Document: Latanoprost Mylan eye drops, solution ENG PL change

• Latanoprost Mylan eye drops solution PL
• Latanoprost Mylan eye drops, solution ENG PL

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Package leaflet: Information for the patient

Latanoprost Mylan 50 microgram/ml eye drops, solution

latanoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor , or the doctor treating your child or your pharmacist.

- This medicine has been prescribed for you or for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

What is in this leaflet

1. What Latanoprost Mylan is and what it is used for

2. What you need to know before you use Latanoprost Mylan

3. How to use Latanoprost Mylan

4. Possible side effects

6. Contents of the pack and other information

Latanoprost Mylan contains the active ingredient latanoprost which belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Latanoprost Mylan is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eyesight.

Latanoprost Mylan is also used to treat increased eye pressure and glaucoma in all ages of children and babies.

Latanoprost Mylan can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost Mylan has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use Latanoprost Mylan:

Warnings and precautions

Talk to your doctor or the doctor treating your child, or your pharmacist before you use Latanoprost Mylan or before treatment in case you or your child:

• are about to have or have had eye surgery (including cataract surgery).

• suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision).

• suffer from dry eyes or have a disease affecting the front of the eye (the cornea).

• have severe asthma or asthma that is not well controlled.

• have certain forms of glaucoma known as ‘chronic angle-closure’ or ‘congenital’ glaucoma.

• have glaucoma caused by pigments forming within the eye’s angle chamber.

• have glaucoma caused by eye inflammation or new blood vessels forming within the eye.

• have glaucoma at the same time as having no lens or an artificial lens, or if your eye is aphakic (the lens in your eye is missing) or pseudoaphakic with a torn posterior lens capsule or anterior chamber lens.

• have known risk factors for swelling at the back of the eye (macular oedema) or for inflammation of the iris (iritis/uveitis) such as if you have a vascular disorder affecting the eye or abnormalities of the retina as a result of diabetes.

• have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV), especially if this was caused by use of prostaglandin analogues.

• wear contact lenses. You or your child can still use Latanoprost Mylan, but follow the instruction for contact lens wearers in Section 3.

• If you are pregnant or trying to become pregnant.

• If you are breastfeeding.

Other medicines and Latanoprost Mylan

Latanoprost Mylan may interact with other medicines. Tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or using, have recently taken or used or might take or use any other medicines including medicines (or eye drops) obtained without a prescription.

The effect of other prostaglandins or prostaglandin derivatives (used to treat increased eye pressure) can be influenced by Latanoprost Mylan. Combining these with Latanoprost Mylan is not recommended, as the eye pressure may increase.

Pregnancy and breast-feeding

Do not use Latanoprost Mylan when you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.

Do not use Latanoprost Mylan when you are breast-feeding. Latanoprost may pass into breast milk and therefore the child might be affected.

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

Driving and using machines

When you use Latanoprost Mylan you might have blurred vision, for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.

Latanoprost Mylan contains benzalkonium chloride

This preservative may cause eye irritation or disruption to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.

If you or your child wear contact lenses, you should remove them before using Latanoprost Mylan. After using Latanoprost Mylan you should wait 15 minutes before putting your contact lenses back in. See the instructions for contact lens wearers in Section 3.

Always use this medicine exactly as your doctor, or the doctor treating your child, or your pharmacist has told you. Check with your doctor, or the doctor treating your child or pharmacist if you are not sure.

The recommended dose for adults (including the elderly) and children is one drop once a day in the affected eye(s). The best time to do this is in the evening.

Do not use Latanoprost Mylan more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use Latanoprost Mylan as instructed by your doctor, or the doctor treating your child until your doctor tells you to stop.

Contact lens wearers

If you or your child wear contact lenses, you should remove them before using Latanoprost Mylan. After using Latanoprost Mylan you should wait 15 minutes before putting your contact lenses back in.

Instructions for use

If you use Latanoprost Mylan with other eye drops

Wait at least 5 minutes between using Latanoprost Mylan and other eye drops.

