Glamidolo

Package leaflet: Information for the patient

GLAMIDOLO 0.25% ophthalmic solution, powder and solvent for solution, 0.50% ophthalmic solution, powder and solvent for solution

Dapiprazole hydrochloride
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GLAMIDOLO eye drops are and what they are used for

Glamidolo eye drops contain the active substance dapiprazole, a molecule capable of reducing intraocular pressure and causing pupil constriction (miosis). It is indicated in the various forms of an eye disease known as glaucoma (prodromal or intermittent angle-closure glaucoma, acute, subacute and chronic glaucoma; mixed glaucoma, pigmentary glaucoma; prophylaxis of angle closure in at-risk eyes).
The medicine is also suitable for reversing pharmacologically induced pupil dilation (reversal of pharmacological mydriasis) and for preparatory pupil constriction (miosis) prior to surgery of the iris (iridectomy).

2. What you need to know before using GLAMIDOLO eye drops

Do not use GLAMIDOLO eye drops if you are allergic to dapiprazole or to any of the other
components of this medicine (listed in section 6). This product must not be used in conditions
where the miotic effect is inappropriate, such as in acute iritis.
Warnings and precautions
Talk to your doctor or pharmacist before using GLAMIDOLO eye drops.
Prolonged use, especially, of this product may lead to sensitization reactions. In such cases:
discontinue treatment. Use the medicine with caution if you have impaired kidney function
(renal insufficiency).
Do not use a higher dose than prescribed or increase the frequency of administration.
Children and adolescents
No data are available.
Other medicines and GLAMIDOLO eye drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
GLAMIDOLO eye drops have no specific incompatibilities with other commonly used drugs or substances. The product must not be mixed with other liquid medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before using this medicine.
Although no contraindications to the use of this medicine during pregnancy and breastfeeding have been identified, its use is recommended only when strictly necessary and under medical supervision.
Driving and operating machinery
After using the medicine, exercise caution when driving or performing activities under poor lighting conditions, as GLAMIDOLO eye drops, by altering pupil diameter, may reduce the ability to adapt visually to changes in ambient light levels.
GLAMIDOLO eye drops contain benzalkonium chloride.
It may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride is known to have a decolorizing effect on soft contact lenses.

3. How to use GLAMIDOLO eye drops

Take this medicine exactly as stated in this leaflet, or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are as follows:

• For re-induction of mydriasis: 1-2 drops every 5 minutes for 3 times in the eye to be treated.
• For acute glaucoma attack: 1-2 drops every minute for 5 minutes; then 1-2 drops every 15 minutes until resolution of the attack in the affected eye.
• For all other indications: 1-2 drops every 8 hours.

Instructions for use

1. Open the glass vial containing the powder. By pressing the plastic bottle, pour the solvent it contains into the glass vial.
2. Close the glass vial again using the rubber stopper and shake well.
3. Remove the rubber stopper and attach to the glass vial the dropper provided separately in the pouch.
4. Remove the plastic cap from the dropper and instill the eye drops.

If you use more GLAMIDOLO eye drops than you should
Consult your doctor or pharmacist.
If you forget to use GLAMIDOLO eye drops
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
GLAMIDOLO eye drops may cause, in hypersensitive patients, local reddening and a burning sensation.
Unknown side effects (frequency cannot be estimated from the available data)

• Ocular hyperemia, eye irritation, eyelid ptosis, eyelid erythema, eyelid edema, conjunctival edema, eye pruritus, punctate keratitis, corneal edema, photophobia, dry eye, increased lacrimation, blurred vision
• Headache
• Facial pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website
.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLAMIDOLO eye drops

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
GLAMIDOLO eye drops are supplied as a powder to be dissolved at the time of use with the provided solvent (see "How to use GLAMIDOLO eye drops").
Once prepared, the solution should be used within 3 weeks.
Do not dispose of medicines 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 GLAMIDOLO eye drops contains
The active substance is dapiprazole hydrochloride.
GLAMIDOLO 0.25% eye drops contains Dapiprazole hydrochloride 12.5 mg
GLAMIDOLO 0.5% eye drops contains Dapiprazole hydrochloride 25 mg
The other components are:

• in the powder: mannitol and sodium chloride;
• in the solvent: hypromellose, benzalkonium chloride, edetate sodium, disodium phosphate, monosodium phosphate, sodium chloride, water for injections.

Description of the appearance of GLAMIDOLO eye drops and contents of the pack
GLAMIDOLO 0.25% eye drops contains a vial of white to almost white, crystalline, odourless powder, 5 ml, and a vial of colourless solvent, clear to slightly opalescent, slightly viscous, 5 ml.
GLAMIDOLO 0.50% eye drops contains a vial of white to almost white, crystalline, odourless powder, 5 ml, and a vial of colourless solvent, clear to slightly opalescent, slightly viscous, 5 ml.
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan
Manufacturers
TUBILUX PHARMA S.p.A. - Via Costarica, 20/22
00071 Pomezia (Rome)