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MEGLARAT 54MG PROLONGED RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package leaflet: Information for the user
Meglarat 18mg, 27mg, 36mg, 54mg Prolonged-release Tablets

methylphenidate hydrochloride

Read all of this leaflet carefully before you or your child starts taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours or your child’s ones.
- If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Meglarat is and what it is used for
2.
What you need to know before you or your child take Meglarat
3.
How to take Meglarat
4.
Possible side effects
5.
How to store Meglarat
6.
Contents of the pack and other information

1.

What Meglarat is and what it is used for

What it is used for
Meglarat is used to treat ‘attention deficit hyperactivity disorder’ (ADHD).

it is used in children and young people between the ages of 6 and 18.

it is used only after trying treatments which do not involve medicines such as counselling and
behavioural therapy.
Meglarat is not for use as a treatment for ADHD in children under 6 years of age or for initiation of treatment
in adults. When treatment was started at a younger age, it might be appropriate to continue taking Meglarat
when you become an adult. Your doctor will advise you about this.
How it works
Meglarat improves the activity of certain parts of the brain which are under-active. The medicine can help
improve attention (attention span), concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually includes:

psychological

educational and

social therapy.
It is prescribed only by doctors who have experience in children or young people's behaviour problems.
Although there is no cure for ADHD, it can be managed using treatment programmes.
About ADHD
Children and young people with ADHD find it:

hard to sit still and

hard to concentrate.
It is not their fault that they cannot do these things.
Many children and young people struggle to do these things. However, with ADHD they can cause problems
with everyday life. Children and young people with ADHD may have difficulty learning and doing
homework. They find it hard to behave well at home, at school or in other places.
ADHD does not affect the intelligence of a child or young person.
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2.

What you need to know before you or your child take Meglarat

Do not take Meglarat if you or your child:

are allergic to methylphenidate or any of the other ingredients of this medicine (listed in section 6)

have a thyroid problem

have increased pressure in your eye (glaucoma)

have a tumour of your adrenal gland (phaeochromocytoma)

have an eating problem when you do not feel hungry or want to eat - such as ‘anorexia nervosa’

have very high blood pressure or narrowing of the blood vessels, which can cause pain in the arms and
legs

have ever had heart problems - such as a heart attack, uneven heartbeat, pain and discomfort in the
chest, heart failure, heart disease or were born with a heart problem

have had a problem with the blood vessels in your brain - 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)

are currently taking or have taken within the last 14 days an antidepressant (known as a monoamine
oxidase inhibitor)- see ‘Other medicines and Meglarat’

have mental health problems such as:
a ‘psychopathic’ or ‘borderline personality’ problem
abnormal thoughts or visions or an illness called ‘schizophrenia’
signs of a severe mood problem like:
feeling like killing yourself
severe depression, where you feel very sad, worthless and hopeless
mania, where you feel unusually excitable, over-active, and un-inhibited.
Do not take methylphenidate if any of the above apply to you or your child. If you are not sure, talk to your
doctor or pharmacist before you or your child take methylphenidate. This is because methylphenidate can
make these problems worse.
Warnings and precautions
Talk to your doctor before taking Meglarat if you or your child:

have liver or kidney problems

have a problem with swallowing or swallowing whole tablets

have a narrowing or blockage of your gut or food-pipe

have had fits (seizures, convulsions, epilepsy) or any abnormal brain scans (EEGs)

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

are a girl and have started your periods (see the ‘Pregnancy, breast-feeding and contraception’ section
below)

have hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words

have high blood pressure

have a heart problem which is not in the ‘Do not take’ section above

have a mental health problem which is not in the ‘Do not take’ section above.
Other mental health problems include:
mood swings (from being manic to being depressed - called ‘bipolar disorder’)
starting to be aggressive or hostile, or your aggression gets worse
seeing, hearing or feeling things that are not there (hallucinations)
believing things that are not true (delusions)
feeling unusually suspicious (paranoia)
feeling agitated, anxious or tense
feeling depressed or guilty.
Tell your doctor or pharmacist if any of the above apply to you or your child before starting treatment. This
is because methylphenidate can make these problems worse. Your doctor will want to monitor how the
medicine affects you or your child.
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Checks that your doctor will make before you or your child start taking methylphenidate
These checks are to decide if methylphenidate is the correct medicine for you or your child. Your doctor will
talk to you about:

