INVEGA 12 mg prolonged-release tablets

INVEGA belongs to the class of antipsychotic medicines and is used to treat schizophrenia and psychotic or manic symptoms of schizoaffective disorder. INVEGA is not effective for depressive symptoms.

Schizophrenia isa disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness. People with this disorder may also feel depressed, anxious, guilty, or tense.

Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad,feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).

Do not take INVEGA

• if you are allergic (hypersensitive) to paliperidone, any of the other ingredients ofINVEGA, or risperidone.

Take special care with INVEGA

• Patients with schizoaffective disorder treated with INVEGA should be carefully monitored for apotential switch from manic to depressive symptoms.

-INVEGA 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)

• if you have Parkinson?s disease or Dementia.
• 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 abnormal movements of the tongue or face (Tardive Dyskinesia). You should be aware that both of these conditions may becaused by this type of medicine .
• if you are diabetic or prone to diabetes.
• if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
• if you have epilepsy.
• if you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements.
• if you have diseases associated with diarrhoea
• if you have a loss of kidney function.
• if you have a loss of liver function.
• if you have prolonged and/or painful erection.
• if you have difficulty controlling core body temperature or overheating.
• 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Since INVEGA works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occurdue to additive effect on brain function.
Since INVEGA can lower blood pressure, care should be taken when INVEGA is taken with other medicines that lower blood pressure.
INVEGA can reduce the effect of medicines against Parkinson?s disease and restless legs syndrome (e.g., levodopa).
Dosage reduction for INVEGA should be considered when INVEGA is co-administered with valproate.

Taking INVEGA with food and drink

Alcohol should be avoided when taking INVEGA.
INVEGA should be taken every morning with breakfast or without breakfast, but in the same way every day. Do not alternate between taking INVEGA with breakfast one day and without having breakfast the next day.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or think you are pregnant. You should not take INVEGA during pregnancy unless this has been discussed with your doctor.
You should not breastfeed when taking INVEGA.

Driving and using machines

Dizziness and vision problems may occur during treatment with INVEGA (see section 4, possible side effects). 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 INVEGA

The 3 mg tablet of INVEGA contains lactose, a type of sugar. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. You should not take the 3 mg tablet of INVEGA because it contains lactose. However, the 1.5, 6 mg, 9 mg, or 12 mg INVEGA tablets can be taken as these do not contain lactose monohydrate.

Always take INVEGA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is 6 mg once a day taken in the morning, but the dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day for schizophrenia or 6 mg to 12 mg once a day for schizoaffective disorder. INVEGA must be taken by mouth, swallowed whole with water or other liquids. It must not be chewed, broken, or crushed. The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is passed out of the body as waste.

If you take more INVEGA than you should

Contact your doctor right away. You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.

If you forget to take INVEGA

Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose on the day following the missed dose. If you miss two or more doses, contact your doctor.

If you stop INVEGA

You will lose the effects of the medicine. You should not stop this medicine told to do so by your doctor as your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Children and adolescents

INVEGA is not for people who are under 18 years old.

Patients with liver or kidney impairment

Your doctor may adjust your dose of INVEGA based upon your kidney function. Adjustment in dose based on liver impairment is typically not necessary.

Elderly

Your doctor may reduce your dose of INVEGA if your kidney function is reduced. Safety and efficacy of INVEGA in patients > 65 years of age with schizoaffective disorder have not been studied.

Like all medicines, INVEGA 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 occurs, seek medical attention immediately.

In elderly patients with dementia, medicines in the same group as INVEGA 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 occur, even for a short period of time, seek medical attention immediately(See section 2, take special care with INVEGA).

The frequency of possible side effects listed below is defined using the following convention:

very common (affects at least1 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: headache may be experienced.
Common side effects may include:

• upper respiratory tract infection; infection of the nose and throat
• increased weight; increased appetite;
• agitation;
• speech impediment, abnormal muscle movements; a collection of symptoms known as extrapyramidal symptoms (EPS) which typically will involve abnormal involuntary muscle movements;
• inner restlessness; tremor (shaking); slow or sustained muscle contractions;
• dizziness; drooling; sedation; sleepiness;
• blurry vision;
• abnormally fast heartbeat; rapid heart rate;
• low blood pressure upon standing;
• cough; pain in the throat and upper part of the windpipe; nasal congestion;
• vomiting; upper abdominal pain; stomach discomfort; being sick (nausea); indigestion; dry mouth; constipation;
• joint pain; back pain; pain in extremity;
• weakness; fatigue. Uncommon side effects may include:
• urinary tract infection; runny nose
• high blood sugar; decreased appetite
• restlessness; nightmare; sleep disorder
• fainting episode; slow movements of your muscles; involuntary muscle contractions; dizziness upon standing; listlessness; slow movements;
• abnormal movements of the eyes;
• blocked nerve in heart; block between two chambers of your heart; slow heart rate; palpitations; abnormal electrocardiogram (ECG); increase in heart rate in relation to breathing;
• low blood pressure;
• increase saliva secretion; excessive passing of gas;
• rash; itching
• difficulty opening the mouth due to spasm of the jaw muscles; muscle tightness; muscle spasms; muscle twitching; muscle pain; muscle aches
• inability to pass urine;
• problems with erections; milk secretion from breasts; absence of menstrual periods;
• increased peripheral fluid retention .

