Invega 9mg Tablets 28

  Information General Information Consumer Medicine InformationWhat is in this leafletThis leaflet answers some of the common questions about Invega. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.If you have any concerns about using Invega, ask your doctor or pharmacist. Your doctor and pharmacist have more information.Keep this leaflet you're your medicine. You may need to read it again.What Invega is used forInvega belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain type of mental illness.It is used to treat symptoms of schizophrenia, a mental illness with disturbances in thinking, feelings and behaviour. Invega helps to correct a chemical imbalance in the brain associated with this condition.Invega tablets are made in an extended release form. The tablets have a special shell that allows the release of the active ingredient at a slow rate throughout the day. The tablet shell does not dissolve completely after all the drug has been released and sometimes the tablet shell may be seen in your stool. This is normal.Your doctor, however, may prescribe this medicine for another use.Ask your doctor if you have any questions about why it has been prescribed to you.Invega is not addictive.Before you take itWhen you must not take itDo not take Invega if you know you are allergic to any of its ingredients listed at the end of this leaflet or medicines containing risperidone (e.g. RISPERDAL). Signs of allergy include skin rash, itching, shortness of breath, and/or swollen face.Do not take it after the expiry date printed on the pack. If you take it after the expiry date has passed, it may not work as well.Do not take it if the packaging is torn or shows signs of being tampered with.Do not take it if the tablets appearance has changed.Do not take it to treat any other complaints unless your doctor says it is safe to do so.Before you start to take itInvega should be used with caution in some patients.1. Tell your doctor if you have or have ever had:heart or blood vessel diseases, including low blood pressure dehydration epilepsy disease of the pituitary gland inflammation of the lungs due to aspiration (the inhalation of food particles or fluids into the lungs). kidney or liver problems Dementia or Lewy body dementia.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.Neuroleptic Malignant Syndrome (a serious reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions) Tardive dyskinesia (a reaction to some medicines with involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk) diabetes disease of the blood vessels of the brain including stroke swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass foods by normal bowel movements diseases associated with diarrhoea priapism (continuous erection) and/or painful erection2. Tell your doctor if:you are pregnant or are planningto become pregnant. Your doctor will advise you whether or not you should take Invega. you are breast feeding. Invega is excreted in breast milk. It is recommended that you do not breast-feed while taking Invega.3. Other medicines and alcohol you should not drink alcohol while taking Invega.Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.In particular tell your doctor if you are taking:sleeping tablets, tranquillisers, pain-killers, antihistamines medicines to treat epilepsy medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder. diuretics medicines for your heart or blood pressure other medicines to treat mental illness or psychotic conditions medicines to relieve severe nausea and vomiting.4. Elderly PeopleIn general your doctor would prescribe the same dose as for adult patients, but he/she may adjust the dose if you have diminished renal function.Taking it for the first timeAt the start of treatment you may have a fall in blood pressure making you feel dizzy on standing up, or your heart may beat faster. These should go away after a few days. Tell your doctor if they continue or worry you.How to take itYour doctor will decide the dose suitable for you.Invega may be taken as a single dose, once a day taken in the morning. Invega must be taken either in always fasting state or always with breakfast, do not switch between fasting and fed states.The tablet should be swallowed with water or other liquid. It should not be chewed, divided or crushed.For patients with impaired kidney functionYour doctor will decide the dose suitable for you.For patients with mild renal impairment the recommended initial dose is 3 mg once daily, your doctor may later decide to increase the dose.For patients with moderate renal impairment the recommended dose is 3 mg once daily.For patients with severe renal impairment the recommended initial dose is 3 mg every other day, your doctor may later decide to increase the dose to 3 mg once daily.Follow your doctor's instructions carefully and do not change or stop the required dosage without consulting your doctor first.Invega cannot be recommended for use in children with schizophrenia under 18 years at the present time as there is little experience with the product in this group.If you forget to take itIf you forget to take it, take the missed dose as soon as you remember instead of your next dose. Then continue taking it as you would normally. Do not take a double dose to make up for the one you missed. If you forget to take it for 5 days or more, tell your doctor before starting your medicine again.If you have problems remembering when to take your medicine, ask your pharmacist for some hints.OverdoseIf you think you or anybody else has taken too much Invega, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do.You