Details for: MYLAN-MIRTAZAPINE

During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.

MYLAN-MIRTAZAPINE is not for use in children under 18 years of age.

Changes in Feelings and Behaviour:
It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as MYLAN-MIRTAZAPINE. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like MYLAN-MIRTAZAPINE for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking MYLAN-MIRTAZAPINE on your own.

BEFORE you use MYLAN-MIRTAZAPINE, talk to your doctor or pharmacist:

• if you have ever had an allergic reaction to any medication;
• if you have QT/QTc prolongation or a family history of QT/QTc prolongation;
• if you have heart disease
• about all your medical conditions, including a history of seizures, liver or kidney disease, heart problems, such as certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart’s rhythm, diabetes, low blood pressure, glaucoma (increased intra-ocular pressure), high cholesterol and/or high triglycerides (fats in the blood), difficulties in urinating as a result of an enlarged prostate, psychiatric diseases such as schizophrenia and bipolar disorder (alternating periods of elation/overactivity and depressed mood);
• about any medications (prescription or nonprescription) you are taking (refer to the next section for specific interactions with MYLAN-MIRTAZAPINE)
• about any natural or herbal products you are taking (e.g., St. John’s Wort);
• if you are pregnant or thinking of becoming pregnant, or if you are breastfeeding;
• about your habits of alcohol consumption;
• if you have hereditary galactose intolerance or glucose- galactose malabsorption.

MYLAN-MIRTAZAPINE is not for use in children under 18 years of age.

Refrain from potentially hazardous tasks, such as driving a car or operating dangerous machines, until you are certain that this medication does not affect your mental alertness or physical coordination.

Contact your physician before stopping or reducing your dosage of MYLAN-MIRTAZAPINE. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of MYLAN-MIRTAZAPINE. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of MYLAN-MIRTAZAPINE to alleviate these symptoms.

Effects on Pregnancy and Newborns
If you are already taking/using MYLAN-MIRTAZAPINE and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Possible complications at birth (from taking any newer antidepressant, including MYLAN-MIRTAZAPINE.
Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressants, such as MYLAN-MIRTAZAPINE during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

If you are pregnant, or nursing, and taking an SSRI or other newer anti-depressants, such as MYLAN-MIRTAZAPINE, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor. See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM section.