BENYLIN DAY & NIGHT

Posology Adults and Children over 12 years Four tablets should be taken daily:

One white tablet to be taken every 4 to 6 hours during the day (no more than three white tablets a day). One blue tablet to be taken at night. Take only one tablet at a time and only at the times of day indicated on the pack. Do not take the nighttime tablets during the day.

Elderly As for adults (see Pharmacokinetics). Children Not recommended for children under 12 years of age. Method of Administration For oral use Hepatic Dysfunction Caution should be exercised when administering this medicine to patients with severe hepatic impairment.

Renal Dysfunction Caution should be exercised when administering this medicine to patients with moderate to severe renal impairment.

Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with diphenhydramine, paracetamol, or pseudoephedrine (single ingredients) or combinations of diphenhydramine + paracetamol or pseudoephedrine + paracetamol, 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) 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 disorders Rare Blood disorders, blood dyscrasias (including thrombocytopenia and agranulocytosis) have been reported following paracetamol use but were not necessarily causally related to the drug Immune system disorder Rare Hypersensitivity (cross-sensitivity may occur with other sympathomimetics) Common Insomnia Nervousness Uncommon Confusional state Irritability Rare Depression Sleep disorder Psychiatric disorders Not known Anxiety Euphoric mood Excitability Hallucinations Paranoid delusions Restlessness Very common Headache Somnolence Sedation Common Dizziness Paradoxical stimulation Psychomotor impairment Rare Extrapyramidal disorder Seizure Tremor Nervous system disorders Not known Cerebrovascular accident Paraesthesia Posterior reversible encephalopathy syndrome (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) Psychomotor hyperactivity Common Vision blurredEye disorders Not known Ischaemic optic neuropathy Ear and labyrinth disorders Uncommon Tinnitus Cardiac disorders Rare Palpitations Not known Dysrhythmias Myocardial infarction/myocardial ischaemia Tachycardia Rare HypotensionVascular disorders Not known Hypertension Common Increased viscosity of bronchial secretion Respiratory, thoracic and mediastinal disorders Not known Dyspnoea Nasal dryness Common Dry mouth Gastrointestinal disorder Nausea Gastrointestinal disorders Not known Ischaemic colitis Vomiting Hepatobiliary disorders Rare Liver disorder Uncommon RashSkin and subcutaneous tissue disorders Not known Angioedema Erythema Fixed eruption Pruritus Rash pruritic Serious skin reactions, including acute generalised exanthematous pustulosis (AGEP) Urticaria Common Urinary retention (in men in whom prostatic enlargement could have been an important predisposing factor) Renal and urinary disorders Not known Dysuria Common AstheniaGeneral disorders and administration site conditions Not known Chest discomfort Very rare cases of serious skin reactions have been reported with paracetamol.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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.

Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, opioid analgesics, antipsychotics and tranquilizers. Alcoholic beverages should be avoided while taking this product.

If any of the following occur, Benylin Day and Night Tablets 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:

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. There have been rare cases of posterior reversible encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine.

Symptoms reported include sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment. Pseudoephedrine should be discontinued, and medical advice sought immediately if signs or symptoms of PRES/RCVS develop.

Patients with the following conditions should be advised to consult a physician before using this product: • Acute or chronic asthma, a persistent or chronic cough such as occurs with chronic bronchitis or emphysema or where cough is accompanied by excessive secretions • Difficulty in urination, urinary retention and/or prostatic hyperplasia • Patients with thyroid disease who are receiving thyroid hormones Use with caution in patients with susceptibility to angle-closure, severe hepatic impairment, moderate to severe renal impairment (particularly if accompanied by cardiovascular disease), or occlusive vascular disease.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Do not use with any other product containing diphenhydramine, including topical formulations used on large areas of skin. Taking this product with other paracetamol-containing products, could lead to overdose and should therefore be avoided.

May cause drowsiness. This product should not be used to sedate a child. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1. 5). The concomitant use of MAOIs may cause a rise in blood pressure and/or hypertensive crisis. Cardiovascular disease including hypertension Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Severe renal impairment