Ciclo 3 Fort

Leaflet attached to the packaging: patient information

Cyclo 3 Fort, 150 mg + 150 mg + 100 mg, hard capsules

Dry extract of butcher's broom rhizome + Hesperidin methylchalcone + Ascorbic acid

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days of taking the medicine for symptoms related to hemorrhoids or after 14 days for symptoms related to venous insufficiency, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Cyclo 3 Fort and what is it used for
• 2. Important information before taking Cyclo 3 Fort
• 3. How to take Cyclo 3 Fort
• 4. Possible side effects
• 5. How to store Cyclo 3 Fort
• 6. Package contents and other information

1. What is Cyclo 3 Fort and what is it used for

Cyclo 3 Fort is a combination of three active substances: butcher's broom rhizome extract, hesperidin methylchalcone, and ascorbic acid (vitamin C). Cyclo 3 Fort belongs to a group of medicines that affect venous elasticity. This medicine has a toning and protective effect on blood vessels - it improves the tension of venous walls, strengthens capillaries, and reduces the permeability of blood vessels. Cyclo 3 Fort is used to treat symptoms related to venous insufficiency (feeling of heaviness in the lower limbs, pain) and as an auxiliary treatment for hemorrhoids. Cyclo 3 Fort is intended for adult patients.

2. Important information before taking Cyclo 3 Fort

When not to take Cyclo 3 Fort

Warnings and precautions

Before starting treatment with Cyclo 3 Fort, the patient should discuss it with their doctor or pharmacist. If skin inflammation, subcutaneous thickening, or skin ulcers occur, the patient should contact their doctor. If sudden swelling of one or both lower limbs, heart or kidney failure occurs, the patient should contact their doctor. If diarrhea occurs, treatment should be discontinued and the doctor contacted (see section 4). Venous circulation disorders: if discomfort and/or fragility of the vessels do not improve after 2 weeks of treatment, the patient should contact their doctor. Hemorrhoids: taking Cyclo 3 Fort cannot replace specialized treatment of other anal conditions. If hemorrhoids persist after a few days of treatment (no longer than a week), a medical consultation is necessary. Ascorbic acid (vitamin C) may affect the results of laboratory tests, such as glucose, bilirubin, aminotransferase, lactate dehydrogenase, and other indicators.

Children and adolescents

This medicine should not be used in children and adolescents.

Cyclo 3 Fort and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Cyclo 3 Fort contains ascorbic acid. Caution should be exercised when using it with deferoxamine and deferiprone (medicines used in cases of iron or aluminum overload in the body). No studies have been conducted on interactions with other medicines.

Cyclo 3 Fort with food, drink, and alcohol

No studies have been conducted on interactions with food, drink, and alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. As a precaution, Cyclo 3 Fort should be avoided during pregnancy. The medicine should not be taken during breastfeeding. There is no data on the effect of the medicine on fertility.

Driving and using machines

No studies have been conducted on the effect of Cyclo 3 Fort on the ability to drive and use machines. Cyclo 3 Fort containsorange yellow FCF (E 110). The medicine may cause allergic reactions.

3. How to take Cyclo 3 Fort

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine is indicated for use in adults. For the treatment of symptoms related to venous insufficiency (feeling of heaviness in the lower limbs, pain), it is recommended to take Cyclo 3 Fort in a dose of 2 to 3 capsules per day. One capsule can 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 more than 2 weeks despite taking the medicine, the patient should contact their doctor or pharmacist.

As an auxiliary treatment for hemorrhoids, Cyclo 3 Fort is used in a dose of 4 to 5 capsules per day. Two capsules can be taken in the morning and two in the evening, or three capsules in the morning and two in the evening.

In the treatment of hemorrhoids, the medicine is intended for short-term use. If symptoms persist after a few days of treatment (no longer than a week), the patient should contact their doctor.

The medicine should be taken orally. The capsules should be swallowed with a glass of water.

Use in children and adolescents

The medicine is indicated for use in adults.

Taking a higher dose of Cyclo 3 Fort than recommended

Excessive doses of ascorbic acid (vitamin C), which is one of the ingredients of the medicine, may cause hemolytic anemia in people with a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD). Taking ascorbic acid in a dose greater than 1g per day may cause the formation of kidney stones (deposits in the urinary tract built from calcium oxalate crystals).

Missing a dose of Cyclo 3 Fort

A double dose should not be taken to make up for a missed dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cyclo 3 Fort can cause side effects, although not everybody gets them. Possible side effects that may occur:

• Frequently(occurring in less than 1 in 10 people): Diarrhea, sometimes severe, rapidly resolving after discontinuation of treatment (see section 2. "Warnings and precautions"). Abdominal pain.
• Less frequently(occurring in less than 1 in 100 people): Insomnia (difficulty sleeping). Gastrointestinal disorders. Nausea.

Rash (skin redness). Itching. Muscle cramps. Limb pain (arms and/or legs).

• Rarely(occurring in less than 1 in 1,000 people): Nervousness. Dizziness. Feeling of cold in the limbs. Venous pain (venous sensitivity). Gastrointestinal disorders. Aphthous stomatitis (gingivitis with the presence of vesicles). Increased activity of alanine aminotransferase (liver enzyme).
• Frequency not known (frequency cannot be estimated from the available data):Stomach pain. Maculopapular rash (skin redness) and urticaria (itchy, swollen skin that may have a blister-like appearance). Reversible microscopic, mainly lymphocytic colitis in some cases (or in some patients).

Ascorbic acid affects the results of some laboratory tests.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cyclo 3 Fort

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. The medicine should be stored at a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Cyclo 3 Fort contains

The active substances of the medicine are: dry extract of Ruscus aculeatus L.,Rhizoma (butcher's broom rhizome) (5-7.5:1) in an amount of 150 mg Extractant: ethanol 85% (V/V) Hesperidin methylchalcone 150 mg Ascorbic acid (vitamin C) 100 mg The other ingredients are: Capsule contents: colloidal silicon dioxide, magnesium stearate, talc, polyoxyethylene glycol (Macrogol) 6000. Capsule shell composition: Yellow (yellow) - quinoline yellow (E 104), orange yellow FCF (E 110), titanium dioxide (E 171), gelatin. Orange (orange) - orange yellow FCF (E 110), titanium dioxide (E 171), gelatin.

What Cyclo 3 Fort looks like and what the package contains

Hard capsule, consisting of an opaque yellow body and an opaque orange cap. 30 or 60 capsules in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Medicament Les Cauquillous 81500 Lavaur France

Manufacturer

Pierre Fabre Medicament Production Site Progipharm Rue du Lycée 45500 Gien France For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder: Pierre Fabre Medicament Polska Sp. z o.o. ul. Belwederska 20/22 00-762 Warsaw tel: 22 559 63 00

Date of last revision of the leaflet: