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RESIDERM 1% GEL

Active substance(s): CLINDAMYCIN PHOSPHATE

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Residerm 1 % Gel (GB) • 148 x 270 mm • Black • Approved on

01103100-0509

Package leaflet: Information for the user

Residerm® 1% Gel
Clindamycin Phosphate

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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Residerm is and what it is used for.
2. Before you use Residerm.
3. How to use Residerm.
4. Possible side effects.
5. How to store Residerm.
6. Further information.
1. What Residerm is and what it is used for
Residerm is used to treat mild to moderate acne
(spots). Residerm contains an antibiotic clindamycin that reduces the number of bacteria
and stops the skin pores becoming blocked and
new spots forming. Residerm may also help
to reduce the redness of the spots you already
have.
It will take some time once you have started
using Residerm before you see your acne
improving.
What is acne?
Acne is an extremely common skin condition
most common in adolescence, but not restricted
to this stage of life. During adolescence, glands
in the skin produce extra grease in response to
normal amounts of sex hormones in the body,
and this can cause blocked pores, resulting in
blackheads. When this happens the pores are
invaded by bacteria. The chemicals produced
by these bacteria go into deeper layers of the
skin and produce red spots filled with pus.
2. Before you use Residerm
Do not use Residerm
➢ If you are allergic (hypersensitive) to the
active substance clindamycin phosphate or
any of the other ingredients (See Section 6).
➢ If you are allergic (hypersensitive) to lincomycin another type of antibiotic.
An allergic reaction may include a rash, red
skin, itching, swelling or breathing difficulties.
Residerm should not be used by children under
the age of 12 years.

PI Residerm_1 GB.indd 1

Take special care with Residerm
➢ Before you use Residerm consult your doctor if you suffer from a condition known as
inflammatory bowel disease (such as colitis or crohns disease) or you have had diarrhoea when you have taken antibiotics. If you
do get diarrhoea, when using Residerm, you
must stop using it straight away and tell your
doctor immediately.
➢ If you are taking other antibiotics consult
with your doctor before using Residerm.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or recently taken or used any other medicines, including medicines you have bought
without a prescription.
Interactions with other antibiotics such as
erythromycin, metronidazole and aminoglycosides are possible.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice
before taking or using any medicine.
Tell your doctor if you are pregnant, think you
might be pregnant, or trying to become pregnant before using Residerm.
Clindamycin can pass into breast milk, even if
you only use it on your skin, so you should not
breast feed while using Residerm.
Important information about some
of the ingredients of Residerm
This product contains
➢ About 20% ethanol. Each gram contains
about 0.2g of alcohol.
➢ Propylene glycol that may cause skin irritation.
3. How to use Residerm
Residerm must not be taken by mouth. It is
for use on the skin only.
Always use Residerm as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
➢ You should use Residerm once a day. Wash
as normal, rinse well and pat your skin dry.
Apply a small amount of gel in a thin layer to
the whole of the area where you usually get
the spots.
➢ It is important to replace the cap after you
have used Residerm.
Do not
➢ apply Residerm to areas where you do not

usually get spots.
➢ use Residerm in an attempt to stop you get-

ting acne, it does not work that way.
➢ just dab Residerm onto individual spots.
➢ apply a thick layer of Residerm in any partic-

ular area as this will not get rid of the spots
any quicker.

13.10.2010 13:32:48 Uhr

Residerm 1 % Gel (GB) • 148 x 270 mm • Black • Approved on

➢ cover Residerm with dressings (e.g. bandages

or plasters) as this may increase the chance
of irritation.
Take care to avoid your eyes, inside your nose
or mouth when applying Residerm. If you accidentally put gel on these areas, wash them
straight away with plenty of water.
Successful treatment of acne can take several
months. You may not see any effect of treatment for several weeks. After that you should
note a gradual but definite improvement but
maximum benefit may take several months.
Your doctor will normally arrange a check
up after 6 to 8 weeks of treatment. Residerm
should be used for a maximum of 12 weeks.
You may need to use more than one tube of
Residerm during each course of treatment. Use
Residerm for as long as your doctor tells you.
Try not to pick or squeeze spots as this can
make your acne worse and even lead to scarring.
If you use more Residerm than you should
You do not need to worry, just wash your
treated skin with plenty of water. Contact your
doctor or your local hospital if you are worried.
If you forget to use Residerm
Use it as soon as you remember and then continue to use as your doctor has told you. Do not
apply a double dose to make up for a forgotten
application.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Residerm can cause side
effects, although not everybody gets them.
Common (affecting fewer than 1 in 10 but more
than 1 in 100)
Dry skin
Redness of the skin
Skin burning
Irritation around eyes
Worsening of acne
Itchy skin
Uncommon (affecting fewer than 1 in 100 but
more than 1 in 1,000)
Painful skin
Scaly rash
You can relieve these unwanted effects by using
an oil free moisturiser on the affected area.
When clindamycin (the active ingredient in
Residerm) is given by mouth or injection it has
been know to cause inflammation of the bowel,
leading to diarrhoea with blood and mucus.
This reaction is extremely rare when clindamycin is applied on the skin. However, if you get
diarrhoea with blood and mucus, stop using
Residerm and contact your doctor immediately.
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.

PI Residerm_1 GB.indd 2

5. How to store Residerm
Keep out of the reach and sight of children.
Residerm does not require any special storage
conditions.
Do not use Residerm after the expiry date
which is stated on the tube and box after the
abbreviation used for expiry date. 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. Further information
What Residerm contains
The name of your medicine is Residerm 1%
Gel.
Residerm gel contains the active ingredient
clindamycin phosphate. Each gram of gel contains 10mg clindamycin (1% w/w) equivalent to
11.88mg clindamycin phosphate. Residerm also
contains propylene glycol, purified water, ethanol, zinc acetate, hydroxyethylcellulose and
sodium hydroxide.
What Residerm looks like and
contents of the pack
Residerm is a white translucent gel.
Residerm is available in 30g laminate tubes
with a seal covering the opening and a screw
cap.
Marketing Authorisation Holder
Crawford Healthcare Ltd, King
Edward Court, King Edward Road,
Knutsford, Cheshire, WA16 0BE, UK.
Manufacturer
Dr. August Wolff GmbH & Co. KG Arzneimittel, Sudbrackstraße 56, 33611 Bielefeld,
Germany.
Date of approval of this leaflet:
December 2013

13.10.2010 13:32:48 Uhr

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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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