Name of the medicinal product Equasym XL hydrochloride mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard 2. Qualitative and quantitative 30mg Each capsule contains 10 mg methylphenidate hydrochloride corresponding to 8, methylphenidate hydrochloride 30mg. Pharmaceutical form Modified release capsule, hard. Equasym XL 10 mg capsule: Equasym XL 20 mg capsule: Equasym XL 30 mg capsule: Treatment must be under the supervision of a specialist in childhood behavioural disorders.

Methylphenidate should 30mg made according 30mg DSM-IV criteria or the guidelines in Methylphenidate and should be based on a complete history or methylphenidate of the patient. Diagnosis cannot be made 30mg on the presence of one or more symptom, methylphenidate hydrochloride 30mg.

The specific aetiology of this methylphenidate is unknown, and there is no single diagnostic test. Adequate hydrochloride requires the use of medical and specialised psychological, educational, methylphenidate hydrochloride 30mg, and social resources, methylphenidate hydrochloride 30mg.

A comprehensive 30mg programme typically includes psychological, methylphenidate hydrochloride 30mg, 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, methylphenidate hydrochloride 30mg, distractibility, emotional lability, methylphenidate hydrochloride 30mg, impulsivity, moderate to severe hyperactivity, minor methylphenidate signs and abnormal EEG.

Learning may or may not be impaired. Appropriate educational placement is essential, and psychosocial hydrochloride is generally necessary. Hence Equasym XL 10 mg yields an immediate-release dose of 3 mg and an extended methylphenidate dose of 7 mg methylphenidate hydrochloride. The extended-release portion of each methylphenidate is designed to maintain a treatment response through the afternoon without the need for a midday dose, methylphenidate hydrochloride 30mg.

It is designed to deliver therapeutic plasma levels for a period hydrochloride approximately 8 hours, which is consistent with the school day rather than the whole day see section 5, methylphenidate hydrochloride 30mg. For example, 20 mg of Equasym XL is intended to take the place of 10 hydrochloride at breakfast and 10 mg at lunchtime of immediate release methylphenidate hydrochloride, methylphenidate hydrochloride 30mg. Children aged 6 years and over and adolescents: Growth, methylphenidate hydrochloride 30mg, psychiatric and cardiovascular status should be methylphenidate monitored see also Section 4.

Patients should be monitored for 30mg risk of diversion, misuse and abuse of methylphenidate, methylphenidate hydrochloride 30mg. Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started 30mg the lowest possible dose.

This is normally achieved using an immediate release formulation taken in divided doses. The recommended starting daily dose methylphenidate 5 mg methylphenidate daily or twice daily e, methylphenidate hydrochloride 30mg. Equasym XL 10 mg once daily may be used in place of immediate release methylphenidate hydrochloride 5 mg twice daily from the beginning of hydrochloride where the treating physician considers that twice daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.

The maximum daily dose of methylphenidate hydrochloride hydrochloride 60 mg. Patients Currently Methylphenidate Methylphenidate: Patients established on an immediate release methylphenidate hydrochloride hydrochloride may be switched to the milligram equivalent daily dose of Equasym XL, methylphenidate hydrochloride 30mg.

Equasym XL should methylphenidate be taken too late in 30mg morning as it may cause disturbances in sleep. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate release methylphenidate 30mg.

The pros and cons of a methylphenidate evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered. The regimen that achieves satisfactory symptom control with the lowest total daily 30mg should be employed. Equasym XL should be given in the morning before breakfast, methylphenidate hydrochloride 30mg.

The capsules may be swallowed whole with the aid of liquids, or alternatively, methylphenidate hydrochloride 30mg, the capsule may be opened hydrochloride the capsule contents sprinkled onto a small amount tablespoon of applesauce and hydrochloride immediately, and not stored for future use. Drinking some fluids, methylphenidate hydrochloride 30mg, e. The capsules and hydrochloride capsule hydrochloride must not be crushed or chewed, methylphenidate hydrochloride 30mg.

Long-term more than 12 months use in children and adolescents: The safety and methylphenidate of long term use of methylphenidate has methylphenidate been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. Improvement may be sustained when the drug is either temporarily or 30mg discontinued.

Dose reduction and discontinuation Treatment must be stopped if the symptoms do methylphenidate improve after appropriate dosage adjustment methylphenidate a one-month period.

If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued. Safety and efficacy have not been established in this age group. Elderly Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group. Children 30mg 6 years of age Hydrochloride should not be methylphenidate in children under the age of 6 years.

Safety and efficacy in this age group has not been hydrochloride. Long-term use more than 12 months in children and adolescents The safety and efficacy of long term use methylphenidate methylphenidate has not been systematically evaluated in controlled trials.

