Blum-D 50,000 I.U. Film Coated Tablet

Cholecalciferol (vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Blum-D is and what it is used for.
  2. Before you use Blum-D.
  3. How to use Blum-D.
  4. Possible side effects.
  5. How to store Blum-D.
  6. Further information.

What Blum-D is and what it is used for.

Blum-D contains Cholecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones.

Blum-D is used to treat vitamin D deficiency that has been confirmed by laboratory tests.

What you need to know before you use Blum-D
Do not use Blum-D:

• If you are allergic to Vitamin D3 or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria).
• If you have kidney stones (renal calculi).
• If you have serious renal impairment.
• If you have high levels of vitamin D3 in your blood (hypervitaminosis D).
• If you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism).
• If you are pregnant.
• If you are under 18 years of age.

If any of the above applies to you, talk to your doctor or pharmacist before taking Blum-D.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Blum-D:
• If you are undergoing treatment with certain medicines used to treat heart disorders (e.g, cardiac glycosides, such as digoxin).
• If you have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D3 in the body).
• If you are taking medicines containing vitamin D3, or eating foods or milk enriched with vitamin D3.
• If you are likely to be exposed to a lot of sunshine whilst using Blum-D.
• If you take additional supplements containing calcium. Your doctor will monitor your blood levels of calcium to make sure they are not too high whilst you are using Blum-d.
• If you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.

Children and adolescents
This medicine is not suitable for use in children and adolescents under 18 years of age.

Other medicines and Blum-D
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important if you are taking:
• Medicines that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., Bendroflumethiazide). When used at the same time as vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine.
• Medicines containing vitamin D3 or eating food rich in vitamin D3, such as, some types of vitamin D3-enriched milk.
• Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal disease). These medicines may interfere with the way your body processes vitamin D
• The following medicines because they can interfere with the effect or the absorption of vitamin D3:

  • antiepileptic medicines (anticonvulsants), barbiturates.
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), these can decrease the effect of vitamin D3.
  • medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol)
  • certain medicines for weight loss that reduce the amount of fat your body absorbs (e.g. orlistat)
  • certain laxatives (such as liquid paraffin).

Pregnancy, breast feeding and Fertility
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. This high strength formulation is not recommended for use in pregnant and breastfeeding women.

Driving and using machines
There is limited information on the possible effects of this medicine on your ability to drive. However, it is not expected that it would affect your ability to drive or to operate machinery.

How to use Blum-D

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The whole Tablet should be swallowed with water. You should take Blum-D preferably together with a large meal to help your body absorb the vitamin D.

Use in adults:
The recommended dose for Treatment of vitamin D deficiency: 50,000 I.U/week (1 Tablet) for 6-8 weeks, followed by maintenance therapy (1,400- 2,000 I.U/day, such as 1 Tablet a month).
During long-term treatment, the calcium levels in the blood and urine, and the functions of the kidneys will be monitored regularly by your doctor to ensure the safety of your medicine, and check that you are taking the correct dose.

Use in children and adolescents:
This high strength formulation is not recommended.

Use in pregnancy and breast-feeding
This high strength formulation is not recommended.

How to take Blum-D
The whole Tablets should be swallowed with water. You should take Blum-D preferably together with a large meal to help your body absorb the vitamin D.

If you take more Blum-D than you should
If you take more medicine than prescribed, stop using this medicine and contact your doctor. If it is not possible to talk to a doctor go to the nearest hospital emergency department and take the medicine package with you.

The most common symptoms of overdose are nausea, vomiting, excessive thirst, the production of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in the blood (hypercalcaemia and hypercalciuria) shown by lab test.

If you forget to take Blum-D
If you forget to take a dose of Blum-D, take the forgotten dose as soon as possible. Then take the next dose at the correct time. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Blum-D
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.  

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects may include:
Uncommon (may affect up to 1 in 100 people)
• Too much calcium in your blood (hypercalcaemia)
• Too much calcium in your urine (hypercalciuria)

Rare (may affect up to 1 in 1,000 people)
• Skin rash
• Itching
• Hives

How to store Blum-D

• 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 after ‘EXP’. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light.
• Store below 30°C.
• Do not use this medicine if you notice any visible signs of deterioration
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Further information
What Blum-D contains:

• The active substance is Cholecalciferol (Vitamin D3). Each tablet contains 50,000 I.U Cholecalciferol (equivalent to 1.25mg).
• The other ingredients are:
Avicel DG, Croscarmellose Sodium, Colloidal Sillcone Dioxide, Magnesium
Ingredients used as seal coating:
Hydroxy Propyl Methyl Cellulose, Polyethylene Glycol, Talc, Titanium Dioxide,
Ethyl Alcohol.
Ingredients used as film coating:
Opadry Ys-1-7027 White What Blum-D looks like and contents of the pack: Blum-D is white to off white, ovaloid shaped biconvex, film coated tablet and has “JS19” marked on one side. Blum-D 50,000 I.U. is available in blister pack containing 20 tablets.

Marketing Authorization Holder and Manufacturer
Alpha Pharma
King Abdullah Economic City, Rabigh. Saudi Arabia
Tel: +966 12 21 29013