Calcium carbonate D3 500 mg/200 IU Chew able Tablets SMPC, Taj Phar maceuticals

Calcium carbonate Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium carbonate Dosage & Rx Info | Calcium carbonate Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium carbonate - Drug Information - Taj Phar ma, Calcium carbonate dose Taj pharmace uticals Calcium carbonate interactions, Taj Pharmaceutical Calcium carbonate contraindications, Calcium carbonate price, Calcium carbonate Taj Pharma Calciu m carbonate D3 500 mg/200 IU Chewabl e Tablets SMPC - Taj Phar ma . Stay connected to all updated on Calcium carbonate Taj Phar maceuticals Taj pharmaceuticals Hyderabad.

Adults
RX
Adjunctive therapy in osteoporosis:
CALCIUM One tablet 2-3 times per day
CARBONATE D3 Calcium and vitamin D deficiency:

CHEWABLE TABLETS One tablet 2-3 times per day.

500MG/200IU Special Patient Populations

Elderly patients
1.NAME OF THE MEDICINAL PRODUCT
Adjunctive therapy in osteoporosis
Calcium carbonate D3 500 mg/200 IU Chewable
Tablets Calcium and vitamin D deficiency
2. QUALITATIVE AND QUANTITATIVE Dosage as for adults.
COMPOSITION
Paediatric population
Per Calcium carbonate 1250mg Calcium and vitamin D deficiency (only)
tablet: (equivalent to 500mg
of elemental calcium) One tablet 1-2 times per day.

Colecalciferol 200iu Impaired hepatic function

(equivalent to 5 No dose adjustment is required.
micrograms vitamin
D3) Impaired renal function
Contains isomalt (E953) and sucrose. For a full Calcium carbonate-D3 chewable tablets should
list of excipients see section 6.1. not be used in patients with severe renal
3. PHARMACEUTICAL FORM impairment (see section 4.3).
Tablet Method of Administration
White, oval, biconvex tablet scored on one side. Oral. The tablets should be chewed or sucked.

4. CLINICAL PARTICULARS 4.3 Contraindications

• Hypersensitivity to the active substances or to
4.1 Therapeutic indications any of the excipients listed in section 6.1
Calcium carbonate-D3 Chewable Tablets should
be used only as a therapeutic and not as a food • Severe renal impairment (glomerular filtration
supplement when the diet is deficient or when rate < 30 ml/min)
normal requirement of both components is • Diseases and/or conditions resulting in
increased. hypercalcaemia and/or hypercalciuria
Calcium carbonate-D3 Chewable Tablets may be • Renal calculi (nephrolithiasis)
used as an adjunct to specific therapy for
osteoporosis or as a therapeutic supplement in • Hypervitaminosis D
established osteomalacia, pregnant patients at
4.4 Special Warnings and precautions for use
high risk of needing such a therapeutic
supplementation or malnutrition when dietary During long-term treatment, serum calcium
intake is less than that required. levels should be followed and renal function
should be monitored through measurement of
4.2 Posology and method of administration
serum creatinine. Monitoring is especially
Posology important in elderly patients on concomitant
treatment with cardiac glycosides or diuretics
Calcium carbonate D3 500 mg/200 IU Chew able Tablets SMPC, Taj Phar maceuticals
Calcium carbonate Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium carbonate Dosage & Rx Info | Calcium carbonate Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium carbonate - Drug Information - Taj Phar ma, Calcium carbonate dose Taj pharmace uticals Calcium carbonate interactions, Taj Pharmaceutical Calcium carbonate contraindications, Calcium carbonate price, Calcium carbonate Taj Pharma Calciu m carbonate D3 500 mg/200 IU Chewabl e Tablets SMPC - Taj Phar ma . Stay connected to all updated on Calcium carbonate Taj Phar maceuticals Taj pharmaceuticals Hyderabad.

