Patient Medication Information: uses, side effects, how to take - PHL-Fluoxetine - Solution 20mg/5mL
ABOUT THIS MEDICATION
What the medication is used for:
phl-FLUOXETINE has been prescribed by your doctor to relieve your symptoms of:
depression (feeling sad, a change in appetite or weight,
difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
bulimia (eating disorder, characterized by self-induced
vomiting after eating)
or obsessive-compulsive disorder (recurrent and intrusive
thought, feeling, idea, or sensation; recurrent pattern of behaviour, or unwanted thoughts or actions)
What it does:
phl-FLUOXETINE (fluoxetine hydrochloride) belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). phl-FLUOXETINE is thought to work by
| increasing |
the levels of a chemical in the brain called serotonin
| (5-hydroxytryptamine). |
When it should not be used:
Do not use phl-FLUOXETINE if you are:
allergic to it or any of the components of its formulation
(see list of components at the end of this section).
- currently or have recently taken the drug thioridazine.
•
| currently or have recently taken monamine oxidase anti- | |
| depressants (e.g. phenelzine sulphate, moclobemide). | |
The medicinal ingredient is:
phl-FLUOXETINE capsules and oral solution contain the active ingredient fluoxetine hydrochloride.
The nonmedicinal ingredients are:
Both phl-FLUOXETINE 10 mg and 20 mg capsules contain the following inactive ingredients: starch, silicone, F D & C Blue No. 1, D & C Yellow # 10, FD & C Yellow # 6, titanium dioxide, and gelatin. Additionally, the 10 mg capsule also contains: iron oxide black.
phl-FLUOXETINE Oral Solution contains the following inactive ingredients: benzoic acid, mint flavor, glycerin, purified water, and sucrose.
There is no gluten, lactose, sulfite, or tartrazine in phl-FLUOXETINE.
What dosage forms it comes in:
phl-FLUOXETINE Capsules:
phl-FLUOXETINE Capsules are available in 10 mg
| (opaque |
| green cap and grey body) |
and 20 mg
| (opaque green cap and |
| opaque ivory body) |
strengths.
phl-FLUOXETINE Oral Solution:
phl-FLUOXETINE oral solution (colourless, with a mint odour) is only available in 20 mg/ 5 mL.
WARNINGS AND PRECAUTIONS
During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.
phl-FLUOXETINE is not for use in children under 18 years of age.
| New or Worsened Emotional or Behaviour Problems | |||||
| Particularly in the first few weeks or when doses are | |||||
| adjusted, a small number of patients taking drugs of this typ | |||||
e
| may feel worse instead of better; for example, they may | |||||
| experience unusual feelings of agitation, hostility or anxiety, | |||||
| or have impulsive or disturbing thoughts such as thoughts of | |||||
| self-harm or harm to others. Should this happen to you, or | |||||
| those in your care if you are a caregiver or guardian, consult | |||||
| your doctor immediately, do not discontinue your | |||||
| medication on your own. | |||||
Before starting phl-FLUOXETINE, tell your doctor or pharmacists:
•
| if you have ever had an allergic reaction to any | |
| medication | |
- all your medical conditions, including a history of liver or kidney problems, seizures or blackouts, diabetes, and heart problems or abnormal bleeding
•
| any medications (prescription or nonprescription) you | |||
| are taking or have recently taken, especially | monoamine | ||
| oxidase (MAO) inhibitors | |||
(e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegeline) or thioridazine
any natural or herbal products you are taking (e.g. St.
John's Wort)
- 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 drive a vehicle or perform hazardous tasks during your work
Effects on Pregnancy and Newborns
Post-marketing reports indicate that some newborns whose IMPORTANT: PLEASE READ
mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant, such as fluoxetine, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jiterriness and constant crying.
In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.
If you are pregnant and taking an SSRI, or other newer anti-depressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.
INTERACTIONS WITH THIS MEDICATION
| Do not use | phl-FLUOXETINE | if you are taking or have | |
| recently taken monoamine oxidase (MAO) inhibitors or | |||
| thioridazine | |||
.
You should tell your doctor if you are taking or have recently taken any medications (prescription, nonprescription or natural/herbal), especially:
- other anti-depressants,
| such as SSRIs, certain tricylics, | ||||
| drugs used to treat schizophrenia, or bipolar depression | ||||
| (e.g. lithium) | ||||
•
| drugs which may affect blood clotting and increase | |||
| bleeding, such as | |||
drugs used to thin the blood (anticoagulants, e.g. warfarin), as well as acetylsalicylic acid (e.g. Aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen)
•
| certain medicines used to treat patients with irregular heart | ||||||
| beats | ||||||
•
| certain drugs use to treat diabetes |
•
| other drugs that affect serotonin, such as |
lithium, linezolid,
| tramadol, drugs containing tryptophan, St. Johns Wort, | |||||
| triptans used to treat migraines | |||||
•
| sedatives such as benzodiazapines |
As with many drugs that work directly on the brain, use of alcohol while taking phl-FLUOXETINE should be limited/moderate.
