ATROPINE Solution for injection Ref.[8249] Active ingredients: Atropine

Atropine sulphate should be used with caution in children, older people and those with Down’s syndrome. It should be given with caution to patients with diarrhoea, urinary retention or fever.

Paradoxical atrioventricular block or sinus arrest has been reported following administration of atropine in a few patients after heart transplantation.

The use of atropine for therapeutic or diagnostic procedures in heart transplant patients should be undertaken with extreme caution, and ECG monitoring and equipment for immediate temporary pacing should be available.

Caution is required when atropine is administered systemically to patients with chronic obstructive pulmonary diseases, as a reduction in bronchial secretions may lead to the formation of bronchial plugs.

Antimuscarinics such as atropine may delay gastric emptying, decrease gastric motility and relax the oesophageal sphincter. They should be used with caution in patient whose condition may be aggravated by these effects. e.g. reflux oesophagitis.

Atropine should be used only with extreme caution in toxic pyrexial children, or in high ambient temperatures, because of the danger of hyperpyrexia.

Atropine should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery.

When used to treat a cholinergic crisis in myasthenia gravis, all anti-cholinesterase medication should be withdrawn, if necessary for several days.

Doses of atropine up to 1mg are mildly stimulant to the central nervous system. Higher doses may induce mental disturbances and depression of the central nervous system. Children and older people are particularly susceptible.

Care is required when using atropine in the presence of acute myocardial ischaemia or infarction as the ischaemia or infarction may be worsened.

Pregnancy

Atropine sulphate crosses the placenta. Studies in humans have not been done and only limited information is available from animal studies. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

Intravenous administration of atropine during pregnancy or at term may cause tachycardia in foetus. Atropine should only be administered to pregnant women if the benefits outweigh the risks to the foetus.

Breast-feeding

Trace amounts of atropine appear in the breast milk and may cause antimuscarinic effects in the infant; lactation may be inhibited.

Fertility

There are no adequate preclinical fertility data with atropine, and no epidemiological data.

Atropine may cause blurred vision, drowsiness, confusion, hallucinations and other neuro-psychiatric effects (see sections 4.8 and 4.9). Patients should be advised that they should not drive, operate machinery or take part in any activities that could, if they are affected, put them or others at risk.

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.

The most commonly reported adverse events are due to the action of atropine on muscarinic receptors and at high doses, nicotinic receptors. These effects are dose related and usually reversible when therapy is discontinued.

Immune system disorders

Very rare: Anaphylaxis

Psychiatric disorders

Not known: Confusion state, especially in the elderly. At higher doses hallucinations, restlessness, delirium (see 4.9 overdose).

Nervous system disorders

Not known: Dizziness

Eye disorders

Not known: Dilatation of the pupils with loss of accommodation and photophobia, raised intraocular pressure.

Cardiac disorders

Very rare: Paradoxical atrioventricular block, especially after heart transplantation (see section 4.4 special warnings and precautions for use).

Not known: Transient bradycardia followed by tachycardia, palpitations, arrhythmias. Exacerbation of myocardial ischaemia or myocardial infarction.

Vascular disorders

Not known: Flushing

Respiratory, thoracic and mediastinal disorders

Not known: Reduced bronchial secretion may result in the formation of thick bronchial plugs which are difficult to eject from respiratory tract (see section 4.4 special warnings and precautions for use)

Gastrointestinal disorders

Not known: Dry mouth with difficulty in swallowing, constipation, nausea, vomiting, inhibition of gastric secretion, retrosternal pain due to gastric reflux.

Skin and subcutaneous tissue

Not known: Dry skin, urticaria, rashes, skin exfoliation.

Renal and urinary disorders

Not known: Urinary retention, difficulty with micturition.

General disorders and administration site conditions

Not known: Thirst, fever.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Atropine Sulphate Injection is incompatible with alkalis, tannic acid and mercury salts.