Rare side effects may include:

• allergic reaction; increased sensitivity to allergy;
• high level of prolactin hormone in your blood;
• sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (mini-stroke); convulsion (fits) with shaking movements and tense muscles; convulsions (fits); slow; involuntary, repetitive muscle movements; slow shuffling walk; stiff muscles like a cogwheel;
• left heart block, prolongation of the QT interval from your heart;
• restriction in blood supply;
• blockage of small bowels;
• sudden swelling of lips and eyes along with difficulty breathing;
• rash with pimples on your skin;
• prolonged contraction of the neck muscles producing an unnatural position of the head;
• problems with leaking urine from your bladder;
• abnormal breast enlargement (males); discharge from the breasts; irregular menstruation; enlargement of the glands in your breasts; breast pain; breast tenderness; ejaculation with semen flowing backwards into the bladder (males);
• increased fluid retention in the tissue (oedema); Not known:
• sudden loss of blood supply to brain (stroke); neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness);
• pneumonia caused by breathing stomach contents into lungs;
• swollen tongue;
• prolonged and painful erection. The patient is advised to seek medical attention if this prolonged and painful erection is not resolved within 3-4 hours.
• 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 in breathing. If you notice any of these symptoms seek medical advice immediately.

While women may experience leakage of fluid or milk from the breast, men may develop breast swelling. Women may experience missed or irregular periods. Men may experience difficulty getting or maintaining an erection.

Uncommonly, you may develop an abnormality in your electrocardiogram (i.e. tracing of the electrical activity of your heart).

Since paliperidone is a compound resulting from the breakdown of risperidone (another medicine used to treat schizophrenia) in the human body, any side effects that may occur after the ingestion of risperidone may also occur with INVEGA.

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.

Keep out of reach and sight of children.

Do not use INVEGA after the expiry date which is stated on the blister/bottle and carton after {MM/YYYY}. The expiry date refers to the last day of that month.

Bottles: Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture. Blisters: Do not store above 30°C. Store in the original package in order to protect from moisture.

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.

What INVEGA contains

• The active substance is paliperidone Each INVEGA 1.5 mg prolonged-release tablet contains 1.5 mg of paliperidone Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone. Each INVEGA 6 mg prolonged-release tablet contains 6 mg of paliperidone. Each INVEGA 9 mg prolonged-release tablet contains 9 mg of paliperidone. Each INVEGA 12 mg prolonged-release tablet contains 12 mg of paliperidone.

The other ingredients are:

Coated tablet core:
Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Ferric Oxide (Yellow) (E172) (3, 12 mg tablet only)
Polyethylene Oxide 7000K
Ferric Oxide (Red) (E172)
Hydroxyethyl Cellulose
Polyethylene glycol 3350
Cellulose acetateIron oxide (Black) (E172)(1.5, 9 mg tablet only)

Colour overcoat:
Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400 (1.5, 6, 9 and 12 mg tablet only)
Ferric Oxide (Yellow) (E172) (1.5, 6, 12 mg tablet only)
Ferric Oxide (Red) (E172) (1.5, 6, 9 mg tablet only)
Lactose monohydrate (3 mg tablet only)
Triacetin (3 mg tablet only)
Carnauba wax

Printing ink:
Iron oxide (Black) (E172)
Propylene glycol
Hypromellose

What INVEGA looks like and contents of the pack

INVEGA Prolonged-Release Tablets are capsule shaped. The 1.5 mg tablets are orange-brown and printed with ?PAL 1 .5?, the 3 mg tablets are white and printed with ?PAL 3?, the 6 mg tablets are beige and printed with ?PAL 6?, the 9 mg tablets are pink and printed with ?PAL 9?, and the 12 mg tablets are dark yellow and printed with ?PAL 12?. All tablets are available in the following pack sizes:

• Bottles: 30 tablet and 350 tablet high-density polyethylene bottles with child-resistant closures. Eachbottle contains two silica gel pouches which are provided to absorb moisture and keep the tablets dry.
• Blisters: 14, 28, 30, 49, 56, and 98 tablets in polyvinyl chloride laminated with polychlorotrifluoroethylene/ aluminium push-through layer (white or clear) or 14, 28, 49, 56, and 98 tablets in oriented polyamidealuminium- polyvinyl chloride/aluminium push-through layer.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Janssen-Cilag International NV,
Turnhoutseweg 30,
B-2340 Beerse,
Belgium

Manufacturer

Janssen-Cilag SpA
Via C. Janssen
04010 Borgo San Michele,
Latina
Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation.

BelgiëBelgiqueBelgien JANSSEN-CILAG NVSA TélTel 32 14 64 94 11 LuxembourgLuxemburg JANSSEN-CILAG NVSA Tél Tel 32 14 64 94 11

.359 2 489 9400 Magyarország JANSSEN-CILAG Kft. Tel36 23 513-858

eská republika JANSSEN-CILAG s.r.o. Tel420 227 012 222 Malta AM MANGION LTD Tel 356 2397 6000

Danmark JANSSEN-CILAG AS Tlf 45 45 94 82 82 Nederland JANSSEN-CILAG B.V. Tel 31 13 583 73 73

Deutschland JANSSEN-CILAG GmbH Tel 49 2137-955-955 Norge JANSSEN-CILAG AS Tlf 47 24 12 65 00

Eesti Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel 372 617 7410 Österreich Janssen-Cilag Pharma GmbH Tel 43 1 610 300

JANSSEN-CILAG ... T 30 210 80 90 000 Polska JANSSENCILAG Polska Sp. z o.o. Tel. 48 22 237 6000

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Italia Janssen-Cilag SpA Tel 39 022510.1 SuomiFinland JANSSEN-CILAG OY PuhTel 358 207 531 300

T 357 22 755 214 Sverige JANSSEN-CILAG AB Tel 46 8 626 50 00

Latvija Janssen-Cilag Polska Sp. z o.o. filile Latvij Tel 371 6789 3561 United Kingdom JANSSEN-CILAG Ltd. Tel 44 1494 567 567

Lietuva

UAB ?Johnson & Johnson?
Tel: +370 5 278 68 88

This leaflet was last approved in MM/YYYY