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Erythromycin 40mg/Ml And Zinc Acetate 12mg/Ml Topical Solution

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ZINERYT® TOPICAL SOLUTION / ERYTHROMYCIN 40MG/ML AND ZINC ACETATE 12MG/ML TOPICAL SOLUTION

_(erythromycin and zinc acetate)_


PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using one of the above names, but will be referred to as Zineryt throughout this leaflet.

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 for

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.

3. How to use Zineryt

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 can cause side effects, although 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.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zineryt

■    Keep out of the sight and reach of children.

■    Do not use after the Expiry date (Exp), which is printed on the carton and bottle label.

■    Do not store above 25°C. Store in the original package.

■    Do not use this medicine after the "Use before" date which has been put on the label by your pharmacist. This date is 8 weeks from the date of preparation.

■    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.

■    If you have any solution left over at the end of treatment, take it back to your pharmacist for safe disposal.

■    If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you further.

6. Further information

What Zineryt contains

Zineryt contains: Erythromycin-zinc complex containing the equivalent of 40 mg/ml erythromycin and 12 mg/ml zinc acetate (as the complex) on constitution. The application also contains di-isopropyl sebacate and ethanol.

What Zineryt looks like and contents of the pack

This medicine is made available as a dry, white powder and clear, colourless solvent for cutaneous solution. The powder and solvent are provided in separate bottles and will be mixed together by your pharmacist to form a solution. Your pharmacist will then fit a special applicator top to the bottle containing the mixed solution.

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

Manufacturer

Your medicine is manufactured by: Astellas Pharma Europe B.V., Hogemaat, 2 NL-7942 JG Meppel, Holland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

PLPI No: 04423/0371

Leaflet revision and issue date (Ref): 29.04.15

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

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