Instructions Neocardil capsules blister No. 30
Composition
active ingredients: 1 capsule contains: hawthorn leaf and flower dry extract (Crataegi folii cum flore extractum siccum)* – 150 mg, ginkgo dry extract (Ginkgonis extractum siccum) – 50 mg, pueraria dry extract (Puerariae extractum siccum) – 50 mg;
Excipients: lactose monohydrate, povidone.
Composition of the hard gelatin capsule: gelatin, titanium dioxide (E 171), tartrazine (E 102), amaranth (E 123), erythrosine (E 127), patent blue V (E 131).
* - Hawthorn leaf and flower dry extract contains 6% maltodextrin and 2% colloidal silicon dioxide.
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules No. 0 with a burgundy cap and body, containing a powder from light brown to greenish-brown with white inclusions. The presence of compressed columns or lumps that disintegrate when pressed is allowed.
Pharmacotherapeutic group
Cardiological drugs. ATX code C01E B.
Pharmacological properties
Pharmacodynamics
Neocardil contains standardized extracts of hawthorn leaves and flowers, ginkgo leaves and pueraria root, the main components of which are flavonoids (quercetin, hyperin, hyperoside, vitexin), isoflavones, organic acids, carotenoids, pectins, triterpene and flavone glycosides, choline. The pharmacological action of the drug is due to the effects of a complex of active substances that make up its composition.
Hawthorn leaf and flower extract has a mild cardiotonic, antianginal, antioxidant, antiarrhythmic, antiplatelet and antispasmodic effect. It improves blood supply and functional state of the myocardium, contractile and pumping function of the heart muscle, increases the sensitivity of the myocardium to cardiac glycosides, reduces high blood pressure and normalizes heart rate.
Due to the content of ginkgo leaf extract, the drug improves cerebral blood circulation and the supply of brain tissue with oxygen and glucose. It has antihypoxic and antioxidant effects, affects the rheological properties of blood and microcirculation, prevents platelet aggregation, improves blood circulation in the extremities. Normalizes metabolic processes, has neuroprotective, antihypoxic and antioxidant effects. The drug improves sensory and cognitive function of the brain, prevents deterioration of mental activity.
Pueraria extract has an anti-atherosclerotic effect, relieves spasm of coronary and cerebral vessels, reduces blood viscosity, and prevents vascular thrombosis and diabetic complications.
Pharmacokinetics
Not studied.
Indication
Neurocirculatory dystonia, as part of complex therapy for chronic ischemic heart disease (angina pectoris, arrhythmias), arterial hypertension.
Disturbances of cerebral circulation and brain functions of various origins, manifested by impaired memory, attention and mental activity, dizziness, a feeling of tinnitus, withdrawal and anxiety, headache and sleep disturbances.
Disorders of peripheral circulation and blood microcirculation in the extremities, including arteriopathy of the extremities, diabetic angiopathies and Raynaud's syndrome.
Neurosensory disorders (dizziness, sensation of noise and ringing in the ears, hypoacusis, involutive macular degeneration, diabetic retinopathy).
Vegetative vascular manifestations of climacteric syndrome.
Contraindication
Increased individual sensitivity to the components of the drug. Severe arterial hypotension and bradycardia.
Pregnancy.
Interaction with other medicinal products and other types of interactions
Results of clinical interaction studies with Ginkgo biloba (EGb 761) have shown potentiation or inhibition of cytochrome P450 isoenzymes. Midazolam concentrations were altered after concomitant administration of Ginkgo biloba (EGb 761), suggesting an interaction via CYP3A4. Therefore, medicinal products that are primarily metabolised by CYP3A4 and have a narrow therapeutic index should be used with caution.
Concomitant use of ginkgo medications with anticoagulants (phenprocoumon, warfarin) or antiplatelet agents (clopidogrel, nonsteroidal anti-inflammatory drugs) may affect the effects of these agents.
Studies conducted with warfarin have not revealed any interaction between warfarin and ginkgo-containing medicines, however, it is recommended to ensure appropriate monitoring in case of concomitant use of warfarin with ginkgo-containing medicines, at the beginning and end of treatment or in case of a change in the medicine.
