Ginkoum Evalar, 120 mg, caps. №30

Method of administration and dosage Orally. Capsules should be swallowed whole, with a small amount of water, regardless of food intake. For symptomatic treatment of cognitive impairment in adults (memory impairment, decreased concentration and intellectual abilities) 120 mg 1–2 times a day. For the treatment of vestibular dizziness and tinnitus (ringing or noise in the ears), the daily dose is 120 mg per day. Duration of therapy is up to 3 months; if it is necessary to continue therapy, you should consult a doctor. With a twice-daily dosing regimen, take in the morning and evening; with a once-daily regimen, preferably in the morning. If a dose of the drug was missed or an insufficient amount was taken, the subsequent dose should be taken as indicated in this instruction without any changes. Side effects Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very common (≥1/10), common (≥1/100, but <1/10), uncommon (≥1/1 000, but <1/100), rare (≥1/10 000, but <1/1 000), very rare (<1/10 000), frequency unknown (cannot be estimated from the available data). Blood and lymphatic system disorders Very rare: decreased blood clotting. There are reports of bleeding (eye hemorrhage; nasal, cerebral, gastrointestinal bleeding) occurring during long-term use of Ginkgo biloba leaf extract preparations in patients simultaneously taking blood-thinning agents. Immune system disorders Frequency unknown: hypersensitivity reactions, including anaphylactic shock. Nervous system disorders Very rare: headache, dizziness, insomnia. Ear and labyrinth disorders Frequency unknown: hearing impairment. Gastrointestinal disorders Very rare: nausea, vomiting, diarrhea, abdominal pain. Skin and subcutaneous tissue disorders Very rare: allergic skin reactions (hyperemia, edema, skin itching, skin rash). In case of any adverse events, you should stop taking the drug and consult your doctor. Overdose Cases of drug overdose have not been registered to date. Interaction with other medicinal products Simultaneous use of GINKOUM® with anticoagulants (including phenprocoumon, warfarin) or antiplatelet agents (including clopidogrel, acetylsalicylic acid), as well as non-steroidal anti-inflammatory drugs, may affect the action of these drugs, so their simultaneous use is not recommended. Simultaneous use with thiazide diuretics, tricyclic antidepressants, anticonvulsants, gentamicin is also not recommended. Isolated cases of bleeding are possible in patients simultaneously taking blood-thinning drugs. A causal relationship between these bleedings and the intake of preparations containing Ginkgo biloba leaf extract has not been confirmed. If simultaneous use with warfarin is necessary, adequate monitoring of blood clotting parameters is recommended at the beginning of treatment with GINKOUM®, when changing the dose, when completing therapy with GINKOUM®, as well as when changing the preparation containing Ginkgo biloba leaf extract. With simultaneous intake with antihypertensive agents, potentiation of the antihypertensive effect is possible. One interaction study showed that Ginkgo biloba leaf extract may increase the maximum concentration of nifedipine in blood plasma. In some study participants, an increase in maximum concentration of up to 100% was observed, which led to the development of dizziness and increased severity of hot flashes. Simultaneous use with efavirenz is not recommended, as a decrease in its concentration in blood plasma is possible due to induction of the CYP3A4 isoenzyme under the influence of Ginkgo biloba leaf extract. A study of interaction with talinolol shows that Ginkgo biloba leaf extract may inhibit intestinal P-glycoproteins. This may increase the exposure to P-glycoprotein-sensitive drugs in the intestine, such as dabigatran, therefore caution should be exercised when using them simultaneously. Special instructions Do not exceed the recommended doses of the drug. If a hypersensitivity reaction develops, the use of the drug must be stopped. Preparations containing Ginkgo biloba leaf extract may increase the tendency to bleed. As a precaution, the use of GINKOUM® should be stopped 3–4 days before surgery. It is important that patients who are about to undergo surgery inform their doctor about the use of this drug. In case of frequently occurring sensations of dizziness and tinnitus, it is necessary to consult a doctor. In case of sudden deterioration or loss of hearing, you should immediately consult a doctor. Patients with a pathologically increased tendency to bleed (hemorrhagic diathesis) and patients with concomitant anticoagulant and antiplatelet therapy should use GINKOUM® only after consulting a doctor. It is not recommended to take the drug together with ethanol. During the use of the drug, epileptic seizures may occur in patients suffering from epilepsy. Influence on the ability to drive vehicles, mechanisms During the period of taking the drug, caution should be exercised when performing potentially dangerous types of activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms). Release form Capsules 120 mg. 15 capsules each in a blister pack made of polyvinyl chloride film and flexible packaging based on aluminum foil. 1, 2, 3, 4, 5 or 6 blister packs together with the instruction for use are placed in a cardboard box. Storage conditions At a temperature not exceeding 25 °C. Keep out of reach of children.