Fluoxetine (Sivem Pharmaceuticals): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is FLUOXETINE used for?

FLUOXETINE is used to relieve your symptoms of:

• Depression (feeling sad, a change in appetite or weight, difficulty concentrating or
• Bulimia (an eating disorder where you force yourself to vomit after eating)
• Obsessive-compulsive disorder (recurrent and intrusive thoughts, feelings, ideas, or sensations; recurrent pattern of behaviour, or unwanted thoughts or actions)

How does FLUOXETINE work?

FLUOXETINE belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). FLUOXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin. This helps to relieve your symptoms of depression, bulimia and/or obsessive-compulsive disorder.

What are the ingredients in FLUOXETINE?

Medicinal Ingredients: Fluoxetine hydrochloride.

Non-medical Ingredients: D & C Yellow # 10, FD & C Blue #1, FD & C Yellow #6, gelatin, lactose, starch, stearic acid, talc and titanium dioxide. The 10 mg capsules also contain iron oxide black. Pharmaceutical ink: D & C Yellow # 10, FD & C Blue #1, FD & C Blue #2, FD & C red #40, iron oxide black, propylene glycol and shellac.

FLUOXETINE comes in the following dosage forms:

Capsules: 10 mg and 20 mg

Do not use FLUOXETINE if:

• you are allergic to fluoxetine hydrochloride or to any of the non-medicinal ingredients in FLUOXETINE (see What are the ingredients in FLUOXETINE:).
• you are currently or have recently taken the drug thioridazine.
• you are currently or have recently taken any monoamine oxidase anti-depressants such as phenelzine sulphate, moclobemide, linezolid. If you are unsure, ask your healthcare professional.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLUOXETINE. Talk about any health conditions or problems you may have, including if you:

• have anorexia
• have bipolar disorder
• have ever had an allergic reaction to any medication
• have QT/QTc prolongation or a family history of QT/QTc prolongation
• have a heart disease
• have a personal history of fainting spells
• have a family history of sudden cardiac death at less than 50 years of age
• have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration)
• have or have a history of a bleeding disorder or have been told that you have low platelets
• have or have a history of liver or kidney problems
• have or have a history of seizures
• have diabetes
• had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• are pregnant, thinking about becoming pregnant, or if you are breast feeding
• drink alcohol and /or use street drugs
• have lactose and sucrose intolerance.

Other warnings you should know about:

Do NOT stop taking FLUOXETINE without talking to your healthcare professional first, as it may cause unwanted side effects such as headache, insomnia, numbness, tingling, burning, or prickling, nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness.

Pregnancy: Only take FLUOXETINE during pregnancy if you and your doctor have discussed the risks and have decided that you should. If you take FLUOXETINE near the end of your pregnancy, you may be at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking FLUOXETINE, tell your doctor right away.

Effects on newborns: In some cases, babies born to a mother taking FLUOXETINE during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they:

• Have trouble breathing or feeding,
• Have muscle stiffness, or floppy muscles (like a rag doll)
• Have seizures (fits)
• Are shaking (jitteriness)
• Are constantly crying

If you take FLUOXETINE:

• During early pregnancy, there is a possible slight increased risk that your newborn may have a heart defect.
• During late pregnancy, your newborn may be at risk of having a serious lung condition called Persistent Pulmonary Hypertension of the Newborn (PPHN), which causes breathing problems.

Effects on Sexual Function: Taking medicines like FLUOXETINE may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping FLUOXETINE treatment. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.

Falls: FLUOXETINE can cause you to feel sleepy or dizzy and can affect your balance. This increases your risk of falling, which can cause fractures or other fall related-injuries, especially if you:

• Take sedatives
• Consume alcohol
• Are elderly
• Have a condition that causes weakness or frailty

Serotonin toxicity (also known as Serotonin syndrome) or Neuroleptic malignant syndrome: FLUOXETINE can cause Serotonin toxicity or Neuroleptic malignant syndrome, rare but potentially life-threatening conditions. They can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin toxicity or Neuroleptic malignant syndrome if you take FLUOXETINE with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.

