Paroxetine Unicorn 20 20 mg Tablets.

• Depression
• Obsessive Compulsive Disorder (OCD)
• Social phobia
• Panic disorder
• Generalised Anxiety Disorder (GAD)

Posology

Depression: 20 mg daily. This dose can be increased gradually if needed by 10 mg increments to a maximum of 50 mg daily according to the patientu2019s response.

Panic Disorder: The recommended dose is 40 mg daily. The initial starting dose is 10 mg daily, which may be increased by 10 mg increments. The maximum dose is 60 mg daily. The low initial starting dose is recommended to minimise the potential worsening of panic symptoms when initiating treatment with PAROXETINE UNICORN 20.

Obsessive Compulsive Disorder: The recommended dose is 40 mg daily. The initial starting dose is 20 mg daily, which may be increased by 10 mg increments to a maximum of 60 mg daily.

Social Phobia: The recommended daily dose is 20 mg. This dose may be increased gradually if needed by 10 mg increments to a maximum of 40 mg according to the patientu2019s response.

Generalised Anxiety Disorder: The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increments of 10 mg of at least one week to a maximum of 50 mg per day according to the patientu2019s response.

Discontinuation of PAROXETINE UNICORN 20: Abrupt discontinuation of PAROXETINE UNICORN 20 should be avoided (see sections 4.4, 4.8). The taper phase regimen involves an increment decrease in the daily dose by 10 mg/day at weekly intervals. When a daily dose of 20 mg/day is reached, patients should continue on this dose for one week before stopping treatment. If intolerable symptoms occur after a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. The general practitioner may continue decreasing the dose, but at a more gradual rate.

Special populations

Elderly: Elderly subjects may experience increased plasma concentrations with PAROXETINE UNICORN 20. Dosing should commence at the adult starting dose and may be increased gradually by 10 mg increments up to 40 mg daily.

Hepatic and renal impairment: Increased plasma concentrations of PAROXETINE UNICORN 20 may occur in patients with severe renal impairment (creatinine clearance < 30 ml/min) or severe hepatic impairment. The dosage should therefore be restricted to the lower end of the dosage range. Patients should be treated for a sufficient period to ensure that they remain free from symptoms. This may be several months or longer.

Paediatric population

Children: The safety and efficacy of PAROXETINE UNICORN 20 in children under the age of 18 years have not been established (see section 4.3). PAROXETINE UNICORN 20 should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 4.4).

Method of administration

It is recommended that PAROXETINE UNICORN 20 be administered as a single dose in the morning with food. PAROXETINE UNICORN 20 should be swallowed rather than chewed.

• Hypersensitivity to paroxetine or any of the ingredients of PAROXETINE UNICORN 20.
• Concomitant use with serotonin precursors (see sections 4.4, 4.5).
• MAO Inhibitors: PAROXETINE UNICORN 20 should not be used in combination with MAO inhibitors or within 2 weeks of terminating treatment with MAO inhibitors. MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with PAROXETINE UNICORN 20.
• Children under the age of 18 years (see section 4.4).
• Patients with epilepsy, seizures or a history of epilepsy.
• PAROXETINE UNICORN 20 should not be used in combination with pimozide (see section 4.5).
• Porphyria. PAROXETINE UNICORN 20 is considered to be unsafe in patients with porphyria.

Safety and efficacy in children under 18 years have not been established (see section 4.3).

Children and Adolescents under 18 years of age u2013 clinical worsening and suicide risk: PAROXETINE UNICORN 20 increase the risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking. PAROXETINE UNICORN 20 is not approved for use in paediatric patients (see sections 4.3, 4.8).

Suicidal thoughts / suicide and psychiatric disorders: 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 medicines in inducing such behaviour has not been established. Patients being treated with PAROXETINE UNICORN 20 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 disorder 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, such as PAROXETINE UNICORN 20, 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 such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing PAROXETINE UNICORN 20, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patientu2019s presenting symptoms.

Discontinuation of PAROXETINE UNICORN 20 treatment: If the decision is made to discontinue treatment, PAROXETINE UNICORN 20 should be tapered (see section 4.2). Abrupt discontinuation of PAROXETINE UNICORN 20 can lead to withdrawal symptoms such as dizziness, sensory disturbances (including paraesthesia, electric shock sensations and tinnitus), sleep disturbances, insomnia, tremor, confusion, agitation or anxiety, headache, palpitations, emotional instability, irritability, nervousness, vertigo, visual disturbances, nausea and sweating. In the majority of these patients, symptoms are mild to moderate and are self-limiting. No particular patient group appears to be a higher risk of these symptoms; it is therefore advised that when PAROXETINE UNICORN 20 treatment is no longer required, gradual discontinuation by dose tapering be carried out (see section 4.2).

