Calvidin FN2012/05/008 8/8/12 10:51 AM Page 1
CALVIDIN CHEWABLE TABLETS
Calvidin FN2012/05/008 8/8/12 10:51 AM Page 2
CALVIDIN CHEWABLE TABLETS Indications: Correction of combined Vitamin D and
barbiturates may reduce the activity of vitamin D3.
calcium deficiencies in the elderly. Supply of Vitamin D
Calcium salts may decrease the absorption of iron,
and calcium as an adjunct to specific treatment for
zinc or strontium and may reduce the absorption of the
osteoporosis, in patients where combined vitamin D
estramustin or thryroid hormones. In the case of
and calcium deficiencies have been diagnosed or
concomitant administration of bisphosphonate,
those at a high risk of such deficiencies. Vitamin D
sodium fluoride or fluoroquinolone it is recommended
supplementation corrects and insufficient vitamin D
that taking Calvidin chewable tablets be spaced by at
intake. It increases the intestinal absorption of calcium.
least 3 hours, as their absorption during digestion may
The optimal vitamin D dose in elderly is 500-100 I.U.
be reduced Oxalic acid (found in spinach and rhubarb)
Dosage and Administration One chewable tablet
and phytic acid (found in wholegrain cereals) can
twice a day. Dose reduction should be considered as
inhibit calcium absorption by forming insoluble
necessary following the monitoring of calcium levels.
compound with calcium ions. Pregnancy and
The tablets are chewed and then swallowed with a
lactation The daily intake should not exceed 1,500 mg
little liquid. In exceptional cases the tablets can be
of calcium and 600 I.U. of vitamin D3. Therefore the
sucked. Contra-indications Hypersensitivity to the
daily dose must not exceed 1 tablet. Vitamin D and its
active substances or to any of the excipients.
metabolites pass into breast-milk. This should be
Renal failure. Hypercalcaemia and hypercalciuria and
considered when giving additional vitamin D to the
hypercalcaemia and/or hypercalciuria (e.g. myeloma,
In pregnant and lactating women, the calcium
bone metastases, primary hyperparathyroidism).
preparation should be taken at a distance of two hours
Kidney stones (nephrolitiasis, nephrocalcinosis).
from a meal due to a possible decrease of iron
Hypervitaminosis D. Precautions and warnings
absorption. Effects on the ability to drive and use
During prolonged treatment, check calcaemia and
machines
renal function by assaying serum creatinine,
No data related these activities this however it is
particularly in the elderly, in cases of combined
unlikely to have an effect. Undesirable effects
treatment with cardiac glycosides and diuretics and in
(frequency) Occurrence of adverse reactions: very
patients frequently subject to the formation of kidney
common (≥1/10), common (≥1/100 to <1/10),
stones. Prescribe with caution to patients who are
uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
immobilized and suffering from osteoporosis. Take into
<1/1,000), very rare (<1/10,000, not known).
account the intake of Vitamin D, calcium and alkali like
Uncommon: hypercalcaemia, hypercalciuria Rare:
carbonate from all other sources before prescribing
Puritus, rash and urticaria, constipation, flatulence,
CALVIDIN®. Use with caution in patients suffering
bloating, abdominal distension, nausea, abdominal
from sarcoidosis and in patients with a decreased
pain, diarrhoea Not known: Vomiting, hypersensitivity,
renal function. CALVIDIN® is not intended for use in
reactions such as angiooedema or laryngeal oedema
children or adolescents. This product contains
Overdose: An overdose can lead to hypervitaminosis
sucrose, therefore patients with rare hereditary
and hypercalcaemia. Symptoms: anorexia, thirst,
problems of fructose intolerance, glucose-galactose
nausea, vomiting, constipation, dehydration,
malabsorption or sucrase-isomaltase insufficiency
abdominal pain, muscle weakness, fatigue, mental
should not take this medicine. Note for diabetics: The
disturbances, polydipsia, polyuria, skeletal pain, renal
proportion of digestible carbohydrate in CALVIDIN®
calcinosis, kidney stones and in some cases severe
chewable tablets is 0.47 g per tablet. The daily dose of
cardiac arrhythmia, coma and death. See SmPC for
2 tablets corresponds to 0.08 carbohydrate units (CU). treatment. Package Quantities: 60 Tablets P.A. No: Interactions
PA868/4/1 P.A. Holder: Rottapharm Ltd. Damastown,
excretion in the urine. Systemic corticosteroids reduce
Mulhuddart, Dublin 15. Date of revision of text: May
calcium absorption. Orlistat, combined ion-exchange
resin treatment (cholestyramine) or laxatives (paraffinoil) can reduce the gastrointestinal adsorption of
Medical product not subject to medical
vitamin D3. Calcium carbonate can alter tetracycline
prescription.
absorption The toxicity of cardiac glycosides mayincrease during treatment with calcium and vitamin D
(risk of cardiac arrhythmia). Rifampicin, phenytoin or
Full prescribing information available upon request from:Fannin House, South County Business Park, Leopardstown, Dublin 18Tel:01 290 7000 Fax:01 290 7111 Email: [email protected]
Over-the-Counter Medications in Pregnancy RONALD A. BLACK, M.D., and D. ASHLEY HILL, M.D. Florida Hospital Family Practice Residency, Orlando, Florida Pregnant women commonly use over-the-counter medications. Although most over- the-counter drugs have an excellent safety profile, some have unproven safety or are known to adversely affect the fetus. The safety profile of some medications ma
Specifications Classification: Chemical System: Designation: Nominal Voltage: Storage Temp: Operating Temp: Typical Weight: Industry Standard Dimensions Typical Volume: Max Discharge: Max Rev Current: Typical Li Content: Typical IR: Shelf Life: 15 years at 21°C (90% of rated capacity) Transportation: Global (except US): Special Provisi