BENYLIN MUCUS COUGH PLUS DECONGESTANT

Posology Adults and children aged 12 years and over: 10 ml syrup every 4 - 6 hours up to 4 times a day. 3). 2]. 2]. 2]. Do not exceed the stated dose. Method of Administration For oral use

Placebo-controlled studies with sufficient adverse event data were not available for the combination of guaifenesin and pseudoephedrine. Adverse drug reactions identified during clinical trials and post-marketing experience with guaifenesin, pseudoephedrine, or the combination of guaifenesin and pseudoephedrine are listed below by System Organ Class (SOC).

The frequencies are defined 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). 4) Psychomotor hyperactivity Somnolence Tremor Not known Not known Not known Not known Not known Eye Disorders Ischaemic optic neuropathy Not known Cardiac Disorders Dysrhythmias Myocardial infarction/myocardial ischaemia Palpitations Tachycardia Not known Not known Not known Not known Vascular Disorders Hypertension Not known Gastrointestinal Disorders Dry mouth Nausea Abdominal pain Diarrhoea Ischaemic colitis Vomiting Common Common Not known Not known Not known Not known Skin and Subcutaneous Tissue Disorders Angioedema Pruritus Rash Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP) Urticaria Not known Not known Not known Not known Not known Renal and Urinary Disorders Dysuria Urinary Retention (in men in whom prostatic enlargement could have been an important predisposing factor) Not known Not known 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 thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician. Patients with the following conditions should be advised to consult a physician before using this product: difficulty in urination and/or enlargement of the prostate; a respiratory condition such as emphysema, chronic bronchitis or acute or chronic bronchial asthma.

This product should be not used for persistent or chronic cough, such as occurs with asthma, or emphysema where cough is accompanied by excessive secretions, unless directed by a physician. Patients should be advised to consult a physician if their cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.

2], or occlusive vascular disease. If any of the following occur, this product should be stopped - Hallucinations - Restlessness - Sleep disturbances Severe Skin reactions: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products.

This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.

Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed.

Ischaemic colitis:

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy:

1. 5). This product is contraindicated in individuals who are concomitantly taking other sympathomimetic decongestants. This product is contraindicated in individuals with diabetes mellitus, closed angle glaucoma, hyperthyroidism or phaeochromocytoma.

This product is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding 14 days. 5). Severe acute or chronic kidney disease/renal failure Not to be used in children under the age of 12 years.