Ciclo 3 Fort

Leaflet attached to the packaging: patient information

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 Ruscus aculeatus root + Hesperidin methylchalcone + Ascorbic acid

You should 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 your doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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: dry extract of Ruscus aculeatus root, 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 adjunct in the treatment of hemorrhoids (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, you should discuss it with your doctor or pharmacist.
If skin inflammation or subcutaneous thickening or skin ulcers occur, you should contact your doctor.
If sudden swelling of one or both lower limbs, heart failure, or kidney failure occurs, you should contact your doctor.
If diarrhea occurs, you should stop treatment and contact your doctor (see section 4).
Venous circulation disorders: if discomfort and/or fragility of the vessels do not improve after 2 weeks of treatment, you should contact your doctor.
Hemorrhoid-related disorders: 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 certain laboratory tests, such as glucose concentration, bilirubin, aminotransferase activity, lactate dehydrogenase, and other indicators.

Children and adolescents

This medicine should not be used in children and adolescents.

Cyclo 3 Fort and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Cyclo 3 Fort contains ascorbic acid. You should be cautious when using it with deferoxamine and deferiprone (medicines used in particular for diseases caused by excess iron or aluminum 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
As a precaution, you should avoid taking Cyclo 3 Fort during pregnancy. You should not take this medicine while 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 your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The medicine is indicated for use in adults.
In 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.
You can take one capsule 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, you should contact your doctor or pharmacist.

As an adjunct in the treatment of hemorrhoid-related symptoms, Cyclo 3 Fort is used in a dose of 4 to 5 capsules per day. You can take two capsules in the morning and two in the evening or three capsules in the morning and two in the evening.

In the treatment of hemorrhoid-related symptoms, the medicine is intended for short-term use. If symptoms persist after a few days of treatment (no longer than a week), you should contact your 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 higher than 1g per day may cause the formation of kidney stones (formation of deposits in the urinary tract made of calcium oxalate crystals).

Missing a dose of Cyclo 3 Fort

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur:

• Often(occurring in less than 1 in 10 people): Diarrhea, sometimes severe, quickly resolving after discontinuation of treatment (see section 2. "Warnings and precautions"). Abdominal pain.
• Uncommon(occurring in less than 1 in 100 people): Insomnia (difficulty falling asleep). Gastrointestinal disorders. Nausea. Redness (skin redness). Itching. Muscle cramps. Limb pain (arms and/or legs).
• Rare(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 redness that may have a vesicular 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 you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information 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.
Store in a temperature 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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 (Ruscus aculeatus root) (5-7.5:1) 150 mg
Extractant: ethanol 85% (V/V)
Hesperidin methylchalcone 150 mg
Ascorbic acid (vitamin C) 100 mg
Other ingredients are:
Caplet contents: hydrophobic colloidal silica, magnesium stearate, talc, macrogol 6000.
Caplet shell composition:
Body (yellow) - quinoline yellow (E 104), orange yellow FCF (E 110), titanium dioxide (E 171), gelatin.
Lid (orange) - orange yellow FCF (E 110), titanium dioxide (E 171), gelatin.

What Cyclo 3 Fort looks like and what the pack contains

Hard capsule, consisting of an opaque yellow body and an opaque orange lid.
30 or 60 capsules in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Authorization number in Romania, the country of export:7293/2006/01

Parallel import authorization number: 449/24

Date of leaflet approval: 30.12.2024

[Information about the trademark]
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń