Ponac Forte 500 mg Tablets

PONAC FORTE contains mefenamic acid. Mefenamic acid belongs to a group of medicinal products called non-steroidal anti-inflammatory medicines (NSAIDs). PONAC FORTE is used for the relief of acute and mild to moderate pain and can also be used for primary dysmenorrhoea (painful cramps during menstruation).

Do not take PONAC FORTE

• if you are allergic (hypersensitive) to mefenamic acid or any of the other ingredients of PONAC FORTE (listed in section 6).
• if you have or are taking other non-steroidal anti-inflammatory medicine and have experienced symptoms of bronchospasm (spasmodic contraction of the muscular lining of the bronchi, as in asthma, causing difficulty in breathing), allergic rhinitis (referred to as hay fever, is an inflammation of the nasal passages) or urticaria (a skin condition characterised by welts that itch intensely).
• if you have a history of gastrointestinal (stomach) perforation, ulceration or bleeding (PUBs).
• if you have an active or history of recurrent ulcer / haemorrhage (bleeding) / perforations.
• if you have chronic inflammation of either the upper or lower gastrointestinal tract (the path that food follows once it is in the stomach).
• if you suffer from epilepsy (fits or seizures, uncontrolled shaking of the body).
• if you have impaired hepatic (liver) or renal (kidney) function.
• if you have heart failure (a condition in which the heart has lost the ability to pump enough blood to the body’s tissues and organs which may result in organ failure).
• if you require treatment for pain after coronary artery bypass graft (CABG) surgery.
• if you are pregnant, do not use NSAIDs, such as PONAC FORTE, from 20 weeks or later in your pregnancy or when breastfeeding your baby.

Warnings and special precautions

Take special care with PONAC FORTE

• if you are elderly, because you may be more susceptible to gastrointestinal (stomach) perforation, bleeding and ulceration which may be fatal.
• if you suffer from asthma or allergic reactions such as hay fever.
• if you suffer from impaired heart, kidney or liver function, are elderly or taking diuretics (also called water pills, which help rid your body of salt (sodium) and water). Your doctor will monitor your condition by taking regular blood tests and may adjust your dose.
• if you are taking warfarin (drug used to thin the blood), because PONAC FORTE may result in your blood becoming too thin.
• if you have a history of high blood pressure, PONAC FORTE may result in oedema (excessive build-up of fluid in the tissues, often causes swelling in the feet and ankles) which may precipitate heart failure.
• if you 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), PONAC FORTE may make these conditions worse.

Do not share medicines prescribed for you with any other person. Always take PONAC FORTE exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will tell you how long your treatment with PONAC FORTE will last. PONAC FORTE must be taken with meals.

The usual dose for adults is:

Mild to moderate pain

500 mg three (3) times a day.

Acute pain

500 mg initial dose followed by 250 mg every six (6) hours for a maximum treatment period of five (5) days.

Primary dysmenorrhoea (painful cramps during menstruation)

500 mg three (3) times a day for a maximum treatment period of three (3) days.

In the elderly and patients with kidney or liver problems, your doctor may want to monitor you more closely. No change in dose is needed. If you have the impression that the effect of PONAC FORTE is too strong or too weak, tell your doctor or pharmacist.

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• Rash or itching,
• Fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to PONAC FORTE. 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:

• Frequent Diarrhoea.
• Nausea with or without vomiting.
• Abdominal pain.

