Decara

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

• It is used to treat or prevent vitamin D deficiency.

• If you have an allergy to cholecalciferol or any other part of Decara (cholecalciferol capsules and tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Malabsorption syndrome, overactive parathyroid gland, sarcoidosis, too much vitamin D or calcium in your body, or Williams syndrome.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Decara with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid other sources of vitamin D.
• Follow the diet and workout plan that your doctor told you about.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Decara while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take Decara.
• Some strengths of this medicine are not taken every day. Be sure you know how to take Decara. Talk with your doctor if you have questions.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to cholecalciferol: compounding crystal, oral capsule, oral liquid, oral solution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral wafer

Metabolic

Metabolic side effects have included hypercalcemia.[Ref]

Renal

Uncommon (0.1% to 1%): Hypercalciuria[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, urticaria[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions such as angioedema or laryngeal edema[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting[Ref]

Some side effects of Decara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.