ALENDRONIC ACID 70 MG TABLETS

Active substance: SODIUM ALENDRONATE

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PATIENT INFORMATION LEAFLET
ALENDRONIC ACID 70MG TABLETS
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 further questions, please ask
your doctor or your pharmacist.
• This medicine has been prescribed for
you personally and you should 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 become
serious, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.
In this Leaflet
1. What Alendronic acid 70mg Tablets
are and what they are used for
2. Before you take Alendronic acid
70mg Tablets
3. How to take Alendronic acid 70mg
Tablets
4. Possible side effects
5. How to store Alendronic acid 70mg
Tablets
6. Further Information

1.

WHAT ALENDRONIC ACID 70MG
TABLETS ARE AND WHAT THEY
ARE USED FOR

The
active
ingredient,
alendronate
monosodium trihydrate, belongs to a group
of medicines called "bisphosphonates". It
works by preventing the loss of bone that
occurs in women after they have been
through the menopause, and helps to
rebuild bone.
Alendronic acid 70mg Tablets are used to
treat the following condition:
- Postmenopausal osteoporosis.

2. ACID 70MG TABLETS

BEFORE YOU TAKE ALENDRONIC

If any of the following applies to you, speak
to your doctor or pharmacist before you start
taking Alendronic acid 70mg Tablets as they
may not be suitable for you.
Do not take Alendronic acid 70mg
Tablets:
- If you are allergic (hypersensitive) to
alendronate monosodium trihydrate or
any of the other ingredients of
Alendronic
acid
70mg
Tablets.
- If you have certain disorders of the
oesophagus (the tube that connects
your mouth with your stomach).
- 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 are or think you may be pregnant.
- If you are breast-feeding.
Take special care with Alendronic acid
70mg Tablets:
It is important to tell your doctor before
taking Alendronic acid if you have any of the
following conditions:
- 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 low blood calcium levels
- you have gum disease

-

you have a planned dental extraction
you suffer from kidney problems
you have any allergies
you have trouble swallowing or digestive
problems.

A dental examination should be considered
before you start the treatment with
alendronic acid if you have any of the
conditions below.
-

you have cancer
you are undergoing chemotherapy or
radiotherapy
you are taking steroids
you don't receive routine dental care.
you have gum disease.

Appropriate preventive dental care, as
recommended by the dentist, should be
followed during treatment.
Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without prescription.
- After swallowing your tablet, wait at least
30 minutes before taking any other
medication for the day. Alendronic acid
70mg Tablets are only effective if taken
when your stomach is empty.
Taking Alendronic acid 70mg Tablets with
food and drink:
Patients must wait at least 30 minutes after
taking alendronate before taking any food or
drink.
Pregnancy and breast-feeding:
Alendronic acid 70mg Tablets can not be
used during pregnancy and if you are breastfeeding.
Driving and using machines:
Your medicine does not usually affect your
ability to drive or operate machinery.
Other precautions you should take:
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
HOW
3. 70MG TO TAKE ALENDRONIC ACID
TABLETS
Your doctor has decided on the dose that is
suited to you. The length of your course of
treatment will depend on what condition you
are suffering from. Always take Alendronic
acid 70mg Tablets exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Children and adolescents:
Alendronate should not be given to children
and adolescents.
You may have previously been prescribed a
10 mg tablet of alendronate which is taken
once a day. One Alendronic acid 70mg
Tablet is taken once a week.
It is very important that you follow actions 2,
3,4 and 5 described below. This will help the
Alendronic acid 70mg Tablet reach your
stomach quickly and help reduce the risk of
irritating your oesophagus.

