I r i s h T r a n s l a t o r s ' & I n t e r p r e t e r s ' A s s o c i a t i o n C u m a n n A i s t r i t h e o i r í a g u s T e a n g a i r í n a h É i r e a n n Irish Translators' & Interpreters' AssociationCumann Aistritheoirí agus Teangairí na hÉireannTel.: +353-1-872 1302 Fax: +353-1-872 6282Email: email@example.com Web:www.translatorsassociation.ie Irish Tran
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Productname™ & dose formRISPERDAL CONSTA
Consumer Medicine Information (CMI)
if the packaging is torn or shows signs of having What is in this leaflet
to treat any other complaints unless your doctor This leaflet contains important information about RISPERDAL CONSTA. It does not contain all of the available information. It does not take the place of Before you start to use it
RISPERDAL CONSTA should be used with caution in If you have any concerns about using RISPERDAL CONSTA, ask your doctor, pharmacist or nurse. Your doctor and pharmacist have more information. 1. Tell your doctor if you have or have ever had
Keep this leaflet with your RISPERDAL CONSTA. You any medical conditions, especially the following:
heart or blood vessel diseases, including low blood pressure. What RISPERDAL CONSTA
is used for?
Low blood pressure can result from using RISPERDAL CONSTA together with medications to treat high blood pressure. So, if you need to use RISPERDAL CONSTA is used to treat symptoms of both RISPERDAL CONSTA and medications to schizophrenia and other types of related psychoses. reduce blood pressure, consult your doctor. These are disorders related to thought, feeling and/or RISPERDAL CONSTA should be used with caution, RISPERDAL CONSTA is also used to treat bipolar and only after consultation with your doctor, if you disorder to prevent or delay mood swings which consist have heart problems, particularly irregular heart of alternating periods of high (manic) or elevated mood rhythm, abnormalities in electrical activity of the with periods of depression. During the manic episodes heart, or if using medications that can change the you may feel very excited, elated, agitated, enthusiastic, or hyperactive, or have poor judgment including disruptive or aggressive behaviours. During the episodes of depression you may experience sadness, low energy, lack of motivation, feelings of parkinson's disease (a disease of the brain affecting guilt and worthlessness, and changes in sleep or RISPERDAL CONSTA helps to correct a chemical imbalance in the brain associated with these RISPERDAL CONSTA has been approved for the uses mentioned above. However, your doctor may restlessness or difficulty sitting still prescribe this medicine for another use. If you want intraoperative floppy iris syndrome (a complication that may occur during cataract extraction) Before you use RISPERDAL
Neuroleptic Malignant Syndrome (a serious reaction to some medicines, consisting of a sudden increase in body temperature, extremely high blood pressure When you must not use it
Do not use RISPERDAL CONSTA:
tardive dyskinesia (a reaction to some medicines, if you know you are allergic to any of its ingredients seen as uncontrollable twitching or jerking (signs of allergy include skin rash, itching, shortness of breath, and/or swollen face - see the last section of this leaflet for a list of ingredients) 2. Tell your doctor if:
• you are pregnant or are planning to become 5. Children and Adolescents
There is no experience with RISPERDAL CONSTA in Shaking, muscle stiffness and difficulty in feeding, all of which are reversible, may occur in newborns, if a mother used RISPERDAL CONSTA in the last Using it for the first time
Treatment with RISPERDAL CONSTA will not be started until it is known that you can tolerate Risperdal Your doctor will advise you whether or not you should treatment by mouth (tablets or oral solution) At the start of treatment you may have a fall in blood pressure making you feel dizzy on standing up, or your 3. Other medicines and alcohol
heart may beat faster. These should go away after a few days. Tell your doctor if they continue or worry RISPERDAL CONSTA can increase the effect of alcohol and other medicines which slow your reactions. Using RISPERDAL CONSTA