Patients with epilepsy: PAROXETINE UNICORN 20 should be used with caution in patients with epilepsy or a history of epilepsy. PAROXETINE UNICORN 20 should be avoided in patients where epilepsy is poorly controlled (see sections 4.3, 4.4).

Akathisia: The use of PAROXETINE UNICORN 20 has been associated with the development of akathisia, which is characterised by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment.

Serotonin Syndrome/Neuroleptic Malignant Syndrome: Development of a serotonin syndrome or neuroleptic malignant syndrome-like events may occur in association with treatment of PAROXETINE UNICORN 20, particularly when given in combination with other serotonergic and/or neuroleptic medicines. As these syndromes may result in potentially life-threatening conditions, treatment with PAROXETINE UNICORN 20 should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus and autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur. Supportive symptomatic treatment should be initiated.

PAROXETINE UNICORN 20 should not be used in combination with serotonin-precursors (such as L-tryptophan, oxitriptan) due to the risk of serotonergic syndrome (see sections 4.3, 4.5).

Mania and Bipolar disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant e.g., PAROXETINE UNICORN 20 alone, can increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Prior to initiating treatment with PAROXETINE UNICORN 20, patients should be adequately screened to determine whether they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression. It should be noted that PAROXETINE UNICORN 20 is not approved for use in treating bipolar depression. PAROXETINE UNICORN 20 should be used with caution in patients with a history of mania.

Haemorrhage: SSRIs/SNRIu2019s may increase the risk of postpartum haemorrhage, and this risk could potentially apply also to PAROXETINE UNICORN 20 (see sections 4.6, 4.8). Patients concomitantly treated with PAROXETINE UNICORN 20 and anticoagulant medicines have an increased risk for bleeding, or patients with a known tendency or with predisposing conditions for bleeding, may have an increased tendency of skin and mucous membrane bleedings. Co-administration of PAROXETINE UNICORN 20 with warfarin may result in increased bleeding in the presence of unaltered prothrombin times. The elderly and patients at high risk of gastrointestinal bleeding should be cautioned against the use of PAROXETINE UNICORN 20 with NSAIDs, due to the increased risk of upper gastrointestinal bleeding.

Haemorrhagic manifestations e.g., gastrointestinal haemorrhage has been reported in patients taking SSRIs concomitantly with NSAIDu2019s. Caution is advised in the elderly and patients with a history of bleeding disorders or conditions which may predispose to bleeding (see section 4.5).

Risperidone: Co-administration with risperidone may lead to increased toxicity (see section 4.5).

Alcohol: The concomitant use of PAROXETINE UNICORN 20 and alcohol is not advised.

Increased risk for bone fractures: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants (TCAs) (see section 4.8).

Cardiac Condition: Administration of PAROXETINE UNICORN 20 to patients with a serious cardiovascular disorder such as (unstable) angina pectoris, poorly monitored cardiac decompensation, ventricular rhythm disorder and acute myocardial infarction, has not been studied and must therefore be avoided. If antidepressant medication is nevertheless indicated for such patients, PAROXETINE UNICORN 20 should be administered with caution.

Seizures: Seizures may occur in patients treated with PAROXETINE UNICORN 20. PAROXETINE UNICORN 20 should be discontinued in any patient who develops seizures or when there is an increase in seizure frequency (see sections 4.3, 4.4).

Electro-Convulsive Therapy (ECT): Clinical experience of the concurrent administration of PAROXETINE UNICORN 20 and electro-convulsive therapy is lacking.

Hyponatraemia: Hyponatraemia, which is generally reversible on discontinuation of PAROXETINE UNICORN 20, may occur predominantly in the elderly.

Glaucoma: PAROXETINE UNICORN 20 may cause mydriasis and should be used with caution in patients with narrow angle glaucoma.

