TEVAQUEL XR 200mg. 30 tablets

WHAT TEVAQUEL XR 200 mg prolonged RELEASE AND WHAT IT IS USED
Tevaquel XR contains an ingredient called quetiapine. Quetiapine belongs to a group of medicines called antipsychotics. These medicines help with conditions whose symptoms are:
Schizophrenia: when you hear or feel things that are not, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, or depressed;
Mania: when you feel very excited, elated, excited, enthusiastic or hyperactive or have impaired judgment, including're aggressive or disruptive behavior;
Bipolar depressive disorder and major depressive episodes in major depressive disorder: you may feel sad. It may find that you feel depressed, feel guilty, you have no energy, you lose appetite and / or can not sleep.
When Tevakvel XR 200 mg prolonged-release tablets are taken for the treatment of major depressive episodes in the major depressive disorder, it should be taken in addition to any other drug that is used for the treatment of this disease.
Your doctor may continue to give you Tevakvel XR 200 mg prolonged-release, even if you feel better.

2. BEFORE YOU TAKE TEVAQUEL XR 200 mg prolonged-release tablets
He Tevaquel take XR 200 mg tablets prolonged release 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;
if you are taking the following medicines:
- Certain medications for treatment of CPIN (HIV);
- Azole medicines (for fungal infections); erythromycin or clarithromycin (to treat infection);
- Nefazodone (for depression).
Do not take Tevakvel XR 200 mg prolonged release if any of these apply to you. If you are unsure, check with your doctor or pharmacist before taking Tevakvel XR 200 mg prolonged release.

Take special care with Tevaquel XR 200 mg prolonged release.
Before you take your medicine, tell your doctor if:
You or someone in your family has or had heart problems, such as abnormal heart rhythm or if you are taking any medicines that may affect your heartbeat;
Have low blood pressure;
You have received a stroke, especially if you are elderly;
Have liver problems;
You have ever had seizures or fits;
You have diabetes or are at risk to develop diabetes. If so, your doctor will check your blood sugar while taking Tevakvel XR 200 mg prolonged release;
You know that you have had low white blood cells (which may or may not be caused by other medicines);
You are the elderly person with dementia (loss of brain function). If you are such a patient, you should not take Tevakvel XR 200 mg prolonged-release because he belongs to a 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 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, sweating increased or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"). It may need immediate medical attention;
Involuntary movements, predominantly of the face or tongue;
Dizziness or a strong sense of sleepiness. This can increase the risk of accidental injury (fall) in elderly patients.
These conditions can be caused by this type of medicine.

Suicidal thoughts and deepening depression
If you are depressed (suppressed) can sometimes thoughts of harming or killing yourself. These thoughts can be intensified at the beginning of treatment, as these drugs need time to AFFF, 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 attempts at suicide. If, and when, 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. It might ask them to tell you if they think your depression is getting worse or are worried about changes in your behavior.
In patients taking Tevakvel XR 200 mg prolonged release is observed 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 or herbal. Do not take Tevakvel XR 200 mg prolonged-release if you are taking any of the following medications:
Some drugs for the treatment of AIDS (HIV);
Azole medicines (for fungal infections);
Erythromycin or clarithromycin (to treat infection);
Nefazodone (for treating depression).

Tell your doctor if you are taking any of the following medications:
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. drugs that can disrupt electrolyte balance (low levels of potassium or magnesium) such as diuretics ("water pills") or certain antibiotics (drugs to treat infections).
Before you stop taking any of your medicines, please consult your doctor.

Taking Tevaquel XR 200 mg prolonged-release tablets with food and drink
Tevakvel XR 200 mg prolonged release may be influenced by food, so you have to take the tablets at least one hour before meals or at bedtime;
Be careful how much alcohol you drink. 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. 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 Tevaquel XR 200 mg prolonged release. You should not take Tevakvel XR 200 mg prolonged-release tablets during pregnancy unless this has already been discussed with your doctor. Tevakvel XR 200 mg prolonged-release should not accept CE if you are breastfeeding.
The following symptoms may occur in newborn infants whose mothers were taking quetiapine in the last trimester (last three months of pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and 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 medication affects you.

Effect on screening charter drugs in urine
If you are taking quetiapine and you do screening for drugs in urine, some testing methods may show false positive results for methadone or TTSA (medicines to treat depression called tricyclic antidepressants), even if you do not take methadone or TTSA. If this happens, it is recommended to confirm these results with a more specific test.

