Package Insert: Information for the User

Latanoprost Aurovitas 50 micrograms/mL Eye Drops Solution

Latanoprost

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Latanoprost Aurovitas 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 circulatory system.

Latanoprost is used to treat certain diseases known asopen-angle glaucoma and ocular hypertensionin adults. Both diseases are related to an increase in pressure within the eye, which can affect vision.

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

Latanoprost can be used in adult men and women (including elderly patients) 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 Aurovitas

• 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 child, consult your doctor, or the doctor treating your child, or the pharmacist before using latanoprost or before administering it to your child::

• If you or your child have undergone or are 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. You may continue to use latanoprost, but you 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 Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Latanoprost 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 used recently other medications (or eye drops), even those purchased without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

Do not use latanoprostwhile breastfeeding,unless your doctor considers it necessary.

Driving and operating machinery

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

Latanoprost Aurovitas contains benzalkonium chloride and sodium

Latanoprost Aurovitas contains a preservative called benzalkonium chloride. Benzalkonium chloride may be absorbed by contact lenses and alter the color of soft contact lenses. You must remove your contact lenses before application and wait at least 15 minutes before reinserting them.

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

If you or your child use contact lenses, you must remove them before using latanoprost. After applying latanoprost, wait 15 minutes before reinserting your contact lenses. Follow the instructions included in section 3 for contact lens users.

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

Follow exactly the administration instructions of this medication indicated by your doctor, or by the doctor treating your child or pharmacist. In case of doubt, consult your doctor again, or the doctor treating your child or pharmacist. It is preferable to administer at night.

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

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

Use latanoprost as your doctor or the doctor treating your child has indicated 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. After applying latanoprost, wait 15 minutes before putting the contact lenses back on.

Follow the following steps to administer Latanoprost Aurovitas properly:

1.Wash your hands and sit or stand comfortably.

2.Remove the cap.

3.Using your finger, gently separate the lower eyelid from the eye to be treated.

4.Place the tip of the bottle close to the eye, but not touching it.

5.Press the bottle carefully so that only one drop enters the eye. Remove your finger from the lower eyelid.

6.Press with your finger the affected eye's outer corner, near the nose. Apply pressure for 1 minute, keeping your eye closed.

7.Repeat the procedure in the other eye, if your doctor has indicated.

8.Replace the cap on the bottle.

Using Latanoprost Aurovitas with other eye drops

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

Using more Latanoprost Aurovitas than prescribed

If too many drops are 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 the doctor treating your child.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Missing a dose of Latanoprost Aurovitas

Continue with the administration of the next dose in the usual manner. Do not apply a double dose to compensate for the missed dose. If you have doubts, consult your doctor or pharmacist.

Stopping treatment with Latanoprost Aurovitas

If you want to stop using latanoprost, consult your doctor or the doctor treating your child.

If you have any other doubts 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:

Very common(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 may be noticeable 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 appear to be associated with any problems. The change in eye color does not progress once treatment with latanoprost has been discontinued.
• Redness of the eye.
• Ocular 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 ocular 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(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):

• 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 the heart rhythm (palpitations).
• Asthma, difficulty 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 damage to the surface of the eye, swelling around 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).
• 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(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 crease).

The side effects observed more frequently in children than in adults are runny nose, itchy nose, 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.

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: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 label. The expiration date is the last day of the month indicated.

Store in refrigerator (between2°Cand8°C).

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

After the first opening of the bottle: Do not store at a temperature above25°C. The product must be discarded four weeks after opening, even if it has not been completely consumed.

Medicines should not be thrown away through drains or in the trash. Dispose of containers and medications that you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. This way, you will help protect the environment.

Latanoprost Aurovitas Composition

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

Each bottle of Latanoprost Aurovitas contains 2.5 ml of eye drops solution corresponding to approximately 80 drops of solution. Latanoprost Aurovitas is available in the following presentations: 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml. Some package sizes may only be marketed.

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

One drop contains approximately: 1.5 micrograms of latanoprost.

Product Appearance and Packaging Contents

Latanoprost Aurovitas is presented in the form of eye drops solution, transparent and colorless, in a low-density polyethylene bottle with a high-density polyethylene screw cap.

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

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

Some package sizes may only be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible Manufacturer:

Jadran Galenski Laboratorij d.d.

Svilno 20,

Rijeka, 51000

Croatia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainLatanoprost Aurovitas 50 micrograms/ml eye drops solution

ItalyLatanoprost Aurobindo

NetherlandsLatanoprost Auro 50 micrograms/ml eye drops, solution

Last review date of this leaflet: March 2022

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)