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Stiemycin 2% W/W Topical Solution

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Stiemycin® 2% w/w topical solution a07-14141

(erythromycin)

PATIENT INFORMATION 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 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.

The name of your medicine is Stiemycin 2% w/w topical solution but will be referred to as Stiemycin throughout the leaflet.

In this leaflet:

1.    What Stiemycin is and what it is used for

2.    Before you use Stiemycin

3.    How to use Stiemycin

4.    Possible side effects

5.    How to store Stiemycin

6.    Further information

1.    WHAT STIEMYCIN IS AND WHAT IT IS USED FOR

Stiemycin contains a medicine called erythromycin. This is an antibiotic.

Stiemycin is used to treat acne (spots). It works by fighting the bacteria that can cause the acne spots. Stiemycin is for use by adults and adolescents with acne. It is not for use by children.

2.    BEFORE YOU USE STIEMYCIN Do not use Stiemycin if:

-    you are allergic to erythromycin or any of the other ingredients of Stiemycin (listed in Section 6).

Do not use Stiemycin if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you start using Stiemycin.

Take special care with Stiemycin:

Before you use Stiemycin tell your doctor if:

-    you cannot tolerate or have previously had a skin reaction or allergy to erythromycin or any of the other ingredients of Stiemycin (listed in Section 6)

-    you have a history of inflammatory bowel disease or antibiotic-associated colitis (severe, prolonged or bloody diarrhoea following antibiotic use).

Only use Stiemycin on your skin. Take care not to get Stiemycin in your eyes, nostrils, mouth or on your lips. If you do, rinse well with water. Take care not to get Stiemycin on any irritated areas of skin, such as cuts, grazes, sunburn, or broken skin. Stiemycin contains propylene glycol, which may cause skin irritation.

Taking other medicines

Please tell your doctor or pharmacist if you are taking any other medicines, if you have taken any recently, or if you start taking a new one. This includes medicines bought without a prescription.

-    Stiemycin can affect how other medicines work. Take care not to use Stiemycin at the same time as clindamycin-containing acne medicines that are used on the skin.

-    Tell your doctor if you are taking any other antibiotic medicine.

-    Take care not to apply Stiemycin at the same time as other acne products that are used on the skin, unless your doctor or pharmacist has told you that you can.

Pregnancy and breast-feeding

-    Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding.

-    If you do become pregnant during treatment with Stiemycin tell your doctor.

-    Don't use Stiemycin on your breast if you are breast-feeding.

Effects of other ingredients (excipients)

Stiemycin contains propylene glycol, which may cause skin irritation.

3.    HOW TO USE STIEMYCIN

Always use Stiemycin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

What you need to know before using Stiemycin

-    Stiemycin should be applied only to your skin.

-    Do not drink the solution.

-    Do not use Stiemycin near a naked flame because it is flammable.

-    When you use the bottle for the first time you will need to break the seal. To do this, remove the cap from the bottle and holding the bottle upright, press gently on the seal with a finger until you hear a 'pop'.

The medicine is now ready to use.

How much to use

-    Apply Stiemycin twice a day, in the morning and the evening.

-    Using the product more frequently does not give better results.

-    It can take at least six to eight weeks before you see the full benefit of Stiemycin

-    You should keep using the medicine according to your doctor's instructions up to a maximum of 6 months.

How to apply Stiemycin

-    Completely remove any make-up.

-    Wash the affected area with mild soap and warm water and gently dry.

-    Remove the cap.

-    Turn the bottle upside down and dab the pad onto the affected area.

-    Use the pad to spread the solution gently over the whole area and not just to each individual spot.

After using Stiemycin

-    Always replace the cap securely after use to stop the medicine from leaking or evaporating.

-    Stiemycin contains ingredients to help the antibiotic reach the bottom of your hair follicles where the acne starts. These ingredients keep the skin wet for a few minutes after applying it.

-    Allow your face to dry completely before using any make-up.

-    You may notice a slight smell while it dries, this is normal.

-    Wash your hands after use.

If you forget to use Stiemycin

-    Don't apply a double dose to make up for forgotten doses.

-    Apply the next dose at the usual time.

If you accidently swallow Stiemycin:

The ingredients of Stiemycin are not expected to be harmful if swallowed in the small amounts normally applied to the face. If you do accidentally get Stiemycin in your mouth, rinse at once with plenty of water. Seek medical advice if you swallow more than a small amount.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Stiemycin can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop using Stiemycin and see a doctor straight away if:

-    you notice an allergic reaction (such as swelling of your face, eyes, lips or tongue, nettle rash or difficulty breathing).

-    you develop severe or prolonged diarrhoea.

The following very common side effects have been reported (at least 1 in 10 people are affected):

-    skin burning sensation

-    skin irritation

-    dry skin, especially at the start of treatment

-    application site stinging

-    redness of your skin, especially at the start of treatment.

Other side effects with frequencies that cannot be estimated from the available data include:

-    allergic reaction

-    diarrhoea, stomach pain, stomach discomfort,

-    itching, rash

-    swelling on the face

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 STIEMYCIN

Keep out of the sight and reach of children.

Do not store above 25oC.

Keep away from heat and flame.

Replace cap firmly after use to prevent evaporation.

Do not use the medicine after the expiry date stated on the bottle and the carton.

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 Stiemycin contains

Stiemycin contains 20mg erythromycin as the active ingredient and it is also contains propylene glycol, absolute ethanol and laureth 4 as inactive ingredients.

What Stiemycin looks like and the contents of the pack

Stiemycin is available as clear liquid in amber glass, white screw capped bottle.

Stiemycin comes in pack sizes of 25ml.

Manufacturer and Product Licence Holder

Manufactured by Famar Nederland B.V., Industrieweg 1,5531 AD Bladel, The Netherlands.

Procured from within the EU by Product Licence holder

Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.

Repackaged by Servipharm Ltd.

POM


PL No: 20636/1242


Leaflet revision and issue date (Ref) 10.07.14[14]

Stiemycin is a registered trademark of Stiefel Laboratories, Inc.