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|3) HOW TO USE ZINERY


can cause side effects, although


502792/PLib    Zineryt® Solution

(erythromycin/zinc acetate)

Patient Information Leaflet

The name of your medicine is Zineryt® Solution. Throughout this leaflet it will be referred to as Zineryt®.

Read all of this leaflet carefully before you start using

this medicine.

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

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

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

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1)    What Zineryt® is and what it is used for

2)    Before you use Zineryt®

3)    How to use Zineryt®

4)    Possible side effects

5)    How to store Zineryt®

6)    Further information

1) WHAT ZINERYT® IS AND WHAT IT IS USED FO

The active substance of Zineryt belongs to the group of antibiotics for treatment of acne, often referred to as pimples or spots. These medicines are used to reduce the growth of bacteria which cause acne.

2) BEFORE YOU USE ZINERYT

Do not use Zineryt

-    if you are allergic (hypersensitive) to erythromycin, or zinc or to any of the other ingredients of Zineryt® (see list in section 6 'Further information').

Your doctor may decide to give you another medicine instead.

-    if you are allergic to antibiotics of the macrolide group. Your doctor or pharmacist will be able to tell you if that is the case.

Take special care with Zineryt®

- Avoid contact with the eyes and mucous membranes of the nose and mouth. However, if this occurs, then rinse the affected area immediately with cold or lukewarm water for several minutes. Contact your doctor for further advice.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You may use Zineryt® if you are pregnant.

You may breast feed during treatment with Zineryt® but do not use this medicine on the area of your chest.

Driving and using machines

It is not likely that Zineryt® affects your ability to drive or use machines.

Instructions for proper use

Wash the affected area first before using Zineryt®.

If you want to apply make-up, use the medicine first and let it dry.

Zineryt® comes to you in a special bottle with a special applicator pad protected by a cap which you should remove just before use and replace firmly after each use. The pad makes it easy to apply the solution to the whole of the affected area of the skin to be treated.

To use Zineryt® unscrew the protective cap, hold the bottle upside down, place the pad against the skin, and spread the solution over the whole of the affected area (including the surrounding skin). The flow of solution can be increased by pressing the pad a little more firmly against the skin.

If you use the applicator properly, just the right quantity should be applied.

But if you do put too much on, blot it off with some toilet tissue, and make sure it does not run into the eyes, nose or mouth. If it does, wash well with plenty of water (see also 'Take special care with Zineryt®' under section 2. Before you use Zineryt®).

Always use Zineryt® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Frequency of administration

Usually, Zineryt® should be applied all over the affected area and the surrounding skin twice a day.

Duration of treatment

Successful treatment of acne may take several weeks or even months.

The normal treatment time is 10 to 12 weeks.

Consult your doctor, if you still have acne at the end of the prescribed course of treatment.

If you use more Zineryt® than you should

If you have applied too much Zineryt®, blot it off with some toilet tissue.

Swallowing the entire contents of a single pack of Zineryt® would mainly lead to symptoms associated with alcohol intake. You should contact your doctor or pharmacist if you or somebody else accidentally swallows this medicine.

If you forget to use Zineryt®

Try not to forget to use Zineryt®, as missing an application will slow down the healing process. If you have missed an application, use Zineryt® when you remember, but leave about three hours before you use it again.

If you stop using Zineryt®

If you stop using Zineryt®, the original symptoms may come back. Always contact your doctor if you want to stop using Zineryt®.

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

4) POSSIBLE SIDE EFFECTS

Like all medicines, Zineryt not everybody gets them.

Zineryt® may very rarely cause allergic reactions. Symptoms may include rash, itching, swelling of the mouth, face and lips or tongue and difficulty breathing.

Please contact your doctor immediately if you experience any of these side effects.

Zineryt® may cause the following rare side effects (likely to affect more than 1 in 10,000 and less than 1 in 1000 patients): - Temporary stinging or slight redness of the skin

If you get a very painful rash or burning feeling after using Zineryt® which does not go away in a few hours, or gets worse each time you use it, stop using it and tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the sight and reach of children.

|5) HOW TO STORE ZINERY


Do not use Zineryt® after the “Use before” date which has been put on the label by your pharmacist.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6) FURTHER INFORMATION

What Zineryt contains

-    The active substances are erythromycin (40 mg/ml) and zinc acetate (12 mg/ml) combined in a special way.

-    The other ingredients are di-isopropyl sebacate and ethanol anhydrous.

What Zineryt® looks like and contents of the pack

Zineryt® is made available as a solution for use on the skin (cutaneous use).

The packaging consists of a bottle containing a white crystalline powder and a bottle containing a clear, colourless alcoholic solvent, to be mixed together by the pharmacist. Also contains an applicator assembly, to be fitted by the pharmacist to the bottle containing the mixed solution.

Zineryt® is available in packs which, when made up, will contain 30 ml of the solution.

Product Licence Holder

Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufacturers

Astellas Pharma Europe B.V., Elisabethhof 19, Leiderdorp, 2353 EW, The Netherlands.

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands.

Zineryt® Solution    _

PL No: 18067/0367    |POM|

Zineryt® is a registered trademark of Astella Pharma Europe B.V.

This leaflet was last approved on 18th October 2013.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.