Package leaflet: information for the patient

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 dryopteris rhizome + Methylhydroxychalcone hesperidinate + Ascorbic acid
Please read the entire leaflet carefully before taking this 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 the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform 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 chronic venous insufficiency, consult your doctor.

Table of contents

What Cyclo 3 Fort is and what it is used for
Important information 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 dryopteris rhizome, methylhydroxychalcone hesperidinate, and ascorbic acid (vitamin C).
Cyclo 3 Fort belongs to a group of medicines that affect venous elasticity. It has a toning and protective effect on blood vessels – improving venous wall tone, strengthening capillaries, and reducing vascular permeability.
Cyclo 3 Fort is used in the treatment of symptoms associated with chronic venous insufficiency (such as heavy feeling in the lower limbs, pain) and as an adjunctive treatment in conditions related to haemorrhoids (piles).
Cyclo 3 Fort is intended for use in adult patients.

2. 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 Acorus calamus 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 ulcers occur, contact your doctor.
If sudden swelling of one or both lower limbs, heart failure or kidney failure occurs, contact your doctor.
If diarrhea occurs, discontinue treatment and contact your doctor (see section 4).
Circulatory disorders: if discomfort and/or vessel fragility have not improved after 2 weeks of treatment, contact your doctor.
Symptoms related to hemorrhoids: taking Cyclo 3 Fort cannot replace specialist treatment for other anorectal conditions. If hemorrhoids persist after several days of treatment (no longer than one week), medical consultation is necessary.
Ascorbic acid (vitamin C) may affect 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 all medicines currently used, recently used, or planned to be used.
Cyclo 3 Fort contains ascorbic acid. Exercise caution when using with deferoxamine and deferiprone (medicines used particularly in diseases caused by excess iron or aluminum 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, 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 precaution, Cyclo 3 Fort should be avoided during pregnancy.
Do not take this medicine 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 vehicles or operate machinery have been conducted.

Cyclo 3 Fort contains Sunset Yellow FCF (E 110). This medicine may cause allergic reactions.

3. How to take Cyclo 3 Fort

This medicine should always be taken according to the recommendations provided in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for use in adults.
For the treatment of symptoms related to venous insufficiency (sensation of heaviness in the lower limbs, pain), it is recommended to take Cyclo 3 Fort at a dose of 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 for longer than 2 weeks despite taking the medicine, consult a doctor or pharmacist.
As an adjunct in the treatment of symptoms associated with haemorrhoidal disease, Cyclo 3 Fort is used 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.
The medicine should be taken orally.
Capsules should be taken with a glass of water.

Use in children and adolescents
This medicine is indicated for use in adults.

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 urolithiasis (formation of 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 regarding 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.
The following adverse reactions 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.

Sensation of cold in the extremities.
Pain in the veins (vein sensitivity).
Gastrointestinal disorders.
Aphthous stomatitis (inflammation of the gums 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, predominantly lymphocytic colitis in some cases (or in some patients).

Ascorbic acid may affect the results of certain laboratory tests.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Cyclo 3 Fort

Keep this medicine out of the 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 you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Cyclo 3 Fort contains
The active substances in the medicine are:
150 mg dry extract of Ruscus aculeatus L., Rhizoma (rhizome of butcher's broom) (5 – 7.5 : 1)
Extraction solvent: ethanol 85% (V/V)
Methylhesperidin chalcone 150 mg
Ascorbic acid (vitamin C) 100 mg

Other ingredients are:
Capsule contents: talc, magnesium stearate, colloidal anhydrous silica, 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.
Pack containing 30 or 60 capsules in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Romania, 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: Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by: Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Romania, country of export: 7293/2006/01
Parallel Import Licence Number: 232/24