Summary of risk management plan for Methylphenidate modifiedrelease hard capsules (methylphenidate)
|
|
- Josephine Knight
- 5 years ago
- Views:
Transcription
1 Part VI: Summary of the risk management plan Summary of risk management plan for Methylphenidate modifiedrelease hard capsules (methylphenidate) This is a summary of the risk management plan (RMP) for Methylphenidate modified-release hard capsules. The RMP details important risks of Methylphenidate modified-release hard capsules, how these risks can be minimised, and how more information will be obtained about Methylphenidate modified- release hard capsules' risks and uncertainties (missing information). Methylphenidate modified-release hard capsules' summary of product characteristics (SmPC) and its package leaflet (PL) give essential information to healthcare professionals and patients on how Methylphenidate modified-release hard capsules should be used. Important new concerns or changes to the current ones will be included in updates of Methylphenidate modified-release hard capsules' RMP. I. The medicine and what it is used for Methylphenidate modified-release hard capsules is authorised: - Attention-Deficit/Hyperactivity Disorder (ADHD) Methylphenidate is indicated as part of a comprehensive treatment programme for attentiondeficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over and adults when remedial measures alone prove insufficient. Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist. Special diagnostic considerations for ADHD in children Diagnosis should be made according to DSM criteria or the guidelines in ICD and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom. The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources. A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised 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. Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the child s symptoms in relation to the child s age. Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms. Methylphenidate should always be used in this way according to the licensed indication and according to prescribing/diagnostic guidelines. - Special diagnostic considerations for ADHD in adults Diagnosis should be made according to DSM criteria or the guidelines in ICD and should be based on a complete history and evaluation of the patient. The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adults with ADHD have symptom patterns characterised by, restlessness, impatience, and inattentiveness. Symptoms such as hyperactivity tend to diminish with increasing age possibly due to adaptation, neurodevelopment and self-medication. 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 pre-existence of childhood ADHD is required
2 and has to be determined retrospectively (by patients records or if not available by appropriate and structured instruments/interviews). Third-party corroboration is desirable and <invented name> should not be initiated when the verification of childhood ADHD symptoms is uncertain. 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 and diagnosis should include moderate or severe functional impairment in at least 2 settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual s life. It contains methylphenidate as the active substance and it is given orally. II. Risks associated with the medicine and activities to minimise or further characterise the risks Important risks of Methylphenidate modified-release hard capsules, together with measures to minimise such risks and the proposed studies for learning more about Methylphenidate modified-release hard capsules risks, are outlined below. Measures to minimise the risks identified for medicinal products can be: Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals; Important advice on the medicine s packaging; The authorised pack size the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly; The medicine s legal status the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks. Together, these measures constitute routine risk minimisation measures. In the case of Methylphenidate modified-release hard capsules, these measures are supplemented with additional risk minimisation measures mentioned under relevant important risks, below. In addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities. II.A List of important risks and missing information Important risks of Methylphenidate modified-release hard capsules are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Methylphenidate modified-release hard capsules. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine); List of important risks and missing information Important identified risks Hypertension Tachycardia Raynaud s phenomenon Hallucinations (auditory, skin, sensation, visual disturbance) Psychosis/Mania Anorexia Decreased rate of growth Aggression Depression
3 Important potential risks Migraine Repetitive behaviours QT prolongation Cyanosis Arrhythmias Sudden death Ischaemic cardiac events Cerebrovascular disorders Hostility Suicidality Tics/Tourette s syndrome/dystonias Effect on final height Sexual maturation (delayed) Carcinogenicity Off-label use Diversion Withdrawal syndrome Drug abuse and Drug dependence Lymphocytic leukaemia Neonatal cardio-respiratory toxicity neonatal Neonatal effects on growth Cardiomyopathy List of important risks and missing information Missing information None II.B Summary of important risks Important identified risk: Hypertension A contraindication in patients with pre-existing severe hypertension is stated in section 4.3. The concomitant or recent use of MAOIs and methylphenidate is also contraindicated as stated in sections 4.3 and 4.5. Recommendations of recording blood pressure and pulse are included in section 4.4 of the SmPC. According to Section 2 of the PL, product must not be used in case of treatment with non-selective, irreversible MAO inhibitors or in case of very high blood pressure; in this section there is also a warning stating that patient should inform the doctor or pharmacist in case of high blood pressure.
