HIRUDOID CREAM
Active substance(s): HEPARINOID
26/1/15
09:42
Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIRUDOID CREAM
heparinoid 0.3% 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 or pharmacist 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 or pharmacist. This includes any possible side-effects
not listed in this leaflet. See section 4.
- You must talk to a doctor if your signs of illness or injury do not improve.
What is in this leaflet:
1. What Hirudoid Cream is and what it is used for
2. What you need to know before you use Hirudoid Cream
3. How to use Hirudoid Cream
4. Possible side-effects
5. How to store Hirudoid Cream
6. Contents of the pack and other information
1. WHAT HIRUDOID CREAM IS AND WHAT IT IS USED FOR
Hirudoid Cream contains the active substance heparinoid.
Hirudoid Cream is a local anti-coagulant preparation which, when applied to the skin, relieves pain
and inflammation in addition to promoting healing in superficial thrombophlebitis (inflammation of the
veins) and bruising (including haematoma).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIRUDOID CREAM
Do not use Hirudoid Cream:
• if you are allergic (hypersensitive) to heparinoid or any of the other ingredients of Hirudoid Cream
(listed in section 6)
• if you have broken skin, or on large areas of skin
• on or near sensitive areas such as the mouth, eyes or ano-genital regions.
Hirudoid Cream should NOT be used on children under the age of 5 years old.
Warnings and precautions
- Hirudoid Cream is for external use only. Do NOT swallow.
- Do not exceed the dose stated in section 3.
- Talk to your doctor if your signs of injury or illness do not improve or get worse.
See section 4 for information about possible side-effects.
Other medicines and Hirudoid Cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 taking this medicine.
Hirudoid Cream contains cetostearyl alcohol
This may cause local skin reactions (for example contact dermatitis).
Hirudoid Cream contains the preservatives propyl parahydroxybenzoate (E216) and methyl
parahydroxybenzoate (E218).
These ingredients may cause allergic reactions (possibly delayed).
Please read the back of this leaflet.
* Trademark
9240372 1411 GB
25192301
GEN/HRDCM/PIL/272_07
23/01/2015
GEN-HRDCM-PIL-272:148 X 210
26/1/15
09:42
Page 2
3. HOW TO USE HIRUDOID CREAM
External use only. Do not swallow.
• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
• Before use, pierce the tube seal with the spiked top of the cap.
• The amount of cream you use will depend on the size of the area being treated.
• Between 2 and 6 inches (5-15 cm) of cream should be gently massaged into the affected area at
any one time.
• You can apply Hirudoid Cream up to four times a day.
• Do not exceed this dose.
• If the area is tender to touch, you can massage the cream into the skin surrounding the affected area.
• Remember to wash your hands after applying Hirudoid Cream, unless this is the area being treated.
• If you accidentally swallow some of this cream, it is unlikely to be serious. However, you should
contact your doctor or a hospital casualty department.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Hirudoid Cream can cause side-effects, although not everybody gets them.
Rarely, Hirudoid Cream can cause a rash in sensitive individuals. If this occurs, STOP using the cream
and tell your doctor or pharmacist.
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 HIRUDOID CREAM
Keep out of the sight and reach of children.
Do not use Hirudoid Cream 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. Store below 25°C.
Do not throw away any medicines via wastewater or 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 Hirudoid Cream contains
The active substance is 0.3% w/w heparinoid.
The other ingredients are anhydrous eucerine, emulsifying cetostearyl alcohol type A, glycerol,
isopropyl alcohol, methyl parahydroxybenzoate (E218), myristyl alcohol, potassium hydroxide, propyl
parahydroxybenzoate (E216), purified water, stearic acid and thymol.
What Hirudoid Cream looks like and the contents of the pack
Hirudoid Cream is a white cream available in aluminium lacquered tubes of 50 grams.
P
PL 06831/0175
Hirudoid Cream
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturers:
Mobilat Produktions GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany.
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.
This leaflet was last revised in December 2014.
* Trademark
25192301
GEN/HRDCM/PIL/272_07
23/01/2015
MHRA Header Box
Product
Title
Hirudoid Cream
Component
Leaflet
Pack Size
50g
IG code
25192301
Dimensions
210 x 148mm
Proof No.
08
Colours used
Pantone 281
Fonts used
Helvetica 55 Roman
Helvetica 75 Bold
Date
26/01/2015
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