RITALIN®

10 mg Immediate Release Tablets

20 mg Slow Release Tablets

Methylphenidate Hydrochloride

What is in this leaflet

This leaflet answers some common questions about Ritalin.

It does not contain all the available information. It does not take the
place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you or your child taking Ritalin against the benefits they expect it will
have.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Ritalin is used for

• Ritalin is used to treat a behavioural disorder called Attention Deficit
  Hyperactivity Disorder (ADHD).

About 3% of children suffer from ADHD. It makes them unable to sit still or
concentrate on tasks for any length of time. They may have trouble learning
and doing school work. They frequently become difficult to manage, both in
school and at home.

Ritalin is a central nervous system stimulant. It is thought to work by
regulating specific chemicals in the brain which affect behaviour. It helps to
focus attention, shut out distraction and allows impulsive people to think
before they act. If successful, it will enhance an inattentive person's
natural ability.

Ritalin is part of a treatment program which usually includes
psychological, educational and social therapy.

• Ritalin is also used to treat narcolepsy, a sleep-attack disorder.

People with narcolepsy have recurring attacks of irresistible day-time
sleepiness in spite of having enough sleep at night. Narcolepsy can be
diagnosed by a doctor by recording wake-sleep patterns.

Narcolepsy is not a normal fatigue state. Ritalin should not be used to
prevent or treat normal fatigue.

Ask your doctor if you have any questions about why Ritalin has been
prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription and your
doctor has special permission to prescribe it.

There is not enough information to recommend its use in children under 6
years old.

Note: Ritalin is a controlled drug B₂

It should be kept in a secure place and under no circumstances should it be
given to anyone else.

Before you take Ritalin

When you must not take it

Do not take Ritalin if you have an allergy to methylphenidate (the
active ingredient in Ritalin) or to any of the other ingredients listed at the
end of this leaflet

Some of the symptoms of an allergic reaction may include rash, itching or
hives on the skin; swelling of the face, lips, tongue or other parts of the
body; shortness of breath, wheezing or troubled breathing.

Do not take Ritalin if you have any of the following medical conditions:

• periods of severe anxiety, tension or agitation
• tics (muscle twitching which is usually in the face or shoulders) or if
  your brothers or sisters have tics
• Tourettes's syndrome or you have a family history of this disorder
• glaucoma (increased pressure in the eye)
• an overactive thyroid
• an irregular heartbeat
• severe angina (chest pain)
• A tumour of the adrenal gland called phaeochromocytoma

If you are not sure whether any of the above medical conditions apply to
you, check with your doctor.

Do not take Ritalin after the expiry date printed on the pack or if the
packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Before you start to take it

Tell your doctor if you are allergic to any other medicines,
foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies.

Tell your doctor if you have any of the following medical conditions:

• severe depression or other mental illness
• epilepsy (seizures or fits)
• high blood pressure (hypertension)
• alcoholism
• drug dependence
• heart problems and/or defects
• disorder of the blood vessels in the brain (e.g aneurysm, stroke,
  vasculitis
• aggressive behaviour
• suicidal thoughts

Your doctor may want to take special precautions if you have any of the
above conditions.

Tell your doctor if you are pregnant or breast-feeding. Ask your doctor
about the risks and benefits of taking Ritalin in this case.

Ritalin may affect your developing baby if you take it while you are pregnant.
It is not known if the active ingredient in Ritalin passes into the breast
milk. Breast-feeding is not recommended.

If you have not told your doctor about any of these things, tell him/her
before you take Ritalin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including
medicines that you buy without a prescription from a pharmacy, supermarket or
health food shop.

Other medicines and Ritalin may interfere with each other. Some of these
medicines include:

• medicines that increase blood pressure
• warfarin, a medicine used to prevent blood clots
• medicines for epilepsy (fits)
• medicines for depression, such as tricyclic antidepressants and MAO
  inhibitors
• phenylbutazone
• guanethidine
• medicines used to treat Parkinson's disease or psychosis

You may need to take different amounts of your medicines or you may need to
take different medicines.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Ritalin.

How to take Ritalin

Follow the directions given to you by your doctor and pharmacist
carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor
or pharmacist for help.

How much to take

Children aged 6 or over: the usual starting dose is 5 mg (half a tablet)
once or twice each day. If necessary, the dose can be increased by 5 or 10 mg
each week up to a maximum of 60 mg (6 tablets) each day.

Adults: the usual dose is 20 to 30 mg (2-3 tablets) each day but some
people may need more or less than that. The maximum dose is 60 mg (6 tablets)
each day.

When to take it

Take the tablets in 2 or 3 doses over the day unless your doctor tells
you otherwise.

Each dose is usually taken 1 or 2 hours before the greatest effect is needed.
For example, a child may take a dose at 7.00 a.m. so that improved behaviour
begins when school starts. If the child tends to misbehave during the
lunchtime play period, the next dose can be taken before the lunch break.

It may be necessary to take a combination of the slow release tablets with
the immediate release tablets to achieve the best results. The effects of the
slow release tablets are maximised when taken with a meal. Check carefully
with your doctor when and how to take this combination.

If you find that this medicine keeps you from sleeping, talk to your
doctor about the best time to take the last dose of the day.

How to take it

Take the tablets with a full glass of water or other liquid. If the
tablets upset your stomach, you can take them with food.

Always take the tablets in the same way (eg. always with food or always
without food).

That way the effect will always be the same.

If the dose is one-half tablet, there is a break-line on the tablet to help
you cut it. You can buy a tablet cutter from your pharmacist to make sure the
dose is accurate.

How long to take it

Continue taking Ritalin for as long as your doctor tells you to.

