Patient Information Leaflet: Information for the User

GALAXIA 50 micrograms/ml eye drops, solution

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

Contents of this leaflet

What GALAXIA is and what it is used for
What you need to know before using GALAXIA
How to use GALAXIA
Possible side effects
How to store GALAXIA
Contents of the pack and other information

1. What GALAXIA is and what it is used for

GALAXIA contains the active substance latanoprost, which belongs to a class of medicines known as prostaglandin analogues. It works by reducing the pressure inside the eye (intraocular pressure), promoting the natural drainage of fluid from within the eye into the bloodstream.

This medicine is used to treat a type of glaucoma called open-angle glaucoma and ocular hypertension. Both of these conditions are associated with increased pressure inside the eye, which over time may damage vision.

Galaxia is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using GALAXIA

Galaxia can be used in adult women and men (including the elderly) and in children from birth up to 18 years of age. The use of Galaxia in premature neonates (gestational age less than 36 weeks) has not been studied.
Do not use GALAXIA

if you are allergic to latanoprost or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or planning to become pregnant;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor, your child’s doctor, or pharmacist before using GALAXIA or before giving this medicine to your child.
Use this medicine with caution and inform your doctor or your child’s doctor:

if you or your child suffer from a type of eye condition called closed-angle glaucoma;
if you or your child are undergoing or have recently undergone eye surgery, including cataract surgery;
if you or your child have an increased risk of developing a condition known as cystoid macular edema;
if you or your child have had cataract removal surgery and have related conditions (aphakia or pseudophakia);
if you or your child experience eye pain, irritation or inflammation, or blurred vision;
if you or your child have dry eyes (ocular dryness);
if you or your child have severe asthma or if asthma is not well controlled;
if you or your child wear contact lenses (you may still use GALAXIA, following the instructions in section 3);
if you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

GALAXIA may permanently change the colour of the eye and/or reversibly change the colour of the eyelashes, surrounding vellus hair, and skin around the eye (see section 4).
Other medicines and GALAXIA
Inform your doctor, your child’s doctor, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including non-prescription medicines (or eye drops).
GALAXIA may interact with other medicines. Do not use other medicines belonging to the prostaglandin class, as this could lead to increased intraocular pressure.
Pregnancy and breastfeeding
Do not use GALAXIA during pregnancy or while breastfeeding.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Driving and using machines
This medicine may cause temporary blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.
GALAXIA contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride is a preservative that can be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (damage to the eye’s outer transparent layer).
If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
GALAXIA contains phosphates
This medicine contains 9.34 mg of phosphate buffer per 1 ml. If you have severe damage to the eye’s outermost transparent layer (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use GALAXIA

Use this medicine exactly as directed by your doctor or the doctor treating your child or by the pharmacist. If you have any doubts, consult your doctor or the doctor treating your child or the pharmacist.

Use in adults and children
The recommended dose for adults (including elderly patients) and children is one drop of eye drops once daily, preferably in the evening, in the affected eye(s).
Do not use GALAXIA more than once a day, as more frequent administration may reduce the medicine's effectiveness.
Continue using GALAXIA as directed by your doctor or the doctor treating your child until your doctor tells you to stop treatment.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying the eye drops. After applying GALAXIA, wait at least 15 minutes before reinserting the contact lenses.
If you need to use other locally administered eye medications, wait at least 5 minutes after using GALAXIA before applying them.

Instructions for use:

Wash your hands thoroughly before using GALAXIA;
Remove the closure cap from the bottle;
Gently pull down the lower eyelid of the eye to be treated with one finger;
Bring the tip of the bottle close to the eye without touching it;
Gently squeeze the bottle to release a single drop into the eye, then release the lower eyelid;
Press with one finger at the inner corner of the eye, near the nose. Keep pressing for 1 minute while keeping the eye closed;
Repeat the procedure for the other eye, if necessary;
Close the bottle with the closure cap and store it (see section 5).

If you use GALAXIA with another eye drop
Wait at least 5 minutes between administering GALAXIA and another eye drop.

If you use more GALAXIA 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 the doctor treating your child for advice.
Seek immediate medical attention from your doctor or the doctor treating your child, or go to the nearest hospital, if you or your child has accidentally ingested GALAXIA.

If you forget to use GALAXIA
If you forget to use GALAXIA, continue with the next dose at the usual time. Do not use a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or the doctor treating your child or the pharmacist.

If you stop treatment with GALAXIA
Inform your doctor or the doctor treating your child if you intend to discontinue treatment with GALAXIA.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people):

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 colour (blue, grey, green or brown). Any change in eye colour may occur after several years, although it generally appears within the first 8 months of treatment. The colour change may be permanent and may be more noticeable if you use GALAXIA in only one eye. There appear to be no problems associated with the change in eye colour. After stopping treatment with GALAXIA, no further change in eye colour has been observed.
Eye redness.
Eye irritation such as burning sensation, sensation of sand in the eyes, itching, stinging (pricking sensation) or foreign body sensation in the eyes. If irritation is severe enough to cause excessive tearing or leads to discontinuation of the medicine, consult your doctor or pharmacist immediately (within one week). Therapy may need to be adjusted to ensure adequate treatment of your condition.
Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, observed mostly in people of Japanese origin. These changes include increased length, thickness, darkening and increased number of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.

Common (may affect up to 1 in 10 people):
Eye irritation or abrasion of the eye surface, 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 and 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 oedema).
Skin rash.
Chest pain (angina), awareness of heartbeat (palpitations).
Asthma, shortness of breath (dyspnoea).
Chest pain.
Headache, dizziness.
Muscle pain, joint pain.

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

Inflammation of the iris, which is the coloured part of the eye (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital oedema), change in eyelash direction or abnormal eyelash growth, scarring of the eye surface, 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.
Intense 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 already affected by heart problems, sunken appearance of the eye (enophthalmos).

Side effects in the paediatric population
Side effects observed more frequently in children than in adults have been: 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, opaque 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
http://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 GALAXIA

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2-8°C) and in the original packaging to protect the medicine from light.
After first opening, the bottle may be stored outside the refrigerator, but must be kept at a temperature not exceeding 25°C and the medicine must be used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the box.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GALAXIA contains

The active substance is latanoprost. Each drop of solution contains approximately 1.5 micrograms of latanoprost (0.005 g in 100 ml).
The other components are: benzalkonium chloride, sodium chloride, monobasic monohydrate sodium phosphate (E339a), dibasic anhydrous sodium phosphate (E339b), purified water.

Description of the appearance of GALAXIA and contents of the pack
Pack containing one bottle with a 2.5 ml dropper dispenser for ophthalmic solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Manufacturer
BRUSCHETTINI S.r.l.
Via Isonzo, 6
16147 Genova (GE)