Package Insert: Information for the User

Latanoprost STADA 50 micrograms/mL Eye Drops in Solution

Read this package insert carefully before you start using this medicine, because it contains important information for you.

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

Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural drainage of fluid from the inside of the eye to the bloodstream.

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

Latanoprost is also used to treat theincreaseinpressurewithin 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.Latanoprosthas not been investigated in premature children (less than 36 weeks of gestation).

DO NOT use Latanoprost STADA

• If you are allergic 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, the doctor treating your child, or your pharmacist before using latanoprost or before administering it to your child:

• If you or your child have undergone or are to undergo ocular 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).

Consult your doctor or the doctor treating your child if you or your child experience or have ever experienced any of the aforementioned circumstances.

Other medications and Latanoprost STADA

Latanoprost may interact with other medications. Inform your doctor, the doctor treating your child, or pharmacist if you or your child are taking, have recently taken, or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

Consult your doctor before using latanoprost.

Your child may be affected. Latanoprost should not be used during breastfeeding.

Driving and operating machinery

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

Latanoprost STADA contains benzalkonium chloride

This medication contains 0.2 mg of benzalkonium chloride in each ml of eye drop solution.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. Remove your contact lenses before using this medication and reinsert them 15 minutes later. See the instructions for contact lens users 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 medication you experience an abnormal sensation in your eyes, stinging, or eye pain.

Latanoprost STADA contains phosphates

This medication contains 6.34 mg of phosphates in each ml of eye drop solution.

If you have severe corneal damage, treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor, or by the doctor treating your child. Consult your doctor, or the doctor treating your child, or your pharmacist if you have doubts.

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

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

If you need to use other eye drops, they must be applied with an interval of at least five minutes.

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

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

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 in.

Instructions for use

To administer latanoprost in an appropriate manner, you must follow the following steps:

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 is introduced into the eye. Remove your finger from the lower eyelid.
6. Press the affected eye with your finger, near the nose. Maintain the pressure for 1 minute, keeping your eye closed.
7. Repeat the procedure in the other eye, if your doctor has instructed you to.
8. Replace the cap on the bottle.

If you useLatanoprost STADAwith 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, so that only one drop is introduced into the affected eye. If more drops have been applied to the eye than you should, you may feel a slight irritation in the eye and also your 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, your or your child's, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Latanoprost STADA

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

If you interrupt treatment with Latanoprost STADA

You must inform your doctor or the doctor treating your child if you want to interrupt treatment with latanoprost.

If you have any other doubts about the use of this medication, ask your doctor, the doctor treating your child, or your pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Very common side effects(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 can usually be seen after 8 months of treatment. The color change 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.
• Eye redness.
• Ocular irritation (a sensation of burning, a sensation of sand in the eye, itching, pain, and a sensation of a foreign body in the eye). If you experience severe ocular irritation that causes excessive tearing 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 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 side effects(may affect up to 1 in 10 people):

• Irritation or erosion of the surface of the eye
• Swelling 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 the heart rhythm (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 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), sensitivity to light (photophobia).
• 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 side effects(may affect up to 1 in 10,000 people):

• Worsening of angina in patients with pre-existing heart problems
• Appearance of sunken eyes (increased depth of the eyelid crease).

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

In 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 or pharmacist, 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: https://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, after CAD.. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°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 above 25°C.

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

Medicines should not be thrown down the drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Latanoprost STADA Composition

The active ingredient is latanoprost.

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

2.5 ml of eye drop solution (contents of a bottle) contain 125 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

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

Appearance of the product and contents of the package

Latanoprost STADA is presented as an eye drop solution, transparent and colorless, in a low-density polyethylene (LDPE) bottle with a high-density polyethylene (HDPE) screw cap.

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible manufacturer:

HBM Pharma s.r.o.

Sklabinskà 30

03680 Martin,

Republic of Slovakia

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 with the following names:

ItalyLATANOPROST EG 50 microgrammi/ml Eye Drops, solution

SpainLatanoprost STADA 50 micrograms/ml eye drops in solution

NetherlandsExprosol 50 micrograms/ml Eye Drops, solution

Last review date of this leaflet:June 2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/