Galminor

Package leaflet: Information for the user

Galminor 3 mg/ml + 1 mg/ml eye drops, solution

Netilmicin and Dexamethasone
Equivalent Medicine
Please read all of this leaflet carefully before you use 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 only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Galminor is and what it is used for

Galminor contains two active substances: netilmicin and dexamethasone.
Netilmicin is an antibiotic with bactericidal action.
Dexamethasone belongs to a group of medicines known as "corticosteroids" with anti-inflammatory activity (reduction of inflammation).
Galminor is indicated to reduce inflammation and to kill bacteria in swollen, irritated eyes that are likely to be infected by bacteria, in adults over 18 years of age and in the elderly.

2. What you should know before using Galminor

Do not use Galminor

• If you are allergic to the active substances (netilmicin and dexamethasone) or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to a class of antibiotics known as "aminoglycosides".
• If your doctor has told you that your eye pressure is too high.
• If you suspect having an infection caused by microorganisms (viruses or fungi) affecting the internal or external part of the eye (intraocular or extraocular).
• If you have, or have previously had, a viral eye infection caused by Herpes Simplex virus (HSV).
• If your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria.
• If you are unsure whether you should use Galminor, contact your doctor or ask your pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Galminor.
Galminor is for ocular use only; do not use it for injections or swallow it.
If you do not notice improvement within a few days after starting treatment with Galminor, consult your doctor, who may change your therapy.
Before using Galminor, inform your doctor if:

• you or a family member suffers from a disease known as glaucoma (damage to the optic nerve caused by increased pressure inside the eye);
• you have corneal problems (the transparent membrane covering the front part of the eye);
• you are taking other medicines containing phosphates; in this case, your doctor will check your cornea at regular intervals;
• you wear contact lenses. You may use Galminor, but follow the instructions for contact lens wearers in section 3.

If you use Galminor for a long time:

• the pressure in your eye may increase, damaging the optic nerve and causing vision problems. If you use Galminor for more than 15 days, your eye pressure must be regularly monitored by your doctor;
• you may develop a condition called cataract;
• wound healing processes may be slowed down;
• your body, due to a weakened immune system, may become less able to effectively respond to other types of eye infections, particularly those caused by certain microorganisms (viruses and fungi);
• eye infections with pus discharge may worsen or make it more difficult to identify the type of bacteria causing the infection when corticosteroids are used;
• in diseases causing thinning of the eye surface, corticosteroid use may lead to corneal and scleral (white part of the eye) perforations;
• you may develop allergic reactions.

Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Galminor. Consult your doctor before stopping treatment on your own.
These risks are particularly significant in children and patients treated with a medicine called ritonavir or cobicistat.

Children and adolescents
Galminor is not recommended in children and adolescents under 18 years of age.

Other medicines and Galminor
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Galminor may affect, or be affected by, other medicines you are taking, including other eye drops.
Inform your doctor if you are taking:

• any other antibiotic, particularly medicines containing polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Using these medicines together with Galminor may increase the risk of kidney problems, hearing issues, or may interfere with the therapeutic action of these antibiotics;
• an anticancer drug containing cisplatin;
• medicines used to reduce fluid retention known as "diuretics," such as ethacrynic acid and furosemide;
• medicines used to block gland secretion known as "anticholinergics," such as atropine;
• medicines containing ritonavir or cobicistat, as they may increase blood levels of dexamethasone;
• other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
It is preferable not to use Galminor during pregnancy unless your doctor considers it necessary.
Breastfeeding
If you are breastfeeding, it is preferable not to use Galminor unless your doctor considers it necessary.

Driving and using machines
While using Galminor, you may experience temporary blurred vision. If this occurs, do not drive and do not operate machinery until your vision clears.

Galminor 3 mg/ml + 1 mg/ml multidose eye drops contain benzalkonium chloride
Benzalkonium chloride is a preservative that may cause eye irritation or damage to the eye surface. Benzalkonium chloride can be absorbed by contact lenses and is known to cause discoloration of soft contact lenses. Therefore, avoid contact between this medicine in multidose form and soft contact lenses.

3. How to use Galminor

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
One drop four times a day in the eye being treated, or as prescribed by your doctor.
Do not change the dose of this eye drop without first consulting your doctor.

Use in children and adolescents
Galminor is not recommended for children and adolescents under 18 years of age.

Contact lens wearers
If you wear contact lenses, you must remove them before applying multidose Galminor eye drops.
After applying Galminor, wait 15 minutes before reinserting your contact lenses.
If you need to use Galminor while wearing soft contact lenses, use the single-dose Galminor eye drops, which are preservative-free.

