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What Quetiapine Tablets are and what they are used for
Quetiapine e tablets contain a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine tablets can be used to treat several conditions such as:
Schizophrenia: in which you may hear or feel non-existent things, believe in things that are not real, or you may be unusually suspicious, anxious, confused, feeling guilty, tense, or oppressed;
Mania: in which you may feel very excited, excited, excited, enthusiastic or hyperactive, or may have poor judgment, including being aggressive and destructive;
Bipolar depression and major depressive episodes of severe depressive disorder: in which you feel sad. You may find that you feel depressed, guilty, feel that you are lacking energy, losing your appetite, or unable to sleep.
When prolonged-release Quetiapine Accord tablets are used to treat major depressive episodes in the context of a major depressive disorder, it should be taken in addition to another medicine used to treat the condition.
Your doctor may continue to prescribe Quetiapine Chord even when you are feeling better.
2. What you need to know before taking Quetiapine Accord Extended-release tablets
Do not take prolonged-release Quetiapine 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 medicines:
some AIDS medicines;
azole medicines (for the treatment of fungal infections);
erythromycin or clarithromycin (for treating infections);
nefazodone (for the treatment of depression).
If any of these apply to you, do not take Quetiapine Accord Extended-release tablets. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Extended-release tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you start taking Quetiapine Chord Extended-release tablets:
You or someone in your family has or has had heart problems, such as rhythmic disorders or weakening of the heart muscle, inflammatory heart disease, or if you are taking medicines that affect the heart rate.
You have low blood pressure.
If you have had a stroke, especially if you are elderly.
If you have liver problems.
If you have ever had a seizure (seizure).
If you have diabetes or are at risk of getting diabetes. In that case, your doctor may monitor your blood sugar while taking Quetiapine Acord Prolonged-Release Tablets.
If you know you have had low white blood cell counts in the past (which may have been caused by other drugs or may have been due to another).
If you are an elderly patient with dementia (impaired brain function). If so, you should not take Quetiapine Acord prolonged-release tablets because the medicines of the group to which it belongs may increase the risk of stroke and, in some cases, death, in elderly patients with dementia .
If you or anyone else in your family has had blood clots because medicines such as these are associated with blood clotting.
If you have or have had a condition that causes your breathing to stop for a short while during your normal night's sleep (called "sleep apnea") and take medications that slow down your normal brain activity ("depressants").
If you have or have had a condition that you cannot completely empty your bladder (urine retention), you have enlarged prostate, bowel obstruction, or increased intraocular pressure. These conditions are sometimes caused by drugs (called "anticholinergic") that affect the way nerve cells used to treat certain diseases function.
If you have abused alcohol or drugs.
Tell your doctor immediately if you have any of the following after taking Quetiapine Chord:
A combination of high fever, severe muscle stiffness, increased sweating or decreased consciousness (a disorder called "malignant neuroleptic syndrome"). Immediate treatment may be required.
Uncontrollable movements, mainly on the face or tongue.
Howling of the world and intense sleepiness. In elderly patients, this can increase the risk of traumatic accidents (falls).
Prolonged and painful erection (priapism).
These conditions may be caused by medication of this kind.
Tell your doctor as soon as possible if you have:
High fever, flu-like symptoms, sore throat or any other infection as this may be due to very low white blood cells, which may require discontinuation of Quetiapine Chord prolonged-release tablets and / or treatment.
Constipation with prolonged abdominal pain or constipation that does not respond to treatment as this can lead to more severe bowel obstruction.
Thoughts of suicide and aggravation of your depression
If you feel depressed, you may sometimes think of hurting yourself or killing yourself. These thoughts can be heightened when you first start treatment because these medications take time to develop - usually about two weeks, but sometimes more. These thoughts can be heightened if you stop taking your medication suddenly. The likelihood of such thoughts may be greater if you are a young person. Clinical trial information indicates an increased risk of suicidal ideation and / or suicidal behavior in young adults below 25 years of age with depression.
