Cholecalciferol Chewable Tablets USP 40,000IU Taj Pharma

Name of the medicinal product

Cholecalciferol Chewable Tablets USP 10,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 20,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 30,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 40,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 50,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 60,000IU Taj Pharma

Qualitative and quantitative composition

a) Cholecalciferol Chewable Tablets USP 10,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 10,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

b) Cholecalciferol Chewable Tablets USP 20,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 20,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

c) Cholecalciferol Chewable Tablets USP 30,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 30,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

d) Cholecalciferol Chewable Tablets USP 40,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 40,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

e) Cholecalciferol Chewable Tablets USP 50,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 50,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

f) Cholecalciferol Chewable Tablets USP 60,000IU Taj Pharma
Each uncoated chewable tablet contains:
Cholecalciferol USP 60,000IU
Excipients: Q.S.
Colors: Sunset Yellow FCF

Per tablet:

Calcium carbonate: 1500mg equivalent to 600mg of elemental calcium

Colecalciferol: 400IU equivalent to 10μg vitamin D₃

This product also contains sucrose (part of the vitamin D3 concentrate: approximately 1.7 milligrams per tablet) and soya oil (also part of the vitamin D3 concentrate: approximately 0.3 milligrams per tablet).

For full list of excipients see 6.1

Pharmaceutical form

Uncoated Chewable Tablet,

The tablets are white, flat faced and circular in shape.

Clinical particulars

Therapeutic indications

As an adjunct to specific therapy for osteoporosis and in situations requiring therapeutic supplementation of malnutrition e.g. in pregnancy and established vitamin D dependent osteomalacia.

The prevention and treatment of calcium deficiency/vitamin D deficiency especially in the housebound and institutionalised elderly subjects. Deficiency of the active moieties is indicated by raised levels of PTH, lowered 25-hydroxy vitamin D and raised alkaline phosphatase levels which are associated with increased bone loss.

Posology and method of administration

Oral

Adults and Elderly and children above 12 years of age:

2 chewable tablets per day, preferably one tablet each morning and evening.

Children:

Not recommended for children under 12 years.

Contraindications

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

Cholecalciferol Taj Pharma-D₃ contains a small quantity of soya oil and is therefore contraindicated in patients who are allergic to peanuts or soya.

Special warnings and precautions for use

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary calcium excretion.

In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours (300mg/24 hours).

Caution is required in patients receiving treatment for cardiovascular disease (see Section 4.5 – thiazide diuretics and cardiac glycosides including digitalis).

Cholecalciferol Taj Pharma-D₃ should also be used with caution in other patients with increased risk of hypercalcaemia e.g. patients with sarcoidosis or those suffering from malignancies.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Each tablet contains a small amount of sugar (about 1.7 mg per tablet) and may be harmful to teeth if used for a prolonged period.

Allowances should be made for calcium and vitamin D supplements from other sources.

Interaction with other medicinal products and other forms of interaction

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.

Pregnancy and lactation

During pregnancy and lactation treatment with Cholecalciferol Taj Pharma-D₃ should always be under the direction of a physician. During pregnancy and lactation, requirements for calcium and vitamin D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Cholecalciferol Taj Pharma-D₃ and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5).

Overdoses of vitamin D have shown teratogenic effects in pregnant animals. However, there have been no studies on the use of this medicinal product in human pregnancy and lactation. In humans, long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin D and its metabolites pass into the breast milk.

Effects on ability to drive and use machines

None known.

Undesirable effects

Hypersensitivity reactions including pruritus, wheezing, urticaria and oropharyngeal swelling have been reported in the postmarketing environment.

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen with long term treatment at high dosages.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.

Pharmacological properties

Pharmacodynamic properties

Strong evidence that supplemental calcium and vitamin D₃ can reduce the incidence of hip and other non-vertebral fractures derives from an 18 month randomised placebo controlled study in 3270 healthy elderly women living in nursing homes or apartments for elderly people. A positive effect on bone mineral density was also observed.

