2.Description and Ccomposition יולי 4102 רופא/ה נכבד/ה, רוקח/ת נכבד/ה, - PDF

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רופא/ה נכבד/ה, רוקח/ת נכבד/ה, יולי 4102 הנדון: capsules Ritalin 10 mg tablets, Ritalin S.R. 20 mg tablets, Ritalin LA 10, 20, 30, 40 mg ריטלין 01 מ ג טבליות, ריטלין ס.ר. 01 מ ג טבליות בשחרור מושהה, ריטלין,10,20,30

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רופא/ה נכבד/ה, רוקח/ת נכבד/ה, יולי 4102 הנדון: capsules Ritalin 10 mg tablets, Ritalin S.R. 20 mg tablets, Ritalin LA 10, 20, 30, 40 mg ריטלין 01 מ ג טבליות, ריטלין ס.ר. 01 מ ג טבליות בשחרור מושהה, ריטלין,10,20,30 40 LA מ ג כמוסות בשחרור מושהה התכשירים שבנדון רשומים בישראל להתוויות הבאות: Ritalin 10 mg and Ritalin S.R. 20 mg: Attention-Deficit Hyperactivity Disorder (ADHD), Narcolepsy. Ritalin LA 10, 20, 30, 40 mg: Attention-Deficit Hyperactivity Disorder (ADHD). המרכיב הפעיל: hydrochloride) Methylphenidate (as העלון לרופא והעלונים לצרכן של התכשירים שבנדון עודכנו. העדכונים מפורטים להלן )קו תחתי משמעו תוספת טקסט, קו חוצה משמעו מחיקת טקסט( עלון לרופא RITALIN / RITALIN SR / RITALIN LA. (Methylphenidate hydrochloride) Tablets: Ritalin 10 mg / Ritalin SR 20 mg Capsules: / Ritalin LA 10 mg, 20 mg, 30 mg, 40 mg Prescribing Information 2.Description and Ccomposition Active substance(s) One Ritalin tablet contains 10 mg methylphenidate hydrochloride. One Ritalin SR tablet contains 20 mg methylphenidate hydrochloride. One Ritalin LA capsule contains 10mg, 20 mg, 30 mg and 40 mg methylphenidate hydrochloride. Excipients Ritalin ttablet [10 mg]: calcium phosphate tribasic, lactose, cryst., wheat starch, gelatine, magnesium stearate, and talc. Ritalin SR ttablet [20 mg]: lactose monohydrate, cetostearyl alcohol, magnesium stearate, hydroxypropyl methylcellulose, polyoxyl hydrogenated castor oil, titanium dioxide (E 171), talc, carnauba wax, and fine black ink. 1 Ritalin LA ccapsule [10mg, 20 mg, 30 mg and 40 mg]: ammonio methacrylate copolymer type B, black iron oxide (E 172) (10 mg and 40 mg capsules only), gelatine, methacrylic acid copolymer type A, polyethylene glycol 6000, red iron oxide (E 172) (10 mg and 40 mg capsules only), sugar spheres, talc, titanium dioxide (E 171), triethyl citrate, and yellow iron oxide (E 172) (10 mg, 30 mg and 40 mg capsules only). 3.Indications Attention-Deficit/Hyperactivity Disorder (ADHD, DSM-IV) Ritalin 10 mg, Ritalin SR, Ritalin LA 10mg, 20mg, 30mg, 40mg: attention deficit hyperactivity disorder (ADHD), Narcolepsy. Ritalin LA 10mg, 20mg, 30mg, 40mg: attention deficit hyperactivity disorder (ADHD). ADHD was previously known as attention-deficit disorder or minimal brain dysfunction. Other terms used to describe this behavioural syndrome include: hyperkinetic disorder, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psychoorganic syndrome of children patients. Ritalin is indicated as part of a comprehensive treatment programme which typically includes psychological, educational, and social measures and is aimed at stabiliszing children patients with a behavioural syndrome characteriszed by moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. Non-localiszing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations for ADHD in children The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Proper diagnosis requires medical and neuropsychological, educational, and social investigation. Special Diagnostic Considerations for ADHD in adults The specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adults with ADHD have symptom patterns characterized by shifting activities, becoming bored easily, restlessness, impatience, and inattentiveness. Symptoms such as hyperactivity tend to diminish with increasing age possibly due to adaptation, neurodevelopment and selfmedication. Inattentive symptoms are more prominent and have a greater impact on adults with ADHD. Diagnosis in adults should include a structured patient interview to determine current symptoms. The preexistence of childhood ADHD is to be determined retrospectively. Diagnosis should not be made solely on the presence of one or more symptoms. The decision to use a stimulant in adults must be based on a very thorough assessment of the severity and chronicity of the symptoms and their impact on the daily life of the patient. Narcolepsy (Ritalin and Ritalin SR only) Ritalin/Ritalin SR is indicated in the treatment of narcolepsy. 