ARLEVERT

Posology Adults: 1 tablet three times daily.

Elderly:

Dosage as for adults.

Renal impairment:

Arlevert should be used with caution in patients with mild to moderate renal impairment. Arlevert should not be used by patients with a creatinine clearance of ≤ 25 ml/min (severe renal impairment).

Hepatic impairment:

No studies in patients with hepatic impairment are available. Arlevert should not be used by patients with severe hepatic impairment.

Paediatric population:

The safety and efficacy of Arlevert in children and adolescents under the age of 18 years has not been established. No data are available. In general, the duration of treatment should not exceed four weeks. The physician shall decide whether longer treatment is required.

Method of administration Arlevert tablets are to be taken unchewed, with some liquid after meals.

The most frequently occurring ADRs are somnolence (including drowsiness, tiredness, fatigue, daze) occurring in about 8% of patients and dry mouth occurring in about 5% of patients in clinical trials. These reactions are usually mild and disappear within a few days even if treatment is continued.

The frequency of ADRs associated with Arlevert in clinical trials and following spontaneous reports are included in the next table. g. cutaneous reactions) Nervous system disorders Somnolence Headache Paraesthesia Amnesia Tinnitus Tremor Nervousness Convulsions Eye disorders Visual disorders Gastrointestinal disorders Dry mouth Abdominal pain Dyspepsia Nausea Diarrhoea Skin and subcutaneous tissue disorders Perspiration Rash Photosensitivity Renal and urinary disorders Urinary hesitancy In addition the following adverse reactions are associated with dimenhydrinate and cinnarizine (frequency cannot be estimated from the available data): Dimenhydrinate: paradoxical excitability (especially in children), worsening of an existing angle-closure glaucoma, reversible agranulocytosis.

Cinnarizine: constipation, weight gain, tightness of the chest, cholestatic jaundice, extrapyramidal symptoms, lupus-like skin reactions, lichen planus. 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 or +44 (0)1480 279482. By reporting side effects you can help provide more information on the safety of this medicine.

Arlevert does not reduce blood pressure significantly, however, it should be used with caution in hypotensive patients. Arlevert should be taken after meals to minimise any gastric irritation. g. raised intra-ocular pressure, pyloro-duodenal obstruction, prostatic hypertrophy, hypertension, hyperthyroidism or severe coronary heart disease.

Caution should be exercised when administering Arlevert to patients with Parkinson’s disease. Sodium Arlevert contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. Diphenhydramine is completely excreted renally, and patients with severe renal impairment were excluded from the clinical development programme. Arlevert should not be used by patients with a creatinine clearance of ≤ 25 ml/min (severe renal impairment).

Since both active components of Arlevert are extensively metabolised by hepatic cytochrome P450 enzymes, the plasma concentrations of the unchanged drugs and their half-lives will increase in patients with severe hepatic impairment.

This has been shown for diphenhydramine in patients with cirrhosis. Arlevert should therefore not be used by patients with severe hepatic impairment. Arlevert should not be used in patients with angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, alcohol abuse or urine retention due to urethroprostatic disorders.