Stablanz PV

Each tablet contains Betahistine (Stablanz PV) dihydrochloride 8 mg.

It also contains the following excipients: β-cyclodextrin, maize starch, microcrystalline cellulose, anhydrous colloidal silica, calcium hydrogen phosphate, povidone, sodium lauryl sulphate, magnesium stearate, purified talc, sodium starch glycolate and purified water.

Each film-coated tablet contains EGb 761^® [dry extract from Ginkgo Biloba (Stablanz PV) leaves (35-67:1)]; Extraction Agent: Acetone 60% (m/m).

The extract in each film-coated tablet is quantified to flavonoids 26.4-32.4 mg, calculated as flavone glycosides, and terpene lactones 6.48-7.92 mg of which gingkgolides A, B, C 3.36-4.08 mg as well as bilobalide 3.12-3.84 mg, and contains ginkgolic acids <0.6 mcg.

Ginkgo Biloba (Stablanz PV) also contains the following excipients: Croscarmellose sodium, colloidal silica; hypromellose, lactose monohydrate, macrogol 1500; magnesium stearate; maize starch, microcrystalline cellulose, dimethicone, α-octadecyl-ω-hydroxypoly(oxyethylene)-5; talcum; titanium dioxide E171; iron oxide E172.

Piracetam (Stablanz PV) is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid. Piracetam (Stablanz PV) is a cyclic derivative of GABA. In the United States, it is not approved by the US Food and Drug Administration for any medical use and it is not permitted to be sold as a dietary supplement. In the UK, Piracetam (Stablanz PV) is prescribed mainly for myoclonus, but is used off-label for other conditions. Evidence to support its use for many conditions is unclear.

Vinpocetine (Stablanz PV) (brand names: Vinpocetine (Stablanz PV), Intelectol; chemical name: ethyl apovincaminate) is a semisynthetic derivative alkaloid of vincamine (sometimes described as "a synthetic ethyl ester of apovincamine"), an extract from the periwinkle (plant) Vinca minor.

Vinpocetine (Stablanz PV) is reported to have cerebral blood-flow enhancing and neuroprotective effects, and is used as a drug in Eastern Europe for the treatment of cerebrovascular disorders and age-related memory impairment.

Vinpocetine (Stablanz PV) is widely marketed as a supplement for vasodilation and as a nootropic for the improvement of memory. In other words, Vinpocetine (Stablanz PV) may help support brain functions such as concentration and memory by activating cerebral metabolism. There exists anecdotal report of uncomfortable adverse reactions to Vinpocetine (Stablanz PV) in a small subset of users. A low initial dosage is often recommended.

Oral

Meniere's disease

Adult: As Betahistine (Stablanz PV) HCl: Initially, 8-16 mg tid.

Maintenance: 24-48 mg daily. As Betahistine (Stablanz PV) mesilate: 6-12 mg tid.

Improvement of memory, concentration and mental alertness.

Prevention of further degeneration of cognitive function, social functioning ability and depressive mood associated with dementia syndromes eg, Alzheimer's and vascular dementia. Tinnitus, vertigo, peripheral arterial occlusive disease, improves blood circulation.

Note: Prior to starting treatment with Ginkgo extract, clarification should be obtained as to whether the pathological symptoms encountered are not based on an underlying disease requiring a specific treatment.

Improvement of the pain-free walking distance in peripheral arterial occlusive disease in Fontaine stage II (intermittent claudication) within the framework of physical therapeutic measures, in particular walking training.

Vertigo of vascular and involutional origin.

Adjuvant treatment in case of tinnitus of vascular and involutional origin.

Frequently occurring dizziness and tinnitus always need to be clarified by a physician.

In case of sudden hearing deficit or hearing loss, patient should immediately consult a physician.

Oral

Adjunct in cortical myoclonus

Adult: 7.2 g daily in 2-3 divided doses, increased by 4.8 g/day every 3-4 days. Max dose: 20 g daily.

Renal impairment:

Oral

As a cognitive enhancer in cerebrocortical insufficiency

Adult: 2.4 g daily, given as 2-3 divided doses. Up to 4.8 g daily may be used in severe cases.

