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What is Ritalin / -SR / -LA and when should it be used?

Ritalin, Ritalin SR and Ritalin LA contain the active substance methylphenidate, a central nervous system stimulant.

The active substance in Ritalin SR (Sustained Release) is released more slowly, which prolongs the duration of activity compared to Ritalin tablets.

The active principle contained in a Ritalin LA (Long Acting = long-acting) capsule taken in the morning is released in the same way as when a Ritalin tablet is administered in the morning and at noon respectively. Ritalin LA is therefore intended to be taken once a day only.

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Ritalin / -SR / -LA should only be used on the prescription of a doctor experienced in the treatment of behavioral disorders in children and adolescents and under the regular supervision of a doctor. Ritalin / -SR / -LA is used to treat two different conditions.

 

1. Behavioral disorder in children and adolescents

Ritalin / -SR / -LA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children from six years of age and adolescents up to 18 years of age as part of a therapeutic program including also psychological, educational and social measures.

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The symptoms of ADHD in particular include the following: rapidly diminishing attention, thoughtlessness, inability to listen, not finishing tasks, not following instructions, being easily distracted, being impulsive, agitated, nervous, speaking excessively , start running at ill-chosen times, hinder or interrupt others and find it difficult to concentrate. Learning is hindered. All of these symptoms can lead to difficulties in the social environment, at school and at work. Sometimes those affected may not have all of these symptoms. Many only have them occasionally, but in ADHD patients they interfere with daily activities and manifest in more than one environment (i.e. i.e. at home, at school, at work). ADHD can continue into adulthood.

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After a thorough examination of your child, your doctor has decided to prescribe Ritalin / ‑SR / -LA.

Ritalin / -SR / -LA should only be used on the prescription of a doctor experienced in the treatment of behavioral disorders in children and adolescents and under the regular supervision of this doctor.

Treatment with Ritalin / -SR / -LA reduces the main manifestations of ADHD such as moderate to severe distraction, rapid relaxation of attention, impulsivity, increased motor activity (agitation) and disturbed behavior in society.

 

Examinations recommended before the start of treatment

Before starting treatment, the doctor should check whether your child has cardiovascular disease which would preclude treatment with Ritalin / -SR / -LA. The doctor will also measure your child’s height and weight before and during treatment.

2. Narcolepsy

Ritalin / -SR is also used in the treatment of narcolepsy, which is a form of abnormal sleep. Patients with this disorder have repeated bouts of irresistible sleep in broad daylight despite having normal nighttime sleep. The diagnosis of narcolepsy should be made by a doctor on the basis of a reading of the sleep-wake rhythm.

 

In patients with narcolepsy, Ritalin / -SR can eliminate this involuntary urge to sleep in broad daylight.

 

Monitoring of Ritalin therapy

To check whether Ritalin causes any side effects, the doctor will check the condition of adult patients (eg blood pressure, heart rate) and the growth of children on Ritalin at regular intervals. Blood tests are indicated in patients taking Ritalin for long periods of time to check the number of blood cells (white and red blood cells, as well as blood platelets).

 

When should Ritalin / -SR / -LA not be taken / used?

You should not take Ritalin / -SR / -LA:

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if you suffer from severe anxiety, mental tension and restlessness, as taking the medicine may worsen these conditions.

if you have severe depression including depressive symptoms like sadness, feelings of inferiority and hopelessness, if you have abnormal thoughts or visions, if you hear abnormal noises, if you have been diagnosed with psychosis or if you have shown suicidal tendencies.

if you abuse or depend on alcohol, medication or drugs, or if you have drunk too much alcohol, taken too many medications or drugs or have been dependent on them.

if you or a family member has been diagnosed with Tourette’s syndrome (tics).

if you have glaucoma (increased pressure in the eye).

if you have pheochromocytoma (a rare tumor of the adrenal gland).

if you have thyroid disease (hyperthyroidism).

if you suffer from heart rhythm disturbances.

if you suffer from heart disease (severe hypertension, heart failure, angina pectoris, congenital heart defect, myocardial conditions, myocardial infarction or diseases which may trigger life-threatening heart rhythm disturbances).

if you have problems with the arterial supply.

if you suffer from changes in the blood vessels in the head or have had a stroke.

if you are taking or have taken in the 14 days before treatment with Ritalin / -SR / -LA so-called monoamine oxidase inhibitors (e.g. depression medicines containing the active substance moclobemide) .

if you are allergic to Ritalin / -SR / -LA or any of the ingredients of the product.