Less frequent

• Anorexia (lack or loss of appetite for food).
• Heartburn.
• Flatulence.
• Enterocolitis (inflammation of the small intestine and colon).
• Colitis (inflammation of the inner lining of the colon).
• Steatorrhoea (abnormal quantities of fat in faeces).
• Cholestatic jaundice (yellowish discolouration of the whites of the eyes, skin and mucous membranes).
• Hepatitis (inflammation of the liver).
• Pancreatitis (inflammation of the pancreas).
• Hepato-renal syndrome (progressive kidney failure seen in people with severe liver damage).
• Mild liver toxicity.
• Constipation.
• Peptic ulceration (open sores that develop on the inside lining of your stomach and the upper portion of your small intestine).
• Perforation with or without gastrointestinal bleeding.
• Haemolytic anaemia (occurs when destruction of red blood cells is faster than the bone marrow’s production of these cells).
• Decreased haematocrit (decreased volume percentage of red blood cells in blood, measured as part of a blood test).
• Leukopenia (a reduction in the number of white cells in the blood).
• Eosinophilia (an increase in the number of eosinophils (white blood cells containing granules that are readily stained by eosin) in the blood).
• Thrombocytopenia (deficiency of platelets in the blood) or thrombocytopenic purpura (autoimmune disorder where the immune system destroys platelets and sometimes impair their production).
• Agranulocytosis (a deficiency of granulocytes (white blood cell with secretory granules in its cytoplasm) in the blood, causing increased vulnerability to infection).
• Aplastic anaemia (deficiency of all types of blood cells).
• Bone marrow aplasia (disease in which the red bone marrow disappears and consequently ceases the production of white blood cells, platelets, and red blood cells).
• Acute hypersensitivity reactions including urticaria (a skin condition characterised by welts that itch intensely), bronchospasm (spasmodic contraction of the muscular lining of the bronchi, as in asthma, causing difficulty in breathing) and anaphylaxis (acute allergic reaction to an antigen).
• Glucose intolerance in diabetic patients.
• Hyponatraemia (low blood sodium or salt deficiency).
• Nervousness.
• Drowsiness.
• Dizziness.
• Headache.
• Visual disturbances.
• Convulsions (uncontrollable muscle contractions).
• Insomnia (sleeplessness).
• Ear pain.
• Palpitations (noticeably rapid, strong, or irregular heartbeat).
• Oedema (excessive build-up of fluid in the tissues, often causes swelling in the feet and ankles).
• Hypertension (high blood pressure).
• Heart failure (a condition in which the heart has lost the ability to pump enough blood to the body’s tissues and organs which may result in organ failure).
• Hypotension (low blood pressure).
• Asthma.
• Dyspnoea (difficulty in breathing).
• Angioedema (swelling in the deep layers of the skin).
• Oedema of the larynx (an abnormal accumulation of fluid and swelling in the tissues of the voice box).
• Steven-Johnson syndrome (rare, serious disorder of the skin and mucous membranes causing flu-like symptoms followed by a painful rash that spreads and blisters).
• Lyell’s syndrome (toxic epidermal necrolysis)/
• Erythema multiforme (acute, self-limiting skin eruption characterised by a typical target lesion).
• Sweating.
• Severe itching of the skin.
• Facial oedema (swelling of the face due to fluid build-up).
• Kidney failure.
• Papillary necrosis (kidney disorder in which all or part of the renal papillae die. The renal papillae are the areas where the openings of the collecting ducts enter the kidney and where urine flows into the uterus).
• Acute interstitial nephritis (a pattern of kidney injury usually associated with an abrupt deterioration of kidney function) with blood in the urine.
• Painful urination.
• Proteinuria (protein in the urine).
• Allergic glomerulonephritis (acute inflammation of the kidney caused by an immune response).
• Frequency unknown
• Hypokalaemia (low levels of potassium in your blood)
• Indigestion.
• Black, tarry stools.
• Vomiting of blood.
• Sore or inflammation inside of the mouth.
• Crohn’s disease (inflammation of the digestive tract, which can lead to abdominal pain, fatigue, severe diarrhoea and weight loss).
• Inflammation of the lining of the stomach.
• Bullous reactions (reactions that result in fluid-filled blisters).
• Nephrotic syndrome (kidney disorders that causes the body to pass too much protein in the urine).
• Renal tubular acidosis (the kidneys are damaged and can't remove a waste, called acid, from the blood.)
• Elevation in blood urea.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. 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/ By reporting side effects, you can help provide more information on the safety of PONAC FORTE.

Store all medicines out of reach of children.

• Store in a cool dry place at or below 25 °C.
• Keep the blisters in the carton until required for use.
• Keep in the original container.
• Protect from light / moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label / carton / bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).