4 Important identified risk: Tachycardia A contraindication in patients with pre-existing cardiovascular disorders is stated in section 4.3. Recommendation of performing a physical exam to assess for the presence of cardiac disease is included in section 4.4 of the SmPC. According to Section 2 of the PL, product must not be used in case of heart problems such as uneven heartbeat. Important identified risk: Tachycardia Important identified risk: Hallucinations (auditory, skin, sensation, visual disturbance) A contraindication in patients diagnosed with schizophrenia, is stated in section 4.3. Recommendation of performing a psychiatric exam to assess the presence of pre-existing psychiatric disorders is included in section 4.4 of the SmPC. According to Section 2 of the PL, product must not be use in patients with mental health problems such as abnormal thoughts, hallucinations or schizophrenia. There is also a warning in this section of the PL stating that patient should inform the doctor or pharmacist in case of having a mental health problem of hallucinations or delusions.
5 Important identified risk: Psychosis/Mania A contraindication in patients diagnosed with psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline disorder is stated in section 4.3. In section 4.4 of the SmPC there is a warning stating that the use of product may cause or exacerbate psychotic or manic symptoms. According to Section 2 of the PL, product must not be used in case of mental health problems such as psychopathic, borderline personality, schizophrenia or mania. Important identified risk: Anorexia A contraindication in patients with anorexia nervosa or anorexic disorders is stated in section 4.3. According to Section 2 of the PL, product must not be used in case of anorexia nervosa. Important identified risk: Decreased rate of growth Recommendation of recording height in children is included in section 4.4 of the SmPC.
6 Important identified risk: Aggression According to section 4.4 of the SmPC, patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit. According to Section 2 of the PL, there is a warning stating that patient should inform the doctor or pharmacist in case of starting or increasing to be aggressive or hostile. Important identified risk: Depression A contraindication in patients with pre-existing severe depression is stated in section 4.3. According to section 4.4 of the SmPC, prior to initiating treatment with methylphenidate, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. According to Section 2 of the PL, product must not be used in case of severe depression; in this Section there is also a warning stating that patient should inform the doctor or pharmacist in case of mood swings.
7 Important potential risk: Migraine PL section 4. Important potential risk: Repetitive behaviours PL section 4. Important potential risk: QT prolongation None. Important potential risk: Arrhythmias A contraindication in patients with pre-existing potentially lifethreatening arrhythmias is stated in section 4.3.
8 Important potential risk: Arrhythmias According to section 4.4 of the SmPC, cardiovascular status should be carefully monitored in patients using product. According to Section 2 of the PL, there is a warning stating that patient should inform the doctor or pharmacist in case of heart problems. Important potential risk: Sudden death As stated in section 4.4 of the SmPC, sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children, some of whom had cardiac structural abnormalities or other serious heart problems; therefore, product is not recommended in patients with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems. In addition, misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events. Section 2 of the PL stated that doctor should check whether there is any family history of sudden unexplained death. Important potential risk: Ischaemic cardiac events
9 Important potential risk: Ischaemic cardiac events A contraindication in patients with pre-existing cardiovascular disorders including heart failure, angina pectoris, and myocardial infarction is stated in section 4.3. Recommendations of monitoring cardiovascular status is included in section 4.4 of the SmPC. In addition, in this section is stated that misuse of stimulants of the central nervous system may be associated with serious cardiovascular adverse events. According to Section 2 of the PL, product must not be used in case of pre-existing heart problems such as a heart attack or heart failure. Important potential risk: Cerebrovascular disorders PL section 4. A contraindication in patients with pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke is stated in section 4.3. Recommendations of considering the diagnosis of cerebral vasculitis in any patient who develops new neurological symptoms that are consistent with cerebral ischaemia during methylphenidate therapy is included in section 4.4 of the SmPC. These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory. According to Section 2 of the PL, product must not be used in case of pre-existing problems with the brain blood vessels such as a stroke, swelling and weakening of part of a blood vessel (aneurysm), narrow or blocked blood vessels, or inflammation of the blood vessels (vasculitis).
10 Important potential risk: Hostility A contraindication in patients with pre-existing severe mood disorders is stated in section 4.3. In section 4.4 of the SmPC is recommended that patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit. According to Section 2 of the PL, there is a warning stating that the patient should inform the doctor or pharmacist in case of starting to be aggressive or hostile. Important potential risk: Suicidality A contraindication in patients with pre-existing suicidal tendencies is stated in section 4.3. In section 4.4 of the SmPC is recommended that patients with emergent suicidal ideation during treatment for ADHD should be evaluated immediately by their physician.