Renal impairment:

Parenteral

As a cognitive enhancer in cerebrocortical insufficiency

Adult: 1-2 g tid via IV/IM admin.

Cerebral circulatory disorders eg, memory problems, acute stroke, aphasia, apraxia, motor disorders, dizziness & other cerebrovestibular problems & headache. Acute or chronic ophthalmological diseases of various origin. Treatment of sensorineural hearing impairment.

Circulation and memory loss due to brain conditions such as stroke, Alzheimer disease, and dementia. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Ginkgo Biloba (Stablanz PV) is an herbal product. It works by increasing blood flow to the brain.

Recommended Dose and Mode of Action: Adults: 16-mg Tab:24-48 mg divided over the day.

24-mg Tab: 48 mg divided over the day.

The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.

Pediatric: Betahistine (Stablanz PV) is not recommended for use in children below18 years due to insufficient data on safety and efficacy.

Geriatric: Although there are limited data from clinical studies in this patient group, extensive post-marketing experience suggests that no dose adjustment is necessary in this patient population.

Renal and/or Hepatic Impairment: There are no specific clinical trials available in this patient groups, but according to the post-marketing experience, no dose adjustment appears to be necessary.

Administration: Should be swallowed with water.

Normal

Dosage: 1 tab daily. For more intensive use, 1 tab may be taken twice daily. The intake of Ginkgo Biloba (Stablanz PV) is independent of meals.

Adults: Symptomatic Treatment of Psycho-Organic Syndromes: The recommended daily dose range from 2.4 g up to 4.8 g, in 2 or 3 sub-doses.

Treatment of Myoclonus of Cortical Origin: The daily dosage should begin at 7.2 g, increasing by 4.8 g every 3 or 4 days up to a maximum of 24 g, in 2 or 3 divided doses. Treatment with other anti-myoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the dosage of other such medicinal products should be reduced, if possible. The dosage must be set individually for each patient by a therapeutic trial.

Once started, treatment with Piracetam (Stablanz PV) should be continued for as long as the original cerebral disease persists. In patients with an acute episode, spontaneous evolution may occur over time and an attempt should be made every 6 months to decrease or discontinue the medicinal treatment. This should be done by reducing the dose of Piracetam (Stablanz PV) by 1.2 g every 2 days (every 3 or 4 days in the case of a Lance-Adams syndrome, in order to prevent the possibility of sudden relapse or withdrawal seizures).

Treatment of Vertigo: Recommended Daily Dose: 2.4-4.8 g, in 2 or 3 divided doses.

Prophylaxis and Remission of Sickle Cell Vaso-Occlusive Crises: Adults and Children 3 years onwards: The recommended daily dose for prophylaxis is 160 mg/kg, orally, in 4 divided doses. For sickle cell anemia, the prophylactic dosage must be permanent.

The recommended daily dose for remission is 300 mg/kg IV, in 4 divided doses.

A dose <160 mg/kg/day or irregular intake may result in relapse of the illness.

Piracetam (Stablanz PV) has been administered only to a limited number of children in the age range 1-3 years.

Children: Dyslexia: The recommended dosage for school age children (from 8 years) and adolescents in 3.2 g/day, that means 8 mL of 20% solution twice per day or 2 tablets of 800 mg in the morning and in the evening, usually during the whole period of the school year.

Elderly: Adjustment of the dose is recommended in elderly patients with compromised renal function. For long-term treatment in the elderly, regular evaluation of the creatinine clearance (CrCl) is required to allow dosage adaptation if needed.

Renal Impairment: Piracetam (Stablanz PV) is contraindicated in severe renal impairment (renal CrCl of <20 mL/min).

The daily dose must be individualized according to renal function. Refer to the table as follows and adjust the dose as indicated. To use the dosing table, an estimate of the patient's CrCl in mL/min is needed. The CrCl in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

Hepatic Impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of dose is recommended.

Administration:

Oral Formulations:

Parenteral Formulations:

Oral

Dementia; Cerebrovascular disorders

Adult: 15-30 mg daily in 3 divided doses.

Hypersensitivity to Betahistine (Stablanz PV) diHCl or to any of the excipients of Betahistine (Stablanz PV).

Phaeochromocytoma.

