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What is Osteo D and what it is used
Osteo D is a medicinal product containing vitamin D.
Osteo D is used to treat a type of bone disease called renal osteodystrophy, which occurs in patients with chronic renal failure, redress the calcium and phosphate metabolism.
Osteo capsules E (0.25 micrograms) was used to treat osteoporosis as a result of menopause, which consists in reducing the density of the bone tissue in women following the "change of life" (due to suspended hormone production).
Please ask your doctor or pharmacist if you need more information.
2. What you need to know before taking Osteo D
Do not use Osteo E:
if you are allergic to the active substance calcitriol or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to certain medicines containing vitamin D, for example. alfacalcidol, colecalciferol;
if you have high concentrations of calcium and minerals in the blood or tissues;
if you have rare hereditary problems of fructose intolerance.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Osteo D.
HE take other medicines containing vitamin D (eg. Vitamin D supplements) while taking Osteo E;
Consult your doctor regarding calcium-containing medications (eg. Calcium supplements).
Other medicines and Osteo D
Talk to your doctor or pharmacist if you are taking the following medicines:
diuretics, e. bendroflumethiazide, chlorthalidone, indapamide, used to treat high blood pressure;
digoxin or digitoxin used for treatment of cardiac diseases;
drugs containing magnesium, for example. antacids used for the treatment of indigestion;
phosphate binders, e. aluminum hydroxide, calcium carbonate, used to treat high levels of phosphate in the blood;
barbiturates, e. amobarbital, phenobarbital, used to treat epilepsy;
anticonvulsant drugs, e. phenytoin, clonazepam, used to treat epilepsy;
steroid drugs, e. hydrocortisone, prednisolone, dexamethasone;
cholestyramine or other "ion-exchange resins", used to treat high cholesterol levels.
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines
During treatment must follow a strict diet that your doctor has recommended. The sharp rise in intake of calcium diet (eg increased consumption of dairy products, uncontrolled additional intake of calcium supplements) can cause hypercalcemia. Immobilized patients (eg after surgery) are particularly at risk of hypercalcemia. Your doctor will tell you how to recognize the signs of hypercalcemia;
Calcitriol increases the level of inorganic phosphate in the blood. This can be a problem (formation of calcifications in unusual places) in patients with renal insufficiency;
Since calcitriol is the most active form of vitamin D during treatment, you should not take other products of this vitamin to avoid hypervitaminosis D;
During treatment with Osteo D should not take sufficient quantity of liquids.
Osteo D with food and drink
Do not consume any food or drink whose effect is enhanced by vitamin D (eg. Margarine, muesli, multivitamin drinks milk with high calcium content or buttermilk) while taking Osteo D. If you need additional information, please consult your doctor;
Do not take any vitamins or supplements containing vitamin D while taking Osteo E;
Talk to your doctor about the consumption of foods that are high in vitamin D (eg. Fatty fish, eggs) or high calcium content (eg. Dairy products). It is very important to follow any diet, appointed by your doctor;
Drink plenty of fluid (eg. Water) as it is important not to become dehydrated. This does not apply if you have kidney problems.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Then your doctor will decide whether you can make treatment with calcitriol. The drug should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Calcitriol passes into breast milk. Due to the risk of hypercalcemia and possible adverse reactions in nursing infants, mothers can breast-feed during treatment with Osteo D provided that the levels of calcium in the blood of mother and child are monitored regularly.
Driving and using machines
The ability to drive or operate machines is not affected by treatment with Osteo D.
Osteo D contains sorbitol
Osteo D contains small amounts of sorbitol. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before to take this product.
3. How to take Osteo D
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
At the beginning of treatment calcium levels in your blood should be regularly measured. The dosage of Osteo D should be adjusted until the right answer. When the correct dose has been established, the values of calcium can be measured less frequently.
Also, if your doctor deems it necessary, he / she may prescribe additional calcium supplements to be taken during treatment.
The capsules should be taken preferably with water.
The usual dose is:
Adults (including the elderly)
The starting dose is one capsule of 0.25 micrograms per day. If necessary, your doctor may increase the dose of 0.25 micrograms at intervals of 2-4 weeks to find the right dose for you.
One capsule of 0.25 microgram twice daily.
The safety and efficacy of Osteo D in children is not sufficiently studied and the drug is not recommended for use in them.
The recommended adult dose is appropriate for treating the elderly (over 65 years).
If you take a larger dose than necessary Osteo D
If you or someone else has taken more capsules at once or you think a child has swallowed even one capsule, please immediately contact the nearest hospital or your doctor.
An overdose is likely to cause high calcium levels in the blood or urine. This causes constipation, dizziness, lack of appetite, weakness, headaches, insomnia and rigid emotions.
Please take this leaflet, capsules and other packaging with you to the hospital or your doctor to know what capsules you take.
If you forget to take Osteo D
If you forget to take a capsule Osteo D, take it as soon as possible after you remember unless it is time to take the next. Then continue treating your regular dosing schedule. Never take a double dose to make up for a missed dose. Take the appropriate dose at the right time.
If you stop taking Osteo D
You must continue to take these capsules as long as you have been told your doctor.
Do not stop taking your medicine without consulting your doctor first even if you feel better.
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.
Calcitriol is accepted by many patients without any problems.
Stop taking the capsules and tell your doctor immediately or go to the emergency room of the nearest hospital if the following happens:
allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives).
These are very serious but rare side effects. You may need urgent medical examination or hospitalization.
Tell your doctor immediately if you experience any of the following adverse events:
fever, dehydration, thirst, increased urination and / or increased need to drink water at night, palpitation, stomach ache or stomach churning, constipation, fatigue, loss of appetite, weakness, headaches, insomnia or stilted emotions.
These side effects are rare and can include symptoms of hypercalcaemia
(High levels of calcium in the blood).
Very common side effects (may affect up to 1 in 10 people):
may start to be postponed calcium in parts of the body other than the bones (eg. kidney as "kidney stones").
Common side effects (may affect up to 1 in 100 people):
urinary tract infection.
Uncommon side effects (may affect up to 1 in 1,000 people):
increased levels of creatinine in the blood.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store D Osteo
Keep out of reach of children.
Store in the original container. Do not store above 30 ° C. Do not put in another container.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Osteo E:
The active substance is calcitriol (calcitriol).
The other ingredients (excipients) are: butylated hydroxy (E320), butylated
hydroxytoluene (E321), fractionated coconut oil.
Contents of the capsule shell: gelatin, glycerol (E422), sorbitol (E420), titanium dioxide (E171), quinoline yellow (E104).
The ink contains: refined shellac (E904), black iron oxide (E172).
Looks like Osteo D and contents of the pack:
Osteo D 0.25 microgram capsules: opaque, oval, yellow, soft gelatin capsules labeled 0.25.
Bottles with polypropylene caps from low density polyethylene (LDPE) 30, 50 and 100 capsules.
Not all pack sizes may be marketed.
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