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ALENDRONIC ACID 10 MG TABLETS

Active substance(s): ALENDRONATE SODIUM / SODIUM ALENDRONATE

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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 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
What is Alendronic Acid?
Alendronic acid belongs to a group of medicines called
'bisphosphonates'. Alendronic acid prevents the loss of bone that
occurs in men, post-menopausal women and patients receiving
glucocorticoids such as prednisolone and methylprednisolone.
Alendronic acid has also been shown to help rebuild bone and
makes bone less likely to fracture in post-menopausal women and
men with osteoporosis.
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.
Alendronic Acid is used:
treat osteoporosis in post-menopausal women
treat osteoporosis in men
prevent osteoporosis in post-menopausal women who are
taking medicines called glucocorticoids but are not taking
oestrogen.
What is osteoporosis?
Osteoporosis is thinning and weakening of your bones. It is
common in women after the menopause. Osteoporosis can also
occur in men. Corticosteroids can also cause bone loss and
osteoporosis in both men and women. Early on, osteoporosis
usually has no symptoms. If left untreated 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 considerable problems like stooped posture
(‘dowager’s hump’).
Osteoporosis in postmenopausal women
Osteoporosis often occurs in women several years after, the
menopause, which occurs when the ovaries virtually stop producing
the female hormone, oestrogen, or are removed (which may occur,
for example, at the time of a hysterectomy). The earlier a woman
reaches the menopause, the greater the risk of osteoporosis.
Severe Osteoporosis in men
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. Therefore,
it is important for a healthy skeleton to maintain bone mass and
preventing further bone loss.
By drugs from the group of corticosteroids (eg. prednisone) induced
osteoporosis in women who did not receive estrogen
Under the influence of corticosteroids bone is removed faster than
it is formed so bone loss occurs and bones become weaker
Therefore, maintaining bone mass and preventing further bone loss
are important to keep your skeleton healthy. If your doctor
prescribes corticosteroids, you should use it as directed.
How can osteoporosis be treated or prevented?
It is important to remember that if you already have osteoporosis
that it can be treated and that it is never too late to begin.
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. In addition to your treatment
with Alendronic Acid, your doctor may recommend that you make
some changes to your lifestyle which may help your condition.
These are:
Smoking appears to increase the rate at
which you lose bone and therefore, may
increase your risk of broken bones.
Exercise
Like muscles, bones need exercise to stay
strong and healthy. Talk to your doctor
before you begin any exercise programme.
Eating a balanced diet Your doctor can advise you about your diet
or whether you should take any dietary
supplements.

Black

P150

P150

Alendronic Acid 10 mg
tablets

Package leaflet: Information for the user

Stopping smoking

Alendronic Acid 10 mg
tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

2. What you need to know before you take Alendronic Acid
Do not take Alendronic Acid if you:


If you are allergic to alendronate sodium trihydrate or any of
the other ingredients of this medicine (listed in section 6).

If you have certain disorders of the oesophagus (the tube that
connects your mouth with your stomach) such as narrowing or
difficulty swallowing

If you are unable to stand or sit upright for at least 30 minutes

If 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 or pharmacist first and follow the advice given
Warnings and precautions
It is important to tell your doctor before taking Alendronic Acid
Tablets

If you suffer from kidney problems

if you have any swallowing or digestive problems

if you have been told you have low blood calcium.

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),

you have poor dental health, gum disease , a planned dental
extraction or you don’t receive routine dental care

