Dihydrocodeine and Paracetamol Other names: Co-dydramol

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Regular use of dihydrocodeine/paracetamol during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

As with all medicines, use should be avoided during the first trimester.

Administration to nursing women is not recommended as dihydrocodeine may be secreted in breast milk and may cause respiratory depression in the infant.

Dihydrocodeine may cause vertigo which may affect the ability to drive or use machines.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely.

• 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.

The information below lists reported adverse reactions, ranked using the following frequency classification: 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).

Dihydrocodeine may cause constipation, nausea, vomiting, headache or vertigo and these are relatively common if the dose is increased above 30mg. If constipation occurs it can be treated with a gentle laxative. Tolerance and dependence may occur with dihydrocodeine especially with prolonged dosage.

There have been very rare occurrences of pancreatitis.

Blood and lymphatic system disorders

Not known: agranulocytosis, thrombocytopenia

Hypersensitivity including skin rash may occur.

Immune system disorders

Not known: anaphylactic shock, angioedema

Skin and subcutaneous disorders

Not known: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption

Psychiatric disorders

Frequency unknown: Drug dependence

General disorders and administration site conditions

Uncommon: drug withdrawal syndrome