Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets

  • Name:

    Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets

  • Company:
    info
  • Active Ingredients:

    Calcium Carbonate, Colecalciferol (Vitamin D3)

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/06/18

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Summary of Product Characteristics last updated on medicines.ie: 15/3/2019

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 March 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of MA number to: PA2229/005/00

Date of revision: 15th February 2019

Updated on 11 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Transfer of MA holder to Takeda Pharmaceuticals Ireland Ltd and update of date of revision to 25th May 2018.

Updated on 11 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 October 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 7 November 2016 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 September 2016 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 4 August 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

6.3 Shelf life

Reduction in the shelf-life for the HDPE tablet container (bottle) presentation Calcichew Double Strength from 3 years to 30 months.

10.  Date of revision of the text

08 July 2016

 

Updated on 4 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 22 April 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 2 the amount of excipients has been corrected to 88.6 mg isomalt (E953) and 1.4 mg sucrose.
In section 10 the date of revision of the text has been updated to 22nd December 2015.

Updated on 26 November 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Changed / re-worded to:

 

One tablet contains 88.7 mg isomalt (E953) (contained in the flavour) and 3 mg sucrose.

 

4.2 Posology

Changed / re-worded to:

Posology

Adults and elderly

 

One tablet, once daily.

 

Special Patient Populations

 

Paediatric population:

Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets are not intended for use in children and adolescents.

 

Impaired renal function:

Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets should not be used in patients with severe renal impairment (see section 4.3).

 

Impaired hepatic function:

No dose adjustment is required.

 

 

Method of Administration

Oral. The tablet should be chewed or sucked.

 

4.3 Contraindications

Changed / re-worded to:

·    Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

·    Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m2)

·    Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria

·    Renal calculi (nephrolithiasis)

·    Hypervitaminosis D

4.4 Special warnings and precautions for use

Changed / re-worded to:

 

Calcium carbonate with cholecalciferol tablets should be used with caution in patients with hypercalcaemia or signs of impaired of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.

 

During concomitant treatment with other sources of vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored.

 

Calcichew-D3 Forte Double Strength should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine. 

 

Calcichew-D3 Forte Double Strength should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

 

Calcichew-D3 Forte Double Strength contains isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.6       Fertility, pregnancy and lactation

 

Changed / re-worded to:

Pregnancy

Calcichew-D3 Forte Double Strength 1000mg/800IU can be used during pregnancy, in case of a calcium and vitamin D deficiency. During pregnancy the daily intake should not exceed 2500 mg calcium and 4000 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans.

4.7          Effects on ability to drive and use machines

Changed / re-worded to:

Calcichew-D3 Forte Double Strength 1000mg/800IU has no known influence on ability to drive and use machines

4.8 Undesirable effects

Changed / re-worded in the following sections to:

 

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), or not known (cannot be estimated from the available data).

 

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare:  Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia ,alkalosis and renal impairment). Seen usually only in overdose (see section 4.9).

 

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain, and diarrhoea.

4.9 Overdose

Changed / re-worded to:

 

Symptoms

Overdose can lead to hypercalcaemia and hypervitaminosis D. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification. 

 

Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali. 

 

Treatment of hypercalcaemia

Treatment is essentially symptomatic and supportive. The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, and cardiac glycosides must also be discontinued (see section 4.5). Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

 

5.1    Pharmacodynamic properties

 

Changed / re-worded to:

 

Pharmacotherapeutic group:  Mineral supplements. Calcium, combinations with vitamin D and/or other drugs

5.2 Pharmacokinetic properties

Sub-heading and following line changed / re-worded to:

 

Cholecalciferol

Absorption: Vitamin D3 is easily absorbed in the small intestine.

6.1 List of excipients

Updated to:

 

Xylitol (E967)

Povidone

Isomalt (E953)

Flavouring (lemon)

Magnesium stearate

Sucralose (E955)

Mono- and diglycerides of fatty acids

All-rac-alpha-tocopherol

Sucrose

Modified Maize starch

Triglycerides, medium-chain

Sodium ascorbate

Silica, colloidal anhydrous

 

Please note:

‘Soya-bean oil, hydrogenated’ and ‘gelatine’ have been deleted.

 

10. DATE OF REVISION OF THE TEXT

 

Changed to:

6th November 2015

Updated on 17 November 2015 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change of contraindications
  • Addition of manufacturer

Updated on 2 December 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 13 October 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 October 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 7 October 2014 SmPC

Reasons for updating

  • Change to MA holder contact details
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes are in the following sections:

 

SECTION 7. MARKETING AUTHORISATION HOLDER

 

Takeda UK Limited

Building 3

Glory Park

Glory Park Avenue

Wooburn Green

Bucks

HP10 0DF

 

SECTION 10. DATE OF REVISION OF THE TEXT

 

26/09/2014

 

Updated on 30 September 2014 SmPC

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 September 2014 PIL

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie