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DEXAMFETAMINE SULFATE 1 MG/ ML ORAL SOLUTION

Active substance(s): DEXAMFETAMINE SULFATE

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Dexamfetamine Sulfate 1 mg/ml Oral Solution
Pharmacode

Dexamfetamine sulfate
This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. You can help by reporting any side effects you may get. See the end of section 4 for how to
report side effects.

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness
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.
See section 4.
What is in this leaflet:
1. What Dexamfetamine Sulfate 1 mg/ml Oral Solution is
and what it is used for
2. What you need to know before you take Dexamfetamine
Sulfate 1 mg/ml Oral Solution
3. How to take Dexamfetamine Sulfate 1 mg/ml Oral
Solution
4. Possible side effects
5. How to store Dexamfetamine Sulfate 1 mg/ml Oral
Solution
6. Contents of the pack and other information.

1. What Dexamfetamine Sulfate 1 mg/ml Oral
Solution is and what it is used for
Dexamfetamine Sulfate 1 mg/ml Oral Solution contains
dexamfetamine, which belongs to a group of medicines called
stimulants. These work by increasing activity in the brain.
Dexamfetamine works by affecting some of the natural
chemicals that are found in the brain. In particular, it increases
the activity of chemicals called dopamine and noradrenaline in
areas of the brain that play a part in controlling attention and
behaviour.
Dexamfetamine stimulates activity in the brain, helping to keep
people alert and active during the day.
Dexamfetamine is used to treat attention-deficit/hyperactivity
disorder (ADHD).
• It is used in children and adolescents aged 6-17 years.
• It is not indicated in all children with ADHD.
• It is used only after when another medicine called
methylphenidate was not sufficiently effective.
• It should be used as part of a treatment programme which
typically includes psychological, educational and social
measures.
Dexamfetamine Sulfate 1 mg/ml Oral Solution treatment must
only be initiated by and used under the supervision of a
specialist in childhood or adolescent behavioural disorders.
Dexamfetamine Sulfate 1 mg/ml Oral Solution is also used:
• To treat narcolepsy (being unable to stop yourself falling
asleep).
You must talk to a doctor if you or your child do not feel better or
feel worse after a month. The doctor may decide that a different
treatment is needed.

