Details for: MINT-QUETIAPINE XR

Like any medication, MINT-QUETIAPINE XR mayproduce side effects in some people.

Increases in blood glucose (sugar) and hyperglycaemia (high blood sugar) have been observed with MINT-QUETIAPINE XR. Also, occasional cases of diabetes have been reported. Your doctor may take blood tests to check your blood sugar before starting MINT-QUETIAPINE XR. They may continue to monitor your blood sugar for as long asyou are being treated.

Light-headedness and dizziness (symptoms of postural hypotension) and drowsiness are among the most common side effects you may experience while taking MINTQUETIAPINE 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 youto be fully alert, use extra caution until you are sure MINT-QUETIAPINE XR does not cause you to be drowsy.

Dry mouth and weight gain have also been reported very commonly in patients taking MINT-QUETIAPINE XR.Your doctor may take your body weight before starting MINTQUETIAPINE XR and continue to monitor it foras long as you are being treated.

Discontinuation symptoms which occur upon stopping MINT-QUETIAPINE XR have been reported very commonlyand 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, feeling like your heart is pounding, racing or has skipped beats, shortness of breath, constipation, indigestion, feeling weak, swelling of arms and legs, fever, upset stomach or abdominal pain, vomiting (mainly in the elderly), blurredvision, abnormal dreams and nightmares, irritability, feelingmore hungry, disturbance in speech and language, and changes in laboratory tests for liver and thyroid functions.

There have been uncommon cases of difficulty swallowing, fainting (may lead to falls), stuffy nose, difficulty in passing urine, and a slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.

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 MINTQUETIAPINE 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 rare cases, there have been reports of decreased body temperature (hypothermia), a combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition called agranulocytosis), bowel obstruction, and walking, talking, eating or other activities while asleep.

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 MINT-QUETIAPINE XR.

Side effects that are of unknown frequency (cannot be estimated from available data) include:

• Symptoms of withdrawal in newborn babies of mothers that have used MINT-QUETIAPINE XR during their pregnancy.
• Formation of a gum like sticky mass of tablets in the stomach may occur when you take more MINTQUETIAPINE XR than you should. Please contact your doctor immediately as it may require endoscopy for removal of the sticky mass.

The following may also occur with MINTQUETIAPINE XR, and may be seen in routine blood testing:

• Decrease in the amount of white blood cells. These changes will normally disappear when stopping the treatment of MINT-QUETIAPINE XR.
• Decrease in the amount of red blood cells. These are the cells that transport oxygen throughout the body.
• Increase in the amount of eosinophils. These are a type of white blood cell sometimes seen in allergic reactions.
• Decrease in platelets (thrombocytopenia), which are cells that help you stop bleeding if you get a cut.
• Increase in the amount of liver enzymes. These changes will normally disappear when continuing thetreatment of MINTQUETIAPINE XR.
• Changes in the amount of fatty substances(lipid levels, such as triglycerides and cholesterol) in theblood.
• Increase in the amount of “creatine phosphokinase”, asubstance in the muscles.
• Increase in the amount of sugar (glucose) in theblood.
• Increase in the amount of hormone prolactin in the blood. Rarely (<0.1% - ≥0.01%) this may lead to swelling of breasts and unexpected production of breast milk in women and in some men, and changesin the regularity of monthly period.
• Changes in the amount of thyroid hormones in your blood. These changes usually do not affect how you feel.
• If you have high levels of prolactin and a condition called hypogonadism you may be at an increased riskof breaking a bone due to osteoporosis. This may occur in both men and women.

One of the most important things for you to do to minimize the risks from side effects, while helping XR work for you, is to contact your doctor or pharmacist if you notice any symptom that worries you, evenif you think it is not connected with this medicine or is not listed here.

This is not a complete list of side effects. For any unexpected effects while taking MINT-QUETIAPINE XR, contact your doctor or pharmacist.