Sertra 50 Mg Tablets

SERTRA TABLETS 50 mg is indicated in adults for:

• The treatment of major depressive disorders including single episodes and recurrent depression.
• The treatment of obsessive-compulsive disorder (OCD).
• The treatment of panic disorder, with or without agoraphobia.

SERTRA TABLETS 50 mg is indicated in:

• The treatment of children aged 13 u2013 17 with OCD.

Panic disorder is characterised by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behaviour related to the attacks. Panic disorder is characterised by recurrent unexpected panic attacks i.e. a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: palpitations, pounding heart, or accelerated heart rate; sweating; trembling or shaking; sensations of shortness of breath or smothering; feeling of choking; chest pain or discomfort; nausea or abdominal distress; feeling dizzy, unsteady, light-headed, or faint; derealisation (feelings of unreality) or depersonalisation (being detached from oneself); fear of losing control; fear of dying; paraesthesias (numbness or tingling sensations); chills or hot flushes.

The effectiveness of SERTRA TABLETS 50 mg in long-term use i.e. for more than 12 weeks, has not been systematically evaluated. Therefore, patients should be periodically re-evaluated regarding the long-term usefulness of the medicine (see section 4.2).

Posology

SERTRA TABLETS 50 mg should be given as a single daily dose with or without food.

Depression

The starting dose is 50 mg daily and the usual therapeutic dose in depression is 50 mg daily. In difficult to treat patients, the dose may be titrated up in 50 mg increments at 2 weekly intervals, to 150 mg u2013 200 mg.

Obsessive-compulsive disorder

Adults

The minimum effective dose in OCD is 50 mg daily and increases above 100 mg daily did not have any additional benefit. Full activity is usually seen after 2 u2013 4 weeks and even longer in OCD. Effect may however be seen within 7 days.

Paediatric obsessive-compulsive disorder (OCD)

The administration of SERTRA TABLETS 50 mg to paediatric OCD patients (aged 13 u2013 17) should commence at 50 mg/day. Subsequent doses may be increased in case of lack of response in 50 mg/day increments up to 200 mg as needed. However, the generally lower body weights of children compared to adults should be taken into consideration in advancing the dose from 50 mg, in order to avoid excessive dosing. Given the 24-hour elimination half-life of SERTRA TABLETS 50 mg, dose changes should not occur at intervals of less than 1 week.

Panic disorder

For panic disorder, the minimum recommended dose of SERTRA TABLETS 50 mg is 50 mg/day. However, therapy for panic disorder should commence at 25 mg/day, increasing to 50 mg/day after one week. This dosage regimen has been demonstrated to reduce the frequency of early treatment emergent side effects characteristic of panic disorder.

Special populations

Use in the elderly

No special precautions are required. The usual adult dosage is recommended.

Use in hepatic and renal impairment

See sections 4.3 and 4.4.

Discontinuation of treatment

If SERTRA TABLETS 50 mg therapy has to be discontinued, SERTRA TABLETS 50 mg should be tapered (see section 4.4).

Method of administration

For oral use.

• SERTRA TABLETS 50 mg is contraindicated in patients with known hypersensitivity to sertraline or any of the ingredients contained in SERTRA TABLETS 50 mg.
• The concomitant use of SERTRA TABLETS 50 mg with a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid, is contraindicated (see section 4.4).
• Concomitant use in patients taking pimozide is contraindicated (see section 4.5).
• Children < 18 years of age with both OCD and a major depressive disorder (see section 4.4).
• Use in hepatic or renal impairment (see section 4.4).
• Pregnancy and lactation (see section 4.6).

Serotonin Syndrome (SS)

The development of potentially life-threatening syndromes like serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS) has been reported with selective serotonin reuptake inhibitors (SSRIs), including treatment with SERTRA TABLETS 50 mg. The risk of SS or NMS with SSRIs is increased with concomitant use of serotonergic medicines (including amphetamines, triptans and fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone and pentazocine), with medicines that impair metabolism of serotonin (including MAOIs), antipsychotics and other dopamine antagonists. SS symptoms include mental status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Some signs of SS, including hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes resemble NMS. Patients should be monitored for the emergence of signs and symptoms of SS or NMS syndrome (see section 4.3).

