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ALENDRONIC ACID 70 MG FILM-COATED TABLETS

Active substance(s): ALENDRONATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Alendronic Acid 70 mg Film-coated Tablets
Alendronic acid
Read all of this leaflet carefully before you start
taking this medicine
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
If you think any of these apply to
you, do not take the tablets. Talk to
your doctor first and follow the
advice given.

In this leaflet:
1. What Alendronic Acid is and what it
is used for
2. Before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Further information

1

Take special care with Alendronic
Acid
It is important to tell your doctor before
taking Alendronic Acid
• if you suffer from kidney problems.
• if you have any swallowing or
digestive problems.
• if you have low blood calcium
levels.
• 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).

What Alendonic Acid is and
what is it used for

What is Alendronic Acid?
Alendronic Acid is a film-coated tablet
containing the active substance
alendronate sodium.
What is alendronate?
Alendronate belongs to a group of
non-hormonal medicines called
bisphosphonates. Alendronate prevents
the loss of bone that occurs in women
after they have been through the
menopause, and helps to rebuild bone.
It reduces the risk of spine and hip
fractures.

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.
These side effects may worsen if
patients continue to take Alendronic
Acid after developing these symptoms.

What is Alendronic Acid used for?
Your doctor has prescribed Alendronic
Acid to treat your osteoporosis.
Alendronic Acid reduces the risk of
spine and hip fractures.

Talk to your doctor before you take
Alendronic Acid if you have or have had
pain or swelling of your gums and/or
jaw, numbness of the jaw, if the jaw
feels heavy or if you have lost a tooth.
This might be a symptom of
osteonecrosis (death of bone tissue).
Talk to your doctor if you suffer from
cancer or if your teeth are in bad
condition as this is a risk factor. If you
are being treated by a dentist or if you
are going to have dental surgery, tell
your dentist that you are taking
Alendronic Acid.

Alendronic Acid is a once weekly
treatment.
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.

Taking other medicines
It is likely that calcium supplements,
antacids, and some oral medicines
will interfere with the absorption of
Alendronic Acid if taken at the same
time. Therefore, it is important that you
follow the advice given in section 3
“How to take Alendronic Acid”.

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 injury that
would not generally break normal bone.
Broken bones usually occur at the hip,
spine, or wrist and can lead not only to
pain but also to considerable problems
like stooped posture (‘dowager’s
hump’) and loss of mobility.

Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
Taking Alendronic Acid with food
and drink
It is likely that food and beverages
(including mineral water) will make
Alendronic Acid 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”.

How can osteoporosis be treated?
Osteoporosis can be treated and it is
never too late to begin treatment.
Alendronic Acid not only prevents the
loss of bone but actually helps to
rebuild bone you may have lost and
reduces the risk of bones breaking in
the spine and hip.

Children and adolescents
Alendronic Acid should not be given to
children and adolescents.

As well as your treatment with
Alendronic Acid, your doctor may
suggest you make changes to your
lifestyle to help your condition, such as:

Pregnancy
You should not take Alendronic Acid if
you are or think you may be pregnant.
Alendronic Acid is only intended for use
in postmenopausal women.

Stopping smoking
Smoking appears to increase the rate
at which you lose bone and, therefore,
may increase your risk of broken bones.

Breast-feeding
You should not take Alendronic Acid if
you are breast-feeding. Alendronic Acid
is only intended for use in
postmenopausal women.

Exercise
Like muscles, bones need exercise to
stay strong and healthy. Consult your
doctor before you begin any exercise
programme.

Driving and using machines
Alendronic Acid should not affect your
ability to drive or operate machines.

Eating a balanced diet
Your doctor can advise you about your
diet or whether you should take any
dietary supplements (especially calcium
and vitamin D).

2

3

Before you take Alendonic
Acid

How to take Alendonic Acid

Always take Alendronic Acid exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.

Do not take Alendronic Acid
• if you are hypersensitive (allergic) to
alendronate sodium trihydrate, other
bisphosphonates or any of the other
ingredients of Alendronic Acid Tablets.
• if you have certain problems with
your gullet (oesophagus - the tube
that connects your mouth with your
stomach) such as narrowing or
difficulty swallowing.
• if you cannot stand or sit upright
for at least 30 minutes.
• if your doctor has told you that you
have low blood calcium.

Take one 70 mg film-coated tablet
once a week.
Follow these instructions carefully to
make sure that you benefit from
Alendronic Acid.
1) Choose the day of the week that
best fits your schedule. Every
week, take one Alendronic Acid
tablet on your chosen day.
Continued on the next page >>

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ulcers (sometimes severe or with
bleeding) but it is not sure whether
these were caused by Alendronic Acid.

It is very important to follow
instructions 2), 3), 4) and 5) to
help the Alendronic Acid reach
your stomach quickly and help
reduce the chance of irritating
your gullet (oesophagus - the
tube that connects your mouth
with your stomach).