See also:
What is the most important information I should know about Ginkgo Biloba (Stablanz PV)?

Hypersensitivity to Ginkgo Biloba (Stablanz PV) or to any of the excipients of Ginkgo Biloba (Stablanz PV).

Use in lactation: It is unknown whether Ginkgo Biloba (Stablanz PV)/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Ginkgo Biloba (Stablanz PV) should not be used during breastfeeding.

Piracetam (Stablanz PV) is contraindicated in pregnant women. While teratogenic studies have not demonstrated any effect attributable to clofibrate, it is known that serum of the rabbit fetus accumulates a higher concentration of clofibrate than that found in maternal serum, and it is possible that the fetus may not have developed the enzyme system required for the excretion of clofibrate.

It is contraindicated in patients with clinically significant hepatic or renal dysfunction. Rhabdomyolysis and severe hyperkalemia have been reported in association with pre-existing renal insufficiency.

It is contraindicated in patients with primary biliary cirrhosis, since it may raise the already elevated cholesterol in these cases.

It is contraindicated in patients with a known hypersensitivity to clofibrate.

It is contraindicated in nursing women.

Patients w/ bleeding tendency.

Use Ginkgo Biloba (Stablanz PV) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dosing depends on the use and the source of the product.
• Use as directed on the package, unless instructed otherwise by your doctor.
• If you miss taking a dose of Ginkgo Biloba (Stablanz PV) for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Ginkgo Biloba (Stablanz PV).

Betahistine (Stablanz PV) is used to treat Meniere's disease, condition which typically causes vertigo (sensation of spinning or rotation),tinnitus (ringing in ears), hearing loss and nausea (urge to vomit).

Cerebrovascular and peripheral activator, dementia.

Piracetam (Stablanz PV) is used in combination with other medicines to treat myoclonus (uncontrolled muscle jerk).

Vinpocetine (Stablanz PV) is used to reduce the severity of ischemic strokes (heart attacks). It is also used in the treatment of other heart-related, mental, and neurological diseases/disorders like Alzheimer’s disease (disorder that causes mental confusion and forgetfulness), as well as for enhancing memory and preventing, memory problems, and tinnitus (ringing in the ear).

No in vivo interaction studies have been performed. Based on in vitro data, no in vivo inhibition on cytochrome P-450 enzymes is expected.

In vitro data indicate an inhibition of Betahistine (Stablanz PV) metabolism by drugs that inhibit monoamine oxidase (MAO), including MAO subtype B (eg, selegiline). Caution is recommended when using Betahistine (Stablanz PV) and MAO inhibitors (including MAO-B selective) concomitantly.

As Betahistine (Stablanz PV) is an analogue of histamine, interaction of Betahistine (Stablanz PV) with antihistamines may in theory affect the efficacy of one of these drugs.

Incompatibilities: Not applicable.

In case of simultaneous application of Ginkgo Biloba (Stablanz PV) with coagulation-inhibiting drugs (eg, phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid and other nonsteroidal antirheumatics) it cannot be excluded that the effect of these medicines are enhanced.

As for all medicinal preparations, it cannot be excluded that Ginkgo Biloba (Stablanz PV) acts on the metabolization of other different medicinal preparations which may influence the potency and/or duration of the effect of the preparation concerned. There are no sufficient investigations available on these effects. Inform the physician if administering or have recently taken any other medicines including medicines obtained without prescription.

Pharmacokinetic Interactions: The drug interaction potential resulting in changes of Piracetam (Stablanz PV) pharmacokinetics is expected to be low because approximately 90% of the dose of Piracetam (Stablanz PV) is excreted in the urine as unchanged drug.

In vitro, Piracetam (Stablanz PV) does not inhibit the human liver cytochrome P450 isoforms CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9/11 at concentrations of 142, 426 and 1422 mcg/mL. At 1422 mcg/mL, minor inhibitory effects on CYP 2A6 (21%) and 3A4/5 (11%) were observed. However, the K_i values for inhibition of these 2 CYP isoforms are likely to be well in excess of 1422 mcg/mL.

Therefore, metabolic interaction of Piracetam (Stablanz PV) with other drugs is unlikely.

