ATROPINE Eye drops (2016)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Atropine Eye Drops 1.0% w/v. Vistatropine Eye Drops 1.0% w/v.

Qualitative and quantitative composition

Atropine sulfate 1.0% w/v. For the full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops. Clear, colourless, solution.

Therapeutic indications

Atropine sulfate is an antimuscarinic agent used as a cycloplegic and mydriatic. The eye drops are used in the treatment of iritis and uveitis to immobilise the iris and ciliary muscle and to prevent or ...

Posology and method of administration

For topical ocular use. The depth of the angle of the anterior chamber should be assessed before the product is used. Adults Refraction: One or two drops to be instilled into the eye(s) one hour before ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The product should not be used in patients with closed angle glaucoma. It is also contraindicated in patients ...

Special warnings and precautions for use

It should only be used with caution in patients who may have raised intra ocular pressure. The product contains benzalkonium chloride solution and soft contact lenses must not be worn during the period ...

Interaction with other medicinal products and other forms of interaction

The effects of atropine may be enhanced by the concomitant use of other drugs with antimuscarinic properties. Studies have indicated that the absorption of atropine sulphate appears to be delayed by solutions ...

Pregnancy and lactation

The safety for use in pregnancy and lactation has not been established, therefore, use only when directed by a physician.

Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.

Undesirable effects

Patients may experience photophobia and eyes should be protected from bright light while the pupils are dilated. Prolonged use of atropine eye drops may lead to local irritation, transient stinging, hyperaemia, ...

Overdose

Symptoms Systemic reactions to topical atropine are unlikely at normal doses. Symptoms which can occur following an overdose, however, include anticholinergic effects (as listed in section 4.8 above), ...

Pharmacodynamic properties

Pharmacotherapeutic group: anticholinergic agents ATC code: S01FA01 Dilation of the pupil normally occurs within half an hour following local application and lasts for seven days or longer. Paralysis of ...

Pharmacokinetic properties

Atropine is readily absorbed from the gastro-intestinal tract and mucous membranes, it is also absorbed from the eye. It is incompletely metabolised in the liver and is excreted in the urine as unchanged ...

Preclinical safety data

No additional pre-clinical data of relevance to the prescriber.

List of excipients

Benzalkonium chloride solution Purified water

Incompatibilities

None known relevant to topical ocular use.

Shelf life

36 months (unopened) 28 days (once opened)

Special precautions for storage

Store bottle upright below 25°C in a dry place and protect from light.

Nature and contents of container

Low density polythene 10ml bottle with polythene insert and high density polythene tamper-evident cap. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, RM3 8UG

Marketing authorization number(s)

PL 00156/0044

Date of first authorization / renewal of the authorization

First authorised: 6 June 1997

Date of revision of the text

06/10/2016

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