Document: leaflet MAH BRAND_PL 00166-0178 change

• label-leaflet MAH BRAND_PL 00166-0178
• leaflet MAH BRAND_PL 00166-0178

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>142878

astellas

Package Leaflet: Information for the user Conotrane Cream

Benzalkonium chloride 0.1% w/w and dimeticone 22% w/w

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

• Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better after 14 days or if you feel worse.

What is in this leaflet

1. What Conotrane is and what it is used for

2. What you need to know before you use Conotrane

3. How to use Conotrane

4. Possible side effects

5. How to store Conotrane

6. Contents of the pack and other information

1. What Conotrane is and what it is used for

Conotrane Cream contains the active substances benzalkonium chloride and dimeticone.

Conotrane Cream is used to protect the skin from moisture, irritants, chafing and contamination with bacteria or yeasts. It is used in the prevention and treatment of nappy rash, and can also be used in the prevention of pressure sores and for other skin irritations caused by rubbing or moisture.

How Conotrane Cream works

Conotrane Cream acts as a barrier cream. The active substance, dimeticone, is water repellent and the other active substance, benzalkonium chloride, has antiseptic properties.

2. What you need to know before you use Conotrane

Do not use Conotrane Cream:

• if you are allergic to benzalkonium chloride or dimeticone or any of the other ingredients

of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Conotrane Cream.

Other medicines and Conotrane Cream

Tell your doctor or pharmacist if you are using, have recently used or might use any 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.

Conotrane Cream contains cetostearyl alcohol

Conotrane Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

3. How to use Conotrane

This medicine is for cutaneous use. Always use this medicine exactly as described in this leaflet

or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The cream is for external use only and should be applied to the affected area(s) several times a day as needed. For nappy rash, the cream should be applied at every nappy change.

If the symptoms persist for more than 14 days without improvement consult your doctor.

4.    Possible side effects

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

On rare occasions, the active ingredient benzalkonium chloride has caused irritation of the skin at the site of application. If this occurs you should stop using Conotrane Cream immediately and consult your doctor if the irritation persists.

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 Conotrane

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 tube and carton, after EXP The expiry date refers to the last day of that month.

Do not store above 25°C (which is normal room temperature).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.

6.    Contents of the pack and other information What Conotrane Cream contains

•    The active substances are benzalkonium chloride 0.1% w/w and dimeticone 22% w/w.

•    The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether, white soft paraffin, light liquid paraffin, macrogol, potassium dihydrogen orthophosphate, geranium (fragrance) and water.

What Conotrane Cream looks like and contents of the pack

Conotrane Cream is a smooth white cream and is available in a tube containing 100 g or a tub containing 500 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Astellas Pharma Ltd.,

2000 Hillswood Drive,

Chertsey,

Surrey, Kt16 0RS UK.

Manufacturer:

Laleham Health and Beauty Limited,

Fairfield, Bradshaw Lane,

Kirkham, Preston,

Lancashire, PR4 3JA UK.

142878_LFT-Conotrane cream GB.indd 2 07-04-15 16:21