STIMULOTON 50 mg. 30 tablets
Stimuloton is a drug which acts on the central nervous system (an antidepressant) and used for the treatment of depression, panic disorder, obsessive compulsive disorder, social phobia (social anxiety disorder), and PTSD.
2. BEFORE TAKE STIMULOTON
Do not take Stimuloton
• If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Stimuloton.
• If you take medications such as MAO-inhibitorige (eg moclobemide selezhelin). Treatment with Sgimulogon can begin at least 14 days after discontinuation of selezhelin and vice versa, 14 days prior to taking MAO inhibitor after treatment with Stimuloton. Stimuloton can be applied one day after discontinuation of moclobemide, however, at least 14 days must elapse before taking moclobemide after discontinuation of Stimuloton.
• If you have epilepsy and have frequent seizures despite taking medicine antiepileltichno.
• The drug can not be given to children under the age of 6 years (efficacy and safety have not been studied in this age group).
• If you are taking a medicine containing promozid.
Take special care with Stimuloton
Obarnege special care with this product in the following cases and tell your doctor immediately if any of the following apply to you:
• If your medical history has a mood disorder associated with abnormally elevated mood (manic) because - like other antidepressants - in very rare cases (about 0.4%) Stimuloton can lead to a recurrence of manic episodes .
• If you are epileptic, but seizure free or have had muscle cramps earlier, as drugs used to treat depression, panic disorder and obsessive-compulsive disorder can cause epileptic seizures. The drug must be stopped at the onset of attacks.
• If you have liver disease, since, depending on the severity of the disease, you may need a change in the daily dose; the elimination of the active substance of these tablets is reduced and its concentration increases in patients severe liver disease.
• Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are depressed and / or have anxiety disorders can sometimes have thoughts of harming or killing themselves. These may to be increased when first starting antidepressants, since these medicines all take time to start running - usually about two weeks but sometimes longer.
You may be more likely to think this way:
• If you have previously had thoughts of suicide or harming yourself.
• If you are a young person. Data from clinical studies suggest an increased risk of behavior associated with suicide in young people (under 25 years)
with psychiatric disorders that are treated with an antidepressant. If at any time there you have thoughts of harming or killing yourself, contact your doctor or go to hospital. It may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or are worried about changes in your behavior.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Please note that the following information relates to the drugs used in the past or will be used in the future.
• If you are taking other drugs acting on the central nervous system, as these medications and Stimuloton may mutually influence their effects.
• If taking other drugs with a high degree of binding to plasma proteins, since they can alter the blood and thus influence each other's effects.
• If you take tsimegidin-containing antacids, as co-administration may decrease the elimination of the active substance of Stimuloton. The clinical significance of this interaction is unknown.
• If you are taking coumarin anticoagulants, since concomitant use of Stimuloton may increase the risk of bleeding. Blood coagulation parameters should be checked carefully before and after treatment with Sgimuloton.
• If you use other The medicament metabolised in the liver, as these medications and Stimuloton may alter the metabolism and thus mutually influence their effects.
• If you use a lithium as increased tremor was observed after co-administration as it may indicate drug interaction.
• If by now you have taken another antidepressant with the same mechanism is not action; length of time in which you do not take medicine needed before moving to Stimulogon will be determined by your doctor.
Taking Stimuloton with food and drink
The use of alcoholic beverages need to be avoided during treatment with Sgimuloton.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Preferably the drug to be avoided during pregnancy, however, it can be used under strict medical supervision and your doctor can prescribe it for you if you believed in your case the expected benefits outweigh the potential risk.
The active ingredient of the drug is excreted in human milk and therefore its use is not recommended during lactation.
Driving and using machines
According to the results of clinical trials, the drug has no effect on psychomotor performance. Since, however, the drug used to given testimony could affect psychomotor behavior, your doctor will decide whether you can drive and use machines should be restricted during the treatment, depending on your response to treatment with Stimuloton, and others types of drugs used simultaneously.
3. HOW TO TAKE STIMUPOTON
Always take Stimuloton exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist. If your doctor prescribes otherwise, the usual doses are:
• In depression or obsessive disorder komlulsivno 50 mg daily.
• In panic disorder, social phobia, and in the treatment of PTSD: 25 mg daily. The daily dose can be administered at any time during the day (but preferably at the same time each day).
Concomitant food intake has no effect on the absorption, which is why a drug can be taken with or without food. If necessary, your physician may increase the dose within a few weeks up to 1 x 200 mg daily. Symptoms may from time to time to stop or abate within 7 days, but in most cases require 2 to 4 weeks, but treatment to achieve the full effect. Relief of symptoms is achieved even more slowly in the case of OCD. To avoid relapse, treatment should be continued for 6 to 12 months after the symptoms begin to subside. Do not stop treatment at random, as this may lead to return to your original state.
