Medikinet XL Special Precautions
Medikinet XL Special Precautions
Warnings: Medikinet XL should not be used in children less than 6 years of age due to a lack of data on safety and efficacy.
Medikinet XL should not be used to treat severe exogenous or endogenous depression.
Clinical experience suggests that Medikinet XL may exacerbate symptoms of behavioural disturbance and thought disorder in psychotic children.
Medikinet XL should be administered with caution to patients with severe depression or with suicidal thoughts or actions because there is a risk of aggravation of this condition.
Available clinical evidence suggests that treatment with methylphenidate during childhood does not increase the likelihood of addiction in later life, though this should always be carefully monitored in each individual case.
Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially in response to parenteral abuse.
The choice between treatment with either Medikinet XL or an immediate release methylphenidate formulation should be determined on an individual basis with particular consideration of the requirement for symptom control in the latter part of the day.
Methylphenidate should not be used for the prevention or treatment of normal fatigue states.
Precautions: Treatment with methylphenidate is not indicated in all cases of ADHD, and should be considered only after detailed history takingand evaluation. The decision to prescribe methylphenidate depend on an assessment of the severity of symptoms and their appropriateness to the child's age and not simply on the presence of one or more abnormal behavioural characteristics. Where these symptoms are associated with acute stress reactions, treatment with methylphenidate is usuallynot indicated.
Reduced weight gain and slight growth XLation have been reported with the long term use of stimulants in children. Careful monitoring of growth is recommended during extended treatment with methylphenidate. Patients who are not growing or gaining weight as expected should have their treatment interrupted temporarily.
Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially those with hypertension.
Exacerbation of motor and phonic tics and Tourette's syndrome has been reported. Therefore, clinical evaluation for tics and Tourette's syndrome should precede use of stimulant medications.
Due to the potential decreased appetite associated with methylphenidate use, caution is advised in the presence of anorexia nervosa.
Caution is called for in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase the dosage on their own initiative.
There is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in absence of history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
The long term safety and efficacy profiles of methylphenidate are not fully known. Patients requiring long term therapy should therefore be carefully monitored and complete and differential blood counts and a platelet count performed periodically.
Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity. Some patients may require long-term follow up.
There is no experience with the use of Medikinet XL in patients with renal insufficiency or hepatic insufficiency.
Women of childbearing potential should use effective contraceptive measures.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Sport: This medicinal product contains methylphenidate which could result in a positive result during drug testing
Medikinet XL Adverse Reactions
Medikinet XL Adverse Reactions
Side-effect assessment is based on the following frequency data:
Very common (1/10)
Common (1/100 to <1/10)
Occasional (1/1.000 to <1/100)
Rare (1/10.000 to <1/1.000)
Very rare (<1/10.000)
Nervousness and insomnia are very common adverse reactions occurring at the beginningof treatment but can usually be controlled by reducing the dosage.
Decreased appetite is also common but usually transient.
Blood and lymphatic system disorders
Very rare: Anaemia,leucopenia, thrombocytopenia, thrombocytopenic purpura.
Common: Arrhythmia, palpitations, tachycardia.
Rare: Angina pectoris.
Very rare: Cardiac arrest.
Congenital, familial and genetic disorders:
Very rare: Tourette's syndrome.
Rare: Difficulties in visual accommodation, blurred vision.
Common: Abdominal pain, nausea and vomiting. These usually occur at the beginning of treatment and may be alleviated by concomitant food intake. Dry mouth.
General disorders and administration site conditions
Rare: Growth XLation during prolonged use in children.
Very rare: Sudden death.
Very rare: Abnormal liver function, ranging from transaminase elevation to hepatic coma.
Common: Changes in blood pressure and heart rate (usually an increase).
Metabolism and nutrition disorders
Common: Decreased appetite, reduced weight gain during prolonged use in children.
Musculoskeletal and connective tissue disorders
Very rare: Muscle spasms.
Nervous system disorders
Common: Dizziness, drowsiness, dyskinesia, headaches, hyperactivity.
Very rare: Convulsions, choreo-athetoid movements.
Very rare reportsof poorly documented neuroleptic malignant syndrome (NMS) have been received. In most of these reports patients were also receiving other medications. It is uncertain what role methylphenidate played in these cases.
Very common: Insomnia, nervousness
Common: Abnormal behaviour, aggression, agitation, anorexia, anxiety, depression,
Very rare: Hallucinations, psychotic disorder, suicidal behaviour (including
completed suicide), tics or exacerbation of pre-existing tics, transient
Skin and subcutaneous tissue disorders
Common: Alopecia,pruritus, rash, urticaria.
Very rare: Erythema multiforme thromobocytopenic purpura, exfoliative dermatitis, fixed drug eruption.
Very rare: Cerebral arteritis and/or occlusion