Rubifen

methylphenidate hydrochloride

What is in this leaflet

This leaflet answers some common questions about Rubifen.

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 Rubifen 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 Rubifen is used for

Rubifen 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 schoolwork. They frequently become difficult to manage, both in school and
at home.

Rubifen is a central nervous system stimulant. It is thought to work by
regulating specific chemicals in the brain that 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.

Rubifen is part of a treatment program that usually includes psychological,
educational and social therapy.

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

People with narcolepsy have recurring attacks of irresistible daytime
sleepiness in spite of having enough sleep at night. A doctor can diagnose
narcolepsy by recording wake-sleep patterns.

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

Ask your doctor if you have any questions about why Rubifen 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: Rubifen 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 Rubifen

When you must not take it

Do not take Rubifen if you have an allergy to methylphenidate (the active
ingredient in Rubifen) 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 Rubifen 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).

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

Do not take Rubifen 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
• alcoholism
• drug dependence.

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 Rubifen in this case.

Rubifen may affect your developing baby if you take it while you are pregnant.
It is not known if the active ingredient in Rubifen 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 Rubifen.

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 Rubifen 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.

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 Rubifen.

How to take Rubifen

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 (e.g. always with food or always without food). That way the
effect will always be the same.

Take RUBIFEN only when prescribed by your doctor.

For children (6 years and over) the dose is one 5mg tablet once or twice
daily (e.g. at breakfast and lunch) with weekly increases of 5-10mg. The total
daily dosage should be taken in divided doses.

For adults the average daily dose is 20-30mg, taken in 2-3 divided doses. If
you are unable to sleep when taking RUBIFEN late in the day, you should take the
last dose before 6p.m.

Rubifen SR tablets must be swallowed whole and never
crushed or chewed. Rubifen SR tablets should not be split or divided like an
immediate release tablet.

Follow all directions given to you by your doctor carefully. They may differ
from the information contained in this leaflet. If you do not understand the
instructions on the box, ask your doctor or pharmacist for help.

How long to take it

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

Rubifen 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, Rubifen is usually stopped every so often (e.g.
over weekends, school holidays and long vacations) 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 Rubifen 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 Rubifen. 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 Rubifen

Things you must do

Take Rubifen exactly as your doctor has prescribed.

Like all stimulants, Rubifen 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 Rubifen, 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 Rubifen.

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

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 Rubifen 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 Rubifen 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 Rubifen.

Drinking alcohol during treatment with Rubifen is not recommended because
alcohol can worsen some of the unwanted effects of Rubifen 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 Rubifen.

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 Rubifen 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 peeling 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.

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 Rubifen

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 25°C.
• Do not store Rubifen 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. Rubifen 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 Rubifen 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

Rubifen 10 mg: RUBIFEN comes as a round white scored tablet with slightly
bevelled edges, marked RU-10.

Rubifen SR 20mg: An oblong white or white-cream smooth tablet containing 20mg
methylphenidate in a modified release formulation

Ingredients

Rubifen tablets contain 10 mg of methylphenidate hydrochloride as the active
ingredient. They also contain: Microcrystalline cellulose, maize starch, calcium
hydrogen phosphate dihydrate and magnesium stearate.

Rubifen SR tablets contain 20mg of methylphenidate hydrochloride as the
active ingredient. They also contain: Cetyl alcohol, Ethyl cellulose, anhydrous
lactose, magnesium stearate, opadry Y-1-700 (containing hydroxypropyl
methylcellulose, polyethylene glycol 400, titanium dioxide (E-171)).

RUBIFEN does not contain gluten or sucrose