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MEDIKINET XL 20MG MODIFIED-RELEASE HARD CAPSULES

Active substance(s): METHYLPHENIDATE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Medikinet® XL 20mg
Modified-Release Hard Capsules
(methylphenidate hydrochloride)

Medikinet XL Modified-Release Hard Capsules are available in
the following strengths: 10mg, 20mg, 30mg and 40mg. Your
medicine is available using the name Medikinet XL 20mg
Modified-Release Hard Capsules but will be referred to as
Medikinet XL throughout this leaflet.

Important things you need to know about your
medicine
This medicine is used to treat ADHD

The full name for ADHD is ‘Attention Deficit
Hyperactivity Disorder’.

The medicine helps with your brain activity. It can help
improve your attention, help you concentrate, and make
you less impulsive.

You need to have other treatments for ADHD as well as
this medicine.
Read section 1 for more information.


Before you take this medicine, talk to your doctor if:
You have heart, circulation, or mental health problems you may not be able to take this medicine.

You are taking any other medicines - this is because
Medikinet XL can affect how other medicines work.
Read section 2 for more information.


While taking this medicine:

See your doctor regularly. This is because your doctor
will want to check how the medicine is working.

Do not stop taking the medicine without first talking to
your doctor.

Your doctor may stop your medicine to see if it is still
needed, if you take it for more than a year.

The most common side effects are feeling nervous, not
being able to sleep or having a headache.
Read sections 3 and 4 for more information.


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

Your mood and how you feel changes.

You feel any problems with your heart.
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.

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. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.

If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
Read section 4 for more information.



How it works

Medikinet XL 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.
Medikinet XL treatment must only be initiated by, and used
under the supervision of, a specialist in childhood and/or
adolescent behavioural disorders. 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.

2. What you need to know before you take
Medikinet XL
Do not take Medikinet XL
If you or your child














The leaflet has been written in sections:

Sections 1 to 6 are for parents and carers (sometimes
called ‘your guardians’).

The last section is a special section for a child or young
person to read.
However, all sections are written as though the child or young
person taking the medicine is reading them.





The sections are:
1.
2.
3.
4.
5.
6.

What Medikinet XL is and what it is used for
What you need to know before you take Medikinet XL
How to take Medikinet XL
Possible side effects
How to store Medikinet XL
Contents of the pack and other information

Tear Here - Information for children and young people

Now read the rest of this leaflet before you
start taking this medicine.
1. What Medikinet XL is and what it is used
for
What it is used for

Medikinet XL 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.
Medikinet XL is not for use as a treatment for ADHD in
children under 6 years of age or in adults. If you have been
successfully treated with Medikinet XL as an adolescent for
ADHD, if your symptoms persist into adulthood and a need
for further therapy has been determined, it might be
appropriate to continue taking Medikinet XL when you
become an adult. Your doctor will advise you about this.

is allergic to Medikinet XL or any of the other ingredients
of this medicine (listed in section 6)
has a thyroid problem
has increased pressure in the eye (glaucoma)
has a tumour of the adrenal gland
(phaeochromocytoma)
has an eating problem when you do not feel hungry or
want to eat - such as ‘anorexia nervosa’
has very high blood pressure or narrowing of the blood
vessels, which can cause pain in the arms and legs
has ever had heart problems - such as a heart attack,
uneven heartbeat, pain and discomfort in the chest,
heart failure, heart disease or was born with a heart
problem
has had a problem with the blood vessels in the 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)
is currently taking or has taken within the last 14 days
an antidepressant (known as a monoamine oxidase
inhibitor) – see ‘Other medicines and Medikinet XL’
has 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.
has a history of pronounced lack of gastric acid
(anacidity of the stomach) with a pH value above 5.5
is taking medicines to reduce secretion of gastric acid or
to treat excessive acidity of the stomach (H2 receptor
blocker or antacid treatment).

Do not take Medikinet XL 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 takes methylphenidate.
This is because Medikinet XL can make these problems worse.

