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MEDOSULPID 400 mg. 30 tablets

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What is MEDOSULPID and what it is used
MEDOSULPID is a drug used in psychiatric disorders (antipsychotic). It reduces the activity of a specific part of the brain that is important for the symptoms of mental disorders.
MEDOSULPID be used to treat a disease called schizophrenia.
Always follow your doctor's instructions.
2. What you need to know before taking MEDOSULPID
Do not take MEDOSULPID:
if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
If you suffer from breast cancer;
if you have a tumor of the pituitary gland;
if you have an adrenal gland tumor (pheochromocytoma);
if you are breastfeeding;
If you suffer from a rare inherited heart disease which is manifested by decreased heart rate and irregular heartbeat (syndrome of long QT);
if you are taking medicines that affect the heart (prolong the QT interval), for example medicines for:
- Parkinson's disease (levodopa);
- Abnormal heart rhythm (eg amiodarone, sotalol, quinidine and disopyramide).
if you are taking other medications such as bepridil, cisapride, sultopprid, thioridazine, methadone, erythromycin IV, vincamine iv, halofantrine, pentamidine, sarfloksatsin.
MEDOSULPID should not be taken by children before puberty.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MEDOSULPID
Talk to your doctor, especially if:
suffer from heart disease or have a family history of heart problems;
someone in your family suffers from a rare inherited heart disease with decreased heart rate and irregular heartbeat (syndrome of long QT);
suffer from kidney problems;
suffer from epilepsy or have a history of seizures;
suffer from Parkinson's disease;
you are diabetic or you have been told you are at risk of diabetes;
if you or someone in your family has a history of blood clots (thrombosis) as drugs such as these are associated with blood clots (thrombi).
Tell your doctor immediately if:
experience malaise, are prone to infections, particularly tonsillitis and temperature (infections) due to low white blood cells (agranulocytosis);
get fever, muscle stiffness, impaired concentration and increased sweating. They can be fatal and requires immediate medical attention.
Some groups of patients (e.g. elderly and patients with dementia) are at a higher risk of adverse events, including stroke.
Tell your doctor if you will be doing blood tests and urine if you are treated with MEDOSULPID as it may affect the results of these studies.
Other medicines and MEDOSULPID
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
This is because MEDOSULPID can affect the way some other medicines work. In addition, some medicines may affect the way in which acts MEDOSULPID.
In particular, do not take this medicine if you are taking:
levodopa medicament for the treatment of Parkinson's disease;
drugs called dopamine agonists (e.g., bromocriptine, ropinirole);
medicines for heart rhythm disturbances (eg amiodarone, sotalol, quinidine, disopyramide);
other drugs such as bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin IV, vincamine iv, halofantrine, pentamidine, sparfloxacin.
Tell your doctor if you are taking any of the following medications:
medicines for high blood pressure (diltiazem, verapamil, beta blockers such as metoprolol);
medicines for heart rhythm problems (digoxin);
medicines for migraine and hot flushes (clonidine);
antidepressants (imipramine);
drugs for arthritis or diseases of the connective tissue (e.g., corticosteroids, prednisone);
medicines for constipation (sodium picosulphate, bisacodyl);
painkillers such as morphine,
oxycodone, tramadol;
medicines for epilepsy (phenobarbital);
antihistamines that make you sleepy;
medicines to treat fear and anxiety (benzodiazepines) and medicines used to treat mental disorders (such as pimozide, haloperidol, lithium);
certain type diuretics;
drugs which promote sleep during surgery (anesthetics);
drugs for the treatment of fungal infections, administered into a vein (amphotericin B);
Medicines for malaria (eg mefloquine).
MEDOSULPID alcohol
Swallow MEDOSULPID with enough water before eating.
Do not drink alcohol while taking MEDOSULPID. This is necessary because it may affect the manner in which the drug acts.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborn if the mother has accepted MEDOSULPID in the last trimester (last three months of pregnancy):
tremors, muscle stiffness;
weakness, drowsiness, irritability, trouble breathing;
difficulty eating.
If your baby develops any of these symptoms, you may need to contact your doctor.
Do not take MEDOSULPID if you are breastfeeding.
Driving and using machines
During treatment with this medicine may experience reduced attention, dizziness or drowsiness. If this happens, do not drive or operate machines or tools.
MEDOSULPID contains lactose
MEDOSULPID contains lactose, a type of sugar. If your doctor has told you suffer from an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take MEDOSULPID
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults
