SEROTIAPIN. 200 mg. 60 tablets
SEROTIAPIN. 200 mg. 60 tablets
What Serotiapin and what it is used
Serotiapin contains the active ingredient quetiapine. Belongs to a group of medicines called antipsychotics. Serotiapin can be used for treatment of several diseases, such as:
Bipolar depression: I feel sad. You may find that you feel depressed, guilty, miss your energy, lose appetite and can not sleep;
Mania: You may feel strongly excited, inspired, excited, enthusiastic or hyperactive or have poor judgment, including to be aggressive or destructive;
Schizophrenia: can you hear or feel things that are not there to believe in things that are not true or feel unusually suspicious, worried, confused, guilty, stressed or depressed.
Your doctor may continue to prescribe Serotiapin, even if you feel better.
2. What you should know before taking Serotiapin
Do not take Serotiapin:
If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine (listed in Section 6);
If you take any of the following medicines:
certain drugs for the treatment of AIDS;
azole drugs (for fungal infections);
erythromycin or klaritromitsii (for infections);
nefazodone (for depression).
Do not take Serotiapin if any of the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Serotiapin.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Serotiapin:
If you or someone in your family you have a history of heart problems, such as heart rhythm problems, or are taking medications that can affect how your heart beats;
If you have low blood pressure;
If you are at increased risk of stroke or temporary decrease in blood flow to the brain, especially if you are elderly;
If you have liver problems;
If you have diabetes or are at risk for developing diabetes. If so, your doctor may check your blood sugar levels while taking Serotiapin;
If you know that you had a decreased number of white blood cells (which may or may not have been caused by the use of other drugs);
If you are elderly with dementia (loss of brain function). If so, Serotiapin should not be considered as a group of medicines to which it belongs, may increase the risk of stroke or in some cases the risk of death in elderly people with dementia;
If you have ever had a seizure (fit);
If you or a member of your family has a history of venous thrombosis (blood clots) as similar to this drug is associated with formation of blood clots.
Tell your doctor immediately if you experience:
Combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called "neuroleptic malignant syndrome"). You may need immediate treatment;
Uncontrollable movements mainly of the face and your tongue;
Dizziness or drowsiness if you feel strong. This may increase the risk of accidental injury (fall) in elderly patients;
Prolonged or painful erection (priapism).
These conditions may be caused by this type of medication.
Thoughts of suicide and worsening of your depression
If you are depressed, you may have thoughts of harming or killing themselves. They may be intensified at the start of treatment because these drugs take time to start to work, usually about two weeks but sometimes longer. These thoughts can be intensified if suddenly stop taking your medicine. More likely to think so, if you are a young man. Information from clinical trials has shown an increased risk of suicidal thoughts and / or suicidal behavior in young people under the age of 25 years with depression.
If at any time have thoughts of harming or killing yourself, contact your doctor or go to hospital. You may also be helpful to tell a relative or friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse or if they are worried about changes in your behavior.
In patients receiving quetiapine was no increase in weight. You and your doctor should regularly check your weight.
Other medicines and Serotiapin
Tell your doctor or pharmacist if you are taking, have recently taken or taking other medicines as Serotiapin can influence the mode of action of these drugs. This includes medicines that you buy without a prescription and herbal remedies.
Do not take Serotiapin if you use any of the following:
Some drugs for the treatment of AIDS;
Azole drugs (for fungal infections);
Erythromycin or clarithromycin (for infections);
Nefazodone (for depression).
Tell your doctor if you are taking any of these medicines:
Medicines to treat epilepsy (such as phenytoin or carbamazepine);
Medicines to treat high blood pressure;
Barbiturates (for insomnia);
Thioridazine (another antipsychotic medicine);
Medicines that affect the heart, such as drugs that may cause electrolyte imbalance (low potassium or magnesium), and diuretics (water tablets), or some antibiotics (medicines to treat infections).
Before you stop taking any of your medicines your doctor.
Serotiapin with food, drinks and alcohol
Serotiapin can be taken with or without food.
Be careful how much alcohol you drink, as the combined effect of quetiapine and alcohol can cause drowsiness.
Do not drink grapefruit juice while taking Serotiapin. It can interfere with the action of the drug.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You should not take Serotiapin during pregnancy, unless discussed with your doctor. Serotiapin should not be taken if you are breastfeeding.
Serotiapin should not be taken if you are breastfeeding.
The following symptoms may occur in newborns of mothers who used Serotiapin last trimester (last three months): tremors, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and difficulty eating. If your baby develops any of these symptoms, you may need to contact your doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or operate machinery until you are sure how these tablets affect you.
Serotiapin contains lactose
Serotiapin contains lactose which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Effect on drug testing in urine
If you do research for drugs in urine Serotiapin intake can lead to positive results for methadone or certain medicines for depression called tricyclic antidepressants (TTSA) using some research methods, although not taking methadone or TTSA. If this happens, you can conduct a more specific test.
3. How to take Serotiapin
Always take the medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine your starting dose. The recommended maintenance dose (daily dose) depends on your condition and spares, but is usually between 150 mg and 800 mg.
Will take the tablets once daily at bedtime or twice daily, depending on your illness.
Swallow the tablets whole with water.
You can take the tablets with or without food.
While taking Serotiapin not drink grapefruit juice. It can affect the way your medicine works.
Even if you feel better, do not stop taking your tablets unless your doctor tells you to.
If you have liver problems, your doctor may change the dose.
If you are elderly, your doctor may change the dose.
Use in children and adolescents
Serotiapin should not be used by children and adolescents under 18 years.
