Colecalciferol Meda – Cholecalciferol uses, dose and side effects

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800 IU tablet 
cholecalciferol ( vitamin D 3 )

1. What Colecalciferol Meda is and what it is used for

Colecalciferol Meda contains vitamin D 3 which regulates the uptake and metabolism of calcium as well as the storage of calcium in the skeleton.

Colecalciferol Meda is used to preventing and treating vitamin D 3 deficiency in adults and adolescents.

Your doctor may prescribe Colecalciferol Meda as an adjunct to specific therapy for osteoporosis ( osteoporosis ).

2. What you need to know before using Colecalciferol Meda

Do not use Colecalciferol Meda

  • if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
  • if you have hypercalcemia (increased amount of calcium in the blood) or hypercalciuria (increased amount of calcium in the urine).
  • if you have hypervitaminosis D (an excess of vitamin D in your blood).
  • if you have kidney stones.

If any of the above apply to you, talk to your doctor or pharmacist before using Colecalciferol Meda.

Warnings and cautions

Talk to your doctor or pharmacist before using Colecalciferol Meda:

  • if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints, among other things).
  • if you are taking other medicines that contain vitamin D.
  • if you have impaired kidney function or have had kidney stones.

Other medicines and Colecalciferol Meda

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

  • Cholestyramine (treatment of high cholesterol ).
  • Phenytoin or barbiturate is (treatment of epilepsy ).
  • Laxatives containing paraffin oil.
  • Thiazide – diuretics (for high blood pressure ).
  • Glucocorticoid is (treatment of inflammation ).
  • Cardiac glycosides, e.g. digoxin (for irregular heartbeat).

Colecalciferol Meda with food and drink

Colecalciferol Meda can be taken with a meal.

Pregnancy and breastfeeding

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 taking this medicine.

During pregnancy, the daily intake should not exceed 600 IU of vitamin D.

Colecalciferol Meda should only be used during pregnancy if your vitamin D deficiency has been determined by your doctor.

Colecalciferol Meda can be used during breast-feeding. Vitamin D 3 passes into breast milk. This should be taken into account when giving another vitamin D supplement to breastfed children.

Driving and using machines

Colecalciferol Meda has no known effects on the ability to drive and use machines.

Colecalciferol Meda contains sucrose and isomalt

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium content

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to use Colecalciferol Meda

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 tablet daily.

The daily dose should not exceed 4000 IU (5 tablets).

The tablets can be swallowed whole or crushed.

Use for children

Colecalciferol Meda should not be used in children under 12 years of age as there is no evidence from clinical trials.

If you forget to take Colecalciferol Meda

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Colecalciferol Meda

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.

Stop taking Colecalciferol Meda and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, lips, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

Uncommon (affects less than 1 user in 100): Hypercalcaemia (increased amount of calcium in the blood) and hypercalciuria (increased amount of calcium in the urine).

Rare (affects less than 1 user in 1,000): Itching, rash, and urticaria ( hives ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Colecalciferol Meda

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister or can after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Sensitive to light.

Close the package tightly. Moisture sensitive.

Medicines should not be disposed of via 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 packaging and other information

Content declaration

  • The active substance is cholecalciferol 20 micrograms equivalent to 800 IU vitamin D 3.
  • The other ingredients are pregelatinized corn starch, isomalt (E953) (see Section 2 “Colecalciferol MEDA contains sucrose and isomalt”), magnesium stearate, sucrose, sodium ascorbate (see Section 2 “Sodium Content”), medium-chain triglyceride s, anhydrous colloidal silica, modified corn starch and all – rac -alpha-tocopherol.

What the medicine looks like and the contents of the pack

Colecalciferol Meda is white to slightly yellowish, biconvex tablets, 7 mm in diameter.

30, 60, or 90 tablets in blisters.

250 tablets in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Tel: 08 – 630 19 00
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Manufacturer
Rottapharm LtdDamastown Industrial ParkMulhuddartDublin 15IrelandVemedia Manufacturing BVVerrijn Stuartweg 60NL-1112 AX Diemen Netherlands

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