Cyclo 3 Fort Heavy Legs and Hemorrhoids - Adults Capsules 60 Capsules

Cyclo 3 Fort capsules combine 3 active ingredients: ruscus extract, hesperidin and vitamin C.

Cyclo 3 Fort medicine for venous circulation

This medication for venous circulation is available without a prescription, it acts on the permeability of small-caliber vessels: blood capillaries.

Cyclo 3 Fort is both a veinotonic medication (i.e. increases the tone of the veins) and vasculoprotective (i.e. improves the resistance of the blood vessels).

This medication is used in venous circulation disorders such as heavy legs , pain or restlessness of primodecubitus ( painful sensations when lying down ) but also in the treatment of hemorrhoidal crisis .

This medication has as active substances the dry extract of ruscus titrated in sterolic heterosides and hesperidin methyl chalcone , both at a rate of 150 mg per capsule, and ascorbic acid ( vitamin C ), at a rate of 100 mg per capsule. 
Its other ingredients are talc, magnesium stearate, colloidal hydrophobic silica, macrogol 6000. The capsule shell consists of quinoline yellow (E104), sunset yellow S (E110), titanium dioxide (E171) and gelatin.

How to take Cyclo 3 Fort?

For blood circulation

Take 2 to 3 capsules of Cyclo 3 Fort per day with a glass of water.
If symptoms do not improve after 2 weeks, consult a doctor.

For hemorrhoids

Take 4 to 5 capsules of Cyclo 3 Fort per day with a little water.
The treatment will not exceed one week without medical advice.
 

Precautions with Cyclo 3 Fort

These veinotonic capsules will not be used if you have an allergy to one of the components of Cyclo 3 Fort whose excipients are talc, magnesium stearate, colloidal hydrophobic silica, macrogol 6000. You can find the detailed composition on the medication leaflet.

This medication will be contraindicated in cases of hemochromatosis, thalassemia, sideroblastic anemia or any other iron storage abnormality because of the vitamin C present in the formula .

Taking Cyclo 3 Fort during pregnancy and breastfeeding is not recommended.

This medication can sometimes cause diarrhea or abdominal pain, but these side effects do not appear in all patients (see leaflet).
In case of diarrhea, treatment should be stopped, and if there is no improvement in the discomfort or fragility of the vessels after two weeks, consult a doctor.

Packaging : box of 60 capsules.

Oral use.
Keep out of the sight and reach of children.
Store below 25°C.

Please read the following full disclosure before taking or purchasing this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 20/02/2023

1. NAME OF THE MEDICINAL PRODUCT

CYCLO 3 FORT, capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dry extract of ruscus standardized in steroidal saponins ...............................................................150.0 mg

Hesperidin methyl chalcone ..............................................................................................................150.0 mg

Ascorbic acid ....................................................................................................................................100.0 mg

Per capsule

Notable excipient: Sunset yellow FCF (E110): 0.2459 mg.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsule. Opaque yellow body and opaque orange cap.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Indicated in adults:

· Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, restless legs syndrome at the onset of sleep).

· Treatment of functional signs related to hemorrhoidal crisis.

4.2. Posology and method of administration

Posology

· In venolymphatic insufficiency: the usual dosage is 2 to 3 capsules per day.

The usual duration of treatment for this indication is one month. If there is no positive progress after 2 weeks of regular treatment, medical advice will be necessary.

· In proctology: 4 to 5 capsules per day.

The usual duration of treatment for this indication is one week. If there is no positive progress after this period, medical advice will be necessary.

Pediatric population

The safety and efficacy of CYCLO 3 FORT in children have not been established. No data are available.

Method of administration

Oral route.

The capsules should be taken with a glass of water.

4.3. Contraindications

· Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

· Disorders of iron storage (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid in the composition of the drug.

4.4. Special warnings and precautions for use

Warnings

· The occurrence of diarrhea requires discontinuation of treatment.