In patients treated with 1200mg elemental calcium and 800IU vitamin D₃ daily, i.e. the same dose delivered by two tablets of Cholecalciferol Taj Pharma-D₃, the number of hip fractures was 43% lower (p=0.043) and the total number of non vertebral fractures was 32% lower than among those who received placebo. Proximal femur bone mineral density after 18 months of treatment increased 2.7% in the calcium/vitamin D₃ group and decreased 4.6% in the placebo group (p < 0.001). In the calcium/vitamin D₃group, the mean serum PTH concentration decreased by 44% from baseline at 18 months and serum 25-hydroxy-vitamin D concentration had increased by 162% over baseline.

Analysis of the intention-to-treat results showed a decreased probability of both hip fractures (p = 0.004) and other fractures (p < 0.001) in the calcium/vitamin D₃ treatment group. Analysis of the other two populations (active treatment and those treated and followed for 18 months) revealed comparable results to the intention-to-treat analysis. The odds ratio for hip fractures among women in the placebo group compared with those in the calcium/vitamin D₃ group was 1.7 (95% CI 1.0 to 2.8) and that for other nonvertebral fractures was 1.4 (95% CI 1.4 to 2.1). In the placebo group, there was a marked increase in the incidence of hip fractures over time whereas the incidence in the calcium/vitamin D₃ group was stable.

Thus treatment reduced the age-related risk of fracture at 18 months (p = 0.007 for hip fractures and p = 0.009 for all non-vertebral fractures). At 3 years follow-up, the decrease in fracture risk was maintained in the calcium/vitamin D₃group.

Pharmacokinetic properties

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

The pharmacokinetics of vitamin D is also well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycholecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25 dihydroxycholecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific α – globin, Vitamin D and its metabolites are excreted mainly in the bile and faeces.

Preclinical safety data

Calcium carbonate and vitamin D are well known and widely used materials and have been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.

Pharmaceutical particulars

List of excipients

Xylitol, modified maize starch, sodium saccharin, magnesium stearate, DL-α-tocopherol, edible fats, gelatin, soya oil, sucrose and corn starch. ‘Tutti-Frutti’ flavour (contains propylene glycol).

Incompatibilities

Not applicable, oral preparation.

Shelf life

18 months

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Blister packs of 10 (physicians sample), 30, 56, 60, 90, 100, 112, 240, 360 and 500 tablets in a cardboard carton.

Not all pack size may be marketed.

Special precautions for disposal and other handling

No special conditions.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Package leaflet: Information for the patient

Cholecalciferol Taj Pharma-D₃^® Chewable Tablets
Calcium carbonate (1500mg) and vitamin D₃ (400 I.U.)

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.
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. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

What Cholecalciferol Taj Pharma-D₃is and what it is used for
What you need to know before you take Cholecalciferol Taj Pharma-D₃
How to take Cholecalciferol Taj Pharma-D₃
Possible side effects
How to store Cholecalciferol Taj Pharma-D₃
Contents of the pack and other information

1. What Cholecalciferol Taj Pharma-D₃is and what it is used for

Cholecalciferol Taj Pharma-D₃ contains calcium and vitamin D₃ which are both essential for healthy bones and teeth.

Cholecalciferol Taj Pharma-D₃ provides extra calcium and vitamin D₃ to your diet. It is therefore used in conditions where your body’s calcium and vitamin D levels need to be increased.

Cholecalciferol Taj Pharma-D₃ can be prescribed by doctors for certain bone conditions, for example, osteoporosis.

Studies show that taking calcium and vitamin D₃ over a long time can prevent hip and other non-vertebral bone fractures in later life.

What you need to know before you take Cholecalciferol Taj Pharma-D₃

Do not take Cholecalciferol Taj Pharma-D₃:

if you are allergic to calcium carbonate, vitamin D₃or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to peanut or soya. Cholecalciferol Taj Pharma-D₃contains soya oil.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Cholecalciferol Taj Pharma-D₃.