(see section 4.5) and in patients with a high Calcium carbonate may interfere with the
tendency to calculus formation. In case of absorption of concomitantly administered
hypercalcaemia or signs of impaired renal tetracycline preparations. For this reason,
function, the dose should be reduced or the tetracycline preparations should be administered
treatment discontinued. at least two hours before, or four to six hours
after, oral intake of calcium carbonate.
Calcium carbonate-D3 chewable tablets should
be used with caution in patients with Hypercalcaemia may increase the toxicity of
hypercalcaemia or signs of impaired renal cardiac glycosides during treatment with
function and the effect on calcium and calcium and vitamin D. Patients should be
phosphate levels should be monitored. The risk monitored with regard to electrocardiogram
of soft tissue calcification should be taken into (ECG) and serum calcium levels.
account. In patients with severe renal
insufficiency, vitamin D in the form of If a bisphosphonate is used concomitantly, this
preparation should be administered at least one
colecalciferol is not metabolised normally and
other forms of vitamin D should be used (see hour before the intake of Calcium carbonate-
section 4.3, contraindications). D3 Chewable Tablets since gastrointestinal
absorption may be reduced.
During concomitant treatment with other high
dose sources of vitamin D and/or medications or The efficacy of levothyroxine can be reduced by
nutrients (such as milk) containing calcium, the concurrent use of calcium, due to decreased
there is a risk of hypercalcaemia and milk-alkali levothyroxine absorption. Administration of
syndrome with subsequent kidney function calcium and levothyroxine should be separated
by at least four hours.
impairment. In these patients serum calcium
levels should be followed and renal function The absorption of quinolone antibiotics may be
should be monitored. impaired if administered concomitantly with
Calcium carbonate-D3 chewable tablets should calcium. Quinolone antibiotics should be taken
be prescribed with caution to patients suffering two hours before or six hours after intake of
from sarcoidosis because of the risk of increased calcium.
metabolism of vitamin D to its active form. Calcium salts may decrease the absorption of
These patients should be monitored with regard iron, zinc and strontium ranelate. Consequently,
to the calcium content in serum and urine. iron, zinc or strontium ranelate preparations
Calcium carbonate-D3 Chewable Tablets should should be taken two hours before or after
Calcium carbonate-D3 Chewable Tablets.
be used with caution in immobilised patients
with osteoporosis due to the increased risk of Treatment with orlistat may potentially impair
hypercalcaemia. the absorption of fat-soluble vitamins (e.g.
vitamin D3).
Calcium carbonate-D3 Chewable Tablets contain
isomalt (E953) and sucrose. Patients with rare 4.6 Fertility, Pregnancy and lactation
hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrase- Pregnancy
isomaltase insufficiency should not take this Calcium carbonate-D3 Chewable Tablets can be
medicine. used during pregnancy, in case of a calcium and
4.5 Interaction with other medicinal products vitamin D deficiency. During pregnancy the
and other forms of interaction daily intake should not exceed 2500 mg calcium
and 4000 IU vitamin D. Studies in animals have
Thiazide diuretics reduce the urinary excretion shown reproductive toxicity with high doses of
of calcium. Due to increased risk of vitamin D (see section 5.3). In pregnant women,
hypercalcaemia, serum calcium should be overdoses of calcium and vitamin D should be
regularly monitored during concomitant use of avoided as permanent hypercalcaemia has been
thiazide diuretics. related to adverse effects on the developing
Calcium carbonate D3 500 mg/200 IU Chew able Tablets SMPC, Taj Phar maceuticals
Calcium carbonate Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium carbonate Dosage & Rx Info | Calcium carbonate Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium carbonate - Drug Information - Taj Phar ma, Calcium carbonate dose Taj pharmace uticals Calcium carbonate interactions, Taj Pharmaceutical Calcium carbonate contraindications, Calcium carbonate price, Calcium carbonate Taj Pharma Calciu m carbonate D3 500 mg/200 IU Chewabl e Tablets SMPC - Taj Phar ma . Stay connected to all updated on Calcium carbonate Taj Phar maceuticals Taj pharmaceuticals Hyderabad.