any other medicines you or your child are taking

whether there is any family history of sudden unexplained death

any other medical problems (such as heart problems) you or your family may have

how you or your child are feeling, such as feeling high or low, having strange thoughts or if you have
had any of these feelings in the past

whether there is a family history of ‘tics’ (hard-to-control, repeated twitching of any parts of the body
or repeating sounds and words)

any mental health or behaviour problems you or other family members have ever had.
Your doctor will discuss whether you or your child are at risk of having mood swings (from being manic to
being depressed - called ‘bipolar disorder’). They will check your mental health history, and check if any of
your family have a history of suicide, bipolar disorder or depression.
It is important that you provide as much information as you can. This will help your doctor decide if
methylphenidate is the correct medicine for you or your child. Your doctor may decide that other medical
tests are needed before you or your child start taking this medicine.
Other medicines and Meglarat Tell your doctor if you or your child are taking, have recently taken or
might take any other medicines.
Do not take methylphenidate if you or your child:

are taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have
taken an MAOI in the last 14 days. Taking an MAOI with methylphenidate may cause a sudden
increase in your blood pressure.
If you or your child are taking other medicines, methylphenidate may affect how well they work or may
cause side effects. If you or your child are taking any of the following medicines, check with your doctor or
pharmacist before taking methylphenidate:

other medicines for depression

medicines for severe mental health problems

medicines for epilepsy

medicines used to reduce or increase blood pressure

some cough and cold remedies which contain medicines that can affect blood pressure. It is important
to check with your pharmacist when you buy any of these products

medicines that thin the blood to prevent blood clots.
If you are in any doubt about whether any medicines you or your child are taking are included in the list
above, ask your doctor or pharmacist before taking methylphenidate.
Please tell you doctor or pharmacist if you or your child are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Having an operation
Tell your doctor if you or your child are going to have an operation. You should not take methylphenidate on
the day of your surgery if a certain type of anaesthetic is used. This is because there is a chance of a sudden
rise in blood pressure during the operation.
Drug testing/anti-doping testing
This medicine may give a positive result when testing for drug use. This includes testing used in sport.
Meglarat with alcohol
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse.
Remember that some foods and medicines contain alcohol.
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Pregnancy, breast-feeding and fertility
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.
It is not known if methylphenidate will affect an unborn baby. Tell your doctor or pharmacist before using
methylphenidate if you or your child are:

having sex. Your doctor will discuss contraception with you

pregnant or think you may be pregnant. Your doctor will decide whether you should take
methylphenidate.

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.
Driving and using machines
You or your child may feel dizzy, have problems focussing or have blurred vision when taking
methylphenidate. If these happen it may be dangerous to do things such as drive, use machines, ride a bike or
horse or climb trees.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
 You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
 It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine.
Meglarat contains lactose
This medicine contains lactose. If you or your child have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take Meglarat

How much to take
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.

your doctor will usually start treatment with a low dose and increase it gradually as required.

the maximum daily dose is 54 mg.

Oral use

Meglarat should be taken once each day in the morning with a glass of water.
The tablet should be swallowed whole and not chewed, broken, divided or crushed. The tablet may be taken
with or without food.
The tablet does not dissolve completely after all of the methylphenidate has been released and sometimes the
tablet shell may appear in your stools. This is normal.
If you or your child do not feel better after 1 month of treatment
If you or your child do not feel better, tell your doctor. They may decide you need a different treatment.
Things your doctor will do when you are on treatment
Your doctor will do some tests
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before you start - to make sure that Meglarat is safe and will be of benefit.
after you start - they will be done at least every 6 months, but possibly more often. They will also be
done when the dose is changed.
these tests will include:
- checking your appetite
- measuring height and weight
- measuring blood pressure and heart rate
- checking whether you have any problems with your mood, state of mind or any other unusual
feelings. Or if these have got worse while taking Meglarat.

Long-term treatment
Meglarat does not need to be taken forever. If you or your child take Meglarat for more than a year, your
doctor should stop treatment for a short time, this may happen during a school holiday. This will show if the
medicine is still needed.
Not using Meglarat properly
If Meglarat is not used properly, this may cause abnormal behaviour. It may also mean that you start to
depend on the medicine. Tell your doctor if you have ever abused or been dependent on alcohol, prescription
medicines or street drugs.
This medicine is only for you. Do not give this medicine to anyone else, even if their symptoms seem
similar.
If you take more Meglarat than you should
If you or your child take too much medicine, talk to a doctor or call an ambulance straight away. Tell them
how much has been taken.
Signs of overdose may include: being sick, feeling agitated, shaking, increased uncontrolled movements,
muscle twitching, fits (may be followed by coma), feeling very happy, being confused, seeing, feeling or
hearing things that are not real (hallucinations), sweating, flushing, headache, high fever, changes in heart
beat (slow, fast or uneven), high blood pressure, dilated pupils and dry nose and mouth.
If you or your child forget to take Meglarat Do not take a double dose to make up for a forgotten dose. If
you forget a dose, wait until it is time for the next dose.
If you stop taking Meglarat If you or your child suddenly stop taking this medicine, the ADHD symptoms
may come back or unwanted effects such as depression may appear. Your doctor may want to gradually
reduce the amount of medicine taken each day, before stopping it completely. Talk to your doctor before
stopping Meglarat.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some
people get side effects, most people find that methylphenidate helps them. Your doctor will talk to you about
these side effects.
Some side effects could be serious. If you or your child has any of the side effects below, see a doctor
straight away:
Common (may affect up to 1 in 10 people)

uneven heartbeat (palpitations)

mood changes or mood swings or changes in personality
Uncommon (may affect up to 1 in 100 people)

thinking about or feeling like killing yourself

seeing, feeling, or hearing things that are not real, these are signs of psychosis
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uncontrolled speech and body movements (Tourette’s)
signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other
parts of the body, shortness of breath, wheezing or trouble breathing

Rare (may affect up to 1 in 1,000 people)

feeling unusually excited, over-active and un-inhibited (mania)
Very rare (may affect up to 1 in 10,000 people)

heart attack

sudden death

suicidal attempt

fits (seizures, convulsions epilepsy)

skin peeling or purplish red patches

inflammation or blocked arteries in the brain

muscle spasms which you cannot control affecting your eyes, head, neck, body and nervous system due to a temporary lack of blood supply to the brain

decrease in number of blood cells (red cells, white cells and platelets) which can make you more likely
to get infections, and make you bleed and bruise more easily

a sudden increase in body temperature, very high blood pressure and severe convulsions (‘Neuroleptic
Malignant Syndrome’). It is not certain that this side effect is caused by methylphenidate or other
medicines that may be taken in combination with methylphenidate.
Not known (frequency cannot be estimated from the available data)

unwanted thoughts that keep coming back

unexplained fainting, chest pain, shortness of breath (these can be signs of heart problems)

paralysis or problems with movement and vision, difficulties in speech (these can be signs of problems
with the blood vessels in your brain)
If you or your child has 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 (may affect more than 1 in 10 people)

headache

feeling nervous

not being able to sleep.
Common (may affect up to 1 in 10 people)

joint pain

blurred vision

tension headache

dry mouth, thirst

trouble falling asleep

high temperature (fever)

decreased interest in sex

unusual hair loss or thinning

muscle tightness, muscle cramps

loss of appetite or decreased appetite

inability to develop or maintain an erection

itching, rash or raised red itchy rashes (hives)

feeling unusually sleepy or drowsy, feeling tired

clenching or grinding your teeth, feeling of panic

tingling feeling, prickling, or numbness of the skin

increased alanine aminotransferase (liver enzyme) level in your blood

cough, sore throat or nose and throat irritation; upper respiratory tract infection; sinus infection
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high blood pressure, fast heart beat (tachycardia)
dizziness (vertigo), feeling weak, movements which you cannot control, being unusually active
feeling aggressive, agitated, anxious, depressed, irritable, tense, jittery and abnormal behaviour
upset stomach or indigestion, stomach pain, diarrhoea, feeling sick, stomach discomfort and being
sick.

