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• Available in seven strengths

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ATOMAID

Atomoxetine Capsules, Hard

Indication:

Atomaid is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD.

In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and Atomaid should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clincial judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life.

Additional information for the safe use of this product:

A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilising patients with a behavioural syndrome characterized by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.

Pharmacological treatment is not indicated in all patients with this syndrome and the decision to use the drug must be based on a very thorough assessment of the severity of the patient's symptoms and impairment in relation to the patient's age and the persistence of symptoms.

Shelf life:  2 Years

Presentation: Capsules, Hard

Format: 1 carton, containing 2 blisters of 14 tablets with a patient information leaflet

Bioequivalence Data

Dr. Reddy's Atomaid^® atomexetine capsule, hard is equivalent to Strattera^® atomexetine capsule, hard.

Plasma Concentration Profile

Bioequivalence studies comparing Atomaid^® atomexetine capsule, hard with Strattera^® atomexetine capsule, hard has been conducted.

Bioequivalence was demonstrated as Cmax and AUC ratios of Dr. Reddy's Atomaid^® atomoxetine capsule, hard to Strattera^® atomoxetine capsule, hard were found to be within the range of 80 to 125%*.

This data provides confidence that suitable patients have the potential to be switched to Dr. Reddy's Atomaid^® atomoxetine capsule, hard from Strattera^® atomoxetine capsule, hard.

*To establish bioequivalence, the calculated 90% confidence interval for the ratio of geometric means for AUC and Cmax should fall within 80%-125%.

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Atomaid 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg Capsules, Prescribing Information

Refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Hard capsules containing 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine.

Indication: Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults

as part of a comprehensive treatment programme.

Dosage and Administration: Administered as a single daily dose in the morning. Patients who do not achieve a satisfactory clinical response (tolerability or efficacy) as a single daily dose might benefit from taking it as twice daily evenly divided doses.

Paediatric Population (age 6 years and above)

Up to 70 kg Body Weight: Initiate at 0.5 mg/kg/day for a minimum of 7 days prior to dose titration. Maintenance dose is 1.2 mg/kg/day.

No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.

Over 70 kg Body Weight: Initiate at 40mg/day for a minimum of 7 days prior to dose titration. The recommended maintenance dose is 80mg. The maximum recommended total daily dose is 100 mg.

Adults: Initiate at 40 mg/day for a minimum of 7 days prior to dose titration.. The recommended maintenance daily dose is 80 mg to 100 mg. The maximum recommended total daily dose is 100 mg. Conduct a baseline evaluation of cardiovascular status, which should be monitored and recorded after each adjustment of dose

and then at least every 6 months. No distinct withdrawal symptoms have been described. Re-evaluation of the need for continued therapy beyond 1 year should be performed.

Hepatic Insufficiency : moderate insufficiency (Child-Pugh Class B), reduce doses to 50% of the usual dose; severe insufficiency (Child-

Pugh Class C), reduce doses to 25% of usual dose.

Renal Insufficiency : no dosage adjustment required. Atomaid may exacerbate hypertension in patients with end stage renal disease.

For CYP2D6 poor metabolisers a lower starting dose and slower up titration of the dose may be considered.

Elderly population: use in patients over 65 years of age has not been evaluated.

Contraindications

Hypersensitivity to Atomaid or to any of the excipients. Use in combination with monoamine oxidase inhibitors (MAOI). Atomaid should not be used within a minimum of 2 weeks after stopping a MAOI or MAOI should not be initiated within 2 weeks of stopping Atomaid. Narrow angle glaucoma. Severe cardiovascular or

cerebrovascular disorders. Pheochromocytoma.

Warnings and Precautions

Suicide-related behavior: suicide attempts and suicidal ideation have been reported.

Sudden death and pre-existing cardiac abnormalities: Atomaid should only be used with caution in patients with known serious

structural cardiac abnormalities.

Cardiovascular effects: Atomaid can affect heart rate and blood pressure including changes in heart rate (20 beats per minute or greater) and blood pressure (15-20 mmHg or greater). Patients should be assessed for the presence of cardiac disease. Patients who develop symptoms suggestive of cardiac disease should undergo a cardiac evaluation. Use with caution in patients with congenital or acquired long QT or family history of QT prolongation; in any condition that

may predispose patients to hypotension or

associated with abrupt heart rate or blood pressure changes.

Cerebrovascular effects: Patients with risk factors for cerebrovascular conditions should be assessed at every visit for neurological signs and symptoms.

Hepatic effects: Discontinue in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

Psychotic or manic symptoms: If symptoms occur, discontinuation of treatment should be considered.

Aggressive behaviour, hostility or emotional lability: Patients should be monitored for the appearance or worsening.

Possible allergic events: Anaphylactic reactions, rash, angioneurotic oedema, and urticaria, have been reported.

Seizures: Introduce with caution in patients with a history of seizure. Discontinuation should be considered in any patient developing a seizure or with an increase in seizure frequency.

Growth and development: Should be monitored in children and adolescents during treatment with Atomaid. Dose reduction or interrupting therapy may be considered.

New-onset or worsening of Comorbid Depression, Anxiety and Tics: There have been rare reports of anxiety and depression or depressed mood and very rare reports of tics. Patients should be

monitored for the appearance or worsening of these signs and symptoms. Atomaid has been associated with increased rates of fatigue, somnolence, and dizziness. Patients should be advised to use caution when driving a car or operating hazardous machinery.