• Use in children and adolescents under 18 years of age
Stimuloton should not be used in children and adolescents below 18 years, except for patients with obsessive compulsive disorder. Also current, you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility when they take this class of drugs. However, your doctor may prescribe Stimuloton patients under 18 years because it may decide that it is in their interest. If your doctor has prescribed Stimuloton, but a patient under 18 and want to discuss this, please go back to your doctor. You should tell your doctor if you develop or worsen some of the symptoms listed below in patients under 18 receiving Sgimupoton. Also, long-term effects of Stimuyaoton regarding safety in growth, maturation, and cognitive and behavioral development in this age group have not yet been proven.
• For children aged 13-17 years with obsessive-compulsive disorder The usual starting dose is 50 mg daily.
• In children aged 6-12 years with OCD recommended starting dose is 25 mg per day, which can be increased to 50 mg daily after 1 week. In case of unsatisfactory therapeutic results, the doctor may increase the dose to 200 mg daily.
• Elderly (over 65 years): No dose adjustment is required in elderly patients.
• Patients with renal impairment: No dose adjustment is required.
• Patients with liver disease: In these cases, dose reduction or increase the interval between doses.
Please consult your doctor or pharmacist if you think the effects of Stimuloton are too strong or too weak.
If you take more dose Stimuloton
Immediately consult your doctor or pharmacist.
If you forget to take Stimuloton
If you forget to take Stimuloton at the usual time, do not take a double dose to make up the missed dose. You can take the missed dose only if there is enough time to the next, otherwise you run the risk of overdose. Then continue with treatment and the way the doses prescribed by your doctor.
If you stop taking Stimuloton
Do not stop taking Stimuloton even if you feel better, unless your doctor tells you to do.
It is important to keep taking the medicine.
Make sure that your drug is not on the decline.
When they stop taking Stimuloton, your doctor will help you by reducing the dose slowly over one or two weeks - this will help reduce the possibility of occurrence of withdrawal symptoms.
After discontinuation of Stimuloton, can be observed the following effects: dizziness; tingling; sleep disturbances (vivid dreams, nightmares, inability to sleep); feelings of restlessness and excitement; anxiety; nausea / vomiting (feeling or being sick); tremor (raztreperenost); headaches.
Most people find that any symptoms after stopping Stimuloton are mild and will pass by itself Roma women in a few weeks. If you experience symptoms when you stop treatment, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Stimuloton can cause side effects, although not everybody gets them.
Adverse reactions are divided into the following categories according to
frequent occurrence: very common (≥ 1/10), Common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥1 / 10,000 to <1 / 1000), very rare (<1/10 000), not known (can not be assessed according to available data).
Uncommon: described asymptomatic increase of liver transaminases (GOT, GPT). The changes occur during the first nine weeks of treatment and disappear immediately after stopping the drug.
Nervous system disorders
Very common: drowsiness, dizziness; Common: shivering.
Common: visual disturbances.
Very common: diarrhea, loose stools, nausea, dry mouth; Common: vomiting, indigestion, flatulence.
Metabolism and nutrition
Common: loss of appetite.
Not known: It has been observed and reversible reduction in the level of sodium in the blood. This occurs mainly in elderly patients and in patients treated with diuretics.
Very common: fatigue.
Common: increased sweating, waves.
Disorders of the reproductive system and breast
Very common: problems with ejaculation.
Very common: insomnia; Common: nervousness, decreased libido.
Cases of suicidal ideation and suicidal behaviors have been reported during treatment with sertrolin or immediately after its termination. Sporadically - although a causal relationship to treatment has not been proven - movement disorders, anxiety, seizures, irregular cycle, initiation of lactation are described in the application of this medicine. In most cases, motor disorders occurred in patients on concomitant treatment with other drugs acting on the central nervous system (known to lead to such side effects) or in patients with movement disorders in the past. Rarely withdrawal symptoms after discontinuation. As with other antidepressants may be some symptoms that are difficult to distinguish from symptoms of the underlying disease: aggressive reactions, hallucinations and decreased sensation. If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE STIMULOTON
Do not store above 25 ° C.
Keep out of reach of children.
Do not use Sgimuloton after the expiry date stated on the packaging. The expiry date answer to the last day of that month. Do not use Stimuloton if you notice visible signs of deterioration (eg color).
Medicines should not be disposed of in wastewater or with household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance:
Stimulogon 50 mg: Each tablet contains 50 mg sertraline (below
sertraline hydrochloride form of a 55.95 mg).
Stimupoton 100 mg: Each tablet contains 100 mg of sertraline
(in the form of sertraline hydrochloride 111.90 mg).
Excipients: magnesium steorat, hydroxypropyl cellulose, sodium
starch glycolate (type A), calcium hydrogen phosphate dihydrate, cellulose
mikrokristolna, macrogol 6000, titanium dioxide (E171), hypromellose.
Stimuloton looks like and contents of the pack
White or almost white, odorless, biconvex, oblong, film-coated tablet with but "E271" (50 mg) and the "E272" (100 mg) on one side and scored on the other side.
The tablets can be divided into equal halves.
Stimuloton 50 mg, 30 tablets (3 x 10);
Stnmuloton 100 mg: 28 film-coated tablets (2 x 14)
in PVC / RVDS blister strips and box.