Remotiv (extract of St. John’s wort) coated tablets 500 mg. №30

Description

Remotiv (extract of St. John’s wort) coated tablets 500 mg. №30

Composition

active substance: 1 tablet contains a dry extract of St. John’s wort (Hypericum perforatum L.) (4–7 : 1), collected during the flowering period [equivalent to 0.5–1.5 mg of hypericin, at least 6.0% flavonoids and no more than 1% hyperforin; extractant – ethanol 57.9% (v/v)] – 500 mg;

excipients: colloidal anhydrous silicon dioxide; tablet core: microcrystalline cellulose, croscarmellose sodium, macrogol 6000, magnesium stearate, colloidal anhydrous silicon dioxide; film shell: hypromellose, titanium dioxide (E 171), stearic acid, microcrystalline cellulose, iron oxide red (E 172); polishing: macrogol 20,000.

1 tablet contains 120 mg of easily digestible carbohydrates.

Medicinal form

Film-coated tablets.

Main physico-chemical properties: pink, oblong, biconvex tablets covered with a film coating with a characteristic smell.

Pharmacotherapeutic group

Antidepressants. Other antidepressants.
ATX code N06A X25.

Pharmacological properties

The antidepressant effect of the drug is based on the inhibition of monoaminergic neurotransmitters norepinephrine, serotonin and dopamine in presynaptic neurons and slowing down the regulation of central beta-adrenoceptors. The clinical effect is explained by an increase in the concentration of neurotransmitters in the synaptic cleft, as well as the modulating effect of neurotransmitters in the postsynaptic membrane.

Indication 

Depressive disorders of mild and moderate severity, accompanied by symptoms such as depressed mood, internal anxiety, chronic fatigue, mood swings.

Contraindication

Hypersensitivity to the active substance or to any of the ingredients (excipients) of the medicinal product.
Concomitant use with the following drugs:

• some immunosuppressants (eg, cyclosporine, tacrolimus or sirolimus);
• antiviral agents from the group of non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and proteinase inhibitors (eg indinavir);
• some cytostatics (eg, imatinib, irinotecan);
• coumarin series anticoagulants for oral administration;
• digoxin;
• hormonal contraceptives;
• methadone;
• antidepressants and other serotonergic agents;
• theophylline;
• antiepileptic drugs;
• hypolipidemic drugs;
• midazolam;
• steroid hormones.

Method of application and dosage

For oral use. Adults are recommended to take 1 film-coated tablet (morning or evening), preferably with or after meals. The tablet should be swallowed whole, not chewed, with a small amount of liquid.

Duration of treatment

Because St. John’s wort extract is slow-acting, Remotiv should be taken for at least 14 days. The recommended treatment period is 4 to 6 weeks. Longer treatment should be carried out only under the supervision of a physician.
The same regimen is recommended for elderly patients as for adults.
Although St. John’s wort extract has been used for many years, no clinical studies have been performed in patients with hepatic or renal impairment. Therefore, these groups of patients should take Remotov with caution and under the supervision of a physician.

Children

The drug is not recommended for use in children and adolescents under 18 years of age (see section 4.4).

Overdose

Only one case of toxic drug overdose was identified, which was accompanied by seizures and anxiety. It is suggested that the adverse reactions described below may be exacerbated in the event of a significant overdose. In addition, it is necessary to take into account the increased light sensitivity. Avoid exposure to sunlight or other UV radiation (such as in tanning beds) on the skin and eyes for 1-2 weeks.

Side effects:

• From the nervous system: headache, sweating, asthenia.
• From the gastrointestinal tract: gastrointestinal disorders.
• From the skin: allergic skin reactions.
  In case of side effects from the skin, the use of film-coated tablets should be stopped and a dermatological examination should be performed by a doctor.
• From the eyes: phototoxic reactions).
  In case of side effects from the eyes, the drug should be discontinued and consult a doctor.