Latanostill

Patient Information Leaflet
Latanostill 50 micrograms/ml eye drops, solution
Latanoprost
Generic medicine
Please read this leaflet carefully before using this medicine. Even if you have used Latanostill or a similar medicine before, we recommend that you read this leaflet carefully. The information may have been updated.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

1. What Latanostill is and what it is used for
2. Before you use Latanostill
3. How to use Latanostill
4. Possible side effects
5. How to store Latanostill
6. Further information

1. What LATANOSTILL is and what it is used for

Latanostill belongs to a class of medicines known as prostaglandin analogues. Latanostill works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Latanostill is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension. Both of these conditions are associated with increased intraocular pressure, which may eventually impair vision.
Latanostill is also used to treat elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. Before using LATANOSTILL

Latanostill can be used in adult women and men (including elderly people) and in children from birth up to 18 years of age. The use of Latanostill in premature infants (with gestational age less than 36 weeks) has not been investigated.
Do not use Latanostill

• if you are allergic (hypersensitive) to the active substance or to any of the other components of Latanostill (see section 6 for the complete list of excipients)
• if you are pregnant or planning to become pregnant
• if you are breastfeeding.

Take special care with Latanostill
Talk to your doctor or the doctor treating your child or the pharmacist before using Latanostill or before giving this medicine to your child if you think any of the following conditions apply to you or your child:

• if you or your child are about to undergo 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 suffer from dry eye;
• 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 Latanostill, following the instructions for contact lens wearers provided in section 3;
• if you have had or currently have a viral eye infection caused by Herpes Simplex virus (HSV).

Use of Latanostill with other medicines
Latanostill may interact with other medicines. Inform your doctor or the doctor treating your child or the pharmacist if you or your child are taking or have recently taken any other medicines, including over-the-counter medicines (or eye drops).
Pregnancy
Do not use Latanostill during pregnancy. Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use Latanostill during breastfeeding.
Driving and use of machines
When using Latanostill, you may experience transient blurred vision.
If this occurs, you must not drive or operate machinery until your vision is clear again.
Important information about some components of Latanostill
Latanostill contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or corneal abrasion.
Benzalkonium chloride can be absorbed by contact lenses and is known to cause changes in the colour of soft contact lenses. Therefore, you should avoid contact between the medicine and soft contact lenses.
If you or your child wear contact lenses, they must be removed before applying Latanostill. After applying Latanostill, you must wait 15 minutes before reinserting the contact lenses. For instructions for contact lens wearers, refer to section 3.

3. How to use LATANOSTILL

Use Latanostill exactly as prescribed 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 usual dose for adults (including elderly patients) and children is one drop once daily in the eye(s) to be treated. The optimal time for administration is in the evening.
Do not use Latanostill more than once a day, as treatment efficacy may be reduced if the medicine is administered more frequently.
Use Latanostill as directed by your doctor or the doctor treating your child, until your doctor instructs you to stop treatment.
Contact lens wearers
If you or your child wear contact lenses, they must be removed before applying Latanostill. After applying Latanostill, wait 15 minutes before reinserting the contact lenses.
Instructions for use

Latanostill is for ophthalmic use only.

The following steps are intended to ensure correct use of Latanostill:

1. To open the container, unscrew the cap.
2. Wash your hands and sit down or assume a comfortable position.
3. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eye.
4. Gently squeeze the inverted bottle until a single drop is dispensed into the eye. Avoid touching the eye, eyelid, or any other object with the dropper tip. Keep the affected eye closed, and press with your finger against the inner corner of the closed eye (the point where the eye meets the nose) for one minute.
5. Repeat steps 3 and 4 in the other eye if your doctor has instructed you to do so.

Immediately close the bottle after use by screwing the cap back on until it fits securely on the container. Do not overtighten.
The dropper tip is designed to deliver a drop of predetermined volume; therefore, do not enlarge the dropper orifice. After instilling all prescribed doses, some Latanostill will remain in the bottle. Do not be concerned about this. The bottle contains an excess amount of Latanostill beyond the quantity prescribed by your doctor. Do not attempt to remove the excess medication from the bottle.

If you use Latanostill with another eye drop
Wait at least 5 minutes between the administration of Latanostill and another eye drop.

