Timolol Eye Drops 0.25%, Timolol Eye Drops 0.5%

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TIMOLOL Eye drops 0.25 %

TIMOLOL Eye drops 0.5 %

Timolol 2.5 mg/ml (as timolol maleate 3.4mg/ml)

Timolol 5.0 mg/ml (as timolol maleate 6.8mg/ml)

Please read this leaflet carefully before you start to take your medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, please 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This medicine will be called Timolol in this leaflet.

In this leaflet:

1. What Timolol is and what is it used for
2. Before you use Timolol
3. How to use Timolol
4. Possible side effects
5. How to store Timolol
6. Further information

What Timolol Is And What Is It Used For

The active ingredient timolol belongs to a group of medicines called beta-blockers.

Timolol is used to treat raised pressure of eye (intraocular pressure) which occurs in various conditions including glaucoma and ocular hypertension.

Before You Use Timolol

Do not use if you:

are allergic (hypersensitive) to timolol maleate or beta-blockers or to any other ingredient of this medicine (see section 6. for more details) suffer from asthma or have history of asthma or any other breathing disorder suffer from a condition known as heart block, which causes your heart to beat at an abnormally slow rate suffer from cardiac failure, a condition where your heart cannot work normally. Take special care with Timolol

Before you use Timolol please tell your doctor if you:

are taking beta-blocking agents or calcium antagonists by mouth or as eye drops are suffering from muscle weakness, condition called myasthenia gravis Taking other medicines

Check with your doctor before using the eye drops if you are taking or using any other medicines, in particular:

a calcium antagonist (e.g. verapamil or diltiazem) often used to treat high blood pressure, angina, or an abnormal heartbeat digoxin, often used to treat heart failure or an abnormal heartbeat medicines known as a catecholamine-depleting agents (e.g. rauwolfia alkaloids/reserpine) used to treat high blood pressure a pressor amine (e.g. adrenaline) used to treat severe allergic reaction clonidine to treat high blood pressure quinidine, a medicine often used to treat abnormal heartbeat other beta-blockers (e.g. other preparations of timolol both oral and/or ocular), which belong to the same group of medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without any prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines.

Timolol should not be used during pregnancy and breast-feeding unless considered essential by your doctor.

Driving and using machines

No effects on ability to drive and use machines have been reported. However do not drive or operate machines if you experience any visual disturbance after using the product. Wait until this clears before driving or using machines.

Important information about some of the ingredients of Timolol Eye Drops:

The eye drops contain benzalkonium chloride as preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting. The preservative is known to discolour soft contact lenses.

How To Use Timolol

Always use Timolol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose is one drop of 0.25% eye drops into each affected eye(s) twice daily, approximately 12 hours apart. Your doctor will change your treatment as necessary. If you are using in combination with another eye drop medicine, wait 5-15 minutes before applying the second eye drop.

Use in children:

It is not recommended to use Timolol in children under 12 years of age.

Instructions for use:

(please also refer to pictograms at the end of the leaflet)

First wash your hands Avoid touching the eye (or any other surface) with the tip of the bottle If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle Tilt your head back and look at the ceiling Pull the lower eyelid gently downwards Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute Repeat for the other eye if necessary Replace and tighten the cap immediately after use.

Be careful not to touch the tip of the bottle on your eye or on any other surface.

Ocular solutions, if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately.

Keep using your medicine until your doctor tells you to stop.

If you use more Timolol than you should

If you accidentally use too much, contact your doctor or go to the nearest hospital casualty department immediately.

Overdose

There is no experience of an overdosage with Timolol which is unlikely when given as eye drops.

The signs of overdosage include slow heart rate, drop of blood pressure, breathing difficulties, and heart attack.

If you forget to use Timolol

Apply the drops as soon as you remember. However, if it is almost time for your next dose, do not double your dose and carry on with the normal schedule dose.

Possible Side Effects

Like all medicines, Timolol can cause side effects, although not everybody gets them.

If you experience a rare (these may affect between 1 in 1,000 and 1 in 10,000 patients) but serious allergic reaction (difficulty breathing, closing of the throat, swelling of the lips, tongue, or face or hives) to timolol, stop using the medication and contact your doctor immediately.

Please tell your doctor if you notice any of the following side effects

irritation of the outer surface of the eye (conjunctivitis, keratitis and decreased corneal sensitivity) and of the eyelids (blepharitis) visual disturbance chest pain, high or low blood pressure, palpitations, irregular heart beat, heart failure, heart block, heart attack, stroke, swelling or coldness of your hands, feet and extremities, caused by constriction of the blood vessels in response to stimuli, including the cold dry mouth, nasal congestion pain or burning in the stomach, loss of appetite low blood pressure with faintness, dizziness depression, anxiety and other psychiatric disturbance increased signs of the condition myasthenia gravis (weakness, dropping eyelids, double vision) nausea headache weakness and somnolence hair loss

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Timolol

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

Protect from light.

Discard the bottle 28 days after opening, even if there is solution remaining.

Do not use Timolol after the expiry date which is stated on the bottle and on the carton the bottle is packed in.

Further Information What Timolol contains

The active ingredient is timolol maleate, where 5mg/ml timolol is equivalent to 6.8mg/ml of timolol maleate and 2.5mg/ml timolol is equivalent to 3.4mg/ml of timolol maleate.

This product also contains sodium dihydrogen phosphate dihydrate, disodium edetate, disodium phosphate dodecahydrate, benzalkonium chloride (as preservative) 0.01% w/v, sodium hydroxide, sodium chloride and water for injection.

What Timolol look like and contents of the pack

One bottle of Timolol contains 5 ml solution.

Your medicine is a clear colourless, sterile solution.

Marketing Authorisation Holder and Manufacturer FDC International Ltd At: Unit 6, Fulcrum 1 Solent Way Whiteley Fareham Hampshire PO15 7FE

PL numbers: 15872/0001 (0.25%) and 15872/0002 (0.5%)

Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help.

This leaflet was last approved in: 09/2009

MODE OF USE

Bottle as received

Tighten the cap on the nozzle till the cap touches the shoulder.

The spike in the cap will pierce the tip of the bottle.

Tilt head backwards. Dispense drops with gentle pressure. Do not touch dropper tip to the surface of the eye.

Replace cap after every use, and screw the cap down

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Timolol Eye Drops 0.25 Timolol Eye Drops 0.5

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