PROPER USE OF THIS MEDICATION
Usual dose:
It is very important that you take phl-FLUOXETINE
exactly as your doctor has instructed. Generally people take between 20 mg to 80 mg per day for depression and obsessive-compulsive disorder and between 20 and 60 mg per day for bulimia.
phl-FLUOXETINE is usually taken once a day. It may be taken with or without food. If you are taking capsules, you should swallow the capsules whole; do not chew them.
- You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.
•
| Keep taking your |
phl-FLUOXETINE until the doctor
| tells you to stop. |
•
| Talk to your doctor before you stop taking your | |||
| medication on your own. | |||
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.
Missed Dose
| If you forget to take a dose of | ||
phl-FLUOXETINE, take
| it as | ||
| soon as you remember. Take your next dose at the next | ||
scheduled time; do not try to make up for a missed dose by taking a double dose the next time.
Overdose:
If you have taken a large number of tablets all at once, contact your doctor or the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your prescription bottle.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Like all other medications, | phl-FLUOXETINE | can cause | |||
| some side effects. You may not experience any of them. Fo | |||||
r
| most patients, side effects are likely to be minor and | |||||
| temporary. However, some may be serious. Some of these | |||||
| side effects may be dose related. Consult your doctor if you | |||||
| experience these or other side effects, as the dose may have | |||||
| to be adjusted | |||||
.
If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.
The most common side effects of phl-FLUOXETINE are:
•
| nausea |
•
| dizziness |
•
| headache |
•
| anxiety |
•
| nervousness |
•
| drowsiness |
•
| insomnia |
•
| fatigue |
- weakness
- diarrhea
- upset stomach
•
| dry mout |
h
•
| loss of appetite |
•
| excessive sweating |
phl-FLUOXETINE does not usually affect people’s normal
activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.
| Although psychiatric disorders may be associated with | ||
| decreases in sexual desire, performance and satisfaction, | ||
| treatment with this medication | ||
may also affect sexual functioning.
| New or Worsened Emotional or Behaviour Problems | ||
| A small number of patients taking a drug of this type may feel | ||
| worse instead of better, such as experiencing new or worsened | ||
| feelings of agitation, hostility, anxiety, or thoughts about | ||
| suicide. Your doctor should be informed of such change | ||
s
| immediately. |
Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also the WARNINGS AND PRECAUTIONS section.
| Discontinuation Symptoms | |
| Contact your doctor before stopping | |
or reducing your dosage of phl-FLUOXETINE. Symptoms such as headache, insomnia, paresthesias (numbness, tingling, burning, or prickling sensation) nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness and other symptoms have been reported after stopping phl-FLUOXETINE. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of phl-FLUOXETINE to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.
| Effects on Newborns | |||
| Some newborns whose mothers took an SSRI (Selective | |||
| Serotonin Uptake Inhibitor) or other newer antidepressants | |||
| during pregnancy have shown such symptoms as breathing and | |||
| feeding difficulties, jitteriness and constant crying. If your | |||
baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNING AND PRECAUTIONS section for more information.
The following table is based on data from placebo-controlled clinical trials involving 10,782 patients.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Allergic reactions (skin rash, hives, swelling, trouble breathing) | 9* | ||
| Uncommon | Bruising or unusual bleeding from the skin or other areas | 9 | ||
| Uncommon | Hallucinations | 9 | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
| Only if severe | In all cases | |||||
| [strange visions or sounds] | ||||||
| Uncommon | Inability to urinate | 9 | ||||
| Uncommon | Akathisia [feeling restless and unable to sit or stand still] | 9 | ||||
| Uncommon | Seizures [i.e. loss of consciousness with uncontrollable shaking (“fit”)] | 9* | ||||
| Uncommon | Mania [overactive behaviour and thoughts] | 9 | ||||
| Rare | Gastrointestinal bleeding [vomiting blood or passing blood in stools] | 9* | ||||
| Rare | Increased pressure in the eyes [symptoms of eye pain and blurred vision] | 9 | ||||
| Rare | Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine] | 9* | ||||
| Rare | Uncontrollable movements of the body or face | 9 | ||||
| Rare | Low sodium level in blood [symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles] | 9 | ||||
| Very Rare | Serotonin syndrome [a combination of most or all of the | 9* | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
following; confusion, restlessness, sweating, shaking, shivering, hallucinations, sudden jerking of the muscles, fast heartbeat] | ||||
See Warnings & Precautions | New or worsened emotional or behavioural problems | 9* | ||
* If you think you have these side effects, it is important that you seek medical advice from your doctor immediately
This is not a complete list of side effects. For any unexpected effects while taking phl-FLUOXETINE, contact your doctor or pharmacist.
HOW TO STORE IT
Keep all medicines out of the reach of children. phl-FLUOXETINE should be stored in its original package at room temperature, in a dry place and out of direct sunlight. The expiry date of this medicine is printed on the package label. Do not use the medicine after the expiry date. If your doctor tells you to stop taking phl-FLUOXETINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmel Inc., at 1-888-550-6060