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ALENDRONIC ACID 10 MG TABLETS

Active substance(s): ALENDRONATE SODIUM / SODIUM ALENDRONATE / ALENDRONATE SODIUM

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Alendronic Acid 10 mg

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

5 (Page 1 of 2) (IB020)

Date

06_10_16 (Alendronic Acid 10 mg (ACC-UK)IB020-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the user

Alendronic Acid 10 mg
Tablets
(Alendronic Acid)

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 sign and 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.
• It is particularly important to understand the
information in section 3 How to take Alendronic
acid, before taking this medicine.
What is in this leaflet
1. What Alendronic Acid Tablets are and what
they are used for
2. What you need to know before you take
Alendronic Acid Tablets
3. How to take Alendronic Acid Tablets
4. Possible side effects
5. How to store Alendronic Acid Tablets
6. Contents of the pack and other information

1. What Alendronic Acid Tablets
are and what they are used for
What is Alendronic acid
Alendronic acid is a tablet containing the active
substance alendronic acid (commonly called
alendronate) and belongs to a group of medicines
called bisphosphonates. Alendronic Acid prevents
the loss of bone that occurs in women after they
have been through the menopause. It can also
prevent loss of bone in men or people taking
steroids, such as prednisolone and
methylprednisolone.. It also has been shown to
help rebuild bone and makes bone and reduce the
risk of spine and hip fractures (broken bones) in
women (after their menopause) and in men who
have thinning of their bones (osteoporosis).
What is Alendronic Acid Tablets are used for
Your doctor has prescribed alendronic acid
because you either have osteoporosis or you are
at risk of developing this disease.
What is osteoporosis
Osteoporosis is a thinning and weakening of the
bones. It is common in women after the
menopause. At the menopause, the ovaries stop
producing the female hormone, oestrogen, which
helps to keep a woman’s skeleton healthy. As a
result, bone loss occurs and bones become
weaker. The earlier a woman reaches the
menopause, the greater the risk of osteoporosis.

Approved By
Quality Assurance

Warnings and precautions
Talk to your doctor or pharmacist before taking
Alendronic acid tablets
It is important to tell your doctor before taking
Alendronic Acid Tablets if
• you suffer from kidney problems
• you have any swallowing or digestive problems
• your doctor has told you that you have Barrett's
oesophagus (a condition associated with
changes in the cells that line the lower
oesophagus)
• you have been told you have low blood calcium
• you have poor dental health, gum disease, a
planned extraction or you don’t receive routine
dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking angiogenesis inhibitors (such as
bevacizumab, or thalidomide)
• you are taking corticosteroids (such as
prednisone or dexamethasone)
• you are or have been a smoker (as this may
increase the risk of dental problems).
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 tablets. 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.
Irritation, inflammation or ulceration of the gullet
(oesophagus – the tube that connects your
mouth with your stomach) often with symptoms of
chest pain, heartburn, or difficulty or pain upon
swallowing may occur, especially if patients do
not drink a full glass of water and/or if they lie
down less than 30 minutes after taking alendronic
acid tablets. These side effects may worsen if
patients continue to take alendronic acid tablets
after developing these symptoms.
Children and adolescents
Alendronic acid tablets should not be given to
children and adolescents less than 18 years of age.
Other medicines and Alendronic acid Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
It is likely that calcium supplements, antacids,
and some oral medicines will interfere with the
absorption of Alendronic acid tablets if taken at
the same time. Therefore, it is important that you
follow the advice given in section 3 How to take
Alendronic acid Tablets.
Certain medicines for rheumatism or long-term
pain called NSAIDs (e.g. acetylsalicyclic acid
(aspirin) or ibuprofen) might cause digestive
problems. Therefore, caution should be used
when these medicines are taken at the same
time as Alendronic acid Tablets.
Alendronic Acid Tablets with food and drink

Osteoporosis can also occur in men due to a
number of causes including ageing and/or a low
level of the male hormone, testosterone. In all
instances, bone is removed faster than it is formed,
so bone loss occurs and bones become weaker.

It is likely that food and drinks (including mineral
water) will make Alendronic acid Tablets less
effective if taken at the same time. Therefore it is
important that you follow the advice given in
Section 3 How to take Alendronic acid Tablets.

Corticosteroids can also cause bone loss and
osteoporosis in both men and women.

Pregnancy, breast-feeding and fertility

Early on, osteoporosis usually has no symptoms.
If left untreated, however, it can result in broken
bones. Although these usually hurt, breaks in the
bones of the spine may go unnoticed until they
cause height loss.
Broken bones can happen during normal,
everyday activity, such as lifting, or from minor
injuries that would not fracture normal bone.
Broken bones usually occur at the hip, spine, or
wrist and can lead not only to pain but also to
considerable deformity problems like stooped
posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated/prevented?
As well as your treatment with alendronic acid,
your doctor may recommend that you make
some changes to your lifestyle, which may help
your condition. These are:
Stopping smoking:

Exercise:

Eating a balanced diet:

Smoking appears to
increase the rate at
which you lose bone
and, therefore, may
increase your risk of
broken bones.
Like muscles, bones
need exercise to stay
strong and healthy.
Consult your doctor
before you begin any
exercise programme.
Your doctor can
advise you about your
diet or whether you
should take any
dietary supplements
(especially calcium
and Vitamin D).

2. Before you take Alendronic
Acid Tablets
Do not take Alendronic Acid Tablets if you:
• are allergic to alendronic acid, the active
ingredient, or any of the other ingredients of this
medicine (listed in section6)
• have certain disorders of the oesophagus
(sometimes called the gullet and is the tube that
connects your mouth with your stomach) such
as narrowing or difficulty swallowing
• cannot stand or sit upright for at least 30 minutes
• your doctor has told you that you have low
blood calcium
If you think any of these apply to you, do not take
the tablets. Talk to your doctor first and follow the
advice given.

