methylphenidate hydrochloride (meth-il-FEN-i-date)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Chem mart Methylphenidate. 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 this medicine against the benefits the medicine is expected to have for you or your child.
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 Chem mart Methylphenidate is used for
Methylphenidate is used for treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD)
- narcolepsy
Methylphenidate belongs to a group of medicines called central nervous system stimulants.
Attention Deficit Hyperactivity Disorder
It is used to treat a behavioural disorder called Attention Deficit Hyperactivity Disorder (ADHD), although not all people with this disorder are hyperactive.
About 3% of children suffer from this disorder. 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 may become aggressive and often are unmanageable, both at school and at home.
Methylphenidate is not a sedative. It does not slow down your mind. It is a stimulant which is thought to work by regulating certain chemicals in the brain which affect behaviour. It helps 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.
Your doctor has decided to prescribe methylphenidate as part of a treatment program which will usually include psychological, educational and social therapy.
Narcolepsy
It is used to treat narcolepsy, a sleep disorder.
Narcolepsy can be diagnosed by your doctor after recording your sleep problems. People with narcolepsy have attacks of severe sleepiness and often fall asleep during the day, in spite of having enough sleep at night. Methylphenidate may relieve this problem.
Your doctor may prescribe methylphenidate for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor’s prescription and when your doctor has special permission to prescribe. It may be habit-forming in some people and may be abused. However, there is no evidence that people become dependent on methylphenidate during treatment or later in life.
Before you take Chem mart Methylphenidate
When you must not take it
Do not take methylphenidate if you have ever had an allergic reaction after taking:
- any medicine containing methylphenidate hydrochloride (the active ingredient)
- any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take methylphenidate if you suffer from:
- periods of severe depression, anxiety, tension or agitation
- tics (muscle twitching which is usually in the face or shoulders) or if your brothers or sisters have tics
- Tourette’s syndrome or you have a family history of this disorder
- glaucoma (increased pressure in the eye)
- an overactive thyroid
- irregular heartbeat
- severe chest pain (angina)
- epilepsy (fits).
If you take methylphenidate, it may make your condition worse.
Do not use it to treat any other complaints unless your doctor says you can.
Do not take methylphenidate tablets after the expiry date (EXP) printed on the pack.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not take methylphenidate tablets if the packaging is torn or shows signs of tampering.
Do not give this medicine to children under 6 years of age unless your doctor says you can.
There is not much information on use in children less than 6 years old.
Do not give this medicine to anyone else.
It may harm them, even if their symptoms seem to be the same as yours.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
- high blood pressure
- mental illness
- alcoholism
- drug dependence.
Your doctor may not want you to take it or may want to take special precautions if you have any of these conditions.
You must tell your doctor if you are pregnant or intend to become pregnant or are breast-feeding.
Ask your doctor about the risks and benefits of taking methylphenidate in this case. It may affect your baby if you take it while you are pregnant. It is not known if methylphenidate passes into the breast milk. For safety reasons, it is not recommended to breast-feed your baby if you are taking methylphenidate.
Taking other medicines
You must 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 may be affected by methylphenidate or they may affect how well it works. These include:
- certain medicines used to treat depression
- warfarin, a medicine used to prevent blood clots
- medicines used to treat epilepsy or fits, eg. phenytoin, phenobarbitone, primidone
- phenylbutazone, a medicine used to treat certain types of arthritis
- guanethidine, an injection used for pain or during surgery
- some cough and cold preparations
- some weight reducing medicines
- medicines to treat blood pressure.
You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
If you have not told your doctor about any of these things, tell them before you take methylphenidate.
How to take Chem mart Methylphenidate
Follow all directions given to you by your doctor or 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
Take the exact amount your doctor tells you to, no more or less.
Methylphenidate is available as 10mg tablets.
For children over 6 years of age, your doctor will start treatment with a small dose (eg. 5mg) once or twice per day. The dose can be slowly increased each week, depending on how well it works, up to a total of 6 tablets per day.
For adults, the usual dose is 2-3 tablets per day. Some people may only need one tablet while others may need up to 6 tablets per day.
When to take it
The tablets are usually taken in 2 or 3 doses during the day. They should be taken 1 or 2 hours before the greatest effect is needed.
For example, a child may take a dose at 7.00am so that improved behaviour begins when school starts. If the child tends to get into trouble during the lunchtime play period, the next dose can be taken before the lunch break.
You may find that this medicine keeps you from sleeping. In that case your doctor can decide when the last dose of the day should be taken.
How to take it
Swallow the tablets with a full glass of water.
When to take it
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.
Do not lie down for about 15 to 30 minutes after taking the tablets.
This helps the tablets reach your stomach quickly and prevents throat irritation which could lead to problems with swallowing.
