Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Adcock lngram Limited, Address, 1 New Road, Erand Gardens, Midrand, 1685 P.O. Box Private Bag X69 Bryanston 2021
If diarrhoea or skin rash appear, PONSTEL should be discontinued immediately. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolyis have been reported. PONSTEL should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with PONSTEL therapy. In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including PONSTEL, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.
The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of PONSTEL, in patients with a history of ulcers, and the elderly.
When gastrointestinal bleeding or ulceration occurs in patients receiving PONSTEL, treatment with PONSTEL should be stopped.
PONSTEL should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
Caution should be exercised in the administration of PONSTEL to patients suffering from dehydration and/or renal disease, particularly the elderly.
Bronchoconstriction may occur with mefenamic acid in asthmatic patients with aspirin sensitivity.
Mefenamic acid and its metabolites may give a false positive reaction to certain urine tests for the presence of bile.
Toxicity has also been seen in patients with prerenal condition leading to a reduction in renal blood flow or blood volume. Patients at greatest risk are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly.
Caution is required in patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) and should only be treated with mefenamic acid after careful consideration.
Regular use of NSAIDs such as PONSTEL during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased (see section 4.6).
Foetal Toxicity: Limit use of NSAIDs, including PONSTEL, between 20 and 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus.
If NSAID treatment is necessary between 20 weeks and 30 weeks gestation, limit PONSTEL use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if PONSTEL treatment extends beyond 48 hours. Discontinue PONSTEL if oligohydramnios occurs and follow up according to clinical practice (see section 4.3 and 4.6).
PONSTEL 250 contains lactose monohydrate
Patients with rare hereditary disorders such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
PONSTEL S contains sodium benzoate
This medicine contains 5 mg sodium benzoate in each 10 mL which is equivalent 0,5% m/v. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new-born babies (up to 4 weeks old) (see section 4.3).
PONSTEL S contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially ‘sodium-free’.
PONSTEL S contains ethanol
This medicine contains 0,025 mL of alcohol (ethanol) in each unit volume which is equivalent to 5% v/v. The small amount of alcohol in this medicine will not have any noticeable effects.
PONSTEL S contains sucrose
Patients with rare hereditary problems of fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take this medicine.
PONSTEL S contains sorbitol
This medicine contains 970 mg sorbitol in each 5 mL which is equivalent to 19,4% m/v. Patients with the rare hereditary condition of sorbitol/maltitol/lactitol intolerance should not take PONSTEL S.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Safety in pregnancy has not yet been established.
Regular use of non-steroidal anti-inflammatory drugs during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased (see section 4.3).
Use of NSAIDs, including PONSTEL, can cause premature closure of the foetal ductus arteriosus and foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the use of PONSTEL dose and duration between 20 and 30 weeks of gestation should be limited and avoided at around 30 weeks of gestation and later in pregnancy (see section 4.3 and 4.4).
Safety in lactation has not yet been established.
No data on male and female fertility is available.
No information available.
No information available.
| SYSTEM ORGAN CLASS | ADVERSE REACTIONS |
|---|---|
| Blood and lymphatic system disorders | Temporary lowering of the white blood cell count has occurred but does not appear to be dose-related. Blood counts should be performed at regular intervals during long term administration. Haemolytic anaemia may develop in patients taking PONSTEL continuously for extended periods. While this condition is generally reversible, death due to PONSTEL-associated haemolytic anaemia has been reported. Liver function tests must be carried out regularly to monitor elevation of enzymes and bilirubin. Other reported haematological effects include agranulocytosis, decreased hematocrit, leukopenia, eosinophilia, aplastic anaemia, pancytopenia, thrombocytopenia or thrombocytotopenic purpura and bone marrow aplasia. |
| Immune system disorders | Acute hypersensitivity reactions (urticaria, bronchospasm, anaphylaxis) have occurred. Because of the possibility of cross-sensitivity due to structural relationships which exist among nonsteroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Angioedema, oedema of the larynx, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), erythema multiforme, perspiration, urticaria, rash and facial oedema may occur. Occurrence of rash is a definite reason for stopping medication because exfoliative dermatitis has been reported on continued use after development of a rash. |
| Metabolism and nutrition disorders | Glucose intolerance in diabetic patients. |
| Nervous system disorders | Headache, drowsiness, dizziness, nervousness, convulsions, insomnia, visual disturbances and ear pain have been reported. |
| Cardiac disorders | Hypotension, palpitations, oedema, hypertension and cardiac failure. |
| Respiratory, thoracic and mediastinal disorders | Asthma, dyspnoea. |
| Gastrointestinal disorders | The most frequently reported side effects were gastrointestinal disturbances, and include: diarrhoea, nausea with or without vomiting and abdominal pain. Diarrhoea may occur within 24 hours following usual analgesic dosage. When diarrhoea occurs, the medication should be discontinued immediately. Serious gastro- intestinal toxicity such as bleeding, ulceration, and perforation can occur at any time with or without warning symptoms, sometimes fatal, in patients treated chronically with nonsteroidal anti-inflammatory agents. Elderly or debilitated patients seem unable to tolerate ulceration or bleeding as well as some other individuals; most spontaneous reports of gastro-intestinal events are in this population. Less frequently reported gastrointestinal side effects include: anorexia, pyrosis, flatulence, enterocolitis, colitis, steatorrhoea, cholestatic jaundice, hepatitis, pancreatitis, hepatorenal syndrome, mild hepatic toxicity, constipation and peptic ulceration with and without gastro-intestinal haemorrhage. Other gastrointestinal effects include: dyspepsia, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis. |
| Skin and subcutaneous tissue disorders | Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. |
| Renal and urinary disorders | Renal failure, allergic glomerulonephritis, papillary haematuria, dysuria and hyponatremia have occurred. There have been reports of acute interstitial nephritis with haematuria, proteinuria and occasionally, nephrotic syndrome. |
No information available.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions 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
No data available.
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