Quetiapine Accord 50 mg. 60 tablets

What are the Accord Quetiapine prolonged-release tablets and what it is used
Accord quetiapine prolonged release tablets contain a substance called quetiapine. It belongs to a group of medicines called "antipsychotic".
Quetiapine Accord prolonged release tablets can be used for the treatment of several diseases, such as:
Schizophrenia: when you hear or feel things that are not, believe things that are not true or are unusually suspicious, anxious, confused, you feel guilty, tense or depressed;
Mania: when you feel excited with high spirits, excited, enthusiastic or hyperactive, or have poor judgment including being aggressive and destructive;
Bipolar depression and major depressive episodes in major depressive disorder - may feel sad or feel depressed, guilty, to feel that you are lacking energy, no appetite and / or can not sleep.
When Quetiapine Accord prolonged release tablets is taken for treatment of major depressive episodes in the context of major depressive disorder, it must be adopted in addition to the other drug used for the treatment of this disease.

2. What you need to know before taking Quetiapine Accord prolonged-release tablets
Do not take Quetiapine Accord prolonged-release tablets:
If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine (listed in section 6);
If you are taking any of the following medications:
some medicines to treat AIDS;
azoles (to treat fungal infections);
erythromycin or clarithromycin (to treat infection);
nefazodone (for depression).
If any of these apply to you, do not take Quetiapine Accord prolonged-release tablets. If you are unsure before taking Quetiapine Accord prolonged-release tablets talk to your doctor or pharmacist.

Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Quetiapine Accord prolonged-release tablets:
You or someone in your family has or had heart problems such as arrhythmias, or if you are taking medicines that affect the heart rhythm
You have low blood pressure;
If you've had a stroke, especially if you are elderly;
If you have liver problems;
If you have ever had a seizure (convulsion);
If you know you have a history of low white blood cells (which may or may not have been caused by other medicines);
If you have diabetes or are at risk of becoming ill from diabetes. In this case, while taking quetiapine Accord prolonged-release tablets Your doctor may monitor your blood sugar;
If you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots;
If you are an elderly patient with dementia (impaired brain function). If you're a patient, you should not take Quetiapine Accord prolonged-release tablets, for the class of medicines to which it belongs Quetiapine Accord prolonged-release tablets in elderly patients with dementia may increase the risk of developing stroke, and in some cases - death.
Tell your doctor if after you take Quetiapine Accord, have any of the following:
A combination of high fever, severe muscle stiffness, increased sweating or depressed level of consciousness (disorder called "neuroleptic malignant syndrome"). It may need immediate treatment;
Involuntary rhythmic movements mainly of the face or tongue;
Dizziness and severe drowsiness. In the elderly may increase the risk of traumatic accidents (falls);
Seizures or convulsions;
Prolonged and painful erection (priapism).
These conditions can be caused by taking drugs of this type.

Thoughts of suicide and worsening of your depression
If you feel depressed, sometimes you may think to injure or kill yourself. These thoughts may be intensified at the start of treatment with antidepressants, since these medicines take time to unfold their effect - usually about two weeks but sometimes longer. These thoughts may be increased if you stop taking your medication suddenly. The likelihood of such thoughts may be greater if you are a young person. Information from clinical trials indicates that there is an increased risk of suicidal thoughts and / or suicidal behavior in young adults under 25 years with depression.
If you come upon thoughts of harming or suicide, immediately contact your doctor or go to hospital. You may find it helpful to tell a relative or close friend that you feel depressed and ask them to read this leaflet. It might ask them to tell you if they think your depression is getting worse or if you are worried about changes in your behavior.
In patients receiving Accord Quetiapine prolonged-release tablets was observed increase in body weight. To you and your doctor should regularly check your weight.

Other medicines and Accord Quetiapine prolonged-release tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Do not take Quetiapine Accord prolonged-release tablets if you are taking any of the following medications:
Some medicines to treat AIDS;
Azoles (to treat 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 for epilepsy (such as phenytoin or carbamazepine);
Medicines for high blood pressure;
Barbiturates (for insomnia);
Thioridazine (another antipsychotic medication);
Drugs that affect heart rate, such as drugs that could cause the development of electrolyte disturbances (reduced levels of potassium or magnesium) such as diuretics ( "water pills") or certain antibiotics (drugs to treat infections).
Please, talk to your doctor before you stop taking any of your medicines.

