ALENDRONIC ACID 70MG TABLETS

Active substance: SODIUM ALENDRONATE

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Package leaflet: Information for the patient

Alendronic Acid
70 mg Tablets

(sodium alendronate)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
•• Keep this leaflet. You may need to read it
again.
•• If you have any further questions, ask your
doctor or pharmacist.
•• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
•• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Alendronic Acid is and what it is used
for
2. What you need to know before you take
Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Contents of the pack and other information
1. What Alendronic Acid is and what it is used
for
Alendronic Acid contains the active substance
sodium alendronate.
Your medicine is in the form of a tablet.
Alendronic Acid belongs to a group
of medicines called bisphosphonates.
Bisphosphonates can be used to help bone
disease such as osteoporosis. Alendronic
Acid can treat and prevent osteoporosis in
post-menopausal women, by stopping bones
becoming thinner and weaker.
2. What you need to know before you take
Alendronic Acid
Do not take Alendronic Acid:
•• if you are allergic to sodium alendronate or
any of the other ingredients of this medicine
(listed in section 6)
•• if you have problems with your gullet
(oesophagus – the tube that connects your
mouth with your stomach) causing difficulty
swallowing or food to become stuck
•• if you know you have very low blood levels of
calcium (hypocalcaemia)
•• if you are unable to stand or sit upright for at
least 30 minutes.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Alendronic Acid:
•• if you suffer from kidney problems
•• if you have any swallowing or digestive or gut
problems
•• if in the last year you have had a stomach
ulcer, bleed or surgery in the stomach, gullet
or throat
•• if you have pain on swallowing
•• if you have been told you have low blood levels
of calcium or you suffer from vitamin D
deficiency or hypoparathyroidism (which can
affect calcium levels). These need to be treated
before you start taking Alendronic Acid
•• if your doctor has told you that you have
Barrett’s oesophagus (a condition associated
with changes in the cells that line the lower
oesophagus)
Irritation, inflammation or ulceration of the
gullet often with symptoms of chest pain,
heartburn, or difficulty or pain upon swallowing
may occur, especially if the tablets are not taken
with a full glass of water and/or if you lie down
less than 30 minutes after taking the tablets.
These side effects may worsen if you continue
to take the tablets after developing these
symptoms. See the ‘How to take’ instructions
later on in this leaflet to see how you should
take the tablets. If you have any questions, ask
your doctor or pharmacist.
Dental and jaw problems
Alendronic Acid can cause damage (including
death or loss) of bone in the jaw. This risk is
increased:
•• if you have poor dental health, gum disease,
poorly fitted dentures, a planned dental
extraction or you do not receive routine
dental care
•• if you have cancer
•• if you are undergoing chemotherapy or
radiotherapy
•• if you are taking corticosteroids (such as
prednisone or dexamethasone)
•• if you are or have been a smoker
Therefore you may be advised to have a dental
check-up before starting treatment with
Alendronic Acid.

It is important to maintain good oral hygiene
when being treated with Alendronic Acid.
You should have routine dental check-ups
throughout your treatment and you should
contact your doctor or dentist if you experience
any problems with your mouth or teeth such as
loose teeth, pain or swelling.
Children and adolescents:
Alendronic Acid should not be given to children
and adolescents.
Other medicines and Alendronic Acid:
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including medicines obtained
without a prescription, or any of the following:
•• calcium supplements
•• antacids for indigestion
•• corticosteroid medicines, such as
prednisolone or dexamethasone, used to
reduce inflammation; as it is important that
you have a good dietary intake of calcium
and vitamin D (a risk factor for dental
problems – see ‘Dental and jaw problems’)
•• certain medicines for rheumatism or longterm pain called NSAIDs (e.g. aspirin or
ibuprofen) might cause digestive problems.
Therefore, caution should be used when
these medicines are taken at the same time
as Alendronic Acid.
Wait at least 30 minutes after taking Alendronic
Acid before taking any other medicines.
Alendronic Acid with food and drink:
If taken at the same time it is likely that food
and drink (including mineral water) will interfere
with the absorption of Alendronic Acid.
Therefore you should take Alendronic Acid with
plain water at least 30 minutes before any food
or drink.
Pregnancy and breast-feeding:
Alendronic Acid is only intended for use in postmenopausal women. Do not take Alendronic Acid
if you are pregnant, or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines:
There have been side effects (including blurred
vision, dizziness and severe bone, muscle or
joint pain) reported with alendronate that may
affect your ability to drive or operate machinery.
Do not drive or operate machinery until you are
sure you are not affected.
Alendronic Acid contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take Alendronic Acid
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is one tablet once
weekly.
Use in patients with kidney problems:
Alendronic Acid is not recommended for
patients with severe kidney problems.
Method of administration
•• Take on an empty stomach, as soon as you
get out of bed in the morning, before you eat
or drink anything.
•• Swallow the tablet whole while standing
upright. Take with a full glass (not less than
200 mls or 7 fl. oz.) of plain water (not mineral
water).
* Do not take with mineral water (still or
sparkling).
* Do not take with coffee or tea.
* Do not take with juice or milk.
•• Do not crush or chew or let the tablet
dissolve in your mouth.
•• Do not take at bedtime. You should not lie
down after taking Alendronic Acid until you
have had something to eat.
•• However, you must leave at least 30 minutes
after swallowing the tablet before you eat,
drink or take any other medicines.
Stop taking this medicine and tell your doctor
if you notice:
•• soreness, pain and difficulty swallowing
•• pain in the centre of the chest
•• heartburn, either new or worse than usual
•• ulcers in your mouth and throat.
If you take more Alendronic Acid than you
should:
Drink a full glass of milk and contact your
doctor or nearest hospital casualty department
immediately. Take any remaining tablets
and the container with you. Do not make
yourself vomit, and do not lie down. In case
of an overdose, you may experience an upset
stomach, heartburn, stomach pain, nausea,
vomiting, vomiting blood, blood in the bowel
motions.
LT1517AH

