Latanoprost Aurovitas 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Latanoprost Aurovitas 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 it may harm them.
• If you experience any side effects, talk to 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.

Contents of this leaflet

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

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

Latanoprost Aurovitas belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural drainage 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 Aurovitas

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 Aurovitas

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

Warnings and precautions

If you or your child are affected by any of the following conditions, consult your doctor, the doctor treating your child, or the pharmacist before using latanoprost or before administering it to your child:

• If you or your child have had or are due 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 have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Latanoprost Aurovitas

Latanoprost 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 (including 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

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.

You should not use latanoprost if you are pregnant or breastfeeding, unless your doctor considers it necessary.

Driving and use of machines

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

Latanoprost Aurovitas contains benzalkonium chloride, phosphate buffers, and sodium

This medicine contains 0.2 mg/ml of benzalkonium chloride. Benzalkonium chloride may be absorbed by contact lenses and may alter the color of soft contact lenses. Contact lenses must be removed before application, and you should wait at least 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent front layer of the eye). If you experience a sensation of a foreign body in the eye, stinging, or pain after using this medicine, inform your doctor.

This medicine contains 6.3 mg/ml of phosphates, equivalent to 0.2 mg per drop.

If you have a severe injury to the transparent front part of the eye (the cornea), phosphates may, in very rare cases, cause cloudy areas in the cornea due to calcium deposits during treatment.

This medicine contains less than 1 mmol of sodium (23 mg) per 2.5 ml vial; this is essentially “sodium-free”.

3. How to use Latanoprost Aurovitas

Follow exactly the instructions for administering this medicine as given by your doctor or by the doctor treating your child. If in doubt, consult your doctor, your child's doctor, or pharmacist again.

The recommended dose for adults (including elderly patients) and children is one drop into the affected eye or eyes once daily. 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.

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

Contact lens wearers

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

Follow these steps to properly administer Latanoprost Aurovitas:

1. Wash your hands and sit or stand comfortably.
2. Remove the cap.
3. Using your finger, 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 so that only one drop enters the eye. Release the lower eyelid.
6. Press with your finger on the inner corner of the treated eye, near the nose. Maintain pressure for 1 minute, keeping the 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 Aurovitas with other eye drops

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

If you use more Latanoprost Aurovitas than you should

If too many drops are applied to the eye, 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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Latanoprost Aurovitas

Continue with the next dose as usual. Do not apply a double dose to make up for missed doses. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Aurovitas

If you wish to discontinue using latanoprost, 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 side effects

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

The following are known side effects when latanoprost is used:

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

• Gradual change in eye colour due to an increase in brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are a single colour (blue, grey, green or brown). The change in eye colour develops gradually over years, although it is usually noticeable by 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if latanoprost is used in only one eye. The change in eye colour does not appear to be associated with any problems. The change in eye colour does not progress once treatment with latanoprost is stopped.
• Redness of the eye.
• 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 making you 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 treatment for your condition.
• Gradual change 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 (may affect up to 1 in 10 people):

• Irritation or erosion of the eye surface, eyelid inflammation (blepharitis), eye pain and light sensitivity (photophobia), conjunctivitis.

Uncommon (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 coloured part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, difficulty in breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare (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 additional row of eyelashes, scarring of the eye surface, accumulation of fluid in the coloured part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense itching of the skin.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare (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 crease).

Side 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 during treatment.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Aurovitas

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

Do not use this medicine after the expiry date stated on the pack and on the bottle after 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 of 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. Return unused medicines and their containers to your pharmacy’s SIGRE point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latanoprost Aurovitas

• The active substance is latanoprost.
• 1 ml of eye drops solution contains: 50 micrograms of latanoprost.
• One drop contains approximately: 1.5 micrograms of latanoprost.
• The other components are: benzalkonium chloride, monohydrate sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium chloride and purified water.

Appearance of the product and contents of the pack

Eye drops solution.

Latanoprost Aurovitas eye drops solution is a clear, colourless liquid.

Latanoprost Aurovitas eye drops solution is supplied in LDPE bottles.

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

Latanoprost Aurovitas is available in packs 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Jadran Galenski Laboratorij d.d.

Svilno 20,

Rijeka, 51000

Croatia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain Latanoprost Aurovitas 50 micrograms/ml eye drops solution

Italy Latanoprost Aurobindo

Netherlands Latanoprost Auro 50 micrograms/ml oogdruppels, oplossing

Date of the most recent review of this leaflet: August 2025

Detailed 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/)