2. What you need to know before you take
Dexamfetamine Sulfate 1 mg/ml Oral
Solution
Do NOT take Dexamfetamine Sulfate 1 mg/ml Oral Solution
if you or your child:
• are allergic (hypersensitive) to dexamfetamine or other
amfetamine compounds or any other ingredients (listed in
Section 6)
• have a thyroid problem
• have increased pressure in the eyes (glaucoma)
• have a tumour of the adrenal gland (phaeochromocytoma)
• have an eating problem, do not feel hungry or do not want
to eat (e.g. anorexia nervosa)
• have very high blood pressure or narrowing of the blood
vessels, which can cause pain in the arms and legs
• have advanced arteriosclerosis
• 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 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)
• have mental health problems such as:
- a psychopathic or borderline personality disorder
- abnormal thoughts or vision or schizophrenia
- signs of a severe mood disorder like:
• suicidal feelings
• severe depression
• mania
• are currently taking or have taken within the last 14 days an
antidepressant (known as a monoamine oxidase inhibitor) see ‘Other medicines and Dexamfetamine 1 mg/ml Oral
Solution’ section below
• have ever abused alcohol, prescription medicines, or street
drugs
• or anyone in your family has Tourette’s syndrome or other
motor or verbal tics
• have a hard-to-control, repeated twitching of any parts of the
body or repeats sounds and words
• have porphyria.
If any of the above applies to you do not take Dexamfetamine
Sulfate 1 mg/ml Oral Solution and talk to your doctor or
pharmacist. This is because this medicine can make these
problems worse.
Warnings and precautions
Talk to your doctor before taking Dexamfetamine Sulfate 1mg/ml
Oral Solution if you or your child:
• have a disease of the blood or liver, or kidney problems
• are hyperexcitable or has an unstable personality
• have had fits (seizures, convulsions, epilepsy) or any
abnormal brain scans (EEGs)
• are female and have started having periods (see ‘Pregnancy
and breast-feeding’ section below)
• 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’
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section above. This may include mood swings, unusual
aggression, hallucinations, delusions, paranoia, agitation and
anxiety, feelings of guilt or depression.
Tell your doctor or pharmacist if any of the above applies to you
or your child before starting treatment. This is because this
medicine 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
Dexamfetamine 1 mg/ml Oral Solution is used
These checks are to decide if this 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 or your child has 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 child’s mental
health history, and check if any of your family has 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 Dexamfetamine 1 mg/ml
Oral Solution 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.
Effect on weight/growing
Dexamfetamine 1 mg/ml Oral Solution may cause reduced
weight in some children and adolescents.
• There may be a lack of weight gain.
• Your doctor will carefully watch the height and weight of
your child, as well as how well your child is eating.
• If your child is not growing as expected, then your doctor
may stop treatment with Dexamfetamine 1 mg/ml Oral
Solution for a short time.
Having an operation
Tell your doctor if you or your child are going to have an
operation. Dexamfetamine 1 mg/ml Oral Solution 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.
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.
Children and adolescents
Dexamfetamine 1 mg/ml Oral Solution is not for use as a
treatment for ADHD in children under 6 years of age, and
adults. It is not known if it is safe or of benefit for these people.
Dexamfetamine 1 mg/ml Oral Solution is not for use as a
treatment for narcolepsy in children and adolescents. It is not
known if it is safe or of benefit for these people.
Dexamfetamine 1 mg/ml Oral Solution is not for use as a
treatment for narcolepsy in children and adolescents. It is not
known if it is safe or of benefit to them.
Other medicines and Dexamfetamine Sulfate 1 mg/ml Oral
Solution
Tell your doctor or pharmacist if you or your child are taking,
have recently taken or might take any other medicines.
Monoamine oxidase inhibitors
Do not use this medicine 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 a MAOI with dexamfetamine may cause a sudden
increase in blood pressure.
If you or your child are taking other medicines, this medicine
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 using Dexamfetamine
1 mg/ml Oral Solution:
• other medicines for depression, e.g. tricyclic antidepressants
and selective serotonin reuptake inhibitors
• medicines for severe mental health problems, e.g.
phenothiazines and haloperidol
• medicines for epilepsy, e.g. anticonvulsants like
phenobarbital, phenytoin, primidone, and ethosuximide
• medical products that help to give up alcohol, e.g. disulfiram
• medicines used to reduce or increase blood pressure,
e.g. guanethidine, clonidine, reserpine, or
alpha-methyltyrosine, or beta-blockers such as propranolol
• 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,
e.g. coumarin anticoagulants
• any medicines that contain glutamic acid HCl, ascorbic acid,
ammonium chloride, sodium acid phosphate, sodium
bicarbonate, acetazolamide, thiazides
• any of the following medicines: beta-blockers, antihistamines,
lithium, noradrenaline, morphine, and meperidine.
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 for advice before taking this medicine.
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Dexamfetamine Sulfate 1 mg/ml Oral Solution with alcohol
Alcohol must not be consumed while taking this medicine.
Remember that some foods and medicines contain alcohol.
Pregnancy and breast-feeding
Dexamfetamine 1 mg/ml Oral Solution may affect an unborn
baby.
If you or your daughter are pregnant or breast-feeding, may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
• Your doctor will discuss contraception.
• If you or your daughter are pregnant you/she may have to
stop taking this medicine.
• It is possible that this medicine is passed into human breast
milk. Therefore, your doctor will decide whether you or your
daughter should stop breast-feeding or stop taking this
medicine.
Driving and using machines
You or your child may feel dizzy, have problems focusing, or
have blurred vision when taking this medicine.
If so, it may be dangerous to do things such as drive, use
machines, ride a bike or horse, or climb trees.
Dexamfetamine Sulfate 1 mg/ml Oral Solution contains
Liquid maltitol
If you 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 Dexamfetamine Sulfate 1 mg/ml
Oral Solution
Always take Dexamfetamine Sulfate 1 mg/ml Oral Solution
exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
For narcolepsy in adults:
• The usual starting dose is 10 mg a day in divided doses.
• Your doctor may increase your dose each week up to a
maximum of 60 mg a day if necessary.
For narcolepsy in the elderly:
• The usual starting dose is 5 mg a day.
• Your doctor may increase your dose by 5 mg each week.
For ADHD in children aged 6 years and over:
Always use this medicine exactly as your doctor has told
you.You should check with your doctor or pharmacist if you are
not sure.
The normal recommended dose is between 5 mg and 20 mg.
- Your doctor will usually start treatment with a low dose of
5 mg of Dexamfetamine Sulfate 1 mg/ml oral solution. This
