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CYCLOPENTOLATE HYDROCHLORIDE 0.5% W/V EYE DROPS SOLUTION

Active substance(s): CYCLOPENTOLATE HYDROCHLORIDE

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Cyclopentolate Hydrochloride 0.5% & 1.0% w/v Eye Drops, Solution, PL 17509/000& & 0008 leaflet text 03/01/2012 PATIENT INFORMATION LEAFLET Cyclopentolate Hydrochloride 0.5% w/v Eye Drops, Solution Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet: 1. 2. 3. 4. 5. 6. What Cyclopentolate Hydrochloride eye drops are and what they are used for Before you use Cyclopentolate Hydrochloride eye drops How to use Cyclopentolate Hydrochloride eye drops Possible side effects How to store Cyclopentolate Hydrochloride eye drops Further information

1. WHAT CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR Cyclopentolate Hydrochloride eye drops are prescription eye drops containing the active ingredient cyclopentolate hydrochloride. They are available in two strengths, 0.5% and 1%. They belong to a group of medicines known as mydriatic (used for pupil dilation) and cycloplegic (used to block the muscles of the eye that control the shape of the lens). Cyclopentolate Hydrochloride eye drops are applied on the surface of the eyes for diagnostic purposes during eye examinations and refraction tests. They can also be used to treat some types of eye inflammation (iritis and uveitis). 2. BEFORE YOU USE CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS Do not use Cyclopentolate Hydrochloride eye drops if you are allergic (hypersensitive) to cyclopentolate hydrochloride, benzalkonium chloride or any other ingredients listed in section 6 if you suffer from glaucoma (high pressure in the eyeball) or if you are at risk of having it (i.e. your close family suffered from glaucoma, you are over 60, you have increased pressure in the eye, you had an eye injury) if you wear soft contact lenses - wait at least 15 minutes after removal of contact lenses prior to application. Cyclopentolate Hydrochloride eye drops may discolour the lenses. if you suffer from paralytic ileus (loss of movement in the gut resulting in intestinal blockage) in children with brain damage, particularly if they may have seizures or fits if you are pregnant or breastfeeding

Cyclopentolate Hydrochloride eye drops should not be used for infants three months of age or younger. Take special care with Cyclopentolate Hydrochloride eye drops if you:

Cyclopentolate Hydrochloride 0.5% & 1.0% w/v Eye Drops, Solution, PL 17509/000& & 0008 leaflet text 03/01/2012

suffer from, or are prone to increased eye pressure especially in elderly patients have an enlarged prostate (males only) suffer from heart problems especially angina, heart attacks or heart failure suffer from ataxia (condition causing unsteadiness and coordination problems) have an inflamed eye(s) - inflammation greatly increases the risk that more of the eye drops are absorbed into the bloodstream are sensitive to belladonna alkaloids (drugs such as atropine used mainly to: dilate the pupils, prevent motion sickness, reduce secretion and dry up a runny nose, relieve stomach cramps)

Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines are known to interact with Cyclopentolate Hydrochloride eye drops: antihistamines medications for mental illness such as butyrophenones and phenothiazines tricyclic antidepressants (e.g. amitriptyline, lofepramine, trimipramine) amantadine, an antiviral drug used in the treatment of influenza A and Parkinsons disease

Pregnancy and Breast-feeding Cyclopentolate Hydrochloride eye drops should not be used if you are pregnant, trying to become pregnant or are breast-feeding unless considered essential by your doctor. Ask your doctor or pharmacist for advice before taking any medications. Driving and using machines Using Cyclopentolate Hydrochloride eye drops may cause blurred vision, difficulty in focusing and sensitivity to light. Driving, operating machinery or engaging in hazardous activities such as climbing ladders should be avoided. Complete recovery from these symptoms takes 24 hours. Important information about one of the ingredients of Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. 3. HOW TO USE CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS Always use Cyclopentolate Hydrochloride eye drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. When using this 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 then unscrew the cap for use. Be sure to replace the cap after use. To reduce absorption into the blood stream place one finger at the inner corner of the eye near the nose and apply gentle pressure immediately after dispensing the drops. This will prevent the medicine from draining from the eye. Ask your doctor how to do this correctly. (please turn over)

Cyclopentolate Hydrochloride 0.5% & 1.0% w/v Eye Drops, Solution, PL 17509/000& & 0008 leaflet text 03/01/2012 Dosage For diagnostic eye examinations your doctor will generally give you Cyclopentolate Hydrochloride eye drops as follows: 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 may require the use of a 1 % solution.

