Stiemycin 2% W/W Topical Solution
Out of date information, search anotherRead all of this leaflet carefully before you start using this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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
S493 LEAFLET Stiemycin 20140710
PACKAGE LEAFLET: INFORMATION FOR THE USER STIEMYCIN® 2%w/w TOPICAL SOLUTION
(erythromycin)
Your medicine is called Stiemycin 2%w/w Topical Solution but will be referred to as Stiemycin throughout the remainder of the leaflet.
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 Stiemcyin 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.
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.
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
^ Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE STIEMYCIN
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Keep away from heat and flame.
• Replace cap firmly after use to prevent evaporation.
• Do not use after the expiry date printed on the carton or bottle label.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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
• Each ml of solution contains 20mg of the active ingredient erythromycin.
• Stiemycin also contains the following: ethanol absolute, propylene glycol and laureth 4.
What Stiemycin looks like and contents of the pack
• Stiemycin is a clear, colourless liquid with an odour of ethyl alcohol.
• Stiemycin is available in 25ml amber glass screw capped bottles.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Stiemycin is manufactured by Farmar Nederland B.V., Industrieweg 1, 5531 AD Bladel, The Netherlands.
|~POMl PL No. 19488/0493
Leaflet revision date: 10 July 2014
Stiemycin is a registered trade mark of Stiefel Laboratories, Inc., USA.
S493 LEAFLET Stiemycin 20140710
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.