MYDRILATE 1.0% Eye drops (2022)
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Περιεχόμενα
Name of the medicinal product
Mydrilate 1.0% Eye Drops. Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution.
Qualitative and quantitative composition
Cyclopentolate Hydrochloride BP 1.0% w/v. <u>Excipient(s) with known effect:</u> Each millilitre contains 0.1 mg benzalkonium chloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops.
Therapeutic indications
Diagnostic purposes for fundoscopy and cycloplegic refraction. Dilating the pupil in inflammatory conditions of the iris and uveal tract.
Posology and method of administration
Refraction/Fundoscopy Adults (and the elderly) One drop of 0.5% solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination. Deeply pigmented eyes ...
Contraindications
Use in narrow angle glaucoma or those with a tendency towards glaucoma e.g. patients with a shallow anterior chamber. Hypersensitivity to cyclopentolate hydrochloride, benzalkonium chloride or any other ...
Special warnings and precautions for use
Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly ...
Interaction with other medicinal products and other forms of interaction
The effects of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with antimuscarinic properties such as some antihistamines, butyrophenones, phenothiazines, tricyclic ...
Pregnancy and lactation
There is insufficient evidence as to drug safety in pregnancy and lactation. This product should not be used during pregnancy unless it is considered essential by a physician.
Effects on ability to drive and use machines
May cause blurred vision, difficulty in focusing and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities (including climbing ladders and scaffolding) unless ...
Undesirable effects
Frequencies are defined according to the following convention: very common (≥1/100), common ≥1/100 to 1/10, uncommon ≥1/1,000 to <1/100, rare (≥11/10,000 to <1,000), very rare (<1/10,000), not known (cannot ...
Overdose
Systemic toxicity may occur following topical use, particularly in children. It is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular ...
Pharmacodynamic properties
Cyclopentolate is an anti-muscarinic agent used topically in the eye as a mydriatic and cycloplegic. The effects are similar to those of atropine, but with a more rapid onset and a shorter duration of ...
Pharmacokinetic properties
None stated.
Preclinical safety data
None stated.
List of excipients
Boric acid Potassium chloride Benzalkonium chloride solution Purified water
Incompatibilities
None stated.
Shelf life
Unopened: 2 years. After first opening: 28 days.
Special precautions for storage
Do not freeze. Keep the bottle in the outer carton in order to protect from light. <u>Before first opening:</u> store at 2°C-8°C in a refrigerator. Prior to first opening: remove from refrigerator and ...
Nature and contents of container
5 ml dropper bottle of 1.0% solution. <u>Bottle:</u> LDPE, natural colour. <u>Cap:</u> White plastic.
Special precautions for disposal and other handling
When using the product for the first time, screw down the cap firmly on the bottle to pierce the seal at the tip of the plastic nozzle and unscrew the cap for use.
Marketing authorization holder
Esteve Pharmaceuticals Ltd, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks SL6 6PT, United Kingdom
Marketing authorization number(s)
PL 17509/0008
Date of first authorization / renewal of the authorization
8 August 2001
Date of revision of the text
27/09/2022
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