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.
Some medicines, for example ibuprofen, may be used in exceptional cases with the occurrence of severe skin problems in patients with chickenpox and herpes zoster. Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely when taking ibuprofen.
Very rarely, ibuprofen may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Ibuprofen has also been shown to sometimes cause a worsening of Crohn"s disease or colitis symptoms.
 
Other side effects:
Common (affect up to 1 in 10 people):
rash.
Feeling dizzy or tired.
Stomach pain, indigestion, diarrhoea, feeling unwell, malaise, wind, constipation.
a headache.
If this occurs while you are taking this medicine, it is important not to take other medicines that are used to relieve pain at the same time as this medicine.
Black stools.
bloody stools;
hematemesis;
 
Uncommon (affect up to 1 in 100 people):
feeling sleepy;
feeling anxious
Numbness or tingling feeling like pins and needles.
difficulty sleeping
hives, itching
The body becomes sensitive to light.
Vision disturbance, hearing problems.
Hepatitis, yellowing of the skin or eyes, liver function disorder.
Kidney function disorder, nephritis, kidney failure.
sneezing, stuffy nose, itchy or runny nose (rhinitis).
Stomach or intestinal ulcer, perforation of the gastrointestinal wall.
Inflammation of the stomach lining.
Small bruises appear on the skin or inside the mouth, nose or ear.
Difficulty breathing, wheezing or coughing, asthma, or worsening of asthma.
ringing in the ears;
Feeling dizzy or dizzy.
Oral ulcers.
Serious allergic reactions that lead to swelling of the face or throat.
 
Rare (affects up to 1 in 1,000 people):
Feeling depressed or confused.
Fluid retention (edema).
A brain infection known as "non-bacterial meningitis".
vision loss;
Changes in the blood count, where the initial symptoms that indicate this occurs include:
High temperature, sore throat, mouth sores, flu-like symptoms, feeling very tired, nose and skin bleeding.
Low blood count (anaemia).
Serious allergic reactions that lead to difficulty breathing or dizziness.
Severe sore throat accompanied by a high temperature (agranulocytosis).
 
Very rare (affects up to 1 in 10,000 people):
liver failure;
heart failure;
Heart attack.
pancreatitis.
Skin problems (which may involve the inside of the mouth, nose or ears) eg Stevens-Johnson syndrome or toxic epidermal necrolysis and erythema multiforme.
Hypertension is not known (the frequency of its occurrence cannot be estimated from the available data).
Exacerbation of ulcerative colitis or Crohn"s disease (colitis).
 
Caffeine side effects:
Nausea, headache, insomnia were reported.
Excessive consumption of caffeinated beverages can cause headache, flushing and symptoms of anxiety neurosis.
Taking high doses causes insomnia, irritability and expulsion of contractions.
Caffeine increases the amount of stomach secretions, causing stomach ulcers.
Please tell your doctor or pharmacist if any side effects occur, including any side effects not mentioned in this leaflet.
 
To report any side effects:
National Center for Pharmacovigilance and Safety
Fax number: +966-11-205-7662
Please contact the National Center for Pharmacovigilance and Safety at: +966-11-2038222
Tel: 2340-2334-2354-2353-2356-2317
Toll Free: 8002490000
Website: www.sfda.gov.sa/npc 5
 
How to store the preparation:
Keep out of reach and sight of children.
Profinal XP should not be taken after the expiry date which is stated on the pack and strip.
Store at a temperature below 30ºC.
You should not take Profinal XP if you notice visible signs of damage.
Medicines should not be disposed of via waste water (wastewater) or household waste.
Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
 
pharmacy :
Online Pharmacy - Taj Al Dawaa Pharmacy.
 
Trade Name:
Profinal XP 400 mg Tablet 20pcs.
 
The scientific name:
Ibuprofen - caffeine.
 
Category:
Over-the-counter medications.
 
For more information about Profinal XP 400 mg 20 tablets, please visit the Saudi Food and Drug Authority website.

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1. What is this preparation and what are the indications for its use?
Provinal XP provides powerful pain relief thanks to its ingredients that relieve pain in many different ways.
 
This medicine contains two active ingredients:
Ibuprofen: It is a non-steroidal anti-inflammatory compound that has anti-inflammatory, anti-rheumatic, analgesic and fever-reducing properties.
Caffeine: It enhances the effect of ibuprofen and speeds up its onset.
 
Profinal XP is used for the rapid relief of pain in the following cases:
It is used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still"s disease), arthritis of the spine (ankylosing spondylitis), joint swelling, frozen shoulder, synovial bursitis, tendinitis tenosynovitis, lower back pain, sprains and strains.
Profinal XP is also used to treat other conditions associated with pain such as toothache, post-operative pain, menstrual pain and headaches, including migraines.
 
