DELMOSART®PROLONGED-RELEASE TABLETDysphagia
(dose form not appropriate).restricted gastro-intestinal
lumen (dose form not appropriate)
XAGGITIN®XLDysphagia (dose form not appropriate)
lINTERACTIONS→Appendix 1 : methylphenidate
lSIDE-EFFECTS
▶Common or very commonAlopecia.anxiety.appetite
decreased.arrhythmias.arthralgia.behaviour abnormal.
cough.depression.diarrhoea.dizziness.drowsiness.dry
mouth.fever.gastrointestinal discomfort.growth
retardation.headaches.hypertension.laryngeal pain.
mood altered.movement disorders.nasopharyngitis.
nausea.palpitations.sleep disorders.vomiting.weight
decreased
▶UncommonChest discomfort.constipation.dyspnoea.
fatigue.haematuria.hallucinations.muscle complaints.
psychotic disorder.suicidal tendencies.tic.tremor.
vision disorders
▶Rare or very rareAnaemia.angina pectoris.cardiac arrest
.cerebrovascular insufficiency.confusion.gynaecomastia
.hepatic coma.hyperfocus.hyperhidrosis.leucopenia.
mydriasis.myocardial infarction.neuroleptic malignant
syndrome.peripheral coldness.Raynaud’s phenomenon.
seizures.sexual dysfunction.skin reactions.sudden
cardiac death.thinking abnormal.thrombocytopenia
▶Frequency not knownDelusions.drug dependence.
hyperpyrexia.intracranial haemorrhage.logorrhea.
pancytopenia.vasculitis
lPREGNANCYLimited experience—avoid unless potential
benefit outweighs risk.
lBREAST FEEDINGLimited information available—avoid.
lMONITORING REQUIREMENTS
▶Monitor for psychiatric disorders.
▶Pulse, blood pressure, psychiatric symptoms, appetite,
weight and height should be recorded at initiation of
therapy, following each dose adjustment, and at least
every 6 months thereafter.
lTREATMENT CESSATIONAvoid abrupt withdrawal.
lDIRECTIONS FOR ADMINISTRATION
MEDIKINET®XLContents of capsule can be sprinkled on a
tablespoon of apple sauce or yoghurt (then swallowed
immediately without chewing).
EQUASYM®XLContents of capsule can be sprinkled on a
tablespoon of apple sauce (then swallowed immediately
without chewing).
lPRESCRIBING AND DISPENSING INFORMATIONDifferent
versions of modified-release preparations may not have
the same clinical effect. To avoid confusion between these
different formulations of methylphenidate, prescribers
should specify the brand to be dispensed.
CONCERTA®XLConsists of an immediate-release
component ( 22 % of the dose) and a modified-release
component ( 78 % of the dose).
MEDIKINET®XLConsists of an immediate-release
component ( 50 % of the dose) and a modified-release
component ( 50 % of the dose).
EQUASYM®XLConsists of an immediate-release
component ( 30 % of the dose) and a modified-release
component ( 70 % of the dose).
lPATIENT AND CARER ADVICE
Driving and skilled tasksPrescribers and other healthcare
professionals should advise patients if treatment is likely
to affect their ability to perform skilled tasks (e.g. driving).
This applies especially to drugs with sedative effects;
patients should be warned that these effects are increased
by alcohol. General information about a patient’sfitness to
drive is available from the Driver and Vehicle Licensing
Agency atwww.dvla.gov.uk.2015 legislation regarding driving whilst taking certain
drugs, may also apply to methylphenidate, seeDrugs and
drivingunder Guidance on prescribing p. 1.
CONCERTA®XLTablet membrane may pass through
gastro-intestinal tract unchanged.
