VENOSTASIN

VENOSTASIN retard 50 mg hard capsule retarded

Important notes (mandatory information)

Venostasin retard 50 mg hard capsules, retarded. Active ingredient: Horse chestnut seed dry extract. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), for example pain and heaviness in the legs, night-time calf cramps, itching and leg swelling.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Venostasin retard 50 mg hard capsules, retarded, herbal medicinal product for use in adults
Active ingredient: Horse chestnut seed dry extract

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take 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 notice 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 4 weeks, talk to your doctor.

What this package leaflet contains

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

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

Venostasin retard is a herbal medicinal product for venous diseases. Venostasin retard is used in adults for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), for example pain and heaviness in the legs, night-time calf cramps, itching and leg swelling. If you do not feel better or if you feel worse after 4 weeks, talk to your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VENOSTASIN RETARD?

Venostasin retard must not be taken if you are allergic to horse chestnut seed dry extract or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Venostasin retard. If you experience sudden, unusually severe symptoms, especially in one leg, which are noticeable through swelling, discolouration of the skin, a feeling of tension or heat as well as pain, a doctor should be consulted immediately. These may be signs of a serious condition (leg vein thrombosis) in connection with the underlying venous weakness. These are not due to taking Venostasin retard. A doctor should also be consulted in the case of signs of heart failure or impaired kidney function.

Note

Other non-invasive measures prescribed by the doctor, such as wrapping the legs, wearing support stockings or cold water jets, should definitely be adhered to. Taking Venostasin retard does not replace other preventive measures or treatment measures such as cold water jets or wearing support stockings prescribed by a doctor.

Children and adolescents

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

Taking Venostasin retard together with other medicines

The effect of anticoagulant medicines can be increased. Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Venostasin retard together with food and drink

There are no special features to be considered.

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 taking this medicine. Venostasin retard must not be used during pregnancy and breast-feeding, as there are no sufficient studies available.

Driving and using machines

No special precautions are required.

3. HOW TO TAKE VENOSTASIN RETARD?

Always take 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: Unless otherwise prescribed by the doctor, adults take 1 hard capsule, retarded, in the morning and evening (corresponding to 100 mg aescin).

• Children and adolescents

  Use in children and adolescents under 18 years of age is not intended.

Method of administration

For oral use. Venostasin retard should be taken whole and with plenty of liquid before meals. If mild stomach or intestinal complaints occur, it is recommended to take the medicine with meals.

Duration of use

Long-term treatment is possible after consultation with your doctor. If the symptoms do not improve within 4 weeks of taking Venostasin retard, you should consult a doctor, as leg swelling can also have other causes. Please also note the information under "Warnings and precautions" and "What side effects are possible?".

Please talk to your doctor or pharmacist if you have the impression that the effect of Venostasin retard is too strong or too weak.

If you have taken more Venostasin retard than you should

The saponins contained in horse chestnut seed extract can increase the side effect of nausea in case of overdose, and vomiting and diarrhoea are also possible. A doctor should be consulted to decide whether countermeasures are necessary.

If you forget to take Venostasin retard

Do not take double the amount to make up for a forgotten dose.

If you stop taking Venostasin retard

An interruption or premature termination of 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, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate 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.

Possible side effects

Digestive tract

Uncommon: Nausea, vomiting, diarrhoea, stomach and intestinal complaints (mucous membrane irritation).

Nervous system

Uncommon: Dizziness and headache.

Hypersensitivity reactions

Rare: Hypersensitivity reactions of the skin (itching, rash).

Very rare: Serious allergic reactions (sometimes with bleeding).

Genitals

Very rare: Gynaecological intermenstrual bleeding.

Heart/circulation

Very rare: Increase in heart rate (tachycardia) and increase in blood pressure.

If you observe any of the above side effects, especially bleeding, stop taking Venostasin retard and inform your doctor so that he/she can decide on the severity and any necessary measures. At the first signs of a hypersensitivity reaction (e.g. rash), the medicine should not be taken any further.

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 to provide more information on the safety of this medicine.

5. HOW TO STORE VENOSTASIN RETARD?

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 the blister pack. The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Store in the original package in order to protect from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Venostasin retard contains

The active ingredient is: Horse chestnut seed dry extract. 1 hard capsule, retarded, contains: Active ingredient: 240 - 290 mg dry extract from horse chestnut seeds (4.5 - 5.5 : 1), corresponding to 50 mg triterpene glycosides, calculated as anhydrous aescin; Extraction agent: Ethanol 50% (v/v). The other ingredients are: Dextrin, copovidone, gelatine, talc, ammonium methacrylate copolymer (type A and type B), triethyl citrate, sodium dodecyl sulphate, titanium dioxide, iron(II,III) oxide, indigo carmine, quinoline yellow, iron(III) oxide, iron(III) hydroxide oxide x H2O.

What Venostasin retard looks like and contents of the pack

Hard gelatine capsules (capsule top brown/opaque, capsule bottom green/transparent), filled with brown pellets. Venostasin retard is available in packs of 20, 50, 100 and 200 hard capsules, retarded.

Pharmaceutical entrepreneur:
Klinge Pharma GmbH
Bergfeldstraße 9
D-83607 Holzkirchen

Manufacturer

Swiss Caps GmbH
Grassingerstraße 9
D-83043 Bad Aibling

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: 10/2019
Active ingredient: Horse chestnut seed dry extract. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), for example pain and heaviness in the legs, night-time calf cramps, itching and leg swelling.