• Fosavance once weekly tablets contain two active ingredients; alendronic acid (as alendronate sodium trihydrate) and colecalciferol. Alendronic acid is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that prevent the breakdown of bone. Colecalciferol is another name for vitamin D3, a vitamin that is essential for healthy bones.

What is it?

  • Fosavance once weekly tablets contain two active ingredients; alendronic acid (as alendronate sodium trihydrate) and colecalciferol. Alendronic acid is a type of medicine called a bisphosphonate. Bisphosphonates are medicines that prevent the breakdown of bone. Colecalciferol is another name for vitamin D3, a vitamin that is essential for healthy bones.
  • Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continously deposit and remove calcium and phophorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.
  • In menopausal women blood levels of the female hormone oestrogen start to decrease. This results in an increase in breakdown of bone by the osteoclasts, which can lead to a loss of bone density.
Bone loss is particularly rapid for the first 10 years after the menopause and it may lead to the development of osteoporosis – a condition in which the bones become weak and brittle and break (fracture) more easily.
  • Alendronic acid is used to treat osteoporosis in women who have passed the menopause. It works by binding very tightly to the bone and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts from breaking down the bone, which helps to keep the bones strong and less likely to break.
  • In women who have passed the menopause, alendronic acid has been shown to reduce the risk of spinal and hip fractures.
  • Vitamin D is an essential nutrient needed by the body to help absorb calcium from food. It is also essential for healthy bones. We get most of our vitamin D from sunlight, which produces vitamin D in the skin. However, as we get older our skin produces less vitamin D and we may also get less exposure to sunlight. Fosavance contains vitamin D as well as alendronic acid for treating osteoporosis in women at risk of vitamin D deficiency.
  • If your dietary intake of Cancium is low, your doctor may also ask you to take calcium supplements.
  • How do I take it?

    • It is very important that the instructions for taking these tablets are followed completely. This is because when alendronic acid is taken by mouth it can cause irritation and ulceration of the foodpipe (oesophagus). Following the instructions below minimises this risk. If you are unclear about anything ask your pharmacist for advice.
    • One Fosavance tablet is taken once a week.
    • Your tablet should be taken on the same day each week, in the morning, at least 30 minutes before the first food, drink or medicine of the day.
    • The tablet should be swallowed whole with a glass of plain water (at least 200ml, not mineral water) while you are sitting or standing in an upright position. Do not crush, chew or suck the tablet.
    • You should not lie down for at least 30 minutes after taking the tablet.
    • You should not eat or drink anything other than plain water for at least 30 minutes after taking the tablet. This is because food and some drinks (including mineral water) can interfere with the absorption of the medicine from the gut and hence make it less effective.
    • You should not take any other medicine by mouth at the same time as this tablet, or for at least 30 minutes after taking the tablet. See the end of this factsheet for more details.
    • If you forget to take your weekly tablet, you should take it the morning after you remember, and then return to taking it once a week on your normal day. Never take two tablets on the same day. You may find it helpful to keep a reminder, eg on a calendar, of when you have taken your tablet and when your next dose is due.

    What are the possible risks or side effects?

    • Decreased kidney function.
    • People with active disorders of the upper part of the digestive system, such as difficulty swallowing, disorders affecting the foodpipe (eg reflux disease), ulcers, inflammation of the lining of the stomach (gastritis), inflammation of the small intestine (duodenitis).
    • People who have had major disorders of the upper part of the digestive system in the last year, eg peptic ulcer, bleeding from the stomach or intestines, or surgery on the stomach or intestines.
    • Disorders of the parathyroid gland (gland that produces hormones responsible for regulating calcium metabolism).
    • Vitamin D deficiency.

    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

    Common (affect between 1 in 10 and 1 in 100 people):

    • Headache.
    • Dizziness.
    • Spinning sensations.
    • Disturbances of the gut such as diarrhoea, constipation, indigestion, flatulence, acid reflux or abdominal pain.
    • Ulceration of the food pipe.
    • Difficulty swallowing.
    • Pain in the joints, muscles or bones.
    • Hair loss.
    • Swelling of joints.
    • Swelling of hands and feet.
    • Feeling weak.

    Uncommon (affect between 1 in 100 and 1 in 1000 people):

    • Nausea.
    • Vomiting.
    • Inflammation of the food pipe (oesophagitis).
    • Inflammation of the stomach (gastritis).
    • Dark coloured, tarry stools, due to the presence of blood altered by the intestinal juices (melaena).
    • Skin reactions, such as itching, rash and redness.
    • Inflammation of the middle layer of the eyeball (uveitis).

    Rare (affect between 1 in 1000 and 1 in 10,000 people):

    • Ulceration, bleeding or perforation of the stomach or intestines.
    • Low level of calcium in the blood (hypocalcaemia). This may cause symptoms such as pins and needles or muscle spasms/twitches/cramps. Tell your doctor if you experience symptoms like these.
    • Osteonecrosis of the jaw (see warning section above).
    • Unusual fractures of the thigh bone (see warning section above).
    • Severe allergic skin reactions.

    The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

    For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

    What if I'm pregnant/Breastfeeding?

    Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

    • This medicine has not been studied in pregnant women, hence its safety has not been established. It should not be used during pregnancy.
    • It is not known if alendronic acid passes into breast milk. It should not be used by breastfeeding mothers.

    If you have any more questions please ask your Pharmacist.

    Remember to keep all medicines out of reach of children
    Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

    References:

    http://www.medicines.ie/medicine/10422/SPC/FOSAVANCE+70mg+2800+IU+Tablets/

    http://www.netdoctor.co.uk/medicines/a8487/fosavance-alendronic-acid-colecalciferol/

    http://www.diagnosia.com/en/drug/fosavance-70-mg5600-iu-tablets

    http://www.health.gov.on.ca/en/pro/programs/drugs/ced/pdf/alendronate.pdf