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DELMOSART 18MG PROLONGED RELEASE TABLETS

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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Package leaflet: Information for the user

Delmosart 18mg, 27mg, 36mg and
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 Delmosart is and what it is used for
2 What you need to know before you or your
child take Delmosart
3 How to take Delmosart
4 Possible side effects
5 How to store Delmosart
6 Contents of the pack and other information
1 What Delmosart is and what it is used for

What it is used for

Delmosart 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.
Delmosart 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 Delmosart when you become
an adult. Your doctor will advise you about this.

How it works

Delmosart improves the activity of certain parts of the brain
which are underactive. 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:
• p sychological
• e ducational and
• s ocial 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:
• h ard to sit still and
• h ard 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.

2 What you need to know before you or your

child take Delmosart

Do not take Delmosart if you or your child:
• a re allergic to methylphenidate or any of the other
ingredients of this medicine (listed in section 6)

• h ave a thyroid problem
• h ave increased pressure in your eye (glaucoma)
• h ave a tumour of your adrenal gland
(phaeochromocytoma)

• h ave an eating problem when you do not feel hungry or

want to eat - such as ‘anorexia nervosa’
• h ave very high blood pressure or narrowing of the blood
vessels, which can cause pain in the arms and legs
• h ave 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
• h ave 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)
• a re currently taking or have taken within the last 14 days an
antidepressant (known as a monoamine oxidase inhibitor) see ‘Other medicines and Delmosart ’
• h ave 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, overactive,
and uninhibited.
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 Delmosart if you or your
child:
• h ave liver or kidney problems
• h ave a problem with swallowing or swallowing whole
tablets
• h ave a narrowing or blockage of your gut or food pipe
• h ave had fits (seizures, convulsions, epilepsy) or any
abnormal brain scans (EEGs)
• h ave ever abused or been dependent on alcohol,
prescription medicines or street drugs
• a re a girl and have started your periods (see the ‘Pregnancy,
breast-feeding and contraception’ section below)
• h ave hard to control, repeated twitching of any parts of the
body or you repeat sounds and words
• h ave high blood pressure
• h ave a heart problem which is not in the ‘Do not take’
section above
• h ave a mental health problem which is not in the ‘Do not
take’ section above.
Other mental health problems include:
•m
 ood swings (from being manic to being depressed called
‘bipolar disorder’)
• s tarting to be aggressive or hostile, or your aggression gets
worse
• s eeing, hearing or feeling things that are not there
(hallucinations)
• b elieving 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.

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:
• a ny other medicines you or your child are taking
•w
 hether there is any family history of sudden unexplained
death
• a ny other medical problems (such as heart problems) you
or your family may have
• h ow 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
•w
 hether there is a family history of ‘tics’ (hard to control,
repeated twitching of any parts of the body or repeating
sounds and words)
• a ny 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 Delmosart

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:
• a re 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:
• o ther medicines for depression
•m
 edicines for severe mental health problems
•m
 edicines for epilepsy
•m
 edicines used to reduce or increase blood pressure
• s ome 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
•m
 edicines 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.

Delmosart 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.

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:
• h aving sex. Your doctor will discuss contraception with you
• p regnant or think you may be pregnant. Your doctor will
decide whether you should take methylphenidate
• b reast-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.
•D
 o 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.
•H
 owever, you would not be committing an offence if:
- T he 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.

Delmosart 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 Delmosart

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.
• y our doctor will usually start treatment with a low dose and
increase it gradually as required
• t he maximum daily dose is 54mg
• F or oral use
•D
 elmosart 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.

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Methylphenidate (Delmosart) 18mg, 27mg, 36mg & 54mg 30 Tablets PIL - UK
item no: AAAJ1131

dimensions: 170 x 600

print proof no: 4

pharmacode:

origination date: 20.06.16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 28.06.16

Technical Approval

revised by: S.Anson

date sent: 20.06.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 28.06.16

Non Printing Colours
1.
2.
3.

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
• b efore you start to make sure that Delmosart is safe and will
be of benefit

• a fter 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
• t hese 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 Delmosart.

Long term treatment

Delmosart does not need to be taken forever. If you or your
child take Delmosart 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 Delmosart properly

If Delmosart 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 Delmosart 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 heartbeat (slow, fast or uneven), high blood
pressure, dilated pupils and dry nose and mouth.

If you or your child forget to take Delmosart

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 Delmosart

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 Delmosart.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4 Possible side effects

Uncommon (may affect up to 1 in 100 people)
• d ry eyes
• c onstipation
• c hest discomfort
• b lood in the urine
• listlessness
• s haking or trembling
• increased need to pass urine
•m
 uscle pain, muscle twitching
• s hortness of breath or chest pain
• feeling hot
• increases in liver test results (seen in a blood test)
• a nger, 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
• t rouble seeing or double vision
• s welling of the breasts in men
• e xcessive sweating, redness of the skin, red raised skin rash.
Very rare (may affect up to 1 in 10,000 people)
•m
 uscle cramps
• s mall red marks on the skin
• a bnormal liver function including liver failure and coma
• c hanges in test results including liver and blood tests
• a bnormal 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)
•m
 igraine
• d ilated pupils
• v ery high fever
• s low, fast or extra heartbeats
• a major fit (‘grand mal convulsions’)
• b elieving things that are not true
• s evere 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.
• t here may be lack of weight gain or height growth
• y our 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

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 Delmosart

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.

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage
conditions.

Common (may affect up to 1 in 10 people)
• u neven heartbeat (palpitations)
•m
 ood changes or mood swings or changes in personality.
Uncommon (may affect up to 1 in 100 people)
• t hinking about or feeling like killing yourself
• s eeing, feeling, or hearing things that are not real, these are
signs of psychosis
• u ncontrolled speech and body movements (Tourette’s)
• s igns 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, overactive and uninhibited
(mania).
Very rare (may affect up to 1 in 10,000 people)
• h eart attack
• s udden death
• s uicidal attempt
• fits (seizures, convulsions epilepsy)
• s kin peeling or purplish red patches
• inflammation or blocked arteries in the brain
•m
 uscle 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
• d ecrease 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)
• u nwanted thoughts that keep coming back
• u nexplained fainting, chest pain, shortness of breath (these
can be signs of heart problems)
• p aralysis 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)
• h eadache
• feeling nervous
• n ot being able to sleep.
Common (may affect up to 1 in 10 people)
• joint pain
• b lurred vision
• t ension headache
• d ry mouth, thirst
• t rouble falling asleep
• h igh temperature (fever)
• d ecreased interest in sex
• u nusual hair loss or thinning
•m
 uscle 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
• c lenching or grinding your teeth, feeling of panic
• t ingling feeling, prickling, or numbness of the skin
• increased alanine aminotransferase (liver enzyme) level in
your blood
• c ough, sore throat or nose and throat irritation, upper
respiratory tract infection, sinus infection
• h igh blood pressure, fast heartbeat (tachycardia)
• d izziness (vertigo), feeling weak, movements which you
cannot control, being unusually active
• feeling aggressive, agitated, anxious, depressed, irritable,
tense, jittery and abnormal behaviour
• u pset stomach or indigestion, stomach pain, diarrhoea,
feeling sick, stomach discomfort and being sick.

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.

Shelf life after first opening the bottle:
18mg tablets: 3 months
27mg tablets: 6 months
36mg tablets: 6 months
54mg 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 Delmosart contains

The active substance is methylphenidate hydrochloride
Delmosart 18mg: Each prolonged-release tablet contains
18mg of methylphenidate hydrochloride equivalent to
15.6mg of methylphenidate.
Delmosart 27mg: Each prolonged-release tablet contains
27mg of methylphenidate hydrochloride equivalent to
23.3mg of methylphenidate.
Delmosart 36mg: Each prolonged-release tablet contains
36mg of methylphenidate hydrochloride equivalent to
31.1mg of methylphenidate.
Delmosart 54mg: Each prolonged-release tablet contains
54mg of methylphenidate hydrochloride equivalent to
46.7mg 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
18mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol
(3350), talc, titanium dioxide (E171), iron oxide yellow (E172),
iron oxide red (E172).
27mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol
(3350), talc, titanium dioxide (E171), iron oxide yellow (E172),
Indigo carmine aluminium lake (E132), iron oxide black
(E172).
36mg Tablets: Polyvinyl alcohol (part hydrolysed), macrogol
(3350), talc, titanium dioxide (E171).
54mg 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 Delmosart looks like and contents of the pack
18mg Tablet: Capsule-shaped, biconvex, yellow tablet,
6.6mm x 11.9mm, with “2392” printed on one side in black
ink.
27mg Tablet: Capsule-shaped, biconvex, grey tablet, 6.7mm x
12.0mm, with “2393” printed on one side in black ink.
36mg Tablet: Capsule-shaped, biconvex, white tablet, 6.7mm
x 12.0mm, with “2394” printed on one side in black ink.
54mg Tablet: Capsule-shaped, biconvex, red-brown tablet,
6.8mm x 12.0mm, with “2395” printed on one side in black
ink.
Delmosart is available in bottles with child-resistant
closure, with silica gel desiccant integrated into the closure,
containing 30 prolonged-release tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in June 2016

If you would like a
leaflet with larger text,
please contact
01271 385257.

Continued top of next column
AAAJ1131

Actavis, Barnstaple, EX32 8NS, UK

Methylphenidate (Delmosart) 18mg, 27mg, 36mg & 54mg 30 Tablets PIL - UK
item no: AAAJ1131

dimensions: 170 x 600

print proof no: 4

pharmacode:

origination date: 20.06.16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 28.06.16

Technical Approval

revised by: S.Anson

date sent: 20.06.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 28.06.16

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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