HEPARIN

HEPARIN 60,000 Heumann Cream

Important notes (mandatory information)

Heparin 60,000 I. U. Heumann Cream. Active ingredient: Heparin sodium. Areas of application: for supportive treatment of acute swelling conditions after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that these cannot be treated by compression.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin 60,000 I. U. Heumann Cream
Active ingredient: Heparin sodium

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Heparin Heumann Cream must be used as directed in order to achieve the best possible treatment results.

• 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 after 14 days, you must see a doctor in any case.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

This package leaflet contains

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

1. WHAT IS HEPARIN HEUMANN CREAM AND WHAT IS IT USED FOR?

Heparin Heumann Cream contains heparin sodium, an active ingredient from the group of mucopolysaccharides, and reduces swelling. Heparin Heumann Cream is used for supportive treatment of acute swelling conditions after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that these cannot be treated by compression.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING HEPARIN HEUMANN CREAM?

Heparin Heumann Cream must not be used:

• if you are hypersensitive (allergic) to heparin sodium or any of the other ingredients of the cream,
• if you have an acute or historically known allergic drop in the number of platelets (thrombocytopenia type II) caused by heparin.

Special care should be taken when using Heparin Heumann Cream

Heparin Heumann Cream should not be applied to open wounds and/or weeping eczema. If new symptoms occur that may indicate thrombosis or pulmonary embolism, such as

• swelling and a feeling of warmth in the affected part of the body,
• reddened and tense skin, possibly blue 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 be ruled out and the platelet count (thrombocyte count) must be checked immediately. Regular checks of the thrombocyte count should be carried out:

• before starting heparin administration
• on the 1st day after starting heparin administration
• then every 3–4 days until the end of heparin treatment.

If medicines that interfere with blood coagulation are used at the same time, an increased risk of bleeding cannot be ruled out. Bruises may occur more frequently or increase in size. During treatment with Heparin Heumann Cream, injections into the muscle should be avoided due to the risk of bruising (haematomas).

When using Heparin Heumann Cream with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. Interactions with other medicines are not known when applied locally.

Pregnancy and breast-feeding

Previous experience with use in pregnant and breast-feeding women has not provided any evidence of harmful effects. Heparin does not cross the placenta and does not pass into breast milk. Heparin Heumann Cream must not be used in the breast area during breast-feeding. Ask your doctor or pharmacist for advice before taking/using any medicines.

3. HOW SHOULD HEPARIN HEUMANN CREAM BE USED?

Always use Heparin Heumann Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Heparin Heumann Cream should be applied thinly and evenly to the affected area 2 to 3 times a day.

Duration of use

The doctor will decide on the duration of use. Unless otherwise prescribed, Heparin Heumann Cream must not be used for longer than 10 days. Please talk to your doctor or pharmacist if you have the impression that the effect of Heparin Heumann is too strong or too weak.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Heparin Heumann 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:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Skin

Very rare: allergic reactions when applied to the skin, such as reddening of the skin and itching, which usually disappear quickly after discontinuation of the preparation. Heparin Heumann Cream should be discontinued if allergic skin reactions occur. Please inform your doctor about this. No further measures are necessary.

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/ml 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 for local application to the skin. However, since the absorption of heparin after local application through healthy skin has been described, this risk cannot be ruled out with certainty. Increased attention is therefore indicated (see section 2 "What should you be aware of before using Heparin Heumann Cream"). In patients without impending 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.

Reporting of side effects

If you get 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 provide more information on the safety of this medicine.

5. HOW SHOULD HEPARIN HEUMANN CREAM BE STORED?

Keep out of the reach of children.

Storage conditions

Heparin Heumann Cream should not be stored above 25°C and should be protected from frost.

Notes on shelf life after opening

After opening the tube, Heparin Heumann Cream should only be used for 12 weeks.

The medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Heparin Heumann Cream contains

The active ingredient is heparin sodium. 1 g of cream contains 600 I. U. of heparin sodium (mucosa from pigs), corresponding to 3.32 - 5.0 mg. The other ingredients are: purified water, propan-2-ol, decyloleate, macrogol 400, isopropyl myristate, liquid paraffin, carbomer, ammonia solution, sodium edetate, perfume oil.

What Heparin Heumann Cream looks like and what pack sizes it is available in

It is a white, soft cream in an aluminium tube. Packs of 40 g and 100 g cream.

Pharmaceutical entrepreneur and manufacturer

HEUMANN PHARMA
GmbH & Co. Generica KG
Südwestpark 50
90449 Nuremberg
Telephone/fax: 0700 4386 2667
E-mail: info@heumann.de

This package leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 04/2016
Active ingredient: Heparin sodium. Areas of application: for supportive treatment of acute swelling conditions after blunt injuries (bruises/haematomas) and superficial phlebitis, provided that these cannot be treated by compression.