can contact the Poisons Information Centre by dialling:Australia: 13 11 26 New Zealand: 0800 POISON or 0800 764 766Signs of overdose may include drowsiness, sleepiness, excessive trembling, excessive muscle stiffness, increased heart rate, very low blood pressure causing fainting or unconsciousness.While you are using itThings you must doFollow your doctor's instructions carefully.Always seek your doctor's advice before changing or stopping treatment. Your doctor will behappy to discuss any questions you may have with your treatment.Things you must not doDo not use Invega to treat any other complaint unless your doctor says so.Do not give this medicine to anyone else, even if their symptoms seem similar.Do not stop taking Invega without first checking with your doctor.Things to be careful ofDo not drink alcohol. Invega can increase the effects of alcohol.Ask your doctor before taking any other medicines. Invega can increase the effects of medicines which slow your reactions. Always ask your doctor or pharmacist before taking other medicines. These include herbal treatments and those bought in a pharmacy or supermarket.Be careful driving or operating machinery until you know how Invega affects you. Invega may cause dizziness, drowsiness or light-headedness in some people, especially after the first dose. Make sure you know how you react to Invega before you drive a car, operate machinery, or do anything else that could bedangerous if you are dizzy.Avoid excessive eating. There is a possibility of weight gain when taking Invega.Side EffectsAll medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.All medicines can have side effects. You may need medical treatment if you get some of the side effects.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Invega. It helps most people with symptoms of schizophrenia, but it may have unwanted side effects in a few people.Tell your doctor if you notice any of the following and they worry you:difficulty thinking or working because of:sleeplessness headache trembling drowsiness, tiredness, difficulty in concentratingbehavioural changes such as:agitation anxietyjoint or movement changes such as:muscle stiffness restlessness in the legsother changes such as:weight gain indigestion, nausea, abdominal pain, constipation excessive thirst unusual secretion of breast milk breast swelling missed or irregular menstrual periods difficulty getting or maintaining an erection; or having continuous and/or painful erectionThese are mild side effects of Invega but may require medical attention.Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:heart or blood pressure problems such as:fall in blood pressure,particularly on standing. This will be apparent to you as light-headedness or dizziness that passes after a few seconds or after sitting down again faster heart rate, slowed heart rate, heart beat irregularitiesbody temperature changes such as:fever abnormally high body temperatureThese may be serious side effects of Invega. You may need urgent medical attention.Serious side effects are uncommon.If any of the following happen, stop taking Invega and tell your doctor immediately or go to Accident and Emergency at your nearesthospital:rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body. If you have them, you may have had a serious allergic reaction to InvegaThese are very serious side effects. You may need urgent medical attention or hospitalisation.After taking Invega for a long time, involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk can occur. Should this happen contact your doctor.Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some consumers.Do not hesitate to report any other side effects to your doctor or pharmacist.Do not be alarmed by this list of possible side effects. You may not experience any of them.After using itStorageKeep the tablets in a dry place where the temperature stays below 25 °C.Do not store it or any medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.Keep it where young children cannot reach it. A locked cupboard at leastone-and-a-half metres above the ground is a good place to store medicines.Do not use it beyond the expiry date (month and year) printed on the pack. Medicines cannot be stored indefinitely, even if stored properly.DisposalMedicines 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.Product DescriptionWhat it looks likeYou can identify Invega tablets by their colour and shape. This is important because each type of tablets, contains a different amount of the active paliperidone:3 mg: White, capsule shaped tablets imprinted with "PAL 3". 6 mg: Beige, capsule shaped tablets imprinted with "PAL 6". 9 mg: Pink, capsule shaped tablets imprinted with "PAL 9". 12 mg: Dark yellow, capsule shaped tablets imprinted with "PAL 12".All tablets come in blister packs of 28 tablets.IngredientsThe active ingredient in Invega is paliperidone.The tablets contain either 3 mg, 6 mg, 9 mg or 12 mg of paliperidone.Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethylcellulose, macrogol, polyethylene oxide, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and glycerol triacetate.SponsorJanssen-Cilag Pty Ltd 1-5 Khartoum Road North Ryde NSW 2113Telephone: 1300 369 949NZ Office: Auckland New ZealandTelephone: 0800 800 806Registration Numbers3 mg prolonged release tablet blister pack AUST R 1305026 mg prolonged release tablet blister pack AUST R 1307149 mg prolonged release tablet blister pack AUST R 13071712 mg prolonged release tablet blister pack AUST R 130732This leaflet was prepared on 9 October 2008.INVEGA® Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications