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ALENDRONIC ACID 10MG TABLETS

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

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TEVA UK Ref:

Version:

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

1

02 December 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 540

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

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ALENDRONIC ACID 10 mg
TABLETS

TEVA UK Ref:

Version:

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

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Rare (may affect up to 1 in 1,000 people)
• allergic reaction, including hives and rapid
swelling of the skin and mucous
membranes (angioedema)
• 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.
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.
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
4 Possible side effects
patients treated for osteoporosis.
Like all medicines, this medicine can cause
side effects, although not everybody gets them. Reporting of side effects
If you get any side effects, talk to your
If the following happens, stop taking the
doctor or pharmacist. This includes any
tablets and tell your doctor immediately or possible side effects not listed in this leaflet.
go to the casualty department at your
You can also report side effects directly via
nearest hospital:
the Yellow Card Scheme at:
• an allergic reaction (swelling of the lips,
www.mhra.gov.uk/yellowcard
face or neck leading to severe difficulty in By reporting side effects you can help
breathing; skin rash or hives).
provide more information on the safety of
This is a very serious but uncommon side
this medicine.
effect. You may need urgent medical
attention or hospitalisation.
5 How to store Alendronic Acid
If the following happens, stop taking your
Keep this medicine out of the sight and
tablets and contact your doctor:
reach of children.
• you develop difficulty or pain when
Do not use this medicine after the expiry
swallowing, pain behind the breastbone
date which is stated on the outer packaging.
(centre of the chest), or new or worsening
The expiry date refers to the last day of that
heartburn.
month.
• blisters/bleeding of the lips, eyes, nose,
Do not throw away any medicines via
mouth and genitals, or a severe blistering
wastewater or household waste. Ask your
rash where large areas of the skin may peel.
pharmacist how to throw away medicines
The following side effects have been reported you no longer use. These measures will help
at the approximate frequencies shown:
protect the environment.
Very common (may affect more than 1 in 10
of the pack and other
people)
6 Contents
information
• pain in the bones, muscles or joints,
sometimes severe
What Alendronic Acid tablets contains:
Common (may affect up to 1 in 10 people)
• The active substance is alendronic acid (as
• stomach pain, indigestion or heartburn,
sodium monohydrate)
constipation, diarrhoea, wind
• The other ingredients are low-substituted
• ulceration of the oesophagus (gullet),
hyprolose, hyprolose, colloidal hydrated
difficulty swallowing, full or bloated feeling
silica, and sodium stearyl fumarate.
in the stomach, a backflow of acid from the What Alendronic Acid tablets look like and
stomach into the gullet and the mouth
contents of the pack:
• joint swelling, swelling in the hands or
• Alendronic Acid tablets are white to
legs (oedema)
off-white, round biconvex tablets. They are
• headache, dizziness, vertigo
debossed with “T” on one side and “10”
• itching, hair loss
on the other side.
• tiredness, weakness, loss of strength
• The product is available in pack sizes of
(asthenia).
14, 28, 30, 50, 56, 84, 90, 98, 112, and 140
Uncommon (may affect up to 1 in 100 people)
tablets.
• rashes and reddening of the skin
Not all pack sizes may be marketed.
• feeling sick, being sick, inflammation
Marketing Authorisation Holder and
and/or erosion of the gullet, inflammation Manufacturer
of the stomach lining, black tarry stools
The Marketing Authorisation holder and
• changes in the sense of taste
company responsible for manufacture: TEVA
• eye inflammation (usually painful)
UK Limited, Eastbourne, BN22 9AG.
• transient symptoms (pain in the muscles,
This leaflet was last revised: 12/2015
malaise and rarely fever) at the initiation
PL 00289/0703
85087-ZD
of the treatment.
The recommended 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.
Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

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02 December 2015

Expand Transcript

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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