Quetiapine

QUETIAPINE TEVA contains the active substance QUETIAPINE. This belongs to a group of medicines called antipsychotics. QUETIAPINE TEVA can be used to treat several illnesses, such as:

• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
• Preventing relapse in stable schizophrenic patients.
• Bipolar disorder:
• Mania associated with bipolar disorder: you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• Depressive episodes associated with bipolar disorder: you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.
• Preventing recurrence in the maintenance treatment of bipolar disorder as monotherapy or in combination with other medicine.
• Major depressive episodes in major depressive disorder.
• Preventing relapse in stable major depressive disorder patients who have been maintained on QUETIAPINE TEVA.

Do not take QUETIAPINE TEVA:

• if you are hypersensitive (allergic) to QUETIAPINE fumarate or any of the other ingredients of QUETIAPINE TEVA
• if you are taking any of the following medicines:
• some medicines for HIV
• azole medicines (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression)
• if you are pregnant or breastfeeding your baby
• if you are a child (10 to 12 years) or adolescent (13 to 17 years) as safety and efficacy have not been established
• if you suffer from advanced liver or renal dysfunction as safety has not been demonstrated.

Warnings and precautions:

Take special care with QUETIAPINE TEVA. Talk to your doctor or pharmacist before taking QUETIAPINE TEVA if:

• you have problems with your liver
• you, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are taking any medicines that may have an impact on the way your heart beats
• you have low blood pressure
• you have or have had a condition where you stop breathing for short periods during your normal nightly sleep (called ‘sleep apnoea’) and are taking medicines that slow down the normal activity of the brain (‘depressants’)
• you have ever had a fit (seizure)
• you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)
• you have or have had a condition where you can’t completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions are sometimes caused by medicines (called ‘anti-cholinergics’) that affect the way nerve cells function in order to treat certain medical conditions
• you have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking QUETIAPINE TEVA
• you are an elderly person with dementia (loss of brain function). If you are, QUETIAPINE TEVA should not be taken because the group of medicines that QUETIAPINE TEVA belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia
• you have had a stroke, especially if you are elderly
• 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
• you have or have had problems with alcohol or drug abuse
• if you have depression or other conditions that are treated with antidepressants. The use of these medicines together with QUETIAPINE TEVA can lead to serotonin syndrome, a potentially life-threatening condition (see Other medicines and QUETIAPINE TEVA).

Tell your doctor immediately if you experience any of the following after taking QUETIAPINE TEVA:

• uncontrollable movements, mainly of your face or tongue
• dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in elderly patients
• a combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called ‘neuroleptic malignant syndrome’). Immediate medical treatment may be needed
• weight problems, you and your doctor should check your weight regularly
• a long-lasting and painful erection (priapism).

These conditions can be caused by QUETIAPINE TEVA. Tell your doctor as soon as possible if you have:

• a fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, which may require QUETIAPINE TEVA to be stopped and/or treatment to be given
• constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.

Thoughts of suicide and worsening of your depression: If you are depressed, 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. These thoughts may also be increased if you suddenly stop taking your medication. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression. Information from clinical trials of QUETIAPINE treatment in patients with major depressive disorder has shown an increased risk of self-harm and suicidal thoughts in patients aged 25 to 64 years without a history of self-harm if you use QUETIAPINE TEVA with other antidepressants. 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 and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Do not share medicines prescribed for you with any other person. Always take QUETIAPINE TEVA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg. You will take your tablets once a day. Do not split, chew or crush the tablets. Swallow your tablets whole with a drink of water. Do not drink grapefruit juice while you are taking QUETIAPINE TEVA. It can affect the way the medicine works.

Liver problems: If you have liver problems your doctor may change your dose. Elderly people: If you are elderly your doctor may change your dose. Use in children and adolescents: QUETIAPINE TEVA should not be used by children and adolescents aged under 18 years. Your doctor will tell you how long your treatment with QUETIAPINE TEVA will last. Do not stop treatment early because you feel better. If you have the impression that the effect of QUETIAPINE TEVA is too strong or too weak, tell your doctor or pharmacist.

If you take more QUETIAPINE TEVA than you should: In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of QUETIAPINE TEVA: Do not take a double dose to make up for forgotten individual doses. If you stop taking QUETIAPINE TEVA: If you suddenly stop taking QUETIAPINE TEVA, you may be unable to sleep (insomnia), or you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your doctor may suggest you reduce the dose gradually before stopping treatment.

QUETIAPINE TEVA can have side effects. Not all side effects reported for QUETIAPINE TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking QUETIAPINE TEVA, please consult your healthcare provider for advice. If any of the following happens, stop taking QUETIAPINE TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting (dizziness). These are all very serious side effects. If you have them, you may have had a serious reaction to QUETIAPINE TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent side effects:
• thoughts of harming or killing yourself at any time
• rapid heartbeat
• feeling like your heart is pounding, racing or has skipped beats
• Less frequent side effects:
• combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition called agranulocytosis
• 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 causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately
• yellowing of the skin and eyes (jaundice)
• a serious allergic skin reaction, including rash, hives, blisters on the skin/peeling skin called Stevens - Johnson syndrome
• a combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint (a disorder called ‘neuroleptic malignant syndrome’).
• Side effects with unknown frequency:
• disorder of the heart muscle (cardiomyopathy)
• inflammation of the heart muscle (myocarditis)
• stroke
• serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome)
• rapid appearance of areas of red skin studded with small pustules [small blisters filled with white/yellow fluid called Acute Generalised Exanthematous Pustulosis (AGEP)]
• inflammation of blood vessels (vasculitis), often with skin rash with small red or purple bumps. These are all serious side effects. You may need urgent medical attention.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Keep in original packaging till needed for use. Protect from moisture. Do not use after the expiry date stated on the label/carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).