· Hemorrhoidal crisis: The treatment should be short-term. Administration of this product does not preclude specific treatment for other anal diseases. If symptoms do not subside quickly, a proctological examination should be performed, and treatment should be reassessed.

Interference with biological tests:

Ascorbic acid is a reducing agent that can influence the results of biological tests, such as blood glucose, bilirubin, the measurement of transaminase activity, lactates, and other parameters.

Precautions for use:

This medicine contains an azo dye, (Sunset yellow FCF, E110), and may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies with other medicines or with food have been conducted.

Precautions for use

• Deferoxamine

With high doses of ascorbic acid administered intravenously: cardiac function abnormalities, even acute heart failure (usually reversible upon discontinuation of vitamin C).

In case of hemochromatosis, vitamin C should be given after the start of treatment with deferoxamine. Cardiac function should be monitored when combined.

• Deferiprone

By extrapolation of the interaction with deferoxamine: caution with high doses of ascorbic acid administered intravenously, risk of cardiac function abnormalities, even acute heart failure (usually reversible upon discontinuation of vitamin C).

4.6. Fertility, pregnancy, and lactation

Pregnancy

There are limited data on the use of CYCLO 3 FORT in pregnant women. Animal studies have not shown direct or indirect harmful effects on reproduction (see section 5.3). As a precaution, it is preferable to avoid the use of CYCLO 3 FORT during pregnancy.

Breastfeeding

It is not known whether the metabolites of CYCLO 3 FORT are excreted in human milk. A risk to newborns/infants cannot be excluded. As a precaution, CYCLO 3 FORT should not be used during breastfeeding.

Fertility

There are no available fertility data.

4.7. Effects on ability to drive and use machines

No specific studies have been conducted.

4.8. Undesirable effects

The table below presents the undesirable effects observed during clinical studies, post-marketing, or in the literature, for which a causal relationship cannot be excluded with the product:

Adverse effects are listed according to MedDRA terminology by organ system class and frequency, as per the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), unknown (cannot be estimated from the available data).

¹ Diarrhea can sometimes be severe (posing a risk of weight loss and electrolyte disturbances if treatment is continued), and is rapidly reversible upon discontinuation of treatment (see section 4.4).

² In some cases (or in certain patients), a reversible microscopic colitis, mainly lymphocytic type, has been identified.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr.

4.9. Overdose

A few cases of overdose have been reported. Excessive doses of ascorbic acid may lead to hemolytic anemia in G6PD-deficient subjects. Oxalate stones may occur with ascorbic acid intake exceeding 1 g per day.

Management: In case of overdose, symptomatic treatment should be administered.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: MEDICINAL PRODUCTS ACTING ON CAPILLARIES

C - CARDIOVASCULAR SYSTEM (ATC code: C05CX)

Venotonic action:

Demonstration:

· In vitro, on isolated and perfused vein, ruscus extract quickly (5 to 8 minutes) causes a significant, progressive, and lasting contraction,

· In vivo, in animals, ruscus administration produces an increase in venous perfusion pressure. The intensity of the effect is comparable in healthy veins and veins made pathological.

Mechanism:

The venotonic effect of ruscus is exerted by an adrenergic-type mechanism, at two levels:

· Direct effect as an agonist of postjunctional alpha-1 and alpha-2 adrenergic receptors of vascular smooth muscle cells,

· Indirect effect by releasing norepinephrine from its pre-junctional neuronal storage sites. The intensity of the ruscus action is proportional to the temperature.

In humans, this action is confirmed by the Aellig method (measuring venous compliance, assessed on a dorsal hand vein using a stereomicroscope).

Dose-effect relationships in single-dose administration, and the respective role of each component of the specialty on venous tone, have also been demonstrated.

Effect on lymphatic circulation:

· The same adrenergic activity on the smooth muscle of the lymphatic vessel has been demonstrated:

· Ruscus induces contraction of the isolated thoracic duct in dogs, via similar adrenergic activation of the lymphatic vessel.

