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AKNEMYCIN PLUS

Active substance(s): ERYTHROMYCIN / TRETINOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Erythromycin Ph Eur 4.0% w/w and Tretinoin Ph Eur 0.025% w/w
Solution

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Aknemycin® Plus

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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1. What Aknemycin Plus is and what it is used for
2. What you need to know before you use Aknemycin Plus
3. How to use Aknemycin Plus
4. Possible side effects
5. How to store Aknemycin Plus
6. Contents of the pack and other information

1. WHAT AKNEMYCIN PLUS IS AND WHAT IT IS USED FOR

Aknemycin Plus is a treatment for acne which is applied to the skin.
Aknemycin Plus is a solution and contains Erythromycin and Tretinoin as active ingredients.
Erythromycin is an antibiotic which kills the germs found in acne and reduces the inflammation
of your skin.
Tretinoin encourages the layer of dead and hardened skin cells that form on the skin surface
to peel off. At the same time, it clears the blackheads which block your skin pores and cause
spots to form. Once the pore is unblocked, sebum can escape so that germ activity is limited.
Aknemycin Plus also helps dissolve away the excess oil in your skin.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE AKNEMYCIN PLUS

Do not use Aknemycin Plus
• if you are allergic (hypersensitive) to Erythromycin, Tretinoin or any of the other ingredients
of Aknemycin Plus (listed in section 6).
• if you are suffering from acute eczema, rosacea (a skin disease which affects the face and
is characterised by redness, pimples and peeling) or acute inflammatory conditions of the
skin, especially around the mouth.
• if your skin is sunburnt.
• if you are using any other medication on your skin which may lead to skin irritation e.g. an
exfoliator.
• if you or a member of your family have ever suffered from skin tumours called Cutaneous
Epithelioma.
If the above apply to you, talk to your doctor before using this medication.
Warnings and precautions
• when applying Aknemycin Plus to the face do not let the solution touch your eyes. If by
mistake it does, rinse your eyes thoroughly with cold water.
• take care that the solution does not build up in creases in the skin.
• if you have to have an X-ray, remove all traces of Aknemycin Plus from the area to be
X-rayed.
• if the solution gets on to your fingers you should wash them thoroughly.
• during treatment with Aknemycin Plus your skin may become more sensitive to UV light
therefore, do not sunbathe, use sunbeds or sunlamps.
• do not apply the solution before swimming.
Other medicines and Aknemycin Plus
Please tell your doctor or pharmacist if you are taking or have recently taken any other
­medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
Do not use Aknemycin Plus when you are pregnant, thinking of becoming pregnant or when you
are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are no effects on the ability to drive and use machines when this medication is used.

3. HOW TO USE AKNEMYCIN PLUS

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Always use Aknemycin Plus exactly as your doctor has told you. You should check with your
­doctor or pharmacist if you are not sure.
• The container has an applicator which allows a simple, hygienic and economic application.
• Before each use press the top of the screw cap on to the foam pad until you “feel” a click,
then invert the bottle so that the solution wets the applicator pad, then wipe the applicator
over the affected skin areas.
Normally you should apply Aknemycin Plus once or twice daily as advised by your doctor. After
use the applicator will close again automatically.

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Activating the applicator
Applying the solution
Duration of treatment
Carry on using Aknemycin Plus for as long as your doctor tells you.
• The length of time depends on the condition of your skin but this will normally be between
9 and 12 weeks. It is important that you use Aknemycin Plus regularly.
• There may not be any improvement in your skin condition for several weeks after starting
the treatment with Aknemycin Plus.
If you use more Aknemycin Plus than you should
Skin irritation like reddening, drying and discomfort may occur. Reduce the frequency of
­application if you experience skin irritation or contact your doctor.
If you forget to use Aknemycin Plus
If you forgot to use Aknemycin Plus at the usual time, use it as soon as you remember. Do not
apply twice the amount to make up for forgetting to use Aknemycin Plus but carry on as before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aknemycin Plus can cause side effects, although not everybody gets them.
For example, when you first use Aknemycin Plus your skin problem may seem to get worse. This
is a sign that the medicine is beginning to act. However this should soon pass and you will then
see an improvement.
Rarely, the skin can be irritated by Aknemycin Plus and you may have a sore, dry or burnt
­feeling or see peeling. In very rare cases these symptoms may also be an expression of an
­allergic reaction. If this happens, see your doctor.
Rarely, the skin may become darker or lighter in colour. People with dark skin may see a
­lightening of their skin where Aknemycin Plus has been used. This is temporary. Your skin will
go back to its usual colour when you stop using Aknemycin Plus.
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, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can also provide more information on the safety of this medicine.

5. HOW TO STORE AKNEMYCIN PLUS

Keep out of the reach and sight of children.
Aknemycin Plus should be kept in the outer carton to protect from direct sunlight.
Do not store above 30°C.
Do not use Aknemycin Plus after the expiry date which is stated on the carton after “EXP”. The
expiry date refers to the last day of that month.
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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aknemycin Plus contains
The active substances are Erythromycin Ph Eur 4.0% w/w and Tretinoin Ph Eur 0.025% w/w
The other ingredients are ethanol, glycerol 85% and copolyvidone.
What Aknemycin Plus looks like and contents of the pack
Aknemycin Plus is a clear solution.
Aknemycin Plus is available in a 25 ml bottle and 50 ml pack (2x25 ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3, 21465 Reinbek, Germany.

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This leaflet was last revised in 04/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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