will be increased gradually by 5 mg at weekly intervals, as
required.
- The maximum daily dose is 20 mg (in rare cases, 40 mg may
be needed).
How to take
The medicinal product is intended for oral use.
Your child should take Dexamfetamine Sulfate 1 mg/ml Oral
Solution with a drink of water, preferably with or immediately
after meals.
Dexamfetamine Sulfate 1 mg/ml Oral Solution should be taken
at the same time in relation to the meals. The last dose should,
in general, not be given too late after lunch in order to prevent
disturbances in falling asleep.
If your child does not feel better, tell your doctor. They may
decide a different treatment is needed.
Long term treatment
Your doctor will decide how long the treatment is given. If you
or your child takes this medicine for more than a year, your
doctor should stop treatment for a short time, e.g. during a
holiday period. This will show if the medicine is still needed.
Not using Dexamfetamine 1 mg/ml Oral Solution properly
If Dexamfetamine 1 mg/ml Oral Solution is not used properly, it
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 have ever abused or been dependent on
alcohol, prescription medicines or street drugs.
This medicine is only for you or your child. Do not give this
medicine to anyone else, even if their symptoms seem similar.
Medical check-ups in children
Your doctor will check the height and weight of your child whilst
they are taking Dexamfetamine Sulfate 1 mg/ml Oral Solution.
If you or your child take more Dexamfetamine Sulfate
1 mg/ml Oral Solution than you should
If you or your child take more solution than you should, you
might experience excitement, hallucinations, convulsions
leading to coma, irregular and rapid heartbeat and reduced
breathing.
1. Tell your doctor, pharmacist or nearest hospital casualty
department immediately.
2. Take the bottle and any remaining solution with you so that
people can see what you have taken.
3. Do this even if you feel well.
If you or your child forget to take Dexamfetamine Sulfate
1 mg/ml Oral Solution
If you or your child forget to take a dose, take it as soon as you
remember, but if it is almost time for your next dose, skip the
missed dose and continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Dexamfetamine Sulfate 1 mg/ml Oral
Solution
Do not stop taking Dexamfetamine Sulfate 1 mg/ml Oral
Solution without first talking to your doctor.
Suddenly stopping taking Dexamfetamine Sulfate 1 mg/ml Oral
Solution can lead to extreme tiredness and depression, mood
disorders, agitation, sleep disturbances, increased appetite, or
involuntary movements. Your doctor may want to gradually
reduce the amount of medicine taken each day, before
stopping it completely. Your doctor will stop the treatment
gradually.
If you have any further questions about 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.
Your doctor will talk to you about these side effects.
Very common: may affect more than 1 in 10 people
• decreased appetite, reduced weight gain and weight loss
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during prolonged use in children
• difficulty in sleeping
• nervousness
Common: may affect up to 1 in 100 people
• irregular or increased heartbeat, a more noticeable heartbeat
• abdominal pain and/or cramps, nausea, vomiting, dry mouth.
These effects usually occur at the beginning of treatment and
may be alleviated by taking the medicine with meals
• changes in blood pressure and heart rate (usually increases)
• joint pain
• a feeling of dizziness or “spinning”, jerky or involuntary
movements, headache, hyperactivity
• abnormal behaviour, aggression, excitation, anorexia,
anxiety, depression, irritability
Rare: may affect up to 1 in 1,000 people:
• angina pectoris
• difficulties in visual sharpening and focus, blurred vision,
dilation of the pupils.
• reduced height increase during prolonged use in children
• fatigue
• rash, hives
Very rare: may affect up to 1 in 10,000 people
• reduction in red blood cells which can make the skin pale and
cause weakness or breathlessness, changes in blood cell
counts (leukopenia, thrombocytopenia, thrombocytopenic
purpura)
• cardiac arrest
• Tourette’s syndrome
• abnormal liver function ranging from hepatic enzyme
elevations to hepatic coma
• muscle cramps
• convulsions, involuntary movements (choreoathetoid
movements), bleeding inside the skull (intracranial
haemorrhage)
• hallucinations, psychosis/psychotic reactions, suicidal
behaviour or suicide, tics, worsening of pre-existing tics
• itchy red skin lesions (erythema multiforme) or scaly skin
patches (exfoliative dermatitis), recurring rash, which
happens in the same place each time the medicine is taken
(fixed drug eruption)
• inflammation of the blood vessels of the spinal cord and brain
(cerebral vasculitis) and/or occlusion
Not known: frequency cannot be estimated from the
available data
• heart muscle disease (cardiomyopathy), heart attack
• inflammation of parts of the large intestine when the blow flow
is reduced (ischaemic colitis), diarrhoea
• chest pain, growth retardation during prolonged use,
increased body temperature, allergic reactions including
serious allergic reaction which causes swelling of the face or
throat (angioedema) and serious allergic reaction which
causes difficulty in breathing or dizziness (anaphylaxis),
sudden death
• disturbance of the acid-base balance of the body (acidosis)
• abnormal muscle breakdown which can lead to kidney
problems (rhabdomyolysis)
• difficulty in controlling movements (ataxia), dizziness,
abnormal or impaired sense of taste, concentration
difficulties, hyperreflexia, stroke, shaking (tremor)
• confusion, dependence, dysphoria, emotional instability,
euphoria, impaired cognitive test performance, altered libido,
night terrors, obsessive-compulsive behaviour, panic states,
paranoia, restlessness
• renal damage
• impotence
• sweating, hair loss
• circulatory failure.
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 at: 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 Dexamfetamine Sulfate 1
mg/ml Oral Solution
Keep this medicine out of the sight and reach of children.
Store the bottle in an upright position.
Do not use this medicine after the expiry date which is stated
on the label and carton. The expiry date refers to the last day of
that month.
Do not use after 30 days from the date of first opening.
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 Dexamfetamine Sulfate 1 mg/ml Oral Solution
contains
The active substance is dexamfetamine sulfate.
The other ingredients are benzoic acid (E210), citric acid
monohydrate (E330), disodium phosphate dihydrate, liquid
maltitol (E965), hypromellose, orange tangerine flavour and
purified water.
What Dexamfetamine Sulfate 1 mg/ml Oral Solution looks
like and contents of the pack
Dexamfetamine Sulfate 1 mg/ml Oral Solution is a clear
colourless solution which smells of orange/tangerine.
Dexamfetamine Sulfate 1 mg/ml Oral Solution is available in a
150 ml brown glass bottle.
Marketing Authorisation Holder:
Essential Pharmaceuticals Ltd, 7 Egham Business Village,
Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom.
Manufacturer:
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley
Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
This medicinal product is authorised in the Member States
of the EEA under the following names:
Dexamfetamine EssPharm (Norway)
Dexamfetamine EssPharm (Iceland)
Dexamfetamine Sulfate 1 mg/ml Oral
Solution (United Kingdom)
This leaflet was last revised in 03/2015