2. WHAT YOU NEED TO KNOW BEFORE USING THIS PRODUCT:
Risks to the heart and blood vessels:
Non-steroidal anti-inflammatory drugs may increase the risk of serious heart and blood vessel clots, myocardial infarction, and stroke, which can lead to death. This risk may increase if this medicine continues to be taken for a long time, and this risk may be greater in patients with or at risk of developing cardiovascular disease.
Non-steroidal anti-inflammatory drugs should not be used to treat pain that occurs before or after coronary artery bypass graft surgery.
Risks to the gut: Non-steroidal anti-inflammatory drugs may increase the risk of serious adverse effects on the gut including bleeding, ulcers, and perforation of the stomach or intestines, which can lead to death. These effects may occur at any time while taking this medicine without the appearance of any warning symptoms. Elderly patients are often more likely to experience these serious effects.
 
This medicine should not be taken in the following cases:
If you are allergic to any of the active ingredients or any of the other ingredients in Profinal XP (listed in section 6).
If you are pregnant or breast-feeding a baby.
If you currently have a peptic ulcer (stomach or duodenal ulcer) or stomach bleeding, or have previously had two or more episodes of peptic ulcer, or have previously suffered from stomach bleeding or perforation.
If you have a problem that increases your risk of bleeding.
If you have asthma or have ever had an allergic reaction or have ever had wheezing after taking ibuprofen, aspirin or any other anti-inflammatory pain medication.
If you have a heart disorder, medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risks may increase with higher doses and longer treatment periods.
The recommended dosage amount or prescribed treatment period should not be exceeded.
 
Please consult your physician and pharmacist about your treatment before taking Profinal XP if you:
You have heart problems including heart failure, angina (chest pain) or have ever had a heart attack, peripheral artery disease (poor circulation in the legs or feet caused by narrowed or blocked arteries) or have previously had heart operations.
you suffer from a type of stroke or think you may be at risk of these conditions (eg if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol levels or are a smoker).
 
Warnings and precautions:
Please tell your doctor or pharmacist before taking Profinal XP:
If you suffer from a liver or kidney disorder.
If you have systemic lupus erythematosus (sometimes called lupus) or a connective tissue disease (an autoimmune disease that affects connective tissue).
If you suffer from swelling or irritation inside the nose
Do you suffer from chickenpox or shingles?
When giving this medicine to children and adolescents. As dehydrated children and adolescents are at risk of kidney damage, other medicines should be taken concomitantly with Profinal XP.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
 
You should tell your doctor or pharmacist if you are taking any of the following medicines:
Anticoagulant medicines (thinners/anticoagulants such as aspirin/acetylsalicylic acid, warfarin, clodipine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, or angiotensin II receptor antagonists such as losartan).
Oral diuretics.
Cardiac glycosides, eg digoxin, which is used to treat heart problems.
lithium;
Zidovudine (an antiviral medicine).
Steroids (medicines used to treat infections).
methotrexate (a medicine used to treat certain types of cancer and rheumatoid arthritis).
Medicines known as immunosuppressants eg ciclosporin and tacrolimus (medicines used to reduce the body"s immune system reactions).
Medicines known as selective serotonin reuptake inhibitors, which are medicines used to treat depression.
Antibiotics belonging to the quinolone group, for example, ciprofloxacin.
Aminoglycosides (a type of antibiotic)
Mifepristone.
Any other products containing ibuprofen, such as those that you can buy without a prescription.
Any other nonsteroidal anti-inflammatory drug, including aspirin.
Cholestyramine (a medicine used to lower cholesterol in the blood).
Medicines known as sulfonylureas, for example glibenclamide (used to treat diabetes).
voriconazole or fluconazole (antifungal medicines).
Ginkgo biloba herbal preparation (there is a chance of bleeding more easily if you take this medicine together with ibuprofen).
 
Pregnancy and breastfeeding:
You should avoid taking Profinal XP during pregnancy or breastfeeding.
Profinal XP should not be taken during the last 3 months of pregnancy and should be taken during the first 6 months of pregnancy only if recommended by your doctor.
 
Driving and using machines:
Profinal XP may cause dizziness or drowsiness.
You should avoid driving, operating machinery, or performing any tasks that require alertness if such effects occur.
 
Provinal XP with food, drink and alcohol:
It is recommended to take Profinal XP either with or after a meal or milk in order to minimize the negative effects on the gastrointestinal tract.
You should not drink alcohol or drink excessively caffeinated beverages.
 
3. What is the method of using this product?
You must always take Profinal XP strictly according to your physician"s instructions.
Please consult your physician or pharmacist if you are not sure how to take this medicine.
This medicine is for oral use only.
The dose listed below should not be exceeded.
 
Dosage:
The recommended dose is one tablet 3 times daily.
This medicine is not recommended for use by children under 12 years of age.
 
If you take Profinal XP at a higher dose than you should:
You should contact your doctor or go to the emergency department of the nearest hospital immediately, and take your tablets with you.
If you miss the missed dose, take the missed dose as soon as possible if you remember, unless it is almost time for the next dose. It is recommended to continue with the dosing schedule without taking the missed dose.
You should not double the dose to make up for the single dose that you may have missed.
If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.
 
4. Possible side effects:
Like all medicines, Profinal XP can cause side effects, but not everybody gets them.
 
Side effects caused by ibuprof:
You should stop taking Profinal XP Tablets and seek medical advice immediately, if you experience any of the following:
Signs of aseptic meningitis eg severe headache, high fever, stiff neck or inability to tolerate bright light.
 
