CALCICHEW Chewable tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Calcichew 500 mg Chewable Tablets.
Qualitative and quantitative composition
One chewable tablet of 500 mg contains calcium carbonate equivalent to 500mg of calcium. Excipients with known effect: Isomalt (E953) For a full list of excipients, see section 6.1.
Pharmaceutical form
Chewable tablet. Round, white, uncoated and convex tablets. May have small specks.
Therapeutic indications
Calcichew 500mg Chewable Tablets are to be chewed as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high. Calcichew 500mg Chewable Tablets may ...
Posology and method of administration
Posology Adults <u>Adjunctive therapy in osteoporosis:</u> 2 to 3 tablets daily. <u>Prevention and treatment of calcium deficiency:</u> 2 to 3 tablets daily. <u>Phosphate binder:</u> Dose as required by ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria, for example in hyperparathyroidism, ...
Special warnings and precautions for use
In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi. Monitoring is especially ...
Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics. Calcium carbonate ...
Pregnancy and lactation
Pregnancy Calcichew 500mg Chewable Tablets can be used during pregnancy. Daily intake should not exceed 2500 mg of calcium as permanent hypercalcaemia has been related to adverse effects on the developing ...
Effects on ability to drive and use machines
Calcium carbonate has no known influence on ability to drive and use machines.
Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) or very rare (≤1/10,000) Metabolism and ...
Overdose
Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Mineral supplements: Calcium <b>ATC-code:</b> A12AA04 An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.
Pharmacokinetic properties
Absorption The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose. Distribution and biotransformation 99% of the calcium in the body is concentrated ...
Preclinical safety data
There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
List of excipients
Xylitol (967) Povidone Magnesium stearate Sucralose (E955) Isomalt (E953) Flavouring (orange) Mono, di-fatty acid glycerides
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Keep the container tightly closed to protect from moisture.
Nature and contents of container
Securitainer containing 100 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Marketing authorization number(s)
PL 45043/0082
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 November 1987 Date of last renewal: 31 March 2005
Date of revision of the text
23/11/2021
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