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Tebokan intens 120 Mg 30 Tablets ingredient ginkgo biloba extract
Active Ingredient: 40 mg Ginkgo biloba leaves dry extract (EGb 761) standardized to be equivalent to 9.6 mg Ginkgo flavone glycosides per 1 ml (20 drops) of active substance.
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The extract contains 2.16 - 2.64 mg of terpene lactones, ranging from 8.8 to 10.8 mg flavonoids calculated as flavon glycosides and from 1.12 to 1.36 mg ginkgolides to B, C to 1.04 to 1.28 mg bilobalide. Each ml contains less than 0.2 μg ginkgolic acid.
Saccharin sodium 3 mg / ml
Glycerol 200 mg / ml
Propylene glycol 527 mg / ml
For auxiliaries, see Section 6.1.
3. PHARMACEUTICAL FORM
Clean, brown solution
4. CLINICAL CHARACTERISTICS
4.1 Therapeutic indications
- Alzheimer's type dementia of light to medium severity, vascular dementia and dementia syndromes in mixed form,
- Fontaine grade II (intermittent klaudikasyon) painless walking distance improvement in peripheral arterial occlusive disease,
4.2 Posology and application form
The recommended dose of TEBOCAN FORT is 120-240 mg / day (2 drops or 40 drops per day); 120-240 mg / day in peripheral arterial occlusive disease (2 drops or 40 drops per day); vertigo and tinnitus 160 mg / day (40 drops twice daily).
Posology / application frequency and duration:
The duration of treatment should be at least 8 weeks.
If the symptoms of the disease do not show any improvement after 3 months of treatment or if it worsens, the physician should check if the treatment will continue.
Treatment for vertigo should not exceed 8 weeks.
Treatment should be continued for at least 12 weeks.
If no treatment success is observed after 6 months, improvement is not expected during longer treatment.
Peripheral arterial occlusive disease:
Improvement of painless walking distance requires at least 6 weeks of treatment.
Method of Application:
TEBOKAN FORT should be drunk after mixing in a specified amount of water.
It can be taken with meals or separately.
Additional information on special populations:
Kidney failure :
There is no data on dose adjustment in patients with renal impairment.
There is no data on dose adjustment in patients with impaired liver function.
Due to lack of adequate data, it is not recommended for use in children under 18 and in adolescents.
There is no data on the need for dose adjustment in the elderly.
Ginkgo should not be used in pre-existing hypersensitivity to the biloba or any of its ingredients, in individuals at risk of intracranial hemorrhage, in patients with impaired clotting, and in pregnancy.
4.4 Special warnings and precautions for use
- Before starting treatment with TEBOCAN FORT during cerebral indications, it should be determined whether any pathological symptoms are associated with any specific treatment requiring treatment.
- Frequent dizziness and tinnitus should always be determined by a doctor. In case of sudden hearing loss or malfunction, medication should always be consulted.
- Some reports indicate that preparations containing Ginkgo may increase the tendency to bleed.
- Increase the risk of bleeding and should be used with anticoagulants and in the case of concurrent use, after consultation with the physician.
- Based on single case reports, ginkgo should be discontinued for preoperative surgery due to postoperative bleeding with Ginkgo preparations.
It can not be ruled out that administration of Ginkgo preparations in epileptic patients can trigger seizure formation and decrease seizure threshold.
This medicinal product contains less than 1 mmol of sodium per ml; ie it is "sodium free".
TEBOKAN FORT contains glycerol and propylene glycol. However, it does not require a warning because of the desire.
4.5 Interactions with other medicinal products and other forms of interaction
It is uncertain that the effects of coagulation inhibitors (fenprocumon, warfarin, clopidogrel, acetyl salicylic acid), non-steroid antiinflammatory drugs and anticonvulsant drugs in combination with TEBOCAN FORT may increase the effects of these drugs and the risk of bleeding
TEBOKAN FORT may exert effects on other medicinal metabolites (trazodone, omeprazole, nifedipine and nicardibine etc.) with the enzymes of the cytochrome P450-3A4, -1A2, -2C19 in the liver, affecting the potency and / or duration of action of these drugs.
