SEROQUEL XR – QUETIAPINE

Description

What the medication is used for:
SEROQUEL XR (quetiapine fumarate extended-release tablets) (pronounced SER-O-KWELL XR) is used to: • treat the symptoms of schizophrenia, such as hallucinations (hearing or seeing things which are not there), fixed false beliefs, unusual suspiciousness or emotional withdrawal. Patients may also feel depressed, anxious or tense. • treat the symptoms of mania associated with bipolar disorder, such as racing thoughts, irritability, aggressiveness, agitation, impulsive behaviour or excessively elevated mood. • treat the symptoms of depression associated with bipolar disorder, such as sadness, feeling guilty, lack of energy, loss of appetite and/or sleep disturbance. • treat symptoms of patients with depression who have failed treatment with currently available antidepressant medications due to lack of appropriate response and/or due to side effect issues. SEROQUEL XR is a new treatment for depression and belongs to a class of drug known as ‘atypical antipyschotic’. It is important to discuss with your doctor about your depressive symptoms and possible side effects. You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and ask them to read this leaflet. You might ask them to tell you if they think your symptoms are getting worse, or if they are worried about any other changes in your behaviour. SEROQUEL XR is not a cure for your condition but it can help manage your symptoms and help you feel better.

What it does:
SEROQUEL XR is a medication that belongs to a class of medicines called “atypical antipsychotics”. Illnesses that affect the brain, such as schizophrenia, bipolar disorder and major depressive disorder, may be due to certain chemicals in the brain being out of balance. These imbalances may cause some of the symptoms you may be experiencing. Doctors and scientists are not sure what causes these imbalances to occur. SEROQUEL XR is thought to work by regulating the imbalance of chemicals in the brain.

When it should not be used:
Do not take SEROQUEL XR if you have had an allergic reaction to SEROQUEL XR or any of the ingredients listed in the “nonmedicinal ingredients” section of this leaflet. What the medicinal ingredient is: SEROQUEL XR tablets contain the active ingredient quetiapine fumarate. What the nonmedicinal ingredients are: The inactive ingredients in SEROQUEL XR tablets are: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, red iron oxide (50 mg tablets only), sodium citrate, titanium dioxide, and yellow iron oxide (50, 200 and 300 mg tablets only).

WARNINGS AND PRECAUTIONS
Studies with various medications of the group to which SEROQUEL XR belongs, including SEROQUEL, when used in elderly patients with dementia have been associated with an increased rate of death. SEROQUEL XR is not indicated in elderly patients with dementia. Before starting SEROQUEL XR, be sure to tell your doctor: • if you have had an allergic reaction to any medicine which you have taken previously to treat your condition, or if you think you might be sensitive or allergic to any of the ingredients in SEROQUEL XR. • if you are pregnant or plan to become pregnant while taking SEROQUEL XR. • if you are breast-feeding or are planning on breastfeeding while taking SEROQUEL XR. You should not breast-feed while taking SEROQUEL XR. • if you drink alcohol or use street drugs. • if you have any health problems. • if you have low or high blood pressure or have had a stroke. • if you or a family member have a history of any problems with the way your heart beats or have a history of heart disease or heart problems or if you are taking any medicines that may have an impact on the way your heart beats. • if you have a history of seizures (fit). • In clinical studies with SEROQUEL XR and other drugs of this type, an increased risk of death has been reported in elderly patients with dementia and behavioural disturbances. SEROQUEL XR is not approved for this use. • if you have diabetes, a family history of diabetes or high blood sugar during pregnancy. • if you have a history of liver or kidney problems. • if you know that you had a low white blood cell count in the past which may or may not have been caused by other medicines. • if you exercise vigorously or work in hot or sunny places. If you already have diabetes, you should be monitored for worsening of your diabetes. Do not drive or operate machinery until you know your response to this medication, as SEROQUEL XR can cause drowsiness. Thoughts of suicide and worsening of your depression or other mental illnesses: If you are depressed and/or have other mental illnesses you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have other mental illnesses, and ask them to read this leaflet. You might ask them to tell you if they think your depression or mental illness is getting worse, or if they are worried about changes in your behaviour.

INTERACTIONS WITH THIS MEDICATION
Because certain medications can seriously affect the way other medications work, it is important to tell all doctors, dentists, and pharmacists who are treating you that you are taking SEROQUEL XR. As well, be sure to tell them about any other medications – prescription, non-prescription or alternative – that you are taking or plan to take. You should not drink alcohol while taking SEROQUEL XR, as the combination could increase the effects of the alcohol. You should tell your doctor if you are taking or about to stop taking medications for anxiety, depression, epilepsy (such as phenytoin or carbamazepine), high blood pressure, or to help you sleep. Dopamine agonists, e.g. levodopa (antiparkinsonian agent), may decrease the effect of SEROQUEL XR. Medications known to interact with SEROQUEL XR include carbamazepine (anticonvulsant), phenytoin (anticonvulsant), ketoconazole (antifungal), and protease inhibitors (for treating Human Immunodeficiency Virus). You should tell your doctor if you are taking erythromycin (antibiotic), clarithromycin (antibiotic), nefazodone, thioridazine (antipsychotic), diltiazem or verapamil (blood pressure medications). You should also tell your doctor if you are taking medicines that have an impact on the way your heart beats, for example drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).

Effect on Urine Drug Screens:
SEROQUEL XR may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking these drugs. Confirmation of the results by more specific tests is recommended.

