NON-DROWSY SINUTAB

Posology Adults and children aged 16 years and over:

Two tablets every four to six hours, up to four times a day. e. 240 mg pseudoephedrine hydrochloride, 4 g paracetamol). Children aged 12 years to 15 years One tablet every four to six hours, up to four times a day. e. 120 mg pseudoephedrine hydrochloride, 2 g paracetamol).

3).

The Elderly:

There have been no specific studies of NON-DROWSY SINUTAB in the elderly. Experience has indicated that normal adult dosage is appropriate. In the elderly the rate and extent of paracetamol absorption is normal but plasma half life is longer and paracetamol clearance is lower than in young adults.

Hepatic dysfunction Caution should be exercised when administering NON-DROWSY SINUTAB to patients with severe hepatic impairment.

Renal dysfunction:

Caution should be exercised when administering NON-DROWSY SINUTAB to patients with moderate renal impairment. Method of administration For oral use

Adverse drug reactions identified during clinical trials and post-marketing experience with paracetamol, pseudoephedrine, or the combination 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, including isolated reports 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’.

4) Psychomotor hyperactivity Somnolence Tremor Eye Disorders Not known Ischaemic optic neuropathy Cardiac disorders Not known Dysrhythmias Myocardial infarction/myocardial ischaemia Palpitations Tachycardia Vascular disorders Not known Hypertension Common Dry mouth Nausea Gastrointestinal disorders Not known Abdominal pain Diarrhoea Ischaemic colitis Vomiting Hepatobiliary disorders Rare Hepatic necrosis Rare RashSkin and subcutaneous tissue disorders Not known Angioedema Fixed eruption Pruritus Rash pruritic Severe skin reactions, including Acute generalised exanthematous pustulosis (AGEP) Urticaria Uncommon Nephropathy toxicRenal and urinary disorders Not known Dysuria Renal papillary necrosis (after prolonged administration) Urinary retention (in men whom prostatic enlargement could have been an important predisposing factor) Metabolism and nutrition disorders Not known High anion gap metabolic acidosis Chronic hepatic necrosis has been reported in a patient who took daily therapeutic dosages of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Patients experiencing difficulty in urination and/or enlargement of the prostate, or patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment (particularly if accompanied by cardiovascular disease), or in occlusive vascular disease.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver 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:

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. 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.

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 acute or chronic kidney disease/renal failure Not to be used in children under the age of 12 years.