Neulactil® periciazine

Consumer Medicine Information

What is in this leaflet 3-6 it should be used only in • If you are taking medicines used exceptional circumstances. to treat Parkinson's disease This leaflet answers some common Ask your doctor or pharmacist if (disease of the brain that affects questions about Neulactil. you have any questions about why movement) It does not contain all the available Neulactil has been prescribed for Do not take Neulactil after the you. information. It does not take the expiry date (EXP) printed on the pack. place of talking to your doctor or If you take this medicine after the pharmacist. expiry date has passed, it may not All medicines have risks and Before you take it work (as well). benefits. Your doctor or pharmacist Do not take Neulactil if the has weighed the risks of you taking When you must not take it packaging is torn or shows signs Neulactil against the benefits they of tampering. expect it will have for you. Do not take Neulactil if you have an allergy to Neulactil, any other Do not give Neulactil to a child If you have any concerns about from the under the age of 1. taking this medicine, ask your family, and/or any of the There is a possible link to Sudden doctor or pharmacist. ingredients listed at the end of Infant Death Syndrome (SIDS) Keep this leaflet with the this leaflet. If you are not sure whether you medicine. Symptoms of an allergic reaction should start taking Neulactil, You may need to read it again. may include: contact your doctor or pharmacist. • asthma, wheezing or shortness of breath Before you start to take it What Neulactil is used • swelling of the face, lips or for tongue which may cause Tell your doctor if you have allergies to: difficulty in swallowing or The active ingredient of Neulactil is breathing • any other medicines periciazine, one of a group of • hives, itching or skin rash • any other substances, such as medicines called . • fainting foods, preservatives or dyes Neulactil is used to treat patients Do not take Neulactil if you have Tell your doctor if you are breast who feel very anxious and/or tense. any of the following- feeding, pregnant or trying to become pregnant. It is used in patients to control • circulatory disorders Your doctor will discuss the symptoms such as impulsiveness • blood or bone marrow disorders possible risks and benefits of using and aggression. • a history of high pressure in the Neulactil during pregnancy and It is also used in patients with eyes (certain types of glaucoma) lactation. severe mental conditions when a • if you are receiving local Tell your doctor if you have or person loses contact with reality and anaesthetics around the spinal have had any medical conditions, is unable to think and judge clearly. cord especially the following: Your doctor may have prescribed • uncontrolled fitting disorders • kidney problems Neulactil for another reason. • liver problems • epilepsy fits Use in children aged below 1 is • phaeochromocytoma (rare • Parkinson's disease contraindicated and is not tumour of the adrenal gland) • decreased thyroid activity recommended in children aged • difficulty passing urine or • heart failure, other problems below 3. In children aged between prostate problems with the heart or blood vessels

Neulactil® Published by MIMS/myDr October 2017 1 • blood clots or a history of blood • desferrioxamine (a medicine It does not matter if you take clots used to remove excess iron from Neulactil before or after food. • bowel problems the body) • dementia • lithium (a medicine used to treat If you forget to take it • diabetes mood swings and some types of If it is almost time for your next depression) • tumour of the adrenal gland dose, skip the dose you missed • medicines metabolised by and take your next dose when you • muscle weakness (myasthenia CYP2D6 enzymes such as are meant to. gravis) . Otherwise, take it as soon as you • certain types of glaucoma- high • , medicines used remember, and then go back to pressure in the eyes to relieve stomach cramps or taking your medicine as you • prostate problems spasms, to prevent travel would normally. • low potassium levels sickness and to treat Parkinson's Do not take a double dose to • brain damage disease. make up for the dose that you missed. If you have not told your doctor These medicines may be affected by about any of the above, tell them Neulactil or may affect how well it This may increase the chance of you before you start taking Neulactil. works. You may need different getting an unwanted side effect. amounts of your medicine, or you If you have trouble remembering Taking other medicines may need to take different to take your medicine, ask your pharmacist for some hints. Tell your doctor if you are taking medicines. Your doctor or any other medicines, including pharmacist will advise you. any that you buy without a How long to take it prescription from your Neulactil helps control your pharmacy, supermarket or health condition, but does not cure it. food shop. How to take it Therefore you must take Neulactil Some medicines and Neulactil may every day. Continue taking the interfere with each other. How much to take tablets for as long as your doctor or pharmacist tells you. These include: Your doctor or pharmacist will tell • sedatives, medicines to help you you how many tablets you will need Do not stop using it unless your sleep or to calm you down. to take each day. This depends on doctor or pharmacist tells you to - • sedative your condition and whether or not even if you feel better. (medicines used to prevent or you are taking any other medicines. If you take too much relieve the symptoms of allergy) Follow all directions given to you (overdose) • medicines used to treat high by your doctor and pharmacist blood pressure. carefully. If you take too much Neulactil These directions may differ from • medicines used to treat mental you are more likely to experience the information contained in this illness. side effects listed below. leaflet. • medicines used to treat a fast or Immediately telephone your irregular heart beat e.g. If you do not understand the doctor or pharmacist or the instructions given to you, ask Poisons Information Centre amiodarone, , your doctor or pharmacist for (telephone Australia 13 11 26, disopyramide. help. New Zealand 0800 POISON or • medicines that can slow your 0800 764 766), or go to accident heart beat e.g. diltiazem, How to take it and emergency at your nearest verapamil. hospital, if you think that you or Swallow the tablets with a glass of • medicines that can reduce anyone else may have taken too water. potassium levels in the blood much Neulactil. Do this even if there are no signs e.g. diuretics, laxatives. When to take it • other medicines that can affect of discomfort or poisoning. your heart rate e.g. , Take Neulactil at about the same You may need urgent medical time each day. pentamidine. attention. Taking your tablets at the same time • (epinephrine) (sends each day will have the best effect. It more oxygen to brain and will also help you remember when muscles) to take the tablets.

