Prospecto: information for the user

Latanoprost Teva-ratiopharm 50 micrograms/ml eye drops in solution

latanoprost

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor orthe doctor treating your child or pharmacist.
• This medicine has been prescribed only for youor your childand should not be given to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experience any adverse effects, consult your doctor or the doctor treating your child or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isLatanoprost Teva-ratiopharmand for what it is used

2. What you need to knowbefore starting to useLatanoprost Teva-ratiopharm

3. How to useLatanoprost Teva-ratiopharm

4. Possible adverse effects

5. Storage ofLatanoprost Teva-ratiopharm

6. Contents of the package andadditional information

Latanoprost 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 bloodstream.

Latanoprost is used totreat certain diseases known asopen-angle glaucomaandocular 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 babies and children of all ages.

Latanoprost Teva-ratiopharmmay be used in adult men and women (including elderly) and in children from birth to 18 years of age.Latanoprost Teva-ratiopharmhas not been investigated in premature children (less than 36 weeks of gestation).

Do not use Latanoprost Teva-ratiopharm

Warnings and precautions

Consult your doctor or the doctor treating your child or the pharmacist before starting to use Latanoprost Teva-ratiopharm or before administering it to your child if you believe that any of the following situations affect you or 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 Teva-ratiopharm, 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).

Use of Latanoprost Teva-ratiopharm with other medications

Latanoprost Teva-ratiopharm may interact with other medications. Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are taking/using, have taken/used recently, or may need to take/use any other medication (or eye drops), even those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use Latanoprost Teva-ratiopharm if you are pregnant or breastfeeding.

If you are pregnant, if you believe you may be pregnant, or if you are planning to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

When using Latanoprost Teva-ratiopharm, 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 Teva-ratiopharm contains benzalkonium chloride and phosphate buffers

This medication contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of the lenses. You must remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in your eye after using this medication.

This medication contains 6.43 mg/ml of phosphates.

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

Follow exactly the administration instructions of this medication indicated by your doctor, by the doctor treating your child, or by the pharmacist.In case of doubt,consult your doctor, the doctor treating your child, or the pharmacist again.

The recommended dose for adults (including elderly people) and children is one drop in the eye or in the affected eyes once a day, preferably administered at night.

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

Use latanoprost as instructed by your doctor or the doctor treating your child 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 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. Unscrew 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 the affected eye's outer corner, near the nose, with your finger. Maintain eye closure and apply pressure for 1 minute.

7. Repeat the procedure in the other eye, if your doctor has instructed you to do so.

8. Replace the cap on the bottle.

Using Latanoprost Teva-ratiopharm with other eye drops

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

Using more Latanoprost Teva-ratiopharm than you should

If more drops are applied to the eye than recommended, you may feel a slight irritation in the eye, and the eyes may become red and watery. This situation 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

Missing a dose of Latanoprost Teva-ratiopharm

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 any doubts, consult your doctor or pharmacist.

Stopping treatment with Latanoprost Teva-ratiopharm

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following are known side effects when using Latanoprost Teva-ratiopharm:

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 can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if you use latanoprost 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 stopped.
• 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 stopping treatment, consult your doctor or pharmacist 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(may affect up to 1 in 10 people):

• Ocular irritation or surface disorders, blepharitis (inflammation of the eyelid), eye pain, 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, uveitis (inflammation of the colored part of the eye), macular edema (swelling of the retina).
• Skin rash.
• Chest pain (angina), feeling the heart rhythm (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Nausea, vomiting.
• Muscle pain, joint pain.

Rare(may affect up to 1 in 1,000 people):

• Iritis (inflammation of the iris), symptoms of swelling or damage to the eye surface, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, corneal scarring, 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 with underlying heart problems.
• Appearance of sunken eyes (greater depth of the eyelid crease).

The side effects observed in children at a frequency greater than in adults are runny nose, nasal itching, 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 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 Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD or EXP. 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 bottle must be discarded four weeks after it has been opened, even if it has not been completely consumed.

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

Latanoprost Teva-ratiopharm Composition

The active ingredient is latanoprost.

One milliliter of eye drop solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

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

Appearance of the product and contents of the package

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

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

Latanoprost Teva-ratiopharm is available in packaging of 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer responsible::

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Or

Jadran Galenski Laboratorij d.d.

Svilno 20,

51000 Rijeka

Croatia

This medicine is authorized in the EEA member states under the following names:

GermanyLatanoprost-ratiopharm 50 Mikrogramm/ml eye drops, solution

FranceLatanoprost Teva Santé 50 microgrammes/ml eye drops in solution

ItalyLatanoprost ratiopharm 50 microgrammi/ml eye drops, solution

NetherlandsLatanoprost 50 microgram/ml Teva, eye drops, solution

SpainLatanoprost Teva-ratiopharm 50 microgramos/ml eye drops in solution

Last review date of this leaflet: April 2022

Other sources of information

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71101/P_71101.html

QR code+ URL

/