Product Details

What you need to know before you have One-Alpha Injection

Do not have One-Alpha • If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients. You can find a list of these ingredients in section 6 of this leaflet. • If you know you have a condition called hypercalcaemia. This means you have high levels of calcium in your blood. Page 2 of 6 • If you know that you have a condition called calcification. This means you have high levels of calcium in your body tissues. If you are unsure if any of the above apply to you, talk to your doctor before having One-Alpha. Warnings and precautions Talk to your doctor or nurse before having One-Alpha • If you are taking any of the medicines in the “Taking other medicines” section below. • If you have any problems with your kidneys. This includes if you have kidney stones. • If you have granulomas or sarcoidosis. You may be more sensitive to alfacalcidol. This medicine contains small amounts of alcohol. This may be harmful to some patients such as patients with liver disease, epilepsy and those suffering from alcoholism. You may get too much calcium or phosphate in your blood when you have this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor may need to change your dose. While you are having One-Alpha your doctor will take regular blood tests. This is very important in children, patients with kidney problems, or patients on a high dose of medicine. This is to check the level of calcium and phosphate in your blood while you have your medicine. Your doctor may prescribe another medicine called a phosphate binding agent to take as well as One-Alpha. This will help to keep the right amount of phosphate in your blood. Your doctor may also prescribe a calcium supplement to take as well as One-Alpha. This is to maintain the right amount of calcium in your blood. Other medicines and One-Alpha Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines: • Anticonvulsants (for example, barbiturates, phenytoin, carbamazepine or primidone): for epilepsy or fits. You may need a larger dose of One-Alpha. • Cardiac glycosides, such as digoxin: for heart problems. You may get too much calcium in your blood. This may cause an abnormal heart beat. • Thiazide diuretics, often called “water pills”: for increasing the amount of water (urine) that your body makes. You may get too much calcium in your blood. • Calcium-containing medicines. You may get too much calcium in your blood. • Other medicines that contain vitamin D. You may get too much calcium in your blood. • Antacids containing magnesium: for heartburn or indigestion. You may get too much magnesium in your blood. • Medicines containing aluminium. Too much aluminium is toxic. Pregnancy and 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 having this medicine. Driving and using machines Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect, for example dizziness, that may stop you from driving or using machines. Important information about some of the ingredients of One-Alpha Page 3 of 6 One-Alpha contains: • Ethanol. This is an alcohol. This medicinal product contains up to 160 mg ethanol per dose (corresponding to 4 micrograms of alfacalcidol), which is equivalent to 10 vol % . The amount of ethanol in each dose of One-Alpha is equivalent to less than 4 ml beer or 1.7 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. • Sodium. This medicine contains less than 1 mmol sodium per dose (corresponding to 4 micrograms of alfacalcidol), that is to say essentially ‘sodium free’. • Propylene glycol. One-Alpha solution for injection contains 415 mg propylene glycol per ml which is equivalent to 20.75 mg/kg/day (corresponding to 0.1 micrograms/kg/day of alfacalcidol). If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol. Please ask your doctor if you are worried about any of the ingredients in this medicine.