DELMOSART®PROLONGED-RELEASE TABLETManufacturer
advises tablet membrane may pass through gastro-
intestinal tract unchanged.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Methylphenidate, atomoxetine and dexamfetamine for
attention deficit hyperactivity disorder (ADHD) (March 2006 )
NICE TA98
Methylphenidate is recommended, within its licensed
indications, as an option for the management of ADHD in
children and adolescents.
http://www.nice.org.uk/TA98lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution
Modified-release tablet
CAUTIONARY AND ADVISORY LABELS 25
▶Concerta XL(Janssen-Cilag Ltd)
Methylphenidate hydrochloride 18 mgConcerta XL 18 mg tablets|
30 tabletP£ 31. 19 DT = £ 31. 19 b
Methylphenidate hydrochloride 27 mgConcerta XL 27 mg tablets|
30 tabletP£ 36. 81 DT = £ 36. 81 b
Methylphenidate hydrochloride 36 mgConcerta XL 36 mg tablets
| 30 tabletP£ 42. 45 DT = £ 42. 45 b
Methylphenidate hydrochloride 54 mgConcerta XL 54 mg tablets
| 30 tabletP£ 73. 62 DT = £ 36. 80 b
▶Delmosart(Actavis UK Ltd)
Methylphenidate hydrochloride 18 mgDelmosart 18 mg modified-
release tablets| 30 tabletP£ 15. 59 DT = £ 31. 19 b
Methylphenidate hydrochloride 27 mgDelmosart 27 mg modified-
release tablets| 30 tabletP£ 18. 41 DT = £ 36. 81 b
Methylphenidate hydrochloride 36 mgDelmosart 36 mg modified-
release tablets| 30 tabletP£ 21. 23 DT = £ 42. 45 b
Methylphenidate hydrochloride 54 mgDelmosart 54 mg modified-
release tablets| 30 tabletP£ 36. 81 DT = £ 36. 80 b
▶Xaggitin XL(Ethypharm UK Ltd)
Methylphenidate hydrochloride 18 mgXaggitin XL 18 mg tablets|
30 tabletP£ 15. 58 DT = £ 31. 19 b
Methylphenidate hydrochloride 27 mgXaggitin XL 27 mg tablets|
30 tabletP£ 18. 40 DT = £ 36. 81 b
Methylphenidate hydrochloride 36 mgXaggitin XL 36 mg tablets|
30 tabletP£ 21. 22 DT = £ 42. 45 b
Methylphenidate hydrochloride 54 mgXaggitin XL 54 mg tablets|
30 tabletP£ 36. 80 DT = £ 36. 80 b
Tablet
▶Methylphenidate hydrochloride (Non-proprietary)
Methylphenidate hydrochloride 5 mgMethylphenidate 5 mg tablets
| 30 tabletP£ 3. 03 DT = £ 3. 03 b
Methylphenidate hydrochloride 10 mgMethylphenidate 10 mg
tablets| 30 tabletP£ 5. 29 DT = £ 3. 76 b
Methylphenidate hydrochloride 20 mgMethylphenidate 20 mg
tablets| 30 tabletP£ 10. 92 DT = £ 10. 92 b
▶Medikinet(Flynn Pharma Ltd)
Methylphenidate hydrochloride 5 mgMedikinet 5 mg tablets|
30 tabletP£ 3. 03 DT = £ 3. 03 b
Methylphenidate hydrochloride 10 mgMedikinet 10 mg tablets|
30 tabletP£ 5. 49 DT = £ 3. 76 b
Methylphenidate hydrochloride 20 mgMedikinet 20 mg tablets|
30 tabletP£ 10. 92 DT = £ 10. 92 b
▶Ritalin(Novartis Pharmaceuticals UK Ltd)
Methylphenidate hydrochloride 10 mgRitalin 10 mg tablets|
30 tabletP£ 6. 68 DT = £ 3. 76 b
▶Tranquilyn(Genesis Pharmaceuticals Ltd)
Methylphenidate hydrochloride 5 mgTranquilyn 5 mg tablets|
30 tabletP£ 3. 03 DT = £ 3. 03 b
Methylphenidate hydrochloride 10 mgTranquilyn 10 mg tablets|
30 tabletP£ 3. 76 DT = £ 3. 76 b
Methylphenidate hydrochloride 20 mgTranquilyn 20 mg tablets|
30 tabletP£ 10. 92 DT = £ 10. 92 b228 Mental health disorders BNFC 2018 – 2019
Nervous system4