Interactions

Do not use with MAOIs. Use caution with CYP2D6 inhibitors, may require lower doses of Atomaid. Caution is advised with use of potent inhibitors of cytochrome P450 enzymes other than CYP2D6.

Use with caution with high dose nebulised or systemically administered salbutamol (or other beta2 agonists), cardiovascular effects can be potentiated. Use with caution with drugs which:

Prolong QT; cause electrolyte imbalance (such as thiazide diuretics); which are known to lower the seizure threshold including when stopping concomitant treatment with benzodiazepines;

antihypertensive drugs; are pressor agents or drugs that increase blood pressure; affect noradrenaline.

Fertility, pregnancy and lactation

Use in pregnancy is not recommended. Women taking Atomaid should not breast-feed.

Undesirable Effects

Refer to the Summary of Product Characteristics for full list.

Paediatric Population:

Headache, abdominal pain and decreased appetite are the adverse events most commonly reported. Associated with decreased appetite, some patients experienced growth retardation early in therapy. On average, after an initial decrease in weight and height gain, patients treated with Atomaid recovered to mean weight and height as predicted by group baseline data over the long-term treatment.

Very common (?1/10): Appetite decreased, headache, somnolence, abdominal pain, vomiting, nausea, blood pressure increased, and heart rate increased

Common (?1/100 to <1/10): Anorexia, Irritability, mood swings, insomnia, agitation, anxiety, depression and depressed mood, tics,

dizziness, mydriasis, constipation, dyspepsia, dermatitis, pruritis, rash, fatigue, lethargy, chest pain, and weight decreased

Uncommon (?1/1,000 to <1/100): Suicide-related events, aggression, hostility, emotional lability, Psychosis, syncope, tremor, migraine,

paraesthesia, hypoaesthesia, seizure, vision blurred, palpitations, sinus tachycardia, QT interval prolongation, dyspnea, blood bilirubin increased, hyperhydrosis, allergic reactions and asthenia

Rare (?1/10,000 to <1/1,000): Raynaud’s phenomenon, Abnormal/increased liver function tests, jaundice, hepatitis, liver injury, acute hepatic failure, urinary hesitation, urinary retention,

priapism, and male genital pain

Adults: Very common (?1/10): Appetite decreased, Insomnia, headache, dry mouth, nausea, blood pressure increased, and heart rate increased

Common (?1/100 to <1/10): Agitation, libido decreased, sleep disorder, depression and depressed mood, anxiety, dizziness, dysgeusia, paraesthesia, somnolence , tremor, palpitations,

tachycardia, flushing, hot flush, abdominal pain, constipation, dyspepsia, flatulence, vomiting, dermatitis, hyperhydrosis, rash, dysuria, pollakuria, urinary hesitation, urinary retention,

dysmenorrhoea, ejaculation disorder, erectile dysfunction, prostatitis, male genital pain, asthenia, fatigue, lethargy, chills, feeling jittery, irritability, thirst, and weight decreased

Uncommon (?1/1,000 to <1/100): Suicide-related events, aggression, hostility and emotional lability, restlessness, tics, syncope, migraine,

hypoaesthesia, vision blurred, QT interval prolongation, peripheral coldness, dyspnoea, allergic reactions, pruritis, urticaria, muscle

spasms, micturation urgency, ejaculation failure, menstruation irregular, orgasm abnormal, feeling cold, and chest pain

Rare (?1/10,000 to <1/1,000): Psychosis, seizure, Raynaud’s phenomenon, abnormal/increased liver function tests, jaundice, hepatitis, liver injury, acute hepatic failure, blood bilirubin increased, and priapism

Legal category: POM

Packs: Clear PVC/PVdC – Aluminium blister pack in Pack sizes: 7, 28 and 56 capsules.

Basic NHS prices:

Atomaid 10 mg Capsules x 28 £37.16

Atomaid 18 mg Capsules x 28 £37.16

Atomaid 25 mg Capsules x 28 £37.16

Atomaid 40 mg Capsules x 28 £37.16

Atomaid 60 mg Capsules x 28 £37.16

Atomaid 80 mg Capsules x 28 £49.55

Atomaid 100 mg Capsules x 28 £49.55

Marketing Authorisation numbers:

Atomaid 10 mg Capsules PL 08553/0643

Atomaid 18 mg Capsules PL 08553/0644

Atomaid 25 mg Capsules PL 08553/0645

Atomaid 40 mg Capsules PL 08553/0646

Atomaid 60 mg Capsules PL 08553/0647

Atomaid 80 mg Capsules PL 08553/0648

Atomaid 100 mg Capsules PL 08553/0649

Marketing Authorisation Holder:

Dr. Reddy’s Laboratories (UK) Ltd

Full prescribing information is available from:

Dr. Reddy’s Laboratories (UK) Ltd

6 Riverview Road, Beverley, East Yorkshire HU17 0LD United Kingdom

Tel: 01748 828873

 

Adverse Event Reporting

Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard

Adverse events may also be reported to Pharmacovigilance at

Dr. Reddy’s Laboratories via

drreddysgb@eu.propharmagroup.com

 

Date of preparation/last revised: 19/02/2020

Good Health Can't Wait.

Atomaid® is a registered trademark of Dr. Reddy's Laboratories (UK) Ltd

This page is sponsored by Dr.Reddy's UK

Date of preparation: September 2021

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road

Beverley HU17 OLD

T: 01482 389858

F: 01482 860204

E: customerserviceuk@drreddys.com