NOTICE
ANSM - Last updated: 20/04/2017
Name of the medicinal product
ANTISTAX 360 mg, coated tablet
Red vine extract
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement
Do not use this medication for children.
What is in this leaflet?
1. What is ANTISTAX 360 mg, coated tablet and in which cases it is used?
2. What should be known before taking ANTISTAX 360 mg coated tablet?
3. How to take ANTISTAX 360 mg, coated tablet?
4. What are the possible side effects?
5. How to store ANTISTAX 360 mg coated tablet?
6. Package contents and other information.
1. WHAT IS ANTISTAX 360 mg, coated tablet AND WHAT IT IS USED FOR?
Herbal medicines.
A herbal medication indicated for the treatment of chronic venous insufficiency characterized by swelling of the legs, varicose veins, a feeling of heaviness, pain, fatigue, itching, tension and calf cramps.
2. BEFORE YOU TAKE ANTISTAX 360 mg, coated tablet?
Do not take ANTISTAX 360 mg, coated tablet:
· if you are allergic to the active substance or any of the other ingredients of this medicinal product mentioned in section 6;
Warnings and Precautions
Talk to your doctor or pharmacist before taking ANTISTAX 360 mg, coated tablet if:
- inflammation of the skin,
- thrombophlebitis (inflammation of a vein due to a blood clot) or subcutaneous induration (abnormal hardening under the skin),
- severe pain,
- sudden swelling in one or both legs, ulcers,
- ulcers,
- heart or kidney failure
- persistence of edema in both legs. This persistence may be due to other causes that need to be assessed by a physician.
In the event of an inadequate or unsatisfactory symptomatic response within two weeks, medical advice should be sought.
In the absence of adequate safety data, this medicinal product is not recommended for use in children and adolescents under 18 years of age.
Other medicines and ANTISTAX 360 mg, coated tablet
Inform your doctor if you are taking, have recently taken or may take any other medication.
ANTISTAX 360 mg, tablet coated with food
Not applicable.
Pregnancy, breast-feeding and fertility
The use of this medication during pregnancy or lactation should be avoided.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
3. HOW TO TAKE ANTISTAX 360 mg, coated tablet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Reserved for adults only.
1 tablet coated per day to take in the morning. The dosage can be increased up to 2 tablets per day.
Method and route of administration
Oral use.
Swallow the tablet with a large glass of water before breakfast.
Duration of treatment
The recommended treatment time is 12 weeks.
2 to 3 weeks of treatment may be necessary to observe beneficial effects.
Prolonged use is possible after consultation with your doctor. The duration of treatment is limited to 6 months.
If you take more ANTISTAX 360 mg, coated tablet than you should:
Consult your doctor or pharmacist. .
If you forget to take ANTISTAX 360 mg, coated tablet:
Do not take a double dose to make up for a missed dose.
If you stop taking ANTISTAX 360 mg, coated tablet:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
The assessment of adverse reactions is based on the following frequencies:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 patients out of 100
Uncommon: affects 1 to 10 of 1,000 patients
Rare: affects 1 to 10 patients out of 10,000
Very rare: affects less than 1 in 10,000 patients
Not known: can not be estimated from the available data.
Gastrointestinal disorders:
- Uncommon: Nausea, digestive disorders.
Skin and subcutaneous tissue disorders:
- Uncommon: generalized rash with itching, urticaria.
Immune system disorders:
- Uncommon: allergic reaction.
Nervous system disorders:
- Frequency not known: Headache.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist . This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ANTISTAX 360 mg, coated tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C. Store in the original package.
Do not remove from the blister pack before use.
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ANTISTAX 360 mg contains: coated tablet
· The active substance is:
Red vine ( Vitis vinifera L.) (leaf extract of) ........................................ ... 360.00mg
Extraction solvent: water
Drug Report / Excerpt: 4-6: 1
for a coated tablet
· The other components are:
Other components are hypromellose, glyceryl tristearate, titanium dioxide (E171), talc, red iron oxide (E 172), microcrystalline cellulose, croscarmellose sodium, anhydrous calcium hydrogen phosphate, crospovidone, anhydrous colloidal silica, magnesium stearate.
What is ANTISTAX 360 mg, coated tablet and contents of the pack
Coated tablet. Box of 20, 30, 40 or 60.
Marketing Authorization Holder
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Marketing Authorization Operator
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
DELPHARM REIMS
10 RUE COLONEL CHARBONNEAUX
51100 REIMS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).