11 Important potential risk: Tics/Tourette s syndrome/dystonias In section 4.4 of the SmPC is recommended that patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate. Monitoring is recommended at every adjustment of dose and then at least every 6 months or every visit. According to Section 2 of the PL, there is a warning stating that patients should inform the doctor or pharmacist if they or any other member of their family have hard-to-control repeated twitching of any parts of the body or repeat sounds and words (tics). Important potential risk: Effect on final height Recommendations of recording of height according to the child s age at least 6 monthly with maintenance of a growth chart is included in section 4.4 of the SmPC. Important potential risk: Off-label use According to section 4.2, product must not be used in children less of 6 years and in elderly as safety and efficacy has not been established in these groups of age.
12 Important potential risk: Off-label use In addition, as stated in section 4.4 of the SmPC, product should not be used for prevention or treatment of normal fatigue states. According to section 1 of the PL, it is not known if product is safe or its benefits in children under 6 years of age. Important potential risk: Diversion Recommendations of monitoring the risk of diversion is included in section 4.4 of the SmPC. Important potential risk: Drug abuse and Drug dependence Recommendations of monitoring the risk of abuse is included in section 4.4 of the SmPC. Important potential risk: Lymphocytic leukaemia None.
13 Important potential risk: Neonatal cardio-respiratory toxicity neonatal In section 4.6 of the SmPC is stated that cases of neonatal cardiorespiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous case reports. In addition, methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy. According to Section 2 of the PL, there is a warning stating that patients should inform the doctor or pharmacist in case of pregnancy. Important potential risk: Neonatal effects on growth In section 4.6 of the SmPC is stated that methylphenidate has been found in the breast-milk of women treated with it. In addition, it is stated to make a decision whether to discontinue breastfeeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. According to Section 2 of the PL, there is a warning stating that patients should inform the doctor or pharmacist if they are breastfeeding or are planning to breast-feed. Important potential risk: Neonatal effects on growth
14 Important potential risk: Cardiomyopathy II.C Post-authorisation development plan As stated in Section 4.3 of the SmPC, product is contraindicated in case of pre-existing cardiovascular disorders, including cardiomyopathies. In addition, there is a warning in Section 4.4 stating that stimulant products are not recommended in patients with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine. According to Section 2 of the PL, product must not be used in patients that have ever had heart problems. II.C.1 Studies which are conditions of the marketing authorisation There are no studies which are conditions of the marketing authorisation or specific obligation of Methylphenidate modified-release hard capsules. II.C.2 Other studies in post-authorisation development plan There are no studies required for Methylphenidate modified-release capsules.
CONCERTA (methylphenidate hydrochloride) Risk Management Plan Version 7.0
VI.2. Elements for a Public Summary CONCERTA contains the active substance methylphenidate hydrochloride. The name methylphenidate will also be used in this summary. VI.2.1. Overview of Disease Epidemiology
More informationCardiff & Vale (C&V) UHB Corporate Medicines Management Group (c MMG) SHARED CARE DRUG: LISDEXAMFETAMINE PROTOCOL NUMBER: CV 57
Cardiff & Vale (C&V) UHB Corporate Medicines Management Group (c MMG) SHARED CARE DRUG: LISDEXAMFETAMINE PROTOCOL NUMBER: CV 57 INDICATION: Attention deficit hyperactivity disorder (ADHD) as part of a
More informationBlood pressure and pulse should be recorded on a centile chart at each dose adjustment and then at least every 6 months
Checklist 1: checklist before prescribing Amfexa 5mg, 10mg and 20mg Tablets It is recommended that this checklist be used in conjunction with the SmPCs for Amfexa Tablets (which can be accessed at http://www.medicines.org.uk/emc/search
More informationPublic Assessment Report Scientific discussion. Methylphenidate E Consult (methylphenidate hydrochloride) Asp no: , ,
Public Assessment Report Scientific discussion Methylphenidate E Consult (methylphenidate hydrochloride) Asp no: 2014-1206, 2014-1207, 2014-1208 This module reflects the scientific discussion for the approval
More informationOpinion 3 October 2012
The legally binding text is the original French version TRANSPARENCY COMMITTEE Opinion 3 October 2012 RITALIN 10 mg, tablet B/30 (CIP code: 34009 339 294 0-4) RITALIN LP 10 mg, sustained-release tablets
More informationAtomoxetine Effective Shared Care Agreement For Attention Deficit Hyperactivity Disorder (ADHD)
Atomoxetine Effective Shared Care Agreement For Attention Deficit Hyperactivity Disorder (ADHD) Section 1: Shared Care arrangements and responsibilities Section 1.1 Agreement to transfer of prescribing
More informationElements for a Public Summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Schizophrenia Schizophrenia is a mental disorder often characterized by abnormal social behaviour and failure to recognize what
More informationPART VI Summary of the RMP
PART VI Summary of the RMP Summary of Risk Management Plan for ORKAMBI This is a summary of the risk management plan (RMP) for ORKAMBI. The RMP details important risks of ORKAMBI, how these risks can be
More informationPUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) MODAFINIL ORION 100 MG, 200 MG Tablets ORION CORPORATION DATE: , VERSION 1.
