Latanoprost Stada 50 micrograms/ml eye drops in solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Latanoprost STADA 50 micrograms/ml eye drops solution

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor treating your child or your pharmacist.
• This medicine has been prescribed for you or your child only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you or your child experience any adverse effects, consult your doctor or the doctor treating your child or your pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Latanoprost STADA is and what it is used for
2. What you need to know before using Latanoprost STADA
3. How to use Latanoprost STADA
4. Possible side effects
5. How to store Latanoprost STADA
6. Contents of the pack and other information

1. What Latanoprost STADA 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 is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which may eventually affect vision.

Latanoprost 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 STADA

Latanoprost can be used in adult men and women (including elderly patients) 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 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 situations apply to you or your child, consult your doctor, your child's doctor, or your pharmacist before using latanoprost 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 asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using latanoprost, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you or your child have had or are currently experiencing a viral eye infection caused by the herpes simplex virus (HSV).

Consult your doctor or your child's doctor if any of the above-mentioned conditions occur or have occurred in you or your child.

Other medicines and Latanoprost STADA

Latanoprost may interact with other medicines. Inform your doctor, your child's doctor, or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The fetus may be affected. Latanoprost must not be used during pregnancy.

Breastfeeding

Consult your doctor before using latanoprost.

The infant may be affected. Latanoprost must not be used during breastfeeding.

Driving and using machines

Blurred vision may occur for a short period after using latanoprost. If this happens to you, do not drive and do not operate tools or machinery until your vision returns to normal.

Latanoprost STADA contains benzalkonium chloride

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

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

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer at the front of the eye). Consult your doctor if, after using this medicine, you experience abnormal eye sensations, stinging, or eye pain.

Latanoprost STADA contains phosphates

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

If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

3. How to use Latanoprost STADA

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 your pharmacist if you have any doubts.

The usual dose for adults (including elderly patients) and children is one drop once daily in the affected eye or eyes. It is preferable to administer it at night.

Do not use latanoprost more than once a day, as treatment efficacy may decrease if administered more frequently.

If you need to use other eye drops, these should be administered at least five minutes apart.

Be careful when squeezing the bottle so that only one drop is instilled into the affected eye.

Use latanoprost exactly as directed by your doctor or the doctor treating your child, until they tell you to stop treatment.

Contact lens wearers

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

Instructions for use

To properly administer latanoprost, follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Unscrew the cap.
3. Using your finger, gently pull down the lower eyelid of the eye to be treated.
4. Hold the tip of the bottle close to the eye, but without touching it.
5. Squeeze the bottle gently so that only one drop enters the eye. Release the lower eyelid.
6. Press your finger against the corner of the treated eye near the nose. Apply pressure for 1 minute, keeping your eye closed.
7. Repeat the procedure in the other eye, if instructed by your doctor.
8. Replace the cap on the bottle.

If you use Latanoprost STADA with other eye drops

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

If you use more Latanoprost STADA than you should

Be careful when squeezing the bottle so that only one drop is instilled into the affected eye. If more drops than intended have been applied, you may experience mild eye irritation, redness, and tearing. This should resolve on its own, but if you are concerned, contact your doctor or the doctor treating your child.

In case of overdose or accidental ingestion, yours or your child's, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to use Latanoprost STADA

Continue with the next dose as usual. Do not instill an extra drop to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop treatment with Latanoprost STADA

Inform your doctor or the doctor treating your child if you wish to discontinue treatment with latanoprost.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• Gradual change in eye color due to increased 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 of a single color (blue, gray, green or brown). The change in eye color develops over years, although it is usually noticeable after 8 months of treatment. The color change may be permanent and may be more pronounced if latanoprost 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 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 causing excessive tearing or leading you to consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within one week). Your treatment may need to be reviewed to ensure you are receiving the appropriate therapy for your condition.
• Gradual changes in the eyelashes of the treated eye and 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
• Eyelid inflammation (blepharitis)
• Eye pain
• Light sensitivity (photophobia)
• Conjunctivitis.

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

• Swelling of the eyelids, dry eye, inflammation 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), awareness of heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• 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, swelling around the eye (periorbital edema), misdirected eyelashes or an extra row of eyelashes, scarring of the eye surface, fluid accumulation in the colored part of the eye (iris cyst), light sensitivity (photophobia).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense skin itching.
• 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 more frequently in children than in adults are runny nose, nasal itching, and fever.

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 STADA

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

Do not use this medicine after the expiry date stated on the label, following EXP. The expiry date refers to the last day of the month indicated.

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

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

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

The product must be discarded four weeks after opening, even if not completely used.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 (the contents of one bottle) contain 125 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

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

Nature of the product and contents of the container

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

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

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

Only some 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 medicinal product 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 Oogdruppels, oplossing

Date of the most recent review of this leaflet: June 2022

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