THROMBOPHOB

THROMBOPHOB 60,000 Cream

Important notes (mandatory information)

Thrombophob 60,000 Cream Active ingredient: Heparin sodium. Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that this cannot be treated by compression.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Thrombophob 60,000 Cream
Active ingredient: Heparin sodium 60,000 IU/100g

Please read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Thrombophob 60,000 Cream must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.
• If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS THROMBOPHOB 60,000 CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING THROMBOPHOB 60,000 CREAM?
3. HOW SHOULD THROMBOPHOB 60,000 CREAM BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD THROMBOPHOB 60,000 CREAM BE STORED?
6. FURTHER INFORMATION

1. WHAT IS THROMBOPHOB 60,000 CREAM AND WHAT IS IT USED FOR?

Thrombophob 60,000 Cream is a medicine that inhibits blood clotting. It is used for supportive treatment in the case of acute swelling after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that this cannot be treated by compression.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING THROMBOPHOB 60,000 CREAM?

Thrombophob 60,000 Cream must not be used if you are hypersensitive (allergic) to heparin sodium or any of the other ingredients of Thrombophob 60,000 Cream.

Thrombophob 60,000 Cream should be used with special care

Thrombophob 60,000 Cream should not be applied to open wounds and/or weeping eczema.

When using Thrombophob 60,000 Cream with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Interactions with other medicines are not known in the case of topical application.

Pregnancy and breastfeeding

Previous experience with use in pregnant and breastfeeding women has not provided any evidence of harmful effects. Heparin does not cross the placenta and does not pass into breast milk. Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

There is no experience regarding impairment of the ability to drive and use machines.

3. HOW SHOULD THROMBOPHOB 60,000 CREAM BE USED?

Always use Thrombophob 60,000 Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Dosage and type of application

Unless otherwise prescribed by your doctor, the usual dose is: Apply Thrombophob 60,000 Cream thinly and evenly to the affected area 2-3 times a day.

Duration of use

The doctor will decide on the duration of use. Unless otherwise prescribed, you should use Thrombophob 60,000 Cream for approx. 1-2 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.

If you have used more Thrombophob 60,000 Cream than you should

No symptoms of overdose are known in the case of use as directed.

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, Thrombophob 60,000 Cream can have 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 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	fewer than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Immune system

Uncommon: Allergic skin reactions.
Rare: Allergic reaction, such as reddening of the skin and itching (usually disappears after discontinuing use of the medicine).
Very rare: One patient with polycythaemia vera (a rare disease of the blood-forming cells in the bone marrow) developed an allergic inflammation of the blood vessels (leucocytoclastic vasculitis) after using a heparin gel, which manifested as a blotchy, reddened skin rash with blistering.
Thrombophob 60,000 Cream should be discontinued if allergic skin reactions occur. Please inform your doctor about this. No further special measures are necessary. Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any 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 THROMBOPHOB 60,000 CREAM BE STORED?

Keep out of the reach of children! Do not use the medicine after the expiry date which is stated on the folding box and tube after "use by". The expiry date refers to the last day of the month.

Storage conditions

This medicine does not require any special storage conditions.

6. FURTHER INFORMATION

What Thrombophob 60,000 Cream contains

The active ingredient is: Heparin sodium. 100 g of cream contain 60,000 IU of heparin sodium (mucosa from pigs). The other ingredients are: Ammonia, carbomer (apparent viscosity 25000 - 45000 mPa-s), decyl oleate, isopropyl myristate (Ph.Eur.), macrogol 400, sodium edetate (Ph. Eur.), liquid paraffin, perfume oil, propan-2-ol, purified water.

What Thrombophob 60,000 Cream looks like and contents of the pack

Thrombophob 60,000 Cream is a homogeneous, white, soft, hydrophilic cream with a characteristic smell of 2-propanol and perfume oil in an aluminium tube with a screw cap.

Pack sizes

Original pack with 100 g of cream (N2).

Pharmaceutical entrepreneur and manufacturer

Nordmark Arzneimittel GmbH & Co. KG
Pinnauallee 4
25436 Uetersen
Tel.: 04122-712-0
Fax: 04122-712-220

Co-distributor

Nordix Pharma Vertrieb GmbH
Pinnauallee 4
25436 Uetersen

This package leaflet was last revised in April 2014.

Source: Information from the package leaflet
Version: 03/2016
Active ingredient: Heparin sodium. Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that this cannot be treated by compression.