Fenamin Suspension

FENAMIN SUSPENSION contains mefenamic acid as an active substance. Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with antipyretic (helps against fever) and analgesic (pain-killing) properties.

FENAMIN SUSPENSION is used for the treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.

Do not take FENAMIN SUSPENSION:

• If you are hypersensitive (allergic) to or have had an allergic reaction to mefenamic acid or aspirin or other related painkillers (NSAIDs), or any other ingredient in FENAMIN SUSPENSION, (listed in section 6).
• If you have ever had symptoms of bronchospasm, allergic rhinitis, or urticaria after using a NSAID.
• If you have or ever had a stomach ulcer, perforation or bleeding due to the use of NSAIDs.
• If you have inflammatory bowel disease such as ulcerative colitis and Crohn’s disease (inflammatory conditions of the small intestine or colon).
• If you have epilepsy (a disorder that causes seizures).
• If you have a liver or kidney problem.
• If you have heart problems.
• If you have been treated for pain after coronary artery bypass graft (CABG) surgery.
• If you are pregnant, do not use NSAIDs at 20 weeks or later in your pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.

Warning and precautions

Special care should be taken with FENAMIN SUSPENSION if you:

• Are asthmatic or suffer from bowel problems, or any allergic reactions e.g., hay fever.
• Suffer from heart problems, have had a previous stroke or think that you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker).
• The elderly have an increased frequency of side effects to NSAIDs such as FENAMIN SUSPENSION, especially gastrointestinal bleeding and perforation (PUBs), which may be fatal.
• Suffer from a bleeding disorder.
• Are dehydrated or suffer from renal disease.
• If you suffer from fluid retention, as FENAMIN may make this worse.
• Tell your doctor or health care provider if you are pregnant or plan to become pregnant. Taking NSAIDs at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs around 30 weeks of pregnancy or later.
• Develop a fever, skin rash, swelling of the lymph nodes and/or swelling of the face. This is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Children

No information available.

Do not share medicines prescribed for you with any other person. Always take FENAMIN SUSPENSION exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. FENAMIN SUSPENSION must be taken with meals.

The usual adult dose is:

• Relief of mild to moderate pain: 500 mg three times a day.
• Acute pain: An initial dosage of 500 mg, thereafter 250 mg every 6 hours.

Children

The dosage for children is 25 mg per kg body-weight daily in divided doses.

• 6 months to 1 year: One medicine measure (5 ml), dose may be repeated up to three times a day.
• 2 years to 4 years: Two medicine measures (10 ml), dose may be repeated up to three times a day.
• 5 years to 8 years: Three medicine measures (15 ml), dose may be repeated up to three times a day.
• 9 years to 12 years: Four medicine measures (20 ml), dose may be repeated up to three times a day.

FENAMIN SUSPENSION should not be given for longer than 5 days.

If you take more FENAMIN SUSPENSION than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take FENAMIN SUSPENSION

Take your missed dose as soon as you remember, if within a few hours after missing a dose. If you only remember about the missed dose the following day, do not take a double dose to make up for the forgotten dose.

FENAMIN SUSPENSION can have side effects. Not all side effects reported for FENAMIN SUSPENSION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FENAMIN SUSPENSION, please consult your healthcare provider for advice.

If any of the following happens, stop taking FENAMIN SUSPENSION and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash and itching;
• severe skin reactions.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FENAMIN SUSPENSION. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Pass blood in your faeces (stools);
• pass black tarry stools;
• vomit any blood or dark particles that look like coffee grounds;
• unexplained wheezing, shortness of breath, or bruising;
• hallucinations;
• medicines such as FENAMIN SUSPENSION have been associated with a small increased risk of heart attack (myocardial infarction) or stroke;
• blood disorders, kidney problems, liver problems may occur rarely with FENAMIN SUSPENSION;
• FENAMIN SUSPENSION has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Diarrhoea, feeling sick and/or vomiting, unexplained stomach pain or other abnormal stomach symptoms.

Less frequent side effects:

• Seeing/hearing strange things;
• fluid retention (e.g., swollen ankles);
• headache, dizziness;
• constipation, flatulence (wind).

The following side effects have been reported but the frequency is unknown:

• Indigestion, heartburn;
• blurred or disturbed vision.
• blistering of the skin.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FENAMIN SUSPENSION. May also report to Adcock Ingram Pharmacovigilance department by using the following email: [email protected], or fax to +27 86 553 0128 or call 011 635 0134.

Store in a cool dry place at or below 25 °C. Protect from light. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets). Keep in original packaging until required for use. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.