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Package Leaflet Page 1 PACKAGE LEAFLET Page 2 PACKAGE LEAFLET: INFORMATION FOR THE USER Cleviprex 0.5 mg/ml emulsion for injection Clevidipine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any of the side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Cleviprex is and what it is used for 2. What you need to know before you are given Cleviprex 3. How Cleviprex is used 4. Possible side effects 5. How to store Cleviprex 6. Contents of the pack and other information 1. What Cleviprex is and what it is used for Cleviprex contains the active substance clevidipine. Clevidipine is a calcium channel blocker. Calcium channel blockers are medicines which lower blood pressure. Cleviprex is used to lower blood pressure in adult patients preparing for surgery, undergoing surgery or immediately after surgery. Page 3 2. What you need to know before you are given Cleviprex Do not use Cleviprex: - if you are allergic (hypersensitive) to clevidipine, soybeans, soya-bean oil, soy products, peanut, eggs or egg products or to any of the other ingredients of this medicine (listed in section 6) - if you have disorders of lipid metabolism (difficulties processing fats), such as extremely high levels of fat in your blood (pathologic hyperlipidaemia), a kidney disorder that causes loss of protein in urine (lipoid nephrosis) or inflammation of the pancreas (acute pancreatitis) if it is accompanied by high levels of fat in the blood (hyperlipidaemia) - if you suffer from severe aortic stenosis (severe narrowing of one of the valves in the heart) - Check with your doctor if you are unsure. Warnings and precautions Talk to your doctor before using Cleviprex: - if you have a heart condition where the aortic valve in your heart does not open completely - if you have an abnormally large heart caused by narrow blood vessels (hypertrophic obstructive cardiomyopathy) - if you have a heart condition where a valve is narrowed (stenosis of the mitral valve) - if you have a tear in the main artery of the body (aortic dissection) - if you have a tumour of the gland on top of the kidney (adrenal gland) that causes high blood pressure (pheochromocytoma) - if you have had a heart attack - if you have a condition where your heart cannot increase in rate in order to compensate for reduced blood pressure such as o an electrical problem with your heart o you are fitted with a pacemaker Page 4 Other medicines and Cleviprex Please tell your doctor if you are taking, have recently taken or might take any other medicines. It is particularly important that you tell your doctor if you have been taking any medicines to lower your blood pressure. Pregnancy and breast-feeding You must tell the doctor if: - you are pregnant or think you may be pregnant - you are planning on becoming pregnant - you are breast-feeding There is no adequate information on the use of Cleviprex in pregnant women. Cleviprex should not be used during pregnancy unless clearly necessary. Your doctor will decide whether or not this treatment is appropriate for you. It is not known whether Cleviprex is excreted in breast-milk. If you are breast-feeding, the doctor will decide whether Cleviprex should be used. Driving and using machines Cleviprex is used to lower your blood pressure, which may make you feel light-headed or dizzy and could affect your ability to drive or use machines. You must not drive or operate machinery until the effects of Cleviprex have worn off. Check with your doctor before leaving hospital if you are unsure. Cleviprex contains soya oil and sodium If you are allergic to peanut or soya, do not use this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. Page 5 3. How Cleviprex is used Cleviprex is for infusion (drip) into a vein. This is administered by a doctor. Your treatment with Cleviprex will be supervised by a doctor as Cleviprex is administered in the hospital. The doctor will decide how much Cleviprex you receive and will prepare the medicine. - Throughout your treatment, the doctor will check your blood pressure - Before the start of infusion the doctor will tell you about the signs of allergic reaction - The dose and duration of infusion depends upon the kind of treatment you are undergoing Dosage An infusion of Cleviprex should be started at 4 ml/hour (2 mg/hour) and increased as tolerated in doubling amounts (i.e. 4 to 8, 8 to 16, 16 to 32, 32 to 64 ml/hour [2 to 4, 4 to 8, 8 to 16, 16 to 32 mg/hour]) every 90 seconds. Cleviprex will reduce blood pressure for most patients at doses up to 32 ml/hour (16 mg/hour). Some patients may require a dose up to 64 ml/hour (32 mg/hour). If you have more Cleviprex than you should These doses are carefully checked by the doctor, so an overdose is very unlikely. In the event of taking too much Cleviprex, the infusion will be reduced or stopped. An overdose of Cleviprex may make you feel light-headed or dizzy or may make your heart beat faster. If you are concerned that you may have been given too much Cleviprex, talk to your doctor or other medical staff immediately. If you forget to have Cleviprex Since treatment with Cleviprex is administered and supervised by a doctor, this is very unlikely. If you are concerned that you may have missed a dose, talk to your doctor immediately. While you are receiving Cleviprex If you develop severe allergic reactions, like swelling of your face and/or throat or fever tell your doctor immediately. If you have further questions on the use of this medicine, ask your doctor. Page 6 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and do not last very long. Cleviprex may cause atrial fibrillation (irregular heart beat), chest discomfort or hypoxia (lower blood oxygen levels, which may make you feel light-headed or dizzy). If this happens to you, talk to your doctor or other medical staff immediately, they will decide if treatment with Cleviprex should continue. Common: may affect up to 1 in 10 people - tachycardia (fast heart beat) - atrial fibrillation (irregular heart beat) - hypoxia (lower blood oxygen levels) - chest discomfort - hypotension (low blood pressure) - polyuria (producing large volumes of urine) - oedema (swelling) at the injection site - flushing (reddening of the skin) - feeling hot - acute kidney injury (damage to the kidney) Uncommon: may affect up to 1 in 100 people - atrial flutter (abnormal heart rhythm) - heart failure - slow heart beat - atrioventricular block (feeling your heart beat) - constipation - lung congestion - headache - dizziness - nausea - vomiting - allergic reaction Rare: may affect up to 1 in 1,000 people - ileus (constipation; obstruction of the digestive system [bowel]) Page 7 Reporting side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Cleviprex Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month. Store and transport refrigerated (2C – 8C). Do not freeze. Once the container is opened, any remaining product should be discarded after 12 hours. Keep vial in the outer carton in order to protect from light. The emulsion should be milky white. The doctor will check the emulsion and will discard it if it contains particles or is discoloured. Do not throw away medicines via wastewater or household waste. The healthcare professional administering Cleviprex will be responsible for ensuring that any unused product or waste material is disposed of in accordance with local requirements. These measures will help protect the environment. 6. Contents of the pack and other information What Cleviprex contains - The active substance is clevidipine. 1 ml emulsion for injection contains 0.5 mg clevidipine. One vial of 50 ml of emulsion contains 25 mg of clevidipine. One vial of 100 ml of emulsion contains 50 mg of clevidipine. - The other ingredients are soya-bean oil refined, glycerol, egg phospholipids, oleic acid, disodium edetate, water for injections and sodium hydroxide (for pH adjustment). What Cleviprex looks like and contents of the pack Cleviprex is a milky white emulsion in a glass vial. Page 8 Cleviprex is available in cartons containing 10 vials of 50 ml and 10 vials of 100 ml. Not all vial sizes may be marketed. Marketing Authorisation Holder <[To be completed nationally]> Manufacturer <[To be completed nationally]> This leaflet was last revised in <[To be completed nationally]> ----------------------------------------------------------------------------------------------------------- -------------- The following information is intended for medical or healthcare professionals only: Cleviprex 0.5 mg/ml emulsion for injection Clevidipine Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information. Cleviprex is indicated for the rapid reduction of blood pressure in the perioperative setting. Safety and efficacy has not been established in children or pregnant women.
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