Anticoagulants, antiplatelet agents, low molecular weight heparins and thrombolytic drugs: Use of Ginkgo with these drugs may lead to an increased risk of bleeding complications. Combined use should be avoided.
Anticonvulsants: It should not be overlooked that Ginkgonun may induce seizures when used with anticonvulsant drugs in epileptic patients. Ginkgo and anticonvulsants should be avoided in patients with epilepsy.
Buspiron: The addition of Ginkgo to the buspirone treatment has been reported in a case report, which may increase hypomanic episodes in patients. Patients using buspirone should be avoided with Ginkgo, especially in combination with psychotropic medications.
Insulin: Although there is no definitive data, Ginkgo may lower insulin levels in type 2 diabetic patients and hypoglycaemic individuals. Ginkgo should be cautious when used in combination with insulin and patients should be closely monitored for blood glucose levels and symptoms of hyperglycemia or hypoglycaemia.
MAO inhibitors: Theoretically, Ginkgo may increase the effectiveness of MAO inhibitors. Ginkgo has been shown to inhibit monoamine oxidase in animal and preclinical studies. Combination of ginkgo and MAO inhibitors should be avoided.
Selective serotonin reuptake inhibitors (SSRIs): In preclinical studies, Ginkgo has been reported to affect SSRIs and lead to serotonin syndrome symptoms. Patients should be closely monitored for serotonin syndrome if selective serotonin reuptake inhibitors are used together with ginkgo.
Thiazide diuretics: A case report reported an increase in blood pressure in a patient using a combination of ginkgo biloba and thiazide diuretic. Whether this is due to a genuine drug interaction or whether it is an unexpected side effect due to Ginkgo or thiazide diuretic is unknown. Caution should be exercised against the risk of increased blood pressure when using ginkgo or thiazide diuretics together.
Aminoglycosides: The risk of ototoxicity may increase if used together.
4.6 Pregnancy and lactation
Pregnancy category is C.
Women with childbearing potential / Contraception (Contraception)
The effect on the birth control of the medicine is unknown.
Studies on animals do not show reproductive / and / or embryonal / fetal development toxicity (see section 5.3).
The potential risk for humans is unknown.
However, TEBOKAN FORT should not be used during pregnancy as it has been reported that some studies increase the risk of bleeding.
It is not known whether TEBOCAN FORT or its metabolites pass to the mother. In newborns / infants the risk can not be ignored. It should not be used during breastfeeding.
Reproduction ability / Fertility
The effect of TEBOCAN FORT on reproductive ability is unknown.
4.7 Effects on vehicle and machine use
There are no reported effects.
4.8 Undesirable effects
The undesirable effects are indicated according to the following frequency rating:
Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1.000 to <1/100); rare
(≥1 / 10.000 to <1 / 1.000); very rare (<1 / 10,000), unknown (can not be estimated from the given data).
There is insufficient data on the incidence of adverse effects observed during treatment with preparations containing Ginkgo biloba. This is because the undesirable effects are derived from notifications made by patients, doctors or pharmacists.
According to these notifications, the following undesirable effects may occur during TEBOCAN FORT treatment:
Blood and Lymphatic System Diseases:
Bleeding (cerebral hemorrhage), postoperative filebit
Immune System Diseases
Unknown: Anaphylactic shock in sensitive individuals
Nervous System Diseases
Very rare: brain hemorrhage
Unknown: Headache, dizziness
Rare: Vision problems
Very rare: bleeding in the eye
Not known: Some organ hemorrhages
Not known: mild gastrointestinal disorders, nausea, vomiting, diarrhea
Skin and Subcutaneous Tissue Diseases
Rare: itching, rash, redness
Very rare: Stevens Johnson syndrome
Reporting of suspicious adverse reactions
Reporting of suspected drug adverse reactions after registration is of great importance. Reporting allows continuous monitoring of the benefit / risk balance of the drug. Health profession of any suspected adverse reactions from members of the Pharmacovigilance Center of Turkey (TÜFAM) What must inform (www.titck is gov.t; e-mail: [email protected] is; tel: 0800 314 00 08; fax: 0 312 21 835 99)
4.9 Overdose and treatment
No overdose has been reported.
