ANTISTAX

ANTISTAX vein cream

Important notes (mandatory information)

Antistax Venencreme 282 mg/10 g. Active ingredient: Dry extract from red vine leaves. Areas of application: For the relief of discomfort and a feeling of heaviness in the legs in connection with minor venous circulatory disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Antistax Venencreme 282 mg/10 g, for use in adults
Active ingredient: Dry extract from red vine leaves, 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 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 a few days, contact your doctor.

What this package leaflet contains

1. WHAT IS ANTISTAX VENENCREME AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING ANTISTAX VENENCREME
3. HOW TO USE ANTISTAX VENENCREME
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ANTISTAX VENENCREME
6. CONTENTS AND FURTHER INFORMATION

1. WHAT IS ANTISTAX VENENCREME AND WHAT IS IT USED FOR?

Antistax Venencreme is traditionally used to relieve discomfort and a feeling of heaviness in the legs in connection with minor venous circulatory disorders. Antistax Venencreme is a traditional herbal medicinal product that is registered exclusively on the basis of many years of use for the area of application.

2. WHAT YOU NEED TO KNOW BEFORE USING ANTISTAX VENENCREME

Antistax Venencreme must not be used:

• If you are hypersensitive (allergic) to the extract from red vine leaves or any of the other ingredients (especially salicylic acid) of this medicine listed in section 6.
• The medicine must not be used on injured skin, in the eye area or on mucous membranes.

This medicine contains 440 mg propylene glycol per 20 g, corresponding to 2.2 g propylene glycol per 100 g cream.

Warnings and precautions

In the case of inflammatory skin changes, phlebitis or hardening of the subcutaneous tissue, severe pain, ulcers, sudden swelling of one or both legs, heart or kidney disease, a doctor should be consulted.

In the traditional use to relieve discomfort in minor venous circulatory disorders, it is pointed out that 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.

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.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended due to lack of data.

Use of Antistax Venencreme together with other medicines

No interaction studies have been conducted. No interactions with other medicines are known to date.

However, 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Safety during pregnancy and breast-feeding has not been studied. In the absence of sufficient data, use during pregnancy and breast-feeding is not recommended. Studies on fertility are not available.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been conducted.

Important information about certain other ingredients of Antistax Venencreme

The other ingredient cetyl stearyl alcohol (Ph. Eur.) can cause local skin irritation (e.g. contact dermatitis). The other ingredient propylene glycol can also cause skin irritation.

3. HOW TO USE ANTISTAX VENENCREME

Always use Antistax Venencreme exactly as described in this package leaflet.

Method of application

For application to the skin. Wash hands after use.

Adults

Apply a thin layer to the affected areas 1 - 3 times daily. Massage the cream in gently until it is completely absorbed by the skin. Always perform the stroking massage in the direction from the foot to the thigh.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended (see section "Warnings and precautions").

Duration of use

The recommended duration of use is 4 weeks.

If symptoms persist for more than 2 weeks during use of the medicine, a doctor or other qualified healthcare professional should be consulted.

There are no sufficient data for specific dosage recommendations in the case of impaired renal or hepatic function.

If you have used more Antistax Venencreme than you should

Antistax Venencreme is well tolerated. No cases of overdose have been reported.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Antistax Venencreme can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of 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

Skin and subcutaneous tissue disorders Contact allergies and/or skin hypersensitivity reactions such as itching and redness, hives (urticaria) have been reported. The frequency is not known.

In the event of contact eczema and/or hypersensitivity reactions, the medicine should be discontinued.

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 ANTISTAX VENENCREME

Keep out of the reach of children.

Do not use the medicine after the expiry date which is stated on the folding box and on the tube fold after "Usable until". The expiry date refers to the last day of the month. Do not dispose of the medicine in wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

Storage conditions

Do not store above 25ºC.

Note on shelf life after opening

After opening, the medicine should be used within 6 months.

6. CONTENTS AND FURTHER INFORMATION.

What Antistax Venencreme contains

The active ingredient is a thick extract from red vine leaves. 10 g of cream contain 282 mg of thick extract from red vine leaves (2.5-4:1), extraction agent: water.

The other ingredients are

Salicylic acid, cetyl stearyl alcohol (Ph. Eur.), macrogol cetyl stearyl ether (Ph. Eur.: 2-33 EO units), decyl oleate, isopropyl myristate (Ph. Eur.), urea, propylene glycol, lemon oil, purified water.

What Antistax Venencreme looks like and contents of the pack

Antistax Venencreme is a light brown-reddish cream with a faint lemon scent. Antistax Venencreme is available in original packs containing 40 g, 50 g and 100 g of cream.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

STADA Consumer Health Deutschland GmbH
Stadastraße 2-18
61118 Bad Vilbel
Telephone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This package leaflet was last revised in October 2023.

Source: Information from the package leaflet
Status: 01/2025
Active ingredient: Dry extract from red vine leaves. Areas of application: For the relief of discomfort and a feeling of heaviness in the legs in connection with minor venous circulatory disorders.