Date: 10 Jul 2014
Description Alendronate Sodium 70 mg 4
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 450803

SAP No. N/A

Superceded Affiliate Item Code 10005107

Vendor Job No. 232355

TrackWise PR No. 450803

Proof No. 2

MA No. 04569/0625
Packing Site/Printer N/A
Supplier Code LT1517AH
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 08:45
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 11 pt

If you forget to take Alendronic Acid:
Take the tablet on the morning after you
remember. Do not take two tablets on the same
day and return to taking one tablet once a week,
on the day instructed by your doctor.
If you stop taking Alendronic Acid:
Always talk to your doctor or pharmacist before
stopping taking Alendronic Acid.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking this medicine and tell your doctor
immediately if you experience any of the
following symptoms:

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Alendronic Acid
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label, carton and blister
after “EXP”. The expiry date refers to the last day
of that month.
This medicinal product does not require any
special storage conditions.

Common (may affect up to 1 in 10 people):
•• pain in the mouth, throat, chest or stomach
which may be associated with eating. You
may feel bloated, sick or be sick, have a loss of
appetite or have a loss of weight. These may
be signs of inflammation or ulceration in the
digestive tract. If you are sick, you may also
notice paricles that looks like coffee grounds
or you may pass black, tar-like stools
•• new or worsening heartburn or indigestion,
pain in the center of chest or pain upon
swallowing or difficulty swallowing. See your
doctor as soon as possible if you have any of
these effects

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

Uncommon (may affect up to 1 in
100 people):
•• soreness or pain in one or both eyes. You
may have redness, blurred vision, watery
eyes, a sensitivity to light or floaters (shadows
passing across your sight)

What Alendronic Acid looks like and contents
of the pack:

Rare (may affect up to 1 in 1,000 people):
•• allergic reactions such as hives, swelling of
the face, lips, tongue and/or throat, possibly
causing difficulty breathing or swallowing
(angioedema)
•• a skin condition with severe blisters and
bleeding in the lips, eyes, mouth, nose
and genitals (Stevens-Johnson syndrome)
or severe skin reactions which starts with
painful red areas, then large blisters and
ends with peeling of layers of skin. This is
accompanied by fever and chills, aching
muscles and generally feeling unwell (toxic
epidermal necrolysis)
•• pain in the mouth, and/or jaw, swelling
or sores inside the mouth, numbness or a
feeling of heaviness in the jaw, or loosening
of a tooth. These could be signs of bone
damage in the jaw (osteonecrosis) generally
associated with delayed healing and
infection, often following tooth extraction
•• unusual fracture of the thigh bone
particularly in patients on long-term
treatment for osteoporosis may occur rarely.
Contact your doctor if you experience pain,
weakness or discomfort in your thigh, hip or
groin as this may be an early indication of a
possible fracture of the thigh bone

Alendronic Acid 70 mg Tablets are available in
blister packs and bottles of 4, 8 or 12 tablets. The
bottles may contain a plastic spacer at the top of
the pack.

6. Contents of the pack and other information
What Alendronic Acid contains:
Each tablet contains 70 mg of alendronic acid
as the active substance sodium alendronate.
The other ingredients are lactose monohydrate;
cellulose, microcrystalline; croscarmellose
sodium; povidone and magnesium stearate.

Alendronic Acid 70 mg Tablets are white, with
two curved sides, marked as ‘AD70’ on one side
and ‘G’ on the reverse.

Not all pack sizes and types may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer:
Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland

Contact your doctor or dentist if you experience
such symptoms.
Other possible side effects:
Very common (may affect more than 1 in
10 people):
•• bone, muscle and/or joint pain which is
sometimes severe.
Common (may affect up to 1 in 10 people):
•• joint swelling, swelling of the hands and legs
•• abdominal pain, uncomfortable or full feeling
in the stomach or belching after eating;
constipation, diarrhoea, flatulence
•• hair loss, itchy skin
•• headache, dizziness, loss of balance or
spinning sensation(vertigo), unusual
weakness
Uncommon (may affect up to 1 in
100 people):
•• nausea, vomiting
•• rash, redness of the skin
•• for a short time flu-like symptoms, such as
aching muscles, generally feeling unwell and
sometimes with fever. This is usually seen at
the start of treatment
•• changes in your taste.
Rare (may affect up to 1 in 1,000 people):
•• symptoms of low blood calcium levels
including muscle cramps or spasms and/or
tingling sensation in the fingers or around
the mouth
•• narrowing of the gullet (oesophageal
stricture)
•• rash made worse by sunlight
Tell your doctor or pharmacist promptly about
these or any other unusual symptoms.
It will help if you make a note of what you
experienced, when it started and how long it
lasted.

This leaflet was last revised in 07/2014

Date: 10 Jul 2014
Description Alendronate Sodium 70 mg 4
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 450803

SAP No. N/A

Superceded Affiliate Item Code 10005107

Vendor Job No. 232355

TrackWise PR No. 450803

Proof No. 2

MA No. 04569/0625
Packing Site/Printer N/A
Supplier Code LT1517AH
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

450803
LT1517AH

Time: 08:45
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 11 pt

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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