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«Latanoprost Actavis 50 mcg/ml Eye Drops Solution. PA 1380/107/1 V009 Package leaflet: Information for the user Latanoprost Actavis 50 microgram/ml ...»

Latanoprost Actavis 50 mcg/ml Eye Drops Solution. PA 1380/107/1

V009

Package leaflet: Information for the user

Latanoprost Actavis 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.

- If you or your child get any side effects, talk to your doctor or the doctor treating your child or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

3. How to use Latanoprost Actavis

4. Possible side effects

5. How to store Latanoprost Actavis

6. Contents of the pack and other information 1. What Latanoprost Actavis is and what it is used for Latanoprost Actavis 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 Actavis is ued 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 eye sight.

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

2. What you need to know before you use Latanoprost Actavis Latanoprost Actavis can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost Actavis has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use Latanoprost Actavis if you are  -Allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6)  Pregnant or trying to become pregnant  Breast feeding 9th September 2014 ie-pl-cl Latanoprost Actavis 50 mcg/ml Eye Drops Solution. PA 1380/107/1 V009 Warnings and precautions Talk to your doctor or the doctor treating your child or your pharmacist before using Latanoprost Actavis or before you give this to your child if you think any of the following apply to you or your

child:

If you or your child are about to have or have had eye surgery (including cataract surgery)  If you or your child suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision)  If you or your child suffers from dry eyes  If you or your child have severe asthma or the asthma is not well controlled  If you or your child wear contact lenses. You can still use Latanoprost Actavis, but follow the instructions for contact lens wearers in Section 3  If you or your child have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV) Other medicines and Latanoprost Actavis Latanoprost Actavis may interact with other medicines: Tell your doctor, the doctor treating your child or pharmacist if you or your child are taking, have recently taken or might take any other medicines.

Pregnancy Do not use Latanoprost Actavis when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.

Breast-feeding Do not use Latanoprost Actavis when you are breast-feeding.

Driving and using machines When you use Latanoprost Actavis 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 Actavis contains benzalkonium chloride Latanoprost Actavis contains a preservative called 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, they should be removed before using Latanoprost Actavis.

After using Latanoprost Actavis you should wait 15 minutes before putting the contact lenses back in.

See the instructions for contact lens wearers in Section 3

–  –  –

Always use this medicinal exactly as your doctor or the doctor treating your child has told you. You should check with your doctor or the doctor treating your child or pharmacist if you are not sure.

The usual dosage 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 Actavis more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use Xalatan as instructed by your doctor or the doctor treating your child until they tell you to stop.





Contact lens wearers If you or your child wear contact lenses, they should be removed before using Latanoprost Actavis. After using Latanoprost Actavis you should wait 15 minutes before putting your contact lenses back into the eyes.

Instructions for use

1. Wash your hands and sit or stand comfortably.

2. Twist off the cap.

3. Use your finger to gently pull down the lower eyelid of your affected eye.

4. Place the tip of the bottle close to, but not touching your eye.

5. Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.

6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.

7. Repeat in your other eye if your doctor has told you to do this.

8. Replace cap on the bottle If you use Xalatan with other eye drops Wait at least 5 minutes between using Xalatan and taking other eye drops If you use more Latanoprost Actavis than you should If you put too many drops into the eye, it may lead to some minor irritation in the eye and the 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 Xalatan accidentally.

If you forget to use Latanoprost Actavis Carry on with the usual dosage at the usual time. Do not take 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 Actavis You should speak to your doctor or the doctor treating your child if you want to stop taking Latanoprost Actavis.

–  –  –

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

The following are known side effects of using Latanoprost Actavis:

Very common (likely to 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 Xalatan 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 Xalatan 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 (likely to affect less than 1 in 10 people):

Irritiation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain and light sensitivity (photophobia).

Uncommon (likely to affect less than 1 in every 100 people):

- Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.

- Skin rash

Rare (likely to affect less than 1 in every 1000 people):

 Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), 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 (likely to affect less than 1 user in 10,000 people):

 Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye sulcus deepening).

Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye (iris cyst), headache, dizziness, awareness of heart rhythm (palpitations), muscle pain, joint pain and developing a viral infection of the eye caused by the herpes simplex virus (HSV).

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

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

–  –  –

Reporting of side effects Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:

+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5. How to store Latanoprost Actavis Keep out of the sight and reachof children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

Before opening the bottle:

Store in a refrigerator (2°C – 8°C). This medicinal product should also be kept refrigerated during transport from the manufacturer to the pharmacy. It is although not necessary for you to keep it refrigerated during transport e.g. from the pharmacy to your home.

After first opening the bottle:

Do not store above 25°C and use within four weeks.

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.

–  –  –

What Latanoprost Actavis contains

- The active substance is latanoprost. One ml of eye drops, solution, contains 50 microgram latanoprost. One drop contains approximately 1.5 microgram latanoprost.

- The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, sodium chloride, purified water.

What Latanoprost Actavis looks like and contents of the pack Latanoprost Actavis is a clear, colourless eye drop solution in a plastic bottle with a dropper and plastic cap. Each bottle contains 2.5 ml eye drops, solution corresponding to approximately 80 drops of solution.

Latanoprost Actavis is available in packs of 1, 3 and 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

–  –  –

Marketing Authorisation Holder:

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturer:

HBM Pharma s.r.o.

03680 Martin Sklabinskà 30 Slovak Republik Jadran Galenski Laboratorij d.d.

Pulac 4A Rijeka, 51000 Croatia This medicinal product is authorised in the Member States of the EEA under the

following names:

Cyprus, Denmark, Finland, Portugal, Sweden: Latanoprost Actavis Germany: Latanoprost-Actavis 0,005% Augentropfen Ireland: Latanoprost Actavis 50 microgram/ml Eye Drops Solution UK: Latanoprost 50microgram Eye Drops Solution This leaflet was last revised in December 2014



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