LATANOPROST QUALIGEN 50 micrograms/ml EYE DROPS SOLUTION

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

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

Do not use Latanoprost Qualigen

• If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If you consider that any of the following situations apply to you or your child, consult your doctor, the doctor treating your child, or pharmacist before starting to use Latanoprost Qualigen 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 uncontrolled asthma.
• If you or your child wear contact lenses. You can continue to use Latanoprost Qualigen, but you must follow the instructions for contact lens wearers included in section 3.
• If you have had or are having a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Latanoprost Qualigen

Latanoprost Qualigen 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 other medicines (or eye drops), even 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 Qualigen if you are pregnant or breastfeeding, unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

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

Latanoprost Qualigen contains benzalkonium chloride and phosphate buffer

This medicine contains 0.01 mg of benzalkonium chloride per drop, equivalent to 0.2 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride can cause eye irritation, especially if you have dry eyes or other corneal disorders (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, stinging, or pain in the eye after using this medicine.

This medicine contains 0.467 mg of phosphates (in the form of disodium phosphate anhydrous and sodium dihydrogen phosphate monohydrate) per drop, equivalent to 9.34 mg/ml. If you have severe corneal damage (the transparent layer on the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium deposits.

3. How to use Latanoprost Qualigen

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

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye(s) once daily. It is best administered at night.

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

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

Contact lens wearers

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

Instructions for use

1. Wash your hands before using the eye drops.
2. Remove the cap.
3. Tilt your head back. Carefully pull down the lower eyelid of the eye to be treated with your index finger.
4. Place the tip of the bottle close to the eye without touching it and gently press the bottle until a drop is released into the eye.
5. Apply pressure to the nasal corner of the eye for 1 minute after applying the eye drops to minimize the absorption of the active substance into the bloodstream.
6. Replace the cap after use.

If you use Latanoprost Qualigen with other eye drops

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

If you use more Latanoprost Qualigen than you should

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may become red and tear; this situation should disappear, but if it concerns you, contact your doctor or the doctor treating your child.

In case of overdose or accidental ingestion by you or your child of Latanoprost Qualigen, consult your doctor or pharmacist as soon as possible or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Latanoprost Qualigen

Continue with the administration of the next dose as usual.

Do not apply an extra drop to make up for missed doses. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Qualigen

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

If you have any other questions about 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.

The following are known side effects of Latanoprost Qualigen:

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

• 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-color eyes (blue-brown, gray-brown, yellow-brown, or green-brown), it is more likely that you will experience this change than if your eyes are a single color (blue, gray, green, or brown). The change in eye color takes 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 Qualigen is used in only one eye. The change in eye color does not progress once treatment with Latanoprost Qualigen has been stopped.
• Redness of the eye.
• Eye irritation (feeling of stinging, feeling of grit in the eye, itching, pain, and 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 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), length, thickness, and number of eyelashes.

Common side effects (may affect up to 1 in 10 people)

• Irritation or erosion of the eye surface.
• Inflammation of the eyelids (blepharitis).
• Eye pain and sensitivity to light (photophobia), conjunctivitis.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the eyelids, dry eye, or irritation of the eye surface (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 heartbeat (palpitations).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea.
• Vomiting.

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

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

Very rare side effects (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).

Side effects observed in children at a higher frequency than in adults are 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 areas in the cornea due to calcium deposits produced during treatment.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Latanoprost Qualigen

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

Do not use this medicine after the expiry date stated on the carton after EXP. 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 to protect it from light.

After first opening: store below 25°C and use within 4 weeks.

Do not use Latanoprost Qualigen if you notice that the solution is not clear and colorless.

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 Qualigen

• The active substance is latanoprost. 1 ml of eye drops contains 50 micrograms of latanoprost. The 2.5 ml eye drop bottle contains 125 micrograms of latanoprost.
• The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium hydroxide (E-524) or hydrochloric acid (E-507), water for injections.

Appearance and packaging

Eye drops, solution. Clear, colorless solution. Packs of 1, 3, and 6 bottles of 2.5 ml eye drops. Not all pack sizes may be marketed.

Marketing authorisation holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Rafarm Pharmaceuticals

Agiou Louka str., Peania

Attiki, Greece

Date of last revision of this leaflet: November 2021

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