Cyclo 3 forte
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cyclo 3 Fort
150 mg + 150 mg + 100 mg, hard capsules
Dry extract of Aesculus hippocastanum rhizome + Methylhesperidin chalcone + Ascorbic acid
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet, so you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If there is no improvement or if you feel worse after 7 days of treatment for haemorrhoidal symptoms or after 14 days for symptoms related to venous insufficiency, consult your doctor.
Table of Contents
- What Cyclo 3 Fort is and what it is used for
- What you need to know before taking Cyclo 3 Fort
- How to take Cyclo 3 Fort
- Possible side effects
- How to store Cyclo 3 Fort
- Contents of the pack and other information
1. What Cyclo 3 Fort is and what it is used for
Cyclo 3 Fort is a combination of three active substances: dry extract of Aesculus hippocastanum rhizome, methylhesperidin chalcone, and ascorbic acid (vitamin C).
Cyclo 3 Fort belongs to a group of medicines affecting venous vessel elasticity. This medicine has a toning and protective effect on blood vessels – it improves venous wall tone, strengthens capillaries, and reduces permeability of blood vessels.
Cyclo 3 Fort is used in the treatment of symptoms related to venous insufficiency (sensation of heaviness in the lower limbs, pain) and as an adjunctive treatment in disorders associated with haemorrhoids (piles).
Cyclo 3 Fort is intended for adult patients.
2. Important information before taking Cyclo 3 Fort
When not to take Cyclo 3 Fort
- if the patient is allergic to the active substances (dry extract of prickly buckthorn rhizome, methylhesperidin chalcone, ascorbic acid) or to any of the other ingredients of this medicine (listed in section 6),
- in case of iron metabolism disorders (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid (vitamin C) in the formulation.
Warnings and precautions
Before starting treatment with Cyclo 3 Fort, consult your doctor or pharmacist.
If skin inflammation, subcutaneous thickening or skin ulceration occurs, contact your doctor.
If sudden swelling of one or both lower limbs, heart failure or renal failure occurs, contact your doctor.
In case of diarrhoea, discontinue treatment and contact your doctor (see section 4).
Venous circulation disorders: if discomfort and/or vessel fragility do not improve after 2 weeks of treatment, contact your doctor.
Symptoms related to haemorrhoids: taking Cyclo 3 Fort cannot replace specific treatment for other anorectal conditions. If haemorrhoids persist after several days of treatment (no longer than one week), medical consultation is necessary.
Ascorbic acid (vitamin C) may interfere with laboratory test results, such as glucose and bilirubin levels, aminotransferase activity, lactate dehydrogenase activity, and other parameters.
Children and adolescents
Do not use this medicine in children and adolescents.
Cyclo 3 Fort and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Cyclo 3 Fort contains ascorbic acid. Use with caution when taking with deferoxamine and deferiprone (medicines used particularly in diseases caused by excess iron or aluminium in the body).
No studies on interactions with other medicines have been conducted.
Cyclo 3 Fort with food, drink and alcohol
No studies on interactions with food, drink or alcohol have been conducted.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, Cyclo 3 Fort should be avoided during pregnancy. The medicine should not be taken during breastfeeding.
There is no data available on the effect of the medicine on fertility.
Driving and operating machinery
No studies on the effect of Cyclo 3 Fort on the ability to drive or operate machinery have been conducted.
Cyclo 3 Fort contains Sunset Yellow FCF (E 110). The medicine may cause allergic reactions.
3. How to take Cyclo 3 Fort
This medicine should always be taken according to the recommendations contained in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is indicated for use in adults.
For the treatment of symptoms related to venous insufficiency (sensation of heaviness in the lower limbs, pain), the recommended dose of Cyclo 3 Fort is 2 to 3 capsules per day.
One capsule may be taken in the morning and one in the evening, or two capsules in the morning and one in the evening.
If symptoms persist despite taking the medicine for more than 2 weeks, consult a doctor or pharmacist.
As an adjunctive treatment for symptoms related to haemorrhoidal disease, Cyclo 3 Fort is administered at a dose of 4 to 5 capsules per day. Two capsules may be taken in the morning and two in the evening, or three in the morning and two in the evening.
For the treatment of symptoms related to haemorrhoids, this medicine is intended for short-term use only. If symptoms persist after several days of treatment (no longer than one week), consult a doctor.
This medicine should be taken orally.
The capsules should be taken with a glass of water.
Use in children and adolescents
This medicine is indicated for use in adults.
Accidental overdose of Cyclo 3 Fort
Excessive doses of ascorbic acid (vitamin C), one of the components of this medicine, may cause haemolytic anaemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Administration of ascorbic acid in doses exceeding 1 g per day may lead to oxalate stone formation (deposits in the urinary tract composed of calcium oxalate crystals).
Missed dose of Cyclo 3 Fort
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions that may occur:
- Common (occur in less than 1 in 10 people): Diarrhoea, sometimes severe, which quickly resolves after discontinuation of treatment (see section 2. "Warnings and precautions"). Abdominal pain.
- Uncommon (occur in less than 1 in 100 people): Insomnia (difficulty sleeping). Dyspepsia (gastrointestinal disturbances). Nausea. Erythema (redness of the skin). Itching. Muscle cramps. Limb pain (arms and/or legs).
- Rare (occur in less than 1 in 1,000 people): Nervousness. Dizziness. Cold sensation in limbs. Vein pain (vein tenderness). Gastrointestinal disorders. Aphthous stomatitis (inflammation of the mouth with presence of blisters). Increased alanine aminotransferase activity (a liver enzyme).
- Frequency not known (frequency cannot be estimated from available data): Stomach pain. Maculopapular rash (skin redness) and urticaria (itchy, swollen red patches which may appear as hives). Reversible microscopic, mainly lymphocytic colitis in some cases (or in some patients).
Ascorbic acid affects the results of certain laboratory tests.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Cyclo 3 Fort
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Cyclo 3 Fort contains
The active substances in this medicine are:
Dry extract of Ruscus aculeatus L., Rhizoma (rootstock of butcher's broom) (5 – 7.5 : 1) 150 mg
Extraction solvent: ethanol 85% (V/V)
Methylhesperidin chalcone 150 mg
Ascorbic acid (vitamin C) 100 mg
Other ingredients are:
Capsule contents: colloidal anhydrous silica, magnesium stearate, talc, macrogol 6000.
Capsule shell composition:
Body (yellow) – quinoline yellow (E 104), orange-yellow FCF (E 110), titanium dioxide (E 171), gelatin.
Cap (orange) – orange-yellow FCF (E 110), titanium dioxide (E 171), gelatin.
What Cyclo 3 Fort looks like and contents of the pack
Hard capsule consisting of an opaque yellow body and an opaque orange cap.
Packaged in cardboard boxes containing 30 or 60 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Romania, the country of export:
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France
Manufacturer:
Pierre Fabre Medicament Production
Etablissement Progipharm
Rue du Lycee B.P.77
45502 Gien, Cedex
France
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Poland
Marketing Authorisation Number in Romania, the country of export: 7293/2006/01
Parallel Import Licence Number: 449/24