Application areas

Hyperkinetic disorder or attention deficit / hyperactivity disorder (AD / HS) at
Children over the age of 6 and continuation of therapy in adolescents as part of a therapeutic
overall political strategy. The diagnosis must be based on the currently valid diagnostic criteria
respectively.
Obsessive sleep attacks during the day (narcolepsy) as part of a therapeutic
Overall strategy.

Contraindications

When should you not use Ritalin?
Ritalin must not be used
- in case of known hypersensitivity to methylphenidate or similar substances and
other ingredients of the medicinal product,
- in severe depression,
- in anxiety disorders,
- Anorexia, as Ritalin can cause anorexia,
- In severe Gilles de la Tourette syndrome (sudden twitching, especially in the
Facial neck and shoulder area),
- in diseases of the schizophrenic type, since temporary mental
Disturbances can occur
- in moderate and severe hypertension,
- in the case of arterial disease,
- in severe angina pectoris,
- in cardiac arrhythmia with accelerated heartbeat,
- in the acute stage of stroke,
- in hyperthyroidism,
- with increased intraocular pressure,
- with enlarged prostate with residual urine formation,
- during or within 14 days after ingestion of MAO inhibitors (certain
Medicines for the treatment of depression and Parkinson's disease),
- in patients with past drug addiction or with drug or alcohol
abuse,
- during pregnancy.
When may you use Ritalin only after consultation with your doctor?
If your family has ever had Gilles de la Tourette syndrome, then you should
Do not use Ritalin. As far as yourself a Gilles de la Tourette syndrome only slightly or
moderate, may be subject to particularly close, careful, specialist medical
a treatment trial with Ritalin.
If you experience motor tics (sudden, rapid muscle twitching) or if
motor verbal tics in your family, you should not use Ritalin. Further
Ritalin should not be used for mild hypertension.
What should you watch out for during pregnancy and lactation?
Ritalin tablets should not be taken during pregnancy. If you
are of childbearing age, you must have a reliable during treatment with Ritalin
Use contraceptive method.
During breast-feeding Ritalin tablets should not be taken.
If necessary, consult your doctor.
What should be considered in children?
For the treatment of children under the age of 6, experience is not sufficient to
recommended by Ritalin.

Precautions for use and warnings

What precautions should be taken?
Methylphenidate can increase spasm readiness. Therefore, Ritalin should be used in patients with
Epilepsy should be used with caution. Clinical experience has shown that in individual cases
the frequency of epileptic seizures may increase. With an increase in seizure frequency
Therapy should be checked and Ritalin discontinued. In case of sudden discontinuation
Symptoms such as increased need for sleep, cravings, upsets, depression, psychotic
Reactions and circulatory disorders occur.
During treatment with Ritalin should be at appropriate intervals blood pressure checks
be performed.
Clinical data show that patients taking Ritalin as children for hyperkinetic therapy
Have received behavioral problems when adolescents or adults
have a risk of use. Even in adults with narcolepsy plays the risk of dependence
practically no role.
Ritalin is part of a therapeutic treatment program that is typically psycholo-
gical, educational and social measures. The aim of the therapy is to
abnormalities such as easy to severe distractibility, short attention span,
to reduce emotional instability and impulsiveness. The cause of hyperkinetic
Malfunction / AD / HS is not completely known. There is no single diagnostic test. For
A correct diagnosis will be both medical and psychological, educational
and social studies needed. Key symptoms are: impaired attention,
Distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, low
pronounced neurological symptoms, learning difficulties. Abnormal EEG findings can
but do not have to be present. The symptoms of narcolepsy include daytime tiredness,
inappropriate sleep episodes and sudden loss of muscle tension.
The clinical significance of retardation of elongation and delayed weight
increase in children with hyperkinetic disorder / AD / HS has not been definitively clarified. A cause
The relationship with Ritalin was not demonstrated for the growth delay
become. Regular length and weight controls are recommended.
Patients should be carefully monitored and
(including differential blood picture).

What do you need in road traffic as well as when working with machines and when working
without a secure hold?
Ritalin improves attention. Nevertheless, unwanted side effects like
z. As drowsiness and dizziness occur that affect the ability to react. you
Then, unexpected and sudden events can no longer be fast and targeted enough
react. The intake of Ritalin can also cause overconfidence and increased
Risk appetite lead. Do not drive your car or other vehicles! Bedie-
Do not use electrical tools and machines! Do not work without a safe grip!
Pay particular attention to the fact that alcohol further worsens your ability to drive!
Narcolepsy patients are untreated unable to drive motor vehicles and operating
of machines. Under treatment with methylphenidate may be driving motor vehicles
may be possible under certain circumstances if an immediate
interruption of active participation in road traffic is assured and traffic situations with
high attention requirements can be avoided.
In patients with a hyperkinetic disorder / AD / HS, treatment with Ritalin seems
unlike untreated patients to improve their ability to drive
fluctuations in attention in the context of the underlying disease or
transmitter effect of Ritalin should be considered.

Interactions

What other medicines affect the effects of Ritalin?
Ritalin must not be taken during or within 14 days of taking MAO inhibitors
be used.
Ritalin should not be given concomitantly with substances used to treat low blood pressure.
because of adrenergic crises (nausea, salivation, gastrointestinal spasms,
Diarrhea, muscle spasms) can occur. When used concomitantly, Ritalin may have the effect
of hypotensives, especially guanethidine. On the other hand can
the initial hypertensive effect of guanethidine and amantadine are enhanced.
Since Ritalin reduces the breakdown of anticoagulants (coumarins),
epilepsy (eg phenobarbital, phenytoin, primidone), neuroleptics (means of
schizophrenia) and certain antidepressants (imipramine, desipramine) and phenyl-
Butazon inhibits in the organism, the dose of which may be combined with Ritalin
be reduced.

Co-administration of carbamazepine may decrease the efficacy of Ritalin.
The administration of drugs that bind stomach acid (antacids) worsens
probably the intake of the active substance methylphenidate considerably.
Please note that this information also applies to recently used drugs
can.

Which semiluxury food, dishes and beverages should you avoid?
Alcohol can increase the effects of Ritalin in an unpredictable way.
Therefore, avoid the simultaneous consumption of alcohol.
Dosage instructions, type and duration of application
The following information applies unless your doctor has prescribed Ritalin differently. You're welcome
Follow the instructions for use, otherwise Ritalin will not work properly!

How much of Ritalin and how often should you use Ritalin?
Therapy with Ritalin should be started with a low dose and should be given weekly.
in small increments until a tolerable and sufficiently effective dose is achieved.
to be cleaned. Your doctor will tailor the dose to your needs. Here is the
Principle to keep the dose as small as possible. The effect occurs at sufficiently high
Dose within one hour of ingestion.

Treatment of hyperkinetic disorder / AD / HS or narcolepsy in children and
Adolescents (6 years and older):
Treatment should be with one tablet (5 mg methylphenidate) once or twice a day (eg.
morning and noon). Subsequently, the daily dose in weekly
Intervals are increased by 1 tablet (5-10 mg methylphenidate). A maximum daily
dose of 6 tablets (60 mg methylphenidate) should not be exceeded. The total
daily dose should be divided into several single doses (usually 2-3).
Treatment of adults with narcolepsy:
The average daily dose is 2-3 tablets (20-30 mg methylphenidate). The daytime
dose should be divided into 2-3 single doses. Some patients require daily doses of
4-6 tablets (40-60 mg methylphenidate), while others are based on doses of 1-1 tablets
(10-15 mg methylphenidate) per day. Doses up to 8 tablets (80 mg methyl
phenidate) per day may be necessary. In case of insufficient effectiveness, a
Switching to another medication may be indicated.

