Mylan-Paliperidone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Mylan-Paliperidone belongs to a group of medicines called antipsychotic drugs.

Mylan-Paliperidone is a prescription medicine used to treat the symptoms of schizophrenia and related psychotic disorders.

The doctor has prescribed Mylan-Paliperidone, also known as paliperidone, to help relieve the symptoms that are bothering you/the patient you are caring for. Although Mylan-Paliperidone cannot cure the illness, it can keep the symptoms under control and reduce the risk of relapse as you/the patient you are caring for continues treatment.

Not all people with schizophrenia and related psychotic disorders have the same symptoms. Some of the most common symptoms of schizophrenia and related psychotic disorders may include:

• hallucinations

  • seeing, feeling, hearing, or smelling things that

    are not there

• delusions

  • believing things that are not true

• paranoia

  • feeing paranoid or not trusting others and

    feeling very suspicious

• avoiding family and friends and wanting to be alone

Related psychotic disorders may also include:

• mania

  • being very over-active or over-excited

• symptoms of depression

  • feeling sad, hopeless, helpless, tired, or sleeping

    a lot or not enough.

What it does:

Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how Mylan-Paliperidone works is unknown. However, it seems to readjust the balance of dopamine and serotonin.

When it should not be used:

Do not take/give Mylan-Paliperidone if you/the patient you are caring for has had an allergic reaction to paliperidone, or a related drug (risperidone), or any of the nonmedicinal ingredients.

Symptoms of an allergic reaction may include: itching, skin rash, swelling of the face, lips or tongue, shortness of breath. If you experience any of these symptoms/if these symptoms are experienced by the patient you are caring for, your doctor/the treating physician should be contacted immediately.

Mylan-Paliperidone is not recommended for use in children under 18 years of age.

What the medicinal ingredient is:

Paliperidone

What the nonmedicinal ingredients are:

3 mg tablets: butylated hydroxytoluene, cellulose acetate, colloidal silicone dioxide, iron oxide red, iron oxide yellow, hydroxypropyl cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, sodium stearyl fumarate, and talc. Coating: hydroxypropylmethyl cellulose, iron oxide black, polyvinyl alcohol, polyethylene glycol, propylene glycol, talc, and titanium dioxide.

6 mg tablets: butylated hydroxytoluene, cellulose acetate, colloidal silicone dioxide, FD&C Blue #1, iron oxide red, iron oxide yellow, hydroxypropyl cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, sodium stearyl fumarate, and talc. Coating: hydroxypropylmethyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, polyvinyl alcohol, polyethylene glycol, propylene glycol, talc, and titanium dioxide.

What dosage forms it comes in:

Mylan-Paliperidone tablets are controlled release tablets available in 3 mg and 6 mg dosage strength.

WARNINGS AND PRECAUTIONS

BEFORE you use Mylan-Paliperidone, talk to your doctor or pharmacist if you:

• have had serious allergic reactions to other

  medications, including risperidone

• have a history of stroke, mini-stroke, high

  cholesterol or high blood pressure. Medicines Serious Warnings and Precautions

Increased Risk of Death in Elderly People with Dementia. Medicines like Mylan-Paliperidone can raise the risk of death in elderly people who have dementia. Mylan-Paliperidone is not approved for use in patients with dementia.

like Mylan-Paliperidone can raise the risk of stroke in elderly people who have dementia. Mylan-Paliperidone is not approved for use in patients with dementia.

• have had neuroleptic malignant syndrome (a disorder

  that causes you to have high fever and stiffness in your muscles)

• have had tardive dyskinesia (a disorder that causes you

  to have uncontrolled and repeated movements of the tongue, face or other body parts).

• have or are at a risk for diabetes or high blood sugar or

  have a family history of diabetes

• are pregnant, think you may be pregnant or are planning

  to become pregnant

• are breast-feeding or planning to breast feed
• have had or have prolonged and/or painful erection

• have a history of:

  • heart problems
  • any problems with the way your heart beats
• are being treated for high blood pressure

• are taking any medications that affect how your heart

  beats

• have or have had a heart disease or heart disease

  treatment that makes you more likely to have low blood pressure or feeling dizzy or faint when you stand up from lying or sitting positions

• have/have ever had blackouts or seizures

• have or have had low white blood cell counts in your

  blood. Let your doctor know right away if you develop a fever or infection while being treated with Mylan-Paliperidone

• have high levels of cholesterol or fats (triglycerides)

  in your blood

• have, have a history of or are at risk of:

  • sleep apnea (a sleep disorder where your breathing is

    interrupted during sleep)

  • sleep walking
  • sleep-related eating disorder

• are at risk for developing blood clots. Risk factors

  include:

  • a family history of blood clots
  • being over the age over 65
  • smoking
  • being overweight

  • having a recent major surgery (such as hip or knee

    replacement)