2 4.Dosage and Aadministration GeneralDosage The dosage of Ritalin should be individualiszed according to the patient's clinical needs and responses. In the treatment of ADHD, an attempt should be made to time administration to coincide with the periods of greatest academic, behavioural, and or social stress. Ritalin should be started at a low dose, with increments at weekly intervals. Daily doses above 60 mg are not recommended. for the treatment of narcolepsy, or for the treatment of ADHD in children. Daily doses above 80 mg are not recommended for the treatment of ADHD in adults.. If the effect of the drug wears off too early in the evening, disturbed behaviour and/or inability to go to sleep may recur. A small evening dose of the normalritalin tablet or an afternoon dose of the Ritalin SR tablet may help to solve this problem. Ritalin should be discontinued periodically to assess the child's condition. Improvement may continue when the drug is temporarily or permanently discontinued. Drug treatment should not, and need not, be indefinite. It can usually be discontinued during or after puberty. Periodic assessment of the treatment in ADHD Drug treatment needs not be indefinite. Physicians should periodically re-evaluate the treatment with trial periods off medication to assess the patient s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued. When used in children with ADHD, treatment can usually be discontinued during or after puberty ADHD Children and adolescents (6 years and over) SR Tablets: Ritalin SR tablets have a duration of action of about 8 hours. They may therefore be used when a prolonged effect is desired exceeding the duration of action of standard Ritalin tablets. Ritalin SR tablets must be swallowed whole and never crushed or chewed and should be taken after meals, preferably after a substantial breakfast (see section 11 Clinical pharmacology). LA Capsules: Ritalin LA (methylphenidate hydrochloride modified-release capsules) is for oral administration once daily in the morning. The recommended starting dose of Ritalin LA 3 is 20 mg. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with Ritalin LA 10 mg. Ritalin LA capsules may be administered with or without food. They may be swallowed as whole capsules or alternatively may be administered by sprinkling the contents over a small amount of food (see specific instructions below). Ritalin LA capsules and/or their contents should not be crushed, chewed, or divided. A maximum daily dose of 60 mg should not be exceeded. Adults Ritalin LA is administered once daily. Patients new to methylphenidate (see section 11 Clinical Pharmacology): The recommended starting dose of Ritalin LA in patients who are not currently taking methylphenidate is 20 mg once daily. Patients currently using methylphenidate: Treatment may be continued with the same daily dose. A maximum daily dose of 80 mg should not be exceeded. No difference in dosing is recommended between male and female adult patients (see section 12 Clinical studies) Switching patient s treatment to Ritalin LA The recommended dose of Ritalin LA should be equal to the total daily dose of the immediate-release formulation not exceeding a total dose of 60 mg in children and 80 mg in adults. An example in patients being switched from the immediate-release formulation or the sustained-release formulation is provided below. Table 4-1 Recommended daily dose when switching patient s treatment to Ritalin LA For other methylphenidate regimens, clinical judgement should be used when selecting the starting dose. Ritalin LA dosage may be adjusted at weekly intervals in 10 mg increments for children and in 20 mg increments for adults. AdultsNarcolepsy Only the Ritalin and Ritalin SR formulations are approved in the treatment of narcolepsy in adults. SR Tablets: Ritalin SR tablets have duration of action of about 8 hours. They may therefore be used when a prolonged effect is desired exceeding the duration of action of standard Ritalin tablets. Ritalin SR tablets must be swallowed whole and never crushed or chewed and should be taken after meals, preferably after a substantial breakfast (see section 11 Clinical pharmacology). A maximum daily dose of 60 mg should not be exceeded. 0 Special populations Renal impairment No studies have been performed in renally impaired patients (see section 11 Clinical pharmacology). Hepatic impairment No studies have been performed in hepatically impaired patients (see section 11 Clinical pharmacology). Geriatric patients No studies have been performed in patients over 60 years of age (see section 11 Clinical pharmacology). Method of administration General recommendations Ritalin 10 mg Ttablets: can be taken with or without food (see section 11 Clinical pharmacology). Ritalin SR Ttablets must be swallowed whole and never crushed or chewed and should be taken after meals, preferably after a substantial breakfast (see section 11 Clinical pharmacology). Ritalin LA Ccapsules and/or their contents should not be crushed, chewed, or divided. 