ANTISTAX

ANTISTAX extra vein tablets

Important notes (mandatory information)

Antistax extra Venentabletten, 360 mg film-coated tablets. Active ingredient: Dry extract of red vine leaves. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), which manifest themselves, for example, through pain and a feeling of heaviness in the legs, varicose veins, night-time calf cramps, itching and swollen legs (leg oedema).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Antistax extra Venentabletten, 360 mg film-coated tablets for use in adults
Active ingredient: Dry extract of red vine leaves
Herbal medicinal product for venous disorders

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 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 a few days, contact your doctor.

What this package leaflet contains

1. WHAT ARE ANTISTAX EXTRA VENENTABLETTEN AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING ANTISTAX EXTRA VENENTABLETTEN?
3. HOW SHOULD ANTISTAX EXTRA VENENTABLETTEN BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ANTISTAX EXTRA VENENTABLETTEN BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE ANTISTAX EXTRA VENENTABLETTEN AND WHAT ARE THEY USED FOR?

Antistax extra Venentabletten are a herbal medicinal product for venous disorders. Antistax extra Venentabletten are used in adults for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), which manifest themselves, for example, through pain and a feeling of heaviness in the legs, varicose veins, night-time calf cramps, itching and swollen legs (leg oedema).

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING ANTISTAX EXTRA VENENTABLETTEN?

Antistax extra Venentabletten must not be taken if you are hypersensitive (allergic) to red vine leaves or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

In the case of skin inflammation, thrombophlebitis or subcutaneous tissue hardening, severe pain, ulcers, sudden swelling of one or both legs, impaired heart or kidney function, a doctor should be consulted. These symptoms are not related to taking Antistax extra Venentabletten, but indicate possible complications of the disease. If there is no adequate or satisfactory reduction in symptoms within 2-3 weeks, a doctor should be consulted, as oedema can also have other causes.

Children and adolescents

Due to the lack of sufficient safety data, use in children and adolescents under 18 years of age is not recommended. Note: Other non-invasive measures prescribed by the doctor, such as wrapping the legs, wearing support stockings or cold water jets, should be strictly adhered to.

Taking Antistax extra Venentabletten together with other medicines

Interactions have not been investigated to date. However, no interactions have been observed to date. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Taking Antistax extra Venentabletten together with food and drink

There are no special precautions to be taken.

Pregnancy, breast-feeding and fertility

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. There are no sufficient data to assess safety during pregnancy and breast-feeding; therefore, use during pregnancy and breast-feeding is not recommended. Fertility studies are not available.

Driving and using machines

No studies on the effect on driving and using machines have been performed.

3. HOW SHOULD ANTISTAX EXTRA VENENTABLETTEN BE TAKEN?

Always take Antistax extra Venentabletten exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, adults should take 1 - 2 film-coated tablets in the morning. Take Antistax extra Venentabletten before breakfast, unchewed, with water. The duration of use depends on the symptoms. You should take Antistax extra Venentabletten for several weeks. Long-term use is possible after consultation with a doctor. If the symptoms do not improve within 23 weeks, you should consult a doctor, as oedema can also have other causes. Please also note the information under "Warnings and precautions" regarding the duration of use.

Use in children and adolescents

Use in children and adolescents under 18 years of age is not recommended, as there is no relevant data for this age group.

If you have taken more Antistax extra Venentabletten than you should

Please notify your doctor. He/she can decide on any necessary measures. The side effects listed in section "Side effects" may occur more frequently.

If you forget to take Antistax extra Venentabletten

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Antistax extra Venentabletten can have 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.

After taking Antistax extra Venentabletten, stomach upset, nausea and other gastrointestinal complaints may occasionally occur. Occasionally, an itchy rash may occur, as well as, with unknown frequency, hives and other hypersensitivity reactions and headaches.

Countermeasures

If you experience any of the side effects listed above, stop taking Antistax extra Venentabletten 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 provide more information on the safety of this medicine.

5. HOW SHOULD ANTISTAX EXTRA VENENTABLETTEN 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 the blister pack after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 30°C. Store in the original package to protect the contents from moisture. Do not remove the tablets from the blister pack until immediately before use.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Antistax extra Venentabletten contain

The active ingredient is a dry extract of red vine leaves. 1 film-coated tablet contains 360 mg dry extract of red vine leaves (4-6:1), extraction solvent: water. The other ingredients are: Highly dispersed silicon dioxide, magnesium stearate, talc, titanium dioxide (E 171), iron(III) oxide (E 172), microcrystalline cellulose, crospovidone, croscarmellose sodium, calcium hydrogen phosphate, hypromellose, glycerol tristearate.

What Antistax extra Venentabletten look like and contents of the pack

Red-brown, oblong tablets in blister packs made of transparent plastic and aluminium foil. Original packs of 30, 60 and 90 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

SanofiAventis
Deutschland GmbH
65926 Frankfurt am Main
Postal address: Postfach 80 08 60
65908 Frankfurt am Main
Telephone: 0800 56 56 010
Telefax: 0800 56 56 011

EMail

info@antistax.de

Manufacturer

Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims, France

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Dry extract of red vine leaves. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), which manifest themselves, for example, through pain and a feeling of heaviness in the legs, varicose veins, night-time calf cramps, itching and swollen legs (leg oedema).