Visuglican

Patient Information Leaflet

VISUGLICAN 40mg/ml + 2mg/ml Eye Drops, solution

Sodium cromoglicate and Chlorpheniramine maleate
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like further information or advice, please consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:
1. What VISUGLICAN is and what it is used for
2. What you need to know before using VISUGLICAN
3. How to use VISUGLICAN
4. Possible side effects
5. How to store VISUGLICAN
6. Package contents and other information

1. What VISUGLICAN is and what it is used for
VISUGLICAN belongs to a group of medicines called decongestants and antiallergics and contains two active substances: Sodium cromoglicate and Chlorpheniramine maleate.
What it is used for:
VISUGLICAN is used for the treatment of allergic conjunctivitis (eye inflammation), including vernal conjunctivitis or that caused by a toxic agent.

2. What you need to know before using VISUGLICAN

Do not use VISUGLICAN
If you are allergic to sodium cromoglicate or maleate chlorpheniramine or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using VISUGLICAN.

Other medicines and VISUGLICAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
No interactions with other medicines are known. However, additive effects are possible when
VISUGLICAN is administered concomitantly with H2 antagonists (e.g. cimetidine, a medicine used to treat ulcers) and corticosteroids (medicines that reduce inflammation and suppress the immune system).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.

Pregnancy
As with any medicine, it is advisable, whenever possible, to avoid administration during the first
trimester of pregnancy.

Breastfeeding
If use of this product is considered essential in a nursing mother, the patient should discontinue
breastfeeding.

Driving and using machines
VISUGLICAN does not impair the ability to drive vehicles or operate machinery.

Visuglican 10 ml bottle contains disodium phosphate 6.50 mg per 1 ml equivalent to 65 mg/10 ml
and monosodium phosphate 2 mg per 1 ml equivalent to 20 mg/10 ml as buffering agents.
Visuglican single-dose contains disodium phosphate 8.12 mg per 1 ml equivalent to 4.06 mg/0.5 ml and
monosodium phosphate 4.5 mg per 1 ml equivalent to 2.25 mg/0.5 ml as buffering agents.

If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause opaque spots on the cornea due to calcium accumulation during treatment.

3. How to use VISUGLICAN

Use 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 dose
is 1-2 drops into the conjunctival fornix (the space between the eye and the eyelid) four times daily.

3.1 Instructions for use – Visuglican 10 ml multidose bottle

Remove the cap.

Instill 1-2 drops into the conjunctival fornix of each eye by gently pulling down the lower eyelid and looking upward. Administer the solution by gently pressing the bottom of the bottle, pushing the dispenser tip downward.

After use, immediately close the container. The solution can be reused within 2 months after first opening.

3.2 Instructions for use – Visuglican 25 Single-dose containers:

After opening the aluminum protective pouch:

• separate one single-dose container from the strip of 5 single-use containers; before use, ensure the single-dose container is intact.
• twist and open the cap by rotating it on itself to open the single dose;
• instill 1-2 drops into the conjunctival fornix by gently pulling down the lower eyelid and looking upward.

.
Use the VISUGLICAN single-dose container immediately after opening.
Any remaining solution must not be reused. Avoid letting the tip of the container come into contact with the eye or any other surface.

If you use more VISUGLICAN than you should
In case of accidental ingestion or overdose of VISUGLICAN, inform your doctor immediately or go to the nearest hospital.

If you forget to use VISUGLICAN
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Irritation and burning sensations have rarely been reported. In such cases, it is advisable to discontinue treatment.
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VISUGLICAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear.
The expiry date applies to the product in its original, unopened packaging and correctly stored.
VISUGLICAN 40mg/ml + 2mg/ml Eye Drops, solution in Bottle must not be used more than
60 days after first opening. Keep the bottle tightly closed. Store below 25°C.
VISUGLICAN 40mg/ml + 2mg/ml Eye Drops, solution in Single-dose container must be used
immediately after opening. Any remaining solution after use must not be reused.
Do not dispose of any medicine 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 VISUGLICAN contains
VISUGLICAN 40mg/ml + 2mg/ml Eye Drops, solution - bottle
The active substances are sodium cromoglicate and maleic acid chlorphenamine.
100 ml of eye drops, solution contain 4 g of sodium cromoglicate and 0.2 g of chlorphenamine maleate.
Other components are: edetate sodium, disodium phosphate, monosodium phosphate, purified water.

VISUGLICAN 40mg/ml + 2mg/ml Eye Drops, solution - single-dose containers
The active substances are sodium cromoglicate and maleic acid chlorphenamine.
100 ml of eye drops, solution contain 4 g of sodium cromoglicate and 0.2 g of chlorphenamine maleate.
Other components are: edetate sodium, disodium phosphate, monosodium phosphate, water for
injections.

Description of the appearance of VISUGLICAN and contents of the pack
VISUGLICAN Eye Drops are a solution supplied in packs containing:
1 bottle of 10 ml
25 single-dose containers of 0.5 ml

Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
00136 Rome - Italy

Manufacturer
VISUGLICAN Eye Drops, solution in pack containing 1 bottle of 10 ml:
Tubilux Pharma S.p.A.
Via Costarica, 20-22 Pomezia (Rome)

VISUGLICAN Eye Drops, solution in pack containing 25 single-dose containers of 0.5 ml:
C.O.C. Farmaceutici S.R.L.
Via Modena, 15
Sant’Agata Bolognese (BO) Italy