If you have thoughts of harming or killing yourself, contact your doctor immediately or go to a hospital. It may be helpful to tell your relative or close friend that you are feeling depressed and ask him or her to read this leaflet. You can ask him to tell you if he thinks your depression is getting worse or if he is worried about changes in your behavior.
Weight gain has been observed in patients taking Quetiapine Acord prolonged-release tablets. You and your doctor should check your weight regularly.
Children and adolescents
Quetiapine Chord is not intended for use in children and adolescents under 18 years of age.
Other medicines and Quetiapine Accord prolonged-release tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Do not take prolonged-release Quetiapine Tablets if you are taking any of the following medicines:
Some AIDS Medicines.
Azole medicines (for the treatment of fungal infections).
Erythromycin or clarithromycin (for the treatment of infections).
Nefazodone (for the treatment of depression).
Tell your doctor if you are taking any of the following medicines:
Epilepsy medicines (such as phenytoin or carbamazepine).
High blood pressure medications.
Barbiturates (for insomnia).
Thioridazine or lithium (another antipsychotic medicine).
Medicines that affect heart activity, such as medicines that could cause electrolyte imbalances (low levels of potassium or magnesium), such as diuretics (drainage pills) or certain antibiotics (medicines to treat infections).
Medications that cause constipation.
Medicines (called "anticholinergic") that affect the way nerve cells used to treat certain diseases function.
Please talk to your doctor first before stopping taking any of your medicines.
Quetiapine Accord prolonged-release tablets with food, drink and alcohol
Some foods may affect the effects of Quetiapine Acord prolonged-release tablets and therefore you should take your tablets at least 1 hour before meals or at bedtime.
Watch how much alcohol you drink. The reason is that the combination of the effects of Quetiapine Acord prolonged-release tablets and alcohol can make you sleepy.
Do not drink grapefruit juice while you are taking Quetiapine Acord prolonged-release tablets. It may affect the effect of the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not take prolonged-release tablets during pregnancy unless you have discussed this with your doctor. If you are breast-feeding you should not take Quetiapine Acord prolonged-release tablets.
The following symptoms, which may represent withdrawal symptoms, may occur in newborn babies whose mothers have used Quetiapine prolonged-release tablets in the last three months of pregnancy: tremors, muscle stiffness and / or weakness, somnolence, agitation, respiratory problems as well as difficulty in eating. If your baby develops any of these symptoms, you should contact your doctor.
Driving and using machines
The pills can make you sleepy. Do not drive or use any tools or machines until you know for sure how your pills affect you.
Quetiapine Prolonged-release tablets contain lactose
Quetiapine Acord Prolonged-release tablets contain lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, talk to him or her before you start taking this
Common side effects (may affect up to 1 in 10 people):
Accelerated cardiac activity;
The feeling that your heart is pounding in your chest is beating too fast or misses a beat;
Constipation, upset stomach (indigestion);
Swelling of arms or legs;
Drop in blood pressure when standing up. As a result, you may feel dizzy or sick (may lead to falls);
Increase in blood sugar;
Unusual dreams and nightmares;
Increased feeling of hunger;
Speech and Speech Disorders;
Thoughts of suicide and aggravation of your depression;
Shortness of breath;
Vomiting (mainly in elderly patients);
Changes in the amount of thyroid hormones in the blood;
Decrease in the number of some types of blood cells;
Increased values of liver enzymes measured in the blood;
Increased levels of the hormone prolactin in the blood. An increase in the hormone prolactin could in rare cases lead to the following:
breast swelling and sudden separation of breastmilk in men and women;
women may not have menstruation or have irregular periods.
Uncommon side effects (may affect up to 1 in 100 people):
Seizures or seizures;
Allergic reactions, which may include raised lumps, swelling of the skin and swelling around the mouth;
Uncomfortable Feeling in the Feet (also referred to as Restless Feet Syndrome);
Uncontrolled movements, mainly of the face or tongue (tardive dyskinesia);
Change in the electrical activity of the heart recorded by ECG (QT interval prolongation);
Slower than normal heart rate, which may occur at the start of treatment and which may be associated with low blood pressure and seizures;
Difficulty in urinating;
Failure (may result in fall);
Reducing the amount of red blood cells;
Reducing the amount of sodium in the blood;
Exacerbation of existing diabetes.