Thyroid Hormones: Confusion, irritability and sleep disorder have been reported during concomitant treatment with thyroid extract (T3 + T4).

Acenocoumarol: In a published single-blind study on patients with severe recurrent venous thrombosis, Piracetam (Stablanz PV) 9.6 g/day did not modify the doses of acenocoumarol necessary to reach international normalized ratio (INR) 2.5-3.5, but compared with the effects of acenocoumarol alone, the addition of Piracetam (Stablanz PV) 9.6 g/day significantly decreased platelet aggregation, β-thromboglobulin release, levels of fibrinogen and von Willebrand's factors (VIII: C; VIII: vW: Ag; VIII: vW: RCo) and whole blood and plasma viscosity.

Antiepileptic Drugs: A 20 g daily dose of Piracetam (Stablanz PV) >4 weeks did not modify the peak and trough serum levels of antiepileptic drugs (carbamazepine, phenytoin, phenobarbitone, valproate) in epileptic patients who were receiving stable doses.

Alcohol: Concomitant administration of alcohol had no effect on Piracetam (Stablanz PV) serum levels and alcohol levels were not modified by a Piracetam (Stablanz PV) 1.6 g oral dose.

Avoid concomitant use w/ anticoagulants ie warfarin, heparin, aspirin.

The following undesirable effects have been experienced with the below indicated frequencies in Betahistine (Stablanz PV)-treated patients in placebocontrolled clinical trials [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)].

Gastrointestinal Disorders: Common: Nausea and dyspepsia.

Nervous System Disorders: Common: Headache.

In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as "not known".

Immune System Disorders: Hypersensitivity reactions, e.g. anaphylaxis.

Gastrointestinal Disorders: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.

Skin and Subcutaneous Tissue Disorders: Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticaria, rash, and pruritus.

See also:
What are the possible side effects of Ginkgo Biloba (Stablanz PV)?

There are no verified data on the frequency of the undesirable effects observed during treatment with Ginkgo Biloba (Stablanz PV)-containing preparations, since these adverse effects have become known through single reports from patients, physicians or pharmacists. According to these reports, the following side effects may occur during treatment with Ginkgo Biloba (Stablanz PV): Nervous System Disorders: Headache.

Vascular Disorders: Bleeding from single organs has been reported.

Gastrointestinal Disorders: Mild gastrointestinal disturbances.

Skin and Subcutaneous Tissue Disorders: Allergic skin reactions (reddening, swelling, itching).

Clinical Trial and Post-Marketing Data: Double-blind, placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available, included >3000 subjects receiving Piracetam (Stablanz PV), regardless of indication, dosage form, daily dosage or population characteristics.

Adverse reactions are ranked under headings of frequency using the following convention: Very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1000 to <1/100, rare ≥1/10,000 to <1/1000, very rare <1/10,000, not known (cannot be estimated from the available data).

Blood and Lymphatic System Disorders: Not Known: Haemorrhagic disorder.

Immune System Disorders: Not Known: Anaphylactoid reaction, hypersensitivity.

Psychiatric Disorders: Common: Nervousness. Uncommon: Depression. Not Known: Agitation, anxiety, confusion, hallucination.

Nervous System Disorders: Common: Hyperkinesia. Uncommon: Somnolence. Not Known: Ataxia, balance disorder, aggravated epilepsy, headache, insomnia.

Ear and Labyrinth Disorders: Not Known: Vertigo.

Vascular Disorders: Rare: Thrombophlebitis (only parenteral formulations), hypotension (only parenteral formulations).

Gastrointestinal Disorders: Not Known: Abdominal pain, upper abdominal pain, diarrhoea, nausea, vomiting.

Skin and Subcutaneous Tissue Disorders: Not Known: Angioneurotic oedema, dermatitis, pruritus, urticaria.

General Disorders and Administration Site Conditions: Uncommon: Asthenia. Rare: Pyrexia (only parenteral formulations), injection site pain (only parenteral formulations).

Investigations: Common: Increased weight.

Nausea, dizziness, insomnia, drowsiness, dry mouth, transient hypotension, tachycardia, pressure-type headache & facial flushing; slight reductions in both systolic & diastolic BP; slight reductions in blood glucose w/ prolonged use.