An interaction study with talinolol suggests that ginkgo may inhibit P-glycoprotein in the small intestine, which may increase the gastrointestinal exposure of P-glycoprotein-sensitive drugs, such as dabigatran etexilate. Caution should be exercised when taking ginkgo with dabigatran.
Concomitant use of ginkgo medicinal products and efavirenz is not recommended due to possible reduction in efavirenz plasma concentrations due to induction of cytochrome CYP3A4.
Hawthorn preparations enhance the effect of quinidine, novocainamide, and cardiac glycosides. It is not recommended to use hawthorn preparations simultaneously with alkaloid salts due to the formation of a precipitate.
The drug potentiates the action of antiarrhythmic drugs, enhances the effects of hypnotics, sedatives, and hypotensive drugs. The drug should not be used together with cisapride.
Application features
You should consult a doctor before use.
Patients with a tendency to bleed (hemorrhagic tendency) who are receiving concomitant therapy with anticoagulants and antiplatelet drugs should consult a doctor before using Neocardil.
Ginkgo medicines increase the tendency to bleed. As a precaution, treatment with Neocardil should be stopped 3-4 days before surgery.
In patients with epilepsy, the possibility of additional seizures while taking ginkgo medications cannot be ruled out.
Concomitant use of ginkgo medicinal products with efavirenz is not recommended (see section “Interaction with other medicinal products and other types of interactions”).
Neocardil contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted to assess the effect on the reaction rate when driving or using other mechanisms. However, drowsiness and/or dizziness may impair the ability to drive or use other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy
Ginkgo extract may reduce platelet aggregation. Bleeding tendency may increase. Animal studies are insufficient to draw conclusions regarding reproductive toxicity.
The drug is contraindicated during pregnancy.
Breast-feeding
There is no evidence that ginkgo metabolites pass into breast milk. A risk to newborns and infants cannot be excluded.
Due to the lack of sufficient data, the use of this medicinal product during breastfeeding is not recommended.
Fertility
There has been no specific study of the effects of ginkgo on human fertility, however, some effects have been observed in female mice.
Method of administration and doses
Adults should take Neocardil 1 capsule 2 times a day, morning and evening, or the entire daily dose once in the morning.
The drug can be used regardless of meals. Capsules should be swallowed with water. The duration of treatment is determined by the doctor. The therapeutic effect is usually observed after 1 month. In the absence of positive changes in clinical symptoms within 6 weeks of treatment or if they worsen, you should consult a doctor. The average duration of the treatment course is 3 months.
Children
Do not use on children.
Overdose
Possible increased manifestations of adverse reactions, drowsiness, decreased blood pressure and bradycardia, requiring discontinuation of the drug.
Adverse reactions
From the blood and lymphatic system: bleeding in individual organs (eyes, nose, cerebral and gastrointestinal bleeding).
On the part of the digestive system: digestive disorders, dyspepsia, diarrhea, abdominal pain, nausea, vomiting.
Immune system: hypersensitivity reactions, including numbness of the tongue, lips and cheeks, swelling of the neck, face, hands and feet, flushing, feeling of heat all over the body, feeling of lack of air, shortness of breath, angioedema, urticaria.
Skin: skin inflammation, redness, swelling, rash, itching, eczema.
From the nervous system: headache, drowsiness, dizziness, weakness, tinnitus, syncope (including vasovagal).
Cardiovascular system: unpleasant sensations in the heart area (feeling of chest tightness), heart rhythm disturbances (slowing or accelerating heart rate), arterial hypotension.
If signs of hypersensitivity appear, the course of treatment should be interrupted and a doctor should be consulted.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister, 3 blisters in a package.
Vacation category
Without a prescription.
Producer
LLC "VALARTIN PHARMA".
Location of the manufacturer and its business address
Ukraine, 08135, Kyiv region, Kyiv-Svyatoshynskyi district, Chayky village, Hrushevskoho st., building 60.
