Document: Crominet eyedrops, solution ENG PL change

• Crominet eye drops, solution PL
• Crominet eyedrops, solution ENG PL

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The PL includes alternative texts for different legal status in different countries as follows:

-Boxed texts are only applicable for OTC versions.

-[Grey-shaded texts in brackets] are only applicable for prescription versions.

For OTC use in Sweden, please refer to the approved Swedish package leaflet published on MPA’s web site.

Package leaflet: Information for the patient

Crominet 20 mg/ml eye drops, solution

sodium cromoglicate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

[Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

[To be completed nationally]

What is in this leaflet

1. What Crominet is and what it is used for

2. What you need to know before you use Crominet

3. How to use Crominet

4. Possible side effects

6. Contents of the pack and other information

Crominet contains the active substance sodium cromoglicate which relieves the symptoms of hypersensitivity (allergy) in the eyes.

[Crominet can be used for the treatment of allergic conjunctivitis (inflammation of the conjuctiva of the eye caused by allergy), among the symptoms are increased tear flow and redness, itching and/or swelling of the eyes.]

[To be completed nationally]

You must talk to a doctor if you do not feel better or if you feel worse.

Do not use Crominet:

Warnings and precautions

Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

[To be completed nationally]

Other medicines and Crominet

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If additional eye preparations are used, wait 5 minutes between uses of the different preparations.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Crominet can be used during pregnancy

Breast-feeding

Crominet can be used during breast-feeding

Driving and using machines

You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.

Crominet contains benzalkonium chloride

Crominet contains benzalkonium chloride, which may cause eye irritation.

Benzalkonium chlorideis known to discolour soft contact lenses.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

[Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.]

The recommended dose is:

Adults and children 7 years and above:

1-2 drops in each eye 4 times daily.

Children below 7 years:

Crominet is not recommended for use in children younger than 7 years.

[To be completed nationally]

If you use more Crominet than you should

Contact your doctor if you have used more Crominet than you should.

If you forget to use Crominet

Do not use a double dose to make up for a forgotten dose. If you forget a dose, use your drops as soon as you remember.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

Very rare: may affect up to 1 in 10,000 people

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Crominet

Keep the eye drop bottle in the outer package in order to protect from light.

Do not store above 25C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

After opening: to be used within 4 weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Crominet contains

• The active substance is sodium cromoglicate. One ml contains 20 mg sodium cromoglicate.

• The other excipients are benzalkonium chloride, disodium edetate, purified water.

What Crominet looks like and contents of the pack

Eye drop bottle with 5 ml, 10 ml or 13.5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden, Denmark, Norway: Crominet

This leaflet was last revised in 2014-10-20