Neulactil® Published by MIMS/myDr October 2017 2 While you are taking it Neulactil helps most people, but it • severe confusion may have unwanted side effects in a • skin rash Things you must do few people. All medicines can have • severe pain in the stomach with side effects. Sometimes they are bloating, gut cramps and Tell any other doctors, dentists, serious, most of the time they are vomiting and pharmacists who are treating not. You may need medical • yellowing of the skin and or the you that you are taking Neulactil. treatment if you get some of the eyes If you become pregnant while side effects. If you are over 65 years • changes in the way the heart taking Neulactil, tell your doctor. of age you may have an increased beats chance of getting side effects. Things you must not do • shallow breathing Ask your doctor or pharmacist to Do not give Neulactil to anyone answer any questions you may • frequent infections such as else, even if they have the same have. fever, severe chills, sore throat, mouth ulcers condition as you. Tell your doctor or pharmacist if Do not take Neulactil to treat any you notice any of the following • distortion of the body other complaints unless your and they worry you: • uncontrollable twitching, jerking doctor tells you to. • drowsiness or writhing movements Do not stop taking Neulactil, or • agitation or aggressiveness • restlessness lower or raise the dosage, without • insomnia • lack of normal muscle checking with your doctor. • vomiting movement • stiffness or tightness in the arms Things to be careful of • nausea or legs • constipation Neulactil may cause you to become • blurred vision • diarrhoea extra sensitive to sunlight. Make • aggravation of glaucoma sure you avoid exposure and protect • dizziness, especially on standing • abnormal pigmentation on your eyes from strong sunlight. up from a sit down or lying position certain areas of the eye Neulactil may put you at risk of • difficulty breathing hyperthermia or hypothermia • nasal stuffiness • altered consciousness particularly during hot or very cold • dry mouth (sometimes with weather if you are over the age of mouth infections) • swelling of the face, lips, mouth, 65 years. • difficulty passing urine tongue or throat which may cause difficulty breathing or Be careful driving or operating • sweating swallowing machinery until you know how • symptoms of sunburn (such as These may be serious side effects. Neulactil affects you. redness, itching, swelling, You may need urgent medical As with other medicines of this blistering) which may occur attention. Serious side effects are kind, Neulactil may cause dizziness, more quickly than normal light-headedness, and drowsiness in rare. • unusual secretion of breast milk some people. Make sure you know Other side effects not listed above • growth of breasts in males how you react to Neulactil before may occur in some patients. Tell you drive a car, operate machinery, • absence or irregular menstrual your doctor or pharmacist if you or do anything else that could be periods notice anything that is making dangerous if you are dizzy or light- • impotence you feel unwell. headed. If this occurs do not drive. • false positive pregnancy tests Do not be alarmed by this list of possible side effects. should be avoided while on • changes in libido You may not experience any of treatment with Neulactil. If you • inability to ejaculate them. drink alcohol, dizziness or light- • swelling of hands, ankles, feet Neulactil tablets should not be headedness may be worse. • increased appetite and weight frequently handled. Care should be gain taken to minimise contact of • mood changes or feeling Neulactil tablets with the skin. Side effects anxious Tell your doctor or pharmacist Tell your doctor or pharmacist as immediately if you notice any of soon as possible if you do not feel the following: well while you are taking • fever Neulactil.

Neulactil® Published by MIMS/myDr October 2017 3 After taking it Distributor sanofi-aventis australia pty ltd Storage 12-24 Talavera Road, Keep your tablets in the pack Macquarie Park, NSW 2113 until it is time to take them. sanofi-aventis new zealand limited If you take the tablets out of the Level 8, 56 Cawley Street Ellerslie pack they will not keep as well. Auckland Keep your tablets in a cool dry Australian Registration Numbers- place protected from light where the temperature stays below Neulactil 2.5mg AUST R 27524 25°C. Neulactil 10mg AUST R 27523 Do not store Neulactil or any This leaflet was updated in August other medicine in the bathroom 2017 or near a sink. neulactil-ccdsv3-cmiv10-aug17 Do not leave it in the car on hot days or on windowsills. Heat and dampness can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Disposal If your doctor tells you to stop taking Neulactil or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like Neulactil 2.5mg tablets are yellow, scored, and marked 'NEULACTIL'. They are available in packs of 100 tablets. Neulactil 10mg tablets are yellow, scored, and marked '10'. They are available in packs of 100. Neulactil tablets contain: • periciazine 2.5 or 10mg (active ingredient) • cellulose microcrystalline • lactose monohydrate • wheat starch • colloidal anhydrous silica • magnesium stearate

Neulactil® Published by MIMS/myDr October 2017 4