Altargo
retapamulin
Retapamulin
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 seem the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Altargo is and what it is used for
What you need to know before you use Altargo
How to use Altargo
Possible side effects
How to store Altargo
Medicinal product no longer authorised
Contents of the pack and other information
Altargo ointment contains an antibiotic called retapamulin, which is used on the skin.
Altargo is used to treat bacterial infections affecting small areas of skin. Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.
Altargo is for adults and children aged nine months and older.
If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before using Altargo.
If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor. See also section 4 of this leaflet.
If there is no improvement in your infection after two to three days of treatment contact your doctor.
Altargo should not be used on children who are less than nine months old.
Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.
Tell your doctor if you are using, have recently used or might use any other medicines. If the patient is a child less than two years old it is especially important that you tell your doctor about any other medicines that the child is being given, including medicines bought without a prescription. It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual. This might lead to side effects. Your doctor will decide if Altargo can be used for a child aged less than 2 years old who is taking other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide if this treatment is right for you.
Altargo is not expected to affect your ability to drive or use machines.
Medicinal product no longer authorised
It may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
A thin layer of ointment is usually put on the infected skin twice a day for five days.
After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
Keep using Altargo for as long as your doctor advises.
Altargo is for use on the skin only. It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area. If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort. If you accidentally use Altargo inside your nose you could have a nose bleed.
Wash your hands before and after applying the ointment.
Carefully wipe off the extra ointment.
Apply the ointment as soon as you remember, and apply the next dose at the usual time.
If you stop using Altargo too soon, the bacteria may start to grow again and your infection may come back. Do not stop using this medicine before talking to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop a severe skin reaction or an allergy: (e.g. severe itching or severe rash, swelling of the
face, lips, or tongue):
stop using Altargo
carefully wipe off the ointment
Medicinal product no longer authorised
contact your doctor or pharmacist immediately.
The following side effects have occurred on the skin where Altargo has been applied: Common side effects (may affect up to 1 in 10 people):
skin irritation
Uncommon side effects (may affect up to 1 in 100 people):
pain, itching, redness or rash (contact dermatitis)
Other side effects (frequency not known, cannot be estimated from the available data):
a burning sensation
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Discard open tubes 7 days after opening, even if they are not empty. They should not be kept for future use.
Do not throw away any medicines via household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
The active substance is retapamulin. Each gram of ointment contains 10 milligrams of retapamulin.
The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a preservative.
Altargo is a smooth, off-white ointment.
It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of ointment, or in an aluminium foil sachet containing 0.5 g of ointment.
Pack of 1 tube. Pack of 12 sachets.
Medicinal product no longer authorised
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Manufacturer
Glaxo Group Ltd
980 Great West Road Brentford
Middlesex TW8 9GS, United Kingdom
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations)
Harmire Road Barnard Castle County Durham DL12 8DT
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tél/Tel: + 32 (0)10 85 52 00
GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
Medicinal product no longer authorised
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
GlaxoSmithKline A.E.B.E.
Τηλ: + 30 210 68 82 100
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
Stiefel Farma, S.A. Tel: + 34 902 202 700
GlaxoSmithKline – Produtos Farmacêuticos, Lda Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
GlaxoSmithKline (GSK) S.R.L. Tel: + 4021 3028 208
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Vistor hf.
Simi: + 354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline Cyprus Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00
Medicinal product no longer authorised