TEVAKVEL XR. 200 mg
TEVAKVEL XR. 200 mg.
WHAT TEVAKVEL XR 200 mg prolonged RELEASE AND WHAT IT IS USED
Tevakvel XR contains an ingredient called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. These medicines help in conditions whose symptoms are:
Schizophrenia: when hearing or feeling things that I believe in things that are not true or feel unusually suspicious, anxious, confused, guilty, or depressed;
Mania: when you feel very excited, elated, agitated, enthusiastic or hyperactive, or have impaired judgment, including aggressive or you have destructive behavior;
Bipolar depressive disorder and major depressive episodes in major depressive disorder: You may feel sad. You may find that you feel depressed, feel guilty, have no energy, have lost appetite and / or can not sleep.
When Tevakvel XR 200 mg prolonged release is considered for the treatment of major depressive episodes in the major depressive disorder, it has to be taken in addition to any other drug that is used for treatment of this disease.
Your doctor may continue to give you Tevakvel XR 200 mg prolonged-release tablets, even if you feel better.
2. BEFORE YOU TAKE TEVAKVEL XR 200 mg RETARDTABLETTEN
He take Tevakvel XR 200 mg prolonged-release tablets c and tell your doctor:
if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Tevakvel XR 200 mg prolonged-release tablets;
if you are taking any of the following medicines:
- Certain medications for treatment of CPIN (HIV);
- Azole drugs (for fungal infections); erythromycin or clarithromycin (to treat infection);
- Nefazodone (for treating depression).
Do not take Tevakvel XR 200 mg prolonged-release tablets if any of the above applies to you. If you are unsure, check with your doctor or pharmacist before taking Tevakvel XR 200 mg prolonged-release tablets.
Take special care with Tevakvel XR 200 mg prolonged-release tablets.
Before taking your medicine, tell your doctor if:
You or someone in your family has or had heart problems, such as heart rhythm disorders or if you are taking any medications that may affect your heartbeat;
Have low blood pressure;
Have received a stroke, especially if you are elderly;
Have liver problems;
Have ever had seizures or fits;
Have diabetes or are at risk to develop diabetes mellitus. If so, your doctor will check your blood sugar while taking Tevakvel XR 200 mg prolonged-release tablets;
You know you had low white blood cells (which may or may not be caused by other drugs);
You are the man in the elderly with dementia (loss of brain function). If you are such a patient, you should not take Tevakvel XR 200 mg prolonged release tablets, because it belongs to the class of drugs that are not recommended for the elderly with dementia. May increase the risk of stroke or in some cases, the risk of death;
If you or someone in your family have had a blood clot, as drugs such as this medication is associated with formation of blood clots.
Tell your doctor immediately if you experience:
High temperature (fever), severe muscle stiffness, increased sweating or decreased level of consciousness (disorder called "neuroleptic malignant syndrome"). You may need immediate medical attention;
Involuntary movements, predominantly of the face or tongue;
Dizziness or a strong sense of drowsiness. This may increase the risk of accidental injury (fall) in elderly patients.
These conditions may be caused by this type of medicine.
Suicidal thoughts and deepening depression
If you are depressed (depressed) can sometimes thoughts of harming or killing yourself. These thoughts can be intensified at the beginning of treatment because these drugs need time to take effect, usually about two weeks but sometimes longer. These may be worse if you suddenly stop taking the drug.
The likelihood of such thoughts may be greater if you are a young person. Information from clinical trials has shown that young people under the age of 25 years with depression have an increased risk of suicidal thoughts and / or suicide attempts. If ever, start thinking about harming or killing yourself, call your doctor or go to the nearest hospital immediately. Perhaps it would be helpful to tell a relative or close 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 are worried about changes in your behavior.
In patients receiving 200 mg XR Tevakvel prolonged-release tablets was no increase in body weight. You and your doctor should check your weight regularly.
