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PATIENT INFORMATION LEAFLET Sandoz® Fluoxetine Fluoxetine Hydrochloride 10 mg and 20 mg capsules Antidepressant INFORMATION ABOUT YOUR SANDOZ FLUOXETINE Please read this information carefully before you start to take your medicine, even if you have taken this drug before. Keep this leaflet until you have finished all your capsules, as you may need to read it again. For further information or advice, please see your doctor or pharmacist. WHAT YOU SHOULD KNOW ABOUT SANDOZ FLUOXETINE • Sandoz Fluoxetine (fluoxetine hydrochloride) belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). • Sandoz Fluoxetine has been prescribed by your doctor to relieve your symptoms of depression, bulimia, or obsessive-compulsive disorder. WHAT YOU SHOULD TELL YOUR DOCTOR BEFORE TAKING SANDOZ FLUOXETINE • All your medical conditions, including a history of liver or kidney problems, seizure, blackouts, or diabetes. • Any medication (prescription or non prescription) you are taking or have recently taken, especially monoamine oxidase inhibitors (eg: phenelzine sulfate, tranylcypromine sulfate moclobemide or selegeline), any other antidepressants, drugs used to treat diabetes, drugs used to thin the blood (anticoagulants) or drugs containing tryptophan. • If you are pregnant or thinking about becoming pregnant or if you are breast-feeding. • Your habits of alcohol and/or street drug consumption. • If you have had an allergic reaction to medication used to treat your current condition. • If you drive a vehicle or perform hazardous tasks during your work. PRECAUTIONS WHILE TAKING THIS MEDICATION • You may experience side effects such as nausea, dizziness, headaches, anxiety, nervousness, drowsiness, insomnia or sexual problems. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted. • Although Sandoz Fluoxetine seldom produces severe drowsiness, you should avoid driving a car, or operating hazardous machinery until you are reasonably certain your ability to do so is not affected. WHAT TO DO IN CASE OF OVERDOSAGE • If you have taken a large number of capsules all at once, contact your doctor immediately or the hospital emergency service nearest you even though you may not feel sick. Show the doctor your prescription bottle. HOW TO STORE SANDOZ FLUOXETINE • Keep all medication out of reach of children. • Keep all medication in its original container at room temperature, in a dry place and away from the rays of the sun. • Do not use the medication after the expiry date printed on the label of the container. SANDOZ FLUOXETINE CONTAINS THE FOLLOWING: • As medicinal ingredients, Sandoz Fluoxetine contains fluoxetine hydrochloride. • As non-medicinal ingredients: pregelatinized maize starch and dimethicone 350. The capsule shell contains indigo carmine (FD & C Blue No. 2), quinoline yellow (D&C Yellow No. 10), titanium dioxide, gelatin, and yellow and black ferric oxide. HOW TO TAKE YOUR SANDOZ FLUOXETINE • Always take the exact amount of Sandoz Fluoxetine that has been prescribed by your doctor. The usual dosage for depression and obsessive-compulsive disorder is between 20 and 80 mg per day and 20 and 60 mg per day to treat bulimia. Your doctor will be able to adjust your dosage during the evolution of your treatment. • Do not take additional capsules of Sandoz Fluoxetine unless otherwise specified by your doctor. • You must continue your medication every day even if you do not feel immediate improvement. Your medication may need a few weeks before you feel any improvement. • Sandoz Fluoxetine is usually taken once a day. It can be taken with or without food. This medication is prescribed in capsule form; you must swallow them whole, without chewing. • You must continue your medication every day until the doctor advises you to stop. You may have to take it for a few months. Always follow the doctor’s advice when taking this medication. • If you forget a dose of Sandoz Fluoxetine, it is not necessary to make up the missed dose. Take the next dose as scheduled, never double dose. Remember: This medication has been prescribed for you specifically and your medical condition. Do not give it to anybody else. WHEN NOT TO TAKE SANDOZ FLUOXETINE • Do not take Sandoz Fluoxetine if you are allergic to this medication or to the non-medicinal ingredients (see list at the end of this section). Stop taking the medication and call your doctor if you have an allergic reaction, (example: rash or urticaria) or any other harmful or unusual side effects. ® Registered trademark used under license by Sandoz Canada Inc. Sandoz Canada Inc. QC, Canada J4B 7K8 [email protected] ? 1-800-361-3062 Revised: March 2006 OUT1004962