ATROPINE Tablet Ref.[8248] Active ingredients: Atropine

Use with caution in patients with urinary retention, acute myocardial infarction, hypertension, conditions associated with tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery), pyrexia and diarrhoea.

Use of atropine in patients with ulcerative colitis may lead to toxic megacolon and ileus.

Increased side effects may be seen in children and the elderly, and in patients with Down’s syndrome.

Atropine may aggravate gastro-oesophageal reflux.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Alcohol: Marked impairment of attention can occur with alcohol, sufficient to make driving more hazardous (see 4.7 Effects on Ability to Drive and Use Machinery).

Anti-arrhythmics: Increased antimuscarinic side-effects may occur with disopyramide. The absorption of mexiletine can be delayed by atropine but the extent of absorption is unaltered and no special precautions are necessary.

Anticholinergics: Many drugs have antimuscarinic effects; concomitant use of two or more such drugs can increase side-effects such as dry mouth, urine retention, and constipation; concomitant use can lead to confusion in the elderly.

Antidepressants: Increased antimuscarinic side-effects may occur with tricyclic antidepressants and mono-amine oxidase inhibitors (MAOIs).

Antifungals: The absorption of ketoconazole can be reduced by atropine.

Antihistamines: Increased antimuscarinic side-effects may occur with some antihistamines.

Antipsychotics: Increased antimuscarinic side-effects may occur with phenothiazines and clozapine.

Antivirals and Dopaminergics: Increased antimuscarinic side-effects may occur with amantadine. The absorption of levodopa may possibly be reduced when administered with antimuscarinic agents.

Metoclopramide & domperidone: Possible antagonism of gastrointestinal effects.

Nitrates: The common side-effect of a dry mouth with atropine may result in the failure of sublingual nitrates to dissolve, thereby reducing their effectiveness.

Parasympathomimetics: Possible antagonism of effect of parasympathomimetics.

Phenylephrine: Hypertensive and other serious adverse effects of phenylephrine absorbed from eye drops may be markedly increased by atropine.

Atropine crosses the placenta and traces are found in breast milk. It should therefore only be used with caution.

Atropine may cause visual disturbances, giddiness and staggering. In addition, marked impairment of attention can occur with alcohol (see 4.5 Interactions). If affected, patients should be cautioned against driving a car or operating machinery.

Some of the central effects of atropine seen at toxic doses (see section 4.9) may also occur at therapeutic doses.

Immune system disorders: Hypersensitivity. In rare cases a fever may develop.

Psychiatric disorders: Confusional states (particularly in the elderly).

Nervous system disorders: Occasionally giddiness and staggering may occur.

Eye disorders: Dilation of the pupils with loss of accommodation and photophobia. Increased intra-ocular pressure. In rare cases, angle-closure glaucoma may develop.

Cardiac disorders: Transient bradycardia, followed by tachycardia, palpitations and arrhythmias.

Respiratory, thoracic and mediastinal disorders: Bronchial secretions may be reduced, with formation of mucous plugs.

Gastrointestinal disorders: Dry mouth with difficulty in swallowing, thirst. Occasionally nausea and vomiting may occur. A reduction in the tone and mobility of the gastro-intestinal tract may lead to constipation. Increased gastric reflux may result in retrosternal pain.

Skin and subcutaneous tissue disorders: Flushing and dryness of the skin. Rashes.

Renal and urinary disorders: Urinary urgency, difficulty or retention.

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.

None known.