LATANOPROST STADA 50 micrograms/ml EYE DROPS SOLUTION

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

Latanoprost 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 investigated in premature infants (less than 36 weeks gestation).

Do not use Latanoprost STADA

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

Warnings and precautions

If you think any of the following apply to you or your child, tell your doctor, the doctor treating your child, or your pharmacist before using latanoprost:

• 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 but follow the instructions for contact lens wearers in section 3.
• If you have had or are having a viral infection of the eye caused by the herpes simplex virus (HSV).

Tell your doctor, the doctor treating your child, or your pharmacist if you or your child have or have had any of the above conditions.

Other medicines and Latanoprost STADA

Latanoprost may interact with other medicines. Tell your doctor, the doctor treating your child, or your pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The baby may be affected. Latanoprost should not be used during pregnancy.

Breastfeeding

Ask your doctor before using latanoprost.

The baby may be affected. Latanoprost should not be used during breastfeeding.

Driving and using machines

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

Latanoprost STADA contains benzalkonium chloride

This medicine contains 0.2 mg of benzalkonium chloride in each ml of eye drops solution.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. You should remove your contact lenses before using this medicine and wait 15 minutes after application before putting them back. See the instructions for contact lens wearers in section 3.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the transparent layer on the front of the eye). Tell your doctor if you feel any abnormal sensation in the eye, stinging, or eye pain after using this medicine.

Latanoprost STADA contains phosphates

This medicine contains 6.34 mg of phosphates in each ml of eye drops solution.

If you have severe corneal damage (the transparent layer on the front of the eye), phosphate treatment may rarely cause blurred vision due to calcium deposits.

3. How to use Latanoprost STADA

Use this medicine exactly as your doctor, the doctor treating your child, or your pharmacist has told you. If you are not sure, ask your doctor, the doctor treating your child, or your pharmacist.

The usual dose for adults (including the elderly) and children is one drop, once daily, in the affected eye(s). It is best to administer it in the evening.

Do not use latanoprost more than once daily, as the efficacy of the treatment may decrease if it is administered more frequently.

If you have to use other eye drops, they should be administered at an interval of at least 5 minutes.

Be careful when pressing the bottle to ensure that only one drop is introduced into the affected eye.

Use latanoprost as your doctor, the doctor treating your child, or your pharmacist has told you, until they tell you to stop.

Contact lens wearers

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

Instructions for use

To administer latanoprost properly, follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Remove the cap.
3. Gently pull down the lower eyelid of the eye to be treated.
4. Place the tip of the bottle close to the eye, but without touching it.
5. Gently squeeze the bottle to release one drop into the eye. Release the lower eyelid.
6. Press the corner of the eye near the nose for 1 minute, keeping the eye closed.
7. Repeat the operation in the other eye, if your doctor has told you to do so.
8. Replace the cap on the bottle.

If you use Latanoprost STADA with other eye drops

Wait at least 5 minutes between the application of Latanoprost STADA and the administration of other eye drops.

If you use more Latanoprost STADA than you should

Be careful when pressing the bottle to ensure that only one drop is introduced into the affected eye. 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 tearful. This should disappear, but if you are concerned, contact your doctor, the doctor treating your child, or your pharmacist.

In case of overdose or accidental ingestion, by you or your child, contact your doctor, pharmacist, or the Poison Information Service (telephone: 91 562 04 20), stating the medicine and the amount taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to use Latanoprost STADA

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

If you stop using Latanoprost STADA

Tell your doctor, the doctor treating your child, if you want to stop treatment with latanoprost.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Gradual change in eye color by increasing 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), 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 is used in only one eye. The change in eye color does not seem to be associated with any problems. The change in eye color does not progress once treatment with latanoprost 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 right 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 surface of the eye
• Inflammation of the eyelid (blepharitis)
• Eye pain
• Sensitivity to light (photophobia)
• Conjunctivitis.

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

• 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 your heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• 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 surface of the eye, swelling around the eye (periorbital edema), misdirected eyelashes or extra 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.
• Severe itching of the skin.
• Development of a viral infection of the eye 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).

The side effects observed in children more frequently 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 caused by treatment.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost STADA

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

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

After opening the bottle: do not store above 25°C.

The product should be discarded 4 weeks after opening, even if it is not empty.

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 STADA

The active substance is latanoprost.

1 ml of eye drops solution contains 50 micrograms of latanoprost.

2.5 ml of eye drops solution (contents of one bottle) contain 125 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate, sodium chloride, purified water.

Appearance and packaging of the product

Latanoprost STADA is a clear, colorless eye drops solution in a low-density polyethylene (LDPE) dropper bottle with a high-density polyethylene (HDPE) screw cap.

Each bottle of Latanoprost STADA contains 2.5 ml of eye drops solution, which is equivalent to approximately 80 drops of solution.

Latanoprost STADA is available in packs of 1 x 2.5 ml, 3 x 2.5 ml, and 6 x 2.5 ml bottles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer:

HBM Pharma s.r.o.

Sklabinskà 30

03680 Martin,

Slovak Republic

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Jadran Galenski Laboratorij D.D.

Svilno 20

51000 Rijeka

Croatia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy LATANOPROST EG 50 micrograms/ml eye drops, solution

Spain Latanoprost STADA 50 micrograms/ml eye drops, solution

Netherlands Exprosol 50 micrograms/ml eye drops, solution

Date of last revision of this package leaflet:June 2022

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/