HEPATHROMB

HEPATHROMB Cream 60,000

Important notes (mandatory information)

Hepathromb 60 000, cream Active ingredient: Heparin sodium. Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (sprains, bruises).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hepathromb 60 000, cream, cream with 60,000 international units per 100 g
Active ingredient: Heparin sodium


Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What is in this package leaflet

1. WHAT IS HEPATHROMB 60 000 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPATHROMB 60 000?
3. HOW IS HEPATHROMB 60 000 USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEPATHROMB 60 000 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEPATHROMB 60 000 AND WHAT IS IT USED FOR?

Hepathromb 60 000 is a remedy for reducing swelling. It is intended for use on the outer skin. Hepathromb 60 000 is used for supportive treatment in the case of acute swelling after blunt injuries (sprains, bruises).

2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPATHROMB 60 000?

Hepathromb 60 000 must not be used:

• if you are allergic to heparin sodium, methyl or propyl-4-hydroxybenzoate (so-called parabens) or any of the other ingredients of this medicine listed in section 6,
• if you have an acute or known history of an allergic drop in the number of platelets (thrombocytopenia type II) caused by heparin.

Warnings and precautions

Please talk to your doctor or pharmacist before using Hepathromb 60 000. Hepathromb 60 000 should not come into contact with the eyes or mucous membranes. Hepathromb 60 000 should not be applied to open wounds or weeping eczema.

If new symptoms appear that may indicate a thrombosis or pulmonary embolism, such as

• Swelling and warmth in the affected part of the body,
• reddened and tense skin, possibly bluish discoloration,
• tension and pain in the foot, calf and hollow of the knee (relief when elevated),
• sudden shortness of breath, chest pain and weakness/collapse

the presence of heparin-induced thrombocytopenia type II must also be ruled out and the platelet count (thrombocyte count) must be checked immediately.

Regular checks of the platelet count are required with every use of heparin. During treatment with Hepathromb 60 000, injections into the muscle should be avoided due to the risk of bruising (hematomas).

Use of Hepathromb 60 000 together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions with other medicines are not known in the case of topical application. Nevertheless, an increased risk of bleeding cannot be ruled out in the case of simultaneous use of medicines that interfere with blood coagulation. Bruising may occur more frequently or increase in size.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Previous experience with the topical application of heparin to the skin in pregnant and breast-feeding women has not provided any evidence of harmful effects. Heparin does not cross the placenta and can therefore not pass into the blood of the unborn child. Heparin also does not pass into breast milk.

Driving and operating machinery

Hepathromb 60 000 has no or negligible influence on the ability to drive and operate machinery.

Hepathromb 60 000 contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW IS HEPATHROMB 60 000 USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Apply Hepathromb 60 000 evenly to the affected area 2 to 3 times a day.

Duration of use

The doctor decides on the duration of use. Unless otherwise prescribed, Hepathromb 60 000 must not be used for longer than 10 days.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Blood and blood-forming system

Not known: The frequency of occurrence of heparin-induced, antibody-mediated thrombocytopenia type II (reduction in the number of platelets < 100,000/µl or a rapid drop in the platelet count to < 50% of the initial value) with arterial and venous thromboses or embolisms, which can be fatal, has not yet been investigated in the case of topical application to the skin. However, since the absorption of heparin after topical application through healthy skin has been described, this risk cannot be ruled out. Increased attention is therefore indicated (see section 2). In patients without pre-existing hypersensitivity to heparin, the drop in the number of platelets usually begins 6-14 days after the start of treatment. In patients with hypersensitivity to heparin, this drop may occur within hours. An increased immunization rate is to be expected in the case of application to inflamed skin.

Hypersensitivity reactions

Allergic reactions to heparin have only been observed very rarely to date. In individual cases, hypersensitivity reactions, such as reddening of the skin and itching, may occur when using Hepathromb 60 000, which usually subside quickly after discontinuation of the preparation.

Other possible side effects

Hepathromb 60 000 contains methyl and propyl-4-hydroxybenzoate (so-called parabens). These can cause hypersensitivity reactions, including delayed reactions.

What countermeasures should be taken in the event of side effects?
If any of the possible side effects mentioned occur, discontinue treatment and consult your doctor.

Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD HEPATHROMB 60 000 BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "Use by:". The expiry date refers to the last day of the month indicated.

Storage conditions

This medicinal product does not require any special storage conditions.

Note on shelf life after first opening

Hepathromb 60 000 can be stored until the expiry date stated after first opening the tube.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hepathromb 60 000 contains

The active ingredient is heparin sodium (from pig intestinal mucosa). 100 g of cream contain 60,000 IU of heparin sodium. The other ingredients are: methyl-4-hydroxybenzoate (Ph.Eur.), propyl-4-hydroxybenzoate (Ph.Eur.), dexpanthenol, allantoin, white petroleum jelly, glycerol 85%, emulsifying cetyl stearyl alcohol (type A) (Ph.Eur.), glycerol monostearate 40-55, purified water.

What Hepathromb 60 000 looks like and contents of the pack

Almost white, homogeneous cream. Original packs of 50 g, 100 g and 150 g of cream.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
phone: +49 30 338427-0
fax: +49 38351 308
e-mail: info@RIEMSER.com

Manufacturer

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems

L-A-W Services GmbH
Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
04328 Leipzig

This package leaflet was last revised in April 2014.

Source: Information from the package leaflet
Status: 03/2016
Active ingredient: Heparin sodium. Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (sprains, bruises).