AMISULPRIDE 100MG/ML ORAL SOLUTION PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

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1 AMISULPRIDE 100MG/ML ORAL SOLUTION PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. THE LEAFLET CONTAINS INFORMATION ON: 1. What Amisulpride Oral Solution is and what it is used for 2. Before you take Amisulpride Oral Solution 3. How to take Amisulpride Oral Solution 4. Possible side effects 5. How to store Amisulpride Oral Solution 6. Further Information 1. WHAT AMISULPRIDE ORAL SOLUTION IS AND WHAT IT IS USED FOR? The name of your medicine is Amisulpride 100mg/ml Oral Solution (called Amisulpride throughout this leaflet). Amisulpride belongs to a group of medicines called antipsychotics. Amisulpride is used to treat schizophrenia, when it starts and also over the long term. Symptoms of this disorder include: so called positive symptoms: - hallucinations, such as feeling, seeing or hearing things which do not exist - strange and/or frightening thoughts - changes in your behaviour, which can be agressive so called negative symptoms: - becoming withdrawn and subdued 2. BEFORE YOU TAKE AMISULPRIDE ORAL SOLUTION You should not take Amisulpride until you are sure it is safe for you to do so. Do not take Amisulpride and tell your doctor if: - you are allergic (hypersensitive) to amisulpride or any of the other ingredients of Amisulpride (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - you are breast-feeding (see Pregnancy and breast-feeding section) - you have breast cancer or something called a prolactin dependent tumour - you have a tumour on the adrenal gland (called phaeochromocytoma) - you have severely impaired kidney function - you are taking levodopa, a medicine used to treat Parkinson's disease (See 'Taking other medicines' section)

2 - the patient is under 15 years old Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Amisulpride. Take special care with Amisulpride. Check with your doctor or pharmacist before taking this medicine if: - you have kidney problems - you have Parkinson s disease, as Amisulpride can make this condition worse - you have ever had fits (epileptic seizures) - you have an unusual heart rate (rhythm) - you have or have had heart disease or family history of heart problems - you are at risk for a stroke or a temporary reduction of blood flow to the brain (transient ischemic attack) - you are diabetic or have been told you have an increased risk of having diabetes - you are over 65 years old. This is because elderly people are more likely to get low blood pressure or feel sleepy - you have been told you have a low amount of potassium or magnesium in your blood or you are taking other medicines that cause these side effects - you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots - you have any involuntary or abnormal movements especially of the tongue, mouth and face while taking this medicine (extrapyramidal symptoms) - You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual - You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leukopenia - You or someone else in your family has a history of breast cancer - If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amisulpride. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Amisulpride can affect the way some other medicines work. Also some medicines can affect the way Amisulpride works. Do not take Amisulpride, and tell your doctor if you are taking any of the following medicines; - Levodopa, a medicine to treat Parkinson's disease Tell your doctor if you are taking any of the following medicines; - Medicines used to control your heart beat such as quinidine, disopyramide, procainamide, amiodarone, sotalol, flecainide, and propafenone - Medicines for depression or to calm emotional and mental illnesses such as, thioridazine - Medicines for severe pain called opiates such as morphine, pethidine or methadone - Medicines used to treat high blood pressure, that could slow your heart rate down, such as clonidine - Medicines to help you sleep such as barbiturates and benzodiazepines - Anaesthetics - Medicines to treat malaria - Medicines causing electrolyte imbalance - Some antihistamines

3 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amisulpride. Taking Amisulpride with food or drink Amisulpride should be taken with a drink that does not contain alcohol. Do not drink alcohol while you are taking Amisulpride because it can affect the way the medicine works Pregnancy and breast-feeding Do not take this medicine if you are breast-feeding or planning to breast-feed. Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant. The following symptoms may occur in newborn babies, of mothers that have used Amisulpride in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. Driving and using machines: You may feel less alert, drowsy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines. Please note that alcohol will make your reactions even slower. Important information about some of the ingredients of Amisulpride Amisulpride contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). 3. HOW TO TAKE AMISULPRIDE ORAL SOLUTION Always take Amisulpride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Adults - If you suffer from positive symptoms, the usual dose is between 400mg (4ml) to 800mg (8ml) a day and will be adjusted individually by your doctor depending on the nature and severity of your illness and your kidney function. The maximum daily dose is 1,200 mg (12ml). - If you suffer from both positive and negative symptoms, your doctor will adjust your dose individually so that there is adequate control of the positive symptoms. To maintain treatment, your doctor will use the lowest possible dose that is effective for you. - If you suffer from negative symptoms, the usual dose is between 50 mg (0.5ml) and 300 mg (3ml) amisulpride daily, and will be adjusted individually by your doctor depending on the nature and severity of your illness and your kidney function Patients over 65 years old Your doctor will need to keep a close check on you as you are more likely to have low blood pressure or sleepiness due to this medicine Children and adolescents Efficacy and safety of amisulpride in children and adolescents under 18 years of age have not been established. If absolutely required treatment of adolescents from 15 to 18 years of age must be initiated and performed by a physician experienced in treating schizophrenia in this age group; children and adolescents under 15 years of age must not take Amisulpride.

