SCOPINAL SYRUP 100 ML

1. What this product is and what it is used forScopinal syrup contains a medicine called “Hyoscine-N-butylbromide”. This belongs to a group of medicines called “antispasmodics”.Scopinal syrup is used to relieve cramps in the muscles of your:• Stomach• Gut (intestine)• Bladder and the tubes that lead to the outside of your body (urinary system)It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).2. What you need to know before you use this product Do not take Scopinal syrup if:• You are allergic (hypersensitive) to hyoscine-N- butylbromide or any of the other ingredients (listed in section 6)• You have glaucoma (an eye problem)• You have something called “myasthenia gravis” (a very rare muscle weakness problem)• You have a suspected or confirmed blockage of the bowel• You have a condition where the bowel is blocked and does not work properly (paralytic or obstructive ileus). Symptoms include severe abdominal pain with lack of stools and/or nausea/vomiting• You have a very enlarged bowel (megacolon)• You are pregnant, likely to get pregnant, or are breast-feedingDo not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.Take special care with Scopinal syrupCheck with your doctor or pharmacist before taking your medicine if:• You have a very fast heart rate or other heart problems• You have a problem with your thyroid gland such as an overactive thyroid gland such as an overactive thyroid gland• You have difficulty or pain passing water (urine) such as men with prostate problems• You have constipation• You have a feverIf you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Scopinal syrup.Check with your doctor or pharmacist straight away if you have unexplained abdominal pain which persists or worsens or occurs with:• fever• feeling sick• being sick• changes in your bowel movements• abdominal tenderness• low blood pressure• feeling faint or,• blood in your bowel movementsTaking other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Scopinal syrup can affect the way some other medicines work. Also some other medicines can affect the way Scopinal syrup work.In particular, tell your doctor or pharmacist if you are taking any of the following:• Medicines for depression called “tetracyclic antidepressants” or “tricyclic antidepressants” such as doxepin• Medicines for allergies and travel sickness called “antihistamines”• Medicines to control your heart beat such as quinidine or disopyramide• Medicines for severe mental illness called ‘antipsychotics’ such as haloperidol or fluphenazine• Medicines usually used for breathing problems such as tiotropium, ipratropium or atropine-like medicines• Amantadine - for Parkinson’s disease and flu• Metoclopramide - for feeling sick (nausea)If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Scopinal syrup.Pregnancy and breast-feedingDo not take Scopinal syrup if you are pregnant, likely to get pregnant or are breast-feeding.Driving and using machinesSome people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.Important information about some of the ingredients of Scopinal syrupScopinal syrup contains:• Sucrose and sorbitol. Talk to your doctor before taking this medicine if they have told you that you cannot tolerate or digest some sugars.• Methyl and propyl paraben. These substances may trigger allergic reactions (possibly delayed).  3. How to use this product.Always take your medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.How much to takeSmooth muscle spasm•   Adults and children over 12 years: 4 teaspoonfuls (20mg) 4 times daily.•   Children 6 - 12 years: 2 teaspoonfuls (10mg) 3 times daily.Irritable bowel syndrome:•   Adults and children over 12 years: 2 teaspoonfuls (10mg) 3 times daily, increased if required up to 4 teaspoonfuls (20mg) 4 times daily.Excessive respiratory secretions and Bowel colic in palliative care•   Children 12 – 18 years: 2 - 4 teaspoonfuls (10mg-20mg) 3 – 4 times daily.•   Children 5 - 12 years: 2 teaspoonfuls (10mg) 3 - 4 times daily.•   Children 2 - 5 years: 1 teaspoonful (5mg) 3 - 4 times daily.•   1 month - 2 years: 300-500 micrograms/kg (maximum 5mg) 3 - 4 times daily.If you take more Scopinal syrup than you shouldIf you take more Scopinal syrup than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you even if there is no Scopinal syrup left.If you forget to take Scopinal syrupIf you forget a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose.Do not take a double dose to make up for a forgotten dose.4. Possible side effectsLike all medicines, Scopinal syrup can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.Stop taking your medicine and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:• Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than 1 in 100 people), rash, redness of the skin• Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feeling faint or dizzy (shock)• Painful red eye with loss of visionOther side effects• Dry mouth (affects fewer than 1 in 100 people)• Small blisters on hands and feet (affects fewer than 1 in 100 people)• Increased heart rate (affects fewer than 1 in 100 people)• Being unable to pass water (urine) (affects fewer than 1 in 1,000 people)If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. To report any side effect(s):The National Pharmacovigilance and Drug Safety Center (NPC)Fax: +966-11-205-7662Call NPC at +966-11-2038222, Exts: 2317-2356-2340Reporting Hotline: 19999E-mail: [email protected]: www.sfda.gov.sa/npc5. How to store this product- Keep out of the reach and sight of children.- Do not use this medicine after the expiry date which is stated on the carton and on the inner label.- Store below 30°C, protect from light. After opening use within one month- Do not use this medicine if you notice any visible sign of deterioration.- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.