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN (RMP) MODAFINIL ORION 100 MG, 200 MG Tablets ORION CORPORATION DATE: 22-04-2015, VERSION 1.1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology
More informationSummary of risk management plan for Prasugrel Mylan (prasugrel)
EMA/243819/2018 Summary of risk management plan for Prasugrel Mylan (prasugrel) This is a summary of the risk management plan (RMP) for Prasugrel Mylan. The RMP details important risks of prasugrel, how
More informationMethylphenidate Shared Care Agreement For attention deficit hyperactivity disorder (ADHD) in adults Effective Shared Care Agreement
Methylphenidate Shared Care Agreement For attention deficit hyperactivity disorder (ADHD) in adults Effective Shared Care Agreement Section 1: Shared Care arrangements and responsibilities Section 1.1
More informationSummary of risk management plan for Trazimera (trastuzumab)
Summary of risk management plan for Trazimera (trastuzumab) Summary of risk management plan for PF-05280014 (trastuzumab) 1 This is a summary of the RMP for PF-05280014. The RMP details important risks
More informationSummary of the risk management plan (RMP) for Aripiprazole Mylan Pharma (aripiprazole)
EMA/370707/2016 Summary of the risk management plan (RMP) for Aripiprazole Mylan Pharma (aripiprazole) This is a summary of the risk management plan (RMP) for Aripiprazole Mylan Pharma, which details the
More informationIRONSHORE TO PRESENT THREE POSTERS AT THE 2019 ANNUAL AMERICAN PROFESSIONAL SOCIETY OF ADHD AND RELATED DISORDERS (APSARD) MEETING
FOR IMMEDIATE RELEASE IRONSHORE TO PRESENT THREE POSTERS AT THE 2019 ANNUAL AMERICAN PROFESSIONAL SOCIETY OF ADHD AND RELATED DISORDERS (APSARD) MEETING George Town, Cayman Islands January 10, 2019 Ironshore
More informationVI.2 Elements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Incidence and prevalence of target indication Schizophrenia is a mental disorder characterized by a breakdown of thought processes
More informationSummary of risk management plan for Dzuveo (Sufentanil (as citrate))
Part VI: Summary of the risk management plan Summary of risk management plan for Dzuveo (Sufentanil (as citrate)) This is a summary of the risk management plan (RMP) for Dzuveo. The RMP details important
More informationSummary of risk management plan for Colpermin (peppermint oil)
Part VI: Summary of the risk management plan Summary of risk management plan for Colpermin (peppermint oil) This is a summary of the risk management plan (RMP) for Colpermin. The RMP details important
More informationSummary of safety concerns Important identified risks
Valley VI.2 Elements for a public summary NL/H/3661/001-002/DC - Ivabradin Medical VI.2.1 Overview of disease epidemiology Ivabradine is a medicine used for two long-term (chronic) heart conditions: to
More informationSummary of risk management plan for Ulunar Breezhaler (Indacaterol/glycopyrronium)
Part VI: Summary of the risk management plan Summary of risk management plan for Ulunar Breezhaler (Indacaterol/glycopyrronium) This is a summary of the RMP for Ulunar Breezhaler. The RMP details important
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN Summary of Risk Management Plan for PREZISTA (Darunavir [TMC114]) This is a summary of the risk management plan (RMP) for PREZISTA. The RMP details important
More information1. What Ritalin LA is and what it is used for
Package Leaflet: Information for the user Ritalin LA, 20 30 40 mg capsules Methylphenidate The name of your medicine is Ritalin LA. It contains the active substance methylphenidate hydrochloride. The name
More informationElements for a Public Summary
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Schizophrenia Schizophrenia is a mental illness with a number of symptoms, including confused or unclear thinking and speech,
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN Summary of Risk Management Plan for REZOLSTA This is a summary of the risk management plan (RMP) for REZOLSTA. The RMP details important risks of REZOLSTA,
More informationEffective Shared Care Agreement (ESCA) Methylphenidate (from age 6 years) Approved for Solihull locality only.