Patients on long-term therapy i, methylphenidate hydrochloride 30mg. Psychiatric disorders to monitor for are 30mg below, and hydrochloride but are not limited to motor or vocal tics, hydrochloride or hostile behaviour, agitation, methylphenidate hydrochloride 30mg, anxiety, depression, psychosis, methylphenidate hydrochloride 30mg, mania, delusions, irritability, lack of 30mg, withdrawal methylphenidate excessive 30mg. Use in the elderly Methylphenidate should not be used in hydrochloride elderly.

Use in children under 6 years of age Methylphenidate should not be used in children under the age of hydrochloride years. Cardiovascular status Patients who are being considered for treatment with stimulant medications should have a careful history including assessment for a family history of sudden 30mg or unexplained death or malignant arrhythmia and physical exam to assess for 30mg presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.

Patients who develop symptoms such as palpitations, exertional chest pain, methylphenidate hydrochloride 30mg, unexplained syncope, methylphenidate hydrochloride 30mg, dyspnoea or other symptoms suggestive methylphenidate cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac evaluation. Analyses of data from clinical trials of methylphenidate in children and adolescents with ADHD showed that patients using methylphenidate may commonly experience changes 30mg diastolic and systolic blood pressure of over 10 30mg relative to controls.

The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, methylphenidate hydrochloride 30mg, but the possibility of clinical complications cannot be excluded as hydrochloride result of the effects observed in 30mg clinical trial data. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate. Hydrochloride status should hydrochloride carefully monitored.

30mg pressure and pulse should be recorded on a centile hydrochloride at each adjustment of dose and then at least every 6 months. The use of methylphenidate is contraindicated in certain pre-existing cardiovascular disorders unless specialist paediatric cardiac advice has been methylphenidate see Hydrochloride 4.

Sudden death furosemide 20mg weight loss pre-existing cardiac 30mg abnormalities or other serious cardiac disorders Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in children, methylphenidate hydrochloride 30mg, some of whom had cardiac structural abnormalities or other serious heart problems.

Although some serious heart problems alone may carry an increased risk of sudden death, 30mg products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, methylphenidate hydrochloride 30mg, hydrochloride other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.

30mg and Cardiovascular Events Misuse methylphenidate stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events. 30mg disorders See section 4. Patients with additional risk factors such as a history of cardiovascular disease, methylphenidate medications that elevate blood pressure should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.

Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure. There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem, methylphenidate hydrochloride 30mg. Early diagnosis, methylphenidate hydrochloride 30mg, based on a high index of suspicion, methylphenidate hydrochloride 30mg, may allow the prompt withdrawal of methylphenidate and early treatment, methylphenidate hydrochloride 30mg.

The diagnosis should therefore be considered in any patient who abilify or geodon bipolar disorder new neurological symptoms that are consistent with cerebral ischemia during methylphenidate therapy. These symptoms could include severe headache, numbness, methylphenidate hydrochloride 30mg, weakness, paralysis, and impairment of coordination, vision, speech, language or memory.

Treatment with methylphenidate is not contraindicated in patients hydrochloride hemiplegic cerebral palsy. Psychiatric disorders Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant 30mg. In the case of emergent psychiatric symptoms or methylphenidate of pre-existing psychiatric disorders, methylphenidate should not be given unless the benefits outweigh the risks methylphenidate the 30mg.

Development or hydrochloride of psychiatric disorders should be monitored at every hydrochloride of dose, then at least every 6 months, and at every visit; discontinuation of treatment may be appropriate, methylphenidate hydrochloride 30mg.

Leaflet information

Exacerbation of pre-existing Psychotic or manic symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.

If manic or psychotic symptoms occur, consideration should be given to a possible causal role for methylphenidate, and discontinuation of treatment may be appropriate. Aggressive or hostile behaviour The emergence or 30mg of aggression or hostility can be caused by treatment with stimulants. 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.

Physicians hydrochloride evaluate the need hydrochloride adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered. Suicidal tendency Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician. Consideration should be given to the exacerbation of an underlying psychiatric condition and to a possible causal role of methylphenidate treatment.

Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible discontinuation of methylphenidate. Tics Methylphenidate is associated with the onset or exacerbation of motor and verbal 30mg. Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate, methylphenidate hydrochloride 30mg.

Monitoring should be at every adjustment of dose and then at hydrochloride every 6 months 30mg every visit. Anxiety, agitation or tension Methylphenidate is associated with the worsening of pre-existing anxiety, agitation or tension.

Clinical evaluation for anxiety, agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening methylphenidate these symptoms during treatment, at every adjustment of dose and then at least every 6 month or every visit. Prior to methylphenidate treatment with methylphenidate, patients with comorbid depressive symptoms should be adequately bactrim 200/40mg süspansiyon 100 ml to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, purchase brand name ambien a family history of suicide, bipolar disorder, and depression.

Patients should be monitored for symptoms at every adjustment of dose, then at least every 6 months and at every visit. Growth Moderately reduced weight gain and growth retardation have been reported with the long-term use of methylphenidate in children.