Monoamine oxidase inhibitors

Cases of serious reactions, sometimes fatal, have been reported in patients receiving SERTRA TABLETS 50 mg in combination with a MAOI, including selegiline, moclobemide, the antibiotic linezolid and methylene blue. Some cases presented with features resembling SS. Therefore, SERTRA TABLETS 50 mg should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should elapse after discontinuing SERTRA TABLETS 50 mg treatment and starting a MAOI (see section 4.3).

Other serotonergic medicines

Co-administration of SERTRA TABLETS 50 mg with other medicines that enhance the effect of serotonergic neurotransmission, such as amphetamines, tryptophan and fentanyl, or 5-HT antagonists, or the herbal medicine St. Johnu2019s Wort (Hypericum perforatum) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction (see section 4.5).

QTc prolongation/Torsade de Pointes (TdP)

Cases of QTc prolongation and TdP have been reported during post-marketing use of SERTRA TABLETS 50 mg. The majority of reports occurred in patients with other risk factors for QTc prolongation/TdP. Therefore, SERTRA TABLETS 50 mg should be used with caution in patients with risk factors for QTc prolongation (see sections 4.5 and 5.1).

Switching from SSRIs, antidepressants or anti-obsessional medicines

There is limited controlled experience regarding the optimal timing of switching from other antidepressants or anti-obsessional medicines to SERTRA TABLETS 50 mg. Care and prudent medical judgement should be exercised when switching, particularly from long-acting medicines such as fluoxetine. The duration of a washout period when switching from one SSRI to another has not been established.

Activation of mania/hypomania

Hypomania or mania may occur in patients treated with SERTRA TABLETS 50 mg.

Seizures

Seizures have been observed in patients using SERTRA TABLETS 50 mg. SERTRA TABLETS 50 mg should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. SERTRA TABLETS 50 mg should be discontinued in any patient who develops seizures.

Suicide/suicidal thoughts or clinical worsening

All patients treated with SERTRA TABLETS 50 mg, in particular younger patients and those at high risk, should be monitored appropriately and observed closely for clinical worsening and suicidality. Patients, their families, and their caregivers should be encouraged to be alert to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour especially when initiating therapy or during any change in dose or dosage regimen. The risk of suicide attempt must be considered, especially in depressed patients, and the smallest quantity of SERTRA TABLETS 50 mg, consistent with good patient management, should be provided to reduce the risk of overdose. Patients with major depressive disorder, both adults and children, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medicines. This risk may persist until significant remission occurs. A causal role, however, for antidepressant medicine in inducing such behaviour has not been established. Patients being treated with SERTRA TABLETS 50 mg should, nevertheless, be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy or at any time of dose changes, either increases or decreases.

Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and non-psychiatric disorders, the same precautions observed when treating patients with major depressive disorders should be observed when treating patients with other psychiatric and non-psychiatric disorders.

The following symptoms have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Although a causal link between the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing SERTRA TABLETS 50 mg, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patientu2019s presenting symptoms.

If a decision is made to discontinue treatment, SERTRA TABLETS 50 mg should be tapered (see section 4.2).

Sexual dysfunction

Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

Abnormal bleeding/haemorrhage

There have been reports of bleeding abnormalities with SSRIs from ecchymosis and purpura to life-threatening haemorrhage. SSRIs/SNRIs may increase the risk of postpartum haemorrhage (see sections 4.6 and 4.8). Caution is advised in patients taking SSRIs, particularly in concomitant use with medicines known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]) as well as in patients with a history of bleeding disorders (see section 4.5).

