PROSPECTO:INFORMATION FOR THE USER

Latanoprost Combix 50 micrograms/ml eye drops in solution

Latanoprost

Read this prospect carefully before starting to use the medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, the doctor treating your child or pharmacist.
• This medicine has been prescribed to you, or your child and must not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, the doctor treating your child or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to use Latanoprost Combix

4.Possible adverse effects

5.Storage of Latanoprost Combix

6.Contents of the package and additional information

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

Latanoprost Combix is used to treat diseases known asopen-angle glaucoma and ocular hypertension. Both diseases are related to an increase in pressure within the eye, which can affect vision.

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

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 investigated in premature children (less than 36 weeks of 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 components in the medication in section 6)
• if you are pregnant or trying to become pregnant
• if you are breastfeeding

Warnings and precautions

If you consider that any of the following situations affect you or your child, consult your doctor, or the doctor treating your child, or your pharmacist before administering Latanoprost Combix or before administering it to your child:

• if you or your child have undergone or are going to undergo 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 use contact lenses. You may continue to use Latanoprost Combix, but you must follow the instructions included in section 3 for contact lens users
• if you or your child have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV)

Other medications and Latanoprost Combix

Latanoprost Combix may interact with other medications. Inform your doctor, doctor treating your child, or pharmacist if you or your child are using or have recently used other medications (or eye drops), even those purchased without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of Latanoprost Combix during pregnancy is not recommended.

Breastfeeding

Do not use Latanoprost Combixif you are breastfeeding.

Driving and operating machinery

When using Latanoprost Combix, blurred vision may appear for a short period of time. If this happens,do not driveor use tools or machinery until your vision returns to normal.

Latanoprost Combix contains benzalkonium chloride

This medication contains 0.500 mg of benzalkonium chloride in each container, equivalent to 0.200 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses.If you or your child use contact lenses, you must remove the contact lenses before using this medication and wait 15 minutes before reinserting them. Follow the instructions included in section 3 for contact lens users.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Latanoprost Combix contains phosphates

This medication contains 15.625 mg of phosphates in each bottle, equivalent to 6.250 mg/ml.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or the doctor treating your child. Consult your doctor or the doctor treating your child or pharmacist if you have doubts.

The usual dose for adults (including elderly) and children is 1 drop in the eye or eyes affected once a day. It is preferable to administer at night.

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

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

Users of contact lenses

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

Usage instructions

Follow the steps below to use Latanoprost Combix correctly:

1. Wash your hands and sit comfortably.
2. Before opening the bottle for the first time, make sure the stopper is intact.
3. Open the bottle by unscrewing the stopper to the left.
4. Incline your head back and gently separate the lower eyelid, forming a pouch between the eye and the eyelid.
5. Hold the bottle upside down and press it gently in the center with your thumb and index finger until a drop falls into the pouch, as indicated by your doctor.Do not let the tip of the bottle touch the eye or eyelid. Press the tear duct for 1 minute (pressing with your finger the end of the eye, near the nose), close the eye/eyes and keep it/ them closed during this time. This ensures that the eye absorbs the drop and that the amount of medication that drips from the tear duct into the nose is likely to be reduced.
6. Repeat steps 4 and 5 in the other eye, if your doctor has instructed you to do so.
7. Replace the stopper on the bottle. Do not tighten the stopper too much.

Using Latanoprost Combix with other eye drops

Wait at least 5 minutes between applying Latanoprost Combix and administering other eye drops.

Using more Latanoprost Combix than you should

If more drops than you should have been applied to the eye, you may feel a slight irritation in the eye and also your eyes may become red and tearful; this situation 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, your or your child's with Latanoprost Combix, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to use Latanoprost Combix

If you forget to administer the drops at your usual time, omit the missed dose. Do not apply an additional drop.Continue with the administration of the next dose in the usual manner.

Stopping treatment with Latanoprost Combix

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

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

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

The following are known side effects when using Latanoprost Combix:

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

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-colored eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, gray, green, or brown). The change in eye color may take years to develop, although it can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Latanoprost Combix is used in only one eye. The change in eye color does not appear to be associated with any problems. The change in eye color does not progress once treatment with Latanoprost Combix has been stopped.
• Redness of the eye.

• Ocular irritation (sensation of burning, sensation of sand in the eye, itching, pain, or sensation of a foreign body in the eye).If you experience severe ocular irritation that causes excessive tearing 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 appropriate treatment for your condition.

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

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

• 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 patients):

• Swelling of the eyelids, dry eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), feeling the heart rhythm (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, the colored part of the eye (iritis/uveitis); swelling of the retina (macular edema), symptoms of swelling or damage to the surface of the eye, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, scarring of the surface of the eye, accumulation of fluid in the colored part of the eye (iris cyst).
• Reactions on the skin of the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Intense itching of the skin.
• 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 who also have heart problems, appearance of sunken eyes (greater depth of the eyelid crease).

The side effects observed in children at a frequency greater than in adults are runny nose and itchy nose and fever.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the bottle. The expiration date is the last day of the month indicated.

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

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

After the first opening of the bottle: Do not store at a temperature above 25°C. The product must be discarded four weeks after it has been opened for the first time, even if it has not been used completely.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines that you do not need in the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

Composition of Latanoprost Combix

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

The other components are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, sodium chloride, sodium hydroxide or hydrochloric acid for pH adjustment, and water for injection preparations.

Appearance of the product and contents of the packaging

Latanoprost Combix is presented in the form of an eye drop solution, transparent and colorless.

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 packaging sizes:

1 bottle dropper of 2.5 ml

3 bottles dropper of 2.5 ml

6 bottles droppers of 2.5 ml

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Combix Laboratories, S.L.U

C/ Badajoz 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible:

Rafarm S.A.

Thesi Pousi-Hatzi Agiou Louka

Paiania Attiki 19002

P.O. Box 37

Greece

This medicine is authorized in the EEA member states under the following names:

SpainLatanoprost Combix 50 micrograms/ml eye drop solutionn

PolandLatanoprost Genoptim

This leaflet was approved in March 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/