If this leaflet is difficult to see or read,
please contact the marketing authorisation
holder for help.

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Information for children / young people
with ADHD and their carers
This information is to help you learn the main things about
Attention Deficit Hyperactivity Disorder (ADHD) and about your
or your child’s medicine called Dexamfetamine 1 mg/ml Oral
Solution.
Some people don’t enjoy reading, however it is very important to
read this information. It may help if you read small bits at a time.
If you don’t enjoy reading, it may help if someone else reads it
for you and answers any questions.
What is ADHD?
ADHD is a condition which affects behaviour of children or
young people.
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.
What is Dexamfetamine 1 mg/ml Oral Solution?
Dexamfetamine 1 mg/ml Oral Solution is a medicine which
helps to keep people alert and active during the day.
This medicine can help children and young people with ADHD.
It is used in children and young people aged 6- 17 years with
ADHD, however not everyone with ADHD may take this
medicine.
• Some people cannot have this medicine
You/your child may not be able to have this medicine if:
- you (or your child) have a problem with your heart
- you (or your child) feel very unhappy, depressed or have a
certain type of 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 (or your child) have epilepsy (fits)
- you (or your child) are pregnant or breast-feeding
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- you (or your child) are taking other medicines – your doctor
needs to know about all the medicines you (or your child) are
taking.
Before you (or your child) will start taking this medicine
Your doctor will first check whether this medicine is right for
you/your child.
• Your doctor will check :
- whether you (or your child) have or ever had heart problems
- whether you (or your child) have been unhappy, depressed or
have had a mental illness
- whether you (or your child) have ever had a problem with
alcohol or other drugs
Your doctor will ask you/your child questions and it is important
that you/your child provide as much information as you can.
Your doctor may decide that other medical tests are needed,
which the doctor will explain to you. This will help your doctor to
decide if this medicine is the correct medicine for you/your
child.
• Your doctor will then decide how much of the medicine
you/your child need to take and how long you/your child will
need to take it for.
While you (or your child) are taking this medicine
As well as taking this medicine, you (or your child) will also get
help with ways to cope with ADHD, such as talking to ADHD
specialists.
This medicine should help you/your child. But it does not cure
ADHD.
It is very important that you/your child go to your doctor several
times a year for check-ups, or as your doctor requests. This is
to make sure the medicine is working and that you (or your
child) are growing as you (or your child) should.
• Your doctor will regularly check:
- that your (or your child’s) heart is healthy
- that your (or your child’s) height and weight is as it should
be for your/your child’s age
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- for any changes in mood or appetite.
How do I (my child) take this medicine?
Your doctor will tell you how much of this medicine you/your
child need to take, how to take it and how many times a day to
take it.
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
(or your child) take a medicine. If any of the following happen,
tell an adult you trust (or your doctor) straight away.
The main things that could affect you (or your child) are:

