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ALENDRONIC ACID 10MG TABLETS

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

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TEVA UK Ref:

231-30-85087-ZC LEA ALENDRONIC ACID 10MG TAB TUK

Version:

3

8 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 540

REG0051335

A dental examination should be considered
before you start treatment with Alendronic
Acid if you have any of the conditions below:
PACKAGE LEAFLET:
• You have cancer
INFORMATION FOR THE USER
• You are undergoing chemotherapy or
Read all of this leaflet carefully before you
radiotherapy
start taking this medicine.
• You are taking steroids
• Keep this leaflet. You may need to read it
• You don’t receive routine dental care
again.
• You have gum disease
• If you have any further questions, ask your • You smoke.
doctor or pharmacist.
Appropriate preventive dental care, as
• This medicine has been prescribed for
recommended by the dentist, should be
you. Do not pass it on to others. It may
followed during treatment.
harm them, even if their symptoms are
If you do develop difficulty or pain when
the same as yours.
swallowing, pain behind the breastbone
• If you get any side effects, talk to your
(centre of the chest), or new or worsening
doctor or pharmacist. This includes any
heartburn, stop taking your tablets and
possible side effects not listed in this
contact your doctor.
leaflet. See section 4.
Taking other medicines
IN THIS LEAFLET:
Do NOT take any other oral medication at
exactly the same time as taking Alendronic
1. What Alendronic Acid is and what it is
Acid Tablets. If you are taking any other
used for
medicines, you should take your dose of
2. Before you take Alendronic Acid
Alendronic Acid at least 30 minutes before
3. How to take Alendronic Acid
you take your other medication.
4. Possible side effects
Talk to your doctor defore you take
5. How to store Alendronic Acid
non-steroidal anti-inflammatory drugs
6. Further information
(NSAID’s) while taking Alendronic Acid.
WHAT
ALENDRONIC
ACID
IS
AND
Please tell your doctor or pharmacist if you
1 WHAT IT IS USED FOR
are taking or have recently taken any other
medicines, including medicines obtained
• Alendronic Acid belongs to a group of
without a prescription.
drugs called bisphosphonates, which
Taking Alendronic Acid with food and drink
prevent bone loss from the body.
These tablets should be taken on an empty
• Alendronic Acid is used to treat
stomach, as food and drink can greatly
osteoporosis (thinning of the bones) in
reduce the effectiveness of the medicine.
men and post-menopausal women. It is
Take the tablets at least 30 minutes before
also used to reduce the risk of back and
your first meal of the day.
hip fractures.
Pregnancy and breast-feeding
YOU TAKE ALENDRONIC
Do NOT take Alendronic Acid 10 mg Tablets
2 BEFORE
ACID
if you are pregnant or are breast-feeding.
Driving and using machines
Do NOT take Alendronic Acid if you:
• are allergic (hypersensitive) to alendronic In some cases Alendronic Acid 10 mg Tablets
acid or any of the other ingredients of this may cause adverse reactions that may affect
medicine
your ability to drive or operate machinery
• have previously had a reaction to other
(like problems with sight). Do NOT drive or
bisphosphonate drugs, e.g. risedronate
operate machinery if you are affected.
sodium
• suffer from certain disorders of the
3 HOW TO TAKE ALENDRONIC ACID
oesophagus (also called the gullet, the
Always take Alendronic Acid 10 mg Tablets
tube that connects your mouth with your
exactly as your doctor has told you. You
stomach)
should check with your doctor or pharmacist
• are unable to stand or sit upright for at
if you are not sure.
least 30 minutes
• have been told by your doctor that you
Your doctor may also prescribe calcium and
have low blood calcium levels, disturbed
vitamin D supplements if you are not getting
calcium and mineral metabolism, vitamin enough from your diet.
D deficiency or parathyroid gland
You should follow the instructions below
problems.
carefully to make sure your medicine is
Take special care with Alendronic Acid
effective and to reduce the risk of your
It is important to talk to your doctor before medicine irritating your gullet.
• Alendronic Acid 10 mg Tablets should be
you start to take this medicine if you have
taken first thing when you get up in the
• difficulty swallowing
morning. It should be taken with a full
• if your doctor has told you that you have
glass of plain water (not tea, coffee,
Barrett’s oesophagus (a condition
mineral water or juice) half an hour before
associated with changes in the cells that
any food, drink or other medication
line the lower oesophagus)
• The tablets should be swallowed whole,
• kidney problems
not chewed, sucked or allowed to dissolve
• inflammation of the stomach lining or the
in the mouth
duodenum (first section of the small
• Do NOT lie down after taking your tablet.
intestine)
You must stay upright (sitting, standing or
• a stomach ulcer or other digestive
walking) until you have taken your first
problems
meal of the day which must be at least half
• recently had stomach surgery (not
an hour after your dose of Alendronic Acid
including pyloroplasty, where the outlet of
• Do NOT take your tablets at bedtime or
the stomach is widened).
before getting out of bed
If any of these conditions applies to you,
• If you develop pain or difficulty on
you must consult your doctor before
swallowing, chest pain or new or
starting treatment with Alendronic Acid.
worsening heartburn, stop taking
Alendronic Acid 10 mg Tablets and contact
your doctor.

