Methylphenidate 5mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Methylphenidate hydrochloride
Available from:
Mylan
ATC code:
N06BA04
INN (International Name):
Methylphenidate hydrochloride
Dosage:
5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
Schedule 2 (CD)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04040000; GTIN: 5016695006864

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Package Leaflet: Information for the user

TRANQUILYN 5 mg, 10 mg or 20 mg Tablets

Methylphenidate

The name of your medicine is Tranquilyn. It contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also

be used in this leaflet.

Important things you need to know about your medicine

This medicine is used to treat ADHD

Read Section 1 for more information.

Before you take this medicine, talk to your doctor if:

Read Section 2 for more information.

While taking this medicine:

Read Sections 3 and 4 for more information.

Talk to your doctor straight away if any of the following happen:

Read Section 4 for more information.

The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine. Read

all of this leaflet carefully before you start taking this medicine because it contains important information for you.

same as yours.

The leaflet has been written in sections:

What is in this leaflet:

1. What Tranquilyn is and what it is used for

2. What you need to know before you take Tranquilyn

3. How to take Tranquilyn

4. Possible side effects

5. How to store Tranquilyn

6. Contents of the pack and other information

Information for children and young people

Now read the rest of this leaflet before you start taking this medicine.

1. What Tranquilyn is and what it is used for

What it is used for

How it works

concentration and reduce impulsive behaviour.

The medicine is given as part of a treatment programme, which usually includes:

be managed using treatment programmes.

About ADHD

It is not their fault that they cannot do these things.

2. What you need to know before you take Tranquilyn

Do not take Tranquilyn if:

were born with a heart problem

o severe depression, where you feel very sad, worthless and hopeless

Checks that your doctor will make before you start taking

Tranquilyn

It is important that you provide as much information as you can. This will help your doctor decide if methylphenidate is the correct medicine

Having an operation

is used. This is because there is a chance of a sudden rise in blood pressure during the operation.

Drug testing

This medicine may give a positive result when testing for drug use. This includes testing used in sport.

Tranquilyn with food, drink and alcohol

medicines contain alcohol.

Information for children and young people

It may help if you read small bits at a time.

Why have I been given this medicine?

While you are taking this medicine

happen in a school holiday.

Some people cannot have this medicine

You cannot have this medicine if:

Other medicines and Tranquilyn

a prescription.

buy any of these products

Warnings and precautions

worse. Your doctor will want to monitor how the medicine affects you.

important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.

fertility'

o the medicine has been prescribed to treat a medical problem and

provided with the medicine and

o it was not affecting your ability to drive safely.

Driving and using machines

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before

taking this medicine.

Pregnancy, breast-feeding and contraception

is sexually active.

or your daughter:

is pregnant or think might be pregnant. Your doctor will decide whether methylphenidate should be taken.

breast-feeding or planning to breast-feed. It is possible that methylphenidate is passed into human breast milk. Therefore, your

doctor will decide whether you should breast-feed while taking methylphenidate.

3. How to take Tranquilyn

How much to take

If you do not feel better after 1 month of treatment

If you do not feel better, tell your doctor. They may decide you need a different treatment.

Not using Tranquilyn properly

if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

If you take more Tranquilyn than you should

If you forget to take Tranquilyn

If you stop taking Tranquilyn

Things your doctor will do when you are on treatment

Your doctor will do some tests

Long-term treatment

may happen during a school holiday. This will show if the medicine is still needed.

4. Possible side effects

Some side effects could be serious. If you have any of the side effects below, see a doctor straight away:

Common (affects less than 1 in 10 people)

Uncommon (affects less than 1 in 100 people)

Rare (affects less than 1 in 1,000 people)

Very rare (affects less than 1 in 10,000 people)

supply to the brain

bleed and bruise more easily

Other side effects (how often they happen is not known)

If you have any of the side effects above, see a doctor straight away.

