Latanoprost Combix 50 microgramos/ml eye drops solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost Combix 50 micrograms/ml eye drops, solution

Latanoprost

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, your child's doctor, or pharmacist.
• This medicine has been prescribed for you or your child; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, your child's doctor, or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Latanoprost Combix is and what it is used for
2. What you need to know before using Latanoprost Combix
3. How to use Latanoprost Combix
4. Possible side effects
5. How to store Latanoprost Combix
6. Contents of the container 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 inside the eye into the bloodstream.

Latanoprost Combix is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which may eventually affect vision.

Latanoprost Combix is also used to treat elevated intraocular pressure and glaucoma in children and infants of all ages.

2. What you need to know before using Latanoprost Combix

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

Do not use Latanoprost Combix

• if you are allergic (hypersensitive) to latanoprost or to any of the other components of Latanoprost Combix (see the list of ingredients in section 6)

Warnings and precautions

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

• 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 asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Latanoprost Combix, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV)

Other medicines and Latanoprost Combix

Latanoprost Combix may interact with other medicines. Inform your doctor, the doctor treating your child, or pharmacist if you or your child are using or have recently used any other medicines (or eye drops), including those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use latanoprost if you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and use of machines

Blurred vision may occur for a short period of time when using Latanoprost Combix. If this happens, do not drive or operate tools or machinery until your vision returns to normal.

Latanoprost Combix contains benzalkonium chloride

This medicine contains 0.500 mg of benzalkonium chloride per container, equivalent to 0.200 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact lenses. You must remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Follow the instructions provided in section 3 for contact lens wearers.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

Latanoprost Combix contains phosphates

This medicine contains 15.625 mg of phosphates per vial, equivalent to 6.250 mg/ml.

If you have a severe injury to the transparent layer at the front of the eye (the cornea), phosphates may, in very rare cases, cause cloudy patches in the cornea due to calcium accumulation during treatment.

3. How to use Latanoprost Combix

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

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once daily. It is preferable to administer it at night.

Do not use Latanoprost Combix more than once a day; the effectiveness of treatment may decrease if administered more frequently.

Use Latanoprost Combix exactly as directed by your doctor or the doctor treating your child until they tell you to stop.

Contact lens users

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

Instructions for use

Follow the steps below to correctly use Latanoprost Combix:

1. Wash your hands and sit comfortably.
2. Before opening the bottle for the first time, ensure the cap is intact.
3. Open the bottle by unscrewing the cap to the left.
4. Tilt the head backwards and gently pull down the lower eyelid to form a pouch between the eye and eyelid.
5. Hold the bottle upside down and carefully squeeze it with your thumb and index finger in the center 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 with your finger at the inner corner of the eye near the nose), close the eye/eyes, and keep it/them closed during this time. This ensures the eye absorbs the drop and likely reduces the amount of medicine draining from the tear duct into the nose.
6. Repeat steps 4 and 5 in the other eye, if your doctor has instructed you to do so.
7. Replace the cap on the bottle. Do not overtighten the cap.

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 into the eye than you should have, you may experience mild eye irritation, redness, and tearing; this should resolve on its own, 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 by you or your child with Latanoprost Combix, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Latanoprost Combix

Continue with the next dose as usual. Do not apply an extra drop in the eye to make up for a missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Combix

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following are known adverse effects when using Latanoprost Combix:

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

• Gradual change in eye colour due to increased 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 of a single colour (blue, grey, green or brown). The change in eye colour may take years to develop, although it is usually noticeable after 8 months of treatment. The colour change may be permanent and may be more pronounced if Latanoprost Combix is used in only one eye. This 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 is stopped.

• Eye redness.

• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain or foreign body sensation in the eye). If you experience severe eye irritation causing excessive tearing or that makes you consider stopping treatment, consult your doctor, pharmacist or nurse as soon as possible (within one week). Your treatment may need to be reviewed to ensure you are receiving the appropriate therapy for your condition.

• Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, observed in most Japanese-origin patients. These changes include increased pigmentation (darkening), lengthening, thickening and increased number of eyelashes.

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

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

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

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

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

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

• Worsening of angina in patients with existing heart problems, appearance of sunken eyes (increased depth of the eyelid groove).

Adverse effects observed in children at a higher frequency than in adults include runny nose, nasal itching and fever.

In very rare cases, some patients with severe damage to the clear front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits during treatment.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Combix

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the bottle. The expiry date refers to the last day of the month indicated.

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

Keep the bottle in the outer packaging to protect it from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This 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 components are benzalkonium chloride, monohydrate monosodium dihydrogen phosphate, anhydrous disodium phosphate, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injection.

Appearance of the product and contents of the container

Latanoprost Combix is available as an eye drop solution, transparent and colourless.

Each bottle contains 2.5 ml of ophthalmic solution, corresponding to approximately 80 drops of solution.

Latanoprost Combix is available in the following pack sizes:

1 dropper bottle of 2.5 ml
3 dropper bottles of 2.5 ml
6 dropper bottles of 2.5 ml

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in EEA member states under the following names:

Spain: Latanoprost Combix 50 micrograms/ml eye drops solution
Poland: Latanoprost Genoptim

This leaflet was last revised in January 2026

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/