Effective Shared Care Agreement (ESCA) Methylphenidate (from age 6 years) Approved for Solihull locality only. ESCA: For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) as part of a comprehensive
More informationSummary of the risk management plan (RMP) for Intuniv (guanfacine)
EMA/530486/2015 Summary of the risk management plan (RMP) for Intuniv (guanfacine) This is a summary of the risk management plan (RMP) for Intuniv, which details the measures to be taken in order to ensure
More informationSwiss Summary of the Risk Management Plan (RMP) for Ongentys (opicapone) 50 mg hard capsules
Swiss Summary of the Risk Management Plan (RMP) for Ongentys (opicapone) 50 mg hard capsules Final Version 1.0 (08 June 2018) The Risk Management Plan (RMP) is a comprehensive document submitted as part
More informationBournemouth, Dorset and Poole Prescribing Forum
SHARED CARE GUIDELINES FOR PRESCRIBING OF METHYLPHENIDATE IN ATTENTION DEFICIT HYPERACTIVITY DISORDER IN CHILDREN INDICATION Methylphenidate is generally regarded as a first line choice of treatment for
More informationElements for a public summary
VI.2 Elements for a public summary Part VI.2 Elements for a public summary is applicable for all products that are covered by this RMP, except from the important potential risk of Medication error with
More information6.2 Elements for a Public Summary
6.2 Elements for a Public Summary 6.2.1 Overview of disease epidemiology Invicorp is to be used for erectile dysfunction, also known as impotence, the inability to get and maintain an erection that is
More informationSummary of Activities in the Risk Management Plan (RMP) for DARZALEX (daratumumab)
DARZALEX - Risk Management Plan Summary of Activities in the Risk Management Plan (RMP) for DARZALEX (daratumumab) Document Version: 3.2 Document Date: 14 August 2018 Page 1 / 8 The Risk Management Plan
More informationChild and Adolescent Mental Health Services (CAMHS)
Child and Adolescent Mental Health Services (CAMHS) Effective shared care agreement (ESCA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with METHYLPHENIDATE This form must be completed
More informationPUBLIC SUMMARY OF RISK MANAGEMENT PLAN MIRTAZAPIN ORION 15MG, 30MG AND 45MG TABLETS ORION CORPORATION DATE: , VERSION 2
PUBLIC SUMMARY OF RISK MANAGEMENT PLAN MIRTAZAPIN ORION 15MG, 30MG AND 45MG TABLETS ORION CORPORATION DATE: 16-12-2014, VERSION 2 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology
More informationHyperandrogenism and polycystic ovary syndrome are clear casual factors (trends) which result in hirsuitism and acne.
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Indication: Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism,
More informationSummary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin)
EMA/285074/2015 Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin) This is a summary of the risk management plan (RMP) for Pregabalin Mylan, which details the measures to be taken
More informationTell your doctor if you have ever abused or been dependent on alcohol, prescription medicine or street drugs.
MEDICATION GUIDE Daytrana (day-tron-ah) (methylphenidate transdermal system) CII Only Use Daytrana on Your Skin Important: Daytrana is a federally controlled substance (CII) because it can be abused or
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN 2 RISKS ASSOCIATED WITH THE MEDICINE AND ACTIVITIES TO MINIMIZE OR FURTHER CHARACTERISE THE RISKS
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN Summary of risk management plan for Briviact This is a summary of the risk management plan (RMP) for Briviact. The RMP details important risks of Briviact,
More informationSummary of the risk management plan (RMP) for Duloxetine Mylan (duloxetine)
EMA/281284/2015 Summary of the risk management plan (RMP) for Duloxetine Mylan (duloxetine) This is a summary of the risk management plan (RMP) for Duloxetine Mylan, which details the measures to be taken
More informationZopiclone Orion. Date: , Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Zopiclone Orion Date: 16-11-2016, Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Insomnia (i.e. sleeplessness) is a common
More informationYour B.E.D. Discussion Guide
Your B.E.D. Discussion Guide Binge Eating Disorder (B.E.D.) is a real medical disorder. Mark any symptoms you ve been experiencing within the last 3 months. Share your results with your doctor to help
More informationDocument Details Shared Care Agreement Lisdexamfetamine Trust Ref No Local Ref (optional) Main points the document covers
Document Details Title Shared Care Agreement Lisdexamfetamine Trust Ref No 1989-33708 Local Ref (optional) Main points the document covers The responsibilities of each partner entering into the shared
More informationPrescribing framework for Dexamfetamine for Attention Deficit Hyperactive Disorder
Hull & East Riding Prescribing Committee Prescribing Framework for Dexamfetamine for Attention Deficit Hyperactive Disorder Patient s Name:.. NHS Number: Patient s Address:... (Use addressograph sticker)
