Fosavance
How does it work?
Fosavance once weekly tablets contain two active ingredients; alendronic acid (as sodium alendronate) 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 D
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 women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten 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 calcium is low, your doctor may also ask you to take calcium supplements.
What is it used for?
- Osteoporosis in women who have passed the menopause and are at risk of vitamin D deficiency.
Warning!
- 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.
- 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 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 experience any signs of irritation to your foodpipe during treatment with this medicine, for example new or worsening problems with swallowing, pain on swallowing, pain behind your breastbone, or heartburn, you should stop taking these tablets and inform your doctor.
- 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 calender, of when you have taken your tablet and when your next dose is due.
- Your doctor may want you to have regular blood tests to monitor the level of calcium in your blood while you are taking this medicine.
- The class of medicines that alendronic acid belongs to (bisphosphonates) has been associated with a rare condition called osteonecrosis of the jaw. The majority of cases of this condition have been in cancer patients treated with bisphosphonates by injection into a vein and many of these patients were also having treatment with chemotherapy or corticosteroids. However, the condition has also been seen in people taking bisphosphonates by mouth. The risk may be increased by poor oral hygiene, dental problems, teeth extractions and oral surgery. For this reason, your doctor may want you to have a dental examination and, if necessary, appropriate preventive dentistry, before you start treatment with this medicine. Discuss this with your doctor. It is important to look after your mouth and teeth as much as possible while you are receiving this medicine. Invasive dental procedures such as tooth extraction or surgery should be avoided if possible. If you need to see a dentist during treatment, make sure they know you are receiving this medicine.
Use with caution in
- Decreased kidney function
- 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.
Not to be used in
- Children
- Abnormalities of the food pipe (oesophagus)
- Conditions causing delayed passage of food through the foodpipe (oesophagus), eg narrowing or obstruction of the foodpipe
- People who cannot stand or sit upright for at least 30 minutes
- Low levels of calcium in the blood (hypocalcaemia)
- Pregnancy
- Breastfeeding
- Rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (Fosavance tablets contain lactose and sucrose).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
Pregnancy and 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.
Side effects
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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
- Indigestion (dyspepsia)
- Excess gas in the stomach and intestines (flatulence)
- Bloating
- Difficulty or pain when swallowing (dysphagia)
- Acid regurgitation
- Ulceration of the food pipe (oesophagus)
- Headache
- Pain in joints, muscles or bones (musculoskeletal pain)
- Inflammation of the food pipe (oesophagitis)
- Skin reactions such as rash or itching
- Flushing of the skin due to widening of the small blood vessels (erythema)
- Inflammation of the stomach (gastritis)
- Low blood calcium level (hypocalcaemia)
- Ulceration, bleeding or perforation of the stomach or intestines
- Dark colored, tarry stools, due to the presence of blood altered by the intestinal juices (melaena)
- Inflammation of the front parts of the eye (uveitis)
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Other medicines may interfere with the absorption of alendronic acid from the gut and could therefore make the medicine less effective. This is especially the case with antacids (indigestion remedies) and calcium supplements. For this reason, you should not take any other medicines by mouth at the same time as this medicine, or for at least 30 minutes after taking it.
There may be an increased risk of irritation to the foodpipe (oesophagitis) or digestive tract if non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, diclofenac or indometacin are taken in combination with alendronic acid. These types of painkiller are best avoided by people taking this medicine. Ask your pharmacist for further advice.
The following medicines may decrease the absorption of vitamin D from the gut:
- orlistat
- cholestyramine
- colestipol.
Antiepileptic medicines such as phenytoin may increase the breakdown of vitamin D by the body.
If you are taking any of these medicines your doctor may decide that you also need additional vitamin D supplements.
Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain both alendronic acid and colecalciferol as the active ingredients.
Fosamax and Fosamax once weekly contain just alendronic acid.
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