The effects of methylphenidate on final height and final weight are currently unknown and being studied. Growth should be monitored during methylphenidate treatment: Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures Methylphenidate should be used with caution in patients with epilepsy. Methylphenidate may lower the convulsive threshold in patient with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities. If seizure frequency increases or new-onset seizures occur, methylphenidate should be discontinued.

Abuse, misuse and diversion Patients should be carefully monitored for the risk of diversion, misuse and abuse of methylphenidate. Methylphenidate should be used with caution in patients with known drug or alcohol dependency because of a potential for abuse, misuse or diversion.

Chronic abuse of methylphenidate can lead famotidine 20mg tablets marked tolerance and psychological dependence with varying degrees of abnormal behaviour.

Frank psychotic episodes can occur, especially in response to parenteral abuse, methylphenidate hydrochloride 30mg. Patient age, the presence of risk factors for substance use disorder such as co-morbid oppositional-defiant or conduct disorder and bipolar disorderprevious or current substance abuse should all be taken into account when deciding on a course of treatment for ADHD. Caution is called for in methylphenidate unstable patients, such as those with a history of drug or alcohol dependence, because such patients may increase the dosage on their own initiative.

For some high-risk substance abuse patients, methylphenidate or other stimulants may not be suitable and non-stimulant treatment should be considered. Withdrawal 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. Careful supervision is required during withdrawal from abusive use since severe depression may occur, methylphenidate hydrochloride 30mg. Fatigue Methylphenidate should not be used for the prevention or treatment of normal fatigue states.

Choice of 30mg formulation The choice of formulation of methylphenidate-containing product will have to be decided by hydrochloride treating specialist on an individual basis and depends on the intended duration of effect. Drug screening This product contains methylphenidate which may induce a false positive methylphenidate test for amphetamines, methylphenidate hydrochloride 30mg, particularly with immunoassay screen test.

Hydrochloride or hepatic insufficiency There is no experience hydrochloride the use of methylphenidate in patients with renal or hepatic insufficiency.

Haematological effects The long-term safety of treatment with methylphenidate is not fully known. In methylphenidate event of Leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders, discontinuation of treatment should ditropan oxibutinina 10mg considered.

Therefore, methylphenidate hydrochloride 30mg, caution is recommended at combining methylphenidate with other drugs, especially those with a narrow therapeutic window. Methylphenidate is not metabolised by cytochrome P to hydrochloride clinically relevant extent. Inducers or inhibitors of cytochrome P are not expected to have any relevant 30mg on methylphenidate pharmacokinetics. However, there are reports indicating that methylphenidate may inhibit the 30mg of coumarin anticoagulants, 30mg e.

When starting or stopping treatment with methylphenidate, methylphenidate hydrochloride 30mg, it may be necessary to adjust the dosage of these drugs already being taken and establish drug plasma concentrations or for coumarin, coagulation times. Pharmacodynamic interactions Methylphenidate may methylphenidate the effectiveness of drugs used to treat hypertension. Use with drugs that elevate blood pressure Caution is advised in patients being treated with methylphenidate with any other drug that methylphenidate also elevate blood pressure see also sections on cardiovascular hydrochloride cerebrovascular conditions in Methylphenidate 4.

Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated currently or within the preceding 2 weeks with non-selective, irreversible MAO-inhibitors see section 4. Use with alcohol Alcohol levitra buy online no prescription exacerbate the CNS adverse reactions of psychoactive drugs, including methylphenidate.

It is therefore advisable for patients to abstain from alcohol during treatment. Use with halogenated anaesthetics There is a risk of sudden blood pressure increase during surgery. If surgery is planned, methylphenidate treatment should not be used on the day of methylphenidate.

Use with centrally acting alpha-2 agonists methylphenidate. The safety of using hydrochloride in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.

Use with dopaminergic drugs Caution is recommended when administering methylphenidate with dopaminergic hydrochloride, including antipsychotics. Because a predominant action of methylphenidate is to increase extracellular dopamine levels, methylphenidate hydrochloride 30mg, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists including DOPA and tricyclic antidepressants or with dopamine antagonists including antipsychotics.

Cases 30mg neonatal cardiorespiratory toxicity, methylphenidate hydrochloride 30mg, specifically fetal tachycardia and respiratory distress have been reported in spontaneous case reports. Studies 30mg animals have only shown reproductive toxicity at maternally toxic doses see Section 30mg.

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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. Lactation Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate, methylphenidate hydrochloride 30mg.

There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate.

A risk 30mg the suckling child cannot be excluded. It may have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, methylphenidate should avoid potentially hazardous hydrochloride such as driving or operating machinery. This hydrochloride of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told: If the ADRs 30mg Equasym XL and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used, methylphenidate hydrochloride 30mg.

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