If you use more Latanostill than you should
Putting too many drops into the eyes may cause mild irritation, tearing, and eye redness. These effects should be temporary, but if you are concerned, contact your doctor or your child's doctor for advice.
Contact your doctor as soon as possible if you or your child has accidentally ingested Latanostill.

If you forget to use Latanostill
Continue with your usual dose at the regular time. Do not use a double dose to make up for the missed dose.
If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanostill
You must inform your doctor or your child's doctor if you intend to discontinue treatment with Latanostill.

4. Possible side effects

Like all medicines, Latanostill can cause side effects, although not
everyone will experience them.
The following are known side effects associated with the use of Latanostill:
Very common (likely to affect more than 1 in 10 people):
Eye-related effects

• Gradual 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 in colour (blue, grey, green or brown eyes). Any change in eye colour may occur after years, although it generally appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable
  if you use Latanostill in only one eye. There appear to be no problems
  associated with the change in eye colour. After discontinuation of
  treatment with Latanostill, no further change in eye colour has been observed.

• Eye redness.

• Eye irritation [burning sensation, sensation of sand in the eyes, itching, stinging pain (pinprick sensation), or foreign body sensation in the eyes].

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

Common (likely to affect less than 1 in 10 people):
Eye-related effects
Irritation or abrasion of the eye surface, inflammation of the eyelid margin (blepharitis), eye pain, and light sensitivity (photophobia).
Uncommon (likely to affect less than 1 in 100 people):
Eye-related effects
Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, and conjunctivitis.
Skin-related effects
Skin rash.
Rare (likely to affect less than 1 in 1,000 people):
Eye-related effects:
Inflammation of the iris, the coloured part of the eye (iritis/uveitis), swelling of the retina (macular edema), symptoms related to swelling or abrasion/damage of the eye surface, swelling around the eyes (periorbital edema), altered eyelash direction, or abnormal eyelash growth.
Skin reactions on the eyelids, darkening of the eyelid skin.
Respiratory effects: asthma, worsening of asthma, and shortness of breath (dyspnea).
Very rare (likely to affect less than 1 in 10,000 people):
Eye-related effects: sunken appearance of the eye (enophthalmos)
Cardiac effects: worsening of angina in patients already suffering from heart disease
Systemic effects: chest pain.
Patients have also reported the following side effects:
Development of a viral eye infection caused by the herpes simplex virus (HSV)
Eye-related effects: fluid-filled area in the coloured part of the eye (iris cyst).
Cardiac effects: awareness of heartbeat (palpitations).
Infections/infestations: herpetic keratitis.
Nervous system effects: headache, dizziness.
Musculoskeletal effects: muscle pain, joint pain.
Side effects observed more frequently in children than in adults were: runny and itchy nose, fever.
In very rare cases, some patients with severe damage to the transparent layer at the front 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 effect, including those not listed in
this leaflet, consult your doctor or pharmacist. You can also report
side effects directly via the national reporting system at the following 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 Latanostill

KEEP OUT OF SIGHT AND REACH OF CHILDREN.
Do not use Latanostill after the expiry date stated on the bottle and
on the carton. The expiry date refers to the last day of that month.
Store the unopened bottle in the refrigerator at a temperature
between +2°C and +8°C. After opening, store the bottle at room
temperature up to 25°C for up to 4 weeks. Do not use Latanostill for
longer than 4 weeks after the first opening.
Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Other information

What Latanostill contains

• The active substance is latanoprost. Each ml contains 50 micrograms of latanoprost.
• The other components are: Sodium chloride, Benzalkonium chloride 10% w/w solution

Disodium hydrogen phosphate dihydrate
Disodium phosphate dodecahydrate
Sodium hydroxide 10% w/v solution and/or phosphoric acid 10% w/v solution
Purified water.

Description of the appearance of Latanostill and contents of the pack
Latanostill is an aqueous ophthalmic solution (eye drops), buffered, isotonic and sterile, containing latanoprost for exclusive ophthalmic use. It is available in sterile dropper bottles with plastic cap. Each bottle contains 2.5 ml of solution and is packaged in a cardboard carton. Each dropper bottle contains 2.5 ml of eye drops. Each carton contains one single bottle.

Marketing Authorisation Holder and Manufacturer
BRUSCHETTINI SRL
VIA ISONZO, 6 - 16147 GENOVA ITALY

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: Latanoprost Bruschettini
Italy: Latanostill