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Ritalin LA (methylphenidate hydrochloride)
2015-01-30 16:55:25 来源: 作者: 【 】 浏览:701次 评论:0
methylphenidate hydrochloride
Consumer Medicine Information
 
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ritalin LA. It does not contain all the information that is known about Ritalin LA. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Ritalin LA is used for

Ritalin LA (long-acting) capsules are used to treat 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 LA 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.
This medicine is part of a treatment program that usually includes psychological, educational and social therapy.
Ask your doctor if you have any questions about why this medicine has been prescribed for you or your child.
Your doctor may have prescribed it for another purpose.
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.

Before you take Ritalin LA

When you must not take it

Do not take Ritalin LA if you are allergic to methylphenidate (the active ingredient) or to 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 Ritalin LA 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
uncontrolled speech and body movements (Tourettes's syndrome) or if you have a family history of this disorder
increased pressure in the eye (glaucoma)
an overactive thyroid (hyperthyroidism)
heart problems such as heart attack, irregular heartbeat, chest pain (angina)
high blood pressure
severe depression or other mental illness
a tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma)
If you are not sure whether any of the above medical conditions apply to you, check with your doctor.
Do not take Ritalin LA if you are taking a medicine called a monoamine oxidase inhibitor (MAOI) or have been taking it within the past 14 days.
Taking Ritalin LA together with MAOI medicines may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Ask your doctor or pharmacist if you are not sure if you have been taking one of these medicines.
Do not take this medicine 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:
any heart defects (e.g. structural cardiac abnormality)
any other current or previous heart problems
a family history of sudden death and /or irregular heart beat
hardening of the arteries
any disorders of the blood vessels in the brain
severe depression, bipolar disorder or other mental illness
suicidal thoughts
epilepsy (seizures or fits)
high blood pressure
history of alcohol or drug abuse
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 LA in this case.
This medicine may affect your developing baby if you take it while you are pregnant. It is not known if the active ingredient in Ritalin LA passes into the breast milk. Breast-feeding is not recommended while taking this medicine.

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.
Some medicines and Ritalin LA may interfere with each other. It may be necessary to change the dose or in some cases to stop one of the medicines.
Some of these medicines include:
medicines that increase blood pressure
medicines used to treat high blood pressure
centrally acting alpha 2 agonists like clonidine
medicines that influence the dopaminergic system (used to treat Parkinson's disease or psychosis)
medicines for depression, such as tricyclic antidepressants and monoamine oxidase inhibitors (MAO inhibitors)
medicines for epilepsy (fits)
warfarin, a medicine used to prevent blood clots
phenylbutazone (used to treat pain or fever)
guanethidine
halogenated anaesthetics
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.
If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.

How to take Ritalin LA

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

Ritalin LA is available in long-acting capsules containing 10 mg, 20 mg, 30 mg or 40 mg of methylphenidate hydrochloride as the active ingredient.
Your doctor will usually start with a low dose and, if necessary, increase it gradually at weekly intervals up to 20 mg to 40 mg each day. The maximum dose is 60 mg each day.

How to take it

Swallow the capsules whole as a single dose in the morning with a full glass of water. Do not crush or chew the capsules.
If you have trouble swallowing the capsules, you can carefully open them and sprinkle the contents (little beads) over a small amount of applesauce.
If the capsules upset your stomach, you can take them with food, but always take them in the same way (e.g. always with food or always without food).
That way the effect will always be the same.

How long to take it

Continue taking Ritalin LA for as long as your doctor tells you.
This medicine helps to control your symptoms but 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.
During treatment for ADHD, your doctor may stop Ritalin LA every so often (e.g. over weekends or school holidays) 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 this medicine for a long time.

If you forget to take it

If you forget to take a dose of Ritalin LA capsules and you remember before mid-day, take the dose as soon as you remember. Then go back to your usual schedule on the following day.
If you do not remember before mid-day, miss your dose of Ritalin LA for that day and wait until the following morning to take your next dose.
Do not take a double dose to make up for the one that you missed.
Your chance of an unwanted side effect may be increased if you do.
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 the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Ritalin LA. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
Some of the 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 LA

Things you must do

Take Ritalin LA exactly as your doctor has prescribed.
Like all stimulants, this medicine 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 or your child's progress can be checked.
Your doctor will want to check your or your child's blood pressure, height, weight and do blood tests from time to time to prevent unwanted side effects from happening.
If your child is not growing or gaining height or weight as expected treatment with Ritalin LA may need to be interrupted.
If you become pregnant while taking Ritalin LA, 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 LA.
Tell any doctor, dentist or pharmacist who treats you that you are taking Ritalin LA.

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 this medicine to treat any other complaints unless your doctor tells you to.
Do not give it to anyone else, even if their condition seems 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 LA until you know how it affects you.
This medicine may cause hallucinations, dizziness, drowsiness or blurred vision in some people. If you have any of these symptoms, do not drive, use machines or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking Ritalin LA.
Drinking alcohol is not recommended because it can worsen some of the unwanted effects of this medicine, such as dizziness and drowsiness.
Tell your doctor if you are going to have an operation.
If you are going to have an operation, tell the doctor that you are on treatment with Ritalin LA. You should not take Ritalin LA on the day of your operation 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ritalin LA.
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 these lists 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 and they worry you:
nausea (feeling sick), vomiting or stomach 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
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital 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
weakness or paralysis of limbs or face, difficulty speaking, or unexplained fainting
rash, itching, red blotches, blisters or peeling of the skin
sudden increase in body temperature, sweating, fast heartbeat, 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) or unexplained fainting
pain or tightness in the chest
fast or irregular heartbeat
changes in blood pressure
yellow colour to the skin or eyes, dark coloured urine or light coloured bowel motions
confusion, delusions or hallucinations (seeing or feeling things that are not really there)
excitement, overactivity and uninhibited behaviour
new or worsening aggressive behaviour
severe or persistent headache
The above side effects may be serious. You may need urgent medical attention.
Additional side effects that occurred with other medicines containing the same drug substance of Ritalin:
Inflammation of the nasal passages and throat; decrease in number of blood cells (red cells, white cells and platelets); swelling of the ears (a symptom of allergic reaction); feeling anxious, irritated and agitated, aggression, mood changes, abnormal behaviour or thinking, anger, thoughts or attempts of suicide (including completed suicide), excessive awareness of surroundings, feeling unusually excited, over-active and un-inhibited (mania), feeling disorientated, changes in sex drive, lack of feeling or emotion, doing things over and over again, being obsessed with one thing, confusion, addiction; trembling, temporary muscle weakness, loss of skin sensation or other functions of the body due to a temporary lack of blood supply to the brain (reversible ischaemic neurological deficit), migraine; double vision, dilated pupils, trouble seeing; stopped heart beat, heart attack; fingers and toes feeling numb, tingling and changing colour (from white to blue, then red) when cold ('Raynaud's phenomenon'); cough, sore throat, shortness of breath; diarrhoea, constipation; swelling of face and throat, excessive sweating, redness of the skin, large red blotches on the skin appearing within a few hours of taking the medicine; muscle pain, muscle twitching; blood in the urine; swelling of the breasts in men; chest pain, tiredness, sudden death; weight decreased, abnormal sounds from heart.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.

After taking Ritalin LA

Storage

Keep your medicine in the original container until it is time to take a dose.
Store it in a cool dry place.
Do not store Ritalin LA or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.

Product description

What it looks like

Ritalin LA 10 mg capsules are white to off-white beads in a light brown and white capsule with imprint NVR and R10 in tan-coloured ink; bottles of 30 capsules.
Ritalin LA 20 mg capsules are white to off-white beads in a white capsule with imprint NVR and R20 in tan-coloured ink; bottles of 30 capsules.
Ritalin LA 30 mg capsules are white to off-white beads in a yellow capsule with imprint NVR and R30 in tan-coloured ink; bottles of 30 capsules.
Ritalin LA 40 mg capsules are white to off-white beads in a light brown capsule with imprint NVR and R40 in tan-coloured ink; bottles of 30 capsules.

Ingredients

Ritalin LA capsules contain 10 mg, 20 mg, 30 mg or 40 mg of methylphenidate hydrochloride as the active ingredient. They also contain:
sugar spheres (sucrose and maize starch)
ammonio methacrylate copolymer
methacrylic acid copolymer
purified talc
triethyl citrate
macrogol 6000
gelatin
titanium dioxide
iron oxide yellow CI77492 (30 mg and 40 mg capsules only)
iron oxide black CI77499 (40 mg capsules only)
iron oxide red CI77491 (40 mg capsules only)
TekPrint SW-8010

Sponsor

Ritalin LA capsules are supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
 
Web site: www.novartis.com.au
® = Registered Trademark
 
This leaflet was prepared in
August 2010.
Australian Registration Number
Ritalin LA 10 mg: AUST R 160228
Ritalin LA 20 mg: AUST R 82957
Ritalin LA 30 mg: AUST R 82958
Ritalin LA 40 mg: AUST R 82959 
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