Lifog 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lifog 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 pharmacist.
• This medicine has been prescribed for you or your child only and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lifog is and what it is used for

2. What you need to know before using Lifog

3. How to use Lifog

4. Possible side effects

   1. How to store Lifog

5. Contents of the pack and other information

1. What Lifog is and what it is used for

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

This medicine 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.

This medicine is also used to treat elevated intraocular pressure and glaucoma in children and infants of all ages.

2. What you need to know before using Lifog

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

Do not use Lifog

• 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 using this medicine if:

• you or your child have severe asthma or poorly controlled asthma
• you or your child have had or are about to have eye surgery (including cataract surgery)
• you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision)
• you or your child have dry eyes
• you or your child wear contact lenses. You may continue using this medicine, but you must follow the instructions provided in section 3 for contact lens wearers.
• you or your child have had or currently have a viral eye infection caused by 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 need to 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, blurred vision may occur for a short period of time. If this side effect occurs, do not drive or operate machinery. Be cautious when driving or operating heavy machinery until you know how this medicine affects you.

Lifog contains phosphates

Lifog contains 0.2 mg of phosphates per drop of eye drop solution, equivalent to 6.4 mg/ml. If you have severe damage to the transparent front layer of the eye (the cornea), treatment with phosphates may, in very rare cases, lead to cloudy patches in the cornea due to calcium deposition.

3. How to use Lifog

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

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 administer it is at night. Do not use this medicine more than once a day, as treatment efficacy may be reduced if administered more frequently.

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

Contact lens users

• If you or your child wear contact lenses, they must be removed before using this medicine. After applying the medicine, wait at least 15 minutes before reinserting the contact lenses.

Instructions for use

Follow the steps below to correctly use Lifog eye drops solution (hereinafter referred to as eye drops):

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, prime the dispenser by pressing it repeatedly about 10 times until the first drop appears.
4. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eye and the eyelid.
5. Place the tip of the bottle close to the eye without touching it.
6. Gently press the nozzle and the bottom of the bottle to release only one drop into the eye being treated, then release the lower eyelid (image 3).
7. Press your finger against the corner of the treated eye next to the nose (image 4). Remain in this position for 1 minute with the eye closed.
8. Repeat the process in the other eye if directed by your doctor.
9. Replace the cap on the bottle.

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

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

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

Mark the date of opening on the space provided on the outer packaging to better monitor expiration once the bottle has been opened.

If you use Lifog with other eye drops

Wait at least five minutes between applying this medicine and administering other eye drops. Ophthalmic ointments should be administered last.

If you use more Lifog than you should

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

If more drops than intended have been 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.

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 at: 91 562 04 20.

If you forget to use Lifog

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 missed dose.

If you stop using Lifog

If you wish 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 adverse effects

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

The following adverse effects have been reported:

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

• Gradual change in eye color due to an increase in brown pigment in the colored part of the eye (iris). This is more likely if your eyes are of mixed color (blue-brown, gray-brown, yellow-brown or green-brown) than if they are of a single color (blue, gray, green or brown). Changes in eye color may take years to develop, but are usually observed within 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, the eye color change does not appear to 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, sensation of sand in the eye, itching, stinging, or feeling of a foreign body in the eye). If you experience severe eye irritation causing excessive tearing or making you consider stopping treatment, consult your doctor, pharmacist, or nurse 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), lengthening, thickening, and increased number of eyelashes.

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

• Irritation or erosion of the eye surface, eyelid inflammation (blepharitis), eye pain, and 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, 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, 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 eyelashes or an 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.
• 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 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 include 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, consult 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 Medicinal Products: www.notificaRAM.es

By reporting adverse 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 packaging and on the label of the vial after the letters CAD. The expiry date refers to the last day of the month indicated.

Do not freeze.

Do not store above 25 °C.

2.5 ml vial once opened: use within 30 days.

7.5 ml vial once opened: use within 90 days.

Record the date of opening the vial in the space provided on the outer packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lifog

• The active substance is latanoprost.

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

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

Appearance of the product and contents of the pack

Lifog is a clear, colourless liquid.

The pack contains a low-density polyethylene (LDPE) bottle closed with a multidose pressure dispenser (PP, LDPE, HDPE), LDPE 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

Some pack sizes may not be marketed.

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

Lomapharm GmbH

Langes Feld 5, Emmerthal

Niedersachsen, 31860

Germany

This medicinal product is authorized in the European Economic Area member states 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 the most recent review of this leaflet: August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)