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ALENDRONIC ACID 70MG TABLETS

Active substance(s): ALENDRONATE SODIUM / ALENDRONATE SODIUM TRIHYDRATE / ALENDRONIC ACID

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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

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 checkups 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
prednisone 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.

Alendronic Acid contains the active substance
sodium alendronate.

Wait at least 30 minutes after taking
Alendronic Acid before taking any other
medicines.

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.

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.

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.

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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 or 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 taking angiogenesis inhibitors –
medicines used in the treatment of cancer
to prevent the growth of new blood vessels,
such as bevacizumab or thalidomide
• if you are or have been a smoker

Pregnancy and breast-feeding:
Alendronic Acid is only intended for use
in post-menopausal 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 staying in
an upright position (sitting, standing or
walking). Take with a full glass (not less than
200 ml) 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.

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Package leaflet: Information for the patient

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.
If you forget to take Alendronic Acid:
Take the tablet in 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 you stop 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:
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 particles that looks like
coffee grounds or you may pass black, tarlike stools
• new or worsening heartburn or indigestion,
pain in the centre of chest or pain upon
swallowing or difficulty swallowing. See
your doctor as soon as possible if you have
any of these effects
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)
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
Very rare (may affect up to 1 in 10,000
people):
• talk to your doctor if you have ear pain,
discharge from the ear, and/or an ear
infection. These could be signs of bone
damage in the ear.

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.

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.
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.

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.
What Alendronic Acid looks like and
contents of the pack:
Alendronic Acid 70 mg Tablets are white, with
two curved sides, marked as ‘AD70’ on one
side and ‘G’ on the reverse.
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.
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
This leaflet was last revised in 10/2016

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

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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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