More informationPART VI. SUMMARY OF THE RISK MANAGEMENT PLAN Summary of risk management plan for ZINFORO
PART VI. SUMMARY OF THE RISK MANAGEMENT PLAN Summary of risk management plan for ZINFORO This is a summary of the risk management plan (RMP) for ZINFORO. The RMP details important risks of ZINFORO, how
More informationIssue date September 2010 (Reviewed October 2013) Clinicians from Andrew Lang Centre, Mental. Specialist Pharmacist & Formulary Pharmacist
Title Document Type Issue no Shared care guidelines in the Treatment of Attention Deficit/ Hyperactivity Disorders Shared Care Guidelines and Information for GPs Clinical Governance Support Team Use Issue
More informationPrescribing Framework for Lisdexamfetamine for Attention Deficit Hyperactivity Disorder
Hull & East Riding Prescribing Committee Prescribing Framework for Lisdexamfetamine for Attention Deficit Hyperactivity Disorder Patient s Name:.. NHS Number: Patient s Address:... (Use addressograph sticker)
More informationPSYCHOTROPIC MEDICATION UTILIZATION PARAMETERS FOR CHILDREN AND YOUTH IN FOSTER CARE
PSYCHOTROPIC MEDICATION UTILIZATION PARAMETERS FOR CHILDREN AND YOUTH IN FOSTER CARE Introduction and General Principles April 2017 Adapted for New Mexico from with permission from the Texas Department
More informationSummary of the risk management plan (RMP) for Hemangiol (propranolol)
EMA/122592/2014 Summary of the risk management plan (RMP) for Hemangiol (propranolol) This is a summary of the risk management plan (RMP) for Hemangiol, which details the measures to be taken in order
More informationElements for a public summary
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Parkinson s disease affects individuals globally (WHO 2006). It is the most common serious movement disorder, including speech
More informationSummary of risk management plan for Nerlynx
Summary of risk management plan for Nerlynx This is a summary of the risk management plan (RMP) for Nerlynx. The RMP details important risks of Nerlyx, how these risks can be minimised, and how more information
More informationSummary of the risk management plan (RMP) for Ivabradine Anpharm (ivabradine)
EMA/518024/2015 Summary of the risk management plan (RMP) for Ivabradine Anpharm (ivabradine) This is a summary of the risk management plan (RMP) for Ivabradine Anpharm, which details the measures to be
More informationSummary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin)
EMA/247834/2014 Summary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin) Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised
More informationSummary of the risk management plan (RMP) for Duloxetine Zentiva (duloxetine)
EMA/450483/2015 Summary of the risk management plan (RMP) for Duloxetine Zentiva (duloxetine) This is a summary of the risk management plan (RMP) for Duloxetine Zentiva, which details the measures to be
More informationElements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Chronic lymphocytic leukaemia 1 Chronic lymphocytic leukemia (CLL) is a condition characterized by a progressive accumulation
More informationPart VI: Summary of the risk management plan by product
Part VI: Summary of the risk management plan by product VI.1 Elements for summary tables in the EPAR VI.1.1 Summary table of Safety concerns Summary of safety concerns Important identified risks Hepatotoxic
More informationSummary of the risk management plan (RMP) for Wakix (pitolisant)
EMA/794885/2015 Summary of the risk management plan (RMP) for Wakix (pitolisant) This is a summary of the risk management plan (RMP) for Wakix, which details the measures to be taken in order to ensure
More informationSHARED PRESCRIBING GUIDELINE
working in partnership with Kingston Richmond Wandsworth SHARED PRESCRIBING GUIDELINE Sutton & Merton Methylphenidate, Dexamfetamine and Atomoxetine for Attention Deficit Hyperactivity Disorder in patients
More informationPregabalin Aristo Version: RMP-Pregabalin0
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised by recurring seizures (or fits). It is one
More informationA study conducted in Norway found the combined estimate for panic and generalized anxiety disorder was 1.10 per 1,000 person-years.
VI.2 Elements for a public summary For sake of completeness, with reference to article 11 of the Directive 2001/83, the applicant retains the option to carve out the patented indication in the national
More informationShared Care Framework for Dexamfetamine the treatment of ADHD in Adults Date approved by Joint Medicines Operational Group 1/12/17
This policy statement is approved by Southport and Formby, and South Sefton CCGs Southport and Formby South Sefton Shared Care Framework for Dexamfetamine the treatment of ADHD in Adults Date approved
More informationTRANSPARENCY COMMITTEE OPINION. 10 March 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 10 March 2010 QUASYM MR 10 mg, modified-release hard capsule Box of 30 (CIP: 377 618-4) QUASYM MR 20 mg, modified-release
More informationRISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: , VERSION 1.
RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: 07-10-2016, VERSION 1.2 VI.2 Elements for a Public Summary Etoricoxib Orion
More informationElements for a Public Summary
VI.2 Elements for a Public Summary Fluticasone propionate / formoterol fumarate are available in pressarised metered dose inhalers (pmdi) under the brand names Flutiform, and in breath actuated inhalers
More information7.2 Part VI.2 Elements for a Public Summary
7.2 Part VI.2 Elements for a Public Summary 7.2.1 Part VI.2.1 Overview of disease epidemiology Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation that is usually
More information1.1 Part VI.2 Elements for a Public Summary
1.1 Part VI.2 Elements for a Public Summary 1.1.1 Part VI.2.1 Overview of disease epidemiology Schizophrenia By using precise methods in its diagnosis and a large, representative population, the incidence
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN VI.1 Summary of activities in the risk management plan The summary below was prepared based on the information included in Part II, IV and V of the present
More informationOverview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Acne vulgaris (or simply acne) is a common human skin disease, characterized by areas of skin with seborrhea (scaly red skin),
More informationAttention Deficit Hyperactivity Disorder
AMS-MOH CLINICAL PRACTICE GUIDELINES 1/2014 Attention Deficit Hyperactivity Disorder Academy of Medicine, Singapore College of Paediatrics and Child Health, Singapore College of Family Physicians Singapore
More informationPackage leaflet: Information for the patient
Package leaflet: Information for the patient Attentin 10 mg/20 mg tablets dexamfetamine sulfate This medicine is subject to additional monitoring. This will allow quick identification of new safety information.
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN VI.1 Summary of risk management plan for RELVAR ELLIPTA (fluticasone furoate/vilanterol) This is a summary of the risk management plan (RMP) for RELVAR ELLIPTA.
More informationSummary of the risk management plan (RMP) for Moventig (naloxegol)
EMA/611606/2014 Summary of the risk management plan (RMP) for Moventig (naloxegol) This is a summary of the risk management plan (RMP) for Moventig, which details the measures to be taken in order to ensure
More informationSummary of the Risk Management Plan
Summary of the Risk Management Plan Summary of Risk Management Plan for Esmya (Ulipristal Acetate) This is a summary of the risk management plan (RMP) for Esmya. The RMP details important risks of Esmya,
More informationDrugs for Emotional and Mood Disorders Chapter 16
Drugs for Emotional and Mood Disorders Chapter 16 NCLEX-RN Review Question 1 Choices Please note Question #1 at the end of Ch 16 pg 202 & Key pg 805 answer is #4 1. Psychomotor symptoms 2. Tachycardia,
More informationACOEM Commercial Driver Medical Examiner Training Program
ACOEM Commercial Driver Medical Examiner Training Program Module 7: Psychological Psychological 49 CFR 391.41(b)(9) "A person is physically qualified to drive a commercial motor vehicle if that person
More informationVyvansePro.com Learn how to use the Formulary Look-up Tool for Vyvanse (lisdexamfetamine dimesylate)
This is intended for US health care professionals only. VyvansePro.com Learn how to use the Formulary Look-up Tool for Vyvanse (lisdexamfetamine dimesylate) INDICATION Vyvanse is indicated for the treatment
More informationGREATER MANCHESTER INTERFACE PRESCRIBING GROUP. Replaces: No previous version available. Management Committee 11 th March 2014
GREATER MANCHESTER INTERFACE PRESCRIBING GROUP On behalf of the GREATER MANCHESTER MEDICINES MANAGEMENT GROUP Methylphenidate and Dexamfetamine in children and adolescents: SHARED CARE GUIDELINE Scope:
More informationSummary of the risk management plan (RMP) for Paliperidone Janssen (paliperidone)
EMA/675927/2014 Summary of the risk management plan (RMP) for Paliperidone Janssen (paliperidone) This is a summary of the risk management plan (RMP) for Paliperidone Janssen, which details the measures
More informationLisdexamfetamine dimesylate (Elvanse )
Dr Robert Schapira EFFECTIVE SHARED CARE AGREEMENT 31 Dec 1969 Lisdexamfetamine dimesylate (Elvanse ) For attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response
More informationRMP version 3.0 Aripiprazole
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Schizophrenia The prevalence (proportion of the population found to have a disease) of schizophrenia (a disease characterised
More informationAnnex III. Amendments to relevant sections of the summary of product characteristics and package leaflets
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets Note: These amendments to the relevant sections of the Summary of Product Characteristics and package