Other side effects include the following. If they get serious, please tell your doctor or pharmacist:

Very common (affects more than 1 in 10 people)

Common (affects less than 1 in 10 people)

Uncommon (affects less than 1 in 100 people)

Rare (affects less than 1 in 1,000 people)

Very rare (affects less than 1 in 10,000 people)

Other side effects (how often they happen is not known)

Effects on growth

When used for more than a year, methylphenidate may cause reduced growth in some children. This affects less than 1 in 10 children.

Reporting of side effects

5. How to store Tranquilyn

These measures will help to protect the environment.

6. Contents of the pack and other information

What Tranquilyn contains

The active substance is methylphenidate hydrochloride.

The other ingredients are:

What Tranquilyn looks like and contents of the pack

Marketing Authorisation Holder and Manufacturer

This leaflet was last revised in October 2019

Some people need to talk to their doctor before they start having this medicine

How do I take my medicine (tablets)?

Possible side effects

with food

sleepy, it is important not to do outdoor sports

If you feel unwell in any way while you are taking your medicine please tell an adult you trust straight away.

Other things to remember

do not let anyone else have it. It may help you, but it could hurt someone else.

don’t

right away.

Who should I ask if there is anything I don’t understand?

Your mum, dad, carer, doctor, nurse or pharmacist will be able to help you.

36119000/0219

contraception

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Methylphenidate Hydrochloride 5mg Tablets

Tranquilyn 5mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5 mg of the active ingredient methylphenidate hydrochloride.

Methylphenidate (INN) is chemically defined as methyl

·phenyl-2-piperidine acetate

hydrochloride.

For the full list of excipients, see Section 6. 1.

3. PHARMACEUTICAL FORM

Tablet.

White, flat, round tablets, marked ‘RU’ on one side and ‘5’ on the other.

4.1 Therapeutic indications

Attention-Deficit/Hyperactivity Disorder (ADHD)

Methylphenidate is indicated as part of a comprehensive treatment programme for

attention-deficit / hyperactivity disorder (ADHD) in children aged 6 years of age and

over when remedial measures alone prove insufficient. Treatment must be under the

supervision of a specialist in childhood behavioural disorders. Diagnosis should be

made according to DSM criteria or the guidelines in ICD-10 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

short

attention

span,

distractibility,

emotional

lability,

impulsivity,

moderate

severe

hyperactivity,

minor

neurological

signs

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 drug 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

essential,

psychosocial

intervention

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. The use of methylphenidate should always be used in this way

according

licensed

indication

according

prescribing

diagnostic

guidelines.

4.2

Posology and method of administration

Treatment must be initiated under the supervision of a specialist in childhood

and/or adolescent behavioural disorders.

Pre-treatment screening

Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s

cardiovascular status including blood pressure and heart rate. A comprehensive

history

should

document

concomitant

medications,

past

present

co-morbid

medical

psychiatric

disorders

symptoms,

family

history

sudden

cardiac/unexplained death and accurate recording of pre-treatment height and weight

on a growth chart (see sections 4.3 and 4.4).

Ongoing monitoring

Growth, psychiatric and cardiovascular status should be continuously monitored (see

also section 4.4).

Blood pressure and pulse should be recorded on a centile chart at each adjustment

of dose and then at least every 6 months;

Height,

weight

appetite

should

recorded

least

monthly

with

maintenance of a growth chart;

Development of de novo or worsening of pre-existing psychiatric disorders

should be monitored at every adjustment of dose and then at least every 6 months

and at every visit.

Patients

should

monitored

risk

diversion,

misuse

abuse

methylphenidate.

Dose titration

Careful dose titration is necessary at the start of treatment with methylphenidate.

Dose titration should be started at the lowest possible dose.

Other strengths of this medicinal product and other methylphenidate-containing

products may be available.

The maximum daily dosage of methylphenidate is 60 mg.

Initially 5mg once or twice daily (e.g. at breakfast and lunch). Increase the dose

and/or frequency of administration as necessary, by weekly increments of 5-

10mg in the daily dose.

