TRAVOPROST 40 MICROGRAMS / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

What is in this leaflet

1.- what-travoprost40-micfograms/ml eye drops solution is and what it isusedfor---2. what you need to know before you use travoprost 40 micrograms/ml eye drops solution

• 3. How to use travoprost 40 micrograms/ml eye drops solution

• 4. Possible side effects

• 5. How to store travoprost 40 micrograms/ml eye drops solution

• 6. Contents of the pack and other information

1.what travoprost 40 micrograms/ml eye drops solution is and what it is used for

Travoprost 40 micrograms/ml eye drops solution contains travoprost, one of a group of medicines calledprostaglandin analogues. It works by reducing the pressure in the eye. It may be used on its own or with other dropse.g. beta-blockers, which also reduce pressure.

Travoprost 40 micrograms/ml eye drops solution is used to reduce high pressure in the eye in adults, adolescents and children from 2 months old onwards. This pressure can lead to an illness called glaucoma.

2. what you need to know before you use travoprost 40 micrograms/ml eye drops solution

Do not use travoprost 40 micrograms/ml eye drops solution solution

• If you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

Ask your doctor for advice if this applies to you.

Warning and Precautions

• Travoprost 40 micrograms/ml eye drops solution may increase the length, thickness, colour and/or number of your eyelashes. Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed.
• Travoprost 40 micrograms/ml eye drops solution may change the colour of your iris (the coloured part of your eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have had cataract surgery, talk to your doctor before you use travoprost 40 micrograms/ml eye drops solution.
• If you have current or previous history of an eye inflammation (iritis and uveitis), talk to your doctor before you use travoprost 40 micrograms/ml eye drops solution.
• Travoprost 40 micrograms/ml eye drops solution may rarely cause breathlessness or wheezing or increase the symptoms of asthma. If you are concerned about changes in your breathing pattern when using travoprost 40 micrograms/ml eye drops solution advise your doctor as soon as possible.
• Travoprost 40 micrograms/ml eye drops solution may be absorbed through the skin. If any of the product comes into contact with the skin, it should be washed off straight away. This isespecially important in women who are pregnant or are attempting to become pregnant.
• Caution is recommended when using travoprost 40 micrograms/ml eye drops solution in patients without lens, or with artificial lens with a rupture of posterior lens capsule or with implant of lens in anterior chamber, or in patients with known risk factors for retinal cystoid macular oedema (which is a condition in which fluids collect on or under the central area of the retina).
• If you wear soft contact lenses, do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.

Children and adolescents

Travoprost 40 micrograms/ml eye drops solution can be used in children from 2 months to < 18 years at the same dose as for adults. Use of travoprost 40 micrograms/ml eye drops solution is not recommended to those children under 2 months of age.

Other medicines and travoprost 40 micrograms/ml eye drops solution

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy, breast feeding and fertility

Do not use travoprost 40 micrograms/ml eye drops solution if you are pregnant. If you think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you could become pregnant you must use adequate contraception whilst you use travoprost 40 micrograms/ml eye drops solution.

Do not use travoprost 40 micrograms/ml eye drops solution if you are breast feeding, travoprost 40 micrograms/ml eye drops solution may get into your breast milk.

Ask your doctor for advice before taking any medicine.

Driving and using machines

You may find that your vision is blurred for a time just after you use travoprost 40 micrograms/ml eye drops solution. Do not drive or use machines until this has worn off.

Important information about some of the ingredients

This medicine contains 0.0042 mg benzalkonium chloride in each drop which is equivalent to 0.150 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine andput them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. how to use travoprost 40 micrograms/ml eye drops solution

Always use travoprost 40 micrograms/ml eye drops solution exactly asyour doctor or the doctor treating your child has toldyou. You should check with your doctor, doctor treating your child or pharmacist if you are not sure.

The recommended dose is 1 drop in the affectedeye or eyes, once a day-in the evening. Only use travoprost 40 micrograms/ml eye drops solution in both eyes if your doctor toldyou to. Use it for as long asyour doctor or the doctor treating your child toldyou to.

Only use travoprost 40 micrograms/ml eye drops solution for dropping in your eyes.

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• Immediately before using a bottle for the first time, write the date of opening on the label in the space provided
• Wash your hands
• Twist off the cap
• Hold the bottle, pointing down, between your thumb andfingers
• Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid andyour eye. The drop will go in here (picture 1)
• Bring the bottle tip close to the eye. Use a mirror if it helps
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
• Gently squeeze the bottle to release one drop of travoprost 40 micrograms/ml eye drops solution at a time (picture 2).
• After using travoprost 40 micrograms/ml eye drops solution, keep the eyelid closed, apply gentle pressure by pressing a finger into the corner of your eye, by the nose (picture 3) for at least 1 minute. This helps to stop travoprost 40 micrograms/ml eye drops solution getting into the rest of the body
• If you take drops in both eyes, repeat the steps for your other eye
• Close the bottle cap firmly immediately after use
• Only use one bottle at a time.

If a drop misses your eye, try again.

If you or your child are using other eye preparations such aseye drop or eye ointment, wait for at least 5 minutes between putting in travoprost 40 micrograms/ml eye drops solution and the other eye preparations.

If you or your child use more travoprost 40 micrograms/ml eye drops solution than you should

Rinse it all out with warm water. Do not put in any more drops until it is time for your next regular dose.

Continue overleaf

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If you forget to use travoprost 40 micrograms/ml eye drops solution, Continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. Never use more than one drop in the affected eye(s) in a single day.

If you stop using travoprost 40 micrograms/ml eye drops solution

Do not stop using travoprost 40 micrograms/ml eye drops solution without first speaking to your doctor or the doctor treating your child, the pressure in your eye will not"be ■controlled’whrich’­coul'd lead- to toss of sight.----------------------------------

If you wear soft contact lenses

Do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.

If you have any further questions on the use of this product ask your doctor, the doctor treating your child or pharmacist.

4. possible side effects

Like all medicines, travoprost 40 micrograms/ml eye drops solution can cause side effects although not everybody gets them.

You can usually carry on using the drops, unless the side effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop taking travoprost 40 micrograms/ ml eye drops solution without speaking to your doctor.

The following side effects have been seen with travoprost 40 micrograms/ml eye drops solution.

Very common side effects: may affect more than 1 in 10 people

Effects in the eye:

• eye redness

Common side effects: may affect up to 1 in 10 people

Effects in the eye:

• changes in the colour of the iris (coloured part of the eye)
• eye irritation
• dry eye
• itchy eye
• eye pain
• eye discomfort

Uncommon side effects: may affects up to 1 in 100 people

Effects in the eye:

General side effects:

In children and adolescents, the most common side effects seen with travoprost are eye redness and growth of eyelashes. Both side effects were observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly via Yellow Card Scheme, website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store travoprost 40 micrograms/ml eye drops solution

Keep this medicine out of the sight and the reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘Exp’. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle. Write down the date you opened it in the space on each bottle label and box.

Do not throw away any medicines via wastewater or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. contents of the pack and other information

What travoprost 40 micrograms/ml eye drops solution contain

• The active substance is travoprost 40 micrograms/ml.
• The other ingredients are benzalkonium chloride, macrogol-15-hydroxystearate, trometamol, boric acid (E284), EDTA disodium, mannitol (E421), water for injection. Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.

What travoprost 40 micrograms/ml eye drops solution look like and the contents of the pack

• Travoprost 40 micrograms/ml eye drops solution is a liquid (a clear, colourless solution) supplied in a pack containing a 2.5 ml plastic bottle with a screw cap.