How to use it
RISPERDAL CONSTA should be given only after the powder has been mixed with the diluent (liquid in the carbamazepine, a drug mainly used for epilepsy or trigeminal neuralgia (severe pain attacks in the face) may decrease the level of RISPERDAL The information for your doctor or nurse on the right way to reconstitute (make up) RISPERDAL CONSTA is included in the package. After it has been made up, RISPERDAL CONSTA should be injected in the arm or buttock every two Tell your doctor if you have ever taken medicines for weeks. Next time the injection will be given into the depression. In particular, fluoxetine and paroxetine other arm or buttock, and so on. Injection is not to be may increase the level of RISPERDAL in your blood. So tell your doctor if you start and/or stop taking The usual dose of RISPERDAL CONSTA is 25mg once every two weeks. However, your doctor might decide to administer a higher dose of 37.5mg or 50mg. The following medicines do not have an effect on Your doctor will decide on the dose of RISPERDAL RISPERDAL: eryrthromycin (antibiotic), galantamine and donepezil (used to treat dementia), lithium or Because risperidone is released gradually into your valproate (used to treat mania), digoxin (a heart drug), body, you will need an injection only every two weeks. topiramate (used to treat epilepsy or migraine), During the first three weeks of treatment additional cimetidine and ranitidine (used to reduce stomach risperidone tablets or liquid, which can be taken by mouth, must be used, because the first injection will not start to work straight away. Your doctor will explain this to you. Tell your doctor if you are taking medicines for: • Later, depending on how well the treatment is working, your doctor may decide to further adjust the dose of RISPERDAL CONSTA or to add oral RISPERDAL • other medicines for your heart or blood pressure. Do not stop your treatment just because you feel better. If you have to stop RISPERDAL CONSTA on the advice of your doctor, it is best to do it gradually. You should not drink alcohol while using RISPERDAL Stopping treatment suddenly may cause effects such as feeling sick, vomiting, sweating, sleeplessness, muscle stiffness, or jerky movements, or your original Your doctor or pharmacist has more information on the medicines to avoid, or to be careful of, while you are Elderly people should receive the lowest dose (25mg)
Patients with impaired kidney and liver function.
4. Elderly People
Elderly people should receive the lowest dose (25mg) of RISPERDAL CONSTA (see “How to use it”). RISPERDAL CONSTA has not been studied in patients whose kidney or liver is not working properly. Be careful driving or operating machinery until you Use in such patients should be with caution, a starting dose of 0.5mg twice-daily oral risperidone is recommended during the first week. In the second light-headedness in some people, especially after week 1mg twice daily or 2mg once daily can be given. the first dose. Make sure you know how you react If a daily total oral dose of at least 2mg is well tolerated to RISPERDAL CONSTA before you drive a car, (i.e. the drug does not upset you), an injection of operate machinery, or do anything else that could RISPERDAL CONSTA can be administered every 2 • Avoid excessive eating as there is a possibility of weight gain when using RISPERDAL CONSTA. If you forget to use RISPERDAL CONSTA
• If you forget to use RISPERDAL CONSTA, contact Side Effects
your doctor or nurse as soon as possible. Overdose
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. If you think you or anybody else has taken too
RISPERDAL CONSTA is generally well tolerated and much RISPERDAL CONSTA, contact your doctor,
side effects are often hard to distinguish from the pharmacist or the Poisons Information Centre who
disease symptoms. You may need medical treatment will advise you what to do.
if you get some of the side effects. Tell your doctor
You can contact the Poisons Information Centre by as soon as possible if you do not feel well while
dialling 13 11 26 in Australia, or 0800 POISONS or
you are using RISPERDAL CONSTA.
0800 764 766 in New Zealand.
