SOMINEX Tablet Ref.[7734] Active ingredients: Promethazine

Cause drowsiness. Do not drive or operate machinery.

Not to be used for more than 7 days without medical advice.

In patients with asthma or other respiratory disorders (eg bronchitis or bronchiectasis), glaucoma, epilepsy, urinary retention, prostatic hypertrophy, hepatic or renal impairment, cardiovascular problems or pyloroduodenal obstruction the product should only be taken after consulting a doctor.

This product should be used with caution in patients with seizure disorders or in patients receiving medication which may affect the seizure threshold because of risk of convulsions.

Excipients

Lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Promethazine hydrochloride may potentiate the action of alcohol and other centrally acting depressants such as sedatives (barbiturates), opiod analgesics, antipsychotics, anticonvulsants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines.

Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs such as atropine and tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy tests to produce false positive or negative results.

Promethazine hydrochloride should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false negative results.

Concomitant use of alcohol should be avoided.

The advice of a doctor should be sought before use.

Pregnancy

Sominex should not be used in pregnancy unless the physician considers it essential. The use of Sominex is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Breast-feeding

Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.

This product causes drowsiness. Do not drive or operate machinery.

Blood and lymphatic system disorders: Agranulocytosis, leucopenia, thrombocytopenia. Blood dycrasias occur rarely.

Psychiatric disorders: Sedation, paradoxical reactions such as hyperexcitability and abnormal movements, drowsiness, confusion, disorientation, restlessness, insomnia.

Nervous system disorders: Convulsive seizures, headache, psychomotor impairment, antimuscarinic effects (dry mouth, blurred vision, urinary retention). Dizziness, tremor and extrapyramidal effects are rare side effects.

Eye disorders: Angle closure glaucoma occurs rarely.

Ear and labyrinth disorders: Tinnitus.

Heart rate and rhythm disorders: Palpitations, arrhythmias.

Vascular disorders: Hypotension.

Respiratory, thoracic and mediastinal disorders: Nasal stuffiness. Bronchospasm occurs rarely.

Gastrointestinal disorders: Nausea, vomiting.

Hepatobiliary disorders: Jaundice occurs rarely.

Skin and subcutaneous tissue disorders: Photosensitivity. Angioedema and rashes occur rarely.

General disorders and administration site conditions: Anaphylaxis occurs rarely.

The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.