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 and herbal preparations. Do not take Tevakvel XR 200 mg prolonged-release tablets if you are taking any of these medicines:
Some drugs for the treatment of AIDS (HIV);
Azole drugs (for fungal infections);
Erythromycin or clarithromycin (to treat infection);
Nefazodone (for treating 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 your heart rate, for example. medications that may affect electrolyte balance (low levels of potassium or magnesium) as diuretics ("water pills"), or some antibiotics (medicines to treat infections).
Before you stop taking any of your medicines, please consult your doctor.
Taking Tevakvel XR 200 mg prolonged-release tablets with food and drink
Tevakvel XR 200 mg prolonged-release tablets may be affected by food, so you have to take the tablets at least one hour before meals or at bedtime;
Be careful how much alcohol taking. This is important because the combined effect of Tevakvel XR 200 mg prolonged release tablets and alcohol can make you sleepy;
Do not drink grapefruit juice while taking Tevakvel XR 200 mg prolonged-release tablets. It can change the way the drug works.
Pregnancy and lactation
If you are pregnant, trying to become pregnant or breast-feeding, tell your doctor before taking Tevakvel XR 200 mg prolonged-release tablets. You should not take Tevakvel XR 200 mg prolonged-release tablets during pregnancy unless it has been previously discussed with your doctor. Tevakvel XR 200 mg prolonged-release tablets should not CE taken if you are breastfeeding.
The following symptoms may occur in newborn babies whose mothers were taking quetiapine in the last trimester (last three months of pregnancy): shaking, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems, feeding problems. If your baby develops any of these symptoms, you should contact your doctor.
Driving and using machines
Your tablets may cause drowsiness. Do not drive or operate machinery until you know how this drug works.
Effect on screening charter drugs in urine
If you are taking quetiapine and you are having a screening for drugs in urine, some testing methods may show false positive for methadone or TTSA (medicines for depression called tricyclic antidepressants), even if you do not take methadone TTSA. If this happens, it is recommended to confirm these results with a more specific test.
3. HOW TO TAKE TEVAKVEL XR 200 mg RETARDTABLETTEN
Always take Tevakvel XR 200 mg prolonged-release tablets exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist. Your doctor will decide what will be your starting dose. Maintenance doses (daily dose) depends on the needs and condition check, but is typically between 150 mg and 800 mg.
Take the tablets once daily;
Do not break, chew or crush tablets;
Swallow the tablets whole with a glass of water;
Take the tablets on an empty stomach (at least one hour before meals or at bedtime, your doctor will recommend when);
Do not drink grapefruit juice while taking Tevakvel XR 200 mg prolonged-release tablets. It can change the way the drug works;
Do not stop taking your tablets even if you feel better, unless your doctor has told you.
If you have liver problems, your doctor may change your dose.
If you are elderly, your doctor may change your dose.
Children and adolescents under 18 years of age
Tevakvel XR 200 mg prolonged-release tablets should not be used by children or adolescents under 18 years.
If you take more dose Tevakvel XR 200 mg prolonged-release tablets
If you take more than prescribed by your doctor Tevakvel XR 200 mg prolonged-release tablets, you may experience drowsiness, dizziness and irregular heartbeat. Call your doctor or go to the nearest hospital immediately. Take the remaining tablets with you.
If you forget to take Tevakvel XR 200 mg prolonged-release 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 take a double dose to make up for a missed dose.
If you stop taking Tevakvel XR 200 mg prolonged-release tablets
If you suddenly stop taking Tevakvel XR 200 mg prolonged-release tablets may be difficult to fall asleep (insomnia), you may have nausea or 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tevakvel XR 200 mg prolonged-release tablets can cause side effects, although not everybody gets them. If any of these side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common (affects more than 1 in 10 patients):
Dizziness (can lead to a fall), headache, dry mouth;
Drowsiness (which may disappear with time, if you keep taking Tevakvel XR 200 mg prolonged-release tablets - can lead to falls);
Discontinuation symptoms (symptoms that occur if you suddenly stop taking Tevakvel XR 200 mg prolonged-release tablets): include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. Recommended phasing for at least 1-2 weeks;
Common (affects 1 to 10 users in 100):
Constipation, stomach upset (indigestion);
Fatigue, loss of consciousness (may lead to falls);
Swelling of the hands or feet;
Low blood pressure when standing. This can make you feel dizzy or faint (may lead to falls);
Increased blood sugar levels;
Abnormal muscle movements. These include difficulty in initiating muscle movement, tremors, feeling restless or muscle stiffness without pain;
Abnormal dreams or nightmares;
Disorders of speech and language;
Thoughts of suicide and worsening of depression.