5. Contraindications 1. Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder. 2. Diagnosis or history of severe and episodic (Type 1) Bipolar (affective) disorder (that is not well controlled) 3. During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 2 weeks of discontinuing those drugs, due to risk of hypertensive crisis (see section 8 Interactions) 6. Warnings and Pprecautions The decision to prescribe Ritalin should depend on an assessment of the severity of symptoms and, in pediatric patients, their appropriateness to the child's age, and not simply on the presence of one or more abnormal behavioral characteristics.. Psychiatric 7 Aggressive behaviour: Emergent aggressive behaviour or an exacerbation of baseline aggressive behaviour has been reported during stimulant therapy, including Ritalin. Physicians should evaluate the need for adjustment of treatment regimen in patients experiencing these behavioural changes, bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered. Suicidal tendency: Patients with emergent suicidal ideation and behaviour during treatment for ADHD should be evaluated immediately by their physician. Tics: Family history should be assessed and clinical evaluation for tics or Tourette s syndrome in childrenpatients should precede use of methylphenidate for ADHD treatment. Ritalin is contraindicated in case of diagnosis or family history of Tourette s syndrome (see section 5 Contraindications).Patients should be regularly monitored for the emergence or worsening of tics during treatment with Ritalin Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. Drug Aabuse and dependence Chronic abuse of Ritalin can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Haematological effects Use in children Pediatric patients under 6 years of age 7. Adverse drug reactions Decreased appetite is also very common but usually transient. Abdominal pain, nausea and vomiting are common to very common, usually occur at the beginning of treatment and may be alleviated by concomitant food intake. 6 Tabulated summary of adverse drug reactions Adverse drug reactions listed in (Table 7-1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked under headings ofby frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the using the following convention: (CIOMS III): very common ( 1/10); common ( 1/100 to 1/10); uncommon ( 1/1,000 to 1/100); rare ( 1/10,000 to 1/1,000); very rare ( 1/10,000).very common 10%, common 1% to 10%; uncommon 0.1% to 1%; rare 0.01% to 0.1%; very rare 0.01%. Table 7-1 Adverse reactions reported with Ritalin use from clinical trials, spontaneous reports and literature Infection and infestation Very common Blood and the lymphatic system disorders Very rare Immune system disorders Very rare Metabolism and nutrition disorders Very Ccommon Rare Psychiatric disorders Very common: Common Very rare Nervous system disorders Common Very rare Eye disorders Rare Cardiac disorders Common Rare Nasopharyngitis* Leucopenia, thrombocytopenia, anaemia Hypersensitivity reactions, including angioedema and anaphylaxis Decreased appetite** Moderately reduced weight gain during prolonged use in children Nervousness, insomnia Anxiety*, restlessness*, sleep disorder*, agitation* Hyperactivity, psychosis (sometimes with visual and tactile hallucinations), transient depressed mood. Dyskinesia, tremor*, Hheadache, drowsiness, dizziness, dyskinesia Convulsions, choreoathetoid movements, tics or exacerbation of existing tics and Tourette s syndrome, cerebrovascular disorders including vasculitis, cerebral haemorrhages and cerebrovascular accidents. Difficulties in visual accommodation, blurred vision Tachycardia, palpitation, arrhythmias, changes in blood pressure and heart rate (usually an increase) Angina pectoris 5 Respiratory, Thoracic and mediastinal disorders Common Cough* Gastrointestinal disorders Very common Nausea**, dry mouth** Common Hepatobiliary disorders Very rare Skin and subcutaneous tissue disorders Common Abdominal pain, nausea, vomiting, dry mouthdyspepsia*, toothache* Abnormal liver function, ranging from transaminase elevation to hepatic coma Rash, pruritus, urticaria, fever, scalp hair loss, hyperhidrosis* Very rare Thrombocytopenic purpura, exfoliative dermatitis, erythema multiforme Musculoskeletal and connective tissue disorders Common Arthralgia Very rare Muscle cramps General disorders and