Buy Vortioxetine Online (Brintellix, Fonksera) 20mg 28 Tablets

Buy Vortioxetine Online (Brintellix, Fonksera) 20mg 28 Tablets
Buy Vortioxetine Online (Brintellix, Fonksera) 20mg 28 Tablets
Product Code: Vortioxetine
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Brintellix is a nervous system medicine belonging to antidepresants sub branch of Psychoanaleptics branches.  Each Brintellix tablets contains 20mg vortioxetine hydrobromide active ingredient.  Brintellix helps to treat major depressive episodes especially in adults. 

Posology and application form
 Posology, application frequency and duration:
In adults under 65 years of age, BRITELLIX is the starting and recommended dose of 10 mg per day.
Depending on the individual patient response, the dose can be increased up to 20 mg / day or lowered to at least 5 mg / day.
After relief of depressive symptoms, it is recommended that treatment be continued for at least 6 months for the antidepressive response to settle.
Treatment termination:
Patients using BRINTELLIX may suddenly stop taking medication without needing to gradually reduce the dose (see 5.1).
Method of Application:
BRINTELLIX is used orally. It can be taken with or without food.
Kidney failure:
Experience with patients with severe renal insufficiency is limited. It should be applied with caution (see 5.2). Liver failure:
Vortiocetin is not studied in patients with severe hepatic insufficiency, and caution should be exercised when treating these patients (see 5.2).
Pediatric population
The safety and efficacy of BRINTELLIX has not been established in children and adolescents under 18 years of age. No data is available (See.4.4).
Geriatric population
For patients aged 65 years and older, the lowest effective dose of 5 mg should be administered as an initial dose. For patients aged 65 years and older, doses greater than 10 mg vortexing once daily are limited and should be used with caution (see section 4.4).
Cytochrome P450 inhibitors
If a strong CYP2D6 inhibitor (eg bupropion, quinidine, fluoxetine, paroxetine) is used in addition to BRINTELLIX treatment, depending on individual patient response, a lower dose of BRINTELLIX may be considered (see section 4.5).
Cytokrom P450 inducers
Depending on the individual patient response, adjustment of the BRINTELLIX dose may be considered if a broad spectrum of cytochrome P450 inducers (eg, rifampicin, carbamazepine, phenytoin) are used in addition to BRINTELLIX treatment (see section 4.5).
4.3. contraindications
- Hypersensitivity to any of the other substances in the formulation or vortexetine (see 6.1).
- Use with non-selective monoaminoxidase inhibitors (MAOI) or selective MAO-A inhibitors (see Section 4.5).
4.4. Special use warnings and precautions
Use in the pediatric population
Use of BRINTELLIX in the treatment of depression in this age group is not recommended, since the safety and efficacy of BRINTELLIX has not been established in children younger than 18 years (see Section 4.2). Suicide-related behaviors (suicide attempts and suicidal thoughts) and hostile behavior (significant aggression, opposing behaviors, anger) were more common in the drug trials than placebo-treated clinical trials in other antidepressant drugs administered in children and adolescents.
Suicide / suicidal thoughts or clinical deterioration
The use of antidepressants, especially in children and young people up to 24 years, is likely to increase suicidal thoughts or behaviors. This is why it is imperative that the patient closely watch for the patient, either the family or the caregivers, especially at the beginning and the first months of treatment, the unexpected behavioral changes such as uneasiness the patient may show during the period of increasing / decreasing or discontinuing treatment, extreme mobility, or the possibility of suicide.
Depression is associated with suicidal thoughts, self-harm and suicide (events associated with suicide). This risk continues until a significant remission is achieved. Recovery may not occur during the first few weeks of treatment or longer. For this reason, patients should be kept under strict observation until a significant improvement is observed. As a general clinical experience, it should be noted that the risk of suicide may increase in the early stages of recovery.

It is known that patients with a history of suicide-related events or markedly more suicidal ideation before the onset of treatment are at a greater risk than those with suicidal ideation and attempted suicide attempts. These patients should be monitored carefully during treatment. A meta-analysis of placebo-controlled clinical trials with antidepressants in adult patients with psychiatric disorders showed that suicidal behavior in patients aged 24 years and younger was higher in patients with antidepressants than in those in placebo groups.

