VENOSTASIN

VENOSTASIN Cream

Important notes (mandatory information)

Venostasin cream. Active ingredient: Horse chestnut seed dry extract. Areas of application: for improving the condition of tired legs.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Venostasin cream 38 mg/g cream for use in adults
Active ingredient: Horse chestnut seed dry extract
Traditional herbal medicinal product

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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get 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 after 2 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS VENOSTASIN CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VENOSTASIN CREAM?
3. HOW TO USE VENOSTASIN CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VENOSTASIN CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VENOSTASIN CREAM AND WHAT IS IT USED FOR?

Venostasin cream is a traditional herbal medicinal product and is traditionally used in adults to improve the condition of tired legs. The medicine is a traditional medicine that is registered exclusively on the basis of long-term use for the area of application. If you do not feel better or if you feel worse after 2 weeks, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VENOSTASIN CREAM?

Venostasin cream must not be used:

• if you are allergic to dry extract from horse chestnut seeds, cinnamon (cinnamaldehyde) or any of the other ingredients of this medicine listed in section 6, in particular methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate. This also applies if you are hypersensitive to Peru balsam (cross-allergy).
• on damaged skin, e.g. in the case of burns, eczema or open wounds.
• in children and adolescents under 18 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Venostasin cream. If you experience new or sudden onset of pain, rapidly increasing swelling or bluish discoloration of the legs, you should see a doctor immediately, as these symptoms may be signs of a deep vein thrombosis, which requires prompt medical attention. If you experience heart problems such as shortness of breath or chest pain, or kidney problems, you should also see a doctor immediately. The user should consult a doctor or other qualified healthcare professional if symptoms persist or if side effects other than those mentioned in the package leaflet occur.

Important information about certain other ingredients of Venostasin cream

Venostasin cream contains cetyl stearyl alcohol, sorbic acid and polysorbate. Cetyl stearyl alcohol, sorbic acid and polysorbate can cause local skin irritation (e.g. contact dermatitis). Venostasin cream contains benzoic acid and benzoates. Benzoic acid, benzyl benzoate and methyl benzoate can cause mild irritation to the skin, eyes and mucous membranes. Venostasin cream contains butylhydroxytoluene. Butylhydroxytoluene can cause local skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes. Contact of Venostasin cream with eyes and mucous membranes as well as open wounds should therefore be avoided. After applying Venostasin cream, hands should be cleaned thoroughly. Note: The use of Venostasin cream does not replace other preventive measures or treatment measures such as cold water jets or the wearing of medically prescribed support stockings.

Children and adolescents

Use in children and adolescents under 18 years of age is not intended due to the area of application.

Use of Venostasin cream with other medicines

No interactions with other medicines have been reported for Venostasin cream to date. Studies with Venostasin cream on interactions with other medicines are not available. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Use of Venostasin cream with food and drink

No special precautions are required.

Pregnancy and breast-feeding

There are no adequate studies on the use of this medicine during pregnancy and breast-feeding. Therefore, Venostasin cream should not be used during pregnancy and breast-feeding. If you are pregnant or breast-feeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No studies have been conducted on this.

3. HOW TO USE VENOSTASIN CREAM?

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: Adults apply Venostasin cream 1 to 3 times a day thinly and evenly to the intact skin of the affected body parts. The medicine should not be used under occlusive dressings and not at the same time as heat application. Please note the information under section 2.

Type of application

For application to the skin.

Duration of use

If symptoms persist for more than 2 weeks, a doctor should be consulted. However, please note the information under "Warnings and precautions" and under "What side effects are possible?"

If you have used more Venostasin cream than you should

If you have accidentally applied too much cream, this usually has no adverse effects.

If you forget to use Venostasin cream

If you have forgotten the previous application, continue using the medicine as prescribed by your doctor or as described in the dosage instructions.

If you stop using Venostasin cream

Interrupting or prematurely terminating treatment is generally harmless. If in doubt, please consult your doctor or pharmacist.

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, Venostasin cream can have side effects, although not everybody gets them.

Possible side effects

Hypersensitivity reactions in the form of allergic skin reactions are possible. The frequency is not known. If hypersensitivity reactions occur (e.g. skin redness and itching), the medicine should be discontinued and a doctor should be consulted. Due to the content of methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate, this medicine can trigger allergic reactions, and late reactions such as contact dermatitis are also possible. In these cases, the medicine should be discontinued and a doctor should be consulted. Cinnamon (cinnamaldehyde) can cause skin irritation.

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, Dept. 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 TO STORE VENOSTASIN CREAM?

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. The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 30°C. Keep the tube tightly closed to protect the contents from light. Note on shelf life after opening or preparation: Shelf life after opening: 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Venostasin cream contains

The active ingredient is: Dry extract from horse chestnut seeds (4.5 - 5.5:1) Extraction agent: Ethanol 50% (V/V). 1 g cream contains 38 mg dry extract from horse chestnut seeds (4.5 - 5.5 : 1) Extraction agent: Ethanol 50% (V/V). The other ingredients are: Methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, ethanol 96%, emulsifying cetyl stearyl alcohol, sodium cetyl stearyl sulfate, white petrolatum, flower and herb fragrance oil (contains, among other things, butylhydroxytoluene, cinnamaldehyde and benzoates), simethicone emulsion 30% (simethicone, polysorbate 65, macrogol stearate 2000, glycerol (mono, di, tri) alkanoate (C12-C18), methylcellulose, xanthan gum, sorbic acid, benzoic acid, sulfuric acid 98%, purified water), purified water.

What Venostasin cream looks like and contents of the pack

Homogeneous, cream-colored cream. Venostasin cream is available in packs of 50 g and 100 g cream.

Pharmaceutical entrepreneur

Klinge Pharma GmbH
Bergfeldstraße 9
D-83607 Holzkirchen

Manufacturer

C.P.M. ContractPharma GmbH & Co. KG
Frühlingstraße 7
D-83620 Feldkirchen

Sidroga Gesellschaft für Gesundheitsprodukte mbH
Arzbacher Straße 78
D-56130 Bad Ems

This package leaflet was last revised in April 2017.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Horse chestnut seed dry extract. Areas of application: for improving the condition of tired legs.