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

Package leaflet: Information for the user

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 linco-mycin 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.

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 getting acne, it does not work that way.

^just dab Residerm onto individual spots.

^ apply a thick layer of Residerm in any particular area as this will not get rid of the spots any quicker.

^ 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.

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 Arznei-mittel, SudbrackstraBe 56, 33611 Bielefeld, Germany.

Date of approval of this leaflet:

December 2013

PI Residerm_1 GB.indd 2 13.10.2010 13:32:48 Uhr