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WHAT IS AND WHAT IT USED SPITOMIN
Spitomin is part of the anxiolytic drugs group. The drug is used for: - Short-term treatment of anxiety disorders in primary generalized anxiety disorder (GAD) - Adjuvant in the treatment of depressive disorders, to relieve symptoms of anxiety, the drug is not indicated for the treatment of depression alone.
BEFORE YOU TAKE SPITOMIN
Do not take Spitomin - If you are allergic (hypersensitive) to buspirone hydrochloride or any of the other components of Spitomin; - If you are taking medications known as MAOIs (moclobemide, selegelina). Treatment with buspirone should be used after a break of 14 days after discontinuation of the irreversible MAOIs (selegelina) and after 1 day after discontinuation of MAOI (moclobemide). Treatment with a MAOI (reversible or irreversible) will start 14 days after discontinuation Spitomin; - If you have severe liver or kidney disease - If you are under 18 years old (safety and efficacy in this patient was not studied). Take special care when using Spitomin The drug should be made with caution in these situations: - In case of moderate hepatic impairment may require dose reduction, depending on the severity of this disease (drug elimination from the body is low and high blood concentration). - Mild to moderate daily doses may reduce, since the active substance is low and plasma concentration is increased. - If you have glaucoma (increased pressure inside the eye) - If you suffer from myasthenia gravis, a disease manifested by excessive muscle weakness 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. - Concurrent administration with MAOIs can accompany hypertensive crises and therefore is contraindicated see paragraph not take Spitomin Caution should be exercised when co-administered with certain drugs such as: - Other drugs acting on central nervous system (diazepam, triazolam), because the therapeutic effect may be influenced each other. - Concentration of buspirone in the blood may increase and thus its effects can be amplified when co-administered with cimetidine (antacid), itraconazole (antifungal), diltiazem, verapamil (drugs to treat hypertension, angina pectoris); - Concentration of buspirone in the blood can be reduced and thus its effects can be reduced when co-administered with rifampicin (an antibiotic); - Co-administration with digoxin (to treat heart disease) may increase the effects of the latter;
Spitomin use with food and drink
Drinking alcohol is not recommended during treatment with Spitomin. Avoid eating grapefruit or appreciable quantities of grapefruit juice because it increases blood concentrations of buspirone and thus increase the frequency and intensity of adverse reactions.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Administration during pregnancy is not recommended unless absolutely necessary and after careful assessment of benefit / risk balance. Buspirone is excreted in breast milk, so treatment is not recommended Spitomin during breastfeeding.
Driving and using machines
Clinical studies have revealed that buspirone does not affect psychomotor performance of patients. However, due to transient side effects that may occur, especially early in treatment during this period should avoid driving or operating machinery. Subsequently, depending on individual reactivity or concomitant treatments, your doctor may decide to maintain or not these restrictions.
Important information about some components of Spitomin
Spitomin tablets contain lactose. If your doctor that you have intolerance to some sugars, please ask him before taking this medicine.
HOW TO TAKE SPITOMIN
Always take Spitomin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. If your doctor has prescribed otherwise not usual doses are: The initial dose is 1 tablet 5mg Spitomin (buspirone 5 mg) 3 times per day. If necessary your doctor may increase this dose buspirone 5 mg every 2-3 days up to a maximum dose of 10 mg Spitomin 2 tablets 3 times daily (60 mg buspirone). The usual daily dose is 20-30 mg given in 2-3 divided doses. Tablets should be taken at the same hours during the day, before or after meals to avoid changes in blood concentrations of buspirone during the day. Elderly: No dosage adjustment is necessary for this population. Mild or moderate: dosage should be reduced. Moderate hepatic impairment: daily dose should be reduced by minimum effective therapeutic dose, or increasing the interval between doses. Children under 18 years: safety and efficacy in this patient population has not been studied yet.
If you take too much of Spitomin
If you accidentally take too many tablets contact your doctor. Symptoms of overdose include nausea, vomiting, dizziness, drowsiness.
If you miss Spitomin
Do not take a double dose to make up the missed dose.
POSSIBLE SIDE EFFECTS
Like all medicines, Spitomin can cause side effects, although not everybody gets them. Buspirone is generally well tolerated and no severe adverse reactions were reported. In general, adverse reactions that may occur early in treatment were reported were transient and disappeared with continued treatment. If these side effects persist or become bothersome contact your doctor. The most common are: dizziness, headache, nervousness, excitement, fainting, gastrointestinal disorders and nausea. Less common: feelings of anger and hostility, confusion, blurred vision, diarrhea, muscle and bone pain, numbness, sensory disturbances, balance problems, tremor, rash, fatigue, weakness, sweating. If you are allergic to Spitomin may occur: itching, urticaria. In these cases immediately stop taking the medicine and ask your doctor about further treatment. Due to the possible consequences that can become serious doctor immediately if rash is severe or the skin all over your body. If you experience these symptoms mean that you have a severe allergic reaction to Spitomin: • swelling of hands, feet, lips, mouth or throat with difficulty swallowing or breathing, • fainting or feeling faint. Discontinue treatment immediately and inform your doctor, ambulance or present yourself to the emergency room of the nearest hospital. These symptoms are particularly severe, but very rare. If any side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE SPITOMIN
Keep out of reach and sight of children. Store below 30 g C in original packaging Spitomin not use after the expiry date on the package. The expiry date refers to the last day of that month.
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