Diabetes mellitus: PAROXETINE UNICORN 20 may alter glycaemic control and therefore caution should be used in patients with diabetes mellitus. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

• Interaction between PAROXETINE UNICORN 20 and serotogenic medicines (e.g., monoamine oxidase (MAO) inhibitors (see section 4.3) and also between PAROXETINE UNICORN 20 L-tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue), SSRIs, pethidine and St. Johnu2019s Wort (hypericum perforatum) may occur, resulting in a u201cserotonin syndromeu201d. The risk of using PAROXETINE UNICORN 20 in combination with other CNS active medicines has not been systematically evaluated. Consequently, caution is advised if concomitant administration is required.
• Co-administration of PAROXETINE UNICORN 20 with anti-convulsants may be associated with an increased incidence of adverse events.
• PAROXETINE UNICORN 20 inhibits the specific hepatic cytochrome P450 isozyme CYP2D6 responsible for the metabolism of debrisoquine and sparteine. This may lead to enhanced plasma levels of those co-administered medicines which are metabolised by this isoenzyme. Medicine metabolised by this isozyme include certain tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine and desipramine), phenothiazine neuroleptics (e.g., perphenazine) risperidone, Type 1c antidysrhythmics (e.g., propafenone) and metoprolol.
• Co-administration with risperidone may lead to increased toxicity thereof.
• Caution is also advised with fentanyl used in general anaesthesia or tramadol in the treatment of chronic pain.
• Concurrent administration of PAROXETINE UNICORN 20 and lithium should be undertaken with caution. Lithium levels should be monitored.
• Co-administration of PAROXETINE UNICORN 20 and phenytoin is associated with decreased plasma concentrations of paroxetine and increased adverse experiences (diarrhoea, indifference, imbalance, nervousness, ataxia and vertigo). No initial dosage adjustment of PAROXETINE UNICORN 20 is considered necessary when these medicines are co-administered. Any subsequent adjustments should be guided by clinical effect.
• Primidone is partially metabolised to phenobarbitone, which induces many cytochrome P450 enzymes. Administration with any of these medicines concomitantly with PAROXETINE UNICORN 20 may reduce the systemic availability of paroxetine. No initial dosage adjustments of PAROXETINE UNICORN 20 are recommended, but subsequent titration should be based on clinical effects.
• Concomitant administration of pimozide with PAROXETINE UNICORN 20 may increase the systemic availability of pimozide. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, concomitant use of pimozide and PAROXETINE UNICORN 20 is contra-indicated (see section 4.3).
• Daily administration of PAROXETINE UNICORN 20 may significantly increase the plasma levels of procyclidine; other anti-cholinergic medicines may be similarly affected. If anti-cholinergic effects are seen, the dose of procyclidine should be reduced.
• PAROXETINE UNICORN 20 should be administered with great caution to patients receiving oral anticoagulants (see section 4.4), aspirin or nonsteroidal medicines (NSAIDs).
• Sumatriptan may increase the risk of adverse reactions when used in combination with PAROXETINE UNICORN 20. If concomitant therapy is clinically warranted, appropriate observation of the patient is advised.
• Elevated theophylline concentrations may occur after concurrent use of PAROXETINE UNICORN 20. Monitoring of theophylline serum concentrations during concurrent use is recommended.
• Reduced efficacy of tamoxifen has been reported with concomitant usage of some SSRI antidepressants. As a reduced effect of tamoxifen cannot be excluded, co-administration with potent CYP2D6 inhibitors (including PAROXETINE UNICORN 20) should whenever possible be avoided.
• The absorption and pharmacokinetics of PAROXETINE UNICORN 20 are not affected, or only marginally affected by food, antacids propranolol.
• Concurrent administration of PAROXETINE UNICORN 20 with digoxin should be undertaken with caution.
• When PAROXETINE UNICORN 20 is to be co-administered with a known medicine metabolising enzyme inhibitor, such as cimetidine, consideration should be given to using doses at the lower end of the range. No initial dosage adjustment of PAROXETINE UNICORN 20 is considered necessary when it is to be co-administered with known medicine metabolising enzyme inducers. Any subsequent dosage adjustment should be guided by clinical effects (tolerability and efficacy).

The safety of PAROXETINE UNICORN 20 in pregnancy or lactation has not been established. Patients should be advised to notify their medical practitioner if they become pregnant or intend to become pregnant during therapy. 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, 4.8).

Teratogenic effects: Epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular (e.g., ventricular and atrial septum defects), associated with the use of PAROXETINE UNICORN 20 during the first trimester. The mechanism is unknown. PAROXETINE UNICORN 20 should only be used during pregnancy when strictly indicated. If a patient becomes pregnant while taking PAROXETINE UNICORN 20, she should be advised of the potential harm to the foetus. Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing PAROXETINE UNICORN 20 therapy or switching to another antidepressant (see section 4.4: Discontinuation of PAROXETINE UNICORN 20 treatment). For women who intend to become pregnant or are in their first trimester of pregnancy, PAROXETINE UNICORN 20 should only be initiated after consideration of the other available treatment options.