foetus. There are no indications that vitamin D at 4.9 Overdose

therapeutic doses is teratogenic in humans.
Symptoms
Lactation
Overdose can lead to hypercalcaemia and
Calcium carbonate-D3 Chewable Tablets can be hypervitaminosis D. Symptoms of
used during breast-feeding. Calcium and vitamin hypercalcaemia may include anorexia, thirst,
D3 pass into breast milk. This should be nausea, vomiting, constipation, abdominal pain,
considered when giving additional vitamin D to muscle weakness, fatigue, mental disturbances,
the child. polydipsia, polyuria, bone pain,
nephrocalcinosis, nephrolithiasis and in severe
4.7 Effects on ability to drive and use cases, cardiac arrhythmias. Extreme
machines hypercalcaemia may result in coma and death.
Calcium carbonate-D3 Chewable Tablets have Persistently high calcium levels may lead to
no known influence on ability to drive and use irreversible renal damage and soft tissue
machines. calcification. Milk-alkali syndrome may occur in
4.8 Undesirable Effects patients who ingest large amounts of calcium
Adverse reactions are listed below, by system and absorbable alkali.
organ class and frequency. Frequencies are
Treatment of hypercalcaemia
defined as: uncommon (≥1/1,000, to <1/100);
rare (≥1/10,000 to <1/1,000); very rare Treatment is essentially symptomatic and
(≤1/10,000) or not known (cannot be estimated supportive. The treatment with calcium and
from the available data). vitamin D must be discontinued. Treatment with
thiazide diuretics and cardiac glycosides must
Immune system disorders
also be discontinued (see section 4.5). Treatment
Not known: Hypersensitivity reactions such as is rehydration, and, according to severity of
angio-oedema or laryngeal oedema. hypercalcaemia, isolated or combined treatment
with loop diuretics, bisphosphonates, calcitonin
Metabolism and nutrition disorders and corticosteroids should be considered. Serum
Uncommon: Hypercalcaemia and electrolytes, renal function and diuresis must be
hypercalciuria. monitored. In severe cases, ECG and CVP
should be followed.
Very rare: Milk-alkali syndrome (frequent urge
to urinate; continuing headache; continuing loss 5. PHARMACOLOGICAL PROPERTIES
of appetite; nausea or vomiting; unusual 5.1 Pharmacodynamic properties
tiredness or weakness; hypercalcaemia, alkalosis
and renal impairment). Seen usually only in Pharmacotherapeutic group: Mineral
overdose (see section 4.9). supplements, Calcium combinations with
Gastrointestinal disorders vitamin D and/or other drugs.

Rare: Constipation, dyspepsia, flatulence, Vitamin D3 increases the intestinal absorption of

nausea, abdominal pain and diarrhoea. calcium.

Skin and subcutaneous disorders Administration of calcium and vitamin

D3 counteracts the increase of parathyroid
Rare: Pruritus, rash and urticaria. hormone (PTH) which is caused by calcium
Reporting of suspected adverse reactions deficiency and which causes increased bone
resorption.
Reporting suspected adverse reactions after
authorisation of the medicinal product is A clinical study of institutionalised patients
important. It allows continued monitoring of the suffering from vitamin D deficiency indicated
benefit/risk balance of the medicinal product. that a daily intake of two tablets of calcium
500mg/vitamin D 400 IU for six months
Calcium carbonate D3 500 mg/200 IU Chew able Tablets SMPC, Taj Phar maceuticals
Calcium carbonate Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium carbonate Dosage & Rx Info | Calcium carbonate Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium carbonate - Drug Information - Taj Phar ma, Calcium carbonate dose Taj pharmace uticals Calcium carbonate interactions, Taj Pharmaceutical Calcium carbonate contraindications, Calcium carbonate price, Calcium carbonate Taj Pharma Calciu m carbonate D3 500 mg/200 IU Chewabl e Tablets SMPC - Taj Phar ma . Stay connected to all updated on Calcium carbonate Taj Phar maceuticals Taj pharmaceuticals Hyderabad.

