What is it and how is it used?
XEPLION is used as a maintenance treatment for the symptoms of schizophrenia in adult patients stabilised on paliperidone or risperidone.
If you have shown responsiveness to paliperidone or risperidone in the past and have mild to moderate symptoms your doctor may start treatment with XEPLION without prior stabilisation with paliperidone or risperidone.
Schizophrenia isa disease with “positive” and “negative” symptoms. Positive means an excess of symptoms that are not normally present. For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel unusually suspicious of others. Negative means a lack of behaviours or feelings that are normally present. For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way. People with this disease may also feel depressed, anxious, guilty, or tense.
What do you have to consider before using it?
Do not use XEPLION
Take special care with XEPLION
XEPLION has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4, possible side effects).
XEPLION should not be used in children and adolescents under 18 years of age.
All medicines have side effects and some of the side effects of XEPLION can worsen the symptoms of other medical conditions. For that reason, it is important to discuss with your doctor any of the following conditions which can potentially worsen during treatment with XEPLION.
If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose or monitor you for a while.
Since XEPLION may reduce your urge to vomit, there is a chance that it may mask the body’s normal response to ingestion of toxic substances or other medical conditions.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Since XEPLION works primarily in the brain, interference from other medicines (or alcohol) that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain.
Since XEPLION can lower blood pressure, care should be taken when XEPLION is used with other medicines that lower blood pressure.
XEPLION can reduce the effect of medicines against Parkinson’s disease and restless legs syndrome (e.g. levodopa).
Paliperidone palmitate may cause an electrocardiogram (ECG) abnormality demonstrating a long time for an electrical impulse to travel through a certain part of the heart (known as “QT prolongation”). Other medicines that have this effect include some medicines used to treat the rhythm of the heart or to treat infection, and other antipsychotics. It is important to notify your doctor of any medicines you are taking to treat such conditions.
If you are prone to develop convulsions, paliperidone palmitate may increase your chance of experiencing them. Other medicines that have this effect include some medicines used to treat depression or to treat infection, and other antipsychotics. It is important to notify your doctor of any medicines you are taking to treat such conditions.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or think you are pregnant. You should not use XEPLION during pregnancy unless this has been discussed with your doctor.
XEPLION can pass from mother to baby through breast milk and may harm the baby. Therefore, you should not breastfeed when using XEPLION.
Driving and using machines
Dizziness, extreme tiredness and vision problems may occur during treatment with XEPLION (see section 4). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machinery.
Important information about some of the ingredients of XEPLION
This medicinal product contains less than 1 mmol sodium (23 mg) per 50 mg dose, i.e., essentially ‘sodium free’.
How is it used?
XEPLION is administered by your doctor or other health care professional in a doctor’s office or clinic. Your doctor will tell you when to come into the doctor’s office or clinic for the injection. It is important not to miss your scheduled dose. If you cannot keep your appointment with the doctor, make sure you call him right away so another appointment can be made as soon as possible. XEPLION will be given by intramuscular injection in the upper arm or buttocks. You will receive the first (150 mg) and second (100 mg) injections of paliperidone palmitate approximately 1 week apart. Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) once a month. Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive by one dose level at the time of your scheduled monthly injection.
Kidney problems
If you have mild kidney problems your doctor may give you a lower dose. If you have moderate or severe kidney problems XEPLION should not be used.
Elderly
If you are elderly and have mild kidney problems your doctor may give you a lower dose.
Liver problems
If you have severe liver problems XEPLION should be used with caution.
If you are given more XEPLION than needed
This medicine will be given to you under medical supervision; it is, therefore, unlikely that you will be given too much.
Patients who have been given too much paliperidone may experience the following symptoms: drowsiness or sedation, fast heart rate, low blood pressure, an abnormal electrocardiogram (electrical tracing of the heart), or slow or abnormal movements of the face, body, arms or legs.
If you stop using XEPLION
If you stop receiving your injections, you will lose the effects of the medicine. You should not stop using this medicine unless told to do so by your doctor as your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, XEPLION can cause side effects, although not everybody gets them.
Uncommonly, you may experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction’). If this should occur, seek medical attention immediately.
In elderly patients with dementia, medicines in the same group as XEPLION have been associated with side effects including sudden weakness or numbness of the face, arms, or legs, instances of slurred speech, or blurred vision. These symptoms may be associated with stroke. If any of these should occur, even for a short period of time, seek medical attention immediately(see section 2, take special care with XEPLION).
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Very common side effects
Common side effects may include:
One of the most well-known side effects of paliperidone is a group of movement problems known as extrapyramidal disorder. Symptoms may include: abnormal muscle movements, abnormal movements of the mouth, tongue or jaw, lockjaw, drooling, slow or sustained muscle contractions, stiff muscles making your movements jerky, slow shuffling walk, muscle spasms, tremor (shaking), abnormal eye movements, involuntary muscle contractions, prolonged contraction of the neck muscles producing an unnatural position of the head, slow movements or restlessness. Sometimes these side effects can be treated with another medicine while you continue on paliperidone.
Other common side effects include:
Uncommon side effects may include:
Rare side effects may include:
The following are a list of additional side effects that have been reported with paliperidone prolonged release tablets:
Common side effects may include:
Uncommon side effects may include:
Rare side effects may include:
Side effects with an unknown frequency may include:
Since paliperidone is a compound resulting from the breakdown of risperidone in the human body, any side effects that may occur after the ingestion of risperidone (another antipsychotic medicine) may also occur with XEPLION. For more information on what these side effects are, speak with your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of reach and sight of children.
Do not use XEPLION after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
