Lastafry

Patient Information Leaflet: Information for the User

LASTAFRY 50 micrograms/mL eye drops, solution

Latanoprost
Generic medicine
Please read all of this leaflet carefully before you start 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, your child's doctor, or pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you or your child experience any side effects, including those not listed in this leaflet, contact your doctor, your child's doctor, or pharmacist. See section 4.

Contents of this leaflet

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

1. What LASTAFRY is and what it is used for

LASTAFRY 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.
LASTAFRY is used to treat conditions known as open-angle glaucoma and ocular
hypertension in adults. Both of these conditions are associated with increased pressure
inside the eye and, over time, may damage vision.
LASTAFRY is also used to treat elevated intraocular pressure and glaucoma in children
and infants of all ages.
LASTAFRY can be used in adult men and women (including the elderly) and in children from
birth up to 18 years of age. LASTAFRY has not been studied in preterm infants (less than 36 weeks
of gestation).
LASTAFRY eye drops are a sterile solution that does not contain preservatives.

2. What you should know before using LASTAFRY

Do not use LASTAFRY

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

Warnings and precautions
Tell your doctor, your child’s doctor, or pharmacist before using LASTAFRY or
before administering it to your child if you think that any of the following conditions applies to you or your child:

• if you or your child are scheduled for or have recently undergone 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 still use LASTAFRY, but you must follow the instructions for contact lens wearers provided in section 3
• if you or your child have previously had or currently have a viral eye infection caused by the herpes simplex virus (HSV)

Other medicines and LASTAFRY
LASTAFRY may interact with other medicines. Inform your doctor, your child’s doctor, or
pharmacist if you or your child are using, have recently used, or might use any other
medicines, including medicines (or eye drops) obtained without a prescription.
Pregnancy and breastfeeding
Pregnancy
Do not use LASTAFRY during pregnancy. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Breastfeeding
Do not use LASTAFRY while breastfeeding.
Driving and using machines
The use of LASTAFRY may cause temporary blurred vision. If this occurs, avoid driving or using machinery until your vision is clear again.
LASTAFRY contains macrogolglycerol hydroxystearate 40.
This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.
LASTAFRY contains phosphate buffer
Each mL of solution of this medicine contains 6.35 mg of phosphates.
If you have severe damage to the transparent outer layer of the front part of the eye (the cornea), phosphates may, in very rare cases, cause the formation of cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use LASTAFRY

Use this medicine exactly as instructed by your doctor or the doctor treating your child. If you have any doubts, consult your doctor, the doctor treating your child, or the pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop once daily in the eye(s) to be treated. The best time to administer it is in the evening.
Do not use LASTAFRY more than once a day, as more frequent administration may reduce the effectiveness of the treatment.
Use LASTAFRY as directed by your doctor or the doctor treating your child until they tell you to stop.
Contact lens wearers
If you or your child wears contact lenses, they must be removed before using LASTAFRY.
After using LASTAFRY, wait 15 minutes before reinserting contact lenses.
Instructions for use

1a 1b	Remove the bottle (figure 1a) from the carton and write the date of opening on both the carton and the bottle in the designated space. - Take the bottle and a mirror. - Wash your hands. - Remove the cap (figure 1b).
2	Hold the bottle upside down with your thumb on the rim of the bottle and the other fingers at the bottom. Before first use, pump the bottle repeatedly about 10 times until the first drops appear (figure 2).
3	Tip your head back or tilt your child's head backward. With a clean finger, gently pull down the lower eyelid until a "pocket" forms between the eyelid and the eye. The drop should be placed here (figure 3). - Bring the tip of the bottle close to the eye. Use the mirror if needed.
4	Do not touch the eye, eyelid, nearby areas, or any other surface with the dropper tip. This could contaminate the eye drops. - Gently press the bottom of the bottle to release one drop at a time (figure 4). - If a drop does not enter the eye, try again.
5	After using the medicine, press a finger against the corner of the eye near the nose for 1 minute (figure 5). This helps prevent the medicine from draining into the rest of the body.
	If using drops in both eyes, repeat the same steps for the other eye. - Close the cap tightly immediately after use. - Use only one bottle of medicine at a time. Do not open the cap until you are ready to use the bottle. - Dispose of the bottle 4 weeks after first opening to prevent infection, and use a new bottle.

If you use LASTAFRY with other eye drops
Wait at least 5 minutes between using LASTAFRY and other eye drops.

If you use more LASTAFRY than you should
If you have applied too many drops into the eye, you may experience mild irritation, tearing, and eye redness. These effects are temporary, but if they occur, it is advisable to contact your doctor or your child’s doctor for advice.
In case of accidental ingestion of LASTAFRY by you or your child, inform your doctor immediately.

If you forget to use LASTAFRY
Continue taking your usual dose at the usual time. Do not use a double dose to make up for a forgotten dose. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you stop using LASTAFRY
You should speak to your doctor or your child’s doctor if you wish to stop treatment with LASTAFRY.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following are known side effects associated with eye drops containing the active substance latanoprost:

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

• Gradual and permanent change in eye colour due to increased brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years, although it usually appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable if you use LASTAFRY in only one eye. There appear to be no associated problems with this change in eye colour. After stopping treatment with LASTAFRY, no further change in eye colour has been observed.

• Eye redness.

• Eye irritation (burning sensation, gritty feeling, itching, stinging or foreign body sensation in the eyes). If you experience eye irritation so severe that your eyes water excessively or you consider stopping this medicine, contact your doctor, pharmacist or nurse promptly (within one week). Your treatment may need to be reviewed to ensure you continue to receive appropriate care for your condition.

• Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, mostly observed in people of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

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

• Eye surface irritation or abrasion, inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

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

• Swelling of the eyelids, dry eyes, 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), awareness of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

Rare (may affect up to 1 in 1000 people):

• Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital edema), misdirected eyelashes or abnormal eyelash growth, eye surface injury, fluid-filled area in the coloured part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe 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 already suffering from heart problems, sunken eye appearance (ocular groove becomes deeper).

Side effects observed more frequently in children than in adults are nasal itching, runny nose and fever.

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LASTAFRY

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. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Discard the bottle 4 weeks after first opening, to prevent infections. Write the date of opening
in the space provided on the label of the bottle and on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LASTAFRY contains:

• The active substance is latanoprost. Each mL of solution contains 50 micrograms of latanoprost.
• The other components are: macrogol glycerol hydroxystearate 40, sodium chloride, edetate disodium, sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, hydrochloric acid and/or sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of LASTAFRY and contents of the pack
LASTAFRY is supplied as 2.5 mL of aqueous solution, a clear, colourless solution free from visible particles, corresponding to approximately 80 drops, contained in a cardboard box with a white multidose container (HDPE) of 5 mL with a pump (PP, HDPE, LDPE), a green pressure cylinder and cap (HDPE).
Pack sizes:
Cardboard boxes containing 1 or 3 bottles with 2.5 mL of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Doc Generici S.R.L., via Turati 40, 20121 Milano, Italy

Manufacturer
Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece or
Lomapharm Rudolf Lohmann GmbH KG, Langes Feld 5, 31860 Emmerthal, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Tanafra
Cyprus Tanafra
France Latanoprost Pharmathen 50 microgrammes/ml, eye drops solution
Germany Tanafra 50 Mikrogramm/ml Augentropfen, Lösung
Greece Tanafra
Italy LASTAFRY
Spain Latanest 50 microgramos/ml eye drops solution