Prospecto: information for the patient

Lifog 50 micrograms/ml eye drops in solution

latanoprost

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to youor to your childand should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What is Lifog and for what it is used

2.What you need to know before starting to use Lifog

3.How to use Lifog

4.Possible adverse effects

1. Storage of Lifog

6.Contents of the package and additional information

Lifog contains latanoprost, which belongs to a group of medications known as prostaglandin analogs. It reduces the pressure within the eye by increasing the natural drainage of fluid from the interior of the eye into the bloodstream.

This medication is used to treat conditions known asopen-angle glaucomaandocular hypertensionin adults. Both conditions are related to the increase in pressure within the eye that can affect vision.

This medication is also used to treat increased pressure within the eye and glaucoma in children and infants of all ages.

This medication may be used in adult men and women (including elderly patients) and in children from birth to 18 years of age. This medication has not been investigated in premature children (less than 36 weeks of gestation).

Do not useLifog

• if you areallergicto latanoprost or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, the doctor treating your child, or your pharmacist before starting to use this medication:

• If youor your childhave severe asthma or asthma that is not well controlled
• if youor your childhave 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 use contact lenses. You may continue to use this medication, 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 Lifog

Inform your doctor, the doctor treating your child, or your pharmacist if you or your child are taking or using, have taken or used recentlyor may need to take or use any other medication.

Lifogmay interact with other medications.

Pregnancy and breastfeeding

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

Do not use this medicationif you are pregnant or breastfeeding, unless your doctor considers it necessary.

Driving and operating machinery

When using eye drops, blurred vision may occur for a short period of time. If this unwanted effect occurs, do not drive orusemachinery.Be careful if you drive or operate heavy machinery until you know how this medication affects you.

Lifog contains phosphates

Lifog contains 0.2 mg of phosphates in each drop of eye drops, equivalent to 6.4 mg/ml. If you suffer from severe damage to the transparent layer of the front of the eye (the cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium.

Follow the exact administration instructions provided for this medication by your doctor or your child's doctor. If in doubt, consult your doctor again, the doctor treating your child, or the pharmacist.

Dosage

The recommended dose in adults (including elderly patients) and children is one drop daily in the affected eye or eyes. The best time to do this is at night. Do not use this medication more than once a day, as the effectiveness of the treatment may be reduced if administered more frequently.

Use this medication as directed 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 this medication. After applying this medication, wait at least 15 minutes before reinserting the contact lenses.

Usage Instructions

Follow the steps below to use Lifog eye drops correctly:

1. Wash your hands thoroughly and sit or stand comfortably.
2. Remove the protective cap (image 1).
3. Hold the bottle upside down with your thumb on the nozzle and the other fingers on the bottom of the bottle (image 2). Before first use, operate the applicator repeatedly, about 10 times, until the first drop appears.
4. Incline your head back and carefully separate the lower eyelid, forming a pouch between the eye and the eyelid.
5. Place the tip of the bottle close to the eye without touching it.
6. Press lightly on the nozzle and the bottom of the bottle to introduce only one drop into the affected eye, then release the lower eyelid (image 3).
7. Press the outer corner of the eye near the nose with your finger (image 4). Remain in this position for 1 minute with the eye closed.
8. Repeat the process in the other eye if your doctor has instructed you to do so.
9. Replace the cap on the bottle.

Image 1.Image 2.Image 3.Image 4.

Use only one bottle of the medication at a time. Do not open the bottle if you do not need to use the eye drops.

To prevent infections, discard the 2.5 ml bottle after 30 days, and the 7.5 ml bottle after 90 days after the first opening, and use a new bottle.

Record the date of opening the bottle in the provided space on the outer packaging to better control the expiration date once the bottle is opened.

Using Lifog with other eye drops

Wait at least five minutes between applying this medication and administering other eye drops. Ointments should be administered last.

Using more Lifog than prescribed

Be careful when pressing the bottle to administer only one drop in the affected eye.

If more drops than prescribed have been 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.

If you or your child accidentally ingest this medication, inform your doctor or your child's doctor as soon as possible.

In the event of an accidental ingestion by you or your child, consult your doctor or pharmacist as soon as possible, or call the Toxicological Information Service, phone: 91 562 04 20

Missing a dose of Lifog

If you forget to administer a dose, continue with the next dose at the usual time. Do not administer a double dose to compensate for the missed dose.

Stopping treatment with Lifog

If you want to stop using Lifog, consult your doctor or your child's doctor first.

If you have any other questions about using this medication, ask your doctor, the doctor treating your child, or the pharmacist.

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

The following side effects have been reported:

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 (iris). This is more likely if your eyes are mixed color (brown-blue, brown-gray, brown-yellow, or brown-green) than if they are a single color (blue, gray, green, or brown). Changes in eye color may take years to develop, but are usually seen in the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use this medicine in only one eye. However, it appears that the change in eye color does not cause any problems. The change in eye color does not continue after stopping treatment with this medicine.

• Redness of the eye.
• Ocular irritation (sensation of burning, sensation of sand in the eye, itching, stinging, or sensation of a foreign body in the eye).If you experience severe ocular irritation that causes excessive tearing or makes you think about 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(may affect up to 1 in 10 people):

• Ocular irritation orerosionof the eye surface, 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 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), feeling the heart rhythm (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle and 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 eye surface, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, scarring of the eye surface, 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 thesimplex virus (HSV).

Very rare(may affect up to 1 in 10,000 people):

• Worsening of angina in patients who also suffer from heart problems, appearance of sunken eyes (greater depth of the eyelid sulcus).

The side effects observed in children at a frequency greater than in adults are runny nose and 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 side effects, consult your doctor or pharmacist,even if they are possibleside effects that do not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 packaging and on the label of the bottle, which is indicated by the letters CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Do not store at a temperature above 25 °C.

Opened 2.5 ml bottle: use within 30 days.

Opened 7.5 ml bottle: use within 90 days.

Mark the date of bottle opening in the space provided on the outer packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofLifog

• The active ingredient is latanoprost.

Each milliliter of the solution contains 50microgramsof latanoprost.One drop contains approximately 1.5 micrograms of latanoprost.

• The other components aresodium chloride, disodium phosphate, sodium dihydrogen phosphate monohydrate, polisorbate 80, disodium edetate, sodium hydroxide (for pH adjustment), diluted hydrochloric acid (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the package

Lifog is a transparent and colorless liquid.

The package includes a closed PEAD bottle with a multidose pressure applicator (PP, PEAD, PEBD), a PEAD stopper, and a PP tip.

Lifog is available in the following package sizes:

1 bottle x 2.5 ml

1 bottle x 7.5 ml

2 bottles x 7.5 ml

Only some package sizes may be marketed.

Marketing authorization holder

BRILL INTERNATIONAL, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

Lomapharm GmbH

Langes Feld 5, Emmerthal

Niedersachsen, 31860

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

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

Bulgaria- Xalofree 50μg/ml??????????,???????

Republic of Czechia- Xaloptic Neo

Germany- Lifog 50 Mikrogramm/ml Eye Drops, Solution

France- LIFOG 50 microgrammes/ml eye drops in solution

Ireland- Loravis, 50 micrograms/ml eye drops, solution

Italy– Lifog

Lithuania- Xalvide 50 mikrogramu/ml eye drops (solution)

Latvia- Xalvide 50 mikrogrami/ml eye drops, solution

Portugal- Lifog 50 microgramas/ml eye drops, solution

Spain – Lifog 50 microgramos/ml eye drops in solution

Last review date of this leaflet:

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