PROPER USE OF THIS MEDICATION
SEROQUEL XR is not recommended for use in patients under 18 years old. USUAL DOSE: Adult In order for SEROQUEL XR to help you feel better, it is very important to take it every day exactly as your doctor tells you to. Take the exact number of tablets your doctor has prescribed at the right time every day. Recommended Dose: Schizophrenia and Bipolar Mania: The usual titration schedule is day 1: 300 mg, day 2: 600 mg and up to 800 mg from day 3 onwards taken once daily. The maximum dose is 800 mg per day. Bipolar Depression: The usual titration schedule is day 1: 50 mg, day 2: 100 mg, day 3: 200 mg and day 4 and onwards: 300 mg taken once daily. Your doctor may further increase the dose depending on your response and tolerability. The maximum dose is 600 mg per day. Major Depressive Disorder: The usual titration schedule is 50 mg on days 1 and 2 and 150 mg on day 3. Your doctor may adjust the dose upwards or downwards within the recommended dose range of 50- 300 mg per day during the course of your treatment depending on your response and tolerability. It takes time to feel better and you should expect some symptoms to improve slowly over the first few weeks of treatment. Do not stop taking SEROQUEL XR, or change the times of day you take SEROQUEL XR without talking to your doctor first. If you stop taking SEROQUEL XR abruptly you may experience withdrawal symptoms such as insomnia (inability to sleep), nausea and vomiting. To make sure you are getting the most benefit from SEROQUEL XR, you must: • Continue taking SEROQUEL XR everyday and • Keep your doctor well informed of how you are feeling, both good and bad. By doing these two things, you and your doctor together will be able to make sure that you are getting the best dose of SEROQUEL XR for you. You may take SEROQUEL XR with or without food. Tablets should be swallowed whole. Do not split, crush or chew. Do not give SEROQUEL XR to anyone else. Your doctor has prescribed SEROQUEL XR for you only.

OVERDOSE:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. In case of SEROQUEL XR overdose or if you think you or anyone else are experiencing severe episodes of any of the side effects of SEROQUEL XR (especially drowsiness, including also rapid heart beat, lightheadedness and/or dizziness, especially when standing up quickly or getting out of bed), call your doctor or poison control centre or go to the nearest hospital emergency room right away. Make sure to bring your medication bottle with you.

MISSED DOSE:
SEROQUEL XR should be taken at the same time each day. If you miss a dose from the previous day, you should take your next regular dose of SEROQUEL XR the next day at the normal time. Here are some tips that can help you remember to take each dose of SEROQUEL XR: • Take your SEROQUEL XR at the same time every day; • Take SEROQUEL XR during daily events which will help you remember to take your medicine as well, e.g., mealtime or bedtime; • Use a pill container that will separate your SEROQUEL XR doses by the day of the week; • Use a calendar to note the day and time after you have taken each dose to help you keep track of when you need to take your SEROQUEL XR; • Keep a written reminder to take your SEROQUEL XR that can be easily seen, e.g., on a mirror or on the refrigerator; • Have a family member or friend remind you to take your medication.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, SEROQUEL XR may produce side effects in some people. Increases in blood glucose (sugar) and hyperglycaemia (high blood sugar) have been observed with SEROQUEL XR. Also, occasional cases of diabetes have been reported. Light-headedness and dizziness (symptoms of postural hypotension) and drowsiness are among the most common side effects you may experience while taking SEROQUEL XR, particularly during the first week of treatment or after an increase in dose. The dizziness and drowsiness are usually mild and should go away with time. To help prevent these feelings, be careful to move slowly when you are getting up from a sitting or lying position. Dizziness and drowsiness may lead to falls. Low blood pressure in standing position is common, which may result in dizziness or feeling faint (may lead to falls). As feelings of drowsiness are also common at the start of treatment, or when your dose is increased, if you have to drive, operate machinery or do anything else that requires you to be fully alert, use extra caution until you are sure SEROQUEL XR does not cause you to be drowsy. Dry mouth and weight gain have also been reported very commonly in patients taking SEROQUEL XR. Discontinuation symptoms which occur upon stopping SEROQUEL XR have been reported very commonly and include insomnia (inability to sleep), nausea, headache, diarrhea, vomiting, dizziness and irritability. Gradual withdrawal over a period of at least one to 2 weeks is advisable. Other common side effects may include: headache, rapid heart beat, constipation, indigestion, feeling weak, swelling of arms and legs, fainting, stuffy nose, upset stomach or abdominal pain, blurred vision, abnormal dreams and nightmares, irritability, feeling more hungry, disturbance in speech and language, and changes in laboratory tests for liver and thyroid functions. There have been uncommon cases of difficulty swallowing. There have also been reports, in a small number of patients, of changes to the lens of the eye. Although it is not known whether or not these changes are caused by SEROQUEL XR, your doctor may advise you that a specific type of eye exam is recommended in order to maximize safe use of this drug. In very rare cases, this type of medicine can interfere with your body’s ability to control body temperature. Therefore, take care to avoid becoming overheated or dehydrated (for example with vigorous exercise, or exposure to extreme heat) while taking SEROQUEL XR.

HOW TO STORE IT
Store SEROQUEL XR at room temperature (between 15 – 30°C) and well out of the reach of children. The expiry date of this medicine is printed on the package label. Do not use the medicine after this date. If your doctor tells you to stop taking SEROQUEL XR or you find that it has passed its expiry date, please return any left over medicine to your pharmacist.