Deprim® Forte (Deprim® Forte)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsptoapsules
Composition:

1 capsule contains:

Active ingredient: extract of St. John's wort dry, standardized by Hypericinum ND firm (from 0.75 to 1.3 mg) 425 mg.

Auxiliary components: lactose monohydrate 18.70 mg, cellulose powdered 6.2 mg, calcium hydrophosphate dihydrate 40,50 mg, silicon dioxide colloid 26,00 mg, magnesium stearate 5,00 mg, talc 10,00 mg. The contents of the capsule are 531.40 mg.

Capsule shell: gelatin 80.465 mg, sodium lauryl sulfate 0.194 mg, titanium dioxide (E 171) 1.229 mg, chlorophyll-copper complex (E141) 0.233 mg, purified water 14.065 mg.

Description:

Solid, opaque gelatin capsules in green, size 0.

Contents of capsules: greenish-brown or grayish-brown compact granules with a characteristic odor.

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 and flavonoids - improve the functional state of the central and autonomic nervous system.

    Deprim® Forte improves mood, increases mental and physical activity, normalizes sleep.

    Indications:

    Deprim® Forte 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 change.

    Contraindications:

    - Hypersensitivity to any of the ingredients of the drug;

    - photosensitization (increased sensitivity of the skin to ultraviolet radiation, including in the anamnesis);

    - Depression of severe severity;

    - simultaneous administration with inhibitors monoamine oxidase (MAO), 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:Application of the drug Deprim® Forte 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 perfumed during these periods.
    Dosing and Administration:

    Capsules are taken orally and washed down with water. Do not open the capsule!

    Adults and adolescents over 12 years of age: 1 capsule 1 time per day, regularly at the same time. If necessary, the dose can be increased to two capsules per day, 1 capsule in the morning and in the evening.

    The greatest effect of the drug is achieved with regular use for several weeks.

    The therapeutic effect of the drug manifests itself 10-14 days after the start of the treatment.

    If there is no improvement within 4-6 weeks after the beginning of treatment, you should stop taking Deprima ® forte and consult your doctor.

    The patient must tell his treating doctor that he is taking Deprim® forte.

    If you miss one dose of Deprima ® forte:

    - 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: itching of the skin, skin rash, erythema; photosensitization (more often in HIV-infected patients); when taking the drug on skin areas exposed to intense sun exposure, due to photosensitivity, 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;

    Disturbances from the nervous system: anxiety, fatigue, headache;

    Violations of the blood and lymphatic system: Iron-deficiency anemia;

    Other: increased sensitization to animal wool.

    Overdose:

    To date, no cases of drug overdose have been reported. When using the drug in doses exceeding the recommended dose, it is possible to increase the severity of dose-dependent side effects. There have been reports of 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 hospitalization.

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

    Treatment symptomatic: should 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:

    Deprim® Forte activates microsomal oxidation (cytochrome P 450), so the drug should be taken with caution, while treatment with drugs containing digoxin, anti-asthmatic drugs containing theophylline, anticonvulsants, antidepressants (tricyclic, selective serotonin reuptake inhibitors, MAO inhibitors), migraine preparations (triptans), cyclosporine, indinavir, reserpine, and oral contraceptives, and may also increase the efficacy of general anesthetics and narcotic analgesics. In this case, before taking Deprima ® forte, you should consult your doctor.

    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 sun baths or use a solarium during the treatment with Deprim® Forte.

    During treatment with the drug Deprim® Forte, one should refrain from drinking alcoholic beverages.

    The drug contains no more than 0.01 XE, which should be taken into account when used by patients with diabetes mellitus.
    Effect on the ability to drive transp. cf. and fur:

    Insufficient data on the effect of the drug on the ability to manage vehicles and perform other activities that require increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Capsules.

    Packaging:

    10 capsules per blister of PVC / PVDC film and aluminum foil.

    For 2, 4 or 6 blisters are placed together with instructions for medical use 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.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015903 / 01
    Date of registration:19.11.2009 / 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
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