BENYLIN CHILDRENS NIGHT COUGHS

3).

Children 6 to 12 years:

Two 5 ml spoonfuls every 6 hours No more than four doses should be given in any 24 hours. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.

Do not exceed the stated dose. Keep out of the sight and reach of children.

Diphenhydramine Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with Diphenhydramine are included in the table below by System Organ Class (SOC).

The frequencies are provided according to the following convention:

Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) System Organ Class (SOC) Frequency* Adverse Drug Reaction Blood and Lymphatic System Disorders Rare Blood disorders Immune System Disorders Rare Hypersensitivity reactions Uncommon Irritability Hallucination Nervousness Psychiatric Disorders Rare Confusional state Very common Somnolence (usually diminishes within a few days) Common Dizziness Headache Paradoxical stimulation Psychomotor impairment Uncommon Agitation Paraesthesia Sedation Nervous System Disorders Rare Convulsion Depression Extrapyramidal effects Insomnia Tremor Eye Disorders Common Vision blurred Ear and Labyrinth Disorders Uncommon Tinnitus Uncommon TachycardiaCardiac Disorders Rare Arrhythmia Palpitations Vascular Disorders Rare Hypotension Common Thickened respiratory tract secretions Respiratory, Thoracic and Mediastinal Disorders Uncommon Chest discomfort Nasal dryness Gastrointestinal Disorders Common Dry mouth Nausea Vomiting Hepatobiliary Disorders Rare Liver dysfunction Skin and Subcutaneous Uncommon Pruritus Rash System Organ Class (SOC) Frequency* Adverse Drug Reaction Tissue Disorders Urticaria Renal and Urinary Disorders Common Urinary retention General Disorders and Administration site conditions Common Asthenia (*) Frequency category based on clinical trials with single-ingredient diphenhydramine Menthol Adverse reactions to menthol at the low concentration present in BENYLIN CHILDREN’S NIGHT COUGHS are not anticipated.

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.

Patients with the following conditions should be advised to consult a physician before using this medicine: • A chronic or persistent cough such as occurs with emphysema or chronic bronchitis, acute or chronic asthma, or where cough is accompanied by excessive secretions • Susceptibility to angle-closure glaucoma • Prostatic hypertrophy and/or urinary retention Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, opioid analgesics, antipsychotics and tranquilizers.

5). Do not use with any other product containing diphenhydramine, including topical formulations used on large areas of skin. Patients with hepatic disease or moderate to severe renal dysfunction should exercise caution when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).

The product may cause drowsiness. This product should not be used to sedate a child. 13 mg/100 ml (see Appendix 1 of report EMA/CHMP/43486/2018). For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

, propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity. 47 mg sodium (main component of cooking/table salt) in each 5 ml.

82% of the recommended maximum daily dietary intake of sodium for an adult. 53 g sorbitol in each 5 ml. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary problems of fructose intolerance (HFI) should not take/be given this medicinal product.

1. 5). Not to be used in children under the age of 6 years.