Hyponatraemia

Hyponatraemia may occur as a result of treatment with SSRIs such as SERTRA TABLETS 50 mg or serotonin norepinephrine inhibitors (SNRIs). In many cases, hyponatraemia appears to be the result of a syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases of serum sodium levels lower than 110 mmol/l have been reported. Elderly patients may be at greater risk of developing hyponatraemia with SSRIs such as SERTRA TABLETS 50 mg. Also, patients taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinuation of SERTRA TABLETS 50 mg should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatraemia include headache, difficulty concentrating, memory impairment, confusion, weakness and unsteadiness that may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest and death.

Bone fractures

Epidemiological studies show an increased risk of bone fractures in patients receiving serotonin reuptake inhibitors (SRIs) including SERTRA TABLETS 50 mg. The mechanism leading to this risk is not fully understood.

Use in patients with concomitant illness

Caution is advisable in using SERTRA TABLETS 50 mg in patients with diseases or conditions that could affect metabolism or haemodynamic responses. SERTRA TABLETS 50 mg has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease.

Use in hepatic impairment

As might be predicted from its primary site of metabolism, liver impairment can affect the elimination of SERTRA TABLETS 50 mg. The elimination half-life of SERTRA TABLETS 50 mg is prolonged. The use of SERTRA TABLETS 50 mg in patients with liver disease must be avoided (see section 4.3).

Use in renal impairment

In patients with mild to moderate renal impairment (creatinine clearance 30 u2013 60 mL/min) or severe renal impairment (creatinine clearance < 30 mL/min), multiple dose pharmacokinetics parameters (AUC or C max) are modest. SERTRA TABLETS 50 mg should not be used in patients with renal impairment (see section 4.3).

Uricosuric effect

SERTRA TABLETS 50 mg is associated with a mean decrease in serum uric acid of approximately 7 %. The clinical significance of this uricosuric effect is unknown.

Diabetes/loss of glycaemic control

Cases of new onset diabetes mellitus have been reported in patients receiving SSRIs including SERTRA TABLETS 50 mg. Loss of glycaemic control including both hyperglycaemia and hypoglycaemia has also been reported in patients with and without pre-existing diabetes. Patients should therefore be monitored for signs and symptoms of glucose fluctuations. Diabetic patients, especially, should have their glycaemic control carefully monitored since their dosage of insulin and/or concomitant oral hypoglycaemic medicine may need to be adjusted.

Laboratory tests

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking SERTRA TABLETS 50 mg. This is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of SERTRA TABLETS 50 mg therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish SERTRA TABLETS 50 mg from benzodiazepines.

Angle-closure glaucoma

SSRIs including SERTRA TABLETS 50 mg may have an effect on pupil size resulting in mydriasis. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients pre-disposed. SERTRA TABLETS 50 mg should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma.

Weight loss

Significant weight loss may be an undesirable result of treatment with SERTRA TABLETS 50 mg for some patients, approximately 0,5 u2013 1,0 kg weight loss.

Paediatric population

The safety and efficacy of SERTRA TABLETS 50 mg have been established in paediatric obsessive-compulsive disorder (OCD) patients aged 13 u2013 17. Safety and efficacy in the paediatric population other than paediatric patients with OCD have not been established. In clinical trials in major depressive disorder, there were increased reports of hostility and suicide-related adverse events such as suicidal ideation and self-harm (see section 4.3).

Withdrawal symptoms

Abrupt discontinuation of SERTRA TABLETS 50 mg may lead to withdrawal symptoms which include dizziness, sweating, nausea, insomnia, tremor, confusion, sensory disturbances, agitation and anxiety.

Monoamine oxidase inhibitors (MAOI)

The concomitant use of SERTRA TABLETS 50 mg with a MAOI is contraindicated (see sections 4.3 and 4.4).

Pimozide

Increased pimozide levels have been demonstrated with SERTRA TABLETS 50 mg co-administration but were not associated with any changes in electrocardiogram (ECG). While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant administration of SERTRA TABLETS 50 mg and pimozide is contraindicated (see section 4.3).

