LATANOPROST COMBIX 50 micrograms/ml EYE DROPS SOLUTION

Introduction

PACKAGE LEAFLET:INFORMATION FOR THE USER

Latanoprost Combix 50 micrograms/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, the doctor treating your child or pharmacist.
• This medicine has been prescribed for you or your child, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, the doctor treating your child or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Latanoprost Combix is and what it is used for
2. What you need to know before you use Latanoprost Combix
3. How to use Latanoprost Combix
4. Possible side effects
5. Storage of Latanoprost Combix
6. Contents of the pack and other information

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

Latanoprost Combix belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from the eye into the bloodstream.

Latanoprost Combix is used to treat conditions known as open-angle glaucoma and ocular hypertension. Both of these conditions are caused by an increase in pressure within the eye, which can lead to impairment of vision.

Latanoprost Combix is also used to treat increased pressure in the eye and glaucoma in children and infants of all ages.

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

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

Do not use Latanoprost Combix

• if you are allergic (hypersensitive) to latanoprost or any of the other ingredients of Latanoprost Combix (see section 6)
• if you are pregnant or trying to become pregnant
• if you are breast-feeding

Warnings and precautions

If you think that any of the following apply to you or your child, consult your doctor, the doctor treating your child or pharmacist before using Latanoprost Combix:

• if you or your child have had or are going to have eye surgery (including cataract surgery)
• if you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision)
• if you or your child have dry eyes
• if you or your child have severe asthma or uncontrolled asthma
• If you or your child wear contact lenses. You can continue to use Latanoprost Combix, but you should follow the instructions for contact lens wearers, which are included in section 3
• If you or your child have had or are suffering from a viral infection of the eye caused by the herpes simplex virus (HSV)

Other medicines and Latanoprost Combix

Latanoprost Combix may interact with other medicines. Tell your doctor, the doctor treating your child or pharmacist if you or your child are using or have recently used other medicines (or eye drops), including those obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

It is not recommended to use Latanoprost Combix during pregnancy.

Breast-feeding

Do not use Latanoprost Combixif you are breast-feeding.

Driving and using machines

When using Latanoprost Combix, blurred vision may occur for a short time. If this happens, do not driveor use tools or machines until your vision is clear again.

Latanoprost Combix contains benzalkonium chloride

This medicine contains 0.5 mg of benzalkonium chloride per bottle, equivalent to 0.2 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the colour of the contact lenses. If you or your child wear contact lenses, you should remove the lenses before using this medicine and wait at least 15 minutes before putting the lenses back in your eyes. Follow the instructions for contact lens wearers, which are included in section 3.

Benzalkonium chloride may also cause eye irritation, especially if you or your child have dry eyes or other corneal disorders. Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

Latanoprost Combix contains phosphates

This medicine contains 15.625 mg of phosphates per bottle, which is equivalent to 6.25 mg/ml.

If you or your child have severe damage to the transparent layer on the front of the eye (the cornea), phosphates may cause, in very rare cases, cloudy patches on the cornea due to calcium deposits during treatment.

3. How to use Latanoprost Combix

Follow exactly the instructions for administration of this medicine given by your doctor or the doctor treating your child. Consult your doctor, the doctor treating your child or pharmacist if you have any doubts.

The usual dose for adults (including the elderly) and children is one drop in the affected eye(s) once daily. It is preferable to administer it in the evening.

Do not use Latanoprost Combix more than once daily; the effectiveness of the treatment may decrease if it is administered more frequently.

Use Latanoprost Combix as your doctor or the doctor treating your child has told you, until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, you should remove them before using Latanoprost Combix. After applying Latanoprost Combix, you should wait at least 15 minutes before putting the contact lenses back in your eyes.

Instructions for use

Follow these steps to use Latanoprost Combix correctly:

1. Wash your hands and sit comfortably.
2. Before opening the bottle for the first time, make sure the cap is intact.
3. Open the bottle by twisting the cap to the left.
4. Tilt your head back and gently pull the lower eyelid down, forming a pouch between the eye and the eyelid.
5. Hold the bottle upside down and press it gently in the centre with your thumb and index finger, until one drop falls into the pouch, as instructed by your doctor. Do not let the tip of the bottle touch the eye or eyelid. Press the tear duct for 1 minute (by pressing the finger on the corner of the eye, near the nose), close the eye/eyes and keep it/them closed for this time. This ensures that the eye absorbs the drop and that the amount of medicine that drains from the tear duct to the nose is probably reduced.
6. Repeat steps 4 and 5 in the other eye, if your doctor has told you to do so.
7. Put the cap back on the bottle. Do not screw the cap too tightly.