Uncommon (may affect up to 1 in 100 people)

dry eyes

constipation

chest discomfort

blood in the urine

listlessness

shaking or trembling

increased need to pass urine

muscle pain, muscle twitching

shortness of breath or chest pain

feeling hot

increases in liver test results (seen in a blood test)

anger, feeling restless or tearful, talking too much, excessive awareness of surroundings, problems
sleeping.
Rare (may affect up to 1 in 1,000 people)

feeling disorientated or confused

trouble seeing or double vision

swelling of the breasts in men

excessive sweating, redness of the skin, red raised skin rash.
Very rare (may affect up to 1 in 10,000 people)

muscle cramps

small red marks on the skin

abnormal liver function including liver failure and coma

changes in test results – including liver and blood tests

abnormal thinking, lack of feeling or emotion, doing things over and over again, being obsessed with
one thing

fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold
(‘Raynaud’s phenomenon’).
Not known (frequency cannot be estimated from the available data)

migraine

dilated pupils

very high fever

slow, fast or extra heart beats

a major fit (‘grand mal convulsions’)

believing things that are not true

severe stomach pain, often with feeling and being sick.
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.

there may be lack of weight gain or height growth.

your doctor will carefully watch your height and weight, as well as how well you are eating.

if you are not growing as expected, then your treatment with methylphenidate may be stopped for a
short time.
Reporting of side effects
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Meglarat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP’. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Shelf life after first opening the bottle:
18 mg tablets: 3 months
27 mg tablets: 6 months
36 mg tablets: 6 months
54 mg tablets: 6 months
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Meglarat contains
The active substance is methylphenidate hydrochloride
Meglarat 18mg: Each prolonged-release tablet contains 18mg of methylphenidate hydrochloride equivalent
to 15.6 mg of methylphenidate.
Meglarat 27mg: Each prolonged-release tablet contains 27mg of methylphenidate hydrochloride equivalent
to 23.3 mg of methylphenidate.
Meglarat 36mg: Each prolonged-release tablet contains 36mg of methylphenidate hydrochloride equivalent
to 31.1 mg of methylphenidate.
Meglarat 54mg: Each prolonged-release tablet contains 54mg of methylphenidate hydrochloride equivalent
to 46.7 mg of methylphenidate.
The other ingredients are:
Tablet Core:
Lactose monohydrate, hypromellose, silica (colloidal anhydrous), magnesium stearate, fumaric acid,
methacrylic acid–methyl methacrylate copolymer (1:1), methacrylic acid–methyl methacrylate copolymer
(1:2), triethyl citrate, talc.
Tablet coating:
18 mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron
oxide yellow (E172), iron oxide red (E172).
27 mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron
oxide yellow (E172), Indigo carmine aluminium lake (E132), iron oxide black (E172).
36 mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171).
54 mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol (3350), talc, titanium dioxide (E171), iron
oxide red (E172).
Printing ink:
Shellac glaze, iron oxide black (E172), propylene glycol.
What Meglarat looks like and contents of the pack

8

18 mg Tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9 mm, with “2392” printed on one side
in black ink.
27 mg Tablet: Capsule-shaped, biconvex, grey tablet, 6.7 mm x 12.0 mm, with “2393” printed on one side
in black ink.
36 mg Tablet: Capsule-shaped, biconvex, white tablet, 6.7 mm x 12.0 mm, with “2394” printed on one side
in black ink.
54 mg Tablet: Capsule-shaped, biconvex, red-brown tablet, 6.8 mm x 12.0 mm, with “2395” printed on one
side in black ink.
Meglarat is available in bottles with child-resistant closure, with silica gel desiccant integrated into the
closure, containing 28, 30 or 90 prolonged-release tablets (18 mg tablets) or 28, 30 or 100 prolonged-release
tablets (27 mg, 36 mg and 54 mg tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Breath Limited
Whiddon Valley
Barnstaple
North Devon
EX32 8NS
United Kingdom
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This leaflet was last revised in July 2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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