Dmex 5000 IU

Colecalciferol (Vitamin D3) Tablets BP 5000 IU

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

• If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1. What Dmex is and what it is used for
2. Before you use Dmex
3. How to use Dmex
4. Possible side effects
5. How to store Dmex
6. Content of the pack

1. What Dmex is and what it is used for

-Pharmacotherapeutic group:

Dmex Colecalciferol (vitamin D3) which is fat soluble vitamin, vitamin D3 substances are well absorbed from the gastrointestinal tract. The presence of bile is essential for adequate intestinal absorption; absorption may be decreased in patients with decreased fat absorption.

Dmex (Colecalciferol) has a slow onset and a long duration of action. It is hydroxylated in the liver and kidneys.

-Therapeutic Indications

• Treatment and prevention of vitamin D3 deficiency states and hypocalcemia in disorders such as hypoparathyroidism.

• Treatment of hypoparathyroidism in pregnancy.
• Treatment of osteomalacia and rickets
• Treatment and prevention of osteoporosis (in conjunction with calcium)

• Prevention of corticosteroid-induced osteoporosis
• Prevention of fractures
• Prevention of various cardiovascular, metabolic disorders including diabetes mellitus, multiple sclerosis and malignant disorders.

2. Before you use Dmex

a-Do not use Dmex:

-If You with hypercalcemia, vitamin D3 should not be given to you.

b- Take special care with Dmex:

• vitamin D3 should be used with caution in infants, who may have increased sensitivity to its effects, and if you with renal impairment or calculi, or heart disease, who might be at increased risk of organ damage if hypercalcemia occurred.

• Plasma phosphate concentrations should be controlled during vitamin D3 therapy to reduce the risk of ectopic calcification.

• It is advised that patients receiving pharmacological doses of vitamin D3 should have their plasma calcium concentration monitored at regular intervals, especially initially or if symptoms suggest toxicity, and in infants if they are breast-fed by mothers receiving pharmacological doses of vitamin D3.

• Dose should be monitored by testing for serum vitamin D3 level.

c- Taking other medicines:

• Thiazide diuretics, calcium, or phosphate: Increased risk of hypercalcemia. Plasma calcium concentrations should be monitored.

• Some antiepileptics (e.g., carbamazepine, Phenobarbital, phenytoin, and primidone): Increased vitamin D3 requirements.

• Rifampicin and isoniazide: Rifampicin and isoniazide may reduce the effectiveness of vitamin D3.

• Corticosteroids: Corticosteroids may counteract the effect of vitamin D3.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

d-Pregnancy and breast-feeding:

• Pregnancy: Hypercalcemia during pregnancy may produce congenital disorders in the offspring, and neonatal hypoparathyroidism. However, the risks to the fetus of untreated maternal hypoparathyroidism are considered greater than the risks of hypercalcemia due to vitamin D3 therapy.

• Breast feeding: vitamin D3 is distributed into breast milk, and its concentration appears to correlate with the amount of vitamin D3 in the serum of exclusively breast-fed infants. The American Academy of Pediatrics considers the use of vitamin D3 to be usually compatible with breast feeding, although they recommend, if the mother is taking pharmacological doses of vitamin D3, that the infant be closely monitored for hypercalcemia or clinical manifestations of vitamin D3 toxicity.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast- feeding.

3. How to use Dmex

Always use Dmex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

*The variation of laboratory results from lab to lab has to be taken into account.

Dmex 5000 I.U. Tablets: One tablet once daily or one tablet every other day.

If you take more Dmex than you should:

Excessive intake of vitamin D3 leads to the development of hyperphosphatemia or hypercalcemia. Associated effects with hypercalcemia include hypercalciuria, ectopic calcification, renal and cardiovascular damage, muscle weakness, apathy, headache, anorexia, nausea , vomiting, bone pain, proteinuria, and hypertension. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis, and rapid deterioration of renal function. Hypercalcemia has been reported in a patient after brief industrial exposure to Colecalciferol.

Symptoms of overdosage include anorexia, lassitude, nausea and vomiting, constipation or diarrhea, polyuria, nocturia, sweating, headache, thirst, somnolence, and vertigo. Infants and children are generally more susceptible to its toxic effects. The vitamin should be withdrawn if toxicity occurs. It has been stated that vitamin D3 dietary supplementation may be detrimental in persons already receiving an adequate intake through diet and exposure to sunlight, since the difference between therapeutic and toxic concentrations is relatively small.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Dmex

–  KEEP THE MEDICINE OUT OF REACH OF CHILDREN. 

–  Store below 30°C. Protect from light and moisture.

–  Do not use Dmex after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

–  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 protect the environment.

6. Content of the pack

a-What Dmex Tablet contains:

–  The active substance : vitamin D3 (Colecalciferol).

–  Each tablet contains 5000 IU colecalciferol (vitamin D3).

b- PRESENTATION :

    30 Tablets in a pack

 

 

Marketed by :

272 Bath Street Glasgow,

United Kingdom G2 4JR