If you use Latanoprost Combix with other eye drops

Wait at least 5 minutes between the application of Latanoprost Combix and the administration of other eye drops.

If you use more Latanoprost Combix than you should

If you have applied more drops in the eye than you should, you may feel a mild irritation in the eye and the eyes may become red and watery; this should disappear, but if you are concerned, contact your doctor or the doctor treating your child.

Contact your doctor as soon as possible if you or your child accidentally ingest Latanoprost Combix.

In case of overdose or accidental ingestion, yours or your child's, with Latanoprost Combix, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Latanoprost Combix

If you forget to apply the drops at the usual time, omit the missed dose. Do not apply an extra drop. Continue with the next dose as usual.

If you stop using Latanoprost Combix

If you want to stop using Latanoprost Combix, consult your doctor or the doctor treating your child.

If you have any other questions about the use of this medicine, ask your doctor, the doctor treating your child or pharmacist.

4. Possible side effects

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

The following are known side effects of Latanoprost Combix:

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

• Gradual change in 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 experience this change than if your eyes are a single colour (blue, grey, green or brown). The change in eye colour may take years to develop, although it can usually be seen after 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if Latanoprost Combix is used in one eye only. The change in eye colour does not appear to be associated with any problems. The change in eye colour does not progress once treatment with Latanoprost Combix has been stopped.
• Redness of the eye.

• Eye irritation (feeling of burning, feeling of grit in the eye, itching, pain or feeling of a foreign body in the eye). If you experience severe eye irritation that makes your eyes water excessively or makes you consider stopping treatment, consult your doctor, pharmacist or nurse as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the right treatment for your condition.

• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, seen in most patients of Japanese origin. These changes include an increase in colour (darkening), length, thickness and number of eyelashes.

Common (may affect up to 1 in 10 people):

• Irritation or erosion of the surface of the eye, inflammation of the eyelid (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):

• Swelling of the eyelids, dry eyes, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
• Skin rash.
• Chest pain (angina), feeling your heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), symptoms of swelling or injury/damage to the surface of the eye, swelling around the eye (periorbital oedema), misdirected eyelashes or extra row of eyelashes, scarring of the surface of the eye, accumulation of fluid in the coloured part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Intense itching of the skin.
• Development of a viral infection of the eye caused by the herpes simplex virus (HSV).

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

• Worsening of angina in patients who also have heart problems, appearance of sunken eyes (greater depth of the eyelid sulcus).

The side effects seen in children are more frequent than in adults and include runny nose and itchy nose and fever.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website for the reporting of adverse reactions: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Combix

Keep 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. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

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

After first opening the bottle: Do not store above 25°C. The product should be discarded 4 weeks after first opening, even if it is not used completely.

Medicines should not be disposed of via wastewater or 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

Composition of Latanoprost Combix

The active substance is latanoprost 50 micrograms/ml. One drop contains approximately 1.5 micrograms of latanoprost.

The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, sodium hydroxide or hydrochloric acid for pH adjustment, water for injections.

Appearance and packaging of Latanoprost Combix

Latanoprost Combix is a clear and colourless eye drop solution.

Each bottle contains 2.5 ml of eye drop solution, which corresponds to approximately 80 drops of solution.

Latanoprost Combix is available in the following pack sizes:

1 x 2.5 ml dropper bottle

3 x 2.5 ml dropper bottles

6 x 2.5 ml dropper bottles

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Combix, S.L.U

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Rafarm S.A.

Thesi Pousi-Hatzi Agiou Louka

Paiania Attiki 19002

P.O. Box 37

Greece

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

Spain Latanoprost Combix 50 micrograms/ml eye drops, solution

Poland Latanoprost Genoptim

This leaflet was approved in March 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/