Children 6 16 years: One drop of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.

Children under 6 years: One or two drops of 1 % solution instilled into the eye, repeated after 15 minutes if necessary, approximately 40 minutes before examination.

For inflammatory conditions of the eye Cyclopentolate Hydrochloride eye drops are generally used as follows: Adults and the elderly: One or two drops of 0.5 % solution instilled into the eye up to 4 times daily or as required. Deeply pigmented eyes may require the use of a 1 % solution.

Children: At the discretion of the physician.

Cyclopentolate Hydrochloride eye drops should not be used for infants three months of age or younger. If you accidentally swallow Cyclopentolate Hydrochloride eye drops You should wash your hands after use. If Cyclopentolate Hydrochloride eye drops are accidentally swallowed, contact your doctor or pharmacist immediately describing the symptoms. If you use more than Cyclopentolate Hydrochloride eye drops you should Contact your doctor, hospital, or pharmacy if you have used more Cyclopentolate Hydrochloride eye drops than prescribed. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines Cyclopentolate Hydrochloride eye drops can cause side effects although not everybody gets them. The following side effects have been observed in the eye(s) after Cyclopentolate Hydrochloride eye drops have been applied:

Cyclopentolate Hydrochloride 0.5% & 1.0% w/v Eye Drops, Solution, PL 17509/000& & 0008 leaflet text 03/01/2012

Increased pressure in the eyeball Temporary stinging Sensitivity to light due to pupil dilation Prolonged usage may lead to eye irritation, hyperaemia (excessive blood in the vessels of the eye), oedema (excessive fluid in the eye) and conjunctivitis (commonly called pinkeye- inflammation of the outermost layer of the eye and the inner surface of the eyelids)

Other side effects that have been observed are: Dry mouth Flushing Dry skin Irregular heart rate Heart palpitations Urinary urgency (difficulty in holding your bladder) Urinary retention (difficulty passing urine) Constipation Vomiting Giddiness and staggering Children may develop a rash, psychiatric reactions, behavioural disturbances and/or collapse affecting breathing, heart rate and blood pressure Bloating of the stomach may occur in infants

If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS Keep out of the reach and sight of children. Store in a refrigerator (between 2 - 8 C). Do not freeze. Store in the original package in order to protect from light. Discard 28 days after opening. Do not use the eye drops after the expiry date which you will find printed on the packaging. 6. FURTHER INFORMATION What Cyclopentolate Hydrochloride eye drops contain: Cyclopentolate Hydrochloride eye drops 5 ml dropper bottle contain either 0.5% or 1% of the active ingredient Cyclopentolate Hydrochloride. Each solution also contains the inactive ingredients: boric acid, potassium chloride, benzalkonium chloride solution and purified water. What Cyclopentolate Hydrochloride eye drops look like: The eye drops are available in 5 ml dropper bottles. Marketing authorisation holder and EU batch release site:

Cyclopentolate Hydrochloride 0.5% & 1.0% w/v Eye Drops, Solution, PL 17509/000& & 0008 leaflet text 03/01/2012 Intrapharm Laboratories Ltd. The Granary, The Courtyard Barns Choke Lane, Cookham Dean Maidenhead, Berkshire SL6 6PT Manufacturer: Holopack Verpackungstechnik GmbH Bahnhofstrasse 74429 Sulzbach-Laufen Germany This leaflet was last revised in January 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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