Consumer Information for: SANDOZ QUETIAPINE

Before starting Sandoz Quetiapine, 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 Sandoz Quetiapine.
• About any other medications - prescription, nonprescription or alternative - that you are taking or plan to take. Certain medications can seriously affect the way other medications work.
• If you are pregnant or plan to become pregnant while taking Sandoz Quetiapine.
• If you are breast-feeding or are planning on breastfeeding while taking Sandoz Quetiapine. You should not breast-feed while taking Sandoz Quetiapine.
• If you drink alcohol or use street drugs.
• If you have a history of alcohol or drug abuse.
• 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).
• 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 have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives (“The Pill”).
• If you suffer or have ever suffered from severe constipation, obstruction of the bowel or any other condition which has affected your large bowel.
• If you have or have had a condition where you stop breathing for short periods during your normal nightly sleep (called “sleep apnea”) and are taking medicines that slow down normal activity of the brain (“depressants”) or breathing.
• If you have or have had a condition where your bladder does not empty or does not empty completely (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eyes. These conditions are sometimes caused by medicines called “anticholinergics”.

Tell your doctor as soon as possible if you have:

• 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 Sandoz Quetiapine to be stopped and/or treatment to be given.
• Constipation along with persistent stomach pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.

In clinical studies with quetiapine fumarate and other drugs of this type, an increased risk of death has been reported in elderly patients with dementia and behavioral disturbances. Sandoz Quetiapine is not approved for this use.

Pancreatitis (inflammation of the pancreas) has been reported in some patients. Many of these patients also had factors which are known to be associated with pancreatitis such as increased triglyceride (a fatty substance in the blood) levels, gallstones and alcohol consumption.

Cardiomyopathy (weakening of the heart muscle) and myocarditis (inflammation of the heart) have been reported in some patients, however, it is not known if Sandoz Quetiapine treatment is related to these problems.

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 Sandoz Quetiapine 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.

Severe cutaneous adverse reactions (SCARs)
Serious skin rashes, which can be life-threatening, have occurred with the use of quetiapine fumerate. Symptoms include blistering, peeling of the lips, eyes, mouth or genitals, swelling of the face and/or tongue, and hives. These serious skin rashes may progress to widespread blistering or peeling of the skin and are often accompanied by flu-like symptoms, blood abnormalities (increase in a type of white blood cells sometimes seen in allergic reactions) and swollen glands (enlarged lymph nodes).

Stop using Sandoz Quetiapine if you develop these symptoms and contact your doctor or seek medical attention immediately.

Effects on Newborns

In some cases, babies born to a mother taking quetiapine fumarate during pregnancy have experienced symptoms of withdrawal that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a ragdoll), are shaking, or are having difficulty feeding.