Patient Medication Information: uses, side effects, how to take - AG-Fluoxetine
Serious Warnings and Precautions
New or worsened emotional or behaviour problems:
Self-harm or Suicide
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What is AG-Fluoxetine used for?
AG-Fluoxetine is used to relieve your symptoms of:
Depression (feeling sad, a change in appetite or weight, difficulty concentrating or
- unexplained aches and pain)
- 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 AG-Fluoxetine work?
AG-Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). AG-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 AG-Fluoxetine?
Medicinal ingredients: fluoxetine hydrochloride.
Non-medicinal ingredients: colloidal anhydrous silica, magnesium stearate, pregelatinized starch and purified talc.
The capsule shells of the 10 mg capsule contains: black ink (black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution), FD&C Blue No. 1, gelatin, iron oxide yellow and titanium dioxide.
The capsule shell of the 20 mg capsule contains: black ink (black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution), erythrosine, gelatin, indigo carmine, quinoline yellow and titanium dioxide.
AG-Fluoxetine comes in the following dosage forms:
Capsules; 10 mg (green) and 20 mg (green and yellow) strengths.
Do not use AG-Fluoxetine if:
- you are allergic to fluoxetine hydrochloride or to any of the non-medicinal ingredients in AG-Fluoxetine (see What are the ingredients in AG-Fluoxetine:).
- you are currently or have recently taken the drug thioridazine.
- you are currently or have recently taken any monamine 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 AG-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
Other warnings you should know about:
Do NOT stop taking AG-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 AG-Fluoxetine during pregnancy if you and your doctor have discussed the risks and have decided that you should. If you take AG-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 AG-Fluoxetine, tell your doctor right away.
Effects on newborns: In some cases, babies born to a mother taking AG-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 AG-Fluoxetine:
During early pregnancy, there is a possible slight increased risk that your newborn may have
- 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 AG-Fluoxetine may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping AG-Fluoxetine treatment. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.
Falls: AG-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: AG-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 AG-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: AG-Fluoxetine may make you feel sleepy. Give yourself time after taking AG-Fluoxetine to see how you feel before driving a vehicle or using machinery.
AG-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 AG-Fluoxetine:
Serious Drug Interactions Do not use AG-Fluoxetine if you are taking or have recently taken:
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- 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 AG-Fluoxetine:
- It is very important that you take AG-Fluoxetine exactly as your doctor has instructed.
AG-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 AG-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:
| If you think you, or a person you are caring for, have taken too much AG-Fluoxetine, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take a dose of AG-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 AG-Fluoxetine?
These are not all the possible side effects you may have when taking AG-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
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | ✓ | ||
| Allergic reactions (skin rash, hives alone) | ✓ | ||
| Anorexia (an eating disorder): extremely low body weight, not eating, obsession with food, calories and dieting, excessive exercise | ✓ | ||
| UNCOMMON | |||
Akathisia (a type of movement disorder): feeling restless, unable to sit or stand still | ✓ | ||
Hallucinations (seeing or hearing things that are not there) | ✓ | ||
Mania: elevated or irritable mood, decreased need for sleep, racing thoughts | ✓ | ||
| Seizures (fits): uncontrollable shaking with or without loss of consciousness | ✓ | ||
Urinary retention (inability to pass urine or to empty the bladder): pain | ✓ | ||
| RARE | |||
| Angle-closure glaucoma (sudden eye pain): increased pressure in your eyes, eye and head pain, swelling or redness in or around the eye, hazy or blurred vision, sudden loss of sight | ✓ | ||
| Gastrointestinal Bleeding (bleeding in the stomach or bowels): black, tarry stool, blood in the stool | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Heart rhythm problems: dizziness, palpitations (rapid, pounding, or irregular heartbeat), fainting or seizures | ✓ | ||
Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching, achy, stiff or uncoordinated muscles, seizure, coma | ✓ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine and pale stools, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
Uncontrollable movements of the body or face | ✓ | ||
| Serotonin toxicity or Neuroleptic malignant syndrome: reactions which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38°C), or rigid muscles | ✓ | ||
| UNKNOWN | |||
Increase in the hormone prolactin: In women: breast discomfort, leakage of milk from the breasts, missed periods, or other problems with your menstrual cycle. In men: decreased body and facial hair, breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction | ✓ | ||
New or worsened emotional or behavioural problems: anxiety, hostility or impulsivity | ✓ | ||
Self-harm and suicide: Have thoughts of harming or killing yourself | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
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
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
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AG-Fluoxetine should be stored in its original package at room temperature 15-30°C, in a
dry place and out of direct sunlight.
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The expiry date of this medicine is printed on the package label. Do not use the medicine
after the expiry date.
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If your doctor tells you to stop taking AG-Fluoxetine or you find that they have passed their
expiry date, please return any leftover medicine to your pharmacist.
Keep all medicines out of the reach and sight of children.
If you want more information about AG-Fluoxetine:
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- Talk to your healthcare professional
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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-products/drug-product-database.html); or by calling 1-450-449-9272.
Angita Pharma Inc
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada