Summary Public Assessment Report. Alfacalcidol Strides 0.25 microgram, 0.5 microgram and 1.0 microgram capsules, soft DK/H/2282/ /DC

Transcription

1 Summary Public Assessment Report Alfacalcidol Strides 0.25 microgram, 0.5 microgram and 1.0 microgram capsules, soft DK/H/2282/ /DC 19 August 2015 Summary PAR Alfacalcidol Strides 1/5

2 Summary Public Assessment Report Alfacalcidol Strides Alfacalcidol, capsules, soft 0.25 microgram, 0.5 microgram and 1.0 microgram This is a summary of the public assessment report (PAR) for Alfacalcidol Strides. It explains how Alfacalcidol Strides was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use Alfacalcidol Strides. For practical information about using Alfacalcidol Strides, patients should read the package leaflet or contact their doctor or pharmacist. What is Alfacalcidol Strides and what is it used for? Alfacalcidol Strides is a medicine with well-established use. This means that the medicinal use of the active substance of Alfacalcidol Strides is well established in the European Union for at least ten years, with recognised efficacy and an acceptable level of safety. Alfacalcidol Strides belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Alfacalcidol Strides is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat: - Changes in bone caused by kidney failure (osteodystrophy). - Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. o The glands may make the amount of calcium in your blood too high. (hyperparathyroidism). o The glands may make the amount of calcium in your blood too low (hypoparathyroidism). - Low levels of calcium in the blood of newborn babies (hypocalcaemia). - Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia). How does Alfacalcidol Strides work? Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth. Alfacalcidol Strides works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. Summary PAR Alfacalcidol Strides 2/5

3 How is Alfacalcidol Strides used? The pharmaceutical form of Alfacalcidol Strides is capsules, soft and the route of administration is oral. Your doctor will tell you how many capsules to take, or to give your child. At first you will have weekly blood tests to check the levels of some substances in your blood. These tests are to check the levels of calcium, an enzyme called alkaline phosphatase or the parathyroid hormone. This is so your doctor knows that you are taking the dose that is right for you. When you are getting the correct dose you will not need blood tests so often. You may also have other tests such as X-rays. This is also so your doctor knows that the dose is right for you. Your doctor may adjust your dose. Your doctor may ask you to take more or less capsules depending on your test results. You may get too much calcium or phosphate in your blood when you take this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor will tell you not to take any more medicine. You will need to have some blood tests. When the blood tests are normal you can start your medicine again. It is important that you only take half the dose you had before. Adults The usual starting dose is 1 microgram each day. People usually take between 1 and 3 micrograms each day. Most people take between 0.25 and 1 microgram each day once the blood test results show the medicine is working. If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 microgram each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as Alfacalcidol Strides. This will help to keep the right amount of calcium level in your blood. Elderly The usual starting dose is 0.5 microgram each day. The medicine can only be obtained with a prescription. Summary PAR Alfacalcidol Strides 3/5

4 What benefits of Alfacalcidol Strides have been shown in studies? As alfacalcidol is a well-known substance, and its use in the treatment of: - Changes in bone caused by kidney failure (osteodystrophy). - Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. o The glands may make the amount of calcium in your blood too high. (hyperparathyroidism). o The glands may make the amount of calcium in your blood too low (hypoparathyroidism). - Low levels of calcium in the blood of newborn babies (hypocalcaemia). - Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia). is well established, the applicant presented data from the scientific literature. The literature provided confirmed the efficacy and safety of alfacalcidol in the treatment of diseases where the amount of calcium in your body needs changing. What are the possible side effects from Alfacalcidol Strides? The side effects reported with Alfacalcidol Strides are very rare (may affect up to 1 in 10,000 people). Skin problems or too much calcium in your blood are the side effects most people get. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: - You have difficulty breathing - Your face or throat swell - Your skin develops a severe rash. You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood: - You need to pass water (urine) more often - You feel thirsty - You have a dry mouth, or a metallic taste in your mouth. You feel weak or have pain in your muscles or bones - You feel sick or have constipation. Other possible side effects: Skin problems: - Itching skin - Rash Summary PAR Alfacalcidol Strides 4/5

5 - Hives (urticaria) Kidney problems: Needing to pass water (urine) less often. Swelling of any parts of your body. Fever with a pain in your side. These are signs that there may be problems developing with your kidneys. Kidney stones may be forming. Kidney stones may cause a sharp spasm in one side of your lower back. Alfacalcidol Strides must not be used: - If you are allergic (hypersensitive) to alfacalcidol, Arachis oil (peanut oil) 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 For the full list of restrictions, see the package leaflet. Why is Alfacalcidol Strides approved? The member states involved in the procedure concluded that Alfacalcidol Strides benefits are greater than its risks and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Alfacalcidol Strides? A risk management plan has been developed to ensure that Alfacalcidol Strides is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Alfacalcidol Strides, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about Alfacalcidol Strides The marketing authorisation for Alfacalcidol Strides was granted on The full PAR and the package leaflet for Alfacalcidol Strides can be found on the website For more information about treatment with Alfacalcidol Strides, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in August Summary PAR Alfacalcidol Strides 5/5