Warnings and precautions
Talk to your doctor before taking Medikinet XL if
you or your child

has liver or kidney problems
has problems with swallowing or swallowing whole
tablets

has a narrowing or blockage of the gut or food-pipe

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

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

is female and has started having periods (see the
‘Pregnancy and breast-feeding’ section below)

has hard-to-control, repeated twitching of any parts of
the body or repeats sounds and words

has high blood pressure

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

has 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 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
Medikinet XL 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 start
taking Medikinet XL

These checks are to decide if Medikinet XL is the correct
medicine for you or your child. Your doctor will talk to you
about:

any other medicines you or your child is 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 is feeling, such as feeling high or
low, having strange thoughts or if you or your child has
had any of these feelings in the past

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

any mental health or behaviour problems you or your
child or other family members have ever had.
Your doctor will discuss whether you or your child is at risk of
having mood swings (from being manic to being depressed called ‘bipolar disorder’). They will check you or your child’s
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 Medikinet XL 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.

Drug testing

This medicine may give a positive result when testing for drug
use. Athletes must be aware that this medicinal product may
cause a positive reaction to ‘anti-doping’ tests.

Other medicines and Medikinet XL

Please tell your doctor or pharmacist if you or your child is
taking, has recently taken or may take any other medicines.

Do not take Medikinet XL if you or your child:


is taking a medicine called a ‘monoamine oxidase
inhibitor’ (MAOI) used for depression, or has taken a
MAOI in the last 14 days. Taking a MAOI with
Medikinet XL may cause a sudden increase in blood
pressure.

If you or your child is taking other medicines, Medikinet XL
may affect how well they work or may cause side effects.
If you or your child is taking any of the following medicines,
check with your doctor or pharmacist before taking
Medikinet XL:

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.
Medikinet XL must not be taken together with H2 receptor
blockers or antacids which are used to reduce gastric acid
secretion or to counteract excessive acidity in the stomach,
as this could lead to a faster release of the total amount of
active substance.
If you are in any doubt about whether any medicines you or
your child is taking are included in the list above, ask your
doctor or pharmacist for advice before taking
methylphenidate.

Having an operation

Tell your doctor if you or your child is going to have an
operation. Medikinet XL should not be taken on the day of
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.

Taking Medikinet XL 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 and breast-feeding

It is not known if Medikinet XL will affect an unborn baby.
Tell your doctor or pharmacist before using Medikinet XL if
you or your daughter:

is having sex. Your doctor will discuss contraception.

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

is breast-feeding or planning to breast-feed. It is
possible that Medikinet XL is passed into human breast
milk. Therefore, your doctor will decide whether you or
your daughter should breast-feed while taking
Medikinet XL.

Page 1 of 2
Tear Here

Information for children and young people

This info is to help you learn the main things about your
medicine called Medikinet XL.
If you don’t enjoy reading, someone like your mum, dad or
carer (sometimes called ‘your guardian’) can read it to you
and answer any questions.
It may help if you read small bits at a time.

Why have I been given this medicine?

This medicine can help children and young people with
‘ADHD’.

ADHD can make you:

run about too much

not be able to pay attention

act quickly without thinking about what will happen
next (impulsive).

It affects learning, making friends and how you think
about yourself. It is not your fault.

While you are taking this medicine











as well as taking this medicine you will also get help
with ways to you cope with your ADHD such as talking
to ADHD specialists.
this medicine should help you. But it does not cure
ADHD.
you will need to go to your doctor several times a year
for check ups. This is to make sure the medicine is
working and that you are growing and developing OK.
if you take the medicine for more than one year, your
doctor may stop your medicine to see if it is still needed.
This will probably happen in a school holiday.
if you take this medicine more than once a day, you
may have to remember to take it at school or college.
You or your mum, dad or carer will need to find out
what the school rules are about this.
do not drink alcohol. Alcohol may make the side effects
of this medicine worse.
If you are having sex, please talk to your doctor about
contraception. Girls must tell their doctor straight away
if they think they may be pregnant. We do not know
how this medicine affects unborn babies.