How long to take it
That will depend on how well it works. In ADHD, if no improvement is found after one month of treatment at the proper dose, your doctor may stop the medicine.
Methylphenidate tablets are usually stopped every so often (eg. over weekends, school holidays and long vacations) so that the doctor can see how the person behaves without the medicine. Sometimes, improvement in behaviour lasts even when the medicine is temporarily or even permanently stopped. In any case, treatment can usually be stopped for good eventually.
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.
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 Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital if you think that you or anyone else may have taken too many methylphenidate tablets. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep the telephone numbers for these places handy.
If you take too much methylphenidate, your nervous system may become too active and you may feel some or all of the following:
- vomiting, trembling or twitching
- nervousness, confusion
- fits
- fever and increased sweating
- rapid or irregular heartbeat or other symptoms.
While you are taking Chem mart Methylphenidate
Things you must do
Tell your doctor immediately if you become pregnant while you are taking methylphenidate.
Your doctor can discuss with you the risks of using it while you are pregnant.
Take your methylphenidate exactly as your doctor has prescribed.
If you do not follow your doctor’s instructions, your condition may not improve or you may have unwanted side effects. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it is not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping.
This will help your doctor to determine the best treatment for you.
Be sure to keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may want to take some blood tests and measure your blood pressure from time to time. This helps prevent unwanted side effects.
Tell all of the doctors, dentists and pharmacists who are treating you that you are taking methylphenidate.
Things you must not do
Do not take any other medicines while you are taking methylphenidate without first telling your doctor.
If you take other medicines together with methylphenidate, they may cause unwanted effects.
Do not stop your treatment without first checking with your doctor.
It may be necessary to gradually reduce the amount you take each day before stopping the medicine completely. This helps to prevent unwanted side effects.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert while you are taking methylphenidate until you know how it affects you.
This medicine may cause dizziness, drowsiness or blurred vision in some people.
Be careful when drinking alcohol while you are taking methylphenidate.
If you drink alcohol, it could make some of the unwanted effects of methylphenidate worse.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking methylphenidate.
Methylphenidate helps most people but it may have unwanted side effects in a few people. All medicines 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of these side effects and they worry you:
- nausea (feeling sick), vomiting or abdominal pain. This can usually be relieved by taking the medicine with food.
- loss of appetite, which can lead to loss of weight or slower growth in children. Breaks from treatment during weekends and school holidays help. Catch-up growth usually happens after treatment is stopped.
- nervousness and insomnia (being unable to sleep). This can usually be relieved by taking the last dose no later than 4 hours before bedtime.
These are the more common side effects which often happen at the start of treatment and sometimes go away as your body adjusts to the medicine.
Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:
- nausea (feeling sick), vomiting or other stomach problems that are severe or don’t go away.
- constant “flu-like” symptoms (chills, fever, sore throat, aching joints, tiredness or lack of energy).
- unusual bleeding or bruising
- rash, itching or hives on the skin; hair loss
- swelling of the face, lips or tongue
- shortness of breath, wheezing or troubled breathing
- pain or tightness in the chest
- fast or irregular heartbeat
- muscle ache, twitching (tics) or unusual movements
- severe dizziness, fainting or fits
- depression, confusion or hallucinations (seeing things that are not really there)
- blurred vision or problems focussing your eyes
- severe or persistent headache
- changes in blood pressure.
These are serious side effects. You may need urgent medical attention or hospitalisation. These side effects are uncommon.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Some people may get other side effects from methylphenidate.
After using Chem mart Methylphenidate
Storage
Keep your tablets in the blister strip until it is time to take them.
If you take the tablets out of the blister strip they may not keep as well.
Keep your tablets in a cool dry place where the temperature stays below 30 °C.
Do not store methylphenidate or any other medicine in the bathroom or near a sink or stove.
Do not leave methylphenidate in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep your Methylphenidate Tablets where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking methylphenidate, 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
Chem mart Methylphenidate Tablets 10mg: White or off-white, circular, flat, bevel-edged tablet, engraved “M” breakline “P” on one face and “10” on the other face.
Ingredients
Active ingredient:
- Methylphenidate hydrochloride 10mg
Other ingredients (excipients):
- lactose
- cellulose – microcrystalline
- starch – pregelatinised maize
- stearic acid
Chem mart Methylphenidate Tablets do not contain sucrose or gluten.
Sponsor
GenRx Pty Ltd
ABN 52 096 916 148
Level 21, 390 St Kilda Road
Melbourne, Victoria 3004
Australia
Distributor
Chem mart Pty Limited
ABN 92 001 235 374
115 Sherriff Street
Underdale
South Australia, 5032
Chem mart Methylphenidate
10mg tablets AUST R 82993
Chem mart is a registered trade mark of FH Faulding & Co Limited
Date of leaflet preparation:
April 2004
Published by MIMS August 2004