Signs of gastrointestinal bleeding for example:
bloody stools;
Black stools.
Vomiting blood or vomit that contains dark-colored particles similar to coffee beans.
 
Please tell your treating doctor and stop taking Profinal XP if you experience any of the following:
Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling unwell and/or vomiting.
Unexplained wheezing, shortness of breath, rash, itching or bruising (may be symptoms of an allergic reaction).
Yellowing of the eyes and/or skin (jaundice).
Severe sore throat accompanied by a high fever (this may be a symptom of a condition known as agranulocytosis).
Blurred or disturbed vision (low vision) or seeing/hearing strange things (hallucinations).
Fluid retention eg swollen ankles (this could be a sign of kidney problems).
Severe rash spreading over large areas of the body (Stevens-Johnson syndrome and erythema multiforme, symptoms include severe rash, skin ulcers, including inside the mouth, nose and genitals, and peeling of the skin that may be accompanied by Symptoms such as pain, headache, and high body temperature).
Some medicines, for example ibuprofen, may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke.
Some medicines, for example ibuprofen, may be used in exceptional cases with the occurrence of severe skin problems in patients with chickenpox and herpes zoster. Blood disorders, kidney problems, liver problems or severe skin reactions may occur rarely when taking ibuprofen.
Very rarely, ibuprofen may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain).
Ibuprofen has also been shown to sometimes cause a worsening of Crohn"s disease or colitis symptoms.
 
Other side effects:
Common (affect up to 1 in 10 people):
rash.
Feeling dizzy or tired.
Stomach pain, indigestion, diarrhoea, feeling unwell, malaise, wind, constipation.
a headache.
If this occurs while you are taking this medicine, it is important not to take other medicines that are used to relieve pain at the same time as this medicine.
Black stools.
bloody stools;
hematemesis;
 
Uncommon (affect up to 1 in 100 people):
feeling sleepy;
feeling anxious
Numbness or tingling feeling like pins and needles.
difficulty sleeping
hives, itching
The body becomes sensitive to light.
Vision disturbance, hearing problems.
Hepatitis, yellowing of the skin or eyes, liver function disorder.
Kidney function disorder, nephritis, kidney failure.
sneezing, stuffy nose, itchy or runny nose (rhinitis).
Stomach or intestinal ulcer, perforation of the gastrointestinal wall.
Inflammation of the stomach lining.
Small bruises appear on the skin or inside the mouth, nose or ear.
Difficulty breathing, wheezing or coughing, asthma, or worsening of asthma.
ringing in the ears;
Feeling dizzy or dizzy.
Oral ulcers.
Serious allergic reactions that lead to swelling of the face or throat.
 
Rare (affects up to 1 in 1,000 people):
Feeling depressed or confused.
Fluid retention (edema).
A brain infection known as "non-bacterial meningitis".
vision loss;
Changes in the blood count, where the initial symptoms that indicate this occurs include:
High temperature, sore throat, mouth sores, flu-like symptoms, feeling very tired, nose and skin bleeding.
Low blood count (anaemia).
Serious allergic reactions that lead to difficulty breathing or dizziness.
Severe sore throat accompanied by a high temperature (agranulocytosis).
 
Very rare (affects up to 1 in 10,000 people):
liver failure;
heart failure;
Heart attack.
pancreatitis.
Skin problems (which may involve the inside of the mouth, nose or ears) eg Stevens-Johnson syndrome or toxic epidermal necrolysis and erythema multiforme.
Hypertension is not known (the frequency of its occurrence cannot be estimated from the available data).
Exacerbation of ulcerative colitis or Crohn"s disease (colitis).
 
Caffeine side effects:
Nausea, headache, insomnia were reported.
Excessive consumption of caffeinated beverages can cause headache, flushing and symptoms of anxiety neurosis.
Taking high doses causes insomnia, irritability and expulsion of contractions.
Caffeine increases the amount of stomach secretions, causing stomach ulcers.
Please tell your doctor or pharmacist if any side effects occur, including any side effects not mentioned in this leaflet.
 
To report any side effects:
National Center for Pharmacovigilance and Safety
Fax number: +966-11-205-7662
Please contact the National Center for Pharmacovigilance and Safety at: +966-11-2038222
Tel: 2340-2334-2354-2353-2356-2317
Toll Free: 8002490000
Website: www.sfda.gov.sa/npc 5
 
How to store the preparation:
Keep out of reach and sight of children.
Profinal XP should not be taken after the expiry date which is stated on the pack and strip.
Store at a temperature below 30ºC.
You should not take Profinal XP if you notice visible signs of damage.
Medicines should not be disposed of via waste water (wastewater) or household waste.
Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
 
pharmacy :
Online Pharmacy - Taj Al Dawaa Pharmacy.
 
Trade Name:
Profinal XP 400 mg Tablet 20pcs.
 
The scientific name:
Ibuprofen - caffeine.
 
Category:
Over-the-counter medications.
 
For more information about Profinal XP 400 mg 20 tablets, please visit the Saudi Food and Drug Authority website.
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