Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging 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 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, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. 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 of treatment 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 contains 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 that affect venous elasticity. This medicine has a protective effect on blood vessels and improves venous wall tone.
Cyclo 3 Fort is used in the treatment of symptoms related to chronic venous insufficiency (such as heavy feeling in the lower limbs, pain) and as an adjunctive treatment in haemorrhoidal disorders (haemorrhoids).
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 Aesculus hippocastanum 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 medicine.

Warnings and precautions
Before starting treatment with Cyclo 3 Fort, discuss it with your doctor or pharmacist.
If skin inflammation, subcutaneous nodules or skin ulceration occur, contact your doctor.
If sudden swelling of one or both lower limbs, heart or kidney failure occurs, contact your doctor.
If diarrhoea occurs, 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 specialist treatment of other anal disorders. If haemorrhoids persist after several days of treatment (no longer than one week), medical consultation is required.
Ascorbic acid (vitamin C) may affect laboratory test results, such as glucose concentration, 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 taken or recently taken, as well as any medicines you plan to take.
Cyclo 3 Fort contains ascorbic acid. Exercise caution when using it concomitantly with deferoxamine and deferiprone (medicines used particularly in diseases caused by excess iron or aluminium in the body) to avoid cardiac problems. In case of doubt, contact your doctor.
No interaction studies with other medicines have been conducted.
No interaction studies with food 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 precaution, avoid taking Cyclo 3 Fort during pregnancy.
This medicine should not be taken during breastfeeding.
There is no data available on the effect of the medicine on fertility.

Driving and operating machinery
It is unknown whether Cyclo 3 Fort affects the ability to drive or operate machinery, as appropriate studies have not 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 information leaflet or as advised 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 chronic 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 for longer than 2 weeks despite taking the medicine, consult a doctor or pharmacist.
As an adjunctive treatment for symptoms associated with 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, the 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.
The 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 the medicine, may cause excessive breakdown of red blood cells (hemolytic anemia) in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Administration of ascorbic acid in doses exceeding 1 g per day may lead to oxalate kidney 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 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 everybody will experience them.
Adverse reactions that may occur:

Common (affects less than 1 in 10 people): Diarrhea, sometimes severe, which quickly resolves after discontinuation of treatment. Continuing treatment may lead to risk of weight loss and disturbances in water-electrolyte balance (sodium, potassium, calcium, chlorides, and bicarbonates) in blood or other body fluids (see section 2. "Warnings and precautions"). Abdominal pain.
Uncommon (affects less than 1 in 100 people): Insomnia (difficulty falling asleep). Dyspepsia. Nausea. Erythema (redness of the skin). Pruritus (itching). Muscle cramps.

Pain in limbs (arms and/or legs).

Rare (affects less than 1 in 1,000 people): Nervousness. Dizziness. Cold sensation in the extremities. Vascular pain (vein sensitivity). Gastrointestinal disturbances. 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 the available data): Stomach pain. Maculopapular rash (skin redness) and urticaria (itchy, swollen red patches which may appear as blisters). Reversible microscopic, mainly 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 or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: 22 49-21-301, Fax: 22 49-21-309, Website:
https://smz.ezdrowie.gov.pl
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.
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.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Cyclo 3 Fort contains
Each hard capsule contains:
150 mg of dry extract from Ruscus aculeatus L., Rhizoma (root extract of butcher's broom) (5 – 7.5 : 1)
Extraction solvent: ethanol 85% (V/V)
150 mg of methylchalcone hesperidin
100 mg of ascorbic acid (vitamin C)
Other ingredients:
Capsule contents: colloidal anhydrous silica, magnesium stearate, talc, macrogol 6000.
Capsule shell composition:
Body (yellow) – quinoline yellow (E 104), patent orange FCF (E 110), titanium dioxide (E 171), gelatin.
Cap (orange) – patent orange 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 blisters containing 20, 30, 40 or 60 capsules, packed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, country of export:
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer:
Pierre Fabre Medicament Production
Etablissement Progipharm
Rue du Lycée B.P. 77
45502 Gien, Cedex
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization Number in Romania, country of export: 7293/2006/01
Parallel Import License Number: 92/26