50 mg - 300 mg daily or 400 mg - 800 mg per day depending on your symptoms. In individual cases the dose can be increased to 1200 mg daily.
Your doctor will adjust the dose according to your individual response.
The amount MEDOSULPID that will take depends on your disease. Carefully follow your doctor's instructions.
Swallow MEDOSULPID with sufficient water.
Use in children and adolescents
MEDOSULPID should not be taken by children before puberty.
The use of amisulpride between puberty and the age of 18 years is not recommended due to limited data.
Elderly
Your doctor may reduce your dose. You should follow your doctor's recommendations.
People with kidney problems
Your doctor may reduce your dose. You should follow your doctor's instructions.
If you take more than the amount MEDOSULPID
If you take more tablets, tell your doctor or visit the nearest hospital immediately. Take the medicine pack with you.
Signs of overdose may include dizziness, drowsiness, seizures, involuntary movements, dizziness, fainting due to low blood pressure and coma.
If you forget to take MEDOSULPID
If you forget a dose, take it as soon as you remember. However, if the time for your next dose is near, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you stop taking MEDOSULPID
Continue to take MEDOSULPID until your doctor tells you to stop. If you suddenly stop treatment after high doses of Solian can occur nausea, vomiting and insomnia. Furthermore, the symptoms of which are treated may recur or occur disorders with involuntary movements (such as akathisia, dystonia and dyskinesia).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MEDOSULPID and visit the doctor or the nearest hospital immediately if:
you have a fever, sweating, muscle stiffness, increased heart rate, rapid breathing or feel confused, sleepy or anxious. These may be symptoms of a serious but rare side effect called 'neuroleptic malignant syndrome';
have abnormal heartbeat, rapid heartbeat or chest pain that can result in heart attack or life-threatening heart disorder;
if you have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately;
You get infections more often than usual. This may be due to a blood disorder (agranulocytosis) or low white blood cells (neutropenia).
Uncommon (may affect up to 1 in 100 people)
have an allergic response. Signs may include: itchy, bumpy rash;
have seizures
Rare (may affect up to 1 in 1000 people)
severe allergic reaction with swelling of the face, lips or throat that may cause difficulty in swallowing or breathing. You may also notice hives (urticaria).
Tell your doctor as soon as possible if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)
tremor, muscle stiffness or spasm, slow movements, increased salivation and restlessness.
Common (may affect up to 1 in 10 people)
movements that you can not control, mainly in the arms and legs (these symptoms can be reduced if your doctor lowered the dose of MEDOSULPID or prescribe an additional drug).
Uncommon (may affect up to 1 in 100 people)
movements that you can not control, mainly of the face or tongue.
Not known (frequency can not be established from the available data):
- Withdrawal symptoms in newborns (see "Pregnancy").
Other side effects include:
Common (may affect up to 1 in 10 people)
difficulty sleeping (insomnia) or feeling anxious or irritated;
a feeling of fatigue or drowsiness;
constipation (constipation), nausea or vomiting, dry mouth;
weight gain;
unusual secretion of milk in women (galactorrhea) and the men, chest pain;
missed periods (amenorrhea);
breast enlargement in men (gynecomastia);
difficulties in achieving and maintaining an erection or ejaculation;
QT prolongation, a heart problem was found in an electrocardiogram;
dizziness (which may be due to low blood pressure).
Uncommon (may affect up to 1 in 100 people)
decreased number of white blood cells (leukopenia, neutropenia);
slow heart beat;
high blood sugar (hyperglycemia).
Rare (may affect up to 1 in 1000 people)
abnormal heart rhythm.
Not known (frequency can not be established from the available data)
confusion;
hypertriglyceridemia and hypercholesterolemia;
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist.
This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system
Drug Agency
str. "Damyan Gruev" № 8
1303 Sofia
Tel .: +359 2 8903417
website: www.bda.bg
As reported adverse reactions, you can do your bit for getting more information on the safety of this medicine.
5. How to store MEDOSULPID
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What MEDOSULPID
The active substance is amisulpride. Each tablet contains 400 mg Solian (amisulpride).
The other ingredients are lactose monohydrate, sodium starch glycolate type A, hypromellose E5, microcrystalline cellulose PH-101, magnesium stearate.
MEDOSULPID looks like and contents of the pack
White, biconvex, oblong tablets, scored on both sides and sizes 19x10 mm. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
PVC / PE / PVDC-Alu blister or PVC / PVDC-Alu blister packs of 30, 60 and 90 tablets. Not all pack sizes may be marketed.

 

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