Accord quetiapine prolonged release tablets with food, drinks and alcohol
Some foods can affect the way Accord Quetiapine prolonged-release tablets and therefore you should take your tablets at least 1 hour before meals or at bedtime;
Be careful how much alcohol you drink. The reason is that the combination of the effects of Quetiapine Accord prolonged release tablets and alcohol can make you sleepy;
Do not drink grapefruit juice while taking Quetiapine Accord prolonged-release tablets. It can affect the action of the drug.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to have a baby, ask your doctor or pharmacist before taking this medicine.
During pregnancy should not take Quetiapine Accord prolonged-release tablets unless you have discussed this with your doctor. If you are breastfeeding, you should not take Quetiapine Accord prolonged-release tablets.
The following symptoms may occur in newborn babies whose mothers used Quetiapine prolonged-release tablets in the last three months of pregnancy, shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines
Your tablets may make you sleepy. Do not drive or use any tools or machinery until you know for sure how the tablets affect you.

Accord quetiapine prolonged release tablets contain lactose
Accord quetiapine prolonged release tablets contain lactose which is a type of sugar. If your doctor has told you have an intolerance to some sugars, talk to him before you start taking this medicine.

Effect of the drug on urine screenings
If you do screening urine Quetiapine can cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TTSA), using certain methods of investigation, even if not taking methadone or TTSA. If this happens, need to be made more specific test.

3. How to take Quetiapine Accord prolonged-release tablets
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 (your daily dose) will depend on the disease and needs, but usually the dose is between 150 mg and 800 mg:
You will take your tablets once a day.
Swallow the tablets whole with a glass of water.
Do not crush, chew or crush the tablets.
Take the tablets on an empty stomach (at least one hour before meals or at bedtime - Your doctor will tell you when).
Do not drink grapefruit juice while taking Quetiapine Accord prolonged-release tablets. It can affect the action of the drug.
Even if you feel better, do not stop taking your tablets unless your doctor tells you to stop.
Liver problems
If you have liver problems, your doctor may change your dose.

Elderly
If you are elderly, your doctor may change your dose.

Use in children and adolescents
Accord quetiapine prolonged release tablets should not be used by children and adolescents aged under 18 years.

If you take more than the amount Accord Quetiapine prolonged-release tablets
If you take more than your prescribed by your doctor Accord Quetiapine prolonged-release tablets, you may experience drowsiness, dizziness, palpitations. Immediately contact your doctor or go to the nearest hospital. Wear Accord Quetiapine prolonged-release tablets with you.

If you forget to take Quetiapine Accord prolonged-release tablets
If you miss a dose, take it as soon as you remember. If it is almost time to take your next dose, wait until then. Do not take a double dose to make up for a missed tablet.

If you stop taking Quetiapine Accord prolonged-release tablets
If you suddenly stop taking Quetiapine Accord prolonged-release tablets may not be able to sleep (insomnia have) to have nausea, headache, diarrhea, vomit, have dizziness or have irritable. Your doctor may suggest that you reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 effects not listed in this leaflet, please tell your doctor or pharmacist.