If you take more Serotiapin than necessary
If you take more than Serotiapin prescribed by your doctor, you may experience drowsiness, dizziness and abnormal heartbeat. Immediately contact your doctor or nearest hospital. Wear tablets Serotiapin you.
If you forget to take Serotiapin
If you forget to take a dose, take it as soon as you remember it. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for a missed dose.
If you stop taking Serotiapin
If you suddenly stop taking Serotiapin, it may be impossible to fall asleep (insomnia) or feeling sick (nausea), or may experience headache, diarrhea, vomiting, dizziness and irritability. Your doctor may suggest a gradual reduction of the dose before stopping treatment.
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. If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The frequency of adverse reactions are defined as:
Very common (may affect more than 1 in 10 patients):
Dizziness (can lead to a fall), headache, dry mouth;
Drowsiness (it may resolve with time, if you keep taking Serotiapin) (can lead to falls);
Withdrawal symptoms (symptoms that occur if you stop taking Serotiapin) include inability to sleep (insomnia), feeling sick (nausea), headache, diarrhea, vomiting, dizziness and irritability. Recommended phasing out period of at least 1 to 2 weeks;
Common (may affect up to 1 in 10 patients):
Feeling like your heart is pounding, racing or miss hit;
Constipation, upset stomach (indigestion);
Fatigue, nausea (may lead to falls);
Swelling of the hands or feet;
Low blood pressure when standing. It can cause dizziness or fainting (can lead to falls);
Elevated blood sugar levels;
Abnormal muscle movements. They include difficulty starting muscle movements, tremors, anxiety or muscle stiffness without pain;
Abnormal dreams and nightmares;
Feeling stronger hunger;
Disorder of speech and speech;
Thoughts of suicide or self-harm;
Shortness of breath;
Vomiting (mostly the elderly);
Uncommon (may affect up to 1 in 100 patients):
Seizures or convulsions;
Allergic reactions, which include raised lumps (hives), swelling of the skin and swelling around the mouth;
Uncomfortable feeling in the legs (known as restless leg syndrome);
Difficulty in swallowing;
Uncontrollable movements mainly of the face or tongue;
Worsening of pre-existing diabetes;
Changes in the electrical activity of the heart, visible in electrocardiography (prolongation of QT-interval).
Rare (may affect up to 1 in 1000 patients):
Combination of high temperature (fever), sweating, muscle stiffness, dizziness or fainting (a disorder called "neuroleptic malignant syndrome");
Yellowing of the skin and eyes (jaundice);
Inflammation of the liver (hepatitis);
Prolonged or painful erection (priapism)
Breast swelling and sudden release of milk (galactorrhea)
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 causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately;
Walking, talking, eating or other activities during sleep;
Decrease in body temperature (hypothermia);
Inflammation of the pancreas.
Very rare (may affect up to 1 in 10,000 patients):
Severe rash, blisters or red spots on the skin;
Severe allergic reaction (called anaphylaxis), which can cause difficulty breathing or shock;
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema);
Unusual secretion of a hormone that controls the amount of urine;
Muscle breakdown and muscle pain (rhabdomyolysis).
Not known (can not be estimated from available data):
Skin rash with red spots with irregular shape (erythema multiforme);
Severe, sudden allergic reaction with symptoms such as fever, blistering and peeling of the skin (toxic epidermal necrolysis).
The class of medicines to which it belongs Serotiapin, can cause problems in heart rate, which can be serious and, in severe cases be fatal.
Some side effects are only found in blood tests. These include changes in the levels of certain fats (triglycerides and cholesterol) and blood glucose, alterations in the levels of thyroid hormones in the blood, increased levels of liver enzymes, decreasing the number of identified cells, decreasing the amount of red blood cells, increased creatine phosphokinase (a substance in the muscles) in the blood, lowering the level of sodium in the blood and increase the levels of the hormone prolactin in the blood. Increase of the hormone prolactin can in rare cases lead to the following:
When men and women appear swollen breasts and unexpected separation of milk;
Missed or irregular periods in women.
Your doctor may want to do blood tests from time to time.
Additional side effects in children and adolescents
In children and adolescents may experience the same side effects as in adults.
The following side effects have only been observed in children and adolescents:
Very common (may affect more than 1 in 10 patients):
Increase in blood pressure.
The following adverse reactions occurred more frequently in children and adolescents:
Very common (may affect more than 1 in 10 patients):
Increasing levels of the hormone prolactin in the blood. The increase of the hormone prolactin can in rare cases lead to the following:
Boys and girls appear swollen breasts and unexpected production of breast milk;
Missed or irregular periods in girls;
Abnormal muscle movements. They include difficulty starting muscle movements, tremors, anxiety or muscle stiffness without pain.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet. You can also report side effects directly through Drug Agency, "Damian Gruev" ? 8; 1303 Sofia; tel +35 928903417; website: www.bda.ba. As reported side effects, you can give the howl contribution to getting more information on the safety of this medicine.
5. How to store Serotiapin
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 required. These measures will help to protect the environment.
6. Contents of the pack and other information
What does Serotiapin
The active ingredient is quetiapine.
Serotiapin 100 mg: Each tablet contains 100 mg quetiapine (as quetiapine hemifumarate).
Serotiapin 200 mg: Each tablet contains 200 mg quetiapine (as quetiapine hemifumarate).
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone (K = 25), sodium starch glycolate type A, glycerol dibehenate; silica colloidal anhydrous; magnesium stearate.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172) (for tablets of 100 mg).
Serotiapin looks like and contents of pack
The film-coated tablets 100 mg Serotiapin are round and yellow.
They are available in packs of 20, 30, 50, 60, 90 or 100 tablets.