4 Patients with kidney problems If you suffer from kidney problems, your doctor will normally prescribe a lower dose. This may be reduced to half or a third of the normal dose depending on the impairment grade of your kidney. Patients with impaired liver function No changes to the normal dose should be necessary. Method of administration If you are taking up to 300mg of Amisulpride a day, this can be taken as a single dose preferably at the same time each day. Larger doses should usually be divided up with part of the dose given in the morning and the other part later in the day. Your doctor will tell you how and when to take your medicine. Use the graduated syringe to measure your medicine. Each 1ml of solution contains 100mg of your medicine. The graduations on the dosage pipette measure the milligrams of active ingredient. After introducing the measuring syringe into the bottle, draw the plunger of the measuring syringe up to the graduation mark corresponding to the number of milligrams to be administered. Wipe off excess solution from the outside of the syringe with a tissue prior to administration of the dose. The oral solution should be drunk with a liquid, which does not contain alcohol. Your doctor will tell you how much Amisulpride you should take and how long you should continue to take it. If you take more Amisulpride than you should It is important to stick to the dose on the label of the medicine. If you or someone else takes too much medicine, contact your doctor or nearest hospital emergency department immediately. Always take any medicine left over with you and also the box, as this will allow easier identification of the medicine. Signs of overdose may include feeling restless or shaky, rigid muscles, feeling drowsy or sleepy which could lead to a loss of consciousness. If you forget to take Amisulpride If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you stop taking Amisulpride Keep taking Amisulpride until your doctor tells you to stop. Do not stop taking Amisulpride just because you feel better. If you stop, your illness may get worse or come back. Unless your doctor tells you otherwise Amisulrpride Oral Solution should not be stopped suddnely. Stopping treatment suddenly may cause withdrawal effects such as feeeling or being sick, sweating, difficulty sleeping or feeling very restless, muscle stiffness or unusual body movements or your original condition may come back. Blood tests Taking Amisulpride may affect the results of some blood tests. These include tests to measure the hormone called prolactin and liver tests. If you are going to have a blood test, it is important to tell your doctor you are taking Amisulpride. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Amisulpride can cause side effects although not everybody gets them. Stop taking Amisulpride and see a doctor or go to a hospital straight away if:

5 You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be the symptoms of a serious but rare side effect called neuroleptic malignant syndrome You have an unusual heart rate, very fast heart rate or chest pain which could result in a heart attack or life-threatening heart disorder You have 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 You get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia) Uncommon (affects less than 1 in 100 people) You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a fit (seizure) Tell your doctor as soon as possible if you have any of the following side effects: Very Common (affects more than 1 in 10 people) Trembling, pronounced muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless. (These symptoms can be reduced if your doctor lowers your dose of Amisulpride or prescribes an additional medicine) Common (affects less than 1 in 10 people) Movements that you cannot control, mainly of the arms and legs (These symptoms can be reduced if your doctor lowers your dose of Amisulpride or prescribes an additional medicine) Uncommon (affects less than 1 in 100 people) Movements that you cannot control, mainly of the face or tongue Other side effects include: Common (affects less than 1 in 10 people) Difficulty sleeping (insomnia) or feeling anxious or agitated Feeling drowsy or sleepy Constipation, feeling or being sick, dry mouth Putting on weight Unusual production of breast milk in women and men, breast pain Increased levels of the hormone prolactin which can lead to milk secretion from the breasts, breast pain or enlargement, menstrual period disorders, impotence, which will gradually disappear after you stop taking Amisulpride. Prolactin-dependent tumours may also appear Feeling dizzy (which can be due to low blood pressure) Orgasm disorders Uncommon (affects less than 1 in 100 people) Slowing of the heart beat Increased liver enzyme levels, high blood sugar (hyperglycaemia) Convulsions (fits) Allergic reactions such as skin rashes, itching or swelling Frequency not known (cannot be estimated from the available data) Abnormal heart rhythms, which may be life-threatening and lead to cardiac arrest and sudden death Feeling confused High levels of fat (triglycerides) or cholesterol in the blood

6 In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: By reporting side effects, you can help provide more information on the safety of this medicine. 5. HOW TO STORE AMISULPRIDE ORAL SOLUTION Keep out of the reach and sight of children. Do not use Amisulpride after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of the month. Store in the original bottle. Amisulpride should be disposed of 2 months after opening. 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. 6. FURTHER INFORMATION What Amisulpride Oral Solution contains? The name of this medicine is Amisulpride Oral Solution. The active substance is amisulpride. 1ml of Amisulpride Oral Solution contains 100mg of amisulpride. The other ingredients are propylene glycol, saccharin sodium, sodium gluconate, glucono-delta-lactone, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate (E202), hydrochloric acid and caramel flavour. Caramel flavour consists of propylene glycol E , nature-identical flavouring substance(s), water, flavouring preparation and ascorbic acid E300. What Amisulpride Oral Solution looks like and contents of the pack Amisulpride is a clear yellow liquid with an odour of caramel. Each bottle contains 60ml of oral solution. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder and manufacturer of this oral solution is Auden Mckenzie (Pharma Division) Ltd. Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL UK This product is authorized in the Member States of the European Economic Area (EEA) under the following names UK: Amisulpride Oral Solution 100 mg/ml DE: Amisulprid AUDEN 100 mg/ml Lösung zum Einnehmen FR: AMISULPRIDE AUDEN 100 mg/ml, solution buvable This leaflet was last updated in 10/2015