Luvox (Fluvoxamine)

• It is very important that you take LUVOX exactly as your doctor has instructed. Generally most people take between 100 mg to 200 mg per day for depression and between 100 mg and 300 mg for obsessive compulsive disorder.

• LUVOX is usually taken once a day at bedtime. However, doses above 150 mg per day may be divided so that a maximum of 150 mg is taken at bedtime. Swallow the tablets whole with water. Do not chew them.

• Establishing an effective dosage level will vary from one person to another. For this reason, your doctor may adjust your dosage gradually during treatment.

• As with all antidepressants, improvement with LUVOX is gradual. You should continue to take your medication even if you do not feel better, as it may take a number of weeks for your medicine to work. Continue to take LUVOX for as long as your doctor recommends.

• Never increase or decrease the amount of LUVOX you are taking unless your doctor tells you to change your dosage.

• Do not suddenly stop taking this medication without talking to your doctor first. Suddenly stopping treatment or changing the dose may cause unpleasant side effects.

• You should avoid taking St. John’s Wort if you are taking LUVOX.

Reminder: This medicine has been prescribed only for you. Do not give it to anybody else as they may experience undesirable effects, which may be serious. If you have further questions, please ask your doctor or pharmacist.

Like all medications, LUVOX can cause some side effects. You may not experience any of them. For most patients, side effects are likely to be minor and temporary. However some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including red skin, hives, itching, swelling of the lips, face tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

The most common side effects of LUVOX are:

• nausea (sometimes with vomiting)

• constipation

• diarrhea

• loss of appetite

• upset stomach

• sleep disturbances

• dry mouth

• tremor (uncontrolled shaking)

• dizziness

• headache

• anxiety

• nervousness

• excessive sweating

• sexual problems

• urinating problems.

LUVOX does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.

Although psychiatric disorders may be associated with decreases in sexual desire, performance and satisfaction, treatment with this medication may also affect sexual functioning.

LUVOX can raise your levels of a hormone called “prolactin” (measured with a blood test). Symptoms of high prolactin may include: (in men) breast swelling, sexual dysfunction; (in women) breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle.

Contact your doctor before stopping or reducing your dosage of LUVOX. Symptoms such as dizziness, abnormal dreams, unusual skin sensations (burning, prickling, tingling), sleep disturbances (including insomnia and intense dreams) confusion, fatigue, agitation, irritability, anxiety, emotional instability, difficulty concentrating, headache, tremor, nausea, vomiting, diarrhea, sweating, palpitations (faster heartbeat) or other symptoms may occur suddenly after stopping or reducing the dosage of LUVOX. 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 LUVOX to alleviate the symptoms. Discontinuation symptoms may occur in an infant if the mother is taking antidepressants at, or shortly before, the time of birth or while nursing.

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 LUVOX. 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 LUVOX 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 LUVOX on your own.

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

LUVOX can cause an acute attack of glaucoma. Having your eyes examined before you take LUVOX 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.

• 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, 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 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.

LUVOX should not be used during pregnancy unless the benefit outweighs the risk.

If you are already taking LUVOX 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 LUVOX without first talking to your doctor.

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants, such as LUVOX, 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.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like LUVOX 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.