Quetiapine ACCORD 25 mg. 60 tablets

What is Quetiapine Accord and what it is used
Quetiapine Accord 25 mg tablets contain a substance called quetiapine. It belongs to a group of medicines called antipsychotics. These drugs help in conditions that cause symptoms such as:
You can see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed;
You may feel very excited, elated, excited, enthusiastic or hyperactive or have poor judgment, including're aggressive or destructive, or have aggressive behavior;
Effects on your mood, so you feel sad. You may find that you feel depressed, guilty, you do not have enough energy, lose your appetite and / or can not sleep.
Your doctor may continue to prescribe Quetiapine Accord when you are feeling better to prevent recurrence of symptoms.
It may be in your favor to share with a friend or relative that you are suffering from these symptoms and ask them to read this leaflet. You might ask them to share if they think your symptoms worsen or if they are worried about other changes in your behavior.

2. Before you take Quetiapine Accord
Do not take Quetiapine Accord if:
you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine Accord (see Section 6: Further information);
taking the following medicines:
protease inhibitors, such as nelfinavir (for HIV infection);
azole medicines (for fungal infections);
medicines for infection (such as erythromycin or clarithromycin);
nefazodone (for depression).
Do not take Quetiapine Accord if any of these apply to you. If you are unsure, talk to your doctor or pharmacist before taking Quetiapine Accord.

Take special care with Quetiapine Accord:
Quetiapine should not be taken by elderly people with dementia (loss of brain function). The reason is that a group of medicines to which it belongs quetiapine might increase the risk of stroke or even in some cases the risk of death in elderly people with dementia.

Before you take your medicine, tell your doctor if:
You or someone in your family has or had heart problems as much increased heart rate or QT-interval prolongation on the ECG (heart tracing), or if you are taking any medicines that may have an impact on your heart rate;
Have low blood pressure;
Have suffered a stroke, especially if you are elderly;
Have liver problems;
You had a fit (seizure);
Have diabetes or at risk of becoming ill from diabetes. If so, your doctor may check your blood sugar while you are taking Quetiapine Accord;
You know that you have had low white blood cells in the past (which may be caused by other medicines);
You or someone in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Tell your doctor if you have:
A combination of temperature (fever), stiff muscles, confusion, sweating, or loss of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate treatment;
Uncontrollable movements, mainly of your face or tongue;
Severe sleepiness. This can increase the risk of accidental injury (fall) in elderly patients;
Seizures (convulsions);
Prolonged and painful erection (priapism).
These conditions can be caused by this type of medicine.

Suicidal thoughts or worsening of your depression
If you are depressed you can sometimes have thoughts of harming or killing themselves. They may increase when you start treatment as all these drugs take time AFFF, usually about two weeks but sometimes longer. There may be more likely to think like this if you're young.
Data from clinical trials indicate an increased risk of suicidal thoughts and / or suicidal behavior in young adults aged less than 25 years with depression.
If you have thoughts of harming or killing yourself, contact your doctor or go to hospital immediately. It may be to your advantage to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to say whether they think your depression is getting worse or if they are worried about other changes in your behavior.
Weight gain has been observed in patients taking Quetiapine Accord. You and your doctor should check your weight regularly.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines because it may affect the way drugs act. This includes medicines you buy without a prescription and herbal medicines.

Do not take Quetiapine Accord if you are taking the following medicines:
Some medicines for HIV;
Azole medicines (for fungal infections);
Erythromycin or clarithromycin (for infections);
Nefazodone (for depression).
Tell your doctor if you are taking the following medicines:
Medicines for epilepsy (such as phenytoin or carbamazepine);
Medicines for high blood pressure;
Rifampicin (for tuberculosis);
Barbiturates (for sleeping);
Thioridazine (another antipsychotic medicine);
Drugs that affect the heart, for example. drugs, which lead to electrolyte imbalance in the blood such as diuretics (water tablets) or certain antibiotics.
Before you stop taking any of your medications, please talk to your doctor.
If you are doing a urine test, your results may be false positive for methadone or drugs to treat depression called tricyclic antidepressants, because taking Quetiapine Accord. It is necessary to make a more specific tests.

Taking Quetiapine Accord with food and drink
Quetiapine Accord can be taken with or without food.
Be careful how much alcohol you drink, as the combined effect of Quetiapine Accord and alcohol can make you sleepy.
Do not drink grapefruit juice while taking Quetiapine Accord. This can affect the manner in which the drug acts.
Pregnancy and lactation
If you are pregnant, trying to become pregnant or breast-feeding, talk to your doctor before taking Quetiapine Accord.
The following symptoms may occur in newborn babies of mothers who used quetiapine in the last quarter (last three months of their pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines
Quetiapine may make you drowsy. Do not drive or operate machines until you know how you affect this medicine.

Hospital - If you go into hospital, tell the medical staff that you are taking Quetiapine Accord.

Important information about some of the ingredients of Quetiapine Accord
Quetiapine Accord contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Quetiapine Accord
Always take Quetiapine Accord exactly as your doctor has instructed. If you're not sure, ask your doctor or pharmacist. Your doctor will determine your starting dose and may gradually increase it. Thereafter, the dosage will typically be between 150 mg and 800 mg daily. This will depend on your type of illness and needs.

Your doctor may start your treatment with a lower dose and increase it slowly if:
you are elderly;
have liver problems.
You will take your tablets once daily at bedtime or twice daily, depending on your illness.
Swallow your tablets whole with water.
You can take your tablets with or without food.
Do not drink grapefruit juice while taking Quetiapine Accord. This can affect the manner in which the drug acts.
Do not stop taking your tablets, even if you feel better, unless your doctor tells you.

Children and adolescents under 18 years
Quetiapine Accord should not be used by children and adolescents under 18 years.

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

If you take more than the amount of Quetiapine Accord
If you take more than prescribed by your doctor Quetiapine film-coated tablets Accord may experience sleepiness, dizziness and abnormal heart rhythms. Immediately contact your doctor or nearest hospital. Wear packaging and / or tablets Quetiapine Accord with you.

If you stop taking Quetiapine Accord
If you suddenly stop taking quetiapine tablets may be difficult to sleep (insomnia), you sick or have a headache, diarrhea, vomit, you dizzy or irritable. Your doctor may suggest you to reduce the dose gradually before stopping treatment.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Quetiapine Accord can cause side effects, although not everybody gets them.