Serotonin toxicity or Neuroleptic malignant syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, changes in reflexes, loss of coordination
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma

Driving and using machines: FLUOXETINE may make you feel sleepy. Give yourself time after taking FLUOXETINE to see how you feel before driving a vehicle or using machinery.

FLUOXETINE can cause serious side effects including:

• Angle-closure glaucoma (sudden eye pain)
• Heart rhythm problems

See the Serious side effects and what to do about them table below for more information on these and other serious side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLUOXETINE:

Serious Drug Interactions

Do not use FLUOXETINE if you are taking or have recently taken:

• Monoamine oxidase inhibitor (e.g., phenelzine, tranylcypromine, moclobemide or selegiline, linezolid, methylene blue)

• Thioridazine

  • drugs that affect how your heart beats such as quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, propafenone
  • drugs used to manage psychosis (antipsychotics) such as chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone, clozapine
  • drugs used to treat depression such as citalopram, venlafaxine, amitriptyline, imipramine, maprotiline, desipramine
  • opioids and pain killers such as methadone, tramadol, fentanyl, tapentadol, meperidine, pentazocine
  • drugs to treat bacterial infections such as erythromycin, clarithromycin, telithromycin, tacrolimus, moxifloxacin, levofloxacin, ciprofloxacin
  • drugs used to treat fungal infections such as ketoconazole, fluconazole, voriconazole
  • drugs used to treat malaria such as quinine, chloroquine
  • drugs used to treat nausea and vomiting such as domperidone, dolasetron, ondansetron
  • drugs used in cancer therapy such as vandetanib, sunitinib, nilotinib, lapatinib, vorinostat, tamoxifen
  • drugs used to treat asthma such as salmeterol, formoterol
  • drugs that affect your electrolyte levels such as diuretics (“water pills”), laxatives and enemas, amphotericin B, high dose corticosteroids (drugs that reduce inflammation)
  • drugs that can affect how your blood clots such as warfarin, acetylsalicylic acid (Aspirin), non-steroidal anti-inflammatory drugs (NSAIDs)
  • lithium, a drug used to treat bipolar disorder
  • benzodiazepines such as diazepam, alprazolam
  • drugs used to treat seizures such as carbamazepine, phenytoin
  • drugs used to treat cough such as dextromethorphan
  • tryptophan, a drug used to treat anxiety or used as a sleep aid
  • sumatriptan, a drug used to treat migraines
  • herbal medicines such as St. John’s Wort
  • alcohol

How to take FLUOXETINE:

• It is very important that you take FLUOXETINE exactly as your doctor has instructed.

• FLUOXETINE may be taken with or without food.

• Swallow the capsules whole; do not chew or open them.
• Continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to start working.
• Keep taking your FLUOXETINE until the doctor tells you to stop.

Remember, 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.

Usual dose:

Depression

Usual initial dose: 20 mg a day in the morning. Maximum dose: 60 mg a day.

Bulimia

60 mg a day.

Obsessive-Compulsive Disorder

20 mg to 60 mg a day.

Overdose:

Missed Dose:

If you forget to take a dose of FLUOXETINE, take it as soon as you remember. If it is almost time to take your next dose, skip the missed dose and take your next dose at the scheduled time. Do not try to make up for a missed dose by taking a double dose the next time.

What are possible side effects from using FLUOXETINE?

These are not all the possible side effects you may have when taking FLUOXETINE. If you experience any side effects not listed here, tell your healthcare professional.

• nausea
• dizziness
• headache
• anxiety
• nervousness
• drowsiness
• insomnia (difficulty falling or staying asleep)
• fatigue
• weakness
• tremors (shaking)
• light-headedness
• diarrhea
• upset stomach
• indigestion
• dry mouth
• loss of appetite
• excessive sweating
• rash or itchy skin
• low sex drive
• weight gain or loss

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

• FLUOXETINE Capsules should be stored in its original package at room temperature (15°C to 30°C). Protect from light.
• Do not use the medicine after the expiry date printed on the package label.
• If your doctor tells you to stop taking FLUOXETINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.

Keep out of reach and sight of children.

If you want more information about FLUOXETINE:

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-

  • -product-database.html); the manufacturer’s website www.sivem.ca, or by calling 1-855-788-3153.

Last Revised: FEB 13, 2025