Fosavanc_

Fosavance tabletr
When used in treating osteoporosir

Fosavance (Fossavvants)
is a medicine which iH
used in treating osteoporosis. Fosavance containH
alendronate sodium/colecalciferol. It is supplied bb
Merck Sharp & Dohme Limited\

Your medicin_

Fosavance is used in postmenopausal

women whG
have osteoporosis and are at risk of getting bonM
fractures\

In osteoporosis the strength of the bones is reduceU

and this can increase the chances of getting bonM
fractures. Fosavance can make bones stronger iK
people with osteoporosis which can reduce thM
chances of getting bone fractures\

It is very important that you take FosavancM

correctly as it may lead to oesophageal problems i_
it is not taken in the right way. A member of youY
medical team will explain to you how to takM
Fosavance\

Do not share your medicine with other people. IQ

may not be suitable for them and may harm them\

The pharmacy label on your medicine tells you hoV

much medicine you should take. It also tells yoX
how often you should take your medicine. This iH
the dose that you and your prescriber have agreeU
you should take. You should not change the dose o_
your medicine unless you are told to do so by youY
prescriber\

If you feel that the medicine is making you unwell oY

you do not think it is working, then talk to youY
prescriber\

When to take your medicin_

Some medicines work best if they are taken at I

specific time of day. Getting the most from youY
medicine can also be affected by what you eat{
when you eat and the times at which you take otheY
medicines. Make sure you follow any specifiL
instructions given to you by your prescriber or thaQ
are in the Patient Information Leaflet that comeH
with this medicine\

In the case of FosavanceV

~
this medicine should only be taken once I
week. If possible, you should take FosavancM
on the same day each weed
~
you should take Fosavance on rising, at leasQ
30 minutes before you have anything to eaQ
or drink. You may drink tap water but do noQ
have any other drinks, food, medicines{
vitamins or mineral supplements for at leasQ
30 minutes after taking FosavancM
~
you should not take this medicine just beforM
you go to bed or before arising for the day\

Do not lie down for at least 30 minutes afteY

you have taken FosavancM

~
if you miss a dose, take one tablet on risinZ
the day after you remember. Do not take twG
tablets in the same day. Return to taking onM
tablet once a week as originally scheduled oK
your chosen dab

How to take your medicin_

Some medicines have specific instructions abouQ

how to take them. This is because they work betteY
when taken correctly. These instructions can includM
getting the right dose and special instructions foY
preparing the medicine\

In the case of FosavanceV

~
detailed advice on how to take FosavancM
can be found in the Patient InformatioK
Leaflet that comes with this medicinM

~
swallow the medicine whole with a full glasH
of tap water. You must not take it with minera]
water or any other drink. You must not crush{
chew or allow it to dissolve in your moutW

If you are having problems taking this medicine, yoX

should talk to your prescriber or pharmacist. Theb
may be able to give you advice on other ways tG
take your medicine or other medicines that arM
easier for you to take\

Taking too much of your medicin_

Taking extra doses of some medicines can bM

harmful. In some cases even one extra dose caK
cause you problems. If you take extra doses of youY
medicine, you must get medical advice immediately\
You may need a test to assess the effect of takinZ
extra doses. This is because the effects of takinZ
too much medicine are very complex so it is verb
important that you seek medical advice\

Contact your prescriber, pharmacist, specialist cliniL

or NHS Direct on 0845 46 47 for advice\
Make sure you take all of your medicine containerH
with you if you are advised to go to hospital\

Stopping your medicin_

If you are having any problems taking your medicinM

you must speak to your prescriber. If you are noQ
having any problems taking this medicine then dG
not stop taking it, even if you feel better, unlesH
advised to do so by your prescriber\

If you are in any doubt, contact your prescriber{

pharmacist, specialist clinic or NHS Direct on 084M
46 47\

Looking after your medicin_

The instructions on how you should keep youY

medicine are on the pharmacy label. You shoulU
keep your medicine in the original container. ThiH
will help to keep your medicine in the best conditioK
and also allow you to check the instructions. Do noQ
take the medicine if the packaging appears to havM
been tampered with or if the medicine shows anb
signs of damage. Make sure that the medicine is ouQ
of the sight and reach of children\
In the case of FosavanceV

~
store the medicine in the original container tG

protect it from moisture and lighQ

You must not take the medicine after the expiry datM
shown on the packaging. If you have any unuseU
medicine, return it to your pharmacist who wil]
dispose of it safely\

Whether this medicine is suitable for yo[

Fosavance is not suitable for everyone and somM

people should never use it. Other people shoulU
only use it with special care. It is important that thM
person prescribing this medicine knows your ful]
medical history\

