Deprim - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspcoated tablets

Composition:

1 tablet, film-coated, contains:

Core:

Active ingredient: extract of St. John's wort (in which total hypericin is not less than 0.3 mg) - not less than 60.00 mg;

inactive components: microcrystalline cellulose

63.25 mg, talc 10.00 mg, magnesium stearate 1.00 mg, colloidal silicon dioxide (Aerosil 200) 2.50 mg, lactose, a sieve of 70-100 to 250 mg.

Sheath:

hydroxypropylmethylcellulose (Pharmacoat 606) 7.552 mg, glaze green, Sicopharm 0.835 mg, glaze blue, Sicopharm 0.085 mg, polyethylene glycol 1.320 mg, titanium dioxide 1.209 mg, carnauba wax 0.045 mg, talc 0.045 mg, purified water.

Description:Large biconvex tablets are green, coated.

Pharmacotherapeutic group:An antidepressant of vegetable origin

ATX: & nbsp

St. John's wort

Pharmacodynamics:Means of plant origin, has an anxiolytic and antidepressant effect. The main active substances of St. John's wort - hypericin, pseudo-hypericin, hyperforin, flavonoids - improve the functional state of the central and autonomic nervous system. Improves mood, increases mental and physical activity.

Indications:Deprim® is used for mood reduction, depressive states of mild and moderate severity, accompanied by anxiety, incl.associated with climacteric syndrome, with increased sensitivity to weather changes.

Contraindications:

- increased individual sensitivity to the ingredients of the drug;

- photosensitivity (skin sensitivity to

ultraviolet radiation, incl. in the anamnesis);

- Depression of severe severity;

- simultaneous admission with monoamine oxidase (MAO) inhibitors, cyclosporin, tacrolimus; indinavir and other HIV protease inhibitors; irinotecan, imatinib and other cytostatics; warfarin; other antidepressants;

- children's age till 12 years;

- pregnancy and the period of breastfeeding;

- rare hereditary forms of intolerance to galactose, deficiency of lactase or impaired absorption of glucose-galactose (because the composition contains lactose).

Pregnancy and lactation:The use of the drug Deprim during pregnancy and breastfeeding is contraindicated in connection with the lack of reliable clinical data confirming the safety of the extract of St. John's Wort extract permeated during these periods.

Dosing and Administration:

Tablets are taken orally and washed down with water.

Adults and adolescents over 12 years of age: one tablet 3 times a day.

The therapeutic effect of the drug Deprim® is manifested after 10-14

14 days after the beginning of the admission. If the condition does not improve within 4-6 weeks after the start of treatment, stop taking Deprim® and consult with your doctor. The patient must tell his doctor about taking Deprim®.

If you miss one dose of Deprim®

should take the medicine as soon as possible.
if the time of taking the next dose of the drug is appropriate, do not take an additional dose to compensate for the missed dose.
do not take two doses of the drug at the same time.

Side effects: Disturbances from the skin and subcutaneous tissues: skin itching, skin rash, erythema; photosensitization (more often in HIV-infected patients); when taking the drug on skin areas exposed to intense solar radiation, due to photosensitization, it is possible to develop skin reactions similar to sunburn (mainly in patients with fair skin).

Disorders from the gastrointestinal tract: nausea, abdominal pain (including in the epigastric region), dryness of the oral mucosa, flatulence, diarrhea or constipation, anorexia;

Impaired nervous system: anxiety, fatigue, headache;

Violations of the blood and lymphatic system:

Iron-deficiency anemia;

Other: increased sensitization to animal hair.

Overdose:

To date, no cases of drug overdose have been reported. When using the drug in doses exceeding the recommended, the the severity of dose-dependent side effects. Reported the appearance of convulsive seizures and confusion after taking up to 4.5 g of dry extract per day for 2 weeks and an additional 15 g of dry extract immediately before admission.

With significant overdoses, the development of phototoxic reactions is possible.

Treatment is symptomatic: it is necessary to cancel the drug, take Activated carbon; avoid exposure to sunlight and UV irradiation for 1-2 weeks. Outdoor activities should be limited, using products and / or clothing that protects the skin from the sun.

Interaction:

St. John's wort extract activates microsomal

oxidation (cytochrome P450); therefore, with simultaneous application

Special instructions:With the simultaneous application of dry extract of St. John's wort with indirect coumarinic anticoagulants (such as fenprokumone), theophylline and digoxin may decrease their effectiveness. Careful monitoring of patients taking these medications (for example, monitoring the concentration in the blood plasma) is necessary in particular at the beginning and after the application of the drug. The use of dry extract of St. John's wort can lead to the occurrence of intermenstrual bleeding in women taking oral contraceptives. It is necessary to use additional measures of contraception, since dry extract of St. John's wort can weaken the effect of oral contraceptives.

It is not recommended to take sunbaths or use a solarium during treatment with Deprim®.

During treatment with the drug Deprim®, you should refrain from drinking alcoholic beverages. The drug contains 0.02 XE, which must be taken into account when used in patients with diabetes mellitus.

Effect on the ability to drive transp. cf. and fur:There is insufficient data on the effect of the drug on the ability to drive vehicles and perform Other activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:10 tablets per blister.

Packaging:For 3 blisters together with instructions for use are included in a cardboard box.

Storage conditions:Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:2 years.

Expiration date printed on the package. Do not use the medicine after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N016054 / 01

Date of registration:22.12.2009 / 25.06.2014

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp24.03.2017

Illustrated instructions

Instructions

Deprim® (Deprim®)