Alfacalcidol 1 mcg. 60 capsules
Alfacalcidol belongs to a group of medicines called analogues of vitamin D. This is a type of vitamin D. Vitamin D controls the levels of the two substances in your body. These nutrients are calcium and phosphate. Your body needs these two substances to keep bones and teeth healthy.
Alfacalcidol works by increasing the amount of vitamin D in your body. This means that the levels of calcium and phosphate in your body will also increase.
Alfacalcidol is used for the treatment of diseases where it is necessary to change the amount of calcium in your body. It is used to treat:
Changes in the bone caused by renal failure (osteodystrophy);
Osteoporosis in postmenopausal osteoporosis and the maintenance treatment with glucocorticoids;
Changes in the parathyroid glands you. These are small glands in the neck. They produce a substance called parathyroid hormone. It changes the level of calcium in your body. Glands can reduce excessive amount of calcium in your blood (hypoparathyroidism);
Softening and deformation of the bones due to a lack of calcium (rickets or osteomalacia).
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE SANDOZ alfacalcidol
Do not take alfacalcidol :
If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients. In section 6 of this leaflet there is a list of those ingredients;
If you know that you suffer from a condition called hypercalcemia. This means that you have high levels of calcium in their blood.
If you are not sure if any of these apply to you, talk to your doctor before taking alfacalcidol .
Warnings and Precautions
Talk to your doctor or pharmacist before taking alfacalcidol :
if you are taking another type of medicine called a cardiac glycoside, such as digoxin. These drugs are used to treat heart problems;
if you have any kidney problems. This includes if you have kidney stones.
It is possible when taking this medicine to accumulate too much calcium or phosphate in your blood. Please refer to section 4 of this leaflet you can find in themselves any possible signs. It may be necessary for your doctor to change your dose.
While taking alfacalcidol your doctor will do regular blood tests. This is necessary in order to verify the levels of calcium and phosphate in your blood while taking this drug.
Your doctor can prescribe another medicine called a phosphate binder, which taken together with alfacalcidol . This will help to maintain the appropriate amount of phosphate in your blood.
Other medicines and alfacalcidol
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should tell your doctor or pharmacist if you are taking any of the following medications:
anticonvulsants, for the treatment of epilepsy or seizures. You may need a higher dose of alfacalcidol ;
barbiturates: for the treatment of epilepsy. You may need a higher dose of alfacalcidol ;
cardiac glycosides, e. Digoxin: to treat heart problems. It is possible for your blood to accumulate too much calcium. This can cause an irregular heartbeat;
cholestyramine: used to lower cholesterol and aid in certain types of diarrhea or itching. It is possible that your alfacalcidol not to do in your blood as usual;
thiazide diuretics, often called "water pills": used to increase the amount of water (urine), which your body produces. It is possible for your blood to accumulate too much calcium;
drugs containing magnesium which have been associated with gastric acid (so-called. antacids) and laxatives containing magnesium: It is possible in your blood to accumulate too much magnesium;
Calcium or products containing calcium: It is in your blood to accumulate too much calcium;
Other products containing vitamin D or its analogues. Their effect can be additive, and it is possible in your blood to accumulate too much calcium.
Alfacalcidol with food and drink
You can take the capsules with or without food.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Usually, this medicine may have very little effect on the ability to drive or operate machinery.
Consult your doctor if you notice any side effects that may prevent you from driving or operating machinery.
Alfacalcidol contains sorbitol
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Consult your doctor if you have concerns about any of the ingredients of this medicine.
3. HOW TO TAKE SANDOZ alfacalcidol
Always take alfacalcidol exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
How to remove the capsule from the blister
Press the shiny side of the blister. The capsule will show the country marked the foil.
How to take alfacalcidol
Your doctor will tell you how many capsules to take or give your child.
In the beginning, you will have two weekly blood tests, which will be checked levels of certain substances in your blood. These studies will verify the levels of calcium, the enzyme, called alkaline phosphatase, or parathyroid hormone. The goal is for your doctor to check whether your dose is right for you. Once you begin to accept your right dose, blood tests will be done to you so often.
Your doctor can adjust your dose. Your doctor may ask you to take more or less tablets, depending on the results of your research. When this medicine is possible in your blood to accumulate too much calcium or phosphate. Please refer to section 4 of this leaflet for you to see yourself in any possible signs.
Your doctor will tell you when to stop taking the drug. You will need to make certain your blood tests.
If the results of these tests are normal, you will be able to start taking it again. It is important to take only half the dose you took before.
The usual starting dose is 1 microgram per day. Most people respond to doses between 1 and 3 micrograms per day.
Most people take between 0.25 and 1 microgram per day after blood tests show that the drug acts.
If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 micrograms per day. A doctor may prescribe another medicine called a calcium supplement to take with alfacalcidol . This will help to maintain normal levels of calcium in their blood.
Children and adolescents:
The dose depends on the weight of the child (called "body weight").
Patients weighing less than 20 kg: The usual starting dose is 0.05 micrograms per day for every kilogram of body weight.
Patients weighing more than 20 kg: The usual starting dose is 1 microgram per day.
If you take more dose alfacalcidol
Immediately tell your doctor. You may need to stop taking the drug.
It is possible for your blood to accumulate too much calcium or phosphate. Please refer to section 4 of this leaflet, if you notice in yourself any signs.
If you forget to take alfacalcidol
If you forget to take your medicine you should take it as soon as you remember. The next dose at the usual time.
If you stop taking alfacalcidol
In general, your treatment is prolonged. Alfacalcidol must be taken regularly. Consult your doctor if you want to stop taking the capsules.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects that need to track:
Urgently need to seek medical help if you have any of these symptoms.
It is possible to have an allergic reaction:
Your breathing is difficult.
Your face or throat are swollen.
Your skin has a serious rash.
Rare (may affect 1 in 1,000 users):
You should tell your doctor if you notice any of these signs, which may mean that you have too much calcium or phosphate in the blood:
More often you need to urinate.
Your mouth is dry or have a metallic taste.
Feel pain or weakness in muscles or bones.
You are sick or have constipation.
Other possible side effects:
Very rare (may affect up to 1 in 10 000 users):
less frequent need to urinate;
edema formation in any part of the body;
fever pain wide.
These signs may indicate problems with your kidneys. It is possible to develop kidney stones. Kidney stones may cause severe spasms in the lower side of the back.
The most common reactions that people receive are skin problems or high level of calcium in the blood.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system to:
str. "Damyan Gruev" № 8
As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. HOW TO STORE SANDOZ alfacalcidol
Keep this medicine out of the reach and sight of children.
Do not use after the expiry date stated on the package. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND ADDITIONAL INFORMATION
The active substance is alfacalcidol.
Alfacalcidol 1 microgram capsules: Each soft capsule contains 1 microgram alfacalcidol.
Other ingredients are:
Alfacalcidol 1 microgram capsules: triglycerides, medium, butylhydroxyanisole (E320), butylated hydroxytoluene (E321), gelatin, sorbitol, liquid (non-crystallising) (E420), glycerol, black iron oxide (E172) and red iron oxide (E172).
Looks like alfacalcidol Sandoz and contents of the pack
Alfacalcidol 1 microgram capsule: oval, brown, opaque, soft gelatin capsules.
Alfacalcidol capsules are available in blister packages of 20, 30, 50, 60, 90 or 100 capsules.
Not all pack sizes may be marketed.