March 30th 2000
Copy of leaflet giving information on Ritalin SR®
Patient information leaflet
Ritalin® 1Omg Tablets and Ritalin SR® 20mg Tablets
What is Ritalin® and Ritalin SR® and when is it used?
The active substance of Ritalin® and Ritalin SR® is methylphenidate, a central nervous stimulant. It is used on doctor's prescription for the treatment of two distinct disorders:
1. Behaviour disorders in children and adolescents
Some 3% of all children suffer from this disturbance (the so-called hyperactive syndrome),
which makes it impossible for them to sit still or to concentrate on a set task. This can lead to
learning difficulties at school and with homework. Such children may become aggressive,
making them difficult to handle at home or at school. After a thorough examination of your
child, your doctor has decided to prescribe Ritalin® and Ritalin SR® as part of a course of
treatment that also includes the usual psychological, educational and social measures.
Ritalin® and Ritalin SR® alleviates the principal symptoms of the hyperactive syndrome,
such as moderate to severe distraction, rapid loss of attention, increased motor activity and
disturbed social behaviour.
2. Narcolepsy
Ritalin® and Ritalin SR® is also employed in the treatment of narcolepsy, a sleep disturbance
in which the patient experiences an intense need to sleep during the day in spite of sleeping
sufficiently at night. Narcolepsy needs to be diagnosed by a physician after observation of the
patient's sleep-wake rhythm.
Ritalin® and Ritalin SR® can correct this excessive sleepiness during the day in patients with
narcolepsy.
The active substance is set free more slowly from Ritalin SR ®(sustained release) tablets than
from Ritalin® tablets, and the duration of action is correspondingly longer.
When should Ritalin® and Ritalin SR® not be taken?
Ritalin® and Ritalin SR® should not be taken to counteract normal fatigue.
Anxious, tense or excited patients should not be treated with Ritalin® and Ritalin SR®.
Patients with glaucoma (increased internal eye pressure), thyroid or heart disease, or with tics
(or who have brothers or sisters who have tics) should not take Ritalin® and Ritalin SR®.
Ritalin® and Ritalin SR® is not recommended for children under six years.
Ritalin® and Ritalin SR® should not be taken when there is known hypersensitivity to one of
its components.
When should caution be exercised in the use of Ritalin® and Ritalin® SR?
Ritalin® and Ritalin SR® may affect the ability to drive a vehicle or operate machinery.
Ritalin® and Ritalin SR® may interact with other drugs, which should therefore be taken only
when explicitly prescribed by a physician.
Drugs that may be subject to interaction with Ritalin® and Ritalin SR® include, for example,
certain compounds that increase or reduce blood pressure, dilute the blood (anticoagulants), or
are used in the treatment of depression or convulsions (epilepsy) and certain anti-inflammatory products.
No alcoholic drinks should be taken during the course of treatment.
Please inform your doctor or chemist if you suffer from other diseases, are subject to allergies
or are taking other drugs (including those bought freely over the counter).
May Ritalin® and Ritalin SR® be taken during pregnancy or by nursing mothers?
Be sure to inform your doctor if you are pregnant or breast-feeding an infant. During
pregnancy Ritalin® and Ritalin SR® should only be taken on explicit orders from the doctor.
Ritalin® and Ritalin SR® should not be taken during breast-feeding.
How is Ritalin® and Ritalin SR® used?
The dosage and intervals between doses will be established by the physician according to the
patient's individual needs. Normally 2-3 single doses will be taken daily. The total daily dose
should not exceed 60 mg (6 tablets of Ritalin® or 3 Ritalin SR® tablets).
Ritalin SR® tablets must be swallowed whole. They should neither be crushed nor chewed.
They should be taken after meals, and unless otherwise prescribed by the doctor, preferably
be taken after a substantial breakfast.
Depending on the needs of the individual, it is possible under some circumstances that the
doctor will prescribe both Ritalin® and Ritalin SR® in combination.
If a dose is missed by mistake, it should be taken as rapidly as possible. Subsequent doses
should then be taken at the normal times. Do not double the dose. If you have any questions
on this subject, please ask your doctor. If you have mistakenly taken more tablets than were
prescribed, consult your doctor or the nearest hospital immediately.
Do not change the prescribed dosage of your own accord. If you think the effect of medication
is too weak or too strong, speak to your doctor or chemist about it.
What side effects may Ritalin® and Ritalin SR® have?
The commonest side effects of Ritalin® and Ritalin SR® are nervousness and insomnia.
Loss of appetite is also common, but is generally only transitory.
When Ritalin® and Ritalin SR® is taken over prolonged periods by children, it may lead to a
moderate fall in weight gain and slight inhibition of growth.
No direct association with therapy has however yet been established.
Especially at the beginning of treatment, occasional stomach-ache, nausea or vomiting may
occur. These can however be alleviated by taking the tablets together with food.
In addition, there may be occasional skin rash, itching, fever, joint pain, hair loss, dryness of
the mouth, dizziness, headache, tiredness, motor disturbances, palpitation, irregular heart beat
and blood pressure changes.
Consult your physician if such problems continue for a long time or become worse.
Rarely: accommodation disturbances and blurred vision.
In occasional cases hyperactivity and depression have been observed.
Consult your doctor if you have any of the following untoward effects: sudden high fever,
severe headache or confusion, pounding of the heart, chest pain, a tendency to bruising,
muscle twitches or tics, sore throat and fever, outbreaks of sweating or shivering, hallucinations or convulsions.
What other considerations are there?
The drug should be protected from humidity and not stored above 30°C.
The drug should not be used after the expiry date printed on the package.
All drugs should be kept out of the reach of children.
Further information may be obtained from your doctor or chemist, who will be in possession
of full information on this product.
What does Ritalin® and Ritalin SR® contain?
Ritalin©
Each tablet contains 10 mg methylphenidate hydrochloride and excipients.
Ritalin SR© (delayed release of the active substance)
Each tablet contains 20 mg methylphenidate hydrochloride and excipients.
What packings are available?
Ritalin® and Ritalin SR® are prescription only medicines
Ritalin®
Tablets containing 10 mg: 30 tablets
Ritalin SR® (delayed release of the active substance)
Sustained release tablets containing 20 mg: 100 tablets
Date of preparation of this leaflet: March 2000