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Apatinac®

coated tablets, OTC drug

APATINAC® contains standardized dry extract of St. John’s wort (Hyperici herbae extractum siccum) demonstrating mild anti-depressive effects.
APATINAC® is applied in mild mood disorders of depressive type.

 

 

If the physician does not prescribe otherwise, adults 1 tablet 2 times a day, orally.
The drug should be taken directly after meals. Therapeutic effect is expected only after 10-14 days of treatment.

The preparation should be applied systematically for several weeks.

If, after 4 weeks of the preparation application, no improvement is seen, treatment should be discontinued.
It is recommended to apply the drug without other anti-depressive, sedative and sleep inducing drugs.

It is necessary to observe 2 weeks’ pause between application of Apatinac® and  other anti-depressive drugs.

In case of taking higher than recommended dose of Apatinac®
No overdose cases have been described. In case of taking higher than recommended dose of the drug and occurrence of undesired effects, it is necessary to immediately consult a physician or a pharmacist.

In case of skipping the dose of Apatinac®
Continue treatment. Do not apply a double dose in order to supplement the omitted one.

The following may appear after discontinuation of treatment with Apatinac®
Discontinuation of treatment with Apatinac® may cause intensification of disease symptoms. Treatment duration should be about 4 weeks. If, after 14 days no significant improvement is seen, it is necessary to discontinue treatment and consult a physician.

Do not apply Apatinac®:

  • in case of hypersensitivity to active substances or to any of the auxiliary substances
  • to the individuals sensitive to UV radiation. Do not apply simultaneously with cyclosporine, digoxin, amprenavir, indinavir and other protease inhibitors, irinotekan and other cytostatic drugs.

Observe special caution in case of specific groups using the drug
Because of lack of data concerning application safety and recommendations, it is not recommended to apply to children younger than 18 years of age. It is not recommended to apply Apatinac® to individuals sensitive to UV radiation. Direct exposure to sunlight and other UV radiation sources (solarium) during the treatment and 1-2 weeks afterwards is not recommended in case of individuals taking St. John’s wort preparations, especially those with light complexion.

Pregnancy and breast feeding
Do not apply Apatinac® tablets during pregnancy and breast feeding because of lack of data concerning safety of use.

Driving of vehicles and operation of moving mechanisms
No data

Use of other drugs
Substances contained by St. John’s wort may cause reduction of other drug effects, while taken simultaneously with those extracts. This has been observed in case of application of St. John’s wort preparations simultaneously with warfarin, cyclosporine, theophylline and digoxin. During combined treatment of HIV virus infections with anti-viral drugs, St. John’s wort extracts cause reduction of protease inhibitors’ plasma levels (e.g. indinavir). It is not recommended to apply Apatinac® together with those drugs.
It is not recommended to apply St. John’s wort preparations with anti-depressive drugs inhibiting serotonin reuptake without consultation with a physician.
It is not recommended to apply the drug with hormonal contraceptives (efficiency decrease, possibility of bleeding and unplanned pregnancy).

 

 

As every drug, Apatinac® may cause undesired effects. These include alimentary tract disorders, allergic reactions, sensation of fatigue and anxiety. In case of individuals especially sensitive and after overdose of the preparation photosensitization may occur, characterized by skin lesions (rash and erythema appearing 24 hours after UV exposure). In case of these or other undesired effects, it is necessary to discontinue treatment and consult a physician.

 

Store at the temperature not exceeding 25° C.
The drug should be stored out of reach and sight of children.
Do not apply Apatinac® after expiry date stated on the package.

 

Composition of 1 coated tablet:

Active substance – dry extract of St. John’s wort (Hyperici herbae extr. sicc.), (3.6-5 :1) -184 mg

[extractant- ethanol 60%]

Auxiliary substances – microcrystalline cellulose, lactose monohydrate, carboxymethyl amylum sodium salt, magnesium stearate, powidon, Aqua Polish white 010 (hypromeloza, makrogol 400, titanium dioxide), indigotin E 132, quinoline yellow E 104.

Package contains 30 or 60 coated tablets.