Brunicrom

Package leaflet: Information for the user

BRUNICROM 2% eye drops, solution

Sodium cromoglicate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
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 need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What BRUNICROM is and what it is used for

BRUNICROM contains the active substance sodium cromoglicate, which belongs to a group of medicines called anti-allergics that reduce the symptoms of allergies.
This medicine is indicated for the prevention of allergic eye reactions such as allergic conjunctivitis and vernal keratoconjunctivitis.
Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you should know before using Brunicrom

Do not use Brunicrom:

• if you are allergic to sodium cromoglicate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Brunicrom.
This medicine is available in sterile single-dose containers which do not contain preservatives; therefore,
it can also be used by people who wear contact lenses.
Avoid touching the eye with the dropper tip of the container.
Discard the container after use.

Other medicines and Brunicrom
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
No interactions with other medicines are known.
If you are using another eye drop, wait at least 15 minutes between applying Brunicrom and the other
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during the first trimester of pregnancy, except in cases of absolute necessity.

Driving and using machines
No effects of this medicine on the ability to drive vehicles or operate machinery are known.

3. How to use Brunicrom

Use Brunicrom exactly as directed 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 instilled into the eye (lower conjunctival sac), 4 times a day. Avoid touching the eye with the dropper tip of the container.
For correct use of the medicine, carefully follow these instructions:

• detach a single-dose vial from the strip (Figure A);
• shake the dropper tip to remove any residual liquid;
• open the single-dose vial by twisting the cap while pulling it off (Figure B);
• turn the vial upside down and apply gentle pressure to dispense the medicine drop by drop;
• discard the single-dose container after use.

Each container contains enough eye drops to treat both eyes once only.
Whenever possible, treatment with this medicine should be started before the allergic reaction occurs and should be continued regularly for as long as you are exposed to the allergen, or until symptoms have disappeared.
If you use more Brunicrom than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of Brunicrom, contact your doctor immediately or go to the nearest hospital.
If you forget to use Brunicrom
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 pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• transient burning and itching of the eyes.

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brunicrom

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 and to the product in its original, unopened packaging stored correctly.
Do not store above 25°C.
Store in the original container and protect from sunlight.
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 Brunicrom contains

• The active substance is sodium cromoglicate. 100 ml of solution contain 2 g of sodium cromoglicate.
• The other ingredients are: sodium chloride (tonicity agent), purified water.

Description of the appearance of Brunicrom and contents of the pack
20 single-dose containers of 0.3 ml in thermoformed blisters.
Marketing Authorization Holder
Bruschettini S.r.l. - Via Isonzo, 6 - 16147 Genova – Italy
Manufacturer
Laboratoire Unither – Espace Industriel Nord - 151, rue André Durouchez - CS28028 80084 AMIENS
CEDEX 02 - FRANCE