REMEDEINE

4). Posology Adults over 18 years 1 or 2 tablets every four to six hours when necessary to a maximum of 8 tablets in 24 hours. Elderly 1 tablet every four to six hours increasing to 2 tablets every four to six hours if required and tolerated.

Caution should be exercised when increasing the dose in the elderly. Paediatric population Adolescents 16 to 18 years 1 or 2 tablets every six hours when necessary to a maximum of 8 tablets in 24 hours. Children 12 to 15 years 1 tablet every six hours when necessary to a maximum of 4 tablets in 24 hours.

Children under 12 years Not recommended. Method of administration For oral use. This medicine should, if possible, be taken during or after meals. Treatment goals and discontinuation Before initiating treatment with Remedeine tablets, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment The duration of treatment should be as short as possible, and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Dihydrocodeine Constipation, if it occurs, is readily treated with a mild laxative. Other side-effects of dihydrocodeine which may occur in a few patients, are nausea, vomiting, headache, vertigo, giddiness, urinary retention, pruritus, sedation, dysphoria, hallucinations, abdominal pain and allergic reactions including skin rashes.

4).

Uncommon frequency:

Drug withdrawal syndrome. Paracetamol Adverse effects of paracetamol are rare but hypersensitivity reactions including skin rash, blood dyscrasias, acute pancreatitis have been reported. Very rare cases of serious skin reactions have been reported.

Prolonged use of a painkiller for headaches can make them worse. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Drug dependence Repeated use of Remedeine tablets can lead to drug dependence, even at therapeutic doses.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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.

This medicine should be given with caution in patients with allergic disorders and should not be given during an attack of asthma. Caution should also be observed if there is marked impairment of liver function, advanced kidney disease and in chronic alcoholics.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of this medicine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe this medicine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Do not exceed the recommended dose. Patients should be advised not to take other paracetamol-containing products concurrently. Dosage should be reduced in the elderly, in hypothyroidism and in chronic hepatic disease.

An overdose can cause hepatic necrosis. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors and should be avoided in those patients with raised intracranial pressure or head injury. Use with caution in patients with prostatic hypertrophy since dihydrocodeine may cause urinary retention.

The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.

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.

1. Respiratory depression. Obstructive airways disease.