NOTICE
ANSM - Last updated: 28/11/2016
Name of the medicinal product
ETIOVEN 30 mg tablet
naftazone
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
Keep this leaflet, you may need to read it again.
If you need more information and advice, ask your pharmacist.
If symptoms worsen or persist, consult your doctor.
If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS ETIOVEN 30 mg tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE ETIOVEN 30 mg tablet?
3. HOW TO TAKE ETIOVEN 30 mg tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ETIOVEN 30 mg tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ETIOVEN 30 mg tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
vasculoprotective
(C: cardiovascular)
Therapeutic indications
This medication is a veinotonic.
It is recommended in disorders of venous circulation.
2. BEFORE YOU TAKE ETIOVEN 30 mg tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take ETIOVEN 30 mg tablets in the following cases:
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients.
Precautions for use; special warnings
Take special care with ETIOVEN 30 mg tablet:
This medication is effective when combined with a healthy lifestyle.
Avoid exposure to sunlight, heat, prolonged standing, overweight.
Walking and possibly wearing adapted stockings promote blood circulation.
Caution is advised in patients with severe hepatic impairment and renal insufficiency.
Interaction with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
Pregnancy is a normal period in the life of a woman where it is particularly important not to take medication without the advice of her doctor. Also, in case of desire for pregnancy, your doctor should be notified.
feeding
In the absence of data on passage through breast milk, breast-feeding is not recommended for the duration of treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE ETIOVEN 30 mg tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
One tablet per day.
Method and route of administration
Oral use.
Frequency of Administration
Take the tablet in the middle of the day
Symptoms and Instructions for Overdose
If you take more ETIOVEN 30 mg tablets than you should:
Worsening of adverse effects is possible in case of overdose.
Instructions for omission of one or more doses
If you forget to take ETIOVEN 30 mg tablet:
Do not take a double dose to make up for the single dose you have forgotten to take
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ETIOVEN 30 mg tablet is likely to have side effects, although not everyone is subject to it:
· eg minor digestive disorders.
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 ETIOVEN 30 mg tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use ETIOVEN 30 mg tablet after the expiry date which is stated on the outer packaging.
The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does ETIOVEN 30 mg contain?
The active substance is :
Naftazone ................................................. .................................................. ....................................... 30 mg
For a tablet.
The other components are :
Calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethyl starch, modified corn starch, anhydrous colloidal silica, talc, magnesium stearate.
Pharmaceutical form and content
What is ETIOVEN 30 mg tablet and contents of the pack?
This medicine comes in tablet form.
Box of 30 tablets.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
CHEPLAPHARM ARZNEIMITTEL GMBH
BAHNHOFSTRASSE 1A
17498 MESEKENHAGEN
GERMANY
exploiting
CHEPLAPHARM France
105, RUE ANATOLE France
92300 LEVALLOIS-PERRET
Maker
FAMAR LYON
29 avenue Charles de Gaulle
69230 SAINT GENIS LAVAL
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.