PROSPECTO: INFORMATION FOR THE USER

Latanoprost Qualigen 50 micrograms/ml eye drops in solution

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

1What Latanoprost Qualigen is and for what it is used

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

3How to use Latanoprost Qualigen

4Possible adverse effects

5Storage of Latanoprost Qualigen

6Contents of the package and additional information

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

Latanoprost Qualigen is used to treat certain diseases known asangle-closure glaucoma and ocular hypertensionin adults. Both diseases are related to an increase in pressure within the eye, which can lead to vision problems.

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

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

Do not use Latanoprost Qualigen

-If you are allergic (hypersensitive) to latanoprost or to any of the other components of this medication (listed in section 6).

Warnings and precautions

If you consider that any of the following situations affect you or your childconsult with your doctor, or with 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 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. They may continue to use Latanoprost Qualigen, but they must follow the instructions included in section 3 for contact lens users.

- If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Other medications and Latanoprost Qualigen

Latanoprost Qualigen may interact with other medications.Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are using or have recently used other medications (or eye drops), even those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, 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, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machines

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

Latanoprost Qualigen contains benzalkonium chloride and phosphate buffer

This medication contains 0.01 mg of benzalkonium chloride in each drop, equivalent to 0.2 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (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.

This medication contains 0.467 mg of phosphates (in the form of disodium anhydrous phosphate and sodium dihydrogen phosphate monohydrate) in each 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, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions for this medication as indicated by your doctor, or by the doctor treating your child. Consult your doctor, or the doctor treating your child, or the 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 a day. It is best to administer it at night.

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

Use Latanoprost Qualigen as directed by your doctor or the doctor treating your child 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 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. Unscrew the cap.

3. Tilt your head back. Carefully lower your lower eyelid with your index finger.

4. Place the tip of the bottle close to the eye without touching it and gently press the bottle until one drop enters the treated eye.

5. Apply pressure to the nasal corner of the eye for 1 minute after applying the eye drops to minimize the reabsorption of the active ingredient into the blood.

6. Replace the cap after use.

Using Latanoprost Qualigen with other eye drops

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

Using more Latanoprost Qualigen than you should

If more drops than prescribed have been applied to the eye, you may feel a slight irritation in the eye and the eyes may become red and tearful; this situation should resolve, but 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 Toxicological Information Service, phone: 91 562 04 20.

Missing a dose of Latanoprost Qualigen

Continue with the administration of the next dose as usual.

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

Stopping treatment with 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 medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following are known side effects when using 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-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 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 discontinued.

- Redness of the eye.

-Eye irritation (sensation of burning, sensation of sand in the eye, itching, pain, and sensation of a foreign body in the eye). If you experience severe eye irritation that causes excessive tearing or makes you consider interrupting treatment, consult your doctor, pharmacist, or nurse as soon as possible (within a week). You may require a review of your treatment 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 side effects (may affect up to 1 in 10 people)

-Irritation or erosion of the surface of the eye.

-Inflammation of the eyelids (blepharitis).

-Eye pain and sensitivity to light (photophobia), conjunctivitis.

Rare side effects may affect up to 1 in 100 people)

-Swelling of the eyelids, dry eye 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.

- Palpitations.

- Headache, dizziness.

- Muscle pain, joint pain.

- Nausea.

- Vomiting.

Rare side effects (may affect up to 1 in 1000 people)

-Inflammation of the iris (iritis), symptoms of swelling or damage to the surface of 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), sensitivity to light (photophobia).

- 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 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 frequency greater than in adults are 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 produced during treatment.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed 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 medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. 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: store below 25°C and use within 4 weeks.

Do not use Latanoprost Qualigen if you observe that the solution is not transparent and colorless.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you no longer need at the Sigre Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

Latanoprost Qualigen Composition

-The active ingredient is latanoprost. 1 ml of eye drop solution contains 50 micrograms of latanoprost. The 2.5 ml eye drop bottle contains 125 micrograms of latanoprost.

-The other components are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, sodium hydroxide (E-524) or hydrochloric acid (E-507), water for injection preparations.

Product appearance and packaging contents

Eye drop solution. Transparent and colorless solution. Packaging of 1, 3, and 6 bottles with 2.5 ml of eye drop solution. Some packaging sizes may only be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for Manufacturing

Rafarm Pharmaceuticals

Agiou Louka str., Peania

Attiki, Greece

Last review date of this leaflet: November 2021

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