DIHYDROCODEINE

4). The analgesic effect is not materially enhanced by increasing the dose above that recommended below; in severe cases the interval between doses should be reduced to obtain the requisite analgesic cover.

Adults and children over 12 years:

One tablet (30mg) every 4 to 6 hours when necessary after food. Maximum dose in 24 hours 180mg (6 tablets).

Paediatric population:

Not recommended for children under 12 years old.

Elderly:

The dosage may have to be reduced in elderly patients. See also sub-section

The adverse drug reactions listed below are classified by system organ class according to their frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

4) Nervous system disorders Somnolence Convulsions, dizziness, headache, paraesthesia, sedation Sleep apnoea syndrome Eye disorders Blurred vision Miosis Ear and labyrinth disorders Vertigo Cardiac disorders Bradycardia, tachycardia, palpitations Vascular disorders Hypotension, flushing Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory depression Gastrointestinal disorders Abdominal pain, constipation, dry mouth, nausea, vomiting, Diarrhoea, Paralytic ileus Hepatobiliary disorders Biliary colic, hepatic enzymes increased Skin and subcutaneous tissue disorders Hyperhidrosis, pruritus, rash, urticaria Renal and urinary disorders Urinary retention, ureteric spasm Reproductive system and breast disorders Decreased libido General disorders and administration site conditions Asthenia, fatigue, malaise, drug withdrawal syndrome, drug tolerance Drug withdrawal syndrome neonatal Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance.

Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse. 6). 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.

4 Special warnings and special precautions for use. Method of administration For oral use. 1. Respiratory depression. Severe chronic obstructive lung disease. Acute alcoholism. Risk of paralytic ileus. Head injuries or conditions in which intracranial pressure is raised.

As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack. 4 Special warnings and precautions for use Drug dependence, tolerance and potential use for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.

g. major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained online, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.

These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in the overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with dihydrocodeine. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.

1. Respiratory depression. Severe chronic obstructive lung disease. Acute alcoholism. Risk of paralytic ileus. Head injuries or conditions in which intracranial pressure is raised. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack.