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Wellbutrin SR online in Australia

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Wellbutrin SR

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Availability: In stock

Prescription required for Generic Wellbutrin SR?: No Prescription

Active ingredient: Bupropion

Medical form: Pills

Delivery time: EMS Trackable (5-9 days), Airmail (10 - 21 days)

What is Wellbutrin SR used for?

ZYBAN L.P. is indicated as a smoking cessation aid accompanied by support to motivate smoking cessation in patients with nicotine dependence.

Conditions for which this medicine may be prescribed

  • Give up smoking

Method of administration and dosage of the drug Wellbutrin SR

Dose

Use in adults

It is recommended to start treatment before quitting smoking and to decide on a specific date to stop smoking during the first two weeks of treatment with ZYBAN L.P. (preferably during the second week).

The starting dose is 150 mg per day for the first six days, then 300 mg / day in 2 daily doses spaced at least 8 hours from the seventh day.

The maximum dose is 150 mg per dose and 300 mg per day. In no case should it be exceeded.

Insomnia is a very common side effect that can be reduced by avoiding taking ZYBAN L.P. at bedtime (provided there is an interval of at least 8 hours between doses).

Pediatric population

The use of ZYBAN L.P. is not recommended in children and adolescents under 18 years of age, in the absence of safety and efficacy data in these patients.

Elderly patients

ZYBAN L.P. should be used with caution in the elderly, due to possible increased individual sensitivity. The recommended dose in elderly patients is 150 mg per day in one dose (see section 4.4).

Patients with liver failure.

ZYBAN L.P. should be used with caution in patients with hepatic impairment. Given the greater variability in pharmacokinetic parameters in these patients, the recommended dose in patients with mild to moderate hepatic impairment is 150 mg once daily.

Patients with kidney failure.

ZYBAN L.P. should be used with caution in patients with renal impairment. The recommended dose in these patients is 150 mg once daily (see section 4.4).

ZYBAN L.P. It should be used according to the recommendations to quit smoking.

The prescriber must assess the patient's motivation to quit smoking. Supportive smoking cessation treatments are more likely to be successful in motivated and quit-supported patients.

ZYBAN L.P. they must be swallowed whole. They should not be cut, crushed, or chewed as this can increase the risk of side effects, including seizures.

ZYBAN L.P. can be taken with or without food (see sections Interactions with other medicinal products and other forms of interactions and pharmacokinetic properties).

The duration of treatment is 7 to 9 weeks.

Although the onset of withdrawal syndrome at the end of treatment seems unlikely, a gradual decrease in dose may be considered.

In the absence of efficacy at the seventh week, there is no reason to continue the treatment of ZYBAN L.P.

Stop treatment

Although the onset of withdrawal syndrome is not expected at the end of treatment, a gradual decrease in dose may be considered.

Possible side effects of Wellbutrin SR

  • Anemia
  • Leukopenia
  • Thrombocytopenia
  • Hypersensitivity reaction
  • Allergic urticaria
  • Angioedema
  • Dyspnoea
  • Bronchospasm
  • Anaphylactic shock
  • Hypersensitivity arthritis
  • Hypersensitivity myalgia
  • Hypersensitivity fever
  • Allergic rash
  • Anorexy
  • Blood sugar alteration
  • Hyponatremia
  • Insomnia
  • Depression
  • Agitation
  • Anxiety
  • Confusion
  • Irritability
  • Hostility
  • Hallucinations
  • Depersonalization
  • Abnormal dreams
  • Nightmares
  • Delirium
  • Paranoid idea
  • Nervousness
  • Aggressiveness
  • Suicidal idea
  • Suicidal behavior
  • Psychosis
  • Shaking
  • Concentration problems
  • Headache
  • Vertigo
  • Taste disorder
  • Seizure crisis
  • Dystonia
  • Ataxia
  • Parkinson's syndrome
  • Coordination disorder
  • Memory impairment
  • Paresthesia
  • Syncope
  • Visual disturbances
  • Tinnitus
  • Tachycardia
  • Palpitation
  • Increased blood pressure
  • Redness
  • Vasodilation
  • Orthostatic hypotension
  • Dry mouth
  • Gastrointestinal disorder
  • Sickness
  • Vomiting
  • Abdominal pain
  • Constipation
  • Elevated liver enzymes
  • Jaundice
  • Hepatitis
  • Acne
  • Skin itching
  • Sweat
  • Polymorphic erythema
  • Stevens-Johnson syndrome
  • Exacerbation of psoriasis.
  • Muscle contraction
  • Pollakiuria
  • Urinary retention
  • Fever
  • Chest pain
  • Asthenia
  • Angioedema
  • Tonic-clonic crisis
  • Amnesia

Show more The following list provides information on the side effects identified in clinical trials, classified by system organ and by incidence. It is important to note that frequent smoking cessation is associated with nicotine withdrawal symptoms (e.g. restlessness, insomnia, tremors, sweating), some of which are also identified as adverse events associated with ZYBAN L.P.