It should not be forgotten that long acting Ginkgo biloba as a potent PAF antagonist and at high doses may lead to bleeding time and increased risk of developing spontaneous haemorrhage.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Antidemic Drugs
ATC code: N06DX02
The following pharmacological effects of the specific Ginkgo biloba extract (EGb 761) found in TEBOCAN FORT DAMLA have been demonstrated in animal experiments:
Inhibition of retinopathy and retinal cell lesions, inhibition of age-related reduction in muscarinergic choline receptors and alpha 2 adrenoceptors, and increased hippocampal colony reuptake at the same time, in particular, improvement of memory performance and learning capacity, improvement of compensation in balance disorders, enhancement of circulation especially in microcirculation areas, improvement of blood rheological properties, inactivation of toxic oxygen radicals (flavonoids), PAF antagonism (ginkgolides) and neuroprotective effect (ginkgolides A and B, bilobalid).
The hypoxia-protective effects, especially the microcirculation areas, have been shown in humans to improve the blood flow and improve the rheological properties of the blood.
5.2 Pharmacokinetic properties
The bioavailability of terpenes lactones ginkgolide, ginkgolide B and bilobalidine is fairly good following oral administration in humans of 80 mg of Ginkgo extract. The absolute bioavailability is 98% for ginkgolida, 79% for ginkgolid B and 72% for bilobalide. The maximum plasma concentration is 15 ng / ml for ginkgolida, 4 ng / ml for ginkgolid B and about 12 ng / ml for bilobalide.
The resorption rate of Egb 761, radioactively labeled with 14 C in rats after oral administration, was determined to be 60% and the time to reach the maximum plasma concentration was 1.5 hours. The half-life is 4.5 hours, and the second is an enterohepatic shunt, with a second plasma spike after 12 hours.
The binding rate to plasma proteins in human blood is 43% for ginkgolide A, 47% for ginkgolide B and 67% for bilobalide.
Cerebral bioavailability of EGb 761 extract in humans has been demonstrated by pharmaco-EEG based on dose-dependent effects on cerebro-electrical activity.
A large portion of Ginkgolida and B are eliminated unchanged in the urine without being metabolized in the body.
The half life is 3.9 hours for ginkgolida, 7 hours for ginkgolid B and 3.2 hours for bilobalid.
Pharmacokinetic data on elimination of Ginkgolida, B and bilobalidn indicate that the primary elimination pathway is clearly renal excretion. A significant portion of each substance is eliminated without change, only a small fraction of which is glucuronidylated. Bilobalid re-uptake is at negligible levels due to the unstable nature of degradation in hydrolytic conditions.
5.3 Preclinical safety data
The effects on nonclinical studies were observed only at exposures considered to be adequate, above the maximum human exposure with minimal relevance for clinical use. Animal studies do not show adverse effects on pregnancy and / or embryonal fetal development and / or birth and / or postnatal development.
6. PHARMACEUTICAL PROPERTIES
6.1 List of auxiliary substances
6.3 Shelf life
6.4 Special measures for storage
It should be stored at room temperature below 25ºC.
6.5 Quality and content of packaging
20 and 50 ml colored glass bottles with plastic screw cap with mouth dropper in the cardboard box.
6.6 Removal of residual substances from human medicinal products and other special measures
Unused products or waste materials are defined in the "Medical Waste Control Regulation" and
Should be disposed of in accordance with "Packaging and Packaging Waste Control Regulation".
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