TEVAQUEL. 200 mg. 60 tablets
TEVAQUEL. 200 mg. 60 tablets
What TEVAQUEL 200 mg film-coated tablets and what it is used
TEVAQUEL 200 mg film-coated tablets contain quetiapine, which belongs to a group of medicines called antipsychotics, which help to control the symptoms of a mental illness called schizophrenia in adults over 18 years of age. These symptoms include delusions (having strange or unusual thoughts), hallucinations (seeing or hearing things that are not there), abnormal behavior, which can be aggressive and become closed and oppressed.
Quetiapine may further be used in the treatment of moderate to severe manic episodes in patients over 18 years of age. These episodes cause periods of unending cheerfulness and increased activity. People with this condition may become unusually irritable, require less sleep than normal and have rapidly changing thoughts. Not been proven whether quetiapine preventing recurrence of manic or depressive episodes.
2. What you should know before taking TEVAQUEL 200 mg film-coated tablets
Do not take TEVAQUEL 200 mg film-coated tablets and tell your doctor if:
you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine described in section 6;
taking medicines to treat HIV (AIDS);
taking azole antifungal medicines such as itraconazole or ketoconazole;
taking antibiotics erythromycin or clarithromycin;
taking nefazodone of depression.
Warnings and Precautions
Before taking quetiapine, consult your doctor or pharmacist if:
suffer from low blood pressure;
suffer from heart disease, irregular heartbeat or heart disease, or blood vessels;
have ever had seizures or fits;
have liver problems;
have diabetes or are at risk to get diabetes. If so, your doctor may monitor your blood sugar while taking quetiapine;
ever received a stroke;
you have low white blood cells;
if you or any member of your family have had a blood clot, as this drug may be associated with formation of blood clots.
If after taking the tablets get palpitations, rapid breathing, muscle stiffness and / or fever, or involuntary movements of the face, body, arms or legs, contact your doctor immediately.
In elderly patients with dementia (loss of mental activity), while taking quetiapine and other drugs of the same type is an increased risk of death. Direct link between quetiapine and this increased risk is unknown. Quetiapine is not approved for this use.
Suicidal thoughts or worsening of depression
If you are in depression may sometimes have thoughts of harming or killing themselves. They can occur more frequently when starting treatment for the first time, as to manifest the effects of these drugs take time, usually about two weeks but sometimes longer. The chances of having such thoughts is greater:
if you have previously had thoughts about killing or harming yourself;
If you are a young person. Information from clinical trials has shown an increased risk of suicidal thoughts and / or suicide attempts in young people under the age of 25 years with depression.
If at any time have thoughts of harming or killing yourself, immediately call your doctor or go to hospital.
It may be helpful to share with your 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 worry about changes in your behavior.
At the beginning of treatment with quetiapine may feel drowsy or dizzy, especially when getting up and this can cause you to fall or have an accident. Be careful while know how you react to quetiapine.
Quetiapine can cause unpleasant or distracting anxiety, need to move often or inability to remain longer in the sitting or standing position (this is called akathisia). More likely is that to occur in the first few weeks of treatment. If you get it, check with your doctor.
Quetiapine may be the reason for severe stomach pain that reaches back; this may be an inflammation of the pancreas. If this happens, call your doctor immediately.
Children and adolescents
Quetiapine is not recommended for use in children and adolescents below 18 years due to lack of data to support its use in this age group.
Other medicines and quetiapine
Please tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines, including herbal products, natural products and medicines obtained without a prescription.
Do NOT take TEVAQUEL 200 mg tablets if you are taking:
drugs for the treatment of HIV (AIDS);
azole antifungal medicines such as itraconazole or ketoconazole;
antibiotics erythromycin or clarithromycin;
nefazodone for depression.
Tell your doctor if you are already taking:
other medicines for mental illness such as thioridazine;
carbamazepine or phenytoin for epilepsy;
barbiturates such as phenobarbital (for epilepsy) or amobarbital (for insomnia);
medicines for cardiac arrhythmias;
drugs that can alter the level of salts (potassium, magnesium) in the blood;
antituberculosis drug rifampicin.
Some medications can cause more rapid elimination of quetiapine from your body than normal, so it is possible your treatment is not effective.
