NOTICE
ANSM - Last updated: 24/04/2017
Name of the medicinal product
CYCLO 3 FORT, capsule
Dry extract of ruscus titrated in sterol heterosides / hesperidin methyl chalcone / ascorbic acid
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use 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 experience no improvement or feel less well after a few days in a haemorrhoidal attack or after 14 days in case of venous circulation problems.
Do not use this medication for children.
What is in this leaflet?
1. What is CYCLO 3 FORT, capsule and in which cases it is used?
2. What should I know before taking CYCLO 3 FORT capsule?
3. How to take CYCLO 3 FORT, capsule?
4. What are the possible side effects?
5. How to store CYCLO 3 FORT, capsule?
6. Package contents and other information.
1. WHAT CYCLO 3 STRONG, capsule AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: ATC code
What is CYCLO 3 FORT, capsule?
CYCLO 3 FORT is a combination of three active substances: ruscus extract, hesperidin methyl chalcone and ascorbic acid (vitamin C).
CYCLO 3 FORT belongs to a group of medicines acting on the permeability of the capillary vessels (cardiovascular system).
This drug is a veinotonic and a vasculoprotective (it increases the tone of the veins and the resistance of the vessels and decreases their permeability.)
In which cases is it used?
It is used in adults to treat:
· Disorders of the venous circulation (heavy legs, pain, painful sensations (so-called impatience of primodecubitus) at bedtime.
· The functional signs related to the hemorrhoidal crisis.
2. BEFORE YOU TAKE CYCLO 3 FORT, capsule?
Do not take CYCLO 3 FORT, capsule:
· if you are allergic (hypersensitive) to the active ingredients (ruscus extract, hesperidin methyl chalcone, and / or ascorbic acid) or any of the other ingredients of this medication mentioned in section 6 .
· if you have iron storage problems (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid (vitamin C) in the composition of this medicine.
Warnings and Precautions
Special warnings
· In case of diarrhea: stop your treatment and tell your doctor (see section 4 What are the possible side effects?)
· Venous circulation disorders: If the discomfort and / or fragility of the vessels does not improve after 15 days of treatment, consult your doctor.
· Hemorrhoidal attack: The administration of this product does not provide specific treatment for other anal diseases. If hemorrhoidal problems persist after a few days of treatment, it is essential to consult your doctor.
Precautions for use
Venous circulation disorders:
This medication is effective when combined with a healthy lifestyle.
Avoid sun exposure, heat, prolonged standing, overweight.
Walking and possibly wearing adapted stockings promote blood circulation.
This medication contains an azo dye (Orange Yellow S, E110) and may cause allergic reactions.
Ascorbic acid (vitamin C) may influence the results of biological tests, such as blood glucose, bilirubin, measurement of transaminase activity, lactates and other tests.
Other medicines and CYCLO 3 FORT, capsule
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CYCLO 3 STRONG, capsule with food and beverages and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid the use of CYCLO 3 FORT during pregnancy and it should not be used during breastfeeding.
Sport
Not applicable.
Driving and using machines
Not applicable.
CYCLO 3 FORT, capsule contains: orange yellow S (E110).
This medication contains an azo dye (Orange Yellow S, E110) and may cause allergic reactions.
3. HOW TO TAKE CYCLO 3 STRONG, capsule?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage:
The recommended dose is:
In venous circulation disorders: 2 to 3 capsules per day.
In the hemorrhoidal crisis: 4 to 5 capsules per day.
Method and route of administration :
This medication is taken orally.
Capsules will be taken with a glass of water.
Usual duration of treatment:
· In venous circulation disorders: If the discomfort and / or fragility of the vessels does not improve after 15 days of treatment, consult your doctor.
· In the hemorrhoidal crisis: treatment should be short-lived. If hemorrhoidal problems persist after a few days of treatment (not more than one week), it is essential to consult your doctor.
Use in children and adolescents
If you take more CYCLO 3 STRONG, capsule than you should:
Excessive doses of ascorbic acid (component of CYCLO 3 FORT) can lead to hemolytic anemia in G6PD-deficient individuals.
Consult your doctor or pharmacist.
If you forget to take CYCLO 3 FORT, capsule:
Do not take a double dose to make up for the single dose you have forgotten to take.
If you stop taking CYCLO 3 STRONG, capsule:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
Common (1 to 10 patients out of 100)
Diarrhea, sometimes severe, rapidly improving upon cessation of treatment (see section 2 Warnings).
Abdominal pain.
Uncommon (1 to 10 of 1000 patients)
Nausea, erythema (redness of the skin), pruritus (itching), muscle spasms, pain in the extremities (hands and / or feet), insomnia (difficulty falling asleep), dyspepsia (functional digestive disorder).
Rare (up to 1 in 1000 patients)
Nervousness, dizziness, coldness of the extremities (coldness of hands and / or feet), venous pain (increased sensitivity of the veins), gastrointestinal disorders, aphthous stomatitis (inflammation of the oral cavity with the presence of vesicles) alanine aminotransferase (increase of a liver biological parameter).
Not known (frequency can not be determined from available data) :
Stomach ache.
Erythema maculopapular (redness of the skin) and urticaria (red plaques in relief associated with itching)
Colitis (inflammation of the colon) reversible upon cessation of treatment.
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 through the national reporting system:
National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers for 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 CYCLO 3 FORT, capsule?
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 package after EXP. The expiry date refers to the last day of that month.
For platelet capsules (PVC / Aclar - Aluminum):
"Store at a temperature not exceeding 25 ° C".
For capsules in flasks (glass):
"Store at a temperature not exceeding 30 ° C".
For platelet capsules (Polyamide / Aluminum / PVC-Aluminum):
No special storage conditions.
Do not throw any medicines into drains or rubbish. 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 CYCLO 3 FORT contains: capsule
· The active substances are :
Dry extract of ruscus titrated in sterolous heterosides .......................................... .......... 150.0 mg
Hesperidin methylchalcone ................................................ ......................................... 150.0 mg
Ascorbic acid (vitamin C) ........................................ ................................... 100.0 mg
For one capsule
· The other components are:
Talc, magnesium stearate, colloidal hydrophobic silica, macrogol 6000.
Capsule envelope composition : quinoline yellow (E104), orange yellow S (E110), titanium dioxide (E171), gelatin (see section 2: CYCLO 3 FORT contains : yellow-orange S (E110)).
What CYCLO 3 FORT, capsule and contents of the pack
This medication is in the form of a capsule (opaque yellow body and orange opaque cap). Boxes of 20, 30, 60 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
LA FRANCE
Marketing Authorization Operator
PIERRE FABRE MEDICAMENT
45, PLACE ABEL GANCE
92100 BOULOGNE
LA FRANCE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
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]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Traffic disorders
Avoid sitting or standing too long, slightly elevating your feet, avoiding sun exposure, heat, ensuring a healthy and balanced diet, and regular physical activity (walking, cycling, etc.) , avoid overweight, avoid tight clothing, wearing socks or stockings as well as showering his legs with cold water promote blood circulation.
Hemorrhoids
Drink 1.5 to 2L of water per day, consume high-fiber foods to avoid constipation (fruits, green vegetables, whole grains), avoid fats, coffee, alcohol and spicy foods , exercise regularly to stimulate blood flow, avoid wearing too heavy objects.