XEPLION prolonged-release suspension for injection 100 mg /Paliperidone/

XEPLION is used as maintenance treatment for the symptoms of schizophrenia in adult patients stabilized with paliperidone or risperidone.
If you have shown a history of paliperidone or risperidone and have mild to moderate symptoms, your doctor may start treatment with XEPLION without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disease with “positive” and “negative” symptoms. “Positive” means excessive symptoms that are not normally observed. For example, a person with schizophrenia may hear voices or see things that do not exist (called hallucinations), believe in things that are not true (distorted perception of reality), or to feel unusually suspicious of others. “Negative” means a lack of behavior or feelings that normally exist. For example, a person with schizophrenia may seem lonely and not react emotionally at all, or may have difficulty speaking clearly and logically. People with this condition may feel depressed, anxious, guilty, or tense.

2. BEFORE YOU USE XEPLION

Do not use XEPLION
– if you are allergic (hypersensitive) to paliperidone or any of the other ingredients of XEPLION.
– if you are allergic (hypersensitive) to another antipsychotic medicine, including risperidone.
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HOW TO USE XEPLION?
XEPLION is given by your doctor or another healthcare professional in a doctor’s office or clinic. Your doctor will tell you when to go to the office or clinic for the injection. It is important not to miss your scheduled dose. If you cannot meet your doctor’s appointment, make sure you call your doctor in time to make another appointment as soon as possible.
You will receive the first injection (150 mg) and the second injection (100 mg) of XEPLION in the upper arm approximately every 1 week. You will then be given an injection (25 mg to 150 mg) once a month, either in the upper arm or in the buttocks.
If your doctor changes your treatment from a long-acting risperidone injection of XEPLION, you will receive your first XEPLION injection (25 mg to 150 mg) either in the upper arm or buttock on the day of the next injection. You will then be given an injection (25 mg to 150 mg) once a month, either in the upper arm or in the buttocks.
Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive by one dose level during your planned monthly injection.
Kidney problems
If you have mild kidney problems, your doctor may give you a lower dose. XEPLION should not be used if you have moderate or severe kidney problems.

Elderly patients
If you are an elderly patient and have moderate kidney problems, your doctor may give you a lower dose.

MORE INFORMATION
What does XEPLION contain?
The active substance is paliperidone.
Each pre-filled syringe contains 156 mg paliperidone palmitate, equivalent to 100 mg paliperidone.
The other ingredients are: Polysorbate 20 Macrogol 4000
Citric acid monohydrate Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections

What XEPLION looks like and contents of the pack
XEPLION is a white to off-white, prolonged-release suspension for injection in a pre-filled syringe, which will be given to you by your doctor in the office or clinic.
Each pack contains 1 pre-filled syringe and 2 needles.

Marketing Authorization Holder
Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Manufacturer:
Janssen Pharmaceutica N.V. Turnhoutseweg 30 B-2340 Beerse Belgium

More about XEPLION fl. 100 mg. * 1 JANSSEN – CILAG (XEPLION fl. 100 mg. * 1 JANSSEN – CILAG)