Non-teratogenic effects: Neonates must be observed if maternal use of PAROXETINE UNICORN 20 continues into the later stages of pregnancy, particularly the third trimester. The following symptoms may occur in the neonate after maternal PAROXETINE UNICORN 20 use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping. These symptoms could be due to either serotonergic effects or withdrawal symptoms. In a majority of instances, the complications begin immediately or soon (<24 hours) after delivery (see section 4.4).

Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the new-born (PPHN). PAROXETINE UNICORN 20 should only be used during pregnancy when strictly indicated. The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant. Abrupt discontinuation should be avoided during pregnancy (see section 4.4: Discontinuation of PAROXETINE UNICORN 20 treatment).

Patients should be cautioned about their ability to drive a car and operate machinery.

System Organ Class Frequency Side effects

Blood and lymphatic system disorders Less frequent Abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis, but also in the gastrointestinal tract, central nervous system and eye) purpura, bruising, thrombocytopenia.

Endocrine disorders Less frequent Syndrome of inappropriate anti-diuretic hormone secretion (SIADH).

Metabolism and nutrition disorders Frequent Decreased or increased appetite, anorexia, weight loss, increased risk of gastrointestinal bleeding, hyponatraemia (which may occur predominantly in elderly patients), changes in blood sugar

Psychiatric disorders Frequent Less frequent Somnolence, insomnia, agitation Confusion, hallucinations, amnesia, impaired concentration, abnormal dreams, anxiety, in children reports of hostility, suicidal ideation and self-harm, depersonalisation, panic attacks, akathisia, manic reactions, suicidal ideation and suicidal behaviour.

Nervous system disorders Frequent Less frequent Dizziness, tremor, drowsiness, headache, fatigue Extrapyramidal disorders, migraine, anxiety, restlessness, nervousness, insomnia, paraesthesia, convulsions, Serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).

Eye disorders Less frequent Blurred or abnormal vision, anisocoria, mydriasis, acute glaucoma.

Cardiac disorders Less frequent Palpitations, tachycardia.

Vascular disorders Less frequent Postural hypotension, hypertension.

Respiratory, thoracic and mediastinal disorders Frequent Less frequent Yawning. Chest pain, difficulty in breathing, sinusitis, bronchitis, coughing, pharyngitis, rhinitis.

Gastrointestinal disorders Frequent Less frequent Constipation, diarrhoea, dry mouth, nausea, vomiting, dyspepsia, abdominal pain, flatulence. Increased risk of gastrointestinal bleeding

Hepato-biliary disorders Less frequent Elevation of hepatic enzymes, hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure). Discontinuation of PAROXETINE UNICORN 20 should be considered if there is prolonged elevation of liver function test results.

Skin and subcutaneous tissue disorders Frequent Less frequent Excessive sweating. Skin rashes, pruritus, eczema, alopecia, pruritus, erythema multiforme, Stevens Johnsonu2019s syndrome, toxic epidermal necrolysis photosensitivity reactions, cutaneous vasculitis.

Musculoskeletal, connective tissue and bone disorders Less frequent Myalgia, myasthenia, myopathy, arthralgia, increased risk of bone fractures.

Renal and urinary disorders Less frequent Urinary retention, urinary tract infection, urinary incontinence.

Reproductive system and breast disorders Frequent Less frequent Frequency unknown Sexual dysfunction. Dysmenorrhoea, menstrual disorder, vaginitis, hyperprolactinaemia / galactorrhoea, priapism.

Postpartum haemorrhage*. Safety of PAROXETINE UNICORN 20 in pregnancy has not been established (see section 4.6)

General disorders and administrative site conditions Less frequent Peripheral oedema, asthenia, body weight gain.

*This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6. 04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. Adverse reactions must also be reported to Unicorn Pharmaceuticals (Pty) Ltd to [email protected].

Symptoms of overdose: Vomiting, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety, tachycardia, coma and ECG changes.

Treatment of overdose: Treatment is symptomatic and supportive. There is no specific antidote. To decrease absorption, the stomach should be emptied by gastric lavage or induction of emesis or both. This should be followed by administration of 20 to 30 g of activated charcoal every four to six hours during the first 24 hours after ingestion. Frequent monitoring of vital signs and careful observation is recommended.