Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mylan Fluoxetine.
Allergy: Approximately 7% of people who take fluoxetine develop a rash or hives. Almost one third of these people need to stop treatment because of the rash. If you get a skin rash while taking Mylan Fluoxetine, consult your doctor as soon as possible.
Bleeding: Fluoxetine may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Bone Health: Fluoxetine, like other SSRI medications, may increase the risk of bone fracture, especially if you are a senior or have Osteoporosis or other major risk factors for breaking a bone. Take extra care to avoid falls, especially if you get dizzy or have Low Blood Pressure. Your doctor may monitor your bones while you are taking Mylan Fluoxetine.
Diabetes: Fluoxetine may cause changes in blood glucose control. If you have diabetes, discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed.
Your doctor may want you to monitor your blood sugar more carefully while you are taking fluoxetine.
Drowsiness/reduced alertness: Fluoxetine may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Mylan Fluoxetine affects you.
Glaucoma: Mylan Fluoxetine may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking Mylan Fluoxetine.
Heart rhythm: Fluoxetine can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed.
Kidney function: Severe Kidney Disease may affect how fluoxetine is removed from the body and contribute to side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Mylan Fluoxetine to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Mylan Fluoxetine.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Low sodium levels: Mylan Fluoxetine may cause low sodium levels, especially for seniors, people who are dehydrated, and people taking diuretics (water pills). Contact your doctor if you notice symptoms of low sodium such as confusion, concentration or memory problems, weakness, or unsteadiness.
Psychiatric Conditions: Fluoxetine has been reported to cause manic episodes, particularly for people who have bipolar disorder. Signs of mania include extreme levels of energy, hallucinations, suspiciousness, aggression or difficulty focusing your thoughts. If you experience any of these, or if you notice these signs in a family member who is taking fluoxetine, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Mylan Fluoxetine.
Seizures: There have been occasional reports of seizures occurring with fluoxetine. Seizures are more likely to occur when higher doses of Mylan Fluoxetine are taken. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Mylan Fluoxetine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Fluoxetine, and whether any special monitoring is needed.
Serotonin Syndrome/ Neuroleptic Malignant Syndrome : Severe reactions are possible when fluoxetine is combined with other medications that act on serotonin, such as tricyclic antidepressants and certain medications for migraine headache. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.
If you are taking other medications, discuss with your doctor how these medications may affect your medical condition, how your medical condition may affect the dosing and effectiveness of these medications, and whether any special monitoring is needed.
Stopping the medication: Some people experience withdrawal effects if fluoxetine is suddenly stopped. Withdrawal symptoms may include headache, difficulty sleeping, numbness, tingling burning or prickling sensations, nervousness, anxiety, nausea, sweating or weakness. Before stopping the medication, talk to your doctor.
Suicidal or agitated behaviour: People taking Mylan Fluoxetine may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. If you experience these side effects or notice them in a family member who is taking Mylan Fluoxetine, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Mylan Fluoxetine.
Pregnancy: It has been reported that babies born to women who took similar medications during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, jitteriness, irritability, and constant crying). There may also be a slight increase in the risk of birth defects if fluoxetine is taken early during the pregnancy. Mylan Fluoxetine should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Mylan Fluoxetine, contact your doctor immediately. Some babies whose mothers took fluoxetine during pregnancy have had withdrawal effects.
Breast-feeding: Mylan Fluoxetine passes into breast milk. If you are a breast-feeding mother and are taking fluoxetine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Mylan Fluoxetine have not been established for children. The use of Mylan Fluoxetine by children and adolescents may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.