Skin
Uncommon: rash; itching; redness of
the skin.
Rare: rash made worse by sunlight.
Very rare: severe skin reactions.
Musculoskeletal
Common: bone, muscle and/or joint
pain.
Rare: Osteonecrosis (death of bone
tissue), severe bone, muscle and/or
joint pain. Unusual fracture of the thigh
bone particularly in patients on
long-term treatment of osteoporosis
may occur rarely. Contact your doctor if
you experience pain, weakness or
discomfort in your thing, hip or groin as
this may be an early indication of a
possible fracture of the thigh bone.
Frequency unknown: joint swelling.

2) After getting up for the day and
before taking any food, drink, or
other medicine, swallow your
Alendronic Acid tablet with a full
glass of water only (not mineral
water) (not less than 200 ml or
7 fl. oz.).
- Do not take with mineral water
(still or sparkling).
- Do not take with coffee or tea.
- Do not take with juice or milk.
3) Do not chew the tablet or allow it to
dissolve in your mouth.

General disorders
Rare: transient flu-like symptoms, such
as aching muscles, generally feeling
unwell and sometimes with fever usually
at the start of treatment;
hypersensitivity reactions including
nettle rash and angio-oedema; symptoms
of low blood calcium levels including
muscle cramps or spasms and/or
tingling sensation in the fingers or
around the mouth.

4) 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.
5) Do not take Alendronic Acid at
bedtime or before getting up for the
day.
6) If you develop difficulty or pain upon
swallowing, chest pain, or new or
worsening heartburn, stop taking
Alendronic Acid and contact your
doctor.

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.

7) After swallowing your Alendronic
Acid, 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 is effective only if
taken when your stomach is empty.

Frequency unknown: weakness,
swollen hands, ankles or feet.
It will help if you make a note of what
you experienced, when it started and
how long it lasted.
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.

8) It is important that you continue
taking Alendronic Acid for as long
as your doctor prescribes the
medicine. Alendronic Acid can treat
your osteoporosis only if you
continue to take the tablets.
If you take more Alendronic Acid
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.

5

Keep out of the reach and sight of
children.
This medicinal product does not require
any special storage conditions.

If you forget to take Alendronic Acid
If you miss a dose, just take one tablet
on the morning after you remember. Do
not take two tablets on the same day.
Return to taking one tablet once a
week, as originally scheduled on your
chosen day.

Do not take the tablets after the expiry
date stated on the blister and the carton.

6

If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4

How to store Alendronic
Acid

Further information

What Alendronic Acid contains
The active substance is sodium
alendronate. Each film-coated tablet
contains 70 mg alendronic acid (as
sodium alendronate trihydrate).

Possible side effects

The other ingredients are:
Tablet core: Microcrystalline cellulose,
Colloidal anhydrous silica,
Croscarmellose sodium, Magnesium
stearate.
Tablets coating: Microcrystalline
cellulose, Carrageenan, Macrogol.

Like all medicines, Alendronic Acid can
have side effects, although not
everybody gets them.
The following terms are used to
describe how often side effects have
been reported.
Common (occurring in at least 1 of 100
and less than 1 of 10 patients treated)
Uncommon (occurring in at least 1 of
1,000 and less than 1 of 100 patients
treated)
Rare (occurring in at least 1 of 10,000
and less than 1 of 1,000 patients
treated)
Very rare (occurring in less than 1 of
10,000 patients treated)

What Alendronic Acid looks like and
contents of the pack
White, round, biconvex film coated tablet,
debossed with “ALN 70” on one side.
The product is packed in
OPA-Aluminium-PVC/Aluminium blister
and may be supplied in the following
pack sizes
2 film-coated tablets
4 film-coated tablets
6 film-coated tablets
8 film-coated tablets
12 film-coated tablets
14 film-coated tablets

Nervous system
Common: headache.
Frequency unknown: dizziness.
Eye disorders
Rare: blurred vision, pain or redness in
the eye.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer

Ear and labyrinth disorders:
Frequency unknown: spinning
sensation.

Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Digestive tract
Common: abdominal pain;
uncomfortable feeling in the stomach or
belching after eating; constipation; full
or bloated feeling in the stomach;
diarrhoea; flatulence; heartburn;
difficulty swallowing; pain upon s
wallowing; 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
Uncommon: 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
Rare: narrowing of the gullet
(oesophagus - the tube that connects
your mouth with your stomach); mouth
ulcers when the tablets have been
chewed or sucked; stomach or peptic

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljubljana,
Slovenia or
Lek S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa, Poland or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen,
Germany.
This leaflet was last approved in
12/2015.
SZ00000LT000

Artwork Proof Box
Ref: V019 - SPC & PIL update in line with PRAC recomm
Proof no.
009.0

Date prepared:
02/12/2015

Colours:
Black
Dimensions: 130 x 500 mm

Font size:
8.5pt
Fonts:
Helvetica

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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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