Page 1 of 2

Some people cannot have this medicine

You cannot have this medicine if:

you have a problem with your heart

you feel very unhappy, depressed or have a mental
illness.

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





need to talk to your doctor if:
you have epilepsy (fits)
you are pregnant or breastfeeding
you have a lack of gastric acid or take medicines for
binding gastric acid
you are taking other medicines – your doctor needs to
know about all the medicines you are taking.

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.

Medikinet XL contains sucrose

If you or your child has 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 Medikinet XL
How much to take

You or your child should always take Medikinet XL exactly as
your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The maximum daily dose is 60mg.

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

Your doctor will tell you what strength of capsule to take
each day.

Do not split the dose of a capsule; take the entire
contents of the capsule.

Medikinet XL should not be taken too late in the morning
as it may cause disturbances in sleep.

Your doctor will do some tests






before you or your child starts – to make sure that
Medikinet XL is safe and will be of benefit.
after you or your child starts – 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 appetite

measuring height and weight

measuring blood pressure and heart rate

checking problems with mood, state of mind or any
other unusual feelings. Or if these have got worse
while taking Medikinet XL.

How to take

The medicinal product is intended for oral use.
Take Medikinet XL in the morning with or after breakfast.
This is very important in order to obtain sufficiently prolonged
action. The capsules may be swallowed whole with a drink of
water. Alternatively, you can open the capsules, sprinkle the
capsule contents onto a small amount (tablespoon) of apple
sauce or yoghurt and take it immediately. In this case food
should be eaten as well, of course. Do not store for future
use.
The capsules and the capsule contents must not be crushed
or chewed.

If you or your child does not feel better after
1 month of treatment

If you or your child does not feel better, tell your doctor. They
may decide a different treatment is needed.

Long-term treatment

Medikinet XL does not need to be taken for ever. If you or
your child takes Medikinet XL 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 Medikinet XL properly

If Medikinet XL is not used properly, this may cause abnormal
behaviour. It may also mean that you or your child starts to
depend on the medicine. Tell your doctor if you or your child
has ever abused or been dependent on alcohol, prescription
medicines or street drugs.

If you or your child takes more Medikinet XL than
you should

If you or your child takes 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 forgets to take Medikinet XL

Do not take a double dose to make up for a forgotten dose. If
you or your child forgets a dose, wait until it is time for the
next dose.

If you or your child stops taking Medikinet XL

If you or your child suddenly stops taking this medicine,
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
Medikinet XL.
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, but
not everybody gets them. Your doctor will talk to you about
these side effects.

Some side effects could be serious. If you have 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
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
fits (seizures, convulsions, epilepsy)
skin peeling or purplish red patches
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
paralysis or problems with movement and vision,
difficulties in speech (these can be signs of problems
with the blood vessels in your 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 Medikinet XL or other drugs that may be
taken in combination with methylphenidate.

Not known: frequency cannot be estimated from
available data



unwanted thoughts that keep coming back
unexplained fainting, chest pain, shortness of breath
(these can be signs of heart problems).

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: 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
dry mouth
high temperature (fever)
unusual hair loss or thinning
feeling unusually sleepy or drowsy
loss of appetite or decreased appetite
itching, rash or raised red itchy rashes (hives)
cough, sore throat or nose and throat irritation
high blood pressure, fast heart beat (tachycardia)
feeling dizzy, movements which you cannot control,
being unusually active
feeling aggressive, agitated, anxious, depressed,
irritable and abnormal behaviour
stomach pain, diarrhoea, feeling sick, stomach
discomfort and being sick.

Uncommon: may affect up to 1 in 100 people










constipation
chest discomfort
blood in the urine
shaking or trembling
double vision or blurred vision
muscle pain, muscle twitching
shortness of breath or chest pain
increases in liver test results (seen in a blood test)
anger, feeling restless or tearful, excessive awareness of
surroundings, problems sleeping.

Rare: may affect up to 1 in 1,000 people







changes in sex drive
feeling disorientated
dilated pupils, trouble seeing
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











heart attack
sudden death
muscle cramps
small red marks on the skin
inflammation or blocked arteries in the brain
abnormal liver function including liver failure and coma
changes in test results – including liver and blood tests
suicidal attempt, 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
available data












migraine
very high fever
slow, fast or extra heart beats
a major fit (‘grand mal convulsions’)
believing things that are not true, confusion
severe stomach pain, often with feeling and being sick
problems with the blood vessels of the brain (stroke,
cerebral arteritis or cerebral occlusion)
dry skin
erectile dysfunction
excessive uncontrolled talking.

Effects on growth

When used for more than a year, Medikinet XL 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 you or your child’s
height and weight, as well as how well you or your child
is eating.

If you or your child is not growing as expected, then
treatment with Medikinet XL may be stopped for a short
time.

Reporting of side effects

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 Medikinet XL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the blister and the box after “Exp”. The expiry date refers
to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from
moisture.
If your doctor decides to stop treatment, return any leftover
capsules to the pharmacist. Only keep them if the doctor tells
you to.
If your medicine appears to be discoloured or shows any
other signs of deterioration, please return to your pharmacist.
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 Medikinet XL contains:

The active substance is methylphenidate hydrochloride.
Each capsule contains 20mg methylphenidate hydrochloride,
equivalent to 17.30mg methylphenidate.
Also contains:
Capsule content: sugar spheres (containing sucrose and
maize starch), methacrylic acid-ethylacrylate-copolymer
(1:1), talc, triethyl citrate, polyvinyl alcohol, macrogol 3350,
polysorbate 80, sodium hydroxide, sodium laurilsulfate,
simeticone, silica colloidal anhydrous, methylcellulose,
sorbic acid and indigo carmine (E132).
Capsule shell: gelatin, erythrosine (E127),
titanium dioxide (E171), sodium laurilsulfate, purified water
and patent blue V (E 131).

What Medikinet XL looks like and contents of the
pack

Medikinet XL are hard capsules with a mauve opaque body
and a mauve opaque cap containing white and blue pellets.
Medikinet XL is available in packs of 30 capsules.

Manufacturer

Manufactured by:
MEDICE Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37,
58638 Iserlohn, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe,
Northumberland, NE42 6PX.
PL No: 21828/0581

POM

CD

Leaflet issue and revision date (Ref): 17.09.15
Medikinet® is a registered trademark of MEDICE Arzneimittel
Pütter GmbH & Co. KG.

Page 2 of 2
Tear Here

How do I take my medicine (capsules)?






Swallow your medicine with water with or after a
meal.
If you have problems to swallow the capsules, the
capsules may be opened, the capsule contents sprinkled
onto a small amount (tablespoon) of apple sauce or
yoghurt and taken immediately.
The capsules and the capsule contents must not be
crushed or chewed.
Your doctor will tell you how many times a day you
should take your medicine.
Do not stop taking the medicine without talking to your
doctor first.

Possible side effects

Side effects are the unwanted things that can happen when
you take a medicine. If any of the following happen, tell an
adult you trust straight away. They can then talk to your
doctor. The main things that could affect you are:

Feeling worried or nervous

Feeling dizzy, or getting head aches

Being very depressed and unhappy or wanting to hurt
yourself

Having different moods than usual, not being able to get
to sleep

Skin rashes, bruising easily, getting out of breath

The medicine can also make you feel sleepy. If you feel
sleepy, it is important not to do outdoor sports like
riding a horse or bike, swimming or climbing trees. You
could hurt yourself and others.

Your heart beating faster than usual.
If you feel unwell in any way while you are taking your
medicine please tell an adult you trust straight away.

Page 2 of 2

Other things to remember










make sure you keep your medicine in a safe place, so
that no one else takes it, especially younger brothers or
sisters.
the medicine is special for you - do not let anyone
else have it. It may help you, but it could hurt
someone else.
if you forget to take your medicine don’t take two
capsules the next time. Just take one capsule at the
next normal time.
if you do take too much medicine, tell your mum, dad or
carer right away.
it is important not to take too much medicine or you will
get ill.
don’t stop taking your medicine until your doctor says
it’s OK.

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.

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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