Alendronic acid tablet is only intended for use in
postmenopausal women. You should not take
alendronic acid tablets 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 alendronic acid tablets that
may affect your ability to drive or operate
machinery. Individual responses to alendronic
acid tablets may vary (See section4.)
Alendronic Acid Tablets contains lactose
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicine

3. How to take Alendronic Acid
Tablets
Always take alendronic acid tablets exactly as
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Taking your medicine
It is very important that you follow actions 1
to 5 help the tablet reach your stomach
quickly and help reduce possible irritation of
your oesophagus (the tube that connects
your mouth with your stomach).
1. After getting up for the day, and before taking
any food, drink or other medicines, swallow your
alendronic acid tablets with a full glass of plain
water only (not less than 200 ml).
- 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 the tablet or allow it to
dissolve in your mouth.
2. Do not lie down - stay fully upright (sitting,
standing or walking) for at least 30 minutes
after swallowing the tablet. Do not lie down
until after your first food of the day.
3. Do not take alendronic acid tablets at bedtime
or before getting up for the day.
4. If you develop difficulty or pain upon
swallowing, chest pain, or new or worsening
heartburn, stop taking alendronic acid tablets
and talk to your doctor immediately.
5. After swallowing your tablet, wait at least 30
minutes before taking your first food, drink, or
other medicine of the day, including antacids,
calcium supplements and vitamins. Alendronic
Acid Tablets will only work if your stomach is
empty.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Alendronic Acid 10 mg

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

5 (Page 2 of 2) (IB020)

Date

06_10_16 (Alendronic Acid 10 mg (ACC-UK)IB020-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

The recommended dose
• for the treatment of osteoporosis in men or
post-menopausal women the recommended
dose is 10 mg once a day.
• for the treatment prevention of steroid induced
osteoporosis in post-menopausal women not
receiving hormone replacement therapy (HRT)
with an oestrogen the recommended dose is 10
mg once a day.
If you take more Alendronic Acid Tablets than
you should
If you take too many tablets by mistake, drink a
full glass of milk and contact your doctor
immediately. Do not make yourself vomit, and do
not lie down.
If you forget to take Alendronic Acid Tablets
If you forget to take your dose, skip the missed
dose. Take the next dose as normal. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Alendronic Acid Tablets
It is important that you continue taking alendronic
acid tablets for as long as your doctor prescribes
the medicine. Since it is not known how long you
should take Alendronic acid tablets, you should
discuss the need to stay on this medicine with
your doctor periodically to determine if Alendronic
acid tablet is still right for you.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, alendronic acid tablets can
cause side effects, although not everybody gets
them.
See your doctor immediately if you notice any
of the following side effects, which may be
serious, and for which you may need urgent
medical treatment:
Common (may affect up to 1 in 10 people):
• Heartburn; difficulty swallowing; pain upon
swallowing; ulceration of the gullet (oesophagus
– the tube that connects your mouth with your
stomach) which can cause chest pain,
heartburn or difficulty or pain upon swallowing.
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;
severe reactions involving your skin, mucous
membranes of your mouth, nose eyes or
genitals. Stop taking this medicine and contact
your doctor right away if you experience such
symptoms;
• 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. Contact your doctor and dentist
if you experience such symptoms;
• 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;
• bone, muscle and/or joint pain which is severe.

Approved By
Quality Assurance

reporting side effets you can help provide more
information on the safety of this medicine.

5. How to store Alendronic Acid
Tablets
• Keep this medicine out of the sight and reach of
children.
• Do not use alendronic acid tablets after the
expiry date, which is stated on the 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 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 Tablets contain:
The active substance is alendronic acid (as
sodium alendronate).
Each tablet contains 10 mg alendronic acid (as
alendronate sodium)
The other ingredients are lactose anhydrous,
cellulose microcrystalline (E460), croscarmellose
sodium and magnesium stearate.
What Alendronic Acid Tablets look like and
content of the pack:
Alendronic Acid 10 mg Tablets are available as
white to off-white, oval, biconvex tablet,
debossed with ‘10’ on one side and plain on other
side.
Alendronic Acid 10 mg Tablets are available in
opaque white PVC/ALU blister packs containing
14, 28, 30, 50, 56, 84, 90, 98, 112* or 140*
tablets.
*Not for UK market
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
UK
This leaflet was last revised in 10/2016.

Other side effects include:
Very common (may affect more than 1 in 10
people):
• Bone, muscle and/or joint which is sometimes
severe.
Common (may affect more than 1 in 10 people):
• joint swelling
• abdominal pain; uncomfortable feeling in the
stomach or belching after eating; constipation;
full or bloated feeling in the stomach; diarrhoea;
flatulence;
• hair loss; itching;
• headache; dizziness;
• tiredness; swelling in the hands or legs.
Uncommon (may affect up to 1 in 100 people):
• nausea;
• vomiting
• irritation or inflammation of the gullet
(oesophagus – the tube that connects your
mouth with your stomach) or stomach
• black or tar-like stools
• blurred vision; pain or redness in the eye;
• rash;
• redness of the skin
• transient flu-like symptoms, such as aching
muscles, generally feeling unwell and
sometimes with fever usually at the start of
treatment;
• taste disturbance.
Rare (may affect up to 1 in 1000 people):
• symptoms of low blood calcium levels including
muscle cramps or spasms and/or tingling
sensation in the fingers or around the mouth
• stomach or peptic ulcers (sometimes severe or
with bleeding)
• narrowing of the gullet (oesophagus – the tube
that connects your mouth with your stomach)
• rash made worse by sunlight
• mouth ulcers when the tablets have been
chewed or sucked
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By

INP001
10 00000 0 000000

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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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