More informationSummary of the risk management plan (RMP) for Laventair (umeclidinium bromide and vilanterol)
EMA/258177/2014 Summary of the risk management plan (RMP) for Laventair (umeclidinium bromide and vilanterol) This is a summary of the risk management plan (RMP) for Laventair, which details the measures
More informationSwiss Summary of the Risk Management Plan (RMP) for Parsabiv (Etelcalcetide)
Swiss Summary of the Risk Management Plan (RMP) for Parsabiv (Etelcalcetide) RMP Summary: Version 2, November 2018 Page 1 of 9 EU RMP: Version 2.0, August 2018 The Risk Management Plan (RMP) is a comprehensive
More informationAnnex II. Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations 12 Scientific conclusions and grounds for variation to the terms of the marketing authorisations The
More informationVI.2 Elements for a Public Summary DULOXETINE Pharmalex 30 mg hard gastro-resistant capsules DULOXETINE Pharmalex 60 mg hard gastro-resistant capsules
VI.2 Elements for a Public Summary DULOXETINE Pharmalex 30 mg hard gastro-resistant capsules DULOXETINE Pharmalex 60 mg hard gastro-resistant capsules VI.2.1 Overview of disease epidemiology Depression
More informationPHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 3/15/18 SECTION: DRUGS LAST REVIEW DATE: 3/15/18 LAST CRITERIA REVISION DATE: ARCHIVE DATE:
DYANAVEL XR (amphetamine) extended-release oral suspension Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit
More informationElements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology High blood pressure, also known as hypertension, occurs in a large percentage of the adult population. Primary (essential) hypertension
More informationCardiff & Vale (C&V) UHB Corporate Medicines Management Group (c MMG) SHARED CARE. Drug: METHYLPHENIDATE Protocol number: CV 42
Cardiff & Vale (C&V) UHB Corporate Medicines Management Group (c MMG) SHARED CARE Drug: METHYLPHENIDATE Protocol number: CV 42 Indication: ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), HYPERKINETIC
More informationADHD/Hyperkinetic Disorder for Children & Young People (6-17 years) - Methylphenidate, Atomoxetine, Dexamfetamine and Lisdexamfetamine
DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AS AND FILED IN NOTES Patient Name: Date of Birth: NHS No: Name of Referring Consultant: Contact number: INTRODUCTION Attention Deficit Hyperactivity Disorder
More informationPrescribing Framework for Methylphenidate for Attention Deficit Hyperactive Disorder
Hull & East Riding Prescribing Committee Prescribing Framework for Methylphenidate for Attention Deficit Hyperactive Disorder Patient s Name:.. NHS Number: Patient s Address:... (Use addressograph sticker)
More informationMEDICATION GUIDE WELLBUTRIN (WELL byu-trin) (bupropion hydrochloride) Tablets
MEDICATION GUIDE WELLBUTRIN (WELL byu-trin) (bupropion hydrochloride) Tablets Read this Medication Guide carefully before you start using WELLBUTRIN and each time you get a refill. There may be new information.
More informationPart VI: Summary of the risk management plan by product
Version 1.3, 28-Dec-2015 Risk Management Plan of a fixed combination of Dexketoprofen trometamol and Tramadol hydrochloride (oral formulation) Part VI: Summary of the risk management plan by product VI.1
More informationElements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Parkinson s disease Parkinson s disease (PD) is in the category of movement disorders. It has four main symptoms: tremor and stiffness
More informationBournemouth, Dorset and Poole Prescribing Forum
SHARED CARE GUIDELINE FOR THE USE OF ATOMOXETINE IN ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER INDICATION Atomoxetine is a non-stimulant non-amphetamine inhibitor of noradrenaline reuptake. It
More information17.9 Food Patients may take STRATTERA with or without food.
17.5 Priapism Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with STRATTERA.
More informationAnnex I. List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant in the Member States 1 Member State EU/EEA Applicant (Invented) Name Strength Pharmaceutical
More informationRisk Management Plan
Risk Management Plan isotretinoin Version number: 4.1 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology There are several types of acne and some severe forms can cause psychosocial
More informationIMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION Sandoz Methylphenidate Tablets 10 and 20 mg (methylphenidate hydrochloride tablets) Sandoz Methylphenidate SR Tablets 20 mg (methylphenidate hydrochloride extended-release
More informationMRCPsych Pharmacology of ADHD treatment. Dr Xanthe Barkla, Consultant Child and Adolescent Psychiatrist
MRCPsych Pharmacology of ADHD treatment Dr Xanthe Barkla, Consultant Child and Adolescent Psychiatrist 04 01 17 Curriculum mapping MRCPsych Paper A(ii) covers clinical psychopharmacology MRCPsych Syllabus:
More information