Your prescriber may only prescribe this medicinN

with special care or may not prescribe it at all if youV

~
have kidney problemH
~
have galactose intolerancM
~
have Lapp lactase deficiencb
~
have glucosegalactose
malabsorptioK
problemH
~
are allergic or sensitive to or have had I
reaction to any of the ingredients in thM
medicinM
~
are unable to stand or sit upright for at leasQ
30 minuteH
~
have had certain types of gastrointestina]
surgerb
~
have fructose intolerancM
~
have sucraseisomaltase
deficiencb
~
have certain types of metabolic problems oY
have risk factors for metabolic problems sucW
as vitamin D deficiencb
~
have a medical condition that increases thM
levels of vitamin D in the bodb
~
have or have had gastrointestinal problemH
such as swallowing difficulties, gastritis{
gastrointestinal bleeding or ulcerH
~
need to have certain types of denta]
procedureH
~
have malabsorption problemH
~
have oesophageal problemH
~
have risk factors for developinZ
osteonecrosis of the jaw such as cancerQ
chemotherapy or radiotherapy treatmentQ

smoking. a history of dental disease. pooY

oral hygiene. invasive dental procedures. oY
poor fitting dentureH

Furthermore the prescriber may only prescribe thiH

medicine with special care or may not prescribe it aQ
all for someone under the age of 18 years\

As part of the process of assessing suitability tR

take this medicine a prescriber may also arrangN
testsV

~
to determine whether or not the medicine iH
suitable and whether it must be prescribeU
with extra carM

~
to check that this medicine is not having anb

undesired effectH
Over time it is possible that Fosavance can becomM
unsuitable for some people, or they may becomM
unsuitable for it. If at any time it appears thaQ
Fosavance has become unsuitable, it is importanQ
that the prescriber is contacted immediately\

Sideeffectr

A medicine is only made available to the public if thM

clinical trials have shown that the benefits of takinZ
the medicine outweigh the risks\

Once a medicine has been licensed, information oK

the medicine's effects, both intended anU
unintended, is continuously recorded and updated\

Some sideeffects
may be serious while others mab
only be a mild inconvenience\

Everyone's reaction to a medicine is different. It iH

difficult to predict which sideeffects
you will havM
from taking a particular medicine, or whether yoX
will have any sideeffects
at all. The important thinZ
is to tell your prescriber or pharmacist if you arM
having problems with your medicine\

Very common: More than 1 in 10 people who takN

FosavancN

~
bone, muscle or joint paiK

Common: More than 1 in 100 people who takN

FosavancN

~
acid refluj
~
constipatioK
~
diarrhoeI
~
distension of the stomacW
~
feeling dizzb
~
flatulencM
~
hair losH
~
headacheH
~
indigestioK
~
itchinZ
~
joint swellinZ
~
oedema of the extremitieH

Provided by www.medicines.org.uk/guideH
Page 1 of V
Last updated 15 Apr 1R
Copyright © 2010 DatapharT
Fosavanc_

Fosavance tabletr
When used in treating osteoporosir

~
oesophageal problems such as oesophagitiH
or oesophageal ulcers seek
medical advicM
if you get any oesophageal irritation such aH
difficulty swallowing, pain when swallowing{
chest pain or new or worsening heartburK
~
stomach paiK
~
vertigG
~
weaknesH

Uncommon: More than 1 in 1000 people who takN

FosavancN

~
eye or eyesight problemH
~
feveY
~
gastritiH
~
general feeling of being unwel]
~
melaenI
~
nauseI
~
redness of the skiK
~
skin rash or rasheH
~
taste changeH
~
vomitinZ

Rare: More than 1 in 10,000 people who takN

FosavancN

~
gastrointestinal problemH
~
hypersensitivity reactions including urticariI

or angioedemI
~
metabolic problemH
~
osteonecrosis of the jaw this
is usuallb

associated with dental procedures or loca]

infection. You or your carer must seed
medical advice if you have dental problemH
such as loose teeth, pain or swelling. If yoX
need to have a dental procedure, make surM
you tell your dentist that you are havinZ
treatment with FosavancM

~
photosensitivity skin reactioK

~
side effects that may occur if Fosavance iH
taken for long period of time. These mab
include stress fractures of the leg witW
delayed healing. You or your carer must seed
medical advice if you receive any injury to thM
leg or develop symptoms such as thigh paiK

~
skin problemH
~
StevensJohnson
syndromM
~
toxic epidermal necrolysiH

The frequency of these sideeffects

is unknowJ

~
abnormal laboratory test resultH
If you feel unwell or if you have concerns about I
sideeffect,
you will need to seek advice. If you fee]
very ill, get medical help straight away. Contact youY
prescriber, pharmacist, nurse or call NHS Direct oK
0845 46 47\