Medicines that prolong the QTc interval

The risk of QTc prolongation and/or ventricular dysrhythmias (e.g. TdP) is increased with concomitant use of other medicines that prolong the QTc interval (e.g. some antipsychotics and antibiotics) (see sections 4.4 and 5.1).

CNS depressants and alcohol

Co-administration of SERTRA TABLETS 50 mg (sertraline 200 mg daily) did not potentiate the effects of alcohol, carbamazepine, haloperidol or phenytoin on cognitive and psychomotor performance in healthy subjects. However, the concomitant use of SERTRA TABLETS 50 mg and alcohol in depressed patients is not recommended.

Lithium

It is recommended that plasma lithium levels be monitored following initiation of SERTRA TABLETS 50 mg therapy, so that appropriate adjustments to the lithium dose may be made if necessary. Co-administration with lithium may lead to a higher incidence of 5HT-associated side effects, resulting in an increase in tremor relative to placebo, indicating a possible pharmacodynamic interaction. Therefore, caution is recommended when co-administering SERTRA TABLETS 50 mg with medicines such as lithium, which may act via serotonergic mechanisms and patients should be appropriately monitored.

Phenytoin

Increased phenytoin concentrations may occur when SERTRA TABLETS 50 mg and phenytoin are used concomitantly, especially in patients with other medical conditions and/or those receiving multiple concomitant medications. Plasma phenytoin concentrations should be monitored when SERTRA TABLETS 50 mg and phenytoin are used concomitantly with appropriate adjustments to the phenytoin dose. In addition, co-administration of phenytoin may cause a reduction of plasma levels of sertraline in SERTRA TABLETS 50 mg.

Sumatriptan

There have been post-marketing reports describing patients with weakness, hyperreflexia, incoordination, confusion, anxiety, and agitation following the use of SERTRA TABLETS 50 mg and sumatriptan. If concomitant treatment with SERTRA TABLETS 50 mg and sumatriptan is clinically warranted, appropriate observation of the patient is advised (see section 4.4 and Other serotonergic medicines below).

Other serotonergic medicines

Co-administration of SERTRA TABLETS 50 mg with other medicines which enhance the effect of serotonergic neurotransmission, such as tryptophan and fentanyl, 5-HT antagonists, or the herbal medicine St. Johnu2019s Wort (Hypericum perforatum) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction (see section 4.4).

Protein-bound medicines

SERTRA TABLETS 50 mg is highly bound to serum proteins (98 %) in the range of 20 to 500 ng/mL. However, at up to 300 and 200 ng/mL concentrations, respectively, sertraline and N-desmethylsertraline as in SERTRA TABLETS 50 mg do not alter the plasma protein binding of two other highly protein-bound medicines, viz. warfarin and propranolol. However, in interaction studies with diazepam, tolbutamide and warfarin respectively, SERTRA TABLETS 50 mg had no significant effects on the protein binding of the substrate (see Warfarin and Other medicine interactions).

Warfarin

Co-administration of SERTRA 200 mg daily with warfarin resulted in a small but statistically significant increase in INR/prothrombin time. Accordingly, prothrombin time should be carefully monitored when SERTRA TABLETS 50 mg therapy is initiated or stopped.

Other medicine interactions

Co-administration of SERTRA 200 mg daily with diazepam or tolbutamide resulted in small, statistically significant changes in some pharmacokinetic parameters. Co-administration with cimetidine caused a substantial decrease in SERTRA TABLETS 50 mg clearance. The clinical significance of these changes is unknown.

Women of childbearing potential

Women of childbearing potential should employ an adequate method of contraception if taking SERTRA TABLETS 50 mg (see section 4.3).

Pregnancy

The safety of SERTRA TABLETS 50 mg during pregnancy and lactation has not been established. Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth (see sections 4.4 and 4.8).

Breastfeeding

Women using SERTRA TABLETS 50 mg should not breastfeed their infants.

Fertility

There is no clinical trial data on fertility. In animal studies, no effect on fertility parameters was observed.

SERTRA TABLETS 50 mg does not cause sedation and does not interfere with psychomotor performance but may cause hypomania. Patients should be cautioned when driving a car or operating machinery until they know how SERTRA TABLETS 50 mg affects them.