Long-term (more than 12 months) use in children and adolescents

safety

efficacy

long-term

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. The physician who elects to use methylphenidate for extended

periods (over 12 months) in children and adolescents with ADHD should periodically

re-evaluate the long-term usefulness of the drug for the individual patient with trial

periods off medication to assess the patient’s functioning without pharmacotherapy. It

is recommended that methylphenidate is dechallenged at least once yearly to assess

child’s condition (preferably during times of school holidays). Improvement may be

sustained when the drug is either temporarily or permanently discontinued.

Dose reduction and discontinuation

Treatment must be stopped if the symptoms do not improve after appropriate dosage

adjustment over a one-month period. If paradoxical aggravation of symptoms or other

serious adverse events occur, the dosage should be reduced or discontinued.

Adults

Methylphenidate is not licensed for use in adults with ADHD. Safety and efficacy

have not been established in this age group.

Elderly

Methylphenidate should not be used in the elderly. Safety and efficacy have not been

established in this age group.

Children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and

efficacy in this age group has not been established.

4.3 Contraindications

Known sensitivity to methylphenidate or any of the excipients listed in section

Glaucoma

Phaeochromocytoma

During treatment with non-selective, irreversible monoamine oxidase (MAO)

inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to

risk of hypertensive crisis (see section 4.5)

Hyperthyroidism or Thyrotoxicosis

Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders,

suicidal

tendencies,

psychotic

symptoms,

severe

mood

disorders,

mania,

schizophrenia, psychopathic/borderline personality disorder

Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder

(that is not well-controlled)

Pre-existing cardiovascular disorders including severe hypertension, heart failure,

arterial occlusive disease, angina, haemodynamically significant congenital heart

disease,

cardiomyopathies,

myocardial

infarction,

potentially

life-threatening

arrhythmias and channelopathies (disorders caused by the dysfunction of ion

channels)

Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities

including vasculitis or stroke.

4.4

Special warnings and precautions for use

Methylphenidate treatment is not indicated in all children with ADHD and the decision to use

the drug 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.

Long-term use (more than 12 months) in children and adolescents

The safety and efficacy of long-term use of methylphenidate has not been systematically

evaluated

controlled

trials.

Methylphenidate

treatment

should

need

not,

indefinite. Methylphenidate treatment is usually discontinued during or after puberty. Patients

on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according

guidance

sections

cardiovascular

status,

growth,

appetite,

development of de novo or worsening of pre-existing psychiatric disorders. Psychiatric

disorders to monitor for are described below, and include (but are not limited to) motor or

vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania,

delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration.

The physician who elects to use methylphenidate for extended periods (over 12 months) in

children and adolescents with ADHD should periodically re-evaluate the long-term usefulness

of the drug for the individual patient with trial periods off medication to assess the patient’s

functioning

without

pharmacotherapy.

recommended

that

methylphenidate

dechallenged at least once yearly to assess the child’s condition (preferably during times of

school holidays). Improvement may be sustained when the drug is either temporarily or

permanently discontinued.

Use in adults

Methylphenidate is not licensed for use in adults with ADHD. Safety and efficacy have not

been established in this age group.

Use in the elderly

Methylphenidate should not be used in the elderly. Safety and efficacy have not been

established in this age group.

Use in children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy

in this age group has not been established.

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 cardiac or unexplained

death or malignant arrhythmia) and physical exam to assess for the 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,

unexplained syncope, dyspnoea or other symptoms suggestive of 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 in

diastolic and systolic blood pressure of over 10 mmHg relative to controls. The short- and

long-term clinical consequences of these cardiovascular effects in children and adolescents

are not known, but the possibility of clinical complications cannot be excluded as a result of

the effects observed in the clinical trial data. Caution is indicated in treating patients whose

underlying medical conditions might be compromised by increases in blood pressure or

heart

rate.

section

conditions

which

methylphenidate

treatment

contraindicated.

Cardiovascular status should be carefully monitored. Blood pressure and pulse should

be recorded on a centile chart 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 obtained (see section 4.3).