  • not being able to move due to air travel or other

    reasons

  • taking oral birth control (“The Pill”)

• have a narrowing or blockage of your gastrointestinal

  tract (your esophagus, stomach, or large or small intestine)

• have diseases associated with diarrhea

• have Parkinson’s disease or Dementia with Lewy

  Bodies (DLB)

  • are taking or planning to take any other medicines

    (prescription or over- the-counter)

  • drink alcoholic beverages or use drugs
  • are taking risperidone
  • have a history of kidney problems
  • have liver problems
  • suffer from Alzheimer’s disease
  • exercise strenuously. This kind of medication may interfere with your body’s ability to adjust to heat. You should avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking Mylan-Paliperidone
  • have a fever or infection
  • have or have had breast cancer
  • have pituitary tumours

  • are planning to have an operation on the eye(s). During surgery to treat the cloudiness of the lens in your eye(s) (known as cataract surgery):

    • the pupil (the black circle in the middle of your eye) may not increase in size as needed
    • the iris (the coloured part of the eye) may become floppy during surgery. This may lead to eye damage Tell your eye doctor you are taking this medicine.
  • are feeling thirsty and unwell

Elderly Patients with Dementia

• Drugs that contain risperidone (such as risperidone) are similar to drugs that contain paliperidone (such as Mylan-Paliperidone). Studies have shown that when risperidone and furosemide (a “water pill”) are taken together by elderly patients who have dementia, it is linked to a higher rate of death.

  Tell your doctor if you are taking furosemide. This drug can be used to treat:

  • high blood pressure
  • some heart problems
  • swelling of parts of the body caused by the build-up of too much fluid

• In elderly patients who have dementia, other drugs that belong to the same group of drugs as Mylan-Paliperidone have also been linked to side effects that include:

  • a sudden change in mental state
  • sudden weakness or numbness of the face, arms or legs, especially on one side of the body
  • slurred speech
  • vision problems

If you have any of these symptoms, get medical help right away.

Effects on newborns

You should not take Mylan-Paliperidone while you are pregnant or if you are planning on becoming pregnant unless you have talked to your doctor about it.

If you took Mylan-Paliperidone at any time while you were pregnant or if you took it before you became pregnant, the following symptoms may happen in your newborn baby:

• shaking
• stiffness in their muscles and/or weakness
• sleepiness
• agitation
• breathing problems
• difficulty feeding

Get medical help right away if your newborn baby has any of these symptoms.

In some cases, babies born to a mother who took paliperidone while she was pregnant have had to be hospitalized after experiencing symptoms that were severe.

Other cautions

Driving and using machines: Do not drive or operate machinery until you know how you respond to Mylan-Paliperidone. Some people experience drowsiness or blurred vision while taking Mylan-Paliperidone.

Falls: Feeling sleepy, a fall in blood pressure when you stand up from sitting or lying down, vision and speech problems have been reported with the use of antipsychotic drugs. This can lead to falls that may cause fractures or other fall related-injuries. Certain medications, diseases or conditions can make this worse.

Weight gain: Weight gain has been seen in patients who are taking antipsychotic drugs. Your doctor may monitor your body weight when you are taking Mylan-Paliperidone.

Blood tests: Your doctor should do blood tests before you start taking Mylan-Paliperidone. They will check your blood sugar levels, and for those with certain risk factors, the level of white blood cells in your blood. Your doctor should continue to check your blood for as long as you are being treated with Mylan-Paliperidone.

It is important for the doctor to have all the above information before prescribing treatment and dosage. This list should be carefully reviewed by you and discussed with the doctor.

INTERACTIONS WITH THIS MEDICATION

Inform all doctors, dentists and pharmacists who are treating you that you are taking Mylan-Paliperidone. Inform them if you are taking or are planning on taking any other medicine, including prescription, over-the-counter, or natural health products. They will tell you which medicines you can take with Mylan-Paliperidone.

Since Mylan-Paliperidone works primarily in the brain, interference with other drugs that work in the brain (including alcohol) could occur. It is recommended that you DO NOT drink alcohol and only take drugs prescribed by your doctor.

The following may interact with Mylan-Paliperidone:

• Valproate (drugs used to treat seizures, manic-depression and migraines)
• Risperidone or injectable paliperidone palmitate. Taking either of these drugs together with Mylan-Paliperidone can increase the amount of paliperidone in your body.

• Mylan-Paliperidone can make you feel sleepy or drowsy.

  You should be careful when you take this drug with other drugs that can also cause you to become sleepy or drowsy.

• Since Mylan-Paliperidone can lower blood pressure, care should be taken when Mylan-Paliperidone is taken with other drugs that lower blood pressure.

• Dopamine agonists, e.g. levodopa (used to treat

  Parkinson’s disease), may decrease the effect of Mylan-Paliperidone. Also Mylan-Paliperidone can affect how drugs used to treat Parkinson’s disease work.

