Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses Modecate (Fluphenazine). If you are concerned about side effects, discuss the risks and benefits of Modecate (Fluphenazine) with your doctor.

The following side effects have been reported by at least 1% of people using Modecate (Fluphenazine). 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.

• changes in menstrual period
• Constipation
• decreased sexual ability
• decreased sweating
• dizziness
• drowsiness or fatigue
• dryness of mouth
• headache
• loss of appetite
• nausea
• rough tongue
• stuffy nose
• swelling or pain in breasts
• trouble sleeping
• unusual secretion of milk
• unusual weight changes
• watering of mouth

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:

• anxiety
• blurred vision, change in colour vision, or difficulty seeing at night
• difficult urination
• infection of the lungs (pneumonia)
• loss of balance control
• mask-like face
• new or worsening constipation
• severe restlessness or need to keep moving
• severe Sunburn
• shuffling walk
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, 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)
• signs of movement disorders
• inability to move eyes
• increased blinking or spasms of eyelid
• lip smacking or puckering
• muscle spasms of the face, neck, body, arms, or legs causing unusual postures or unusual expressions on face
• puffing of cheeks
• rapid or worm-like movements of the tongue
• sticking out of tongue
• trouble breathing, speaking, or swallowing
• twitching movements
• uncontrolled chewing movements
• uncontrolled movements of arms or legs
• uncontrolled twisting movements of neck, trunk, arms, or legs
• skin rash
• stiffness of arms and legs
• swelling of the hands or feet
• symptoms of infection (e.g., Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• long-lasting (more than 4 hours) and painful erection
• seizures
• signs of a serious allergic reaction (e.g., Hives, difficulty breathing, or swelling of the face and throat)
• signs of abnormal heart rhythm (e.g., rapid heartbeat, chest pain, fainting)
• symptoms of neuroleptic malignant syndrome
• difficult or fast breathing
• fast heartbeat
• fever
• high or Low Blood Pressure
• increased sweating
• loss of bladder control
• severe confusion or coma
• severe muscle stiffness
• trembling or shaking
• trouble speaking or swallowing
• signs of a Stroke:
• sudden weakness or numbness in the face, arms, or legs (often on one side of the body)
• speech problems
• vision problems
• balance problems or dizziness
• confusion
• sudden severe headache with no known cause

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 Modecate (Fluphenazine).

Each mL of injectable solution contains 100 mg of Modecate (Fluphenazine) decanoate. Nonmedicinal ingredients: benzyl alcohol 1.5% w/v (preservative) and sesame oil.

You should not receive Modecate (Fluphenazine) decanoate if you:

• are allergic to Modecate (Fluphenazine) decanoate, other phenothiazine medications (e.g., Prochlorperazine, Chlorpromazine), or any ingredients of the medication
• are taking large doses of CNS depressant medications such as alcohol, sedatives (e.g., Lorazepam, Diazepam), or narcotics (e.g., Codeine, Oxycodone, Hydromorphone)
• have blood disorders
• have serious heart, brain, or Kidney Disease
• have suspected or documented brain damage or hardening of the arteries in the brain
• have liver damage
• have a pheochromocytoma, a tumour of the adrenal glands has severe central nervous system (CNS) Depression that can cause decreased heart rate and breathing

There may be an interaction between Modecate (Fluphenazine) decanoate and any of the following:

• Abiraterone
• aclidinium
• alcohol
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• antihistamines that cause drowsiness (e.g., Diphenhydramine)
• antiseizure medications (e.g., Phenytoin, Carbamazepine)
• asunaprevir
• azelastinebarbiturates (e.g., Phenobarbital, butalbital)
• benzodiazepines (e.g., Alprazolam, Clonazepam, diazepam, lorazepam)
• beta-blockers (e.g., Atenolol, Carvedilol, Propranolol)
• Bupropion
• Buspirone
• Bromocriptine
• chloral hydrate
• chloroquine
• Clonidine
• cobicisat
• Darifenacin
• Dextromethorphan
• Donepezil
• Dronedarone
• Epinephrine
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• Flavoxate
• imatinib
• ipratropium
• levodopa
• lithium
• Mefloquine
• Methylphenidate
• Metoclopramide
• Mirabegron
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, orphenadrine, Tizanidine)
• narcotic pain medication (e.g., codeine, Morphine, oxycodone)
• nefazodone
• other antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• potassium chloride
• Pramipexole
• Primaquine
• Pseudoephedrine
• quinidine
• quinine
• quinolone antibiotics (e.g., moxifloxacin)
• Ropinirole
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• Solifenacin
• thiazide diuretics (water pills; e.g., Hydrochlorothiazide, Indapamide, Metolazone)
• tiotropium
• tipranavir
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Imipramine, Nortriptyline)
• "triptan" migraine medications (e.g., Eletriptan, Sumatriptan)
• Tryptophan
• umeclidinium
• Zolpidem
• Zopiclone

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 Modecate (Fluphenazine). 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.

