NOTICE
ANSM - Last updated: 17/09/2013
Name of the medicinal product
ARKOGELULES FRAGON, capsule
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 a physician.
· 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 ARKOGELULES FRAGON, capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE ARKOGELULES FRAGON, capsule?
3. HOW TO TAKE ARKOGELULES FRAGON, capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARKOGELULES FRAGON, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS ARKOGELULES FRAGON, capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Herbal medicines.
Therapeutic indications
Traditionally used in order to decrease the sensations of heavy legs or haemorrhoids.
2. BEFORE YOU TAKE ARKOGELULES FRAGON, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take ARKOGELULES FRAGON , capsule:
· If you are allergic to any of the ingredients in ARKOGELULES FRAGON , capsule.
Precautions for use; special warnings
Precautions for use
Hemorrhoidal Hemorrhoidal Disorder: If haemorrhoids do not give up in 15 days, it is essential to consult your doctor.
Venous circulation disorders : this treatment has all its effectiveness when combined with a healthy lifestyle.
· Avoid exposure to sunlight, heat, prolonged standing, overweight.
· Walking and possibly wearing adapted stockings promote blood circulation.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
There is insufficient data on the use of this medication during pregnancy and lactation. Therefore, as a precautionary measure, it is preferable not to take ARKOGELULES FRAGON, capsule without medical advice.
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 ARKOGELULES FRAGON, capsule?
Instructions for proper use
Capsules to swallow with a large glass of water.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults only.
1 capsule morning, noon and evening, to be taken at the time of the meals.
The dosage may be increased to 6 capsules per day if necessary.
Method and route of administration
Oral use.
Symptoms and Instructions for Overdose
If you take more ARKOGELULES FRAGON, capsule than you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take ARKOGELULES FRAGON, capsule:
Do not take a double dose to make up for a missed dose. Continue your treatment normally.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ARKOGELULES FRAGON, capsule is likely to have side effects, although not everyone is subject to it.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE ARKOGELULES FRAGON, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use ARKOGELULES FRAGON capsule after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the month.
Storage conditions
Store away from moisture and at temperatures below 25 ° C.
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 ARKOGELULES FRAGON contain, capsule?
The active substance is:
Small holly ................................................ .................................................. ...................................... 350 mg
For a capsule.
The other components are:
Excipients : magnesium stearate, hydrated colloidal silica
Capsule of the capsule : hypromellose
Pharmaceutical form and content
What is ARKOGELULES FRAGON, capsule and contents of the pack?
This medication is in the form of a capsule. Case of 45 capsules.
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
Laboratories ARKOPHARMA
BP 28
06511 Carros Cedex
exploiting
Laboratories ARKOPHARMA
BP 28
06511 CARROS Cedex
Maker
Laboratories ARKOPHARMA
LID of Carros le Broc
1 st Avenue 2709 M
06510 CARROS
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
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 medication is available on the ANSM website (www.ansm.sante.fr).
Information for health professionals only
Not applicable.
Other
Not applicable.