Zineryt
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PATIENT INFORMATION LEAFLET
ZINERYT® POWDER AND SOLVENT FOR CUTANEOUS SOLUTION (ertythromycin/zinc acetate dihydrate)
Your medicine is known as Zineryt powder and solvent for cutaneous solution but will be referred to as Zineryt throughout the following 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 is it 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 IS IT 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.
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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.
5. HOW TO STORE ZINERYT
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the “Use before” date which your pharmacist has put on the label.
• If your medicine becomes discoloured or shows any sign of deterioration, consult your pharmacist.
• 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
• Each millilitre contains 40 mg erythromycin and 12mg zinc acetate dihydrate on constitution.
• The other ingredients are di-isopropyl sebacate and anhydrous ethanol.
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 contains a bottle of white powder, a bottle of clear, colourless solvent and a plastic applicator with a light blue pad in a plastic holder.
The contents of the bottles will be mixed together by your pharmacist to form a solution.
Your pharmacist will also fit the special applicator top to the bottle containing the mixed solution. The applicator top is protected by a cap.
Zineryt is available in packs which, when made up, will contain 30 ml of the solution.
Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden, The Netherlands.
I POM | PL No: 19488/1551
Leaflet revision date: 20 September 2013.
Zineryt is a registered trademark of Astellas Pharma Europe B.V.
S1551 LEAFLET 20130920