The classification of undesirable effects according to their frequency uses the following convention: very common (≥ 1/10), frequent (≥ 1/100, minus 1/10), infrequent (≥ 1/1000, minus 1/100), rare (≥ 1 / 10,000, minus 1 / 1,000), very rare (less than 1 / 10,000); frequency not known (cannot be estimated from the available data).

Organ-system Frequency Undesirable effects
Blood and lymphatic system disorders. Indeterminate Anemia, leukopenia, and thrombocytopenia.
Immune system disorders * Frequent Hypersensitivity reactions like urticaria
Rare More severe hypersensitivity reactions, including angioedema, dyspnea / bronchospasm, and anaphylactic shock.
  Arthralgia, myalgia, and fever have also been reported in association with skin rashes and other symptoms suggestive of late hypersensitivity. These symptoms may resemble those of serum sickness.
Metabolism and nutrition disorders. Rare Anorexy
Rare Blood sugar disorders
Indeterminate Hyponatremia
Psychiatric disorders Very common Insomnia (see section Dosage and method of administration)
Frequent Depression (see section 4.4), agitation, anxiety.
Rare Confusion
Rare Irritability, hostility, hallucinations, depersonalization, abnormal dreams, even nightmares.
Very rare Delusions, paranoid ideas, nervousness, aggressiveness.
Indeterminate Suicidal thoughts and suicidal behavior ***, psychosis
Nervous system disorders Frequent Tremor, difficulty concentrating, headache, dizziness, taste disturbances.
Rare Convulsive seizures (see below) **, dystonia, ataxia, parkinsonian syndrome, coordination disorders, memory impairment, paresthesia, syncope
Eye conditions Rare Visual disturbances
Ear and labyrinth disorders. Rare Tinnitus
Heart conditions Rare Tachycardia
Rare Palpitations
Vascular disorders Rare High blood pressure (sometimes severe), redness
Rare Vasodilation, orthostatic hypotension.
Gastrointestinal disorders. Frequent Dry mouth, gastrointestinal upset, including nausea and vomiting, abdominal pain, constipation.
Hepatobiliary disorders. Rare Elevation of liver enzymes, jaundice, hepatitis.
Skin and subcutaneous tissue disorders * Frequent Rash, itching, sweating.
Rare Polymorphic erythema and Stevens-Johnson syndrome have also been reported.
  Exacerbation of psoriasis.
Musculoskeletal and connective tissue disorders. Rare Muscle contraction
Kidney and urinary tract disorders. Rare Polyakiuria and / or urinary retention
Very rare Urinary incontinence
General disorders and administration site conditions. Frequent Fever
Rare Chest pain, asthenia

* Hypersensitivity can be manifested through skin reactions. See "Immune System Disorders" and "Skin and Subcutaneous Tissue Disorders."

** The incidence of seizures is approximately 0.1% (1/1000). These seizures are primarily generalized to the tonic-clonic type which, in certain cases, can cause confusion or post-critical amnesia (see Warnings and Precautions for Use section).

*** Cases of suicidal thoughts and suicidal behavior have been reported during bupropion treatment (see Warnings and Precautions for Use section).

Contraindications: when not to use this medicine?

  • Bupropion hypersensitivity
  • Seizure disorder
  • Convulsive history
  • CNS tumor
  • Alcohol withdrawal
  • Benzodiazepine withdrawal and seizure risk-related products
  • Bulimia
  • History of bulimia
  • Anorexia nervosa
  • History of anorexia nervosa.
  • Severe liver cirrhosis
  • History of bipolar disorder.
  • Severe liver failure
  • Child under 6
  • Pregnancy
  • Breastfeeding
  • Child from 6 to 18 years old.

See more ZYBAN L.P. It is contraindicated in patients with a history of hypersensitivity to bupropion or to any of the excipients included in the Composition section.

ZYBAN L.P. it is contraindicated in patients with active seizure disorder or with a seizure history.

ZYBAN L.P. is contraindicated in patients with a known central nervous system (CNS) tumor.

ZYBAN L.P. is contraindicated in patients who, at any time during treatment, initiate or continue alcohol withdrawal or withdrawal from any other medicinal product, the discontinuation of which carries a risk of seizures (in particular benzodiazepines and related products).

ZYBAN L.P. is contraindicated in patients with a diagnosis of bulimia or anorexia nervosa.

The use of ZYBAN L.P. is contraindicated in patients with severe liver cirrhosis.

The combination of ZYBAN L.P. with monoamine oxidase inhibitors (MAOIs) it is contraindicated. An interval of at least 2 weeks should be observed between discontinuation of nonselective MAOIs and initiation of treatment with ZYBAN L.P. For selective MAOIs, an interval of 24 hours is sufficient.

ZYBAN L.P. It is contraindicated in patients with a history of bipolar disorder where it can cause a manic episode during the depressive phase of their illness.

ZYBAN L.P. should not be administered to patients already treated with another medicine containing bupropion, as the incidence of seizures is dose dependent and to avoid overdose.

Presentation of this medicine

10 tablets in blister with childproof film (Polyamide - Aluminum - PVC / Paper - Aluminum); Box of 3, 4, 5, 6 or 10 plates.

Not all presentations can be marketed.

Appearance and shape

Long-release tablet.

White, round, biconvex, film-coated tablet marked "GX CH7" on one side and nothing on the other.

Composition of the drug Wellbutrin SR

Active principle Prolonged release tablet
Bupropion 150 mg *

* per unit dose Active ingredients: Bupropion Excipients: Core: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate, film coating: hypromellose, Macrogol 400, titanium dioxide, carnauba wax, printing ink: oxide of black iron, hypromellose No noticeable effect? not present in the composition of this medicine

Effects on ability to drive and use machines

Like any product that acts on the central nervous system, bupropion can affect the ability to perform tasks that involve judgment, motor and cognitive abilities.

Dizziness and dizziness have also been reported with Wellbutrin SR. Also, driving a vehicle or using machines should only be considered with caution by patients, and after making sure to take Wellbutrin SR it did not affect their performance.

Warnings and precautions for use

  • Risk of seizures
  • Lowering the epileptogenic threshold
  • Alcohol abuse
  • Head trauma history
  • Diabetes
  • Psychiatric history
  • Depressive symptom
  • Patient from 18 to 25 years old.
  • Hypersensitivity reaction
  • Increased blood pressure
  • Control of blood pressure
  • Old subject
  • Mild to moderate liver failure
  • Renal insufficiency

Show more seizures

The recommended dose of ZYBAN L.P. in no case should it be exceeded, taking into account the dose-dependent risk of seizures. For doses up to 300 mg per day of ZYBAN L.P. (recommended maximum daily dose), the incidence of seizures is approximately 0.1% (1/1000).

The risk of seizures during treatment with ZYBAN L.P. increases in patients with risk factors that lower the epileptogenic threshold. ZYBAN L.P. should not be administered to these patients, unless absolutely necessary and if the expected benefit of quitting smoking outweighs the risk of seizures. In these patients, the maximum dose to be used throughout the treatment is 150 mg per day.

The following risk factors should be sought in all patients:

Co-administration of other medicinal products known to lower the epileptogenic threshold (eg, antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemically administered steroids, quinolones, and sedative antihistamines). In the event of prescription of such medicinal products in a patient treated with ZYBAN L.P., the maximum dose of 150 mg per day is recommended for the remaining treatment period.

Alcohol abuse (see Contraindications section),

History of head trauma,

Diabetes treated with hypoglycemic agents or insulin,

· Use of psychostimulants or appetite suppressants.

ZYBAN L.P. it should be discontinued and should not be resumed in patients who develop seizures during treatment.

Pharmacological interactions (see section Interactions with other medications and other forms of interaction)

Pharmacokinetic interactions can modify plasma concentrations of bupropion or its metabolites and, therefore, favor the appearance of undesirable effects (for example, dry mouth, insomnia, seizures). Caution should be exercised when co-administering bupropion and medicinal products that induce or inhibit your metabolism.

Bupropion inhibits metabolism by the 2D6 isoenzyme of cytochrome P450. Caution should be exercised when medicinal products metabolized by this isoenzyme are administered concomitantly.

Medicines that inhibit CYP2D6 have been shown in the literature to lead to reduced concentrations of endoxifene, the active metabolite of tamoxifen. Therefore, the use of bupropion, which is a CYP2D6 inhibitor, should be avoided as much as possible during treatment with tamoxifen (see section Interactions with other medicinal products and other forms of interaction).