Tabulated summary of adverse reactions

The adverse event terms in clinical studies were categorised utilising the incidence rate as follows: Very common (u2265 1/10); common (u2265 1/100 to < 1/10); uncommon (u2265 1/1 000 to < 1/100); rare (u2265 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

MedDRA System organ class

Frequency

Adverse reactions

Infections and infestations

Common

Pharyngitis

Uncommon

Upper respiratory tract infection, rhinitis

Rare

Diverticulitis, gastroenteritis, otitis media

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Rare

Neoplasm

Blood and lymphatic system disorders

Rare

Lymphadenopathy

Immune system disorders

Rare

Allergic reaction, allergy

Metabolism and nutrition disorders

Common

Anorexia, decreased appetite

Rare

Hypercholesterolaemia

Psychiatric disorders

Very common

Insomnia

Common

Depersonalisation, nervousness, suicidal ideation/behaviour, suicide attempts

Uncommon

Apathy, abnormal thinking

Rare

Paroniria, psychosis, conversion disorder, medicine dependence, paranoia, sleep walking, premature ejaculation

Nervous system disorders

Very common

Dizziness, somnolence

Common

Tremor, dysgeusia, disturbance in attention

Uncommon

Abnormal coordination, amnesia, speech disorder, postural dizziness

Rare

Choreoathetosis, dyskinesia, hyperaesthesia, sensory disturbance

Not known

Psychomotor restlessness (see section 4.4)

Eye disorders

Common

Abnormal vision, visual disturbance

Rare

Glaucoma, lacrimal disorder, scotoma, diplopia, photophobia, hyphaemia

Not known

Unequal pupils

Ear and labyrinth disorders

Uncommon

Ear pain

Cardiac disorders

Rare

Myocardial infarction, bradycardia, cardiac disorder

Vascular disorders

Uncommon

Flushing

Rare

Peripheral ischaemia, haematuria, abnormal bleeding (such as gastrointestinal bleeding)

Respiratory, thoracic and mediastinal disorders

Uncommon

Dyspnoea

Rare

Laryngospasm, hyperventilation, hypoventilation, stridor, dysphonia, hiccups

Not known

Interstitial lung disease

Gastrointestinal disorders

Very common

Diarrhoea/loose stools, dry mouth, nausea

Common

Dyspepsia, flatulence

Uncommon

Oesophagitis, dysphagia, haemorrhoids, salivary hypersecretion, tongue disorder, eructation

Rare

Melaena, haematochezia, stomatitis, tongue ulceration, tooth disorder, glossitis, mouth ulceration

Hepatobiliary disorders

Rare

Abnormal hepatic function, serious liver events (including hepatitis, jaundice and hepatic failure)

Skin and subcutaneous tissue disorders

Common

Hyperhidrosis

Uncommon

Cold sweat, dry skin

Rare

Dermatitis, bullous dermatitis, follicular rash, abnormal hair texture, abnormal skin odour

Musculoskeletal and connective tissue disorders

Common

Myalgia

Uncommon

Muscle cramps, osteoarthritis, muscular weakness, back pain, muscle twitching

Rare

Bone disorder

Renal and urinary disorders

Uncommon

Nocturia, polyuria, pollakiuria, micturition disorder

Rare

Oliguria, urinary hesitation

Reproductive system and breast disorders

Very common

Ejaculation failure

Common

Ejaculation disorder, erectile dysfunction, sexual dysfunction (see section 4.4)

Uncommon

Vaginal haemorrhage, female sexual dysfunction (see section 4.4)

Rare

Menorrhagia, atrophic vulvovaginitis, balanoposthitis, genital discharge

General disorders and administration site conditions

Uncommon

Chills, thirst

Rare

Hernia, decreased medicine tolerance

Investigations

Rare

Abnormal semen

Injury, poisoning and procedural complications

Rare

Injury

Surgical and medical procedures

Rare

Vasodilation procedure

Other

Rare

Symptoms following the discontinuation of SERTRA TABLETS 50 mg have been reported and included agitation, anxiety, dizziness, headache, nausea, paraesthesia