If you use Galminor with other eye drops
Wait at least 10 minutes between administering Galminor and any other eye drop.

Instructions for use
Multidose eye drops
Ensure the bottle is intact.

1. Wash your hands and sit comfortably.
2. Remove the cap with a gentle twist.
3. Tilt your head backward.
4. Gently pull down the lower eyelid of the affected eye with your fingers.
5. Turn the bottle upside down and position the tip near the eye without touching it. Do not touch the eye or eyelid with the dropper tip.
6. Gently squeeze the bottle so that a single drop enters the eye, then release the lower eyelid.
7. Close the eye and press with one finger at the inner corner of the affected eye, near the nose, for 2 minutes.
8. Repeat the procedure in the other eye, if your doctor has instructed you to do so.
9. Immediately close the bottle after use.

Single-dose eye drops
Ensure the single-dose container is intact.

1. Wash your hands and sit comfortably.
2. Remove one vial from the strip and unscrew the cap with a gentle twist.
3. Tilt your head backward.
4. Gently pull down the lower eyelid of the affected eye with your fingers.
5. Turn the single-dose container upside down and position the tip of the vial near the eye without touching it. Do not touch the eye or eyelid with the vial tip.
6. Gently squeeze the vial so that a single drop enters the eye, then release the lower eyelid.
7. Close the eye and press with one finger at the inner corner of the affected eye, near the nose, for 2 minutes.
8. Repeat the procedure in the other eye, if your doctor has instructed you to do so.
9. Dispose of the vial and any remaining contents immediately. Galminor single-dose eye drops should be used immediately after opening. After administration, the single-dose container and any leftover medicine must be discarded.

If you use the eye drops incorrectly, they may become contaminated with bacteria, which could lead to eye infections. Using contaminated eye drops may cause serious eye damage and even result in loss of vision.

If you use more Galminor than you should
If you use more eye drops than prescribed by your doctor, it is unlikely to cause problems. Apply the next dose as usual, but if you feel concerned, speak to your doctor.
If you accidentally swallow the product, consult your doctor immediately, as adverse effects may occur.

If you forget to use Galminor
Do not take a double dose to make up for a missed dose.
If you forget to use the eye drops at the usual time, wait until the next scheduled dose and then use it as normal.

If you stop using Galminor
If you have any questions about the use of 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.
Side effects related to both active substances (dexamethasone and netilmicin) contained in Galminor may occur.
There are insufficient data available to determine the frequency of the individual side effects listed below.

Eye disorders

• Increased intraocular pressure after 15–20 days of application in patients suffering from glaucoma or predisposed to it;
• development of cataract following prolonged use of the medicine;
• development or worsening of viral infections caused by Herpes Simplex virus (HSV) or by microorganisms (fungi);
• delayed healing processes. In very rare cases (less than 1 in 10,000), some patients with severe damage to the transparent layer at the front of the eye (cornea) developed cloud-like spots on the cornea due to calcium accumulation during treatment.

Immune system disorders

• Local allergic reaction: conjunctival redness, burning, and itching.

Endocrine disorders

• Increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (see section 2 “Warnings and precautions”).

In all these cases, you should stop treatment and consult your doctor for appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: 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 Galminor

Galminor eye drops, solution (5 ml bottle)
Store the medicine below 30°C.
Keep in the original packaging to protect the medicine from light.
After first opening, store the bottle below 30°C and use within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the carton.

Galminor eye drops, solution (0.3 ml single-dose containers)
Store the medicine below 30°C.
Keep in the original packaging to protect the medicine from light.
After first opening of the aluminium pouch: store below 30°C and use within 28 days; after this period, any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP”.
The expiry date refers to the last day of that month and applies to the product unopened and properly stored.
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 Galminor contains
Galminor eye drops, solution (5 ml bottle)
In 1 ml of solution:
The active substances are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and dexamethasone sodium phosphate
equivalent to 1.00 mg of dexamethasone.
The other components are: sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
benzalkonium chloride, water for injections.
Galminor eye drops, solution (single-dose containers of 0.30 ml)
In 1 ml of solution:
The active substances are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and dexamethasone sodium phosphate
equivalent to 1.00 mg of dexamethasone.
The other components are: sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
water for injections.

Description of the appearance of Galminor and contents of the pack
Galminor is available as a clear, colourless ophthalmic solution for use as eye drops.
Galminor eye drops, solution (5 ml bottle)
Pack contents: one 5 ml bottle.
Galminor eye drops, solution (single-dose containers of 0.30 ml)
5 single-dose containers containing 0.30 ml of eye drops solution, packed in an aluminium pouch.
Packs containing 20 single-dose containers are also available.

Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)