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Diclofenac sodium (the active ingredient in Rofenac) belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to reduce pain and inflammation.
Product Description:
Directions for Use:
Your doctor will tell you how many Rofenac tablets to take and when to take them. Follow your doctor's instructions carefully.
If you are unsure, ask your doctor or pharmacist. Use Rofenac for the duration your doctor has told you to, unless you experience any problems, in which case consult your doctor.
Taking Rofenac with food and drink:
Take the tablets before or with food.
Take the tablet with a full glass of water. Do not crush or chew the tablet, as this will affect its effectiveness.
The usual doses are:
Adults:
100–150 mg per day, divided into two or three doses. The number of tablets you take will vary depending on the strength your doctor prescribes.
Elderly:
Your doctor will advise you to take the medication at a lower dose than usual if you are elderly. Your doctor may also order a thorough examination to ensure that Rofenac does not affect your stomach.
These tablets are not suitable for children.
Your doctor may prescribe another medication to protect your stomach at the same time, especially if you have previously suffered from stomach problems, are elderly, or are taking certain medications.
Warnings and Precautions:
Do not take Rofenac if:
• You think you may be allergic to diclofenac sodium, aspirin, ibuprofen, any other NSAID, or any of the other ingredients of Rofenac (listed at the end of this leaflet). Symptoms of hypersensitivity include swelling of the face and mouth, breathing problems, runny nose, itchy skin, or any other type of allergic reaction.
• You have or have had a stomach or duodenal ulcer, or gastrointestinal bleeding (which may cause blood in vomit, bleeding during bowel movements, blood in the stool, or black, tarry stools).
• You have experienced stomach or intestinal problems after taking another NSAID.
• You have severe heart, kidney, or liver failure.
• If you are more than six months pregnant (see the section on pregnancy and breastfeeding).
• Ischemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease
• Congestive heart failure (New York Heart Association [NYHA] Class IV-II)
You should be careful when taking Rofenac:
• If you have any stomach or intestinal conditions, including ulcerative colitis or Crohn's disease
• If you have kidney or liver problems, or if you are elderly
• If you have porphyria
• If you have any blood or bleeding problems, your doctor may ask you to have regular checkups while taking this medicine
• If you have ever had asthma
• If you are breastfeeding
• If you have heart problems, have had a stroke, or if you think you are at risk for these conditions (such as if you have high blood pressure, diabetes, or cholesterol, or if you (Smoker)
• If you suffer from lupus or a similar condition.
Diclofenac treatment should be initiated after careful evaluation of patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes, and smoking).
The cardiovascular risk of diclofenac may increase with dose and duration of exposure. Therefore, it should be used for the shortest possible time and at the lowest effective daily dose. The patient's need for symptomatic relief and response to treatment should be periodically reassessed.
Based on post-marketing reports, cases of hepatotoxicity associated with the drug (occurring within the first month of use or during any other period) have been reported, including severe liver reactions such as hepatic necrosis, jaundice, hepatitis with or without jaundice, or liver failure. Some of these cases have led to death or the need for liver transplantation.
Healthcare professionals should periodically monitor patients' liver enzymes, especially transaminases, and begin testing within 4–8 weeks of starting treatment.
Possible Risks to the Cardiovascular System:
All NSAIDs are likely to increase the risk of blood clots, myocardial infarction, and stroke. These conditions can be fatal. The risk increases with the duration of use of these products. Patients with circulatory system diseases or those at increased risk of developing circulatory system diseases are more susceptible to the above-mentioned conditions.
All forms of diclofenac should not be used to treat pain associated with coronary artery bypass surgery (CABG) before, during, and after surgery.
Gastrointestinal Risk:
All NSAIDs increase the risk of gastrointestinal complications, including inflammation, bleeding, ulcers, and perforation of the stomach and small intestine, which can be fatal.
These complications can occur at any time during use and without any prior warning signs.
Elderly patients are more susceptible to the above-mentioned gastrointestinal effects.
Ingredients:
Diclofenac sodium 50 mg
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