Post-marketing side effects

MedDRA System organ class

Adverse reactions

Blood and lymphatic system disorders

Thrombocytopenia, leukopenia, abnormal platelet function test

Immune system disorders

Hypersensitivity, anaphylactoid reaction

Endocrine disorders

Inappropriate antidiuretic hormone secretion, hyperprolactinaemia, hypothyroidism

Metabolism and nutrition disorders

Increased appetite, diabetes mellitus, hyponatremia, hypoglycaemia, hyperglycaemia

Psychiatric disorders

Depressive symptoms, depression, anxiety, agitation, bruxism, nightmare, decreased libido, hallucination, aggression, confusional state, euphoric mood, psychotic disorder

Nervous system disorders

Headache, paraesthesia, syncope, movement disorders (including extrapyramidal symptoms such as hyperkinesia, hypertonia, dystonia, teeth grinding or gait abnormalities), involuntary muscle contractions, hypoaesthesia, hyperkinesia, migraine. Also reported were signs and symptoms associated with Serotonin Syndrome or Neuroleptic Malignant Syndrome: In some cases associated with concomitant use of serotonergic medicines that included agitation, confusion, diaphoresis, diarrhoea, fever, hypertension, rigidity, and tachycardia, coma, convulsion, dystonia, akathisia

Eye disorders

Visual impairment, mydriasis, periorbital oedema

Ear and labyrinth disorders

Tinnitus

Cardiac disorders

Palpitations, tachycardia, Torsade de Pointes, QTc prolongation, increased blood cholesterol

Vascular disorders

Hot flush, haemorrhage, hypertension, cerebral vasoconstriction (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome)

Respiratory, thoracic and mediastinal disorders

Yawning, bronchospasm, epistaxis

Gastrointestinal disorders

Vomiting, constipation, abdominal pain, gastrointestinal haemorrhage, pancreatitis

Hepatobiliary disorders

Increased alanine aminotransferase, increased aspartate aminotransferase, liver injury

Skin and subcutaneous tissue disorders

Rash, urticaria, purpura, pruritus, alopecia, rare reports of severe cutaneous adverse reactions (SCAR) e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, exfoliative rash, photosensitivity skin reaction

Musculoskeletal and connective tissue disorders

Arthralgia, muscle spasms, rhabdomyolysis, trismus

Renal and urinary disorders

Urinary retention, haematuria, urinary incontinence, enuresis

Reproductive system and breast disorders

Irregular menstruation, priapism, galactorrhoea, gynaecomastia, postpartum haemorrhage* (This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).

General disorders and administration site conditions

Chest pain, malaise, pyrexia, asthenia, fatigue, gait disturbance, peripheral oedema, face oedema, medicine withdrawal syndrome

Investigations

Increased weight, decreased weight, abnormal clinical laboratory results

Injury, poisoning and procedural complications

Fracture

On the evidence available, SERTRA TABLETS 50 mg has a wide margin of safety in overdose. Deaths have been reported involving overdoses of SERTRA TABLETS 50 mg, primarily in combination with other medicines and/or alcohol. Therefore, any overdosage should be treated aggressively.

Symptoms of overdose include serotonin-mediated side effects such as electrocardiogram QT prolonged, TdP (see sections 4.4, 4.5 and 5.1), somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness. Less frequently reported was coma.

No specific therapy is recommended and there are no specific antidotes to SERTRA TABLETS 50 mg. Establish and maintain an airway, ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, a cathartic, should be considered for the induction of emesis or lavage in treating overdosage. Induction of emesis is not recommended. Monitoring of cardiac and vital signs is recommended, along with general symptomatic and supportive measures. Due to the large volume of distribution of SERTRA TABLETS 50 mg, forced diuresis, dialysis, haemoperfusion, and exchange transfusion are unlikely to be of benefit.