BENYLIN CHESTY COUGHS (ORIGINAL)

For oral use Adults and Children aged 12 years and over:

One 10 ml dose of syrup 4 times a day. Maximum daily dose: 40 ml syrup. 3).

The Elderly:

As for adults above (see Pharmacokinetics - The elderly). Hepatic dysfunction Caution should be exercised if moderate to severe hepatic dysfunction is present (see Pharmacokinetics - Hepatic dysfunction). Renal dysfunction It may be prudent to increase the dosage interval in subjects with moderate to severe renal failure (see Pharmacokinetics - Renal dysfunction).

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 secretionsRespiratory, Thoracic and Mediastinal Disorders Uncommon Chest discomfort Nasal dryness Gastrointestinal Disorders Common Dry mouth Nausea Vomiting Hepatobiliary Disorders Rare Liver dysfunction System Organ Class (SOC) Frequency* Adverse Drug Reaction Skin and Subcutaneous Tissue Disorders Uncommon Pruritus Rash 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 CHESTY COUGHS (ORIGINAL) 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.

This product may cause drowsiness. If affected individuals should not drive or operate machinery. This product should not be used to sedate a child. 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. Subjects with hepatic disease or moderate to severe renal dysfunction should exercise caution when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).

5 g of glucose and 1 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product contains Ponceau 4R (E 124) red colouring which may cause allergic reactions. 62 mg sodium (main component of cooking/table salt) in each 5 ml. 83% of the recommended maximum daily dietary intake of sodium for an adult. 22 mg benzyl alcohol in each 5ml.

Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast
feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis). This medicine contains 10 mg sodium benzoate (E 211) in each 5 ml.

This medicine contains 197 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

1. 5). Not to be used in children under the age of 12 years.