Quetiapine may give false-positive results of certain laboratory tests (tests for the presence of methadone and certain types of antidepressants in the blood).
Taking TEVAQUEL 200 mg film-coated tablets with food and alcohol
Do not drink grapefruit juice while taking this medicine.
While taking TEVAQUEL 200 mg film-coated tablets careful with alcohol intake. This medicine may be taken with or without food.
Pregnancy and lactation
Safety of quetiapine during pregnancy or lactation has not been confirmed. Do not take quetiapine before checking with your doctor if you are pregnant or trying to get pregnant.
The following symptoms may occur in newborns when mothers used TEVAQUEL 200 mg film-coated tablets in the last trimester (last three months of pregnancy): shaking, numbness and / or weakness, drowsiness, anxiety, respiratory problems and difficulty in feeding. If your baby develops any of these symptoms, you may need to contact your doctor.
You should not breast-feed during treatment with quetiapine.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.
Driving and using machines
The use of quetiapine may lead to drowsiness. Do not drive or operate machinery until you know how this drug works.
TEVAQUEL 200 mg film-coated tablets contain lactose
This medicinal product contains small amounts of lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
TEVAQUEL 200 mg film-coated tablets containing sodium
This medicinal product contains less than 23 mg sodium per tablet: in practice it does not contain sodium.
3. TEVAQUEL How to take 200 mg film-coated tablets
Always take TEVAQUEL 200 mg film-coated tablets exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
The usual starting dose is 50 mg. During the first four days of treatment will take an increasing number of tablets. After the 4th day, the dose can be further increased, depending on how to react to the treatment. Your doctor will tell you how many tablets you need to take each day. The maximum daily dose is 750 mg.
Manic episodes associated with bipolar disorder
The usual starting dose is 100 mg. After the 4th day, the dose may be increased further depending on how to react to the treatment. Your doctor will tell you how many tablets you need to take each day. The maximum daily dose is 800 mg.
Method of administration
Half the daily dose should be taken in the morning and half in the evening. The tablets should be swallowed with water and can be taken with or without food.
Your doctor may give you a lower dose if you have liver disease.
If you are elderly, your doctor may prescribe a lower dose.
Children and adolescents
TEVAQUEL 200 mg film-coated tablets are not recommended for use in children and adolescents.
If you take a larger dose TEVAQUEL 200 mg film-coated tablets required
Signs and symptoms of overdose include sedation and dizziness, fast heartbeat, low blood pressure, seizures (epileptic seizures), muscle breakdown, who leads to kidney damage (rhabdomyolysis), water retention, respiratory arrest, a state of confusion, agitation, delirium.
Immediately call your doctor or the nearest emergency room. Take the packaging and other tablets with you.
If you forget to take TEVAQUEL 200 mg film-coated tablets
If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not double dozayu to make up the missed dose.
If you stop taking TEVAQUEL 200 mg film-coated tablets
Do not suddenly stop taking this medicine before checking with your doctor as you may experience withdrawal symptoms such as nausea, vomiting and insomnia.
Gradual withdrawal of the drug.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, quetiapine can cause side effects, although not everybody gets them.