3. HOW TO TAKE TEVAQUEL XR 200 mg prolonged-release tablets
Always take Tevaquel XR 200 mg prolonged-release tablets exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist. Your doctor will decide what will be your starting dose. The maintenance dose (daily dose) will depend on your illness and needs but is typically between 150 mg and 800 mg.
Take the tablets once a day;
Do not split, chew or crush the 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. 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.

Liver problems
If you have liver problems, your doctor may change your dose.

Elderly
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
If you take more than your prescribed by your doctor Tevakvel XR 200 mg prolonged-release, you may experience sleepiness, 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 Tevaquel XR 200 mg prolonged release
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Tevaquel XR 200 mg prolonged release
If you suddenly stop taking Tevakvel XR 200 mg prolonged-release hard can fall asleep (insomnia), you may have nausea or headache, diarrhea, vomiting, dizziness or 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, Tevaquel 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 (affecting more than 1 in 10 patients):
Dizziness (may lead to a fall), headache, dry mouth;
Drowsiness (which may disappear over time if you continue to take Tevakvel XR 200 mg prolonged release - can lead to falls);
Discontinuation symptoms (symptoms that occur if you suddenly stop taking Tevakvel XR 200 mg prolonged release) include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. It recommended phasing out for at least 1-2 weeks;
Weight gain.

Common (affects 1 to 10 patients in 100):
Rapid heartbeat;
Stuffy nose;
Constipation, upset stomach (indigestion);
Fatigue, loss of consciousness (may lead to falls);
Swelling of the hands or feet;
Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls);
Increased blood sugar levels;
Blurred vision;
Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or stiff muscles without pain;
Abnormal dreams or nightmares;
Increased appetite;
Irritability;
Disorders of speech and language;
Thoughts of suicide and worsening of depression.

Uncommon (affects 1 to 10 patients in 1000):
Seizures or fits;
Allergic reactions that may include raised lumps (hives), swelling of the skin and swelling around the mouth;
Unpleasant sensations in the legs (also called restless legs syndrome);
Difficulty swallowing;
Mostly uncontrollable movements of the face and tongue;
Sexual offenses.

Rare (affects 1 to 10 patients in 10,000):
High temperature (fever), prolonged sore throat or ulcers in the mouth, rapid breathing, sweating, muscle cramps, feeling dizzy or fainting;
Yellowing of the skin and eyes (jaundice);
Prolonged and painful erection (priapism);
Swelling of breasts and unexpected separation of milk (galactorrhoea);
Menstrual irregularities;
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which can move in the vessels to the lungs causing chest pain and difficulty breathing. If you notice these symptoms, seek immediate medical attention.

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;
A 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 that controls the amount of urine;
Disintegration of muscle fibers and pain in muscles (rhabdomyolysis).

This class of drugs to which it belongs and Tevakvel XR 200 mg prolonged-release tablets can cause heart rhythm problems, which 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 total cholesterol) or blood glucose, reduced numbers of certain blood cells, a reduced amount of sodium in the blood, decreased hemoglobin, and increased level of the hormone prolactin in the blood.

Increase prolactin could in rare cases lead to the following:
Swelling of breasts and unexpected separation of milk in men and women;
Women do not have a monthly cycle or receive it at irregular intervals.
Your doctor may order periodic blood tests.

Children and adolescents
They can be observed the same side effects that have been observed in adults.
The following adverse reactions have been seen only in children and adolescents:

Very common (affecting more than 1 in 10 patients):
Increased blood pressure.
The following adverse reactions have been observed in children and adolescents with greater frequency:
Very common (affecting more than 1 in 10 patients):
Increased levels of the hormone prolactin in the blood. Increased levels of prolactin could in rare cases lead to:
- Breast enlargement in boys and girls and the separation of milk;
- Girls have no or irregular menstruation
Increased appetite;
Abnormal muscle movements. They include difficulty in initiating movements, tremor, anxiety or muscle cramps without pain.

5. HOW TO STORE TEVAQUEL HR 200 mg prolonged-release tablets
Keep out of reach of children.
Do not use Tevaquel XR 200 mg prolonged release 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 requires no special storage conditions.
Medicines should not be disposed of 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. ADDITIONAL INFORMATION
What Tevaquel XR 200 mg prolonged release:
The active ingredient is quetiapine. Each tablet contains 200 mg quetiapine (as fumarate kvetiapinov).
Other ingredients are:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium nitrate, magnesium stearate.
The coating: titanium dioxide (E171), hypromellose, macrogol / PEG 400, polysorbate 80, iron oxide yellow (E172), red iron oxide (E172), black iron oxide (E172).