Lifog

Package leaflet: Information for the user

Lifog 50 micrograms/ml eye drops, solution

latanoprost
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this 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
5. How to store Lifog
6. Contents of the pack and other information

1. What Lifog is and what it is used for

Lifog contains latanoprost and belongs to a group of medicines known as prostaglandin analogues. It reduces the pressure inside the eye by increasing the natural outflow of fluid from within the eye into the bloodstream.
Lifog is used to treat a type of glaucoma called open-angle glaucoma and also a condition known as ocular hypertension in adults. Both of these conditions are associated with increased pressure inside the eye, which can affect vision.
Lifog 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

Lifog can be used in adult men and women (including the elderly) and in children from birth up to 18 years of age. Lifog has not been studied in premature infants (less than 36 weeks of 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, the child's doctor, or pharmacist before using Lifog:

• if you or your child suffers from severe asthma or if asthma is not well controlled;
• if you or your child is about to undergo or has recently undergone eye surgery (including cataract surgery);
• if you or your child has eye problems (such as pain, irritation or inflammation, blurred vision);
• if you or your child suffers from dry eye;
• if you or your child wears contact lenses. You may still use Lifog, but follow the instructions for contact lens wearers in section 3;
• if you or your child has had or currently has a viral eye infection caused by the herpes simplex virus (HSV). Other medicines and Lifog Inform your doctor, the child's doctor, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Lifog may interact with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Do not use Lifog during pregnancy or breastfeeding unless your doctor considers it necessary.
Driving and using machines
The use of eye drops may cause temporary blurred vision. If this side effect occurs, do not drive or operate machinery. Do not drive or operate heavy machinery until you are certain about the possible effects of this medicine.
Lifog contains phosphates
Lifog contains 0.2 mg of phosphates per drop, equivalent to 6.4 mg/ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use Lifog

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or your child’s doctor. If you have any doubts, consult your doctor, your child’s doctor, or pharmacist.

Dosage
The recommended dose for adults (including elderly patients) and children is one drop once daily in the affected eye(s). The best time to administer it is in the evening. Do not use Lifog more than once a day, as the effectiveness of treatment may decrease.

Use Lifog as directed by your doctor or your child’s doctor until they tell you to stop.

Contact lens wearers

• If you or your child wears contact lenses, they must be removed before using Lifog. Wait 15 minutes after using Lifog before reinserting contact lenses.

Instructions for correct use
Follow these steps to correctly use Lifog eye drops, solution (hereinafter referred to as eye drops):

1. Wash your hands and sit or stand in a comfortable position.
2. Remove the protective cap (Image 1).
3. Hold the bottle upside down, placing your thumb on the shoulder of the bottle and the other fingers at the bottom (Image 2). Before first use, press the bottle repeatedly about 10 times until the first drop appears.
4. Tilt the head backwards and gently pull down the lower eyelid to form a pouch between the eye and the eyelid.
5. Bring the tip of the bottle close to the eye, but do not touch the eye.
6. Squeeze the tube and lower part of the bottle so that only one drop enters the eye, then release the lower eyelid (Image 3).
7. Press a finger against the corner of the treated eye near the nose (Image 4). Press for 1 minute while keeping the eye closed.
8. If instructed by your doctor, repeat the same procedure in the other eye.
9. Replace the cap on the bottle.

Image 1. Image 2. Image 3. Image 4.
Use only one bottle at a time. Do not remove the cap until the next application.
After opening, discard the 2.5 ml bottle 30 days after opening and the 7.5 ml bottle 90 days after opening, to prevent infection; then use a new bottle.
Record the date of opening on the carton to keep track of the shelf life after opening.

If you use Lifog with other eye drops
If you need to use other eye drops, wait at least five minutes after applying Lifog. Use ophthalmic ointments last.

If you use more Lifog than you should
Be careful when pressing the bottle to ensure only one drop is administered into the affected eye.
If too many drops are applied, mild irritation may occur, and the eyes may water and become red. This effect should pass quickly, but if you are concerned, contact your doctor or your child’s doctor.
If a child accidentally swallows Lifog, contact a doctor as soon as possible.

If you forget to use Lifog
If you forget to apply the eye drops at the usual time, wait until the next scheduled dose. Do not apply 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.
For any questions about the use of this medicine, consult 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 most commonly reported side effects are listed below:

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

• Gradual change in eye colour, with an increase in brown pigment in the coloured part of the eye, known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to notice this change than if you have eyes of a single colour (blue, grey, green or brown). Any changes in eye colour may take years to develop, although they are usually observed within 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if Lifog is applied to only one eye. There appear to be no associated problems with the change in eye colour. The change in eye colour does not continue after stopping treatment with Lifog.
• Eye redness.
• Eye irritation (burning, grittiness, itching or sensation of a foreign body in the eye). If you experience eye irritation severe enough to cause excessive tearing, or if you are considering stopping this medicine, consult a doctor, pharmacist or nurse (within one week). You may need to review your treatment to ensure you continue to receive appropriate management for your condition.
• Gradual changes in the eyelashes of the treated eye and fine hairs around it, mainly observed in people of Japanese origin. These changes include an increase in colour (darkening), length, thickness and number of eyelashes.

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

• Irritation or discomfort on the eye surface, inflammation of the eyelids (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 coloured part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), change in heart rhythm (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

• Inflammation of the iris (iritis), symptoms of swelling or scratch/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or an extra row of eyelashes, scarring on the eye surface, accumulation of fluid within the coloured part of the eye (iris cysts).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe 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 existing heart disease, sunken appearance of the eye (deepening of the eyelid groove).

Side effects observed more frequently in children than in adults include runny nose, itching and fever.
In very rare cases, some patients with severe damage to the outermost transparent layer of the eye (the cornea) developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lifog

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the
vial after “EXP”. The expiry date refers to the last day of that month.
Do not freeze.
Do not store above 25°C.
2.5 ml vial after opening: use within 30 days.
7.5 ml vial after opening: use within 90 days.
Record the date on which you opened the vial in the space provided on the cardboard box.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lifog contains

• The active substance is latanoprost. Each ml of solution contains 50 micrograms of latanoprost. Each drop contains approximately 1.5 micrograms of latanoprost.
• The other components are sodium chloride, sodium phosphate dibasic, monosodium dihydrogen phosphate monohydrate, polysorbate 80, disodium edetate, sodium hydroxide (to adjust pH), diluted hydrochloric acid (to adjust pH), water for injections.

Description of the appearance of Lifog and contents of the pack
Lifog is a clear, colourless liquid.
The pack consists of an HDPE bottle closed with a multidose pump dispenser (PP, HDPE,
LDPE), HDPE cap, and a PP tube.
Lifog is available in the following pack sizes:
1 bottle of 2.5 ml
1 bottle of 7.5 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
Italy
Manufacturer
Lomapharm GmbH
Langes Feld 5, Emmerthal
Niedersachsen, 31860
Germany
This medicinal product is authorized in the European Economic Area countries under the
following names:
BG - Xalofree 50 μg/ml капки за очи, разтвор
CZ - Xaloptic Neo
DE - Lifog 50 Mikrogramm/ml Augentropfen, Lösung
ES - Lifog 50 microgramos/ml colirio en solución
FR - LIFOG 50 microgrammes/mL, collyre en solution
IE - Loravis 50 micrograms/ml eye drops, solution
LV - Xalvide 50 mikrogrami/ml acu pilieni, šķīdums
LT - Xalvide 50 mikrogramų/ml akių lašai (tirpalas)
PT - Lifog 50 microgramas/ml colírio, solução