Intetrix^® (Capsules) Instructions for Use

Marketing Authorization Holder

Ipsen Consumer Healthcare SAS (France)

Manufactured By

Beaufour Ipsen Industrie (France)

ATC Code

P01AA (Hydroxyquinoline derivatives)

Dosage Form

Intetrix®

Capsules: 20 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 1; the body is opaque, white in color; the cap is opaque, dark red in color; the capsule contents are a microcrystalline powder of a grayish-yellow color.

* the total content of tyliquinol in 1 caps. ranges from 65.2 mg to 72.2 mg (theoretically 68.7 mg).

Excipients: lactose monohydrate – 90 mg, corn starch – 30 mg.

Composition of the capsule body: titanium dioxide (E171) – about 2%, gelatin – up to 100%.
Composition of the capsule cap: dye azorubine (E122) – about 0.6619%, indigo carmine (E132) – about 0.0286%, titanium dioxide (E171) – about 0.6666%, gelatin – up to 100%.

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial, antiprotozoal and antifungal action, a derivative of 8-hydroxyquinoline. Antidiarrheal drug

Pharmacotherapeutic Group

Antiprotozoal agent

Pharmacological Action

The pharmacological effect in chronic amebiasis is achieved due to the synergy of the amebicidal action of the three antimicrobial components that make up Intetrix^®.

The drug acts in the intestinal lumen and is used for the treatment of intestinal amebiasis.

Intetrix^® is effective against vegetative forms of amebiasis. Intetrix^® does not disturb the balance of the normal intestinal microflora.

Pharmacokinetics

C_max in plasma after capsule intake is observed after 3-4 hours. With oral administration of the drug, the degree of its absorption in the gastrointestinal tract is low, which allows maintaining an effective concentration in the intestinal lumen.

The metabolism of the drug is carried out in several ways

• Entry into the blood after absorption from the intestine,
• Transformation in the intestine, after partial absorption and excretion,
• Entry into the intestine without absorption and excretion with intestinal contents.

T_1/2 is about 10 hours. The maximum excretion is determined after 12-24 hours. The entire drug is excreted within 48 hours.

Indications

Intestinal amebiasis in adults

• As part of complex therapy with tissue amebicides;
• Monotherapy of asymptomatic cases of diagnosed amebiasis.

ICD codes

Dosage Regimen

For the treatment of intestinal amebiasis, administer a total daily dose of four capsules.

Take two capsules in the morning and two capsules in the evening.

Adhere to this regimen for a duration of ten days.

For asymptomatic cases of diagnosed amebiasis, this regimen may be used as monotherapy.

When used as part of complex therapy with tissue amebicides, follow the same dosage and duration.

Swallow the capsules whole with a sufficient amount of water.

Take the capsules at the beginning of a meal to optimize tolerability.

Do not exceed the recommended dosage or treatment duration.

Discontinue use and consult a physician if symptoms of peripheral neuropathy or visual disturbances occur.

Adverse Reactions

Rarely, skin reactions such as urticaria, angioedema, and persistent pigmented erythema may occur.

Very rarely, in cases of long-term use of the drug, peripheral neuropathy and transient optic nerve disorders may be observed.

Rarely, when taking the drug, an increase in transaminase levels is possible.

Contraindications

• Individual hypersensitivity to the components of the drug.

With caution hepatic insufficiency.

Use in Pregnancy and Lactation

Animal studies have not revealed a teratogenic effect. Currently, there is insufficient data to assess the potential risk of congenital malformations or fetotoxic effects of the drug when prescribed during pregnancy. Studies on the effect of the drug on lactation in animals have not been conducted.

Therefore, the use of Intetrix^® during pregnancy and breastfeeding is undesirable. In the presence of habitual miscarriages, the use of the drug is not recommended, as this condition requires careful monitoring and well-planned prenatal monitoring.

Use in Hepatic Impairment

With caution: hepatic insufficiency.

Special Precautions

If transaminase levels increase, especially in hepatic insufficiency, it is necessary to discontinue treatment with the drug.

Prolonged use of Intetrix^® is not advisable due to the risk of peripheral neuropathy.

Overdose

In case of overdose, it is necessary to monitor serum transaminase activity, as well as prothrombin levels.

Drug Interactions

The drug should not be prescribed simultaneously with drugs containing hydroxyquinolines.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.