LIFOG 50 micrograms/ml eye drops solution

Introduction

Package Leaflet: Information for the Patient

Lifog 50 micrograms/ml eye drops, solution

latanoprost

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Lifog and what is it used for
2. What you need to know before you use Lifog
3. How to use Lifog
4. Possible side effects
   1. Storage of Lifog

1. Contents of the pack and further information

1. What is Lifog and what is it used for

Lifog contains latanoprost, which belongs to a group of medicines known as prostaglandin analogues. It reduces pressure in the eye by increasing the natural outflow of fluid from the inside of the eye into the bloodstream.

This medicine is used to treat diseases known as open-angle glaucomaand ocular hypertensionin adults. Both of these diseases are related to increased pressure in the eye, which can affect vision.

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

2. What you need to know before you use Lifog

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

Do not useLifog

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

Warnings and precautions

Consult your doctor, your child's doctor, or pharmacist before starting to use this medicine:

• If you or your child have severe asthma or uncontrolled asthma
• 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 use contact lenses. You can continue to use this medicine, but you must follow the instructions included in Section 3 for contact lens users.
• If you have had or are having a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Lifog

Tell your doctor, your child's doctor, or pharmacist if you or your child are taking or using, have recently taken or used, or might take or use any other medicines.

Lifog may interact with other medicines.

Pregnancy and breastfeeding

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

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

Driving and using machines

When using eye drops, you may experience blurred vision for a short time. If this happens, do not drive or use machines until your vision is clear.

Be careful when driving or operating heavy machinery until you know how this medicine affects you.

Lifog contains phosphates

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

3. How to use Lifog

Follow the instructions for administration of this medicine provided by your doctor or your child's doctor. If you are unsure, consult your doctor, your child's doctor, or pharmacist again.

Dosage

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

Use this medicine as directed by your doctor or your child's doctor until they tell you to stop.

Contact lens users

• If you or your child use contact lenses, you must remove them before using this medicine. After applying this medicine, wait at least 15 minutes before putting the contact lenses back in.

Instructions for use

Follow these steps to use Lifog eye drops, solution (hereafter referred to as eye drops):

1. Wash your hands well and sit or stand comfortably.
2. Remove the protective cap (image 1).
3. Hold the bottle upside down with your thumb on the tip of the bottle and your other fingers on the bottom of the bottle (image 2). Before the first use, actuate the dispenser repeatedly, about 10 times, until the first drop appears.
4. Tilt your head back and carefully separate the lower eyelid, forming a pocket between the eye and the eyelid.
5. Place the tip of the bottle close to the eye without touching it.
6. Gently press the tip of the bottle and the bottom of the bottle to release only one drop into the eye to be treated, then release the lower eyelid (image 3).
7. Press the finger on the edge of the affected eye next to the nose (image 4). Keep it like this 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. Put the cap back on the bottle.

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

Use only one bottle of the medicine at a time. Do not open the bottle unless you need to use the eye drops.

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

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

If you use Lifog with other eye drops

Wait at least five minutes between the application of this medicine and the administration of other eye drops. Ophthalmic ointments should be administered last.

If you use moreLifogthan you should

Be careful when squeezing the bottle to administer only one drop into the affected eye.

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may also become red and tearful. This situation should disappear, but if you are concerned, contact your doctor or your child's doctor.

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

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

If you forget to useLifog

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

If you stop usingLifog

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

If you have any further questions about the use of this medicine, ask your doctor, your child's doctor, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

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

• Gradual change in eye color by increasing the amount of brown pigment in the colored part of the eye (iris). This is more likely if your eyes are mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) than if they are a single color (blue, gray, green, or brown). Changes in eye color may take years to develop, but are usually observed in the first 8 months of treatment. The change in eye color may be permanent and may be more noticeable if you use this medicine in only one eye. However, it seems 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.
• Eye irritation (burning sensation, feeling of grit in the eye, itching, stinging, or feeling of having a foreign body in the eye). If you experience severe eye irritation that makes your eyes water excessively 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), length, thickness, and number of eyelashes.

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

• Irritation or erosion of 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 heartbeat (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), misdirected or extra row of eyelashes, scarring of the eye surface, accumulation of fluid in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe 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 sulcus).

The side effects observed in children at a higher frequency than in adults are runny nose and itchy nose and fever.

In very rare cases, some patients with severe damage to the clear layer on the front of the eye (cornea) have developed cloudy areas on the cornea due to calcium deposits caused by treatment.

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lifog

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

Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date is the last day of the month stated.

Do not freeze.

Do not store above 25°C.

2.5 ml bottle opened: use within 30 days.

7.5 ml bottle opened: use within 90 days.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofLifog

• The active substance is latanoprost.

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

• The other ingredients are sodium chloride, disodium phosphate, sodium dihydrogen phosphate monohydrate, polysorbate 80, disodium edetate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

Appearance and packaging

Lifog is a clear, colorless liquid.

The packaging includes a PEAD bottle with a multidose pressure applicator (PP, PEAD, PEBD), PEAD cap, and PP tip.

Lifog is available in the following pack sizes:

1 bottle x 2.5 ml

1 bottle x 7.5 ml

2 bottles x 7.5 ml

Not all pack sizes may be marketed.

Marketing authorisation holder

BRILL INTERNATIONAL, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

Lomapharm GmbH

Langes Feld 5, Emmerthal

Niedersachsen, 31860

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

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

Czech Republic - Xaloptic Neo

Germany - Lifog 50 Mikrogramm/ml Augentropfen, Lösung

France - LIFOG 50 microgrammes/ml collyre en solution

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

Italy – Lifog

Lithuania - Xalvide 50 mikrogramu/ml akiu lašai (tirpalas)

Latvia - Xalvide 50 mikrogrami/ml acu pilieni, škidums

Portugal - Lifog 50 microgramas/ml colírio, solução

Spain – Lifog 50 microgramos/ml colirio en solución

Date of last revision of this package leaflet:

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/)