Medine.co.uk

Hydrocortisone Ointment

Document: label-leaflet ALMUS PHARMACEUTICALS_PL 00014-0364 change

Label for Almus Hydrocortisone 1% Ointment - CURRENT

Page 1

FRONT OF PACK (Refer to Brand Principles and readability guideline)

AUVIUS* •

•••

Hydrocortisone 1% Ointment

For the relief of contact dermatitis, reactions to insect bites and mild to moderate eczema

15g e

BACK OF PACK (Refer to Brand Principles and readability guideline)

Read and keep carton for full instructions.

S How to use this medicine

Pierce tube seal with end of cap before first use.

Apply to the skin only.

Adults and children of 10 years and over: Use a very small amount on the affected area. Apply to the skin once or twice a day.

Don’t use for more than 7 days.

Do not us on children under 10 years, unless your doctor tells you to.

Do not use more than the amount recommended.

If symptoms do not go away, see your doctor.

This ointment contains Hydrocortisone 1% w/w.

Also contains: white soft paraffin.

Do not store above 25°C

Keep all medicines out of the sight and reach of children.

PL 00014/0364 [P]

PL Holder: BCM Nottingham NG2 3AA Lot:

Use By:

Item code Component code

PACK MOCK UP BOX

Product Name: Almus Hydrocortisone 1% Ointment

Product Licence No: PL00014/0364

Wording Ref: CURRENT

Status: Almus Internally Approved 9/10/14

Pack details: tube

Pack size: 15g

Version No: 1, draft 3

Date issued: MHRA approved 06/07/2011

Reason for change: A4 text label submitted with ADR reporting statement on carton-leaflet

FRONT OF PACK (Refer to Brand Principles and readability guideline)

® A#

AUM US* •

•••

Hydrocortisone 1% Ointment

For the relief of contact dermatitis, reactions to insect bites and mild to moderate eczema

[P] PHARMACY MEDICINE 15g e

BACK OF PACK (Refer to Brand Principles and readability guideline)

Read all of this carton for full instructions.

What this medicine is for

A corticosteroid ointment, which reduces swelling. For the relief of allergic contact dermatitis (e.g. reactions to plants, cosmetics), irritant contact dermatitis (e.g. reactions to detergents) reactions to insect bites and mild to modrate eczema.

Before you use this medicine

X Do not use:

•    If you are allergic to any of the ingredients in this medicine

   If you are pregnant or breastfeeding, unless your doctor tells you to

   On broken or infected skin including impetigo, cold sores, acne, athlete’s foot

   On the face, eyes, anal or genital areas

S How to use this medicine

Check the tube seal is not broken before first use.

Pierce tube seal with end of cap. Apply to the skin only.

Adults and children of 10 years and over: Use a very small amount on the affected area. Apply to the skin once or twice a day.

Don’t use for more than 7 days.

Do not us on children under 10 years, unless your doctor tells you to.

Do not use more than the amount recommended.

If symptoms do not go away, see your doctor.

Possible side effects

Most people will not have problems.

If you get these side effects, stop using the ointment and see a doctor.

• Allergic reaction (e.g. skin rash, red or itchy skin, worsening of the condition you are treating)

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 on this carton. 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.


How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This ointment contains Hydrocortisone 1% w/w.

Also contains: white soft paraffin.

PL 00014/0364

PL Holder: BCM Nottingham NG2 3AA Manufacturer: BCM Ltd Nottingham NG2 3AA Almus® is a registered trademark If you need more advice ask your pharmacist.

T ext prepared 4/15 Lot:

Use By:

Item code Component code

BRAILLE NAME (on back of pack)

Almus Hydrocortisone #1% Ointment

PACK MOCK UP BOX

Product Name: Almus Hydrocortisone 1% Ointment

Product Licence No: PL00014/0364

Wording Ref: A4 text as not currently marketed

Status: Almus Internally Approved

Pack details: Carton-leaflet

Version No: 1

Date issued: 09/10/14

Reason for change: Inclusion of ADR reporting statement