Neuropsychiatry

ZYBAN L.P. acts on the central nervous system by inhibiting the reuptake of norepinephrine / dopamine. Neuropsychiatric reactions have been reported (see section 4.8). In particular, psychotic or manic symptoms have been observed, mainly in patients with a known psychiatric history.

A depressed mood can be a symptom of nicotine withdrawal. Depression, rarely associated with suicidal ideation and behavior (including suicide attempt), has been reported in patients in the process of quitting smoking.

These symptoms have also been reported during treatment with ZYBAN L.P. and they generally occur at the beginning of treatment.

In some countries, bupropion is indicated for the treatment of depression. A meta-analysis of placebo-controlled clinical studies with antidepressant drugs in adults with major depressive episode or other psychiatric disorders, showed that the risk of suicidal ideation and behavior increased with antidepressants compared to placebo in patients younger than 25 years.

The prescriber should consider the possibility of significant depressive symptoms in patients who continue to quit smoking and will give them appropriate advice.

Animal data suggest a risk of addiction. However, studies of the potential for abuse in humans and extensive clinical experience show that bupropion has a low potential for abuse.

Hypersensitivity

ZYBAN L.P. should be discontinued if there is a hypersensitivity reaction during treatment. The prescriber should be aware that symptoms may worsen or reappear even after stopping ZYBAN L.P. and you must ensure that symptomatic treatment is administered long enough (at least one week).

Symptoms generally include a rash, itching, hives, or chest pain.

However, more serious reactions may include angioedema, dyspnea / bronchospasm, anaphylactic shock, erythema multiforme, or Stevens-Johnson syndrome.

Arthralgia, myalgia, and fever, associated with skin rashes and other symptoms suggestive of late hypersensitivity, have also been reported. These symptoms may suggest serum sickness (see section 4.8). In most patients, these symptoms return when bupropion is discontinued and after treatment with antihistamines or corticosteroids are started, and gradually disappear.

Arterial hypertension

Hypertension, sometimes severe and requiring specific treatment (see section 4.8), has been reported in clinical practice in patients receiving bupropion alone or in combination with nicotine replacement therapy, that these patients do or do not have pre-existing hypertension. . Blood pressure should be measured at the start of treatment and monitored later, especially in patients with pre-existing hypertension.

Suspending ZYBAN L.P. should be considered in the event of a clinically relevant increase in blood pressure.

Limited clinical data suggests that a higher success rate for smoking cessation could be achieved by combining ZYBAN L.P. with transdermal nicotine patches. However, a higher proportion of hypertension has been observed with this association. However, such association requires precautions for use. Weekly blood pressure monitoring is recommended. If this association is envisaged, the prescriber is requested to consult the information intended for physicians regarding nicotine transdermal devices.

Specific populations

Elderly patient

Clinical experience with bupropion has not shown any difference in terms of tolerance between the elderly and adult patients. However, the possibility of increased sensitivity in some elderly patients cannot be excluded; Therefore, the recommended dose in these patients is 150 mg per day in one dose (see sections Dosage and method of administration and pharmacokinetic properties).

Patients with liver failure.

Bupropion is extensively metabolized in the liver to active metabolites, which in turn are metabolized. No statistically significant difference in bupropion pharmacokinetics was observed between patients with mild to moderate liver cirrhosis and healthy volunteers, but plasma bupropion concentrations exhibited greater interindividual variability.

Therefore, ZYBAN L.P. should be used with caution in patients with mild to moderate hepatic impairment. The recommended dose in these patients is 150 mg once a day.

All patients with hepatic impairment should be closely monitored due to the risk of adverse effects (eg, insomnia, dry mouth, seizures) that may reveal elevated plasma concentrations of the product or its metabolites.

Patients with kidney failure.

Bupropion and its metabolites are mainly excreted in the urine. In patients with renal impairment, the recommended dose is 150 mg once daily, due to the risk of further accumulation of bupropion and its active metabolites (see sections 4.2 and 5.1). ) These patients require close monitoring to detect possible side effects that may be related to high plasma concentrations of the product or its metabolites.

Interference with urine tests.

With an amphetamine-like chemical structure, bupropion interferes with the tests used in certain rapid urine screening tests, which can lead to false positives, particularly for amphetamines. A positive result should generally be confirmed with a more specific method.

Inadequate routes of administration.