Taking other mediciner

If you are taking more than one medicine they mab

interact with each other. At times your prescribeY
may decide to use medicines that interact, in otheY
cases this may not be appropriate\
The decision to use medicines that interact dependH
on your specific circumstances. Your prescriber mab
decide to use medicines that interact, if it is believeU
that the benefits of taking the medicines togetheY
outweigh the risks. In such cases, it may bM
necessary to alter your dose or monitor you morM
closely\

Tell your prescriber the names of all the medicineH

that you are taking so that they can consider al]
possible interactions. This includes all the medicineH
which have been prescribed by your GP, hospita]
doctor, dentist, nurse, health visitor, midwife oY
pharmacist. You must also tell your prescriber abouQ
medicines which you have bought over the counteY
without prescriptions\

The following medicines may interact witM

FosavanceV

~
cimetidinM
~
colestipo]
~
colestyraminM
~
orlistaQ
~
OlestrI

The following types of medicine may interact witM

FosavanceV

~
anticonvulsantH
~
thiazide diureticH
~
bile acid sequestrantH
~
mineral oilH
~
antacidH
~
nonsteroidal
antiinflammatorieH
~
glucocorticosteroidH

If you are taking Fosavance and one of the abovM

medicines or types of medicines, make sure youY
prescriber knows about it\
Complementary preparations and vitaminr

Medicines can interact with complementarb

preparations and vitamins\

Make sure you tell your prescriber the names of al]

the complementary preparations and vitamins thaQ
you are taking or are planning to take\

Your prescriber can then decide whether it iH

appropriate for you to take combinations that arM
known to interact\

In the case of FosavanceV

~
this medicine may interact with vitamins oY
preparations containing calcium. ThesM
preparations can affect the absorption o_

Fosavance and stop it from working as wel]

as normal. You may take these preparationH
30 minutes after taking FosavancM

If you have been prescribed Fosavance you shoulU

only take something on the above list on the specifiL
advice of your prescriber or pharmacist\

Driving and operating machineri

When taking any medicine you should be aware thaQ

it might interfere with your ability to drive or operatM
machinery safely\

In the case of FosavanceV

~
this medicine could affect your ability to drivM

or operate machinerb
You should see how this medicine affects yoX
before you judge whether you are safe to drive oY
operate machinery. If you are in any doubt abouQ
whether you should drive or operate machinery, tald
to your prescriber\
Dief

Medicines can interact with certain foods. In somM

cases, this may be harmful and your prescriber mab
advise you to avoid certain foods\

In the case of FosavanceV

~
this medicine interacts with olestrI
~
during treatment with Fosavance youY
prescriber may advise you to supplemenQ
your diet with extra vitamin D and calcium\
However calcium may affect the absorptioK
of Fosavance and stop it from working aH
well as normal. You should take FosavancM
at least 30 minutes before you havM
supplements, foods or drinks that contaiK
calciuT

For more advice speak to your prescriber{

nutritionist or pharmacist\

Alcohot

Alcohol can interact with certain medicines\

In the case of FosavanceV

~
there are no known interactions betweeK
alcohol and FosavancM

Family planning and pregnanci

This medicine is only given to postmenopausa]

women so its effects in pregnancy are not relevant\

Breastfeedinm

This medicine is only given to postmenopausa]

women so its effects on breastfeeding
are noQ
relevant\
Ingredients of your medicin_

Medicines contain active ingredients. They may alsG

contain other, additional ingredients that help ensurM
the stability, safety and effectiveness of thM
medicine. They are also added to improve thM
medicine's taste and appearance and to make iQ
easier to take. Some may be used to prolong the lifM
of the medicine\

You should check that you are able to take thM

ingredients in your medicine, especially if you havM
any allergies\

Fosavance containsV

~
lactose anhydrouH
~
medium chain triglycerideH
~
gelatiK
~
croscarmellose sodiuT
~
sucrosM
~
magnesium stearate (E572R
~
butyl hydroxytoluene (E321R
~
alendronate sodium and colecalcifero]
~
microcrystalline cellulose E46.
~
modified starch (maizeR
~
sodium aluminium silicate (E554R
~
silica colloidal anhydrouH

If you are not able to take any of the ingredients iK

your medicine, talk to your prescriber or pharmacisQ
to see if they can suggest an alternative medicine. I_
you have reacted badly to Fosavance before, do noQ
take Fosavance. Talk to your prescriber, pharmacisQ
or nurse as soon as possible\

Provided by www.medicines.org.uk/guideH
Page 2 of V
Last updated 15 Apr 1R
Copyright © 2010 DatapharT