Quetiapin 200 mg. 60 tablets
Quetiapine Prolonged-release tablets contain a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine Prolonged-release 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 Quetiapine Prolonged-release tablets are taken for the treatment of 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 even when you feel better.
2. What you need to know before taking Quetiapine Prolonged-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 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 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 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
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 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:
Fever, flu-like symptoms, sore throat or any other infection as this could
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 prolonged-release Quetiapine Tablets. You and your doctor should check your weight regularly.
Children and adolescents
Quetiapine is not intended for use in children and adolescents under 18 years of age.
Other medicines and Quetiapine 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 prolonged-release tablets with food, drink and alcohol
Some foods may affect the effects of Quetiapine 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 prolonged-release tablets and alcohol can make you sleepy.
Do not drink grapefruit juice while taking Quetiapine 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 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 Prolonged-release tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before you start taking this medicine.
Effect of the drug on urine screening
If you are being screened for urine for medicines, taking quetiapine can produce positive results for methadone or certain depression medicines called tricyclic antidepressants (TCAs), using some test methods, even if you do not take methadone or TCAs. If this happens, a more specific test must be performed.
3. How to take Quetiapine Extended-release tablets
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the starting dose. The maintenance dose (your daily dose) depends on your illness and your needs, but usually the dose is between 150 mg and 800 mg.
You will take your pills once a day.
Do not break, chew, or crush the tablets.
Swallow the tablets whole with a glass of water.
Take your 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 Acord prolonged-release tablets. It may affect the effect of the medicine.
Even if you feel better, do not stop taking your pills unless your doctor tells you to stop.
If you have liver problems, your doctor may change your dose.
If you are old, your doctor may change your dose,
Use in children and adolescents
Quetiapine Prolonged-release tablets should not be used in children and adolescents under 18 years of age.
If you take more Quetiapine prolonged-release tablets
If you take more prolonged-release doses of Quetiapine , prescribed by your doctor, you may feel drowsy, dizzy, and get palpitations. Contact your doctor immediately or go to the nearest hospital. Take Quetiapine Extended-release tablets with you.
If you forget to take Quetiapine prolonged-release tablets
If you forget to take a dose, take it as soon as you remember. If it's almost time to take your next dose, wait until then. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Quetiapine Prolonged-release tablets
If you suddenly stop taking Quetiapine prolonged-release tablets, you may not be able to sleep (have insomnia), have nausea, headache, diarrhea, vomit, be dizzy, or be irritable. Your doctor may suggest that you reduce your 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.
Very common side effects (may affect more than 1 in 10 people):
Dizziness (can lead to falls), headache, dry mouth;
Drowsiness (over time, if you continue taking Quetiapine prolonged-release tablets, this may resolve) (may lead to falls);
Symptoms of withdrawal (symptoms that develop when you stop taking quetiapine), including inability to sleep (insomnia), nausea (nausea), headache, diarrhea, vomiting (vomiting), dizziness and irritability. Gradual stopping is recommended for a period of at least one to two weeks;
Abnormal muscle movements. This includes difficulty starting muscle movements, trembling, feeling tense or muscle stiffness without pain;
Changes in the amount of some fats (triglycerides and total cholesterol).
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 (prolongation
How to store Quetiapine Extended-release 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 Prolonged-Release 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 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 200 mg prolonged-release 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.