SOLPADEINE PLUS SOLUBLE

Posology Adults 2 tablets dissolved in at least half a tumbler of water every 4-6 hours up to four times a day. The minimum dosing interval is 4 hours. No more than 4 doses (8 tablets) should be given in 24 hours.

Paediatric population:

Adolescents aged 16-18 years: 1-2 tablets every 6 hours up to 4 times a day. The minimum dosing interval is 6 hours. No more than 4 doses (8 tablets) should be given in 24 hours. Adolescents aged 12 – 15 years: 1 tablet every 6 hours up to 4 times a day.

The minimum dosing interval is 6 hours. No more than 4 doses (4 tablets) should be given in 24 hours. 4).

Elderly patients:

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). 9) Method of administration For oral administration only. 9). Minimum dosing interval: 4 hours for adults and 6 hours for adolescents.

The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. 4. CLINICAL PARTICULARS

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system.

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, 363 <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Paracetamol Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis Not known Anaphylaxis Not known Immune system disorders Allergies (not including angioedema) Rare Metabolism and nutrition disorders High anion gap metabolic acidosis Not known Respiratory, thoracic and mediastinal disorders Bronchospasm* Not known Hepatobiliary disorders Hepatic dysfunction Not known Skin and subcutaneous tissue disorders Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema Very rare 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 Body System Undesirable effect Frequency Central nervous system Nervousness Dizziness Not known When the recommended paracetamol-caffeine-codeine 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.

Codeine Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known. 4) Not known Gastrointestinal disorder Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis Not known Nervous system disorder Dizziness Hyperalgesia Drowsiness.

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.

Care should be observed in administering the product to any patient, whose condition may be exacerbated by opioids, including the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy, hypothyroidism and those with inflammatory or obstructive bowel disorders, Addison's disease or myasthenia gravis.

Care should also be observed if prolonged therapy is contemplated. 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).

Do not exceed the stated dose. Patients should be advised not to take other paracetamol or codeine- containing products concurrently. 9). If symptoms persist for more than 3 days or get worse, or if any other symptoms occur, treatment should be discontinued, and a physician consulted.

Solpadeine Plus Soluble Tablets are contraindicated in patients with hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents. 6). In respiratory depression, chronic constipation. In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.