normalised the value of the 25-hydroxylated 6. PHARMACEUTICAL PARTICULARS

metabolite of vitamin D3 and reduced secondary
hyperparathyroidism and alkaline phosphatases. 6.1 List of excipients
Xylitol (E967)
5.2 Pharmacokinetic properties
Povidone
Calcium
Isomalt (E953)
Absorption: The amount of calcium absorbed
through the gastrointestinal tract is Flavour (orange)
approximately 30% of the swallowed dose.
Magnesium stearate
Distribution and biotransformation: 99% of the
Sucralose (E955)
calcium in the body is concentrated in the hard
structure of bones and teeth. The remaining 1% Mono, di-fatty acid glycerides
is present in the intra- and extracellular fluids.
About 50% of the total blood-calcium content is Sucrose
in the physiologically active ionised form with Modified maize starch
approximately 10% being complexed to citrate,
phosphate or other anions, the remaining 40% Triglycerides, medium-chain
being bound to proteins, principally albumin. Sodium ascorbate
Elimination: Calcium is eliminated through Silica, colloidal anhydrous
faeces, urine and sweat. Renal excretion depends
on glomerular filtration and calcium tubular Tocopherol
reabsorption.
6.2 Incompatibilities
Cholecalciferol Not applicable.
Absorption: Vitamin D3 is easily absorbed in the 6.3 Shelf life
small intestine. 30 months.
Distribution and biotransformation: 6.4 Special precautions for storage
Colecalciferol and its metabolites circulate in the Do not store above 30°C. Keep the container
blood bound to a specific globulin. tightly closed to protect from moisture.
Colecalciferol is converted in the liver by
6.5 Nature and contents of container
hydroxylation to 25-hydroxycolecalciferol. It is
then further converted in the kidneys to the White HD Polyethylene containers with a
active form 1,25-dihydroxycolecalciferol; 1,25- primary tamper-evident seal and secondary re-
dihydroxycolecalciferol is the metabolite sealable closure containing 60 and 100 tablets.
responsible for increasing calcium absorption.
Vitamin D which is not metabolised is stored in Not all pack sizes may be marketed.
adipose and muscle tissues. 6.6 Special precautions for disposal and other
Elimination: Vitamin D3 is excreted in faeces handling
and urine. No special requirements.
5.3 Preclinical safety data 7. MANUFACTURER:
At doses far higher than the human therapeutic
range teratogenicity has been observed in animal
studies. There is no further information of
relevance to the safety assessment in addition to Manufactured in India by:
what is stated in other parts of the SmPC. TAJ PHARMACEUTICALS LTD.
Mumbai, India
Calcium carbonate D3 500 mg/200 IU Chew able Tablets SMPC, Taj Phar maceuticals
Calcium carbonate Taj Phar ma : Uses, Side Effects, Interactions, Pictures, Warnings, Calcium carbonate Dosage & Rx Info | Calcium carbonate Uses, Side Effects -: Indications, Side Effects, Warnings, Calcium carbonate - Drug Information - Taj Phar ma, Calcium carbonate dose Taj pharmace uticals Calcium carbonate interactions, Taj Pharmaceutical Calcium carbonate contraindications, Calcium carbonate price, Calcium carbonate Taj Pharma Calciu m carbonate D3 500 mg/200 IU Chewabl e Tablets SMPC - Taj Phar ma . Stay connected to all updated on Calcium carbonate Taj Phar maceuticals Taj pharmaceuticals Hyderabad.

At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad

438225, Gujarat, INDIA

This leaflet was last revised in October 2019