Uncommon (affects 1 to 10 users in 1000):
Convulsions or seizures;
Allergic reactions, which may include raised lumps (hives), swelling of the skin and swelling around the mouth;
Unpleasant sensations in the legs (also called restless leg syndrome);
Difficulty in swallowing;
Uncontrollable movements mainly of the face or tongue;
Rare (affects 1 to 10 users in 10,000):
High temperature (fever), prolonged sore throat or ulcers in the mouth, rapid breathing, sweating, muscle stiffness, feeling light-headed or fainting;
Yellowing of the skin and eyes (jaundice);
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 in vessels to the lungs causing chest pain and difficulty breathing. If you notice these symptoms, seek medical attention immediately.
Very rare (affects less than 1 in 10,000 patients):
Worsening symptoms of diabetes;
Inflammation of the liver (hepatitis);
Severe rash, blisters or red patches on the skin;
Severe allergic reaction (called anaphylaxis) which is the cause of shortness of breath or shock;
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema);
Inadequate secretion of the hormone, which controls the volume of urine;
Breakdown of muscle fibers and muscle pain (rhabdomyolysis).
This class of drugs to which it belongs and Tevakvel XR 200 mg prolonged-release tablets can cause heart rhythm problems that are severe and in some cases fatal.
Some side effects were observed only in blood tests. These include changes in the amount of certain fats (triglycerides and cholesterol) and blood glucose, reduced numbers of certain blood cells, a reduced amount of sodium in the blood, decreased hemoglobin, and increased levels of the hormone prolactin in the blood.
Increasing prolactin could in rare cases lead to the following:
Breast swelling and sudden release of milk in men and women;
Women have a monthly cycle or receive it at irregular intervals.
Your doctor may order regular blood tests.
Children and adolescents
Can observe the same side effects that have been observed in adults.
The following adverse reactions have been observed only in children and adolescents:
Very common (affects more than 1 in 10 patients):
Elevated blood pressure.
The following adverse reactions have been observed in children and adolescents with greater frequency:
Very common (affects more than 1 in 10 patients):
Increased levels of the hormone prolactin in the blood. Increased levels of prolactin can in rare cases lead to:
- Enlargement of breasts in boys and girls and separation of milk;
- The girls have no or irregular monthly cycle
Abnormal muscle movements. They include difficulty in initiating movements, tremors, anxiety or cramps without pain.
5. HOW TO STORE TEVAKVEL HR 200 mg RETARDTABLETTEN
Keep out of reach of children.
Do not use Tevakvel XR 200 mg prolonged-release tablets after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Tevakvel XR 200 mg prolonged-release tablets do not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What does Tevakvel XR 200 mg prolonged-release tablets:
The active ingredient is quetiapine. Each tablet contains 200 mg quetiapine (as fumarate kvetiapinov).
Other ingredients are:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate.
Film-coating of titanium dioxide (E171), hypromellose, macrogol / PEG 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Looks like Tevakvel XR 200 mg prolonged release tablets and contents of the pack
Any prolonged-release tablets are capsule-shaped, film-coated tablets.
The 200 mg tablets are yellow, debossed with "Q 200" on one side of the tablet and plain on the other.
Packs 10, 20, 30, 50, 50 × 1 (hospital pack) 56 (calendar pack) 60, 90 and 100 tablets of all amounts of the active ingredient. Not all pack sizes may be marketed.