About this Medication
- How does this medication work? What will it do for me?
- How should I use this medication?
- What form(s) does this medication come in?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
How does this medication work? What will it do for me?
Fluvoxamine belongs to the class of medications called selective serotonin reuptake inhibitors (SSRIs). It is used to treat depression and obsessive-compulsive disorder (OCD). It helps to reduce anxiety and unpleasant thoughts associated with OCD and improves mood by treating depression.
Serotonin reuptake inhibitors are thought to work by increasing the amount of a neurotransmitter (a chemical found in the brain) called serotonin. Although you may start feeling better within a few weeks of treatment, the full effects of the medication may not be evident until several weeks of treatment have passed.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
How should I use this medication?
The recommended adult dose of fluvoxamine ranges from 50 mg to 300 mg depending on circumstances. A low dose of fluvoxamine (e.g., 50 mg) is usually used to start treatment, with increases in dose every few days as tolerated until the best dose is reached.
Doses of up to 150 mg are taken once daily at bedtime. Doses above 150 mg are taken twice daily, with 150 mg being taken at bedtime.
The tablets should be swallowed whole with water and without chewing.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you forget a dose of fluvoxamine, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does this medication come in?
Each white, round, biconvex, film-coated tablet, scored and engraved "PRO 50" on one side, plain on the other side, contains 50 mg of fluvoxamine maleate. Nonmedicinal ingredients: magnesium stearate, mannitol, hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, titanium dioxide, and carnauba wax.
Each white, round, biconvex, film-coated tablet, scored and engraved "PRO 50" on one side, plain on the other, contains 100 mg of fluvoxamine maleate. Nonmedicinal ingredients: magnesium stearate, mannitol, hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, titanium dioxide, and carnauba wax.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to fluvoxamine or any ingredients of the medication
- are also taking thioridazine, tizanidine, pimozide, or any of the following medications that are no longer available in Canada: cisapride, terfenadine, astemizole, ramelteon, or mesoridazine
- have taken an MAO inhibitor (e.g., tranylcypromine, phenelzine, linezolid, methylene blue) within the last 14 days
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- decreased appetite
- dry mouth
- feeling restless or unable to sit still
- increased sweating
- trembling or shaking
- trouble sleeping
- upset stomach
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- behaviour, mood, or mental changes
- change in sexual performance or desire
- hallucinations (seeing or hearing things that are not there)
- irregular menstrual cycles
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
- symptoms of low sodium levels in the blood (e.g., achy, stiff or uncoordinated muscles; confusion; tiredness; weakness)
- trouble urinating
- unusual secretion of milk (women) or breast swelling (men)
- unusual, uncontrolled, or sudden body or facial movements
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- symptoms of serotonin syndrome/neuroleptic malignant syndrome, including:
- increased sweating
- mood or behaviour changes
- overactive reflexes
- racing heartbeat
- shivering or shaking
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- thoughts of suicide or self-harm
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Behaviour changes: People taking this medication have reported behaviour and mood changes. These changes include restlessness, agitation, mood swings, aggression, hostility, decreased impulse control, and suicidal behaviour. If you notice any of these effects in yourself or a family member who is taking this medication, contact the doctor as soon as possible.
Bleeding: Fluvoxamine, like other SSRI medications, may cause an increased risk of bleeding, particularly if you are taking acetylsalicylic acid (ASA) or other medications that affect how the blood clots. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Bones: Fluvoxamine, like other SSRI medications, may increase the risk of bone fracture, especially if you are a senior or have osteoporosis or other major risk factors for breaking a bone. Take extra care to avoid falls, especially if you get dizzy or have low blood pressure. Your doctor may monitor your bones while you are taking this medication.
Change in blood sugar levels: Changes in blood sugar levels have been reported in the early stages of treatment for people taking fluvoxamine, whether or not they have been diagnosed with diabetes. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness/reduced alertness: Some people who take fluvoxamine may become drowsy. Avoid activities that require complete mental alertness, judgment, and physical coordination (such as driving a car or performing hazardous tasks) until you determine how fluvoxamine affects you.
Glaucoma: This medication may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking this medication.
Liver function: Rarely, this medication has been linked to decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Seizures: There have been occasional reports of seizures occurring with fluvoxamine. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Serotonin syndrome or neuroleptic malignant syndrome: Severe reactions are possible when fluvoxamine is combined with other medications that act on serotonin, such as tricyclic antidepressants and certain medications used to treat migraines. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.
If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Stopping the medication: Stopping this medication suddenly may lead to side effects such as dizziness; abnormal dreams; confusion; burning, prickling, or tingling skin; difficulty concentrating; fatigue; anxiety or agitation; shaking; nausea or vomiting; or sweating. If you are thinking of stopping the medication, check with your doctor first.
Suicidal or agitated behaviour: Adults and children taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after the person starts taking this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Pregnancy: It has been reported that babies born to women who took medications of this kind during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, jitteriness, irritability, and constant crying). This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking fluvoxamine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and efficacy of this medication have not been established for children and adolescents under 18 years of age. The use of this medication by people in this age group may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.
What other drugs could interact with this medication?
There may be an interaction between fluvoxamine and any of the following:
- acetylsalicylic acid (ASA)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- antiarrhythmics (e.g., amiodarone, disopyramide, lidocaine, mexiletine, propafenone, quinidine)
- anticoagulants ("blood thinners"; e.g., apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
- ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- grapefruit juice
- icosapent ethyl
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- monoamine oxidase inhibitors (MAOIs; e.g., linezolid, methylene blue, moclobemide, rasagiline, selegiline, tranylcypromine)
- multivitamins with mineral supplements
- muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine, tizanidine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
- omega-3 fatty acids
- proton pump inhibitors (e.g., dexlansoprazole, lansoprazole, omeprazole)
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
- thyroid replacements (e.g., desiccated thyroid, levothyroxine)
- tricyclic antidepressants (e.g., desipramine, nortriptyline)
- triptans (e.g., almotriptan, eletriptan, sumatriptan, rizatriptan)
- tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
- Vitamin E
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Fluvoxamine-by-Pro-Doc