Package Leaflet: Information for the User

Package Leaflet: Information for the User

Fluoxetine 60 mg capsules* What is in this leaflet

1. What Fluoxetine is and what it is used for

2. What you need to know before you take Fluoxetine 3. How to take Fluoxetine

4. Possible side effects 5. How to store Fluoxetine

1. What Fluoxetine is and what it is used for

Fluoxetine is an anti-depressant medicine used to treat:

 Depression

 Obsessive Compulsive Disorder (OCD)

 Bulimia Nervosa (eating disorder)

Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the levels of a chemical in the brain called serotonin.

2. What you need to know before you take Fluoxetine Do not take Fluoxetine

 If you’re allergic to the active substances or any other component of this medicine.

 If you took within the past 2 weeks a monoamine oxidase inhibitor (MAOI).

 If you are taking the medicines Pimozide or Thioridazine.

Warnings and precautions

Talk to your doctor about all your medical conditions before taking this medicine including:

 If you have liver or kidney problems.

 If you have heart problems including QT interval prolongation.

 If you have or had seizures or convulsions.

 If you have bipolar disorder or mania.

 If you have low sodium levels in your blood.

 If you have a history of a stroke.

 If you have high blood pressure.

 If you have or had bleeding problems.

This medicine may cause suicidal thoughts or actions, especially in young patients, in the first few months of treatment. Call your doctor if you experience such symptoms.

You may experience worsening of your symptoms at the beginning of your treatment. Do not stop taking this medicine; it may take several weeks to see its full effect.

Do not stop taking this medicine all of a sudden. You might experience side effects. Talk to your doctor on how to discontinue Fluoxetine.

Other medicines and Fluoxetine

Tell your doctor about all the medicines you are taking. Fluoxetine interacts with a lot of medications including:

 Monoamine oxidase inhibitors (MAOIs): do not take MAOIs within 5 weeks of stopping Fluoxetine and do not start Fluoxetine within 2 weeks of stopping MAOIs. These include Isocarboxazid, Phenelzine, Tranylcypromine, Moclobemide, Selegiline, or Rasagiline.

 Thioridazine: Do not take Thioridazine within 5 weeks of stopping Fluoxetine.

 Pimozide: Do not take Pimozide while taking Fluoxetine.

 Linezolid

 Methelyene Blue

 Triptans used for migraine

 Medicine used to treat depression or anxiety

 Amphetamines

 Metoprolol

 Tramadol

 Tamoxifen

 St John’s Wort

 Anticoagulants such as Warfarin

 Phenytoin

 ECT treatment

Pregnancy and breastfeeding

Ask your doctor before taking this medicine if you are pregnant or planning to become pregnant. Do not breast-feed while taking this medicine, it is excreted in the breast milk. Talk to your doctor. Driving and using machines

3. How to take Fluoxetine

 This medicine is intended for adults over 18 years of age.

 Your doctor might prescribe it to children aged 8 years and older if necessary for depression.

 Take as indicated by your doctor.

 Take with or without food. How much to take

 For depression and obsessive-compulsive disorder, the usual starting dose is 20 mg once daily. Your doctor may gradually increase the dose up to 60 mg daily.

 For bulimia nervosa, the recommended dose is 60 mg once daily.

 In children aged 8 years and older the initial dose is 10 mg once daily. Your doctor may gradually increase the dose up to 20 mg daily.

If you take Fluoxetine more than you should

If you take Fluoxetine more than you should, you may experience a change in your mental status, confusion, trouble breathing, heart palpitations, shaking and sometimes seizures.

If you know you have exceeded the recommended daily dose, contact your doctor, poison center or the hospital immediately.

If you forgot to take Fluoxetine

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

4. Possible side effects

Stop using this product and seek immediate medical help if you develop rash; hives; itching; red, swollen, blistered, or peeling skin; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Serious side effects

 Suicidal thoughts or actions, especially at the beginning.

 Serotonin syndrome: this condition may be life threatening, symptoms include agitation, hallucination, tremor, sweating, fever, dizziness and seizures.

 Allergic reactions

 Seizures and convulsions

 Heart problems: irregular heartbeat

Very Common side effects (may affect more than 1 in 10 people)  Headache

 Fatigue

 Nausea

 Diarrhea

 Insomnia

 Impotence

Common side effects (may affect up to 1 in 10 people)  Anxiety

 Loss of appetite

 Weight loss

 Decreased sex drive

 Shaking

 Increase in blood pressure

 Sweating

 Stomach upset

 Dry mouth

Other side effects include: eye problems, rash, heart palpitations, flu-like symptoms, abnormal liver function tests, changes in blood sugar level and flushing.

5. How to store Fluoxetine

 Store at room temperature 68 to 77°F (20 to 25°C).

 Protect from light.

 Keep this medicine out of reach of children.

 Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.

 Do not throw away any medicines via wastewater or household waste.

*Dosage form and route of administration of Fluoxetine 60 mg capsules should be prescribed according to therapeutic indication and disease severity of each individual patient.

Contact with Saudi Food Drugs Authority

Phone 0118806000-0112038222 Free Phone 8002490000

Email: [email protected]

Postal address

Saudi Food & Drugs Authority (3292) North Road – Al Nafal Unit (1)