Invega

(paliperidone)

http://chealth.canoe.ca/drug_info_details.asp?brand_name_id=4853

DIN (Drug Identification Number)

02300273 02300281 02300303 INVEGA 3 MG TABLET INVEGA 6 MG TABLET INVEGA 9 MG TABLET

How does Invega work? What will it do for me?

Paliperidone belongs to the class of medications called antipsychotics. It is used to control the symptoms of schizophrenia. It works by readjusting the balance of chemicals in the brain that are involved in schizophrenia. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. 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 Invega?

The recommended adult dose is 6 mg taken once daily, preferably in the morning with or without food. For some people, a lower dose of 3 mg may be enough. The dose may be adjusted by 3 mg every 5 days as recommended by your doctor, according to response and severity of side effects. The maximum daily dose is 12 mg. Lower maximum daily doses are recommended for people with decreased renal function. The tablets must be swallowed whole with water or other liquids and must not be chewed, divided, or crushed. The tablet shell is not absorbed and you may notice it in your stool (this is normal).

Many things can affect the dose of a 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 use this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose. If you miss 2 or more doses, contact your doctor. Store this medication at room temperature, protect it from 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 Invega come in?

3 mg Each white, extended-release, capsule-shaped tablet, printed with "PAL 3", contains paliperidone 3 mg. Nonmedicinal ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, ferric oxide red, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, iron oxide black, lactose monohydrate, polyethylene oxides, polyethylene glycol, propylene glycol, povidone, sodium chloride, stearic acid, titanium dioxide and triacetin. 6 mg Each beige, extended-release, capsule-shaped tablet, printed with "PAL 6", contains paliperidone 6 mg. Nonmedicinal ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, ferric oxide red, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, iron oxide black, polyethylene oxides, polyethylene glycol, propylene glycol, povidone, sodium chloride, stearic acid and titanium dioxide. 9 mg Each pink, extended-release, capsule-shaped tablet, printed with "PAL 9", contains paliperidone 9 mg. Nonmedicinal ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, ferric oxide red, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, iron oxide black, polyethylene oxides, polyethylene glycol, propylene glycol, povidone, sodium chloride, stearic acid and titanium dioxide.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take Invega?

Paliperidone should not be taken by anyone who is allergic to paliperidone, risperidone, or to any of the ingredients of this medication.

What side effects are possible with Invega?

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.

anxiety blurred vision breast swelling and sexual difficulties (men) constipation dizziness drowsiness dry mouth fatigue headache increased appetite increased saliva production leakage of fluid or milk from breasts (women)

muscle stiffness or spasm nightmares restlessness runny nose sensations that the room is spinning slowness of movement stomach or abdominal pain toothache tremor vomiting weakness weight gain

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:

abnormal heart rhythms such as fast or slow heart rate (palpitations) changes in body temperature, or feeling very hot and unable to cool down confusion, reduced consciousness, high fever, or muscle stiffness dizziness, especially when standing from a lying or seated position painful eye movements swelling of the legs or other parts of the body

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

abnormal movements of the face or tongue continuous erection (an erection that lasts more than 4 hours) muscle twitching seizures sudden changes in mental state symptoms of a severe allergic reaction (itching, skin rash, shortness of breath, swelling of the face, lips, or tongue) symptoms of a stroke such as sudden weakness or numbness of the face, arms, or legs (especially on one side); slurred speech; vision problems

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 Invega?

Before you begin using a medication, be sure to inform your doctor of any medical conditions 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. Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., quinidine, procainamide, amiodarone, sotalol, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with paliperidone. People who have a slow heart rate, low potassium or magnesium levels, or have congenital prolongation of the QT interval are more at risk for this type of abnormal heart rhythm and its complications. Talk to your doctor about the risks and benefits of using this medication.

Blood sugar: This medication may cause high blood sugar levels. If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor. Body temperature: This medication, like other antipsychotic medications, can disrupt the body's ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication. Drowsiness/reduced alertness: Paliperidone may interfere with activities requiring mental alertness. People taking this medication should not drive or operate machinery until they know how this medication affects them. Gastrointestinal problems: Paliperidone should not be taken by people with conditions associated with narrowing of the gastrointestinal tract (e.g., esophagus disorders, inflammatory bowel disease, "short gut" syndrome, cystic fibrosis), or by people who have difficulty swallowing. Low blood pressure: Paliperidone may cause low blood pressure when rising from a sitting or lying position. If you feel dizzy, lightheaded, or feel your pulse racing, call your doctor. While you are taking this medication, get up slowly after you have been sitting or lying down for a prolonged period. Neuroleptic malignant syndrome (NMS): Paliperidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you experience the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, and fainting, get immediate medical attention. Parkinson's disease: People with Parkinson's disease or dementia with Lewy bodies (DLB) may be at an increased risk of NMS (see warning about NMS), as well as other side effects associated with paliperidone. Talk to your doctor about the risks and benefits of using this medication. Risperidone: People who are taking risperidone should not take paliperidone at the same time. These medications are related, and taking them together may cause an increased risk of side effects. Seizures: Paliperidone may increase the risk of seizures, especially in people who have had seizures in the past. People who are at risk of seizures who take this medication should be closely monitored by their doctor. Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the face and tongue muscles, may develop in people who take certain antipsychotic medications including paliperidone. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of

developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible. Pregnancy: 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. Women should not breast-feed while they are taking paliperidone. Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age. Seniors: Medications similar to paliperidone can increase the risk of death when used to treat seniors with dementia. Paliperidone should not be used to treat seniors with dementia.

What other drugs could interact with Invega?

There may be an interaction between paliperidone and any of the following:

alcohol amiodarone blood-pressure medications chlorpromazine dopamine agntagonists (e.g., pramipexole, ropinirole) gatifloxacin levodopa moxifloxacin procainamide quinidine risperidone sotalol thioridazine

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.