feeling worried or nervous

feeling dizzy, or getting headaches

being very depressed and unhappy or wanting to hurt
yourself

having different moods than usual, not being able to
get to sleep or sleeping too much

skin rashes, bruising easily, getting out of breath

the medicine can also make you (or your child) feel
sleepy. If this happens, 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 (or your child’s) heart beating faster than usual
If you (or your child) feel unwell in any way while taking
this medicine, please tell a doctor, nurse or a pharmacist
straight away.
Other things to remember:
Make sure you keep your (or your child’s) medicine in a safe
place so that no one else takes it, especially younger brothers
or sisters.
The medicine is special for the person it was prescribed for - do
not let anyone else have it. It may help you (or your child), but it
could hurt someone else.
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Tell a doctor, nurse or a pharmacist if:
- anyone asked you (or your child) to give them your (or your
child’s) medicine
- anyone told you (or your child) they want to take your
(or your child’s) medicine.
Always take your medicine as your doctor told you to. This is
very important because if this medicine is not taken correctly, it
could cause an abnormal behaviour – for example dependency
on your medication (feeling that you want or need to take more
of your medication).
Tell a doctor, nurse or a pharmacist if:
- you (or your child) feel that you (or he/she) would like
to take more of your (or their) medicine
- you (or your child) feel that you (or he/she) need to
take more of your (or their) medicine.
If you (or your child) forget to take your (or his/her) medicine
don’t take two doses the next time. Just take the next dose at
the next normal time.
If you (or your child) do take too much medicine, tell an adult,
doctor, nurse or a pharmacist right away.
It is important not to take too much medicine or you (or your
child) will get ill.
Don’t stop taking your medicine until your doctor tells you to
stop.
Do not drink alcohol. Alcohol may make the side effects of this
medicine worse.
If you (or your child) are/is 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.
Who should I ask if there is anything I don’t (or my child
doesn’t) understand?
Your doctor, nurse or pharmacist will be able to help you.

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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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