Anavenol Zentiva (Tablets) Instructions for Use

Marketing Authorization Holder

Zentiva, k.s. (Czech Republic)

ATC Code

C05CX (Drugs reducing capillary permeability, other)

Dosage Form

Anavenol Zentiva

Coated tablets: 60 pcs.

Dosage Form, Packaging, and Composition

Coated tablets from green to bluish-green color.

Auxiliary substances : core lactose monohydrate – 12.74 mg, corn starch – 7 mg, stearic acid – 1.8 mg, povidone – 25 2.4 mg, sodium carboxymethyl starch – 1.2 mg.

Composition of coating sucrose – 28.619 mg, talc – 9.163 mg, titanium dioxide – 1.841 mg, polyvinyl acetate – 0.069 mg, carmellose sodium 20 – 0.134 mg, stearic acid – 0.103 mg, white beeswax and carnauba wax – 0.031 mg, dye patent blue – 0.007 mg, dye lemon yellow CH – 0.033 mg.

20 pcs. – PVC/Al blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Venotonic drug

Pharmacotherapeutic Group

Venotonic agent

Indications

• Symptomatic treatment of chronic venous insufficiency of the lower limbs, such as sensations of heaviness, tension, and pain in the legs, as well as nocturnal calf cramps.
• Supportive therapy for symptoms associated with hemorrhoids, including pain, itching, and discomfort.
• Adjunctive treatment for varicose veins and post-thrombotic syndrome to alleviate related symptoms.
• Management of capillary fragility and related conditions where reduced vascular permeability is beneficial.

The therapeutic effect is achieved through the combined action of its active components, which improve venous tone and reduce capillary permeability.

Contraindications

• Hypersensitivity to any of the active substances (dihydroergocristine, esculin, rutoside) or to any of the excipients listed in the composition.
• Severe hepatic impairment or severe renal impairment, as the safety and efficacy in these patient groups have not been established.
• Concomitant use with potent CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors) due to a potential increase in the concentration of dihydroergocristine and the risk of adverse reactions.
• Pregnancy and lactation; the safety of Anavenol during pregnancy and breastfeeding has not been established, and its use is therefore contraindicated.
• History of ergot alkaloid intolerance, as dihydroergocristine is a hydrogenated ergot alkaloid derivative.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Dosage Regimen

The recommended dosage for adults and elderly patients is one coated tablet taken two to three times daily. The tablets should be swallowed whole with a sufficient amount of liquid, preferably during or after a meal to improve gastrointestinal tolerance.

The duration of treatment is determined by the treating physician based on the severity of symptoms and clinical response. For chronic conditions like venous insufficiency, long-term therapy may be required. Do not exceed the recommended daily dose. There is no dosage adjustment recommendation for patients with mild to moderate renal or hepatic impairment; however, the drug is contraindicated in severe impairment. The safety and efficacy in children and adolescents under 18 years of age have not been established, and therefore use in this population is not recommended.

Adverse Reactions

Adverse reactions are generally mild and transient. The following adverse reactions have been reported, primarily affecting the gastrointestinal and nervous systems.

Gastrointestinal disorders are relatively common and may include nausea, epigastric discomfort, dyspepsia, and diarrhea. These effects can often be minimized by taking the tablet with food.

Nervous system disorders such as headache and dizziness have been reported infrequently. In rare cases, allergic skin reactions, including pruritus, rash, and urticaria, may occur. Isolated cases of palpitations or tachycardia have been observed, though a direct causal relationship with the drug has not been definitively established for all reports. If any adverse reaction becomes severe or persistent, patients should consult their physician.

Drug Interactions

Concomitant use with potent inhibitors of the CYP3A4 isoenzyme is contraindicated. This includes drugs like ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, telithromycin, ritonavir, and indinavir. These agents can significantly increase the plasma concentration of dihydroergocristine, potentially leading to an increased risk of adverse effects, including ergotism (e.g., severe vasospasm).

Caution is advised when co-administering with other vasoconstrictor substances, including other ergot alkaloids, as there is a theoretical risk of additive vasoconstrictive effects. While clinical evidence is limited, the potential for pharmacodynamic interaction should be considered.

No other clinically significant drug interactions have been reported. However, as with any medication, patients should inform their healthcare provider about all other medicines they are taking, including prescription, over-the-counter, and herbal products.

Overdose

Information on acute overdose with Anavenol is limited. Based on the pharmacological properties of the components, symptoms of overdose could be an extension of the known adverse reactions.

Potential symptoms may include severe nausea, vomiting, abdominal pain, dizziness, hypotension, or tachycardia. Due to the dihydroergocristine component, symptoms resembling ergot alkaloid toxicity, such as vasospasm or paresthesia, could theoretically occur in cases of significant overdose.

There is no specific antidote. In case of suspected overdose, all medication should be discontinued immediately. Management should be supportive and symptomatic. Gastric lavage or administration of activated charcoal may be considered if ingestion was recent. Patients should be monitored for cardiovascular and neurological functions, and appropriate supportive measures should be instituted. It is essential to seek immediate medical attention or contact a poison control center.

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

Rx Only

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.