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 Modecate (Fluphenazine).

Abnormal heart rhythm: Modecate (Fluphenazine) may cause or increase the risk for a certain type of abnormal heart rhythm called QT prolongation. Other medications can also increase the risk of QT prolongation when taken together with Modecate (Fluphenazine) decanoate. If you experience symptoms of an abnormal heart rhythm such as dizziness, heart palpitations (fast, pounding, or irregular heartbeat), fainting, or seizures, stop taking Modecate (Fluphenazine) and get immediate medical attention.

Blood Clots: Modecate (Fluphenazine) may increase the chance of blood clot formation. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Blood counts: Modecate (Fluphenazine) can decrease the number of neutrophils (a type of white blood cell that helps fight infection) and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Drowsiness/reduced alertness: Especially in the first few days of treatment, Modecate (Fluphenazine) may impair the mental and physical abilities required for driving a car or operating heavy machinery. Avoid these activities until you know Modecate (Fluphenazine) does not affect your ability to perform them safely. Avoid drinking alcohol while using Modecate (Fluphenazine), as it can produce extreme drowsiness.

Heat exposure and sweating: Modecate (Fluphenazine) decanoate may prevent the body from cooling when overheated by reducing your ability to sweat. Avoid becoming overheated when using Modecate (Fluphenazine) decanoate.

Involuntary movement: Like other medications to control symptoms of schizophrenia, Modecate (Fluphenazine) decanoate may cause rhythmic involuntary movements, known as tardive dyskinesia. Tardive dyskinesia is more likely to occur in women and seniors. These movements may involve only the tongue, face, mouth, or jaw, or they may include the extremities and trunk. Tardive dyskinesia is not reversible for some people. Report involuntary movements including sticking out the tongue, puckering mouth, or chewing movements to your doctor as soon as possible.

Kidney function: Modecate (Fluphenazine) decanoate may cause decreased kidney function and should not be used by people with kidney disease. Your doctor may want to regularly monitor your kidney function with blood tests when you first start taking Modecate (Fluphenazine) decanoate to monitor for reduced kidney function.

Liver problems: Modecate (Fluphenazine) decanoate may cause liver problems. Your doctor may want to test your liver function with blood tests regularly while you are taking Modecate (Fluphenazine). If you notice any signs of liver problems such as yellowing of the skin or whites of the eyes, nausea, vomiting, diarrhea, loss of appetite, weight loss, dark urine, or pale stools, contact your doctor as soon as possible.

Low blood pressure: Modecate (Fluphenazine) can cause low blood pressure. If you have heart disease, disorders of the blood vessels in the brain, or are having surgery, discuss with your doctor how Modecate (Fluphenazine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Modecate (Fluphenazine), and whether any special monitoring is needed.

Neuroleptic malignant syndrome: Very rarely, Modecate (Fluphenazine) decanoate has been reported to cause a severe reaction called neuroleptic malignant syndrome. If you or someone in your family who is being given Modecate (Fluphenazine) decanoate develops symptoms including high body temperature (above 38°C), sweating, rapid heartbeat, severe muscle stiffness, and change in alertness, seek emergency help immediately.

Seizure disorders: Seizures have been reported by people who are taking Modecate (Fluphenazine) decanoate. If you have seizure disorders, discuss with your doctor how Modecate (Fluphenazine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Modecate (Fluphenazine), and whether any special monitoring is needed.

Sun: Modecate (Fluphenazine) makes you more sensitive to the harmful effects of sunlight.

Tremor and stiffness: As with other medications used to treat schizophrenia, Modecate (Fluphenazine) decanoate may cause tremors or stiffness, or difficulty beginning purposeful movement. If this occurs, report it to your doctor as soon as possible.

Vision changes: Modecate (Fluphenazine) decanoate has been reported to cause changes in vision. Tell your doctor about any changes as soon as possible.

Withdrawal: Suddenly stopping Modecate (Fluphenazine) can cause withdrawal symptoms such as nausea, vomiting, dizziness, and shaking. Do not stop using Modecate (Fluphenazine) unless recommended by your doctor.

Pregnancy: Modecate (Fluphenazine) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Modecate (Fluphenazine), contact your doctor immediately.

Breast-feeding: It is not known if Modecate (Fluphenazine) decanoate passes into breast milk. If you are a breast-feeding mother and are taking Modecate (Fluphenazine), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Modecate (Fluphenazine) have not been established for children.

Seniors: Seniors with Dementia may be more at risk of heart attack, stroke and death while using Modecate (Fluphenazine). They are also more likely to experience side effects. Talk to your doctor about the risks and benefits of using Modecate (Fluphenazine).