If any of the described below occurs, stop taking Quetiapine Accord prolonged release tablets and contact your doctor or head to the nearest hospital as you may need urgent medical attention.
Uncommon (may affect up to 1 in 100 people):
Seizures or convulsions;
Allergic reactions that may include raised "lumps" (hives), swelling of the skin and swelling around the mouth;
Uncontrollable movements, mainly of the face or tongue (tardive dyskinesia).
Rare (may affect up to 1 in 1000 people):
A combination of high temperature (fever), prolonged sweating, muscle stiffness, feeling strong drowsiness or fatigue (a disorder called "neuroleptic malignant syndrome");
Yellowing of the skin and eyes (jaundice);
Inflammation of the liver (hepatitis);
Prolonged and painful erection (priapism);
Clots in the veins, especially those in the legs (symptoms include swelling, pain and redness in the leg) that can be detached and blood vessels to reach the lungs, causing chest pain and shortness of breath. If you notice any of these symptoms, seek medical advice immediately.
Very rare (may affect up to 1 in 10,000 people):
A severe allergic reaction (called "anaphylactic"), which may cause difficulty in breathing or shock;
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema);
Severe rash associated with blistering of the skin, mouth, eyes and genitals (syndrome of Stevens-Johnson).
Other possible side effects:
Very common: may affect more than 1 in 10 people:
Dizziness (may lead to falls), headache, dry mouth;
Drowsiness (over time if you continue taking Accord Quetiapine prolonged-release tablets, this can be resolved) (may lead to falls);
Withdrawal symptoms (symptoms that develop in discontinuation of quetiapine), including inability to sleep (insomnia), feeling sick (nausea), headache, diarrhea, sick (vomiting), dizziness and irritability. It is recommended phasing out period of at least one to two weeks;
Weight gain;
Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling of tightness or muscle stiffness without pain.
Common: may affect up to 1 in 10 people:
Rapid heartbeat;
Feeling that your heart is pounding chest beating too fast or miss hits;
Nasal congestion;
Constipation, upset stomach (indigestion);
Fatigue, fainting (may lead to falls);
Swelling of hands or feet;
Drop in blood pressure on standing. As a result, you may feel dizzy or faint (may lead to falls);
High blood sugar;
Blurred vision;
Abnormal dreams and nightmares;
Increased hunger;
irritability;
Speech disorders and speech;
Thoughts of suicide and worsening of your depression;
shortness of breath;
Vomiting (mainly in the elderly);
Fever.
Uncommon: may affect up to 1 in 100 people:
Discomfort in the legs (called "restless leg syndrome");
Difficulty swallowing;
Sexual dysfunction;
diabetes;
Changes in the electrical activity of the heart recorded by ECG (QT prolongation);
Slower than normal heart rate, which can occur during initiation of treatment and which may be associated with low blood pressure, and fainting.
Rare: may affect up to 1 in 1000 people:
Swelling of breasts and unexpected production of breast milk (galactorrhoea);
Menstrual irregularities;
Walking, talking, eating or other activities while asleep;
Decreased body temperature (hypothermia);
Inflammation of the pancreas (pancreatitis);
Condition (termed "metabolic syndrome") to have a combination of 3 or more of the following: abdominal obesity, reduction of the "good cholesterol" (HDL-C), an increase in the type of lipids called triglycerides in your blood, high blood pressure and high blood sugar.
Very rare: may affect up to 1 in 10,000 people:
Worsening of existing diabetes;
Severe rash, blisters on the skin, red patches on the skin;
Improper secretion of the hormone that controls the amount of urine;
Tearing of muscle fibers and pain in muscles (rhabdomyolysis).
Not known: frequency can not be estimated from available data:
Skin rash with irregular red patches (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 Quetiapine belongs Accord prolonged-release tablets can cause abnormal heart rhythms that are serious and in severe cases - fatal.
Some side effects are only found in a blood test. These include changes in the levels of certain lipids (triglycerides and total cholesterol) or blood glucose change in the levels of thyroid hormones in your blood, elevated liver enzymes, reducing the number of certain types of blood cells, decrease the amount of red blood cells, elevated blood creatine phosphokinase (a substance in the muscles), lowering the level of sodium in the blood and increasing the level of the hormone prolactin in the blood. In rare cases, raising the level of the hormone prolactin can cause:
Swelling of the breasts of men and women and unexpected separation of milk;
For women - lack of menstruation or irregular menstruation.
Periodically, your doctor may ask you to have blood tests.
Additional side effects in children and adolescents:
In children and adolescents may experience the same side effects that develop in adults.
The following adverse reactions have only been observed in children and adolescents:
Very common: may affect more than 1 in 10 people:
Increase in blood pressure.
The following adverse reactions were observed more frequently in children and adolescents:
Very common: may affect more than 1 in 10 people:
Increasing the level of the hormone prolactin in the blood. In rare cases it can cause:
Swelling of breasts in boys and girls and unexpected separation of milk;