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March 30th 2000

Copy of leaflet giving information on Ritalin SRŽ

Patient information leaflet

RitalinŽ 1Omg Tablets and Ritalin SRŽ 20mg Tablets

What is RitalinŽ and Ritalin SRŽ and when is it used?

The active substance of RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ as part of a course of treatment that also includes the usual psychological, educational and social measures. RitalinŽ and Ritalin SRŽ 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
RitalinŽ and Ritalin SRŽ 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.
RitalinŽ and Ritalin SRŽ can correct this excessive sleepiness during the day in patients with narcolepsy.
The active substance is set free more slowly from Ritalin SR Ž(sustained release) tablets than from RitalinŽ tablets, and the duration of action is correspondingly longer.

When should RitalinŽ and Ritalin SRŽ not be taken?
RitalinŽ and Ritalin SRŽ should not be taken to counteract normal fatigue.
Anxious, tense or excited patients should not be treated with RitalinŽ and Ritalin SRŽ.
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 RitalinŽ and Ritalin SRŽ.
RitalinŽ and Ritalin SRŽ is not recommended for children under six years.
RitalinŽ and Ritalin SRŽ should not be taken when there is known hypersensitivity to one of its components.

When should caution be exercised in the use of RitalinŽ and RitalinŽ SR?
RitalinŽ and Ritalin SRŽ may affect the ability to drive a vehicle or operate machinery.
RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ should only be taken on explicit orders from the doctor. RitalinŽ and Ritalin SRŽ should not be taken during breast-feeding.

How is RitalinŽ and Ritalin SRŽ 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 RitalinŽ or 3 Ritalin SRŽ tablets).
Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ have?
The commonest side effects of RitalinŽ and Ritalin SRŽ are nervousness and insomnia. Loss of appetite is also common, but is generally only transitory.
When RitalinŽ and Ritalin SRŽ 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 RitalinŽ and Ritalin SRŽ contain?
Each tablet contains 10 mg methylphenidate hydrochloride and excipients.
Ritalin SRŠ (delayed release of the active substance)
Each tablet contains 20 mg methylphenidate hydrochloride and excipients.

What packings are available?
RitalinŽ and Ritalin SRŽ are prescription only medicines
Tablets containing 10 mg: 30 tablets
Ritalin SRŽ (delayed release of the active substance)
Sustained release tablets containing 20 mg: 100 tablets

Date of preparation of this leaflet: March 2000

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