BENYLIN MUCUS COUGH NIGHT, BENYLIN DUAL ACTION NIGHT COUGH & CONGESTION

Posology Adults and children aged 12 years and over:

Two 5 ml spoonfuls four times a day. Or to aid sleep patients may start with two 5 ml spoonfuls at bedtime followed by two 5 ml spoonfuls every 6 hours. Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24 hours. 3).

Elderly (over 65 years):

As for adults. Do not exceed the stated dose. Keep out of the sight and reach of children. Method of Administration For oral use

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with diphenhydramine, guaifenesin, levomenthol or the combination 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) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Blood and Lymphatic System Rare Blood disorder1 Rare Hypersensitivity1,2 Immune System Disorders Not known Angioedema1 Uncommon Agitation1 Insomnia1 Irritability1 Nervousness1 Rare Confusional state1 Depression1 Sleep disorder1 Psychiatric Disorders Not known Hallucination1 Very common Somnolence (usually diminishes within a few days)* Sedation1 Common Dizziness* Headache1 Paradoxical stimulation Psychomotor impairment1 Nervous System Disorders Rare Convulsion1 Extrapyramidal disorder1 Tremor1 Not known Coordination abnormal1 Paraesthesia1 Eye Disorders Common Blurred Vision1 Ear and Labyrinth Disorders Uncommon Tinnitus1 Rare Arrhythmia1 Palpitations1 Cardiac Disorders Not known Tachycardia1 Vascular Disorders Rare Hypotension1 Common Dry throat1 Increased viscosity of bronchial secretion1 Respiratory, Thoracic and Mediastinal Disorders Not known Nasal dryness1 Common Dry mouth* Gastrointestinal disorder1 Gastrointestinal Disorders Not known Abdominal discomfort2 Abdominal pain upper2 Constipation1 Diarrhoea1, 2 Dyspepsia1 Nausea 1,2 Vomiting 1,2 Hepatobiliary Disorders Rare Liver Disorder1 Uncommon Rash1,2 Skin and Subcutaneous Tissue Disorders Not known Erythema1 Pruritus1,2 Urticaria1,2 Renal and Urinary Disorders Common Urinary retention1 Not known Dysuria1 Common Asthenia*General Disorders and Administration Site Conditions Not known Chest discomfort * Frequency category based on clinical trials with single-ingredient diphenhydramine.

This product may cause drowsiness. This product should not be used to sedate a child. 2). Do not use with any other product containing diphenhydramine including topical formulations used on large areas of skin. Diphenhydramine may enhance the sedative effects of central nervous system depressants, including alcohol, opioid analgesics, antipsychotics, sedatives and tranquilizers.

5). Excitability may occur. Patients with the following conditions should be advised to consult a physician before using this product: • Acute or chronic bronchial asthma, a persistent or chronic cough such as occurs with smoking, chronic bronchitis or emphysema or where cough is accompanied by excessive secretions • Susceptibility to angle-closure glaucoma • Prostatic hypertrophy and/or urinary retention If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.

Do not take with a cough suppressant. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This product contains 7 g glucose and 2 g sucrose per 10 ml dose.

This should be taken into account in patients with diabetes mellitus. Patients with rare glucose-galactose malabsorption should not take this medicine. This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

e. 62 mg per 5ml dose, which is equivalent to less than 5 ml beer, 2 ml wine per 5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects. 853% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

47 mg benzoic acid in 5ml dose.

The label contains the following statements:

May cause drowsiness. If affected, do not drive, cycle or operate machinery. Do not use to sedate a child.

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