Marble House, 1 Crystal Glass Close, Amuwo-Odofin Industrial Estate, Lagos, Nigeria
Tel: 08023526222, 08094109185
PHAMATEX INDUSTRIES LIMITED Marble House, 1 Crystal Glass Close, Amuwo-Odofin Industrial Estate, Lagos, Nigeria.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet(NRN: B4-2965): Each tablet of ACECLOFEN contains 100 mg of Aceclofenac.
Pack size: ACECLOFEN tablets: 10 x 10 blistered tablets in one packet with a leaflet. Each dark pink, round, film-coated tablet engraved with 'PIL' on one side is plain on the other side.
ACECLOFEN is the glycolic acid ester of diclofenac. It is an orally administered phenylacetic acid derivative with analgesic and anti-inflammatory properties. As a cytokine inhibitor, ACECLOFEN exhibits a higher anti-inflammatory action than conventional non-steroidal anti-inflammatory drugs (NSAIDs).
MODE OF ACTION:
ACECLOFEN works by blocking the action of cyclo-oxygenase. Cyclo-oxygenase is involved in the production of prostaglandins which cause pain, swelling and inflammation.
ACECLOFEN is used to relieve pain and inflammation in patients suffering from:
• Rheumatoid arthritis.
• Ankylosing spondylitis.
Do not take ACECLOFEN if you:
• Are allergic or hypersensitive to aceclofenac or other NSAIDs.
• Are pregnant; unless considered essential by your physician.
• Are suffering from active peptic ulcer.
• Suffer from severe heart, liver or kidney failure.
PREGNANCY AND LACTATION:
Do not take ACECLOFEN if you plan to become pregnant because ACECLOFEN therapy may make it more difficult for you to become pregnant.
Do not take ACECLOFEN if you are pregnant.
ACECLOFEN is excreted into human breast milk.
Use by nursing mothers is not recommended.
PRECAUTIONS AND WARNING:
Check with your doctor or pharmacist before taking ACECLOFEN. Take special care with ACECLOFEN if:
• You suffer from asthma or any other breathing problems.
• You have experienced stomach pain, vomiting of blood or heart-burn after taking aspirin or other
• You suffer from any form of kidney or liver disease. You suffer from any blood-clotting problems.
• You have recently undergone a major surgery. As a precaution, you should refrain from driving or operating machinery if you feel dizzy or sleepy after ACECLOFEN therapy.
As with all medicines, ACECLOFEN may cause side effects although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects not listed in this leaflet, please tell your physician or pharmacist.
You can minimize the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms. The following are possible side effects associated with ACECLOFEN therapy:
• Increased risk of myocardial infarction and stroke. The risk is more likely with high doses and prolonged treatment; so do not exceed the recommended dosage.
• Symptoms of allergic reaction and anaphylactic shock like difficulty in breathing, wheezing, abdominal pain, diarrhea and vomiting.
• Swelling of the face.
• Black tarry stools and bloody stools.
• Heartburn and indigestion.
• Kidney failure.
Dosage & Administration
Always take ACECLOFEN exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Continue to take the tablets for as long as your doctor recommends but do not take more than the recommended dose. If symptoms persist for more than 3 days, consult your doctor or pharmacist.
The tablets should be taken with food and swallowed whole with sufficient quantity of liquid.
Children - ACECLOFEN is not recommended for use in patients under the age of 18.
Adults - The recommended dosage is 200 mg daily. One 100 mg tablet should be taken in the morning and one in the evening.
Elderly - Elderly patients are more likely to experience serious side effects associated with ACECLOFEN therapy. The lowest effective dose is recommended over the shortest duration.
If you have taken more ACECLOFEN than has been prescribed for you or someone else accidentally ingests your medicine, immediately see a physician or go to a hospital straight away. Take the leaflet, the remaining tablets and packet with you to the hospital so they know which tablets were consumed.
Local treatment of overdose includes emptying of the stomach by induced vomiting or gastric lavage. Careful monitoring and supportive treatment, monitoring of renal function, and maintaining adequate hydration is recommended.
Keep all medicines out of the reach of children. Do not store above 25 degrees centigrade.
Protect from direct sunlight and store in a cool, dry place. Ask your pharmacist how to dispose of medicines no longer required or have expired.