SOLPAPAIN

Posology Adults and adolescents 16 years and over:

Two tablets every 4-6 hours up to four times daily. Do not exceed 4 doses, equivalent to 8 tablets in 24 hours. Do not take more frequently that every 4 hours. 9) Adolescents 12 to 15 years of age: One tablet every 4-6 hours up to four times daily.

Do not exceed 4 tablets in 24 hours. Do not take more frequently that every 4 hours.

Children aged under 12 years:

Not recommended for children under 12 years.

Elderly:

Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing Renal impairment: Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.

It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours. 4).

Hepatic impairment:

Patients who have been diagnosed with hepatic impairment or Gilbert’s Syndrome must seek medical advice before taking this medication. 4). Method of Administration Solpadeine Headache Soluble Tablets are for oral administration only.

Solpadeine Headache Soluble Tablets should be dissolved in at least half a tumblerful of water. 9). Minimum dosing interval: 4 hours. If pain or fever persist for more than 3 days or gets worse, or if any other symptoms occur, treatment should be discontinued, and a physician consulted.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Adverse reactions reported from extensive post- marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Post marketing data Paracetamol System Organ Class Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Very rare Immune system disorders Anaphylaxis Allergies (not including angioedema) Very rare Metabolism and nutrition disorders High anion gap metabolic acidosis Not known Respiratory, thoracic and mediastinal disorders Bronchospasm* Rare Hepatobiliary disorders Hepatic dysfunction Very rare Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema Very rareSkin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. Caffeine System Organ Class Undesirable effect Frequency Central Nervous system Nervousness Dizziness Not known 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 such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Paracetamol 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. g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued. The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid, since mild bronchospasms are reported in association with paracetamol (cross reaction). Patients should be advised not to take other paracetamol containing products concurrently.

g. coffee, tea and some canned drinks) should be avoided while taking this product. Do not exceed the stated dose. Patients should be advised to consult their doctor if their headaches become persistent. 7 % of the WHO recommended maximum daily intake for sodium.

8 % of the WHO recommended maximum daily intake for sodium. Solpadeine Headache Soluble Tablets is considered high in sodium. This should be particularly taken into account for those on a low salt diet. This medicine contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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