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ALENDRONIC ACID 10 mg
TABLETS

TEVA UK Ref:

Version:

231-30-85087-ZC LEA ALENDRONIC ACID 10MG TAB TUK

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

The usual dosage instructions are given
below:
• Adults (including the elderly):
One 10 mg tablet once a day.
• Children and adolescents:
Alendronate should not be given to
children and adolescents.
If you take more Alendronic Acid than you
should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child
has swallowed any of the tablets, contact
your nearest hospital casualty department
or your doctor immediately. Drink a full
glass of milk and do not lie down.
An overdose is likely to cause an upset
stomach or heartburn.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
If you forget to take Alendronic Acid
If you forget to take a tablet when you first
get up in the morning, do NOT take a tablet
later in the day, take one when you first get
up the next morning. Never take two doses
together or on the same day. Take the
remaining doses at the correct time.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Alendronic Acid can
cause side effects, although not everybody
gets them.
If the following happens, stop taking the
tablets and tell your doctor immediately or
go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but uncommon side
effect. You may need urgent medical
attention or hospitalisation.
If the following happens, stop taking your
tablets and contact your doctor:
• you develop difficulty or pain when
swallowing, pain behind the breastbone
(centre of the chest), or new or worsening
heartburn.
• blisters/bleeding of the lips, eyes, nose,
mouth and genitals, or a severe blistering
rash where large areas of the skin may
peel.
The following side effects have been reported
at the approximate frequencies shown:
Very common (affecting more than 1 user
in 10)
• pain in the bones, muscles or joints,
sometimes severe
Common (affect 1 to 10 users in 100)
• stomach pain, indigestion or heartburn,
constipation, diarrhoea, wind
• ulceration of the oesophagus (gullet),
difficulty swallowing, full or bloated
feeling in the stomach, a backflow of acid
from the stomach into the gullet and the
mouth
• joint swelling, swelling in the hands or
legs (oedema)
• headache, dizziness, vertigo
• itching, hair loss
• tiredness.
Uncommon (affect 1 to 10 users in 1,000)
• rashes and reddening of the skin
• allergic reaction, including hives and rapid
swelling of the skin and mucous
membranes (angioedema)
• feeling sick, being sick, inflammation
and/or erosion of the gullet, inflammation
of the stomach lining, black tarry stools

REG0051335

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• changes in the sense of taste
• eye inflammation (usually painful)
• transient symptoms (pain in the muscles,
malaise and rarely fever) at the initiation
of the treatment.
Rare (affect 1 to 10 users in 10,000)
• rash on exposure to sunlight and other
allergic reactions (for example,the
potentially fatal Stevens-Johnson
syndrome or toxic epidermal necrolysis)
• low blood calcium levels
• stomach and other peptic ulcers, stomach
tears and bleeding
• mouth, throat ulcers when the tablets
have been chewed or sucked
• narrowing of the oesophagus (gullet)
• jaw problems (generally following tooth
extraction and/or local infection)
• unusual fracture of the thigh bone.
Blood calcium and phosphate levels may be
affected by Alendronic Acid 10 mg Tablets.
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.
Osteonecrosis (arthritis) of the jaw has been
reported mainly in cancer patients, but
some cases have also been reported in
patients treated for osteoporosis.
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 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 out of the reach and sight of children.
Do not use Alendronic Acid after the expiry
date that is stated on the outer packaging.
The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

What Alendronic Acid tablets contains:
• The active ingredient is alendronic acid
(as sodium monohydrate)
• The other ingredients are low-substituted
hyprolose, hyprolose, colloidal hydrated
silica, and sodium stearyl fumarate.
What Alendronic Acid tablets look like and
contents of the pack:
• Alendronic Acid tablets are white to
off-white, round biconvex tablets. They are
debossed with “T” on one side and “10”
on the other side.
• The product is available in pack sizes of
14, 28, 30, 50, 56, 84, 90, 98, 112, and 140
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: May 2015
PL 00289/0703

Approved

85087-ZC
160 x 323

Page 2 of 3

8 May 2015

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-Alendronic-Acid-10mg-Tablets

APPROVALS
Signed by
Hemal Joshi

REG0051335

Meaning of Signature
Regulatory Affairs Approval

Version 3.5

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Server Date
08-May-2015 04:17:19 PM

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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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