LATANOPROST AUROVITAS 50 micrograms/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Latanoprost Aurovitas 50 micrograms/ml eye drops, solution

Latanoprost

Read this entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Latanoprost Aurovitas is and what it is used for
2. What you need to know before you use Latanoprost Aurovitas
3. How to use Latanoprost Aurovitas
4. Possible side effects
5. Storage of 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 outflow of fluid from the eye into the bloodstream.

Latanoprost is used to treat diseases such as open-angle glaucoma and ocular hypertensionin adults. Both of these diseases cause increased pressure in the eye due to the build-up of fluid.

Latanoprost also reduces pressure in the eye in children and infants from birth to <18 years of age.< p>

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

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 gestational age).

Do not use Latanoprost Aurovitas

• If you are allergic (hypersensitive) 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 to your child, talk to your doctor or to the doctor treating your child, or to your pharmacist before using latanoprost or before giving 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 can still use latanoprost but follow the instructions given in section 3 for contact lens wearers.
• If you have had a viral infection in the eye caused by the herpes simplex virus (HSV).

Other medicines and Latanoprost Aurovitas

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Latanoprost may have an effect on other medicines, or other medicines may affect Latanoprost. Tell your doctor or pharmacist if you are taking or have taken other medicines (including those obtained without a prescription) especially prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy, breastfeeding and fertility

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

Do not use latanoprostif you are pregnant, unless your doctor considers it necessary.

Breastfeeding

Do not use latanoprostif you are breastfeeding, unless your doctor considers it necessary.

Driving and using machines

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

Latanoprost Aurovitas contains benzalkonium chloride and sodium

Latanoprost Aurovitas contains a preservative called benzalkonium chloride. Benzalkonium chloride may be absorbed by contact lenses and may change the colour of your contact lenses. You should remove your contact lenses before applying Latanoprost Aurovitas and wait at least 15 minutes after application before putting them back in.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or problems with the cornea (the transparent layer on the front of your eye). If you experience eye irritation, talk to your doctor.

If you or your child wear contact lenses, you should remove them before using Latanoprost Aurovitas. Wait for at least 15 minutes before putting them back in. Follow the instructions given in section 3 for contact lens wearers.

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

3. How to use Latanoprost Aurovitas

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

It is recommended to apply the eye drops in the evening.

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

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

Use Latanoprost Aurovitas as prescribed by your doctor until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, you should remove them before using Latanoprost Aurovitas. Wait for at least 15 minutes before putting them back in.

Follow these steps to use Latanoprost Aurovitas correctly:

1. Wash your hands and sit or stand comfortably.
2. Remove the cap.
3. Gently pull down the lower eyelid to form a pouch.
4. Place the tip of the bottle close to your eye, but not touching it.
5. Gently squeeze the bottle to release one drop into your eye. Release the lower eyelid.
6. Press the corner of your eye (near your nose) for about 1 minute, keeping your eye closed.
7. Repeat the process for your other eye, if your doctor has told you to.
8. Replace the cap on the bottle.

If you are using Latanoprost Aurovitas with other eye drops

Wait at least 5 minutes between using Latanoprost Aurovitas and other eye drops.

If you use more Latanoprost Aurovitas than you should

If you put too many drops in your eye, you may feel some mild irritation in the eye and the eye may water and turn red; this should go away on its own but if you are worried, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or contact the Poisons Information Service on 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to use Latanoprost Aurovitas

Continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. If you are unsure, talk to your doctor or pharmacist.

If you stop using Latanoprost Aurovitas

If you want to stop using latanoprost, talk to your doctor or your child’s doctor.

If you have any other questions on 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 of latanoprost:

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

• Gradual change in eye colour by increasing the amount of brown pigment in the coloured part of the eye called the iris. If your eyes are a mixture of colours (e.g. 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 (e.g. blue, grey, green or brown). The change in eye colour may be permanent and may be more noticeable if latanoprost is used in one eye only. The change in eye colour does not appear to be associated with any problems.
• Eye redness.
• Eye irritation (feeling of something in the eye, burning sensation, stinging, itching, itching sensation, eye pain, and sensation of a foreign body in the eye). If you experience severe eye irritation, talk to 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, seen in most patients of Japanese origin. These changes include increased length, thickness, and/or colour (darkening) of the eyelashes.

Common(may affect up to 1 in 10 people):

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

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

• Swollen eyelids, dry eyes, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
• Skin rash.
• Chest pain (angina), awareness of heart rhythm (palpitations).
• Asthma, difficulty breathing (dyspnoea).
• 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 surface of the eye, swelling around the eye (periorbital oedema), misdirected eyelashes or an extra row of eyelashes, scarring of the surface of the eye, accumulation of fluid in the coloured part of the eye (iris cyst).
• Skin reactions on 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(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 most frequently observed side effects in children are runny nose, 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 during 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 leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: 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 which is stated on the label. The expiry date is the last day of the month stated.

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

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

After first opening: Do not store above 25°C. The product should be discarded 4 weeks after first opening even if there is still some solution left.

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 Aurovitas

• The active substance is latanoprost.
• The other ingredients are: benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate, sodium chloride, purified water.

Each 2.5 ml bottle of Latanoprost Aurovitas contains approximately 80 drops of eye drops solution. Latanoprost Aurovitas is available in the following pack sizes: 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml. Not all pack sizes may be marketed.

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

One drop contains approximately 1.5 micrograms of latanoprost.

Appearance and packaging

Latanoprost Aurovitas is a clear, colourless eye drops solution in a low-density polyethylene dropper bottle with a high-density polyethylene screw cap.

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

Latanoprost Aurovitas is available in packs of 1, 3 and 6 bottles.

Not all 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 medicine 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 last revision of this leaflet: March 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)