Ritalin helps to control your symptoms but it does not cure your condition.
Your doctor will check your progress to make sure the medicine is working and
will discuss with you how long your treatment should continue. If you are
unsure, talk to your doctor.

During treatment for ADHD, Ritalin is usually stopped every so often (eg.
over weekends, school holidays and long vacation) to see whether it is still
needed. Breaks from treatment also help to prevent a slow-down in growth that
sometimes happens when children take Ritalin for a long time.

If you forget to take it

Take the dose as soon as you remember. Then make sure to wait the same
amount of time as usual before you take the next dose.

For example, if there are usually 4 hours between doses, wait 4 hours
before taking the next dose and so on for the rest of that day. On the next
day go back to your usual times.

Do not take a double dose to make up for the one that you missed.

Your chance of having an unwanted side effect may be increased.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or National Poisons Information
Centre, Dunedin (telephone 0800 POISON or 0800 764 766) for advice, or go to
the Accident and Emergency Department at your nearest hospital if you think
that you or anyone else may have taken too much Ritalin. Do this even if there
are no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

Symptoms of an overdose may include vomiting, agitation, headache, tremors,
muscle twitching, irregular heart beat, flushing, fever, sweating, dilated
pupils, breathing problems, confusion and seizures.

While you are taking Ritalin

Things you must do

Take Ritalin exactly as your doctor has prescribed.

Like all stimulants, Ritalin may become habit-forming and can be abused by
some people. If you take it correctly as instructed by your doctor, abuse or
dependence should not be a problem, either now or later in life.

Be sure to keep all of your doctor's appointments so that your progress
can be checked.

Your doctor will want to check your blood pressure and do blood tests from
time to time to prevent unwanted side effects from happening.

If you become pregnant while taking Ritalin, tell your doctor.

Your doctor can discuss with you the risks and benefits of taking it
while you are pregnant.

If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are taking Ritalin.

Tell any other doctor, dentist or pharmacist who treats you that you are
taking Ritalin.

Things you must not do

Do not stop your treatment without first checking with your doctor.

If you suddenly stop taking this medicine, your condition may reappear or you
may get unwanted effects such as depression. To prevent this, your doctor may
want to gradually reduce the amount of medicine you take each day before
stopping it completely.

Do not take Ritalin to treat any other complaints unless your doctor
tells you to.

Do not give this medicine to anyone else, even if their symptoms seem to
be similar to yours.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you
to be alert while you are taking Ritalin until you know how it affects you.

This medicine may cause dizziness, drowsiness or blurred vision in some
people. If you have any of these symptoms, do not drive or do anything else
that could be dangerous.

Be careful when drinking alcohol while you are taking Ritalin.

Drinking alcohol during treatment with Ritalin is not recommended because
alcohol can worsen some of the unwanted effects of Ritalin such as dizziness
and drowsiness.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking Ritalin.

All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and
they worry you:

• nausea (feeling sick), vomiting or abdominal pain
• loss of appetite
• loss of weight and slower growth in children
• feeling nervous or unable to sleep
• dry mouth
• headache
• drowsiness
• dizziness
• mood changes such as depression or irritability
• blurred vision or problems focussing your eyes
• muscle cramps
• hair loss

Stomach upset, loss of appetite and difficulty sleeping are common,
especially at the start of treatment. Your doctor can usually help to reduce
these symptoms by lowering the dose of Ritalin or changing the times when the
tablets are taken.

Tell your doctor immediately if you notice any of the following:

• signs of allergy such as swelling of the face, lips or tongue; shortness
  of breath, wheezing or troubled breathing
• rash, itching, red blotches, blisters or pealing of the skin
• sudden increase in body temperature, sweating, fast heart beat, muscle
  stiffness and fluctuating blood pressure, which may lead to coma
• constant "flu-like" symptoms such as chills, fever, sore throat, swollen
  glands, aching muscles or joints
• unusual bleeding or bruising
• unusual tiredness, shortness of breath when exercising, dizziness, pale
  skin
• uncontrollable twitching, jerking or writhing movements
• seizures (fits)
• pain or tightness in the chest
• fast or irregular heart beat, changes in blood pressure
• yellow colour to the skin or eyes, dark coloured urine or light coloured
  bowel motions
• confusion or hallucinations (seeing or feeling things that are not
  really there)
• severe or persistent headache
• weakness or paralysis of limbs or face, difficulty speaking

The above side effects may be serious. You may need urgent medical
attention.

Tell your doctor if you notice anything else that is making you feel
unwell.

Other side effects not listed above may happen in some people.

After taking Ritalin

Storage

• Keep your tablets in the original container until it is time to take
  them.
• Store the tablets in a cool dry place. Store below 30°C.
• Do not store Ritalin or any other medicine in the bathroom or near a
  sink.
• Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines. Ritalin will keep well if it
is cool and dry.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

If your doctor tells you to stop taking Ritalin or the tablets have
passed their expiry date, ask your pharmacist what to do with any that are
left over.

Product description

What it looks like

Ritalin 10 mg: round white tablet, marked "CG" on one side and "AB"
with a break-line on the other; packs of 30 tablets.

Ritalin SR 20mg: round white to off white tablet marked "CIBA" on one side
and "16: on the other, packs of 100 tablets

Ingredients

Ritalin tablets contain 10 mg of methylphenidate hydrochloride as the
active ingredient.

They also contain:

• lactose
• calcium phosphate
• gelatin
• magnesium stearate
• talc-purified
• starch-wheat

Ritalin SR tablets contain 20mg of methylphenidate hydrochloride as the
active ingredient.

They also contain:

• lactose
• cetostearyl alcohol
• magnesium stearate
• hydroxypropyl methylcellulose
• polyoxyl 40
• hydrogenated castor oil
• titanium dioxide
• talc
• carnauba wax