ZYBAN L.P. it is for oral use only. Inhalation of crushed tablets or injection of dissolved bupropion has been reported to cause rapid release, accelerated absorption, and possible overdose. Seizures and / or death have been reported after administration of intranasal bupropion or parenteral injection.

Mechanism of action: how does it work?

Pharmacotherapeutic group: Other antidepressants, ATC code: N06AX12.

Mechanism of action

Bupropion is a selective inhibitor of neuronal uptake of catecholamines (norepinephrine and dopamine). Its action is minimal in the reuptake of indolamines (serotonin). It does not inhibit monoamine oxidases. The mechanism of action of bupropion to help stop smoking is unknown, but its action is mediated by noradrenergic and / or dopaminergic mechanisms.

Clinical efficacy and safety

The proportion of congenital heart defects after maternal exposure to bupropion during the first trimester of pregnancy, prospectively observed in the International Register of Pregnancies, was 9/675 (1.3%).

In a retrospective study, no increase in the proportion of congenital or cardiovascular defects was observed among more than 1,000 bupropion exposures in the first trimester compared to the use of other antidepressants.

In a retrospective analysis using data from the National Study of Prevention of Birth Defects, a statistically significant association was observed between the appearance of malformations in the left ventricular outflow tract in infants and the intake of bupropion in early pregnancy declared by Mother. No association was observed between the use of bupropion in the mother and another type of cardiac malformation or all combined cardiac malformations.

Further analysis of data from the Slone Center for Epidemiology Birth Defects study found no statistically significant increase in left ventricular outflow malformations during maternal exposure to bupropion. However, a statistically significant association was observed between ventricular septal malformations and maternal exposure to bupropion only during the first trimester of pregnancy.

Interactions: do not take this medicine with ..

In patients receiving other drugs known to lower the epileptogenic threshold, Wellbutrin SR should only be prescribed in case of absolute medical necessity, that is, when the expected benefit of quitting smoking outweighs the risk. increased potential for seizures (see section 4.4).

Effects of bupropion on other medicines.

Although not metabolized by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, are inhibitors of the CYP2D6 isoenzyme.

In healthy volunteers known to be important metabolizers of CYP2D6 isoenzyme, concomitant administration of bupropion hydrochloride and desipramine leads to a large increase (2 to 5 times its value) in C max and AUC desipramine Inhibition of CYP2D6 isoenzyme persists for at least 7 days after the last dose of bupropion hydrochloride.

The combination with drugs with a low therapeutic index and metabolized mainly by the CYP2D6 isoenzyme should be started with the lowest possible dose of these drugs. Such medications include certain antidepressants (eg, desipramine, imipramine, paroxetine), antipsychotics (eg, risperidone, thioridazine), beta-blockers (eg, metoprolol), and type 1C antiarrhythmics (eg, propafenone, flecainide).

If ZYBAN L.P. is added When treating a patient who is already receiving such a drug, a reduction in the dose of this product should be considered. In these situations, the expected benefit of treatment with ZYBAN L.P. it must be carefully evaluated with respect to potential risks.

Medications that require metabolic activation by CYP2D6 to be effective (eg, tamoxifen) may have reduced efficacy when administered concomitantly with CYP2D6 inhibitors such as bupropion (see section 4.4). 'job).

Although CYP2D6 isoitalo does not primarily metabolize citalopram, one study shows that bupropion increases the C max and AUC of citalopram by 30% and 40% respectively.

Co-administration of digoxin with bupropion may decrease digoxin levels. The AUC of 0-24 h of digoxin decreased and renal clearance increased in healthy volunteers according to a comparison from a crossover study. Physicians should be aware that digoxin levels may increase when bupropion treatment is discontinued, and therefore the patient should be closely monitored due to the possible toxicity of digoxin.

Effects of other drugs on bupropion

Bupropion is metabolized to its main active metabolite, hydroxybupropion, mainly by the cytochrome P450 isoenzyme CYP2B6 (see section Pharmacokinetic properties). The combination of Wellbutrin SR with products that can interfere with the metabolite of bupropion through CYP2B6 isoenzyme (CYP2B6 substrates: cyclophosphamide, ifosfamide and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel) can cause an increase in plasma concentration and bupropion a decrease in that of its active metabolite hydroxybupropion. The clinical consequences of inhibiting bupropion metabolism through the CYP2B6 isoenzyme and the consequent changes in the bupropion / hydroxy-bupropion ratio are currently unknown.

