Patient Medication Information: uses, side effects, how to take - Bactroban Cream
ABOUT THIS MEDICATION
What the medication is used for:
BACTROBAN® CREAM is used for:
- the topical treatment of minor skin infections and minor infection in small cuts, wounds or abrasions.
What it does:
BACTROBAN® CREAM is an antibiotic. It heals minor cuts, wounds and abrasions in the skin by killing or controlling the growth of the bacteria.
When it should not be used:
BACTROBAN® CREAM should not be used:
- To treat infections in or near the eyes, nostrils or mouth.
- If you are allergic to mupirocin or any of the other ingredients in BACTROBAN® CREAM (see, “What the important non-medicinal ingredients are” section). Signs of an allergic reaction may include local irritation, itchy skin rash, shortness of breath and swelling of the face or tongue.
What the medicinal ingredient is:
BACTROBAN® CREAM contains mupirocin 2% (w/w). (as mupirocin calcium 21.5 mg/g).
What the important nonmedicinal ingredients are:
Benzyl Alcohol, Cetomacrogol 1000, Cetyl Alcohol, Mineral Oil, Phenoxyethanol, Purified Water, Stearyl Alcohol , Xanthan Gum.
What dosage forms it comes in:
Cream; 2% as mupirocin calcium (w/w)
BACTROBAN® CREAM is available in 15 g tubes.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
BACTROBAN® CREAM is not suitable for eyes or into nose use. Care should be taken to avoid contact with the eyes.
Your doctor will have asked you many questions about your health, lifestyle and medications before recommending BACTROBAN® CREAM. That is why it is very important you tell your doctor all such information. If you have forgotten to tell your doctor about any of the following, call your doctor or pharmacist before using this medication (or any medicine):
- You are allergic to mupirocin or any other ingredients in the product.
You are pregnant or plan to become pregnant.
- You are breastfeeding your baby. If you are applying BACTROBAN® CREAM to the nipple area, wash thoroughly before breastfeeding or manual expression of milk.
- You're taking any other medicines, if you’ve taken any recently or if you start taking new ones. This includes any new types of medicines you bought without a prescription and natural health products.
You are a child (younger than 12 years) or older than 65 years of age.
This medicine is for external use only.
Discontinue use and consult with your doctor if condition worsens or if irritation occurs or if no improvement after 10 days.
Antibacterial drugs like BACTROBAN® CREAM treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, BACTROBAN® CREAM should be used exactly as directed. Misuse or overuse of BACTROBAN® CREAM could lead to the growth of bacteria that will not be killed by BACTROBAN® CREAM (resistance). This means that BACTROBAN® CREAM may not work for you in the future. Do not share your medicine.
Long term use may result in development of antibiotic resistance.
If this medicine does get into your eyes, wash them out immediately, with large amounts of cool tap water.
INTERACTIONS WITH THIS MEDICATION
There are no known drug interactions noted for BACTROBAN® CREAM.
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor’s instructions about how and when to use BACTROBAN® CREAM.
Wash your hands before and after applying BACTROBAN® CREAM.
Squeeze a small amount onto a piece of clean wool or a gauze swab and apply to the affected area 3 times daily for up to 10 days.
Scabs do not have to be removed. Your doctor may tell you to cover the area with a dressing after you have applied BACTROBAN® CREAM.
Do not mix BACTROBAN® CREAM with other lotions, creams or ointments. This may dilute BACTROBAN® CREAM, which may affect your treatment.
It is important that you take the full course of BACTROBAN® CREAM until the infection has fully cleared up or for up to 10 days. Don't stop early as your symptoms may disappear before the infection is fully cleared.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If an application of BACTROBAN® CREAM is missed, apply as soon as you remember or when it is convenient, then continue as before.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side-effects with BACTROBAN® CREAM are generally mild. A few people may experience some unwanted effects. Allergic responses (such as rash, local pain or swelling) have been reported rarely.
If you get a skin reaction, stop using BACTROBAN® CREAM. Wipe off any cream and tell your doctor as soon as possible.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | ||
| Only if severe | In all cases | |||
| Common | Application Site Allergic Reaction (skin: burning sensation, itchy, redness of the skin and swelling | √ | √ | |
| Hives; itchy rash (urticaria) | √ | √ | ||
| Very Rare | Systemic Allergic Reaction: raised itchy rash, swelling of the face or mouth, difficulty in breathing | √ | √ | |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate medical help | |||
|---|---|---|---|---|---|
| Unknown | Inflammation of the colon (large bowel); symptoms: diarrhea, usually with blood and mucus, stomach pain, fever | √ | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking BACTROBAN® CREAM, contact your doctor or pharmacist.
HOW TO STORE IT
Keep your tube of BACTROBAN® CREAM at room temperature (Store between 15°C- 25°C) in a dry place. Do not freeze.
Store medicine out of the reach and sight of children.
The expiry date of BACTROBAN® CREAM is printed on the tube. Do not use after this date.
Reporting Side Effects You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor:
GlaxoSmithKline Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Last revised: July 6, 2016
©2015 The GSK group of companies. All rights reserved./Le groupe d’entreprises GSK. Tous droits réservés.
® BACTROBAN is a registered trademark, used under license by GlaxoSmithKline Consumer Healthcare Inc.
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1-800-250-8866
www.gsk.com