Rare side effects (may affect up to 1 in 1,000 people):
A combination of fever, sweating, muscle stiffness, feeling drowsy or tired (a disorder called "malignant neuroleptic syndrome");
Yellowing of the skin and eyes (jaundice);
Liver inflammation (hepatitis);
Prolonged and painful erection (priapism);
Breast swelling and unexpected breastfeeding (galactorrhea);
Clots in the veins, especially those in the legs (symptoms include swelling, pain, and redness of the legs), which can tear apart and reach the lungs in the blood vessels, causing chest pain and shortness of breath. If you notice any of these symptoms, seek medical attention immediately;
Walking, talking, eating or other activities during sleep;
Decreased body temperature (hypothermia);
A condition (called "metabolic syndrome") in which you have a combination of 3 or more of the following: obesity in the abdomen, a decrease in "good cholesterol" (HDL-C), an increase in the type of lipids called triglycerides in your blood, high blood pressure and high blood sugar;
A combination of fever, flu-like symptoms, sore throat, or other very low white blood cell infection, a condition called agranulocytosis;
Increased creatine phosphokinase in the blood (an enzyme in the muscle).
Very rare side effects (may affect up to 1 in 10,000 people):
Severe rash, blisters on skin, red skin plaques;
Severe allergic reaction (called "anaphylactic"), which may cause shortness of breath or shock;
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema);
Severe rash with blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
Incorrect secretion of the hormone that controls the amount of urine;
Muscle fiber tearing and muscle pain (rhabdomyolysis).
Unknown frequency (frequency cannot be estimated from available data):
Skin rash with irregular red spots (erythema multiforme);
Serious, sudden allergic reaction with symptoms such as fever, blisters and skin peeling (toxic epidermal necrolysis);
Withdrawal symptoms can occur in babies born to mothers who have taken Quetiapine prolonged-release tablets during pregnancy.
The class of medicines to which Quetiapine Acord prolonged-release tablets belong can cause cardiac arrhythmias that are serious and, in severe cases, fatal.
Some side effects are only detected by a blood test. These include changes in the levels of certain lipids (triglycerides and total cholesterol) or blood sugar, changes in the levels of thyroid hormones in your blood, increased liver enzymes, decrease in the number of certain types of blood cells, decrease in the amount of red blood cells, increased creatine
How to store Quetiapine tablets
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
This medicinal product does not require any special storage conditions.
6. Contents of the pack and other information
What Quetiapine Tablets contains
The active substance is quetiapine.
Each prolonged-release tablet contains 50 mg, 200 mg, 300 mg and 400 mg of quetiapine (such as quetiapine fumarate).
The other ingredients are:
Tablet core: lactose monohydrate, hypromellose, sodium chloride, povidone K30, talc and magnesium stearate. The 50 mg tablet also contains cellulose, microcrystalline silicalized (silica and cellulose, microcrystalline);
Sheath: titanium dioxide (E171), macrogol 400 (E1521). The 50 mg tablet also contains polyvinyl alcohol (E1203), talc (E553b), iron oxide, red (E172). The 50 mg, 200 mg and 300 mg tablets also contain iron oxide, yellow (E172). The 200 mg, 300 mg and 400 mg tablets also contain hypromellose 6 cP (E464),
What Quetiapine Acord Prolonged-release tablets look like and contents of the pack
Quetiapine Acord 50 mg prolonged-release tablets are peach colored, round, biconvex film-coated tablets, engraved with "Q50" on one side and smooth on the other.
The diameter of the 50 mg tablet is approximately 11.2 mm.
Quetiapine Accord 200 mg tablets are yellow, round, biconvex film-coated tablets, engraved with "I2" on one side and smooth on the other.
The diameter of the 200 mg tablet is approximately 9.6 mm.
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