Below is a list of possible side effects you could get Signs 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 RISPERDAL
Things you must do
• Always follow your doctor's instructions carefully, and seek your doctor's advice before changing or stopping treatment. Your doctor will be happy to • fall in blood pressure, particularly on standing. This discuss any questions you may have with your will be apparent to you as light-headedness or treatment. Remember, this medicine has been dizziness that passes after a few seconds or after • Tell all doctors, dentists and pharmacists who are treating you, that you are using RISPERDAL CONSTA. • If you become pregnant while using RISPERDAL • Pre-menopausal women should tell their doctor if Although these effects are generally not harmful, they do not have a period for more than six months contact your doctor if they bother you too much. while using RISPERDAL CONSTA, even if they are • drowsiness, tiredness, difficulty in concentrating, Things to be careful of
somnolence, usually mild and short lasting may occur more often in children than in adults Do not drink alcohol. RISPERDAL CONSTA can
Ask your doctor before taking any other medicines. RISPERDAL CONSTA can increase the effects of • indigestion, nausea, abdominal pain, constipation medicines which slow your reactions. Always ask • sexual function disturbances – erectile dysfunction, your doctor or pharmacist before taking other problems with ejaculation, decreased sexual drive medicines. These include herbal treatments and those bought in a pharmacy or supermarket. • During a long treatment, twitching of the tongue, Disposal
face, mouth and jaws can occur. Should this Once you have finished using RISPERDAL CONSTA, ask your pharmacist what to do with any unused • In the early stages of treatment, in some people, blood pressure may decrease slightly and the heart beat increase resulting in dizziness. This usually goes away after a few days. (See "Using it for the Product Description
• After using RISPERDAL CONSTA for a long time, What it looks like
some women may experience breast enlargement RISPERDAL CONSTA is available in vials (small or get a discharge from the breasts. They may also bottles) which contain different amounts of risperidone. experience irregular or heavy periods or absence of The package contains everything required to their periods. In men, breasts may enlarge slightly. reconstitute and administer the product. • A vial with white powder contains the • Oversensitivity (allergy). (See “When you must not • A syringe with diluent, with which the powder is • In extremely rare cases, significant changes in body temperature may occur. This rise or fall in temperature is caused by a combination of several factors such as extreme cold or heat. Call your doctor if this happens. Ingredients
• In elderly patients with dementia, sudden weakness The active ingredient in RISPERDAL CONSTA is or numbness of the face, arms or legs, especially risperidone, which is present in amounts of either on one side, instances of slurred speech and stroke 25mg, 37.5mg or 50mg in an injection of RISPERDAL have been seen. If any of these should occur, even for a short period of time, seek medical attention The powder is made from a 7525 DL JN1 poly-(d/l- lactide-co-glycolide) polymer called polyglactin. A In very rare cases, high blood sugar has been polymer is a small particle made up of many smaller, reported. The symptoms of high blood sugar may similar particles bound together. Risperidone is be the need to urinate more often or feeling thirsty attached to this polymer and then slowly released from all the time. Contact your doctor if you experience it once it has been injected into the body. The diluent contains polysorbate 20, carmellose sodium, sodium phosphate-dibasic dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide and water for IMPORTANT: If you experience high fever, stiff
muscles, fast breathing, abnormal sweating or
decreased mental alertness, contact your doctor
immediately. Your body may not be reacting
properly to the medicine.
Do not hesitate to report any other side effects to
your doctor or pharmacist.
NZ Office: Auckland, New Zealand Telephone: 0800 800 806 After using RISPERDAL CONSTA
Keep the entire pack of RISPERDAL CONSTA in a This leaflet was prepared in February 2013 Do not store it or any medicines in the bathroom or near a sink. Heat and dampness can destroy some ® RISPERDAL CONSTA is a registered trademark of • Keep it where young children cannot reach it. • Do not use RISPERDAL CONSTA beyond the date (month and year) printed on the pack after the letters "EXP", even if it has been stored properly. Medicines cannot be stored indefinitely.
Verzeichnis wissenschaftlicher Originalarbeiten in Journalen mit Peer review (Stand Dezember 2009) 1. Saletu B., Oberndorfer S., Gruber G., Divos H., Lachner A., Mandl M., Parapatics S., Saletu M., Strobl R., Tschida U., Winkler A., Anderer P.: Efficiency of CPAP versus Theophylline therapy in sleep apnea:comperative sleep laboratory studies on objective and subjective sleep and awak