Latanoprost Teva-Ratiopharm 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Latanoprost Teva-ratiopharm 50 micrograms/ml eye drops solution

latanoprost

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 only for you or your child, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or the doctor treating your child or your pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Latanoprost Teva-ratiopharm is and what it is used for

Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow 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 infants and children of all ages.

2. What you need to know before using Latanoprost Teva-ratiopharm

Latanoprost Teva-ratiopharm can be used in adult men and women (including elderly patients) and in children from birth up to 18 years of age. Latanoprost Teva-ratiopharm has not been studied in premature infants (less than 36 weeks gestation).

Do not use Latanoprost Teva-ratiopharm

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

Warnings and precautions

Talk to your doctor, your child's doctor, or pharmacist before starting to use Latanoprost Teva-ratiopharm or before administering it to your child if you think any of the following situations apply to you or 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 may continue to use Latanoprost Teva-ratiopharm, but you must follow the instructions provided in section 3 for contact lens wearers
• If you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Using Latanoprost Teva-ratiopharm with other medicines

Latanoprost Teva-ratiopharm may interact with other medicines. Inform your doctor, your child's doctor, or pharmacist if you or your child are taking/using, have recently taken/used, or might need to take/use any other medicines (or eye drops), including 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

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

When using Latanoprost Teva-ratiopharm, blurred vision may occur for a short period of time. If this happens, do not drive and do not operate tools or machinery until your vision returns to normal.

Latanoprost Teva-ratiopharm contains benzalkonium chloride and phosphate buffers

This medicine contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of contact lenses. You must remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

This medicine contains 6.43 mg/ml of phosphates.

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.

3. How to use Latanoprost Teva-ratiopharm

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

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

Do not use latanoprost more than once a day, as the effectiveness of treatment 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, you must wait 15 minutes before reinserting the contact lenses.

Instructions for use

To properly administer latanoprost, follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Unscrew 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 near the eye, but without touching it.
5. Gently squeeze the bottle so that only one drop goes into the eye. Release the lower eyelid.
6. Press with your finger on the corner of the treated eye near the nose. Apply pressure for 1 minute, keeping your 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 Teva-ratiopharm with other eye drops

Wait at least 5 minutes between the administration of latanoprost and other eye drops.

If you use more Latanoprost Teva-ratiopharm than you should

If more drops than intended are applied to the eye, you may experience mild eye irritation, redness, and tearing. This should resolve on its own, but if you are concerned, contact your doctor or your child's doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Latanoprost Teva-ratiopharm

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

If you stop using Latanoprost Teva-ratiopharm

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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• Gradual change in eye color due to increased brown pigment in the colored part of the eye known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is usually noticeable after 8 months of treatment. The color change may be permanent and may be more pronounced if you use latanoprost in only one eye. The change in eye color does not appear to be associated with any eye problems. The change in eye color 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 or pharmacist as soon as possible (within one week). Your treatment may need to be reviewed to ensure you are receiving the appropriate therapy for your condition.
• Gradual changes 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), elongation, thickening, and increased number of eyelashes.

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

• Eye surface irritation or disorders, eyelid inflammation (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

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

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, breathing difficulty (dyspnea).
• Chest pain.
• Headache, dizziness.
• Nausea, vomiting.
• Muscle pain, joint pain.

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, fluid accumulation in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense skin itching.
• 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 pre-existing heart problems.
• Appearance of sunken eyes (increased depth of the eyelid groove).

Adverse effects observed in children at a higher frequency 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 adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP or CAD. 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 the bottle: Do not store above 25°C. The bottle should be discarded four weeks after opening, even if there is still some medicine left.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Latanoprost Teva-ratiopharm

The active substance is latanoprost.

One 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, disodium hydrogen phosphate, sodium chloride, purified water.

Appearance of the medicine and contents of the container

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

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 EEA Member States under the following names:

Germany: Latanoprost-ratiopharm 50 microgram/ml eye drops, solution
France: Latanoprost Teva Santé 50 micrograms/ml eye drops, solution
Italy: Latanoprost ratiopharm 50 micrograms/ml eye drops, solution
Netherlands: Latanoprost 50 microgram/ml Teva, eye drops, solution
Spain: Latanoprost Teva-ratiopharm 50 micrograms/ml eye drops, solution

Date of the most recent review of this leaflet: April 2022

Other sources of information

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/

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

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