GALAXIA 0.005 % Eye drops, solution

Зміст інструкції

1. GALAXIA 50 micrograms/ml eye drops, solution
   1. What is GALAXIA and what is it used for
   2. What you need to know before using GALAXIA
   3. How to use GALAXIA
   4. Possible side effects
   5. How to store GALAXIA
   6. Contents of the pack and other information

GALAXIA 50 micrograms/ml eye drops, solution

Latanoprost
Generic medicine

Read 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet

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

1. What is GALAXIA and what is it used for

GALAXIA contains the active substance latanoprost which belongs to the class of medicines known
as prostaglandin analogues. It works by lowering the pressure inside the eye
(intraocular pressure), promoting the natural outflow of fluid from inside the eye to the
blood circulation.
This medicine is used to treat a type of glaucoma called open-angle glaucomaand ocular hypertension. Both of these conditions are related to an increase
in pressure inside the eye and over time can 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 to 18 years. The use of Galaxia in premature infants (gestational age less than 36 weeks) has not been investigated.

Do not use GALAXIA

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

Warnings and precautions
Consult your doctor or the doctor caring for your child, or your pharmacist before using GALAXIA or before giving this medicine to your child.
Use this medicine with caution and inform your doctor or the doctor caring for your child:

• if you or your child suffers from a type of condition called closed-angle glaucoma;
• if you or your child is about to have or has just had eye surgery, including cataract surgery;
• if you or your child has a high chance of having an eye condition known as cystoid macular edema;
• if you or your child has undergone cataract removal surgery and has related conditions (aphakia or pseudophakia);
• if you or your child suffers from eye pain, irritation or inflammation, blurred vision;
• if you or your child suffers from dry eyes (ocular dryness);
• if you or your child suffers from severe asthma or if asthma is not well controlled;
• if you or your child uses contact lenses (you can still use GALAXIA following the instructions in section 3);
• if you or your child has suffered or is currently suffering from a viral eye infection caused by the herpes simplex virus (HSV).

GALAXIA may permanently alter the color of the eye and/or, reversibly, that of the eyelashes, vellus hair and skin around the eye (see section 4) .

Other medicines and GALAXIA
Inform your doctor or the doctor caring for your child, or your pharmacist if you or your child is taking, has recently taken or might take any other medicine, including over-the-counter medicines (or eye drops).
GALAXIA may interact with other medicines. Do not use other medicines that belong to the class of prostaglandins, as this could increase the pressure inside the eye.

Pregnancy and breastfeeding
Do not use GALAXIAduring pregnancy and breastfeeding.
Immediately inform your doctor if you are pregnant, if you think you may be pregnant, or if you are planning a pregnancy.

Driving and using machines
Using this medicine may cause temporary blurred vision. If this happens, do not drive vehicles or use machines 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 lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye).
If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

GALAXIA contains phosphates
This medicine contains 9.34 mg of phosphate buffer per 1 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 GALAXIA

Use this medicine following the instructions of your doctor or the doctor
treating your child, or your pharmacist, exactly as prescribed. If you have any doubts, consult your doctor or the doctor
treating your child, or your pharmacist.

Use in adults and children
The recommended dose, for adults (including the elderly) and for children, is one drop of
eye drops once a day, preferably in the evening, in the eye(s) to be treated.
Do not use GALAXIA more than once a day, as frequent administrations may
decrease the effect of the medicine.
Use 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 uses contact lenses, you must remove them before applying the eye drops.
After applying GALAXIA, wait 15 minutes before reinserting the contact
lenses.
If you need to use other eye medications for local use, wait at least 5 minutes after using GALAXIA before using them.

Mode of use:

• wash your hands thoroughly before using GALAXIA;
• remove the cap from the bottle;
• gently lower the lower eyelid of the eye to be treated with a finger;
• bring the tip of the bottle close to the eye, without touching it;
• apply gentle pressure to the bottle, allowing one drop to fall into the eye, then release the lower eyelid;
• press with a finger on the corner of the eye, near the nose. Keep pressing for 1 minute while keeping the eye closed;
• repeat the operation for the other eye if necessary;
• close the bottle with the cap and store it (see section 5).

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

If you use more GALAXIA than you should
If you have applied too many drops to the eye, you may experience mild irritation, tearing and
redness of the eyes. These effects are transient, but if they occur, it is advisable to
contact your doctor or the doctor treating your child for advice.
Contact your doctor or the doctor treating your child immediately if you or your child has
accidentally ingested GALAXIA or go to the nearest hospital.

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

If you stop using GALAXIA
You should inform your doctor or the doctor treating your child if you intend to stop
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 color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change is more likely if your eyes are mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) rather than a uniform color (blue, gray, green, or brown). Any change in eye color can occur after years, although it generally appears within the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use GALAXIA in only one eye. There do not appear to be any problems associated with the change in eye color. No further change in eye color has been observed after discontinuation of GALAXIA treatment.
• Redness of the eyes.
• Eye irritation such as a burning sensation, gritty feeling, itching, stinging pain (a pinprick sensation), or a feeling of something in the eye. If you experience irritation severe enough to cause excessive tearing or to induce discontinuation of the medicine, contact your doctor or pharmacist immediately (within one week). An update to the therapy may be necessary to ensure adequate treatment for your condition.
• Gradual change in the eyelashes of the treated eye and change in the fine hairs around the treated eye, observed mostly in people of Japanese origin. These changes include an increase in the length, thickening, darkening, and density of the eyelashes. Eyelash changes are reversible with discontinuation of treatment.

Common(may affect up to 1 in 10 people):
Irritation or abrasion of the eye surface, inflammation of the eyelid margin
(blepharitis) and eye pain, sensitivity to light (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 colored 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 1,000 people):

• Inflammation of the iris, which is the colored part of the eye (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital edema), alteration of the orientation of the eyelashes or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe 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 already suffering from heart problems, sunken appearance of the eye (hollowing of the eye socket).

Adverse effects in the pediatric population
The side effects observed more frequently in children compared to adults were
runny and itchy nose, and fever.
In very rare cases, some patients with severe damage to the transparent layer in the front
part of the eye (the cornea) have developed cloudy, cloud-shaped spots
on the cornea due to calcium buildup during treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 package to protect the medicine from
light.
After first opening, the vial can be stored outside the refrigerator, but must be
stored 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 designated space on the box.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GALAXIA contains

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

Description of the appearance of GALAXIA and contents of the pack
Pack containing a bottle with dropper applicator of 2.5 ml eye drops.

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)