· Ruscus has been able to improve the canal lymphatic flow in a small lymphatic vessel in the hind leg of a dog, in duration and intensity, in a dose-dependent manner, reflecting an increase in the contractility of the lymphatic vessel.

The combination of Ruscus, hesperidin methyl chalcone, and vitamin C induces the contraction of human lymphatic smooth muscle cells (LSMC), through a significant increase in cytosolic Ca²⁺ concentration ([Ca²⁺]i) and cell shortening.

Thus, the pharmacological properties of ruscus are extended to the lymphatic vessels, leading to an increase in the motricity of these vessels, contributing to the drainage of the edema observed in venous insufficiency.

Effect on capillary permeability:

· The hesperidin methyl chalcone present in the specialty significantly increases capillary resistance (Schrödinger's method in guinea pigs).

· In clinical pharmacology, after oral administration, hesperidin methyl chalcone induces a significant increase in capillary resistance.

· After 3 weeks of treatment, vitamin C, by restoring the endothelium's glycocalyx, induces a reduction in capillary permeability in humans.

Mechanism:

The vitamin C of the specialty inhibits the action of collagenase and hyaluronidase (hydrolysis of the mucopolysaccharides of the vessel walls).

In humans, the vitamin C present in CYCLO 3 FORT restores the endothelial glycocalyx after one week of oral administration, leading to a reduction in capillary permeability, thus exerting its beneficial role in cases of venous edema.

5.2. Pharmacokinetic properties

Ruscus extract:

The bioavailability of ruscus extract was studied using radiolabeling. After oral administration in rats, ruscus extract is mainly eliminated in the feces. The absorbed fraction (approximately 40%) is eliminated in the urine (10% of the administered dose).

In animals, ruscogenins administered by oral route are subject to hepatic biotransformation and enterohepatic recirculation. The unchanged fraction is excreted in the urine, and the main metabolite is excreted in the feces.

Hesperidin methyl chalcone:

The bioavailability of hesperidin methyl chalcone in humans is low (less than 25% of the administered dose). It is extensively metabolized by the intestinal flora and the liver. It is excreted in the urine as phenolic acids and in the feces as intact hesperidin.

Vitamin C:

Vitamin C is rapidly absorbed from the intestine, with bioavailability close to 100% for usual doses, but decreasing with high doses. Vitamin C is widely distributed in the body, with higher concentrations in leukocytes, liver, eyes, and adrenal glands.

The elimination of vitamin C is primarily through the urine. The renal reabsorption capacity is saturable and depends on plasma concentrations.

5.3. Preclinical safety data

In toxicity studies, CYCLO 3 FORT showed low acute and chronic toxicity in animals.

No mutagenic effects have been observed in vitro or in vivo. No carcinogenicity studies have been conducted.

Reproductive toxicity studies have not demonstrated teratogenicity or adverse effects on fertility or development.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Capsule filling: lactose monohydrate, magnesium stearate, silica (colloidal anhydrous), talc.

Capsule shell: gelatin, sunset yellow FCF (E110), quinoline yellow (E104), titanium dioxide (E171).

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25°C, in the original package, protected from light.

6.5. Nature and contents of container

Box of 30 or 60 capsules in PVC/PVDC-Alu blister packs.

6.6. Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Laboratoires BOUCHARA-RECORDATI 70 Avenue du General de Gaulle 92800 PUTEAUX FRANCE

8. MARKETING AUTHORISATION NUMBER(S)

· 34009 325 571 4 2: 30 capsules in blister packs (PVC/PVDC-Alu). · 34009 325 573 0 3: 60 capsules in blister packs (PVC/PVDC-Alu).

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

First authorization: 13/01/1997 Last renewal: 21/12/2016

10. DATE OF REVISION OF THE TEXT

20/02/2023

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicine not subject to medical prescription.