Heptral enteric-coated tablets 500 mg 20 pcs.

• intrahepatic cholestasis in adults, including patients with chronic hepatitis of various etiologies and liver cirrhosis;
• Intrahepatic cholestasis in pregnant women.

• active ingredient: ademetionine;
• 1 tablet contains 949 mg of ademethionine 1,4-butanedisulfonate, which corresponds to 500 mg of ademethionine cation;
• excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, methacrylate copolymer (type A), polyethylene glycol 6000, polysorbates, simethicone emulsion, sodium hydroxide, talc.

Hypersensitivity to the active substance or to any of the excipients of the drug (see section “Composition”).

Genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g. cystathionine beta synthase deficiency, vitamin B12 metabolism defect).

The most commonly reported side effects during treatment with ademetionine were headache, diarrhea, and nausea.

Gastrointestinal disorders: common – abdominal pain, diarrhea, nausea; uncommon – dry mouth, dyspepsia, flatulence, gastrointestinal pain, gastrointestinal bleeding, gastrointestinal disorders, vomiting, esophagitis; rare – abdominal distension.

General disorders and administration site conditions: common: asthenia; uncommon: edema, hyperthermia, chills*, injection site reactions*1, injection site necrosis*1; rare: malaise.

Nervous system disorders: common – headache; uncommon – dizziness, paresthesia, dysgeusia*.

Psychiatric disorders: common – anxiety, insomnia; uncommon – agitation, confusion.

Respiratory, thoracic and mediastinal disorders: uncommon – laryngeal edema*.

Skin and subcutaneous tissue disorders: common: pruritus; uncommon: hyperhidrosis, angioedema*, allergic skin reactions (e.g. rash, pruritus, urticaria, erythema)*.

Treatment can begin with parenteral administration of the drug (use Heptral® in the form of a lyophilized powder for injection solution complete with a solvent) followed by the use of the drug in tablet form or immediately with the use of tablets. The daily dose of tablets can be divided into 2–3 doses.

The tablets should be swallowed whole, without chewing. Heptral® tablets are coated with a special coating that dissolves only in the intestine, due to which ademetionine is released in the duodenum. For better absorption of the active substance and for the full therapeutic effect, the tablets should be taken between meals.

The Heptral® tablet should be removed from the blister immediately before taking it. If the tablets are any color other than white to yellowish (due to a violation of the integrity of the aluminum wrapper), it is recommended to refrain from using them.

Initial therapy

Oral: The recommended dose is 10–25 mg/kg body weight per day. The usual starting dose is 800 mg/day, the total daily dose should not exceed 1600 mg.

Supportive therapy

Administer orally (inside) 800–1600 mg/day.

The individual initial and maintenance dose should be determined by the doctor depending on body weight and severity of the disease, as well as taking into account the available dosages of the drug in circulation.

The duration of therapy depends on the severity and course of the disease and is determined by the doctor individually.

Use during pregnancy or breastfeeding

In clinical studies, no adverse reactions were observed in women treated with ademetionine during the third trimester of pregnancy. Ademetionine should be used only if clearly needed during the first two trimesters of pregnancy.

During breastfeeding, ademetionine should be used only if the potential benefit from its use outweighs the potential risk to the infant.

Children

The safety and effectiveness of ademetionine in children have not been established.

Ability to influence reaction speed when driving vehicles or other mechanisms

Some patients may experience dizziness when taking ademetionine. Patients should refrain from driving or operating other machinery until they are certain that ademetionine therapy does not affect their ability to perform these activities.

Cases of overdose with ademetionine have been observed rarely. In case of overdose, physicians should contact local poison control centers. In general, patient monitoring and supportive treatment are recommended.

Serotonin syndrome has been reported in a patient taking ademetionine while taking clomipramine. Therefore, although the possibility of an interaction is theoretical, caution should be exercised when ademetionine is used concomitantly with selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (such as clomipramine), and drugs and herbal remedies containing tryptophan.

Does not require any special storage conditions. Store in the original blister out of the reach of children.