Details for: ACT FLUVOXAMINE

ACT FLUVOXAMINE is not for use in children under 18 years of age.

During treatment with ACT FLUVOXAMINE or any type of antidepressant medication, it is important that you and your doctor have good ongoing communication about how you are feeling. Treatment with antidepressant medications is most safe and effective when you and your doctor have good communication about how you are feeling.

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 ACT FLUVOXAMINE. You may feel more anxious, agitated, hostile, or impulsive, or may have thoughts about suicide, self-harm or harm to others. These changes in feelings can happen in patients treated with drugs like ACT FLUVOXAMINE for any condition, and at any age, but it may be more likely in patients 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking ACT FLUVOXAMINE on your own.

Bone Fractures
Taking ACT FLUVOXAMINE may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.

Medicines like ACT FLUVOXAMINE may affect your sperm. Fertility in some men may be reduced while taking ACT FLUVOXAMINE. This effect is reversible. Full impact on fertility in men is not yet known.

Angle-closure Glaucoma:
Fluvoxamine maleate can cause an acute attack of glaucoma. Having your eyes examined before you take fluvoxamine maleate could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye

Talk to your doctor or pharmacist before using ACT FLUVOXAMINE:

• if you have had any allergic reaction to medications, food, etc.
• about all your medical conditions, including a history of seizures, liver or kidney disease, heart problems or a history of any abnormal bleeding
• about any medications (prescription or over-the-counter) you are taking or have recently taken, especially monoamine oxidase (MAO) inhibitors (e.g., phenelzine sulphate, moclobemide), any other antidepressants, tizanidine, thioridazine, pimozide, mesoridazine, neuroleptics, clopidogrel, warfarin, propranolol, phenytoin, theophylline, lithium, tryptophan, terfenadine, astemizole, cisapride, triptans used to treat migraines, lithium, tramadol, drugs containing tryptophan, drugs used to prevent seizures (anticonvulsants).
• about any natural or herbal products you are taking (e.g., St. John's Wort).
• if you have a history or family history of mania/hypomania or bipolar disorder.
• if you have high or low blood sugar, or diabetes mellitus.
• if you have a bleeding disorder or a tendency to easily develop bruises, have been told that you have low platelets
• if you have been told you have a low sodium level in the blood;
• if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• if you have glaucoma or increased pressure in your eyes
• if you are pregnant, or are thinking about becoming pregnant, or if you are breast feeding
• about your habits of alcohol and/or street drug consumption
• if you drive a vehicle or perform hazardous tasks during your work.

Effects on Pregnancy and Newborns

ACT FLUVOXAMINE should not be used during pregnancy unless the benefit outweighs the risk. If you are already taking ACT FLUVOXAMINE 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. It is very important that you do NOT stop taking ACT FLUVOXAMINE without first talking to your doctor.

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants, such as ACT FLUVOXAMINE, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included: feeding and / or breathing difficulties, vomiting, fits (or seizures), body temperature changes, stiff or floppy muscles, jitteriness, bluish skin, irritability, lethargy, drowsiness, difficulty in sleeping and constant crying.

In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant 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.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants:
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like ACT FLUVOXAMINE may increase the risk of a serious lung condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), that causes breathing difficulties in newborns soon after birth, making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your doctor immediately.

If you are pregnant and taking an SSRI, or other newer antidepressants, 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 SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.