Latanoprost Qualigen 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost Qualigen 50 micrograms/ml eye drops solution

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 or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only and must not be given to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you experience any side effects, consult your doctor or the doctor treating your child, or your pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents

1 What Latanoprost Qualigen is and what it is used for

2 What you need to know before using Latanoprost Qualigen

3 How to use Latanoprost Qualigen

4 Possible side effects

5 How to store Latanoprost Qualigen

6 Contents of the pack and other information

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

Latanoprost 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 Qualigen is used to treat conditions known as narrow-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure within the eye, which may lead to vision damage.

Latanoprost Qualigen 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 Qualigen

Latanoprost Qualigen can be used in adult men and women (including the elderly) and in children from birth up 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 to any of the other components of this medicine (listed in section 6).

Warnings and precautions

If you think that any of the following situations apply to you or your child, consult your doctor, the doctor treating your child, or the 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 poorly controlled asthma.
• If you or your child wear contact lenses. You may continue using Latanoprost Qualigen, 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 Qualigen

Latanoprost Qualigen may interact with other medicines. Inform your doctor, the doctor treating your child, or the 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 Qualigen during pregnancy or while breastfeeding unless considered necessary by your doctor. 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 use of machines

Blurred vision may occur for a short period after using Latanoprost Qualigen. If this happens, do not drive and do not operate tools or machinery until your vision clears 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 reinserting them.

Benzalkonium chloride may 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.

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

3. How to use Latanoprost Qualigen

Follow exactly the administration instructions for this medicine given 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 or eyes once daily. It is best administered at night.

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

Use Latanoprost Qualigen exactly as your doctor or your child's doctor has instructed you, until they tell you to stop.

Contact lens users

If you or your child wear contact lenses, they must be removed before using Latanoprost Qualigen. After applying Latanoprost Qualigen, wait 15 minutes before reinserting the contact lenses.

Instructions for use

1. Wash your hands before using the eye drops.
2. Unscrew the cap.
3. Tilt your head backwards. Gently pull down the lower eyelid of your eye with your index finger.
4. Place the tip of the bottle close to the eye without touching it, and gently squeeze the bottle until one drop enters the affected eye.
5. Apply pressure to the inner corner of the eye (near the nose) for 1 minute after administering the eye drops to minimize 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 than you should, you may experience mild eye irritation, redness, and tearing; this should resolve on its own. However, if you are concerned, contact your doctor or your child's doctor.

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 at telephone: 91 562 04 20.

If you forget to use Latanoprost Qualigen

Continue with the next dose as usual.

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

If you stop using Latanoprost Qualigen

If you wish to stop using Latanoprost Qualigen, consult your doctor or your child's doctor.

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 Qualigen:

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

• Gradual change in eye color due to an increase in 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 of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is usually noticeable after about 8 months of treatment. The color change may be permanent and may be more pronounced if Latanoprost Qualigen is used in only one eye. The change in eye color does not progress once treatment with Latanoprost Qualigen is discontinued.
• Eye redness.
• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation in the eye). If you experience severe eye irritation that causes excessive tearing or makes you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within one week). You may need your treatment 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 patients. These changes include increased pigmentation (darkening), lengthening, thickening, and increased number of eyelashes.

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

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

Uncommon adverse 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.
• Skin pain (angina), awareness of heartbeat (palpitations).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea.
• Vomiting.

Rare adverse 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 an additional 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 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 adverse effects (may affect up to 1 in 10,000 people)

• Worsening of angina in patients who also have 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 transparent front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits during treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Qualigen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. 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: store below 25°C and use within 4 weeks.

Do not use Latanoprost Qualigen if the solution is not clear and colourless.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Latanoprost Qualigen

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

Appearance of the product and contents of the container

Eye drops solution. A clear, colourless solution. Pack sizes of 1, 3 and 6 bottles with 2.5 ml of eye drops. Some pack sizes may not be marketed.

Marketing Authorization 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 the most recent revision of this package leaflet: November 2021

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