CP.ALD.70T.4.RC.V2P1

Dimensions: 140mm x 320mm

1. Choose the day of the week that best fits
your schedule. Every week, take your
Alendronic acid 70mg Tablets on your
chosen day.
2. After getting up for the day and before
taking your first food, drink or other
medication, swallow your Alendronic
acid 70mg Tablet with a full glass of plain
water only (not less than 200 ml or 7 fl.
oz.).
Do not chew or allow the tablet to
dissolve in your mouth.
3. After swallowing your Alendronic acid
70mg Tablet do not lie down. Stay fully
upright (or sat upright) for at least 30
minutes and do not lie down until after
your first food of the day.
4. Do not take Alendronic acid 70mg
Tablets at bedtime or before getting up
for the day.
5. If you develop difficulty or pain
swallowing, chest pain, or new or
worsening heartburn, stop taking
Alendronic acid 70mg Tablets and
contact your doctor.
6. After swallowing your Alendronic acid
70mg Tablet, wait at least 30 minutes
before taking your first food, drink or
other medication of the day, including
antacids, calcium supplements and
vitamins. Alendronic acid 70mg Tablets
are only effective if taken when your
stomach is empty.
If you take more Alendronic acid 70mg
Tablets than you should:
If you (or someone else) accidentally take
too many Alendronic acid 70mg Tablets,
drink a full glass of milk and contact your
doctor or pharmacist immediately.
If you forget to take Alendronic acid 70mg
Tablets:
If you forget to take a dose, take one
Alendronic acid 70mg Tablet on the morning
after you remember. Do not take a double
dose to make up for forgotten individual
doses.
If you stop taking Alendronic acid 70mg
Tablets:
Always contact your doctor or pharmacist
before you stop taking Alendronic acid
70mg Tablets. Alendronic acid 70mg
Tablets can treat your osteoporosis only if
you continue to take the tablets.
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 70mg
Tablets can cause side effects, although not
everybody gets them. These are usually mild
but some patients may experience digestive
disturbances which may be severe.
If the following happens, stop taking the
tablets and tell your doctor immediately
or go to the accident and emergency
department at your nearest hospital:
- An allergic reaction (angioedema):
swelling of the face, lips, tongue or
throat, or difficulty breathing or
swallowing.
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.
Side effects sometimes seen are:
Common
more than one in a hundred
people but less than one in ten:
stomach pain, constipation, diarrhoea,
flatulence,
oesophageal
ulcer,
acid
regurgitation, swollen abdomen, swallowing

CP.ALD.70T.4.RC.V2P1

Pantone Blue
280 C

difficulties, digestive problems, bone,
muscle or joint pain, headache.
Uncommon more than one in a thousand
people but less than one in a hundred:
rash, reddening of the skin, itching.
feeling sick, being sick, swelling of the
stomach wall, black or bloody stools,
inflammation of the food passage, wearing
away of the food passage.
Rare more than one in ten thousand people
but less than one in a thousand:
allergic reaction including hives and swelling
of the lips, tongue and throat, fever,
discomfort,
muscle
pains,
rash
(occasionally made worse by sunlight),
reduced blood calcium levels.
Symptoms of low blood calcium levels
including muscle cramps or spasms and/or
tingling sensation in the fingers or around
the mouth.
difficulty in swallowing, ulcers of the mouth,
stomach and other peptic ulcers (some with
bleeding).
eye pain, diminished or hazy vision and/or
seeing black floating spots.
jaw problems associated with delayed
healing and infection, often following tooth
extraction
During post-marketing experience the
following side effects have been reported
(frequency unknown):
• dizziness, vertigo, alopecia, joint
swelling, tiredness, swelling in the hands
or legs.
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE ALENDRONIC ACID
70MG TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require any
special storage conditions.
Do not use Alendronic acid 70mg Tablets
after the expiry date which is stated on the
outer packaging. The expiry date refers to
the last day of the 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 70mg Tablets
contain
- The active substance is alendronate
monosodium trihydrate and each tablet
contains 70 mg of alendronate
monosodium trihydrate.
- The
other
ingredients
are
microcrystalline cellulose, crospovidone
and magnesium stearate.
What Alendronic acid 70mg Tablets look
like and contents of the pack
Each tablet is white, oval, flat and marked
with a "70" on one side.
Alendronic acid 70mg Tablets are available
in blisters of 4 tablets.
Marketing Authorisation Holder and
Manufacturer
Relonchem Limited,
Cheshire House, Gorsey Lane, Widnes,
Cheshire, WA8 0RP, U.K.
Distributor
Kent Pharmaceuticals Limited,
Repton Road, Measham, DE12 7DT, U.K.
PL: 20395/0070
This Leaflet was revised in October 2012.

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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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