Cyclo 3^® Fort (Capsules) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Medicament (France)

Manufactured By

Pierre Fabre Medicament Production (France)

ATC Code

C05CX (Drugs reducing capillary permeability, other)

Dosage Form

Cyclo 3® Fort

Capsules 100 mg+150 mg+150 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin (size 1); cap – opaque, orange-colored, body – opaque, yellow-colored; capsule contents – powder from yellow to brownish-yellow with inclusions of darker and lighter color; the presence of lumps and compressed mass is allowed.

Excipients: talc, magnesium stearate, colloidal anhydrous silicon dioxide, macrogol 6000, titanium dioxide (E171), quinoline yellow dye (E104), sunset yellow FCF dye (E110), gelatin.

The capsule shell contains the dye “sunset yellow FCF” (E110).

10 pcs. – PVC/PE/PVDC/aluminum blisters (3) – cardboard packs.
20 pcs. – PVC/PE/PVDC/aluminum blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Drug improving microcirculation. Angioprotector

Pharmacotherapeutic Group

Angioprotectors; drugs that reduce capillary permeability; other drugs that reduce capillary permeability

Pharmacological Action

A combination of three active substances with proven action on veins and capillaries: extract of butcher’s broom rhizomes – venotonic, vasoprotective, and anti-edematous action; Hesperidin methylchalcone – vasoprotective and anti-edematous action; Ascorbic acid – vasoprotective action.

The venotonic action of butcher’s broom extract is due to an adrenergic mechanism of action at two levels: direct stimulation of postsynaptic α₁– and α₂-adrenergic receptors in the smooth muscle cells of the vascular wall; indirect action by releasing norepinephrine from the granules of presynaptic nerve endings. The intensity of the extract’s action is proportional to temperature.

The venotonic action of this agent on human vessels was confirmed by the stereomicroscopic examination method of the dorsal veins of the wrist (Aellig’s method). A dose-effect relationship was also demonstrated after a single dose, and the corresponding role of each component of this combination for venous tone was demonstrated.

Pharmacokinetics

After absorption of the drug, C_max of butcher’s broom glycosides and hesperidin (the active substance of citrus) in plasma is reached after 2 hours. The therapeutic effect of the drug reaches its maximum at the end of the 2nd hour after its intake and persists for 6 hours.

Indications

For the symptomatic treatment of venous-lymphatic insufficiency (with manifestations such as heaviness in the legs, pain, “tired” legs syndrome).

ICD codes

Dosage Regimen

Take orally.

Administer two capsules per day, one in the morning and one in the evening with meals.

Follow this regimen for a recommended duration of one month.

Consult a physician if no symptomatic improvement is observed after two weeks of regular use.

Discontinue use immediately if diarrhea occurs.

Do not use in children or adolescents under 18 years of age.

Adverse Reactions

Psychiatric disorders uncommon – insomnia; rare – increased excitability.

Ear and labyrinth disorders dizziness.

Cardiac and vascular disorders cold sensation in the extremities, vein pain.

Gastrointestinal disorders common – diarrhea, abdominal pain; uncommon – dyspepsia, nausea; rare – aphthous stomatitis; frequency unknown – reversible microscopic colitis (lymphocytic), stomach pain.

Hepatobiliary disorders rare – increased ALT activity.

Skin and subcutaneous tissue disorders uncommon – erythema, pruritus; frequency unknown – maculopapular rash, erythema, urticaria.

Musculoskeletal and connective tissue disorders uncommon – muscle spasm, limb pain.

Investigations frequency unknown – effect on laboratory test parameters.

Contraindications

Hypersensitivity to the components of the combination; iron metabolism disorders (thalassemia, hemochromatosis, sideroblastic anemia) due to the presence of ascorbic acid in this combination; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

As a precautionary measure, it is preferable to avoid the use of this combination during pregnancy.

Should not be used during breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

If diarrhea occurs, treatment should be discontinued.

Ascorbic acid may affect the results of biochemical studies regarding blood glucose concentration, bilirubin concentration, transaminase activity, lactate concentration, and other parameters.

Drug Interactions

Deferoxamine: with high-dose intravenous ascorbic acid – impairment of cardiac function or acute heart failure (usually reversible after vitamin C withdrawal).

In hemochromatosis, vitamin C should be prescribed after starting deferoxamine therapy. Monitor cardiac function when using the combination.

Deferiprone: by extrapolation of data on interaction with deferoxamine – precautions should be taken when used with high-dose intravenous ascorbic acid, there is a risk of impairment of cardiac function or development of acute heart failure (usually reversible after vitamin C withdrawal).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.