Product Details

Product Information Quetiapine Tablets

What you need to know before you take Quetiapine Tablets

Do not take Quetiapine Tablets : • if you are allergic 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 medicines for HIV – azole medicines (for fungal infections) – erythromycin or clarithromycin (for infections) – nefazodone (for depression). If you are not sure, talk to your doctor or pharmacist before taking Quetiapine tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Quetiapine if: • if 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. • if you have low blood pressure • if you have had a stroke, especially if you are elderly • if you have problems with your liver. • if you have ever had a fit (seizure). • if 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 tablets. • if 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). • if you are an elderly person with dementia (loss of brain function). If you are , Quetiapine tablets should not be taken because the group of medicines that Quetiapine tablets belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia. • if you are an elderly person with Parkinson’s disease/parkinsonism. • if 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. • if 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”). • if 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 “anticholinergics”) that affect the way nerve cells function in order to treat certain medical conditions. • if you have a history of alcohol or drug abuse. Tell your doctor immediately if you experience any of the following after taking Quetiapine tablets: • A combination of fever, severe muscle stiffiness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.. • 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. • Fits (seizures). • A long-lasting and painful erection (priapism). • Have a fast and irregular heartbeat, even when you are at rest, palpitations, breathing problems, chest pain or unexplained tiredness. Your doctor will need to check your heart and if necessary, refer you to a cardiologist immediately. These conditions can be caused by this type of medicine. 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 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. 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. Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs) which can be life threatening or fatal have been reported very rarely with treatment of this medicine. These are commonly manifested by: • Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals • Toxic Epidermal Necrolysis (TEN), a more severe form causing extensive peeling of the skin • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) consists of flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) Stop using Quetiapine tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. Weight gain Weight gain has been seen in patients taking Quetiapine. You and your doctor should check your weight regularly. Children and Adolescents Quetiapine is not for use in children and adolescents below 18 years of age. Other medicines and Quetiapine tablets Tell your doctor if you are taking , have recently taken or might take any other medicines Do not take quetiapine tablets 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). Tell your doctor if you are taking any of the following medicines: • Epilepsy medicines (like phenytoin or carbamazepine). • High blood pressure medicines. • Barbiturates (for difficulty sleeping). • Thioridazine or Lithium (other anti-psychotic medicines). • 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). • Medicines that can cause constipation. • Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions. Before you stop taking any of your medicines, please talk to your doctor first. Quetiapine tablets with food, drink and alcohol • Quetiapine tables can be taken with or without food. • Be careful how much alcohol you drink. This is because the combined effect of quetiapine tables and alcohol can make you sleepy. • Do not drink grapefruit juice while you are taking quetiapine tablets. It can affect the way the medicine works. Pregnancy and breast-feeding: If you are pregnant, or breast-feeding, think you may be pregnant or planning to have a baby ask your doctor for advice before taking this medicine. You should not take Quetiapine tablets during pregnancy unless this has been discussed with your doctor. Quetiapine tablets should not be taken if you are breast-feeding. The following symptoms which can represent withdrawal may occur in newborn babies of mothers that have used quetiapine tablets in the last trimester (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 Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you. Quetiapine tablets contains lactose Quetiapine tablets contains 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 taking this medicine. Quetiapine tablets contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Effect on Urine Drug Screens If you are having a urine drug screen, taking Quetiapine tablets 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 methadone or TCAs. If this happens, a more specific test can be performed.