PACKAGE LEAFLET: INFORMATION FOR THE USER

Haelan Ointment

0.0125%w/w Fludroxycortide

TYPHARM

LIMITED

Read all of this leaflet carefully before you start using this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Haelan Ointment is and what it is used for

2.    Before you use Haelan Ointment

3.    How to use Haelan Ointment

4.    Possible side effects

5.    How to store Haelan Ointment

6.    Further information

1. WHAT HAELAN OINTMENT IS AND WHAT IT IS USED FOR

Haelan Ointment is a white ointment for application to the skin. Haelan Ointment belongs to a group of medicines called topical steroids and is used to treat skin conditions such as eczema and dermatitis of all types, especially when the skin is dry and scaly. Haelan Ointment can be used in adults and children.

2. BEFORE YOU USE HAELAN OINTMENT

Do not use Haelan Ointment for

•    skin tuberculosis

•    rosacea of the face

•    acne

•    dermatitis around the mouth

•    itchiness of the genitals or anus

•    skin conditions in babies including eczema or napkin rash

•    bacterial skin infections such as impetigo

•    viral skin infections such as cold sores

•    fungal skin infections such as atheletes foot

Do not use Haelan Ointment if you are allergic (hypersensitive) to fludroxycortide or any of the other ingredients in Haelan Ointment (see section 6).

Take special care with Haelan Ointment

•    The ointment should not be used on or near your eyes or inside your mouth.

•    Do not use Haelan Ointment for long periods of time and do not cover it tightly.

•    Do not use Haelan Ointment on large areas of damaged skin or in skin folds such as the armpits or groin area.

•    Do not use Haelan Ointment on your face for more than five days and do not cover it up tightly.

•    If you have a skin infection or think you have a skin infection, tell your doctor.

•    Do not use Haelan Ointment on children’s skin for more than five days and do not cover it up tightly. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Haelan Ointment if you are pregnant, think you could be pregnant, are planning to become pregnant or are breast-feeding.

Please ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Haelan Ointment

Haelan Ointment contains cetyl alcohol which may cause local skin reactions such as contact dermatitis.

1 /HO/05/1507/017.V.1    204364 LC 223

PRINT

We ox re for your

>- GOLDPRINT NVVAUCAMPSLAAN 32 J 1654 HUIZINGEN

TEL.: 021363.89.79 - FAX: 02/363.89.80 www.goldprintbe - webcentergoldprintbe

Color side R

APPROVAL PROOF N° |

□ID

DATE

Black

Cad

10-JUL-15 - 11:12:15

SIGNATURE

ARTWORK INFORMATION

3. HOW TO USE HAELAN OINTMENT

Always use Haelan Ointment exactly as your doctor has told you. Check the label for how to use your medicine and how often to use it. Only put the ointment on the parts of your skin your doctor wants to treat.

You should check with your doctor or pharmacist if you are not sure.

Usual dose

Only use Haelan Ointment on your skin. Do not put it in your mouth or eyes.

Apply the ointment gently to the affected area of skin two or three times each day. If you are elderly your skin may be thin so you will need to apply the ointment sparingly.

If your doctor has told you to cover the skin tightly where you are using Haelan Ointment, you should only have to cover a small area.

If you forget to use Haelan Ointment

If you forget to use Haelan Ointment do not worry, just put on the next application when it is due.

If accidently swallowed, contact your nearest hospital casualty department or tell your doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Haelan Ointment can cause side effects, although not everybody gets them. Some patients may have one or more of the following side effects in the area where they apply Haelan Ointment

•    Burning, itching, irritated or dry skin.    • Inflammation at the bottom of skin hairs.

•    Excess hair growth.    • Acne pimples.

•    Pale skin.    • Dermatitis around the mouth.

•    Allergic contact dermatitis.    • Limp, flabby or thin skin where the ointment was.

•    Skin softening.    • Skin infections may get worse.

•    Red spots or lines on the skin.    • Blood vessels in the skin become visible.

•    Infected wounds may take longer to heal.

The amount of sugar in your blood and urine may change or some of your hormones may be affected causing weight gain, menstrual irregularities and hair growth. These effects are very rare. Some steroids are known to affect certain hormones. If your doctor thinks you need to be treated for longer periods of time, they may arrange for you to have hormone tests. If the ointment is affecting your hormones, your doctor may tell you to stop using it. Then your hormones should return to normal.

Children treated with topical steroids have rarely had high fluid pressure in their skulls. This has caused headaches and swelling.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HAELAN OINTMENT

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Haelan Ointment after the expiry date that is stated on the tube crimp and on the carton after Use Before. The expiry date refers to the last day of the month.

Medicines should not be disposed of via household waste. Please return any unused Haelan Ointment to your pharmacist for safe disposal. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Haelan Ointment contains

-    The active substance is fludroxycortide, 0.0125% w/w

-    The other ingredients are white soft paraffin, white beeswax, cetyl alcohol and sorbitan sesquioleate. What Haelan Ointment looks like and contents of the pack

Haelan Ointment is white and comes in a 60g aluminium tube.

Marketing Authorisation Holder:

Typharm Ltd., 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH. Manufacturer:

PURNA PHARMACEUTICALS NV/SA, Rijksweg 17, 2870 Puurs, Belgium.

Date of Leaflet Preparation: Month YYYY.

1 /HO/05/1507/017.V.1    204364 LC 223

PRINT

We core for your

>- GOLDPRINT NVVAUCAMPSLAAN 32 J 1654 HUfZINGEN

TEL.: 021363.89.79 - FAX: 021363.89.80 www.goldprintbe - webcenter.goldprintbe

Color side V

APPROVAL PROOF N° I

DATE

Black

Cad

I0-JUL-I5- 11:09:23

SIGNATURE

ARTWORK INFORMATION