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INVEGA SUSTENNA (paliperidone) – Information for consumers

INVEGA SUSTENNA (paliperidone) Intramuscular Injection is a Prescription Medicine. It is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings and behaviour. Your doctor will advise you if INVEGA SUSTENNA may be suitable for you. Always read the label and use strictly as directed. If symptoms continue, or if you experience side effects, contact your doctor, pharmacist or health professional.

INVEGA SUSTENNA is a funded medicine (pharmacy charges and doctor’s visit fee may apply).

INVEGA SUSTENNA has risks and benefits.

Do not use if you are allergic to INVEGA SUSTENNA or any of its ingredients or medicines containing paliperidone or risperidone. Tell your doctor if you have or have ever had: heart or blood vessel diseases, including low blood pressure; dehydration; kidney or liver problems; Parkinson’s disease; dementia or Lewy body dementia; epilepsy, seizures or fits; disease of the pituitary gland; Neuroleptic Malignant Syndrome (a serious reaction to some medicines, consisting of a sudden increase in body temperature, extremely high blood pressure and severe convulsions); tardive dyskinesia (a reaction to some medicines, seen as uncontrollable twitching or jerking movements of the face, mouth, jaw, arms and/or legs; diabetes or high blood sugar; a stroke; blood clots or a family history of blood clots; continuous or painful erection; low white blood cell count. Tell your doctor if: You are pregnant or are planning to become pregnant or you are breast feeding or you are taking any other medicines. Avoid alcohol while taking INVEGA SUSTENNA and take care when driving or operating machinery. Carefully manage your diet to avoid possible weight gain. Side Effects: Heart or blood pressure problems e.g. light headedness or dizziness, fast, slow or irregular heart beat; high fever; abnormal sweating; sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech. Allergic reactions: Symptoms may include rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, difficulty swallowing, swelling of the face, lips, mouth, tongue or other parts of the body. If you experience any of these side effects or symptoms, contact your doctor immediately or go to Accident and Emergency at your nearest hospital. Other side effects may include: sleeplessness; agitation; anxiety; headache; trembling; drowsiness; injection site pain; stiff muscles; joint stiffness or swelling; pneumonia; infection; blurred vision; flu-like symptoms; toothache; inability or pain to urinate; dry mouth; depression; acne; dry skin; hardening of the skin; elated mood; lack of emotion; vertigo; nosebleeds; weight gain or loss; increase or decrease in appetite; indigestion, nausea abdominal pain and vomiting; diarrhoea; excessive thirst; unusual secretion of breast milk; breast swelling; missed or irregular menstrual periods; getting or maintaining an erection or prolonged and/or painful erection; involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk. Tell your doctor as soon as possible if you do not feel well while you are using INVEGA SUSTENNA.

Each pre-filled syringe contains either 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of paliperidone (as palmitate) for intramuscular injection.

Supplier: Janssen-Cilag (New Zealand) Ltd, 507 Mount Wellington Hwy, Mount Wellington, Auckland 1060, New Zealand.

Additional product information (including the Consumer Medicine Information) can be obtained by contacting Janssen on 0800 800 806, or on the Janssen website (available from www.janssen.com/newzealand/our-medicines).

Date of Preparation: 13 July 2018