administration site conditions Common Feeling jittery* Rare Slight growth retardation during prolonged use in children Investigations Common Weight decreased* * ADRs reported from the clinical trial performed with Ritalin LA in adult ADHD patients ** The reported frequency of ADRs was based on the frequency observed in the adult ADHD clinical study which was higher than that previously reported for children. Additional adverse reactions reported with other methylphenidate-containing products The list below shows adverse reactions not listed for Ritalin (see Table 7-1) that have been reported with other methylphenidate-containing products based on clinical trials data and post-marketing spontaneous reports. Infections and infestations: Nasopharyngitis Psychiatric disorders: Anxiety, iirritability, aggression, affect lability, agitation, abnormal behaviour or thinking, anger, suicidal ideation or attempt (including completed suicide), mood altered, mood swings, hypervigilance, mania, disorientation, libido disorder, apathy, repetitive behaviours, over-focussing, confusional state, dependence, cases of abuse and dependence have been described, more often with immediate release formulations. Nervous system disorders: Tremor, rreversible ischaemic neurological deficit, migraine Eye disorders: Diplopia, Mmydriasis, visual disturbance Respiratory, thoracic and mediastinal disorders: Cough, ppharyngolaryngeal pain, dyspnoea 8 Gastrointestinal disorders: Diarrhoea, constipation Skin and subcutaneous tissue disorders: Angioneurotic oedema, hyperhidrosis, erythema, fixed drug eruption Renal and urinary disorders: Haematuria Reproductive system and breast disorders: Gynaecomastia, priapism Investigations: Weight decreased, ccardiac murmur 8. Interactions Pharmacodynamic interactions Use with drugs that elevate blood pressure Because of possible hypertensive crisis, Ritalin is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 5 Contraindications) Use with halogenated anaesthetics There is a risk of sudden blood pressure and heart rate increase during surgery. If surgery is planned, Ritalin should not be taken on the day of surgery. Use with dompampinergic drugs Pharmacokinetic interactions Case reports suggested a potential interaction of Ritalin with coumarin anticoagulants, some anticonvulsants (e.g. phenobarbital, phenytoin, primidone), phenylbutazone, and tricyclic antidepressants but pharmacokinetic interactions were not confirmed when explored at higherlarger sample sizes. The dosage of these drugs might have to be reduced. An interaction with the anticoagulant ethylbiscoumacetate in 4 subjects was not confirmed in a subsequent study with a higher larger sample size (n=12). 9.Women of child-bearing potential, Ppregnancy, and Bbreast-feeding and fertility Women of child-bearing potential There are no data to support special recommendation in women of child-bearing potential. 7 Pregnancy Studies to establish safe use of methylphenidate in pregnant women have not been conducted. There is insufficient experience with use of methylphenidate in pregnant women. Ritalin should not be given to pregnant women unless the potential benefit outweighs the risk to the foetus. Methylphenidate is potentially teratogenic in rabbits (see section 13 Non-clinical safety data). Fertility No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice (see section 13 Non-clinical safety data). 10. Overdosage. Management When treating an overdose, practitioners should bear in mind that a second release of methylphenidate from Ritalin LA (methylphenidate hydrochloride modified-release capsules) occurs at approximately four hours after administration. The efficacy of peritoneal dialysis or extracorporeal haemodialysis for Ritalin overdosage has not been established. Clinical experience with acute overdosage is limited. 11. Clinical pharmacology Pharmacotherapeutic group, ATC: Pharmacotherapeutic group: ppsychostimulants - ATC code: NO6B AO4. Mechanism of action (MOA)/ Pharmacodynamics (PD) Pharmacokinetics (PK) Absorption Food Effects Biotransformation/metabolism Characteristics in patients Special populations Effect of age: 14 Patients with renal impairment: 12. Clinical studies Ritalin has been used for over years in the treatment of ADHD. Children with ADHD Adults with ADHD Ritalin LA was evaluated in a randomized, double-blind, placebo-controlled, multicentre study (RIT124D2302) in the treatment of 725 adult patients (395 male and 330 female) diagnosed with ADHD according to DSM-IV ADHD criteria. The study was desig
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