Stop taking quetiapine and call your doctor or go to the nearest hospital immediately if:
Some people (may affect up to 1 in 10,000 people) may experience a severe allergic reaction called anaphylactic shock. This is a rare but very serious side effects. If any of the following side effects, call your doctor immediately: swelling of the face, hands, lips, feet, tongue or throat, difficulty swallowing or breathing;
You have muscle weakness, tension or pain, malaise or fever. You may have rare but serious disease that can be life threatening, called rhabdomyolysis. This may affect up to 1 in 10 000;
You have very high fever, sweating, stiff muscles, fast heart beat, rapid breathing and drowsiness or feeling confused. You can also get difficulties in gait, staggering or have unusual muscle movements, which you can not control. In rare cases, it may appear eye movement. This could be signs of a serious condition called neuroleptic malignant syndrome. It may affect up to 1 in 1000 people;
Notice yellowing of the skin or eyes, and darkened urine, you may have a fever, feel tired, lose your appetite, have abdominal pain or nausea. This could be signs of liver problems such as jaundice or hepatitis. May affect up to 1 in 1000 people;
You have seizures (convulsions). These may affect up to 1 in 100 people;
If you notice any clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which can move through blood vessels to the lungs causing chest pain and difficulty breathing. This is called an embolism and can affect up to 1 in 1000 people;
Have severe stomach pain that reaches back to back; this may be a manifestation of pancreatitis and affects up to 1 in 1000 people;
Symptoms of the disease called diabetes mellitus and may affect up to 1 in 100 people;
Some people may experience life-threatening skin disease (syndrome Stevens-Johnson, which affects up to 1 in 10 000 people and toxic epidermal necrolysis, whose frequency can not be estimated from the available data). These are very very serious side effects. If any of these effects, tell your doctor or nurse:
- Peeling skin;
- Inflammation of the mucous membranes;
- Skin rash;
If you have itchy spots starting to appear on the feet and hands. These may be symptoms of a skin condition called erythema multiforme. The incidence of this condition can not be estimated from the available data;
Get swelling of the face (eyelids, lips), tongue, hands and feet. Furthermore, it may occur difficulty in breathing. This condition is called angioedema and may affect up to 1 in 10 000;
If you have difficulty speaking or swallowing, loss of balance, lack of facial expression, uncertain gait, stiff shoulders and legs, trembling or shaking of the hands or fingers. They are called extrapyramidal symptoms and may affect up to 1 in 10 people;
Notice that more often than usual getting infections or bruising. These may be symptoms of a serious condition called agranulocytosis (reduction in the number of blood cells);
Experience persistent painful penile erection that does not go away (priapism) - this effect is rare;
Feel uneven and rapid heart beat. This can be a symptom of a condition called elongation of the QT-interval, which is observed in a study called ECG. May affect up to 1 in 100 people;
Have a very high temperature;
Reports indicate that some antipsychotic drugs can cause abnormal heart rhythms, heart attack or sudden unexplained death. If you suffer from chest pain, palpitations or irregular heart beat, inform your doctor immediately.
Other adverse reactions are:
Very common (affect more than 1 in 10 people):
Increased levels of cholesterol;
symptoms of withdrawal (symptoms that occur when you stop taking quetiapine) include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. Usually disappear after about one seven the last dose;
Some side effects were only detectable in blood tests. These include reduction of a molecule called hemoglobin in the blood.
Common (may affect up to 1 in 10 people):
loss of consciousness;
fast or irregular heartbeat;
Some side effects were only detectable in blood tests. These are:
- Reduction of the number of certain types of blood cells (eosinophils);
- Increased amount of the hormone prolactin in the blood (hyperprolactinemia). Increase in prolactin levels may be the cause of:
1. The men and women get breast swelling and unexplained secretion of milk;
2. Women not menstruating or their cycle is irregular;
- An increase of certain enzymes in the blood (ALT, AST, GGT);
- High blood sugar levels;
- Reducing the amount of certain hormones in the blood (CA, T4);
- Changes in the number of white blood cells (which can be a cause of fever and serious deterioration of your general condition, or fever with signs of local infection as a constant sore throat, mouth ulcers, or urinary problems);
swelling of the hands or feet;
rhinitis (itchy or stuffy nose);
dyspnea (shortness of breath);
low blood pressure when standing up, which can cause dizziness;
abnormal dreams and nightmares;
unusual muscle movements;
speech disorders or language;
constant feeling of hunger.
Uncommon (may affect up to 1 in 100 people):
restless leg syndrome;
Some side effects were only detectable in blood tests. These include:
- Reducing the number of red blood cells (anemia), which is the cause of fatigue, tiredness and lack of energy;
- Reduction of electrolytes in the blood, called sodium (a condition called hyponatremia);
impaired function of the thyroid (hypothyroidism), which can lead to fatigue, drowsiness, constipation, obesity.
Rare (may affect up to 1 in 1,000 people):
breast swelling and sudden release of milk (galactorrhea)
metabolic syndrome (a group of conditions that put you at risk of heart disease and diabetes, these conditions are: high blood pressure, high blood sugar, high triglycerides (a type of blood fat), low HDL (good levels cholesterol), accumulation of fat around the waist);
sleep walking, sleep talking, sleep eating;
low body temperature;
irregular monthly cycle;
Some side effects are identified only when performing blood tests. These include lowering blood enzyme called creatine phosphokinase (CPK).