Tell your doctor or pharmacist if you:

Have high levels of calcium in your blood (hypercalcaemia) or high levels of calcium in your urine (hypercalciuria). If you are unsure your doctor will advise you.
Have problems with your kidneys, for example kidney stones.
Have sarcoidosis (inflammation that produces lumps of cells in various organs in the body), your doctor will be able to tell you if you do.
Have previously been told by your doctor that you have an intolerance to some sugars.
Are taking any other medication, even those you may have bought for yourself without prescription.

Other medicines and Cholecalciferol Taj Pharma-D₃

Tell your doctor if you are taking calcium supplements or antacids for indigestion, digitalis drugs (eg. Lanoxin), diuretics or corticosteroids.

If you are taking thyroxine, bisphosphonates, iron or fluoride medicines, tetracycline or quinolone antibiotics make sure your doctor knows this. When taking these medicines leave a period of about 4 hours before taking your Cholecalciferol Taj Pharma-D₃ tablets. Do not take them at the same time.

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

Pregnancy and breast-feeding

In pregnancy or when breast feeding, Cholecalciferol Taj Pharma-D₃ should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.

Cholecalciferol Taj Pharma-D₃ with food

This medicine should not be taken within 2 hours of eating foods rich in oxalic acid (e.g. spinach and rhubarb), phosphate (e.g. bran), or phytic acid (e.g. whole cereals).

Important information about some of the ingredients of Cholecalciferol Taj Pharma-D₃

Cholecalciferol Taj Pharma-D₃ contains a small amount of sugar and may be harmful to the teeth if used for a prolonged period.

Cholecalciferol Taj Pharma-D₃ contains soya oil. If you are allergic to peanut or soya, do not use this medicine.

How to take Cholecalciferol Taj Pharma-D₃

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

Adults, elderly and children over 12 years of age:

2 tablets daily, ideally one tablet taken in the morning and one in the evening. Cholecalciferol Taj Pharma-D₃ tablets should be chewed. Do not swallow whole.

Children under 12:

Cholecalciferol Taj Pharma-D₃ must not be given to children under 12 years old.

If you take more Cholecalciferol Taj Pharma-D₃ than you should

You should only take what your doctor recommends. If you take too many Cholecalciferol Taj Pharma-D₃ tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Cholecalciferol Taj Pharma-D₃ pack and remaining tablets with you.

If you forget to take Cholecalciferol Taj Pharma-D₃

If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Cholecalciferol Taj Pharma-D₃

Always talk to your doctor or pharmacist before stopping using Cholecalciferol Taj Pharma-D₃.

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.

Frequency not known (frequency cannot be estimated from the available data):

Allergic reactions – symptoms include itching, wheezing, rash, swelling of the tongue or throat. If you have an allergic reaction stop taking the tablets and seek medical attention immediately.

Rare side effects (may affect up to 1 in 1,000 people):

Constipation, wind, feeling sick, stomach ache, diarrhoea.
Skin rash.
Hypercalcaemia (too much calcium in your blood) or hypercalciuria (too much calcium in your urine).

If you are on long term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine samples to monitor kidney function.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Cholecalciferol Taj Pharma-D₃

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister strip has passed. The expiry date refers to the last day of that month.
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 to protect the environment.

Contents of the pack and other information

What Cholecalciferol Taj Pharma-D₃ contains

Each chewable tablet contains:

Cholecalciferol Chewable Tablets USP 10,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 20,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 30,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 40,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 50,000IU Taj Pharma
Cholecalciferol Chewable Tablets USP 60,000IU Taj Pharma

The active substances are calcium carbonate (1500mg, equivalent to 600mg calcium) and vitamin D₃(400iu, equivalent to 10μg colecalciferol).
The other ingredients are xylitol, modified maize starch, sodium saccharin, magnesium stearate and ‘Tutti-Frutti’ flavouring (contains propylene glycol).
The vitamin D₃compound contains DLα-tocopherol, edible fats (including soya oil), gelatin, sucrose and corn starch.

What Cholecalciferol Taj Pharma-D₃ looks like and contents of the pack

The tablets are white, flat faced and circular in shape.
Cholecalciferol Taj Pharma-D₃tablets are provided in packs of 30, 56,60, 112, 240, 360 and 500 tablets.

Not all pack size may be, marketed.