Sudden death and pre-existing cardiac structural 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, 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, stimulant products are not recommended in children or

adolescents

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.

Misuse and Cardiovascular Events

Misuse of stimulants of the central nervous system may be associated with sudden death and

other serious cardiovascular adverse events.

Cerebrovascular disorders

section

cerebrovascular

conditions

which

methylphenidate

treatment

contraindicated. Patients with additional risk factors (such as a history of cardiovascular

disease, concomitant 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.

Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of

methylphenidate and early treatment. The diagnosis should therefore be considered in any

patient who develops new neurological symptoms that are consistent with cerebral ischemia

during methylphenidate therapy. These symptoms could include severe headache, numbness,

weakness, paralysis, and impairment of coordination, vision, speech, language or memory.

Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral

palsy.

Psychiatric disorders

Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account

when prescribing stimulant products. In the case of emergent psychiatric symptoms or

exacerbation of pre-existing psychiatric disorders, methylphenidate should not be given

unless the benefits outweigh the risks to the patient.

Development

or

worsening

of

psychiatric

disorders

should

be

monitored

at

every

adjustment of dose, then at least every 6 months, and at every visit; discontinuation of

treatment may be appropriate.

Exacerbation of pre-existing psychotic or manic symptoms

psychotic

patients,

administration

methylphenidate

exacerbate

symptoms

behavioural disturbance and thought disorder.

Emergence of new psychotic or manic symptoms

Treatment-emergent

psychotic

symptoms

(visual/tactile/auditory

hallucinations

delusions) or mania in children and adolescents without prior history of psychotic illness or

mania can be caused by methylphenidate at usual doses. 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 behavior

The emergence or worsening of aggression or hostility can be caused by treatment with

stimulants.

Patients

treated

with

methylphenidate

should

closely

monitored

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 should evaluate

the need for adjustment of the treatment regimen in patients experiencing behaviour changes.

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

underlying

psychiatric

condition

necessary

consideration should be given to a possible discontinuation of methylphenidate.

Tics

Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.

Worsening of Tourette’s syndrome has also been reported. Family history should be assessed

and clinical evaluation for tics or Tourette’s syndrome in children should precede use of

methylphenidate. Patients should be regularly monitored for the emergence or worsening of

tics during treatment with methylphenidate. Monitoring should be at every adjustment of

dose and then at least every 6 months or 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 of these

symptoms during treatment, at every adjustment of dose and then at least every 6

months or every visit.

Forms of bipolar disorder

Particular care should be taken in using methylphenidate to treat ADHD in patients with

comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of

bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in

such patients. 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; such screening should include a detailed psychiatric history, including a

family history of suicide, bipolar disorder, and depression. Close ongoing monitoring is

essential in these patients (see above ‘Psychiatric Disorders’ and section 4.2). 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: height, weight and

appetite should be recorded at least 6 monthly with maintenance of a growth chart.

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 patients 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

methylphenidate

lead

marked

tolerance

psychological

dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur,

especially in response to parenteral abuse.

Patient age, the presence of risk factors for substance use disorder (such as co-morbid

oppositional-defiant or conduct disorder and bipolar disorder), previous or current substance

abuse should all be taken into account when deciding on a course of treatment for ADHD.

Caution is called for in emotionally 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.

Fatigue

Methylphenidate should not be used for the prevention or treatment of normal fatigue states.

Choice of methylphenidate formulation

The choice of formulation of methylphenidate-containing product will have to be decided by

the 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 laboratory test for

amphetamines, particularly with immunoassay screen test.

Renal or hepatic insufficiency

There is no experience with 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 the event of

Leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of

serious renal or hepatic disorders, discontinuation of treatment should be considered.

Priapism

Prolonged and painful erections have been reported in association with methylphenidate

products, mainly in association with a change in the methylphenidate treatment regimen.

Patients who develop abnormally sustained or frequent and painful erections should seek

immediate medical attention.

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