• Carbamazepine (a drug used to treat seizures) has been shown to decrease the levels of Mylan-Paliperidone in your blood.

Mylan-Paliperidone should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).

PROPER USE OF THIS MEDICATION

Do not chew, crush or divide the tablets. Swallow Mylan-Paliperidone tablets whole with water or other liquids.

Take Mylan-Paliperidone once each day preferably in the morning with or without food.

The Mylan-Paliperidone tablet does not dissolve completely after all the drug has been released, and you may sometimes notice it in your stool. This is normal.

It is very important that you take/give Mylan-Paliperidone the way the doctor has prescribed it.

The doctor has decided on the best dosage for you/the patient you are caring for based on individual needs. Dosage may be increased or decreased depending on the response.

It is important that you keep taking/giving Mylan-Paliperidone even after your/the symptoms have improved or disappeared. Do

not change or stop taking/giving Mylan-Paliperidone without consulting the doctor.

DO NOT give Mylan-Paliperidone to anyone else. The doctor has prescribed it for you/the patient you are caring for.

Usual adult dose:

The usual starting dose is 6 mg once daily.

For patients with impaired kidney function:

Mild impairment: the recommended initial dose is 3 mg once daily; your doctor may later decide to increase the dose to 6 mg once daily.

Moderate to severe impairment: the recommended initial dose is 3 mg every other day; your doctor may later decide to increase the dose to 3 mg once daily.

Overdose:

Patients who have been given too much paliperidone may experience the following symptoms:

• feeling drowsy or sleepy
• a fast heart rate
• low blood pressure

• irregular heartbeat or other symptoms of an irregular

  heartbeat, such as lightheadedness or fainting

• unusual movements of the face, body, arms or legs (such

  as excessive trembling or muscle stiffness)

Missed dose:

If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you miss one dose, take your next dose on the day following the missed dose.

If you miss two or more doses, contact your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

These are not all the possible side effects you may feel when taking Mylan-Paliperidone. If you experience any side effects not listed here, contact your healthcare professional.

Very commonly headache, or feeling sleepy or less alert may be experienced.

Common side effects may include: common cold symptoms, sinus infection, difficulty falling or staying asleep, mania, irritability,

depression, anxiety, faster heart rate, slowed heart rate, heartbeat irregularities, lack of energy, restlessness, feeling dizzy, stuffy nose, drop in blood pressure upon standing, high blood pressure, stomach ache, dry mouth, itching, increased saliva, being sick (vomiting), diarrhea, uncontrollable movements of the face, eyes or body, trembling, slowness of movement, muscle stiffness or spasm, weight gain, and increased appetite.

Uncommon side effects may include: urinary tract infection, feeling like you have the flu, weight loss, anemia, high blood triglycerides (a fat), nightmares, swelling of legs or other body area, increased liver transaminases in your blood, rash, a restless urge to move parts of your body, fainting, sensation the room is spinning, sensation your heart is racing, variation in heart rate, heart rhythm changes, decreased blood pressure, decreased blood flow, rigid muscles, muscle weakness, and joint swelling.

Mylan-Paliperidone can raise your levels of a hormone called “prolactin”. This is measured with a blood test. Symptoms may include:

• In men:

  • swelling in the breast
  • difficulty in getting or maintaining an erection or other sexual dysfunction

• In women:

  • discomfort in the breasts
  • leaking of milk from the breasts (even if not pregnant)
  • missing your menstrual period or other problems with your cycle

If you have high levels of prolactin and a condition called hypogonadism you may be at an increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

High blood sugar has been reported. See your doctor if you experience symptoms such as excessive thirst or urination.

In rare cases, the following may happen: low blood sugar, diabetes mellitus or worsening of diabetes, increased cholesterol, loss of consciousness, heartbeat irregularities, joint stiffness, and vaginal discharge.

Lack of bowel muscle movement that causes blockage may occur very rarely.

Side effects where the frequency is not known include glaucoma (increased pressure within the eyeball), and problems with the movement of your eyes.

Since paliperidone is a compound resulting from the breakdown of risperidone in the human body, any side effects that may occur after taking risperidone may also occur with Mylan-Paliperidone.

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

HOW TO STORE IT

Store Mylan-Paliperidone in its original package.

Store Mylan-Paliperidone between 15°C to 30°C. Protect from moisture.

Keep Mylan-Paliperidone out of the sight and reach of children.

The expiry date for Mylan-Paliperidone is printed on the package. Do not use the medicine in the package after this date.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

MORE INFORMATION

If you want more information about Mylan-Paliperidone:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; or by calling 1-844 596-9526
• This document can be found at: www.mylan.ca.

Last Revised: December 5, 2018

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-844 596-9526

www.mylan.ca