Seizures are a potential risk with antidepressant drugs. For this reason, BRINTELLIX should be administered with caution in patients with seizure traumas or in patients with unstable epilepsy, as is the case with other antidepressant drugs (see section 4.5). Treatment should be discontinued in patients with seizures or in patients with increased seizure frequency.
Serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)
With BRINTELLIX, serotonin syndrome or neuroleptic malignant syndrome can occur, which can pose life threatening effects. The risk of SS and NMS increases with serotonergic drugs including triptans, drugs that disrupt serotonin metabolism (including MAOI), antipsychotics and other dopamine antagonists. Patients should be monitored for the occurrence of SS and NMS symptoms (see 4.3 and 4.5).
Symptoms of serotonin syndrome include: changes in the mental state (eg agitation, hallucinations, coma), autonomic instability (eg tachycardia, leprosy blood pressure, hyperthermia), neuromuscular disorders (eg hyperreflexia, coordination disorders) and / or gastrointestinal symptoms Ex: Nausea, vomiting, diarrhea). If these symptoms occur, BRINTELLIX should be discontinued immediately and symptomatic treatment should be initiated.
Mania / Hypomania
BRINTELLIX should be used with caution in patients with mania / hypomania, and treatment should be discontinued in the event of a manic episode.
Sedation, purpura and other bleeding anomalies (such as gastrointestinal or gynecological bleeding) have been reported rarely with the use of serotonergic antidepressants (SSRI, SNRI). Patients who are known to have anticoagulation and / or platelet function (eg, atypical antipsychotics and phenothiazines, the majority of tricyclic antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA) should be
With the use of serotonergic antidepressants (SSRI drugs, SNRI drugs), hyponatremia has been reported infrequently and is probably due to inappropriate release of the antidiuretic hormone (SIADH). It should be used with caution in patients at risk (such as elderly, cirrhotic patients, or patients treated simultaneously with drugs known to cause hyponatremia).
In patients with symptomatic hyponatremia, BRINTELLIX treatment should be discontinued and appropriate medical intervention should be performed.
Data on the use of BRINTELLIX in elderly patients with major depressive episodes are limited. For this reason, caution should be exercised when vortexing at doses higher than 10 mg once daily in patients aged 65 years or older (see 4.8 and 5.2).
Kidney failure
Experience with patients with severe renal insufficiency is limited. It should be applied with caution (see 5.2). Hepatic insufficiency
Vortiocetin is not studied in patients with severe hepatic insufficiency, and caution should be exercised when treating these patients (see 5.2).
BRINTELLIX contains less than 23 mg of sodium per dose; that is essentially 'sodium free'. Due to the amount it contains, no adverse effects due to sodium are expected.
Patients, especially those in the high-risk group, should be monitored closely, especially in the early stages of treatment and after dose changes. Patients  should be warned that prompt medical advice is required if any deterioration in the clinical condition, suicidal behavior, or unusual changes in behaviors or thoughts occur.
4.6. Pregnancy and lactation
General advice
Pregnancy Category: C
Women with childbearing potential / Contraception (Contraception)
If the patients become pregnant during vortexetine treatment, or if they plan to become pregnant, they should notify their doctor.
Pregnancy period
Data on the use of vortexetine in pregnancy are limited.
Animal studies have shown reproductive toxicity (see 5.3).
When the mother uses serotonergic drugs in the late stages of her pregnancy, the following symptoms may be seen in the newborn: the respiratory distress, cyanosis, apnea, seizures, lack of body temperature, difficulty in nutrition, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, irritability, irritability, crying, somnolence and difficulty in sleeping. These symptoms may depend on shear effects, as well as on excessive serotonergic activity. In the majority of cases, such complications start after or shortly after birth (<24 hours).
Epidemiological data suggest that the use of SSRI medications in pregnancy, especially in the late period, may increase the risk of persistent pulmonary hypertension (PPHN) in newborns. Although there is no study investigating the association of vorioxetin with persistent pulmonary hypertension, this potential risk can not be excluded if the relevant mechanisms of action (increase in serotonin concentrations) are taken into consideration.
BRINTELLIX should not be used during pregnancy unless the mother's clinical condition requires treatment with vortexetin.
Lactation period
Existing animal pharmacodynamic / toxicological data indicate that vortexetine and its metabolites have been passed on. It is expected that vortexetin will also pass on to humans (see 5.3).
The risk to the abs baby can not be ignored.
It should be decided whether breastfeeding or BRINTELLIX treatment should be discontinued, taking into account the benefits of breastfeeding to the baby and the benefits of treatment for the breastfeeding woman.
Reproduction ability / Fertility
In fertility studies conducted in male and female rats, vortexetin did not affect fertility, sperm quality or mating performance (see 5.3).
Human case reports reported with antidepressant drugs (SSRI) of the relevant pharmacological class have shown a reversible effect on sperm quality. The effect on human fertility has not been observed to date.
4.7. Effects on vehicle and machine use
BRINTELLIX has no or little effect on the use of the vehicle and the machine, or has an negligible impact. However, patients should be cautious when driving or operating hazardous machinery, especially when starting vortexine treatment or when changing doses.
8.4. Undesirable effects
Summary of safety profile
The most common undesirable effect is nausea. Adverse reactions are usually mild to moderate and occur during the first two weeks of treatment. Adverse reactions are usually transient and do not lead to cessation of treatment. Gastrointestinal adverse reactions such as nausea were more common in women than in men.
List of adverse effects
Adverse reactions were listed by frequency definitions below: 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).
Metabolism and nutritional diseases
Common: decreased appetite
Psychiatric diseases
Common: abnormal dreams
Uncommon: tooth creaking
Nervous system diseases
Common: dizziness
Vascular diseases
Uncommon: flushing
Gastrointestinal diseases
Very common: nausea
Common: diarrhea, constipation, vomiting
Skin and subcutaneous tissue diseases
Common: generalized prerit
Uncommon: night sweats
Explanations of selected adverse effects
Elderly patients
The rate of withdrawal from studies for> 10 mg vortexetine once a day is higher in patients> 65 years of age.
The rate of nausea and constipation for vortexetine 20 mg / day is higher in patients aged> 65 years (42% and 15%, respectively) than patients aged <65 years (27% and 4%, respectively).
Sexual dysfunction
In clinical trials, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses between 5 and 15 mg did not differ from placebo. However, 20 mg dose of vortexine has been associated with treatment-related sexual dysfunction (see 5.1).
Class effect
Particularly epidemiological studies conducted in patients aged 50 years or older have shown that patients with pharmacologic class antidepressant drugs (SSRI or TCA) increase bone fracture risk. It is not known whether the mechanism underlying this risk and whether this risk is also valid for vortexetin.

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