Fosavance

alendronic acid / colecalciferol

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This is a summary of the European public assessment report (EPAR) for Fosavance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fosavance.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Fosavance?

Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3). It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).

What is Fosavance used for?

Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin-D levels. Fosavance 70 mg / 5,600 IU is for use in patients who are not taking vitamin-D supplements. Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.

The medicine can only be obtained with a prescription.

How is Fosavance used?

The recommended dose of Fosavance is one tablet once a week. It is intended for long-term use.

The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.

Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.

How does Fosavance work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.

Fosavance contains two active substances: alendronic acid and colecalciferol (vitamin D3). Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s. It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight. Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation. Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.

How has Fosavance been studied?

Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.

To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavance’s ability to increase vitamin-D levels. Patients received either Fosavance 70 mg / 2,800 IU or alendronic acid only once a week. The main measure of effectiveness was the reduction in the number of patients with low vitamin-D levels after 15 weeks. This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg / 2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg / 5,600 IU).

What benefit has Fosavance shown during the studies?

The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.

The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin-D levels. After 15 weeks, fewer patients had low vitamin-D levels when they took Fosavance 70 mg / 2,800 IU (11%) than when they took alendronic acid only (32%). In the extension study, similar numbers of patients taking Fosavance 70 mg / 2,800 IU and Fosavance 70 mg / 5,600 IU had low vitamin-D levels (below 6%), but the patients taking Fosavance 70 mg / 5,600 IU had greater increases in vitamin-D levels over the 24 weeks of the study.

What is the risk associated with Fosavance?

The most common side effects with Fosavance (seen between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), ulcers in the oesophagus, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints). For the full list of all side effects reported with Fosavance, see the package leaflet.

Fosavance must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes. for the full list of restrictions, see the package leaflet.

Why has Fosavance been approved?

The CHMP decided that Fosavance’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Fosavance?

A risk management plan has been developed to ensure that Fosavance is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fosavance, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Fosavance

The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.

For more information about treatment with Fosavance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

 

Name Language First published Last updated
Fosavance : EPAR - Summary for the public BG = bălgarski 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public ES = español 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public CS = čeština 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public DA = dansk 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public DE = Deutsch 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public ET = eesti keel 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public EL = elliniká 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public EN = English 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public FR = français 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public IT = italiano 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public LV = latviešu valoda 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public LT = lietuvių kalba 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public HU = magyar 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public MT = Malti 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public NL = Nederlands 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public PL = polski 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public PT = português 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public RO = română 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public SK = slovenčina 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public SL = slovenščina 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public FI = suomi 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public SV = svenska 2009-08-13 2015-07-07
Fosavance : EPAR - Summary for the public HR = Hrvatski 2009-08-13 2015-07-07

This EPAR was last updated on 28/04/2016 .

Authorisation details

Product details

Product details for Fosavance
NameFosavance
Agency product numberEMEA/H/C/000619
Active substance

alendronic acid / colecalciferol

International non-proprietary name (INN) or common name

alendronic acid / colecalciferol

Therapeutic area Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code M05BB03

Publication details

Publication details for Fosavance
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision18
Date of issue of marketing authorisation valid throughout the European Union24/08/2005

Contact address:

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

01/04/2016  Fosavance -EMEA/H/C/000619 -WS/0862

Name Language First published Last updated
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28
Fosavance : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-04-28

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19
Fosavance : EPAR - All Authorised presentations HR = Hrvatski 2008-01-27 2011-05-19

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.

Fosavance reduces the risk of vertebral and hip fractures.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Fosavance : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Fosavance : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21  

Authorised

This medicine is approved for use in the European Union

More information on Fosavance