Ritalin / -SR / -LA should not be taken to combat normal fatigue.

 

Children under 6 years old should not take Ritalin / -SR / -LA.

 

What precautions should be observed while taking / using Ritalin / -SR / -LA?

Please tell your doctor if you or your child

have developed aggressive behavior or your / his / her aggressiveness has increased.

have motor tics (repeated involuntary muscle contractions that are difficult to control from any part of the body) or verbal tics (repetitive expressions that are difficult to control in sounds or words).

have abnormal thoughts or visions, hear abnormal sounds, or have been diagnosed with psychosis in your child.

have seizures (epilepsy) or abnormal EEG results (electroencephalogram = brain scan).

have unusual prolonged erections (longer than 2 hours) or frequent and painful erections, possibly also after a break or stopping treatment with Ritalin. It requires emergency medical treatment.

have high blood pressure, blood pressure should be controlled, especially in patients with high blood pressure.

have a narrowing or blockage of the digestive tract (digestive tract, stomach, large intestine or small intestine).

have difficulty swallowing tablets.

see blur or have other visual disturbances.

suffer from galactose intolerance, lactase deficiency or glucose and galactose malabsorption (rare metabolic diseases).

suffer or have suffered from heart disease or other serious heart problems.

The so-called serotonin syndrome (severe changes in the functions of the brain, muscles and digestive system caused by high levels of serotonin in the body), which can be life-threatening, can occur during a treatment with methylphenidate, especially when combined with other drugs that affect serotonin balance.

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These medicines include medicines used for the treatment of migraine called triptans, medicines used for the treatment of depression such as selective serotonin reuptake inhibitors (SSRIs), serotonin reuptake inhibitors and noradrenaline (SNRI), tricyclic antidepressants, lithium, analgesics tramadol, fentanyl and tapentadol, dextromethorphan (cough suppressant), methadone, preparations based on St. John’s wort (natural remedy for mild depression), MAO inhibitors (including the antibiotic linezolid and methylene blue) and tryptophan preparations (for sleep disorders and depression).

 

Serotonin syndrome manifests itself by the following signs: anxiety, restlessness, irritability, hallucinations, tremors, exaggerated reflexes, muscle cramps, nausea, vomiting, diarrhea, increased body temperature, sweating, rapid heartbeat, changes in blood pressure, dizziness, delirium, loss of consciousness. If you or your child have such symptoms, tell a doctor straight away, so that appropriate treatment can be started. The doctor will ask you if your child is taking any other medicines or if your child or your family suffers from other illnesses (eg heart disease). It is important that you give him all of this information so that he can decide if Ritalin / -SR / -LA is the right medicine for your child. The doctor may decide whether your child needs to have

 

The doctor will measure your child’s blood pressure and heart rate each time the dose is changed or if he decides that these measurements are necessary. The doctor will also check if your child has any mood or mood problems, if he has any other unusual feelings or if these have worsened during the time your child has taken Ritalin / -SR / -THE.

 

As muscle damage can occur in the event of an overdose of this medication, the prescribed dosage should not be exceeded under any circumstances.

 

Please tell the doctor or pharmacist if your child:

 

suffers from another disease,

is allergic or

is already taking other drugs or already using other drugs for external use (even self-medication!).

When methylphenidate has been taken for a long time, children have been observed to have growth retardation (weight gain and / or height increase). When children are at an age where they are still growing, the doctor will carefully monitor their height and weight. If they do not continue to grow or gain weight as expected, your doctor may stop treatment with Ritalin / -SR / -LA.

 

There is clinical evidence showing that psychiatric disorders (including addictive and suicidal behavior) as well as weight loss and appetite loss occur more frequently with the administration of drugs containing methylphenidate.

 

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During the use of Ritalin / -SR / -LA, accommodation disturbances (difficulty in switching from far vision to near vision) and visual disturbances (e.g. blurred vision have been observed). ). Ritalin / -SR / -LA may cause clouding. This medicine may therefore affect reactions, the ability to drive and the ability to use tools or machines! In addition, it is not recommended to drink alcohol while taking Ritalin / -SR / -LA.

 

If other medicines are used, Ritalin / -SR / -LA may influence their effectiveness or cause side effects. If any of the following medicines are used, you should talk to your doctor before you can take Ritalin / -SR / -LA:

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medicines for the treatment of depression and medicines to prevent epilepsy or blood clots (anticoagulants), because Ritalin / -SR / -LA can negatively influence the way these are assimilated by the body.

medicines which increase blood pressure, due to possible increase in hypertension when used concomitantly with Ritalin / -SR / -LA.

hypotensive medicines containing the active substance clonidine, as serious side effects have been reported with simultaneous administration of methylphenidate and clonidine.

medicines which increase the level of serotonin in the body (serotonergic medicines, for example those for the treatment of depression, migraine, pain, cough). (For details, see earlier in the section “What precautions should I take when taking / using Ritalin / -SR / -LA?”.)

If you are not sure whether the medicines your child is taking are listed above, ask your doctor or pharmacist before giving your child Ritalin / -SR / -LA.

 

Ritalin: The wheat starch in this medicine contains only very small amounts of gluten and it is very unlikely to cause problems if you have celiac disease.

 

One 10 mg tablet contains no more than 4.8 micrograms of gluten.

 

If you are allergic to wheat (not to be confused with celiac disease) you should not take this medicine.

 

Ritalin SR: Macrogolglycerol hydroxystearate can cause indigestion and diarrhea.

 

Ritalin / -SR / -LA: Please only take Ritalin / -SR / -LA after consulting your doctor if you know you are suffering from sugar intolerance.

 

Can Ritalin / -SR / -LA be taken / used during pregnancy or breastfeeding?

Tell your doctor if you are pregnant or breastfeeding.

 

Ritalin / -SR / -LA should only be used during pregnancy on the express prescription of a doctor. You should not breast-feed during treatment. The active substance in Ritalin can pass into breast milk.

 

How to use Ritalin / -SR / -LA?

The doctor will choose the dose and schedule for taking Ritalin / -SR / -LA according to the patient’s needs. For Ritalin / -SR the daily dose is usually divided into 2–3 divided doses and for Ritalin LA in one dose. The total daily dose should not exceed 60 mg (6 tablets of Ritalin or 3 prolonged-release tablets of Ritalin SR or 2 capsules of Ritalin LA 30 mg).

 

Ritalin SR prolonged-release tablets should be swallowed whole and should not be crushed or chewed. Without the doctor’s instructions to the contrary, the tablets should be taken after a meal and preferably after a substantial breakfast.

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Ritalin LA capsules (capsules to be used once a day) can be taken with or without food. They can be swallowed as they are or their contents can be spread over a small amount of food (see below). The Ritalin LA capsules themselves or their contents, however, should not be chewed, crushed or divided.

 

Ritalin LA (capsules to be used 1 × per day), use by distributing the contents of the capsule over the food: the capsule can be opened with care and the small granules can be distributed over a little soft food, such as e.g. cold mashed potatoes. The food chosen should not be hot. The mixture thus prepared should be swallowed immediately and completely, but without chewing the small granules. Do not keep this mixture and do not take it in part.

 

In some cases your doctor may prescribe Ritalin as well as Ritalin SR, in order to best cover individual needs.

 

If you forgot to take your medicine, take it as soon as possible; the following tablets (Ritalin or Ritalin SR) will be taken at the usual time. Do not take a double dose. For Ritalin LA (capsules to be used once a day) you must not “catch up” the missed dose. If you have any questions about this, please ask your doctor. If, by accident, the number of tablets, resp. number of capsules taken exceeds what your doctor has prescribed, go to your doctor or nearest hospital straight away.

 

Do not stop treatment with Ritalin / -SR / -LA without discussing this with your doctor. It may be necessary to reduce the daily doses in stages before completely stopping treatment. Medical supervision is necessary after any discontinuation of treatment.

