Dr Du Toitã•S Pain Expeller 300 mg Tablets

Effective for the relief of pain of moderate intensity.

Use the lowest effective dose for the shortest possible duration of treatment.

Posology

ADULTS: One or two tablets three times a day with water.

Method of administration

Dr Du Toitu2019s Pain Expeller tablets can be dissolved in water, or if preferred, on the tongue.

• Hyper sensitivity to aspirin, or to any of the excipients in Dr Du Toitu2019s Pain Expeller
• Heart failure
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including Dr Du Toitu2019s Pain Expeller
• Active or history of recurrent ulcer, haemorrhage or perforations
• Severe renal impairment
• Concomitant oral anti-coagulant therapy
• Haemophilia
• Pregnancy and lactation (see section 4.6)
• Not to be used in children under the age of 12 years (see section 4.4).

Do not use continuously for longer than ten days without consulting your doctor. Not for children under 12 years of age (see section 4.3).

Heart conditions:

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 Dr Du Toitu2019s Pain Expeller therapy. In view of the Dr Du Toitu2019s Pain Expelleru2019s 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 Dr Du Toitu2019s Pain Expeller, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.

Gastrointestinal perforation, ulceration or bleeding (PUBs):

The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of Dr Du Toitu2019s Pain Expeller, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving Dr Du Toitu2019s Pain Expeller, treatment with Dr Du Toitu2019s Pain Expeller should be stopped.

Dr Du Toitu2019s Pain Expeller should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastroesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.

Dr Du Toitu2019s Pain Expeller should be stopped several days before scheduled surgical procedures because of the possibility of increased bleeding times.

Hypersensitivity reactions:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Dr Du Toitu2019s Pain Expeller should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity including paroxysmal bronchospasm and dyspnoea. Dr Du Toitu2019s Pain Expeller should not be used in patients with asthma or allergic disorders. It should not be given to patients with a history of sensitivity reactions to aspirin or to other NSAIDs, including those in whom attacks of asthma, angioedema, urticaria, or rhinitis have been precipitated by such medicines (see section 4.3).

Pregnancy:

Regular use of NSAIDs such as Dr Du Toitu2019s Pain Expeller 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. The use of Dr Du Toitu2019s Pain Expeller around 20 weeks of gestation or later in pregnancy may cause foetal renal dysfunction, which may progress to renal failure with oligohydramnios, and in some cases neonatal renal impairment. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation.

Reyeu2019s Syndrome:

Aspirin as contained in Dr Du Toitu2019s Pain Expeller has been implicated in Reye's syndrome, a rare but serious illness in children and teenagers with chickenpox and influenza. A doctor should be consulted before Dr Du Toitu2019s Pain Expeller is used in such patients.

General:

High doses of Dr Du Toitu2019s Pain Expeller may precipitate acute haemolytic anaemia in patients with G6PD deficiency. Aspirin such as Dr Du Toitu2019s Pain Expeller should be administered with caution to patients with impaired renal function, dyspepsia, anaemia and when the patient is dehydrated.

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 diclofenac after careful consideration.

Dr Du Toitu2019s Pain Expeller contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Dr Du Toitu2019s Pain Expeller Tablets. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Dr Du Toitu2019s Pain Expeller Tablets and evaluate the patient immediately.

NSAIDs:

The use of two or more NSAIDs concomitantly could result in an increase in side effects. The plasma concentrations of some other NSAIDs, for example fenbufen, indomethacin and piroxicam, may be decreased when given concomitantly with Dr Du Toitu2019s Pain Expeller.

Corticosteroids:

Concomitant treatment with corticosteroids may increase the risk of gastrointestinal perforation, ulceration or bleeding (PUBs). Corticosteroids may reduce plasma-salicylate concentrations. Conversely, salicylate toxicity may occur if corticosteroids are withdrawn.

Anti-coagulants:

Dr Du Toitu2019s Pain Expeller may enhance the effects of anti-coagulants such as warfarin.

Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs):

Increased risk of gastrointestinal bleeding.

Others:

Antacids may increase the excretion of aspirin, as in Dr Du Toitu2019s Pain Expeller, in alkaline urine. Dr Du Toitu2019s Pain Expeller inhibits the effect of uricosurics such as probenecid and sulfinpyrasone and may alter the efficacy of mifepristone. Dr Du Toitu2019s Pain Expeller may increase the activity of sulfonylurea hypoglycaemic medicines, zafirlukast, methotrexate, phenytoin and valproate. Use of Dr Du Toitu2019s Pain Expeller with medicines such as dipyridamole, metoclopramide, metoprolol and carbonic anhydrase inhibitors may result in increased plasma-salicylate concentrations. Barbiturates and other sedatives may mask the respiratory symptoms of Dr Du Toitu2019s Pain Expeller overdosage and have been reported to enhance its toxicity. Alcohol may exacerbate the gastrointestinal effects of Dr Du Toitu2019s Pain Expeller.

Interference with laboratory tests:

Dr Du Toitu2019s Pain Expeller may produce falsely increased results for blood creatinine, urate (low dose aspirin) and urea. Falsely decreased results may be obtained for blood thyroxine and urate (> 4 g/day aspirin) and for urinary 5-HIAA (with nitrosonaphthol method). Urinary VMA (HMMA) levels may be falsely increased or decreased depending on the method of analysis. Urinary glucose oxidase: Dr Du Toitu2019s Pain Expeller may cause a false negative test in the presence of glycosuria.

Dr Du Toitu2019s Pain Expeller is contraindicated during pregnancy and lactation.

Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) 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. The administration of Dr Du Toitu2019s Pain Expeller around 20 weeks or later in pregnant patients may cause foetal renal dysfunction, which may progress to renal failure with oligohydramnios, and in some cases neonatal renal impairment (see 4.3 & 4.4).

None known.

Side effects of Dr Du Toitu2019s Pain Expeller treatment are listed below. The frequencies of these reported side effects are unknown.

Blood and lymphatic system disorders

Increased bleeding time decreased platelet adhesiveness. Prolonged use in high doses may lead to hypoprothrombinaemia and other blood disorders including thrombocytopenia.

Immune system disorders

Hypersensitivity reactions, including skin eruptions, urticaria, angioedema, rhinitis, paroxysmal bronchospasm and dyspnoea.

Nervous system disorders

Dizziness

Cardiac disorders

Oedema, hypertension and cardiac failure

Gastrointestinal disorders

The most frequently observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohnu2019s disease, gastritis.

Hepato-biliary disorders

Hepatotoxicity, especially in patients with juvenile idiopathic arthritis or other connective tissue disorders.

Skin and subcutaneous tissue disorders

Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (see section 4.4).

Respiratory, thoracic and mediastinal disorders

Bronchospasm, asthma attacks.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf

Symptoms include dizziness, tinnitus, deafness, sweating, nausea, headache, vomiting and mental confusion. Symptoms of more acute or severe intoxication following overdose include hyperventilation, fever, ketosis, respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma, cardiovascular collapse or respiratory failure. In children drowsiness and metabolic acidosis commonly occur, hypoglycaemia may be severe. In cases of overdosage consult a doctor immediately. Gastric lavage, fluid and electrolyte management is the mainstay of treatment with the immediate aim being correction of acidosis, hyperpyrexia, hypokalaemia and dehydration. Salicylate remaining in the stomach may be adsorbed by activated charcoal. Alkaline diuresis, haemodialysis or haemoperfusion are effective methods of removing salicylate from the plasma.