Stopadol Extra 20 tablets

Stopadol Extra 20 tablets

Composition:

Paracetamol 500mg + Caffeine anhydrous 65mg

Inactive ingredients:

Pregelatinized starch, Maize starch, Povidone (K 90), Sodium starch glycolate, Stearic acid, Sodium bicarbonate, Microcrystalline cellulose (PH 102), Kollidon Cl, Sodium lauryl sulfate, Anhydrous colloidal silica, Magnesium stearate, Ethanol 96%,

Opadry white.

Description:

Pharmacodynamic properties: The combination of paracetamol and caffeine is a well-established analgesic combination. 

Properties:

Relieves headache

Effective analgesic

Antipyretic

Gentle on stomach

Easy to swallow

Indications:

A mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and the relief of the symptoms of colds, influenza and sore throat.

Dosage and Method of administration:

Oral use. Adults (including the elderly), and children aged 16 years and over: Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours. Children aged 12-15 years: One tablet up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years.

Contraindications:

Hypersensitivity to paracetamol, caffeine or any of the other constituents.

Precautions:

Do not exceed the stated dose. Contains paracetamol.

Do not use any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose.

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non- cirrhotic alcoholic liver disease. Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis. Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product. If symptoms persist, medical advice must be sought. 

Pregnancy:

Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption. 

Lactation:

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants. Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

Side Effects:

Blood and lymphatic system disorders: thrombocytopenia, agranulocytosis.

Immune system disorders: Very rare cases of serious skin reactions have been reported, anaphylaxis, cutaneous hypersensitivity reactions including (amongst others) skin rashes and angioedema.

Respiratory, thoracic and mediastinal disorders: bronchospasm- more likely in patients sensitive to aspirin and other NSAIDs. Hepatobiliary disorders: hepatic dysfunction. 

Paracetamol / Caffeine: When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects. Central nervous system: dizziness, headache. 

Cardiac disorders: palpitation. 

Psychiatric disorders: insomnia, restlessness, anxiety and irritability.

Gastrointestinal disorders: gastrointestinal disturbances.

Storage:

Store in a dry place, at a temperature not exceeding 30°C. 

Keep out of the reach of children.

Package:

Carton box containing 2 (blisters each of 10 film coated tablets and instruction.