Zineryt Topical Solution
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ZINERYT® TOPICAL SOLUTION (erythromycin/zinc acetate dihydrate)
Patient Information Leaflet
The name of your medicine is Zineryt Topical Solution, but will be referred to as Zineryt throughout this
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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.
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.
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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.
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
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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.
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
• Do not store above 25°C.
• Do not use after the ‘Use before' date which has been put on the label by your pharmacist.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment
• If the solution becomes discoloured or shows any other signs of deterioration you should seek the advice of your pharmacist who will tell you what to do.
6. Further information
What Zineryt contains
Each millilitre contains 40mg erythromycin and 12 mg zinc acetate dihydrate on constitution.
The other ingredients are di-isopropyl sebacate and anhydrous ethanol.
What Zineryt looks like and contents of the pack
The medicine is available as powder and solvent for cutaneous use. Each pack contains one white screw-capped bottle containing white powder and one white screw-capped bottle containing a clear colourless solution, and one white plastic applicator with a light blue pad.
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 to the top of the bottle containing the mixed solution.
Zineryt Topical Solution is available in packs, which when made up will contain 30ml of the solution.
POM PL No: 18799/2660
This product is manufactured by Astellas Pharma Europe BV, Sylviusweg 62, 2333 BE Leiden, Holland and procured within the EU and repackaged by the Product Licence holder:
Leaflet revision and issue date (Ref.)
Zineryt is a registered trademark of ASTELLAS PHARMA EUROPE B.V.
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WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