If you use more Latanoprost Mylan than you should

If you put too many drops into your eye, you may experience some minor irritation in your eye and your eyes may water and turn red. This should pass, but if you are worried contact your doctor or the doctor treating your child for advice.

Contact your doctor as soon as possible if you or your child swallows Latanoprost Mylan accidentally.

If you forget to use Latanoprost Mylan

Carry on with the usual dose at the usual time. Do not use a double dose to make up for the dose you have forgotten. If you are unsure about anything talk to your doctor or pharmacist.

If you stop using Latanoprost Mylan

You should speak to your doctor or the doctor treating your child if you want to stop using Latanoprost Mylan.

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

4. Possible side effects

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

If you get any of the following side effects, stop using the medicine and contact your doctor or go to your nearest hospital emergency department as soon as possible:

• Inflammation of the surface of the eye (the cornea).

• Inflammation of the iris or the coloured part of the eye (iritis/uveitis).

• Swelling of the retina - the back of the eye (macular oedema).

• a viral infection of the eye caused by the herpes simplex virus, associated with inflammation/irritation of the surface of the eye (keratitis).

The following side effects have also been reported:

Very common (may affect more than 1 in 10 people)

• A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Latanoprost Mylan in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Latanoprost Mylan treatment is stopped.

• Redness of the eye.

• Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).

• A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly in people of Japanese origin. These changes involve an increase of the colour (darkening), length, thickness and number of your eye lashes.

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

• Eyelid swelling, dryness of the eye, blurred vision and conjunctivitis.

• Skin rash.

Rare (may affect up to 1 in 1000 people)

• Symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema) misdirected eyelashes or an extra row of eyelashes.

• Skin reactions on the eyelids, darkening of the skin of the eyelids.

• Asthma, worsening of asthma and shortness of breath (dyspnoea).

Very rare (may affect up to 1 in 10,000 people)

• Angina (chest pain).

• Sunken eye appearance (eye sulcus deepening).

• In some patients with severe damage to the clear layer at the front of the eye (the cornea), the use of eye drops containing a source of phosphate, such as this medicine, the development of cloudy patches on the cornea has been seen due to a build-up of calcium during treatment.

Other side effectswhich have been reported since latanoprost was marketed (frequency cannot be estimated from the available data):

• Fluid filled area within the coloured part of the eye (iris cyst).

• Headache, dizziness.

• Awareness of heart rythym (palpitations).

• Muscle pain and joint pain.

Additional side effects in children and adolescents

Side effects seen more often in children compared to adults are runny itchy nose and fever.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Latanoprost Mylan

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

Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The

expiry date refers to the last day of that month.

Do not use this medicine if you notice that the tamper evident seal has been broken or damaged before you first open it.

Store the unopened bottle in a refrigerator (between 2 °C – 8 °C). After first opening the bottle it is not necessary to store the bottle in a refrigerator but do not store it above 25°C. Use within 4 weeks of opening. .

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw

away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Latanoprost Mylan contains

• The active substance is latanoprost.

• Each ml eye drops solution contains 50 micrograms of latanoprost.

• The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate and water for injections.

What Latanoprost Mylan looks like and contents of the pack

Latanoprost Mylan is a clear colourless, aqueous solution.

Latanoprost Mylan is packaged in a round translucent plastic dropper bottle with translucent plastic dropper plug and turquoise plastic screw cap with tamper evident sealing ring.

Each bottle contains 2.5 ml of Latanoprost Mylan eye drops, solution.

Latanoprost Mylan is available in the following pack sizes:

1 bottle of 2.5 ml, eyes drops solution,

3 bottles of 2.5 ml, eye drops solution,

6 bottles of 2.5 ml, eye drops solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Mylan S.A.S (Saint Priest) 117 Allee des Parcs, 69 800 Saint Priest, France.

Wessling Hungary Kft., Fóti út 56, H-1047 Budapest, Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in 2015-10-29