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«Package leaflet: Information for the user TREVICTA 175 mg prolonged release suspension for injection TREVICTA 263 mg prolonged release suspension for ...»

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Package leaflet: Information for the user

TREVICTA 175 mg prolonged release suspension for injection

TREVICTA 263 mg prolonged release suspension for injection

TREVICTA 350 mg prolonged release suspension for injection

TREVICTA 525 mg prolonged release suspension for injection

Paliperidone

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor, pharmacist or nurse.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What TREVICTA is and what it is used for

2. What you need to know before you use TREVICTA

3. How to use TREVICTA

4. Possible side effects

5. How to store TREVICTA

6. Contents of the pack and other information

1. What TREVICTA is and what it is used for TREVICTA contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients.

If you have responded well to treatment with paliperidone palmitate injection given once a month, your doctor may start treatment with TREVICTA.

Schizophrenia is a 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 For example, a person with schizophrenia may appear withdrawn and may not respond at all emotionally or may have trouble speaking in a clear and logical way.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.

TREVICTA can help alleviate the symptoms of your disease and reduce the chance of your symptoms coming back.

2. What you need to know before you use TREVICTA Do not use TREVICTA

- if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic to another antipsychotic medicine including the substance risperidone.

Warnings and precautions Talk to your doctor, pharmacist or nurse before using TREVICTA.

This medicine 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).

1 All medicines have side effects and some of the side effects of this medicine 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 this medicine:

- if you have Parkinson’s disease

- if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)

- if you have ever experienced twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body (Tardive Dyskinesia)

- if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)

- if you are diabetic or prone to diabetes

- if you have had breast cancer or a tumour in the pituitary gland in your brain

- if you have a heart disease or heart disease treatment that makes you prone to low blood pressure

- if you have low blood pressure when you stand up or sit up suddenly

- if you have a history of seizures

- if you have kidney problems

- if you have liver problems

- if you have prolonged and/or painful erection

- if you have problems with controlling body temperature or overheating

- if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour

- if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.

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.

As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking this medicine, your doctor may check your white blood cell counts.

Even if you have previously tolerated oral paliperidone or risperidone, rarely allergic reactions occur after receiving injections of TREVICTA. Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.

This medicine may cause you to gain weight. Significant weight gain may be bad for your health.

Your doctor should regularly measure your body weight.

As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking this medicine, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.





Since this medicine 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.

During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery and that may lead to eye damage. If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.

Children and adolescents Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

–  –  –

Taking this medicine with carbamazepine (an anti-epileptic and mood stabiliser) may require a change to your dose of this medicine.

Since this medicine works primarily in the brain, using other medicines that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.

Since this medicine can lower blood pressure, care should be taken when this medicine is used with other medicines that lower blood pressure.

This medicine can reduce the effect of medicines against Parkinson’s disease and restless legs syndrome (e.g., levodopa).

This medicine 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.

If you have a history of seizures, this medicine 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.

TREVICTA with alcohol Alcohol should be avoided.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine during pregnancy unless this has been discussed with your doctor. The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms seek medical attention for your baby.

This medicine can pass from mother to baby through breast milk and may harm the baby. Therefore, you should not breast-feed when using this medicine.

Driving and using machines Dizziness, extreme tiredness and vision problems may occur during treatment with this medicine (see section 4). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.

Important information about some of the ingredients of TREVICTA The normal dose range for this medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium free’.

3. How to use TREVICTA This medicine is administered by your doctor or other health care professional. Your doctor will tell you when you need your next 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.

–  –  –

Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive at the time of your next scheduled injection.

Patients with kidney problems If you have mild kidney problems your doctor will determine the appropriate dose of TREVICTA based on the dose of 1-monthly paliperidone palmitate injectable that you have been receiving. If you have moderate or severe kidney problems this medicine should not be used.

Elderly Your doctor will determine your dose of this medicine if your kidney function is reduced.

If you are given more TREVICTA 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 TREVICTA If you stop receiving your injections, your symptoms of schizophrenia may get worse. You should not stop using this medicine unless told to do so by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you:

• experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.

• experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.

• experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be needed.

• are a man and experience prolonged or painful erection. This is called priapism. Immediate medical treatment may be needed.

• experience twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body (tardive dyskinesia).

• 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’). Even if you have previously tolerated oral risperidone or oral paliperidone, rarely allergic reactions occur after receiving injections of paliperidone.

• are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine. During an operation on the eye for cloudiness of the lens (cataract), the iris (the coloured part of the eye) may become floppy during surgery (known as “floppy iris syndrome”) that may lead to eye damage.

• are aware of having dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood

–  –  –

Very common side effects: may affect more than 1 in 10 people

• difficulty falling or staying asleep.

Common side effects: may affect up to 1 in 10 people

• common cold symptoms, urinary tract infection, feeling like you have the flu

• high blood sugar, weight gain, weight loss

• irritability, depression, anxiety

• feeling restless

• parkinsonism: slow movements, with tremor, stiffness and a shuffling walk

• tremor (shaking)

• dystonia: slow or sustained involuntary contraction of muscles. While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.

• dizziness, feeling sleepy, or less alert, headache

• slow heart rate, rapid heart rate

• high blood pressure

• cough, stuffy nose

• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache

• increased liver transaminases in your blood

• rash

• bone or muscle ache, back pain, joint pain

• loss of menstrual periods

• fever, weakness, fatigue (tiredness)

• a reaction at the injection site, including itching, pain or swelling.

Uncommon side effects: may affect up to 1 in 100 people

• pneumonia, infection of the chest (bronchitis), infection of the breathing passages, sinus infection, bladder infection, ear infection, tonsillitis, fungal infection of the nails, infection of the skin

• white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding)

• anaemia

• allergic reaction

• TREVICTA can raise your levels of a hormone called "prolactin" found on a blood test (which

may or may not cause symptoms). When symptoms of high prolactin occur, they may include:



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