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Altargo (retapamulin) – Package leaflet - D06AX13

Updated on site: 05-Oct-2017

Medication nameAltargo
ATC CodeD06AX13
Substanceretapamulin
ManufacturerGlaxo Group Ltd

Package leaflet: Information for the patient

Altargo 10 mg/g ointment

Retapamulin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-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 is in this leaflet

1.What Altargo is and what it is used for

2.What you need to know before you use Altargo

3.How to use Altargo

4.Possible side effects

5.How to store Altargo

6.Contents of the pack and other information

1.What Altargo is and what it is used for

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.

2. What you need to know before you use Altargo

Do not use Altargo

If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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.

Children

Altargo should not be used on children who are less than nine months old.

Other medicines and Altargo

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.

Pregnancy and breast-feeding

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.

Driving and using machines

Altargo is not expected to affect your ability to drive or use machines.

Altargo contains butylated hydroxytoluene (E321)

It may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.

3.How to use Altargo

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

How to apply Altargo

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.

If you use more Altargo than you should

Carefully wipe off the extra ointment.

If you forget to use Altargo

Apply the ointment as soon as you remember, and apply the next dose at the usual time.

If you accidentally swallow Altargo

Contact your doctor or pharmacist for advice.

If you stop using Altargo

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.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to look out for

Severe skin reactions or allergies (frequency not known)

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

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

Reporting of side effects

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.

5.How to store Altargo

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.

6. Contents of the pack and other information

What Altargo contains

-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.

What Altargo looks like and contents of the pack

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.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Glaxo Group Ltd

Glaxo Operations UK, Ltd, (trading as Glaxo

980 Great West Road

Wellcome Operations)

Brentford

Harmire Road

Middlesex TW8 9GS,

Barnard Castle

United Kingdom

County Durham

 

DL12 8DT

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 (0)10 85 52 00

Belgique/Belgien

 

Tél/Tel: + 32 (0)10 85 52 00

България

Magyarország

ГлаксоСмитКлайн ЕООД

GlaxoSmithKline Kft.

Teл.: + 359 2 953 10 34

Tel.: + 36 1 225 5300

Česká republika

Malta

GlaxoSmithKline s.r.o.

GlaxoSmithKline (Malta) Limited

Tel: + 420 222 001 111

Tel: + 356 21 238131

cz.info@gsk.com

 

Danmark

Nederland

GlaxoSmithKline Pharma A/S

GlaxoSmithKline BV

Tlf: + 45 36 35 91 00

Tel: + 31 (0)30 6938100

dk-info@gsk.com

nlinfo@gsk.com

Deutschland

Norge

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKline AS

Tel.: + 49 (0)89 36044 8701

Tlf: + 47 22 70 20 00

produkt.info@gsk.com

firmapost@gsk.no

Eesti

Österreich

GlaxoSmithKline Eesti OÜ

GlaxoSmithKline Pharma GmbH

Tel: + 372 6676 900

Tel: + 43 (0)1 97075 0

estonia@gsk.com

at.info@gsk.com

Ελλάδα

Polska

GlaxoSmithKline A.E.B.E.

GSK Services Sp. z o.o.

Τηλ: + 30 210 68 82 100

Tel.: + 48 (0)22 576 9000

España

Portugal

Stiefel Farma, S.A.

GlaxoSmithKline – Produtos Farmacêuticos, Lda

Tel: + 34 902 202 700

Tel: + 351 21 412 95 00

es-ci@gsk.com

FI.PT@gsk.com

France

România

Laboratoire GlaxoSmithKline

GlaxoSmithKline (GSK) S.R.L.

Tél.: + 33 (0)1 39 17 84 44

Tel: + 4021 3028 208

diam@gsk.com

 

Hrvatska

Slovenija

GlaxoSmithKline d.o.o.

GlaxoSmithKline d.o.o.

Tel: + 385 1 6051 999

Tel: + 386 (0)1 280 25 00

Ireland

medical.x.si@gsk.com

 

GlaxoSmithKline (Ireland) Limited

 

Tel: + 353 (0)1 4955000

 

 

Ísland

Vistor hf.

Simi: + 354 535 7000

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Κύπρος

GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com

Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com

Lietuva

GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com

This leaflet was last revised in

Slovenská republika

GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Finland.tuoteinfo@gsk.com

Sverige

GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)800 221441 customercontactuk@gsk.com

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

____________________________________________________________________________

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