you have cancer

you are undergoing chemotherapy or radiotherapy

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. 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. These side effects may worsen if patients continue
to take Alendronic Acid after developing these symptoms.
Other medicines and Alendronic Acid
Tell your doctor 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 if taken at the same time. Therefore, it is important
that you follow the advice given in section 3.How to take
Alendronic.
Certain medicines for rheumatism or long-term pain called NSAIDs
(e.g. aspirin or ibuprofen) might cause irritation of the digestive
tract. Therefore, caution should be used when these medicines are
taken at the same time as Alendronic Acid.
Tell your doctor if you are taking have recently taken or might take
any other medicines.
Taking Alendronic Acid with food, drink and alcohol
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.
Children and adolescents
Alendronic Acid should not be given to children and adolescents.
Pregnancy, breast-feeding and fertility
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 any medicine
Alendronic Acid is only intended for use in postmenopausal women.
You should not take Alendronic Acid if you are or think you may be
pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (including blurred vision, dizziness
and severe bone, muscle or joint pain) reported with Alendronic
Acid that may affect your ability to drive or operate machinery.
Individual responses to Alendronic Acid may vary (See section 4.
Possible side effects).
3. How to take Alendronic Acid
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Follow these instructions carefully to make sure you will benefit
from Alendronic Acid
It is very important to follow instructions 1), 2), 3), 4) and 5) to help
the Alendronic Acid tablet reach your stomach quickly and help
reduce the chance of irritating your gullet (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 medicine, swallow your Alendronic Acid tablet whole with
a full glass of plain water only (not less than 200ml)





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)

After swallowing your alendronic acid tablets 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 contact your doctor.

5)

After swallowing your tablet, wait at least 30 minutes before
taking your first food, beverage, or other medication of the day,
including antacids, calcium supplements and vitamins,
alendronic acid tablets is effective only if taken when your
stomach is empty,

You must take Alendronic Acid exactly as your doctor has told you.
It is important that you continue taking Alendronic Acid for as long
as your doctor prescribes the medicine.
The recommended dosage is

for the treatment of osteoporosis in men and post-menopausal
women the usual dose is 10 mg once a day.

for the treatment and prevention of steroid induced
osteoporosis in post-menopausal women not receiving
hormone replacement therapy (HRT) with an oestrogen the
usual dose is 10 mg once a day.
Elderly patients
No dose adjustment in elderly patients is necessary.
If you have kidney problems
Alendronic Acid must not be used in patients with severe kidney
problems.
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.











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;
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.
mouth ulcers when the tablets have been chewed or sucked;

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 possible side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system
listed in Yellow Card Scheme.
Website: 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 carton 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

If you forget to take Alendronic Acid
Take Alendronic Acid once a day as prescribed. Do not take a
double dose to make up for a forgotten dose. Follow the usual
schedule with one tablet per day.

What Alendronic Acid contains
-

If you stop taking Alendronic Acid
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.

The active substance is alendronic acid.
Each tablet contains 10 mg alendronic acid (equivalent to
13.052 mg sodium alendronate trihydrate).

-

The other ingredients are: Microcrystalline cellulose, maize
starch, sodium starch glycolate (Type A), povidone
(Kollidon 30) and magnesium stearate

If you have any further questions on the use of thismedicine, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

What Alendronic Acid looks like and contents of the pack
Tablet.
White to off-white, round, biconvex, uncoated tablets debossed with
‘F’ on one side and ‘18’ on the other side. The tablets are 5 mm in
diameter.

Contact your doctor immediately when you experience the
following symptoms. These can be serious and you might
need immediate medical care.

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,

They are supplied in blister packs and HDPE tablet container
packs.
Pack size:
PVC/Aclar – Aluminium blister pack: 10, 14, 20, 28, 30, 50, 56, 60,
84, 90, 98, 100, 112, 140 and 250 tablets
HDPE tablet container pack: 30, 50, 100, 250 and 1000 tablets

Very common (may affect more than 1 in 10 people):

bone, muscle and/or joint pain which is sometimes severe.

Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom

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,

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:

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 1,000 people):

allergic reactions such as hives; swelling of the face, lips,
tongue and/or throat, possibly causing difficulty breathing or
swallowing.

Not all pack sizes may be marketed.

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
Denmark
Finland
Italy
Malta
Netherlands
Poland
Romania
Spain
Sweden
United Kingdom

Alendronat “Aurobindo”
Alendronat Aurobindo 10 mg tabletit
Acido Alendronico Aurobindo
Alendronic Acid 10 mg tablets
Alendroninezuur Aurobindo 10 mg, tabletten
Alendronat Aurobindo
Acid Alendronic Aurobindo 10 mg comprimate
ACIDO ALENDRÓNICO AUROBINDO 10 mg
comprimidos EFG
Alendronat Aurobindo 10 mg tabletter
Alendronic Acid 10 mg tablets

This leaflet was last revised in 09/2014.

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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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