Since bupropion is extensively metabolized, concomitant administration of enzyme inducing drugs (eg carbamazepine, phenytoin, ritonavir, efavirenz) or enzyme inhibitors (eg valproate) should be used with caution as they may affect its efficacy and clinical tolerance

In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or a combination of ritonavir 100 mg and lopinavir 400 mg (Kaletra) twice daily, caused a dependent decrease of the dose of approximately 20 to 80% on exposure to bupropion and its main metabolites (see section Pharmacokinetic properties). Similarly, 600 mg of efavirenz once daily for two weeks results in an approximately 55% reduction in bupropion exposure in healthy volunteers. Patients receiving any of these bupropion medications may require higher doses of bupropion, but the maximum recommended dose should not be exceeded.

Nicotine administered through transdermal patches does not affect the pharmacokinetics of bupropion and its metabolites.

Other interactions

Tobacco causes an increase in CYP1A2 activity. Quitting smoking can lead to decreased elimination of drugs metabolized by this enzyme. This can lead to an increase in plasma concentrations of these drugs, which may be particularly important for those who are primarily metabolized by CYP1A2 and whose therapeutic index is narrow (eg theophylline, tacrine and clozapine). The clinical consequences of smoking cessation in other drugs partially metabolized by CYP1A2 (eg Imipramine, Olanzapine, Clomipramine, and Fluvoxamine) are unknown. Furthermore, limited data indicates that tobacco may also induce metabolism of flecainide or pentazocine.

Administration of ZYBAN L.P. in patients receiving concomitant levodopa or amantadine should be considered with caution. Limited clinical data suggests an increased incidence of unwanted effects (eg, Nausea, vomiting, and neuropsychiatric effects; see the Unwanted Effects section) in patients treated with bupropion and levodopa or amantadine at the same time.

Although clinical data have not demonstrated a pharmacokinetic interaction between bupropion and alcohol, rare cases of neuropsychiatric adverse reactions or decreased alcohol tolerance have been reported in patients who have ingested alcohol during treatment. Alcohol consumption during treatment with ZYBAN L.P. should be limited or avoided.

Since monoamine oxidase A and B inhibitors (MAOIs) inhibit catabolism of catecholamine by a different mechanism than that related to bupropion, the concomitant use of Wellbutrin SR and monoamine oxidase inhibitors (MAOIs) is contraindicated (see section Contraindications ) due to a higher risk of undesirable effects related to its joint administration. A period of at least 14 days must be respected between the cessation of nonselective MAOIs and the start of treatment with ZYBAN L.P. For selective MAOIs, a 24-hour period is sufficient.

Studies suggest a possible increase in bupropion exposure when ZYBAN L.P. they are taken with a meal rich in fats (see section Pharmacokinetic properties).

Incompatibilities

Aimlessly

How to react in case of overdose?

Acute ingestion of doses greater than 10 times the maximum therapeutic dose has been reported. In addition to events reported as adverse reactions, the following symptoms have been observed: drowsiness and loss of consciousness and / or ECG changes, such as conduction disorders (including prolongation of the QRS interval), arrhythmias and tachycardia were also reported. a prolongation of the QTc interval, but was generally associated with an extension of the QRS interval and an increase in heart rate.

Although most patients have developed favorably and without sequelae, rare cases of death have been reported after ingestion of very high overdoses of bupropion.

Treatment: In case of overdose, hospitalization is recommended. Monitor ECG and vital signs.

Ensure adequate patient oxygenation and ventilation. Administration of activated carbon is recommended. There is no specific antidote for bupropion. Additional measures will be taken depending on the patient's clinical condition.

Wellbutrin SR: pregnancy, lactation and fertility

Pregnancy

Epidemiological studies in children of mothers who have been treated with bupropion during the first trimester of pregnancy reported an association between exposure to the product and an increased risk of congenital heart defects, specifically ventricular septal defect and left ventricular ejection pathway abnormalities. However, these observations are not consistent across studies.

Animal studies have shown no direct or indirect harmful effects on reproduction (see Preclinical Safety Data section).

Zyban L.P. should not be used during pregnancy. Pregnant women should be encouraged to stop smoking without using medication.

Breastfeeding

Bupropion and its metabolites are excreted in breast milk.

The decision not to breastfeed or not to be treated with ZYBAN L.P. should be taken in relation to the benefit of breastfeeding for the child and the benefit of treatment with ZYBAN L.P. for the mother.

Fertility

There are no data on the effect of bupropion on human fertility. A study in rats showed no effect on fertility (see section Preclinical safety data).

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