Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets
- Name:
Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- 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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Takeda Products Ireland Ltd

Company Products
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 SPC
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 SPC
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 SPC
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 |
10. Date of revision of the text |
08 July 2016 |
Updated on 4 August 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 22 April 2016 SPC
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 10 the date of revision of the text has been updated to 22nd December 2015.
Updated on 26 November 2015 SPC
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.
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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 SPC
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 SPC
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
Updated on 30 September 2014 PIL
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie