1. What this product is and what it is used for 1. What Prokinin is and what it is used for Prokinin is an anti-emetic which can stop you feeling sick. The active ingredient is domperidone. Prokinin is used to relief symptoms of nausea (feeling sick) and vomiting (being sick) in adults and children. 2. What you need to know before you use this product 2. Before you take Prokinin Do not take Prokinin - If you are allergic (hypersensitive) to domperidone or any of the other ingredients of Prokinin. - If you have or think you may have a serious intestinal problem such as internal bleeding (symptom being persistent black bowel motions), or an obstruction or perforation of the stomach or intestine (usually this involves severe stomach cramps). - If you suffer from a tumour of the pituitary gland called prolactinoma. - If you have a moderate or severe liver disease. - If your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval”. -If you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure). -If you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood. -If you are taking certain medicines. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Prokinin -If you suffer from kidney problems (kidney function impairment or failure). It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly. -If you suffer from liver problems (liver function impairment or failure). -If you are taking a medicine called levodopa. Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. The risk also increases when domperidone is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV. Domperidone should be used at the lowest effective dose in adults and children. While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with domperidone should be stopped. Important information about some of the ingredients in Prokinin - If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking Prokinin. - This medicinal product contains sodium. To be taken into consideration by patients on a controlled sodium dose. - The oral suspension contains sorbitol and may be unsuitable for patients with sorbitol intolerance. - The oral suspension also contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216). These substances may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm. Taking other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Prokinin if you are taking medicine to treat: - Fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole. - Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are antibiotics). - Heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, diltiazem, verapamil). - Psychoses (e.g., haloperidol, pimozide, sertindole). - Depression (e.g., citalopram, escitalopram). - Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride). - Allergy (e.g., mequitazine, mizolastine). - Malaria (in particular halofantrine). - AIDS/HIV (protease inhibitors). - Cancer (e.g., toremifene, vandetanib, vincamine). - Opioids, used to treat pain or as an analgesic. - Ritonavir, used to treat virus infections. Tell your doctor or pharmacist if you are taking levodopa (a medicine used to treat the symptoms of Parkinson's disease), drugs to treat infection, heart problems or AIDS/HIV. It is important to ask your doctor or pharmacist if Prokinin are safe for you when you are taking any other medicines, including medicines obtained without prescription. If you are pregnant or breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted side effects affecting the heart in a breast-fed baby. Domperidone should be used during breast feeding only if your physician considers this clearly necessary. Ask your doctor for advice before taking this medicine. Driving and using machines You may have less control over your movements whilst taking Prokinin.If this happens do not drive or use any tools or machines. 3. How to use this product. 3. How to take Prokinin Duration of treatment: Your doctor will decide how long you will need to take this medicine. Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Prokinin for longer than 7 days without consulting your doctor. The usual dose is: Adults and teenagers (12 years of age and older with a body weight of 35 kg or more) The usual dose is 10 mg taken up to three times per day, if possible before meals. Do not take more than 30 mg per day. Children and adolescents from birth to a body weight of less than 35 kg Your doctor will calculate the dose. This will depend on the weight of your child. The usual dose is 0.25 mg per kilogram. Give the dose maximum 3 times per day, if possible before meals/feeding. Do not give more than 3 times in a 24 hour time period. People with kidney problems Your doctor may tell you to take a lower dose or to take the medicine less often. Your doctor may advise you to take your medicine in a different way, so you should always follow your doctor’s advice about how and when to take your medicine and always read the patient information leaflet. If you feel that the effect of Prokinin is too strong or too weak, talk to your doctor or pharmacist. If anyone takes too much If anyone takes too many Prokinin, contact a doctor or your nearest Accident and Emergency department (Casualty) taking this leaflet and pack with you. If you forget to take the medicine You should only take this medicine as required following the dosage instructions above carefully. If you forget to take a dose, take the next dose when needed as long as you do not take more than 3 tablets in any 24 hour period. Do not take a double dose. 4. Possible side effects 4. Possible side effects Prokinin can have side effects, like all medicines, although these don’t affect everyone and are usually mild. If you experience any of the following, stop using the medicine and seek immediate medical help: - Fits or seizures. - Involuntary movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm. - Allergic reactions: Signs of allergy include rash (such as hives), itching, shortness of breath, wheezing and/or swollen face or neck, flushing or fainting. - You have a very fast or unusual heartbeat. This could be a sign of a life-threatening heart problem. Common (less than 1 in 10 people) - Dry mouth. Uncommon (less than 1 in 100 people) - Anxiety. - Loss of interest in sex or diminished interest in sex. - Sleepiness or headache. - Diarrhea. - Rash or itchiness. - Painful or tender breasts. - Milk discharge from breasts.. - A general feeling of weakness. Other side effects which occur but it is unknown how often: - Agitation or Nervousness. - Eye movement disorder. - Inability to urinate. - Swollen breasts (even in men). - Changes in certain laboratory test results. - If you have a blood test to check your liver function tell your doctor or nurse that you are taking Prokinin. - In women, menstrual periods may be irregular or stop. Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30 mg per day. Domperidone should be used at the lowest effective dose in adults and children. Some patients who have been prescribed domperidone for conditions and dosages requiring medical oversight have experienced the following unwanted effects: Restlessness; swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in women, difficulty breast-feeding, depression, and hypersensitivity. If you experience any side effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist. 5. How to store this product 5. How to store Prokinin Keep out of reach of children. Store below 30°C. After opening, it should be used within three months. Close the bottle tightly after opening, and store it in the original pack. Do not use beyond the expiry date or if the product shows any sign of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.