 

Do not change the prescribed dosage on your own. Talk to your doctor or pharmacist if you feel that the effectiveness of the drug is too weak or on the contrary too strong.

 

What side effects can Ritalin / -SR / -LA cause?

The most common side effects of medicines containing methylphenidate such as Ritalin / -SR / -LA are:

 

headache, nervousness, insomnia, joint pain, dry mouth, high body temperature (fever), excessive hair loss or thinning hair, unusual drowsiness or clouding, loss or decrease in appetite, pruritus, rash or itchy rash with redness (hives), cough, sore throat, irritation of the nose and pharynx, high blood pressure, rapid heartbeat (tachycardia), dizziness, uncontrollable movements, hyperactivity, aggressiveness, agitation, anxiety, depressed mood , irritability and abnormal behavior, stomach pain, diarrhea, nausea, stomach discomfort and vomiting.

 

Your doctor should also tell you about other important or serious side effects that may occur with the use of medicines containing methylphenidate:

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stereotypical behaviors often pathologically repeated, tactile hallucinations.

Musculoskeletal disorders, tics or worsening of existing tics (Tourette’s syndrome), damage to the nerves, migraine, particular nervous or muscular disorders, conditions accompanied by high fever and muscle stiffness which can go as far as loss of knowledge (“neuroleptic malignant syndrome”); if these symptoms appear, contact a doctor or hospital straight away. blurry vision. sudden cardiac death, problems with the vessels of the brain (stroke, inflammation or blockage of blood vessels in the brain. liver function disturbances. special inflammations or skin changes (exfoliative dermatitis, Stevens-Johnson syndrome), allergic rashes. blood in the urine, increased breast volume in men. Appearance of an unusual prolonged erection (lasting more than 2 hours) and painful on the penis, possibly also after stopping treatment. Taking or using Ritalin / -SR / -LA may cause the following side effects:

 

The most common side effects are: sore throat, dry mouth, nausea, decreased appetite, nervousness and insomnia.

 

In children and adolescents who have not previously had a psychotic disorder or mania, treatment with normal doses may cause psychotic or manic symptoms such as hallucinations, delusions or manias.

 

Some of these side effects can be serious. See your doctor straight away if you experience any of the following side effects: swelling of the lips and tongue or difficulty breathing (signs of a serious allergic reaction), sudden high fever, very high blood pressure and severe cramps, stiffness muscle (neuroleptic malignant syndrome), severe headache or confusion, weakness or paralysis in a limb or face, difficulty speaking (signs of a circulation problem in the brain), palpitations, chest pain, uncontrollable twitching (signs dyskinesia), tendency to bruising (bruising), muscle spasms or tics, sore throat and fever, sweating or chills, hallucinations, convulsions, blisters or itching,

 

Common side effects: headache, cloudiness, drowsiness, tremors, change in blood pressure (usually in the direction of an increase), abnormally fast heart rate, palpitations; stomach pain, nausea or vomiting which may be reduced by taking food at the same time may occur more particularly at the start of treatment; cough, toothache, rash, itching, hives, fever, excessive sweating, hair loss or thinning hair, joint pain, weight loss, restlessness, feeling restless and disturbed sleeping, feeling of depression ( depression), aggressiveness (aggression), excessive teeth grinding (bruxism).

 

Occasional side effects: muscle cramps in the jaw that make it harder to open your mouth (trismus).

 

Rare side effect: blurred vision.

 

In case of prolonged administration in children, Ritalin / -SR / -LA may induce moderate weight reduction and mild growth retardation. However, a direct relationship with the treatment could not be established.

 

Very rare side effects: decreased number of red blood cells (anemia), decreased number of platelets (thrombocytopenia), hyperactivity, transient depressed mood, uncontrolled speech and abnormal movements (Tourette’s syndrome), impaired liver function (including coma), muscle cramps, inflammation of the blood vessels (vasculitis).

 

Adverse reactions of unknown frequency: stuttering (dysphemia), night wetting of the bed in children (enuresis).

 

If you notice any side effects which are not mentioned in this leaflet, please inform your doctor or pharmacist.

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