If you develop any of the following, stop taking Quetiapine Accord and contact a doctor or go to the nearest hospital as you may need urgent medical attention:
Suicidal thoughts or worsening of your depression.
Uncommon (affects less than 1 in 100 patients):
Seizures or convulsions;
Allergic reactions, which may include the appearance of bumps (hives), swelling of the skin and swelling around the mouth;
Uncontrolled movements, especially of the face or tongue (tardive dyskinesia).
Rare (affects less than 1 in 1000 patients):
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 and cause chest pain and difficulty breathing;
A combination of high temperature (fever), sweating, stiff muscles, feeling strong drowsiness or fainting, severe increase in blood pressure or heart palpitations (a disorder called "neuroleptic malignant syndrome");
Jaundice (yellow skin and eyes);
Hepatitis (inflammation of liver);
Priapism (prolonged and painful erections).
Very rare (affects less than 1 in 10,000 patients):
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema);
A severe allergic reaction (called anaphylaxis), which may include difficulty breathing, dizziness and collapse;
Severe rash that can develop very quickly. Symptoms may include redness, blistering or peeling of the skin with possible blisters in the mouth or nose.
Other possible side effects:
Very common (affecting more than 1 in 10 patients):
Dizziness (may lead to falls), headache, dry mouth, anemia;
Feeling sleepy (may disappear over time if you keep taking Quetiapine Accord) (may lead to falls);
Symptoms of a sudden interruption of therapy (symptoms that may occur when you stop taking quetiapine) include inability to sleep (insomnia), feeling sick (nausea), headache, diarrhea, sick (vomiting), dizziness and irritability. They usually disappear a week after your last dose;
Weight gain.
Common (affects less than 1 in 10 patients):
Increased heart rate;
Feeling that your heart is pounding chest beating too fast or jump hit;
Constipation, upset stomach (indigestion);
A feeling of weakness;
Swelling of the hands or feet;
Low blood pressure when standing up. It may cause dizziness or fainting (may lead to falls);
High blood sugar;
Blurred vision;
Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle cramps without pain;
Abnormal dreams and nightmares;
Feeling more hungry;
irritability;
Speech disorder and speech;
Shortness of breath;
Vomiting (mainly in the elderly);
Fever;
syncope;
Rhinitis.
Uncommon (affects 1 in 100 patients):
Fainting (may lead to falls);
Uncomfortable feeling in the legs and / or restless legs (also called restless legs syndrome);
Difficulty in swallowing;
Sexual dysfunction;
Stuffy nose;
Development of diabetes;
Changes in the electrical activity of the heart observed by ECG (QT prolongation);
Slower than normal heart rate, which may occur at the beginning of the treatment and which can be associated with low blood pressure, and fainting.
Rare (affects less than 1 in 1000 patients):
Menstrual irregularities;
Walking, talking, eating or other activities while asleep;
Decreased body temperature (hypothermia);
Swelling of breasts and unexpectedly separation of milk (galactorrhoea);
Inflammation of the pancreas, which causes severe pain in the abdomen and back.
Very rare (affects less than 1 in 10,000 patients):
High blood sugar or worsening of existing diabetes;
Inadequate secretion of a hormone which controls the volume of urine;
Damage to the muscle fibers and pain in muscles (rhabdomyolysis).
Not known (can not be estimated from available data):
Skin rash in the form of red spots with irregular shape (erythema multiforme).
The class of medicines to which Quetiapine belongs Accord can cause heart rhythm problems, which can be serious and in severe cases can be fatal.
Some side effects can be established only when the blood sample was taken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, a decrease in the number of certain types of blood cells (including red blood cells), a decrease in the quantity of sodium in the blood, changes in the levels of thyroid hormones in the blood , elevated liver enzymes, increased blood creatine phosphokinase (a substance in muscles) and increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin in rare cases can lead to the following:
Swelling of breasts and unexpected production of breast milk in men and women;
Lack of menstruation or irregular periods in women.
Therefore, your doctor may want to do blood tests at regular intervals.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Children and adolescents:
The same side effects that may occur in adults may be present in children and adolescents.
The following adverse reactions have been observed only in children and adolescents:
Very common (affecting more than 1 in 10 patients):
Increase in blood pressure.
The following adverse reactions were observed more frequently in children and adolescents:
Very common (affecting more than 1 in 10 patients):
An increase in the amount of the hormone prolactin in the blood. The increased amount of the hormone prolactin in rare cases can lead to the following:
Swelling of breasts and unexpected lactation in boys and girls;
Absent or irregular menstruation in girls;
Increased appetite;
Abnormal muscle movements. These may include difficulty the movements of muscles, tremors, restlessness or stiff muscles without pain.

5. How to store Quetiapine Accord
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Do not use Quetiapine Accord after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
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. Further information
What contain Quetiapine Accord 25 mg tablets:
The active substance is quetiapine hemifumarate.
Each tablet contains 25 mg quetiapine (as quetiapine hemifumarate).
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, magnesium stearate (E470b), sodium starch glycolate (type A), calcium hydrogen phosphate, dihydrate;
The film coating contains: Opadry pink (03V84929) 6cP Hypromellose Titanium dioxide Macrogol 400, Yellow iron oxide, iron oxide red.