How and when should you use Ritalin?
The tablets should be taken with some liquid.
The intake should be done at or after meals. There is evidence that the
Ingestion with meals may be accompanied by increased loss of appetite. If reinforced
Loss of appetite, you should take Ritalin one hour after meals.
For the treatment of hyperkinetic disorders / AD / HS, the timing of the withdrawal should be
me of Ritalin be chosen so that Ritalin best at the times of the greatest school,
social and behavioral difficulties.
If the effect of Ritalin subsides too early in the evening, behavioral problems and / or
Sleep disorders occur again. A small extra dose in the evening (tablet) can then
help eliminate this problem. Your doctor should then check to see if your sleeping
disorders may be caused by Ritalin. In these cases it is recommended
Ritalin not take after 16.00 clock.
In narcolepsy, it is important to have a same day-night rhythm with fixed times.
hold. The intake of Ritalin should be adapted to this rhythm. If the effect
If you are not sufficient for the symptoms of narcolepsy, you should not increase the dose on your own initiative.
hen. Talk to your doctor if you are considering switching to another medicine.

How long should you use Ritalin?
If, after the dose adjustment recommended by the doctor, the
Symptoms of hyperkinetic syndrome do not improve, treatment should be stopped
become. When symptoms increase or when adverse reactions occur
the dose is reduced or Ritalin discontinued.
The treatment should not be extended indefinitely. From time to time (about all
12 months) Ritalin should be discontinued after consultation with your doctor
to assess the course of the disease and the need for further therapy with Ritalin
can.

Application error and overdose

What to do if Ritalin has been used in excessive amounts (intended or
accidental overdose)?
The symptoms of overdose mainly affect the cardiovascular system and the
Central nervous system. It can lead to accelerated heartbeat, arrhythmia and too
high blood pressure come. Also headache, confusion, trembling, nausea and vomiting
are possible. In case of overdose, medical treatment is essential.

What you need to keep in mind if you have too little Ritalin applied or an application
have forgotten?
If you forget to take Ritalin, take it as soon as you take it
notice it. If it is already time for your next dose, skip the missed dose
path. Never double the single dose on your own.

What should you watch out for if you stop or prematurely stop treatment?
In case of interruption or premature termination of treatment with Ritalin may be the symptoms
the disease reappear. Talk to your doctor before you stop taking the tablets
want.

Side effects

What side effects can occur when using Ritalin?
As very common side effects occur insomnia, increased irritability, loss of appetite
and stomach upset. These unwanted effects sound in the course of therapy
mostly off.
In addition, headaches and dizziness are very common.
Frequently the following side effects are observed: drowsiness, disorders of the
dyskinesias, restlessness, over-excitability, aggression, tachycardia, palpitations,
Cardiac arrhythmia, changes (usually increase) in blood pressure, nausea, vomiting,
Dry mouth, hypersensitivity reactions and allergic skin conditions such as itching
irritation, tingling sensations, skin rashes, hair loss, fever, joint pain.
Occasionally, weight loss and slightly delayed growth rate are at
the long-term therapy of children.

Rarely occur: blurred vision and blurred vision, heart pain.
Very rare were observed: hyperactivity, seizures, muscle cramps, twitching movements.
conditions, triggering muscle twitching (tics) and behavioral stereotypies, strengthening of
existing tics and involuntary facial movements (Tourette syndrome), psychotic
Reactions with hallucinations and ideas of persecution, temporary sadness, anxiety
nausea, tearfulness, inflammation or occlusion of cerebral vessels, increased dreams,
impaired liver function with transaminase elevations to hepatic coma, diarrhea and
Constipation, blistering of the skin and swelling even with fever. Reductions in the
Number of platelets (thrombocytopenia), which also causes punctiform haemorrhages.
can be called (thrombocytopenic purpura), the white blood cells
(Leukopenia) and red blood cells (anemia).

In adults with narcolepsy
Beyond that very often lack of concentration,
Noise sensitivity and sweating observed. Very rarely was inflammation of the
Oral mucosa reported.
If you experience any side effects that are not in this leaflet
please tell your doctor or pharmacist.
What countermeasures are to be taken with side effects?
Talk to your doctor if the Ritalin dose is reduced because of side effects
should or should the treatment be discontinued.