Detailed product information
Key characteristics
• Trade name: Actovegin®
• Strength: 200 mg
• Package quantity: 50 tablets
• Weight: 0.1 kg / 3.53 oz
• Active ingredient: Deproteinized hemoderivative of calf blood — 200 mg per tablet.
• Manufacturer: Takeda
• Country of manufacture: Austria
• EAN: 4031083005480
• Expiration date of current batch: March 2030.
Directions and dosage
Take the tablets orally before meals, without chewing, with a small amount of liquid. The dose and duration of treatment are determined by a physician according to the indication and the patient's condition.
Post-stroke cognitive impairment: after an initial course of intravenous therapy, treatment may be switched to tablets, usually 2 tablets three times daily (1,200 mg per day). The total duration of treatment may be up to 6 months.
Dementia: the usual regimen is 2 tablets three times daily. The recommended course may last up to 20 weeks.
Peripheral circulatory disorders and their consequences: usually 1–2 tablets three times daily. The treatment course is 4–6 weeks.
Diabetic polyneuropathy: after an initial course of intravenous therapy, treatment may be switched to 3 tablets three times daily (1,800 mg per day). The treatment course is 4–5 months.
Regimens involving intravenous administration must be carried out only by a medical professional. Follow the dosage prescribed by your physician.
Composition
Each film-coated tablet contains:
Active ingredient: deproteinized hemoderivative of calf blood — 200 mg; the active ingredient is contained in 345 mg of Actovegin granulate.
Tablet core excipients: povidone K90 — 10 mg; microcrystalline cellulose — 135 mg; magnesium stearate — 2 mg; talc — 3 mg.
Coating components: acacia gum — 6.8 mg; glycolic montan wax — 0.1 mg; hypromellose phthalate — 29.45 mg; diethyl phthalate — 11.8 mg; quinoline yellow aluminum lake — 2 mg; macrogol 6000 — 2.95 mg; povidone K30 — 1.54 mg; sucrose — 52.3 mg; talc — 42.2 mg; titanium dioxide — 0.86 mg.
Contraindications
Do not use in patients with hypersensitivity to Actovegin, similar products, or any excipient; fructose intolerance; glucose-galactose malabsorption; sucrase-isomaltase deficiency; or in persons under 18 years of age.
Use with caution during pregnancy and breastfeeding. In these cases, the medicine should be used only under medical supervision when the expected benefit to the mother outweighs the potential risk to the fetus or child.
Special warnings
Data on the use of Actovegin in patients under 18 years of age are limited; therefore, it is not recommended for pediatric use.
The ARTEMIDA study evaluated Actovegin in patients with cognitive impairment following ischemic stroke. The overall incidence of serious adverse events and deaths was similar in the Actovegin and placebo groups. Recurrent ischemic strokes were reported more often in the Actovegin group, but the difference was not statistically significant and a causal relationship with the medicine was not established.
The effect on the ability to drive and operate machinery has not been established. Exercise caution if individual adverse reactions occur. Because the coating contains sucrose, contraindications related to impaired absorption of certain sugars must be considered.
Packaging and release form
Film-coated tablets, 200 mg. One consumer package contains 50 tablets. Packaging appearance may vary by batch and market of supply.
Adverse effects
Adverse-reaction frequency is classified as follows: very common — more than 1 in 10; common — from 1/100 to less than 1/10; uncommon — from 1/1,000 to less than 1/100; rare — from 1/10,000 to less than 1/1,000; very rare — less than 1/10,000; not known — cannot be estimated from available data.
Immune system disorders — rare: allergic reactions, drug fever, and symptoms of anaphylactic shock.
Skin and subcutaneous tissue disorders — rare: hives and sudden flushing.
Stop using the product and seek immediate medical attention if signs of a severe allergic reaction occur.
Pharmacotherapeutic group
Tissue-regeneration stimulant. Antihypoxic agent with metabolic, neuroprotective, and microcirculatory effects.
Interactions with other medicines
No interactions between Actovegin and other medicines are currently known. Patients taking prescription or over-the-counter medicines, vitamins, or dietary supplements should inform their physician before starting Actovegin.
Pharmacodynamics
Actovegin is a deproteinized hemoderivative of calf blood. According to the manufacturer, its activity includes three main components: metabolic, neuroprotective, and microcirculatory.
Metabolic action: Actovegin promotes oxygen uptake and utilization. Inositol phospho-oligosaccharides in the product positively affect glucose transport and utilization. This may support cellular energy metabolism and reduce lactate formation under conditions of insufficient blood supply.
Neuroprotective action: Actovegin affects apoptosis and inflammatory processes in the central and peripheral nervous systems. The proposed mechanism involves modulation of nuclear factor NF-kB and poly(ADP-ribose) polymerase (PARP), an enzyme involved in detecting and repairing single-strand DNA damage.
Microcirculatory action: the product may increase capillary blood-flow velocity, reduce the pericapillary zone, and lower the tone of precapillary arterioles and capillary sphincters. Effects on endothelial nitric oxide synthase, which participates in microcirculatory regulation, have also been described.
According to the prescribing information, activity may begin within 30 minutes after administration. The maximum effect after oral administration is reported approximately 2–6 hours later.
Storage temperature
Store at 2–25 °C (36–77 °F) in a dry place protected from light. Keep in the original package and out of reach of children. Do not use after the expiration date printed on the package.
Dosage form
Round, biconvex tablets with a glossy greenish-yellow film coating. Each tablet contains 200 mg of deproteinized hemoderivative of calf blood.
Overdose
According to preclinical data, toxic effects were not observed even at doses substantially higher than recommended. Confirmed cases of Actovegin overdose have not been described. If a large number of tablets is taken accidentally, especially if unusual symptoms occur, seek medical attention. Do not increase the prescribed dose without consulting a physician.
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