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ALENDRONIC ACID/COLECALCIFEROL TABLET 70 MG/2800 IU

Active substance(s): ALENDRONATE SODIUM TRIHYDRATE / COLECALCIFEROL

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Package Leaflet: Information for the user

Alendronic Acid/Colecalciferol 70 mg/2800 IU tablets
alendronic acid /colecalciferol

What is in this leaflet
1. What Alendronic Acid/Colecalciferol is and
what it is used for
2. What you need to know before you take
Alendronic Acid/Colecalciferol
3. How to take Alendronic Acid/Colecalciferol
4. Possible side effects
5. How to store Alendronic Acid/Colecalciferol
6. Contents of the pack and other information

1. What Alendronic Acid/Colecalciferol
is and what it is used for
What is Alendronic Acid/Colecalciferol?
Alendronic Acid/Colecalciferol is a tablet
containing the two active substances, alendronic
acid (commonly called alendronate) and
colecalciferol known as vitamin D3.

Pharmacode: 9694

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.

60mm

What is vitamin D?
Vitamin D is an essential nutrient, required for
calcium absorption and healthy bones. The body
can only absorb calcium properly from our food
if it has enough vitamin D. Very few foods contain
vitamin D. The main source is through exposure
to summer sunlight, which makes vitamin D in
our skin. As we get older our skin makes less
vitamin D. Too little vitamin D may lead to bone
loss and osteoporosis. Severe vitamin D
deficiency may cause muscle weakness which
can lead to falls and a greater risk of fractures.
What is Alendronic Acid/Colecalciferol
used for?
Your doctor has prescribed Alendronic
Acid/Colecalciferol to treat your osteoporosis and
because you are at risk of vitamin D insufficiency.
Alendronic Acid/Colecalciferol reduces the risk of
spine and hip fractures in women after
menopause.

How can osteoporosis be treated?
As well as your treatment with Alendronic
Acid/Colecalciferol, your doctor may suggest you
make changes to your lifestyle to help your
condition, such as:
Stopping smoking
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. Consult your doctor before you
begin any exercise program.
Eating a balanced diet
Your doctor can advise you about your diet or
whether you should take any dietary
supplements.

2. What you need to know before you
take Alendronic Acid/Colecalciferol
Do not take Alendronic Acid/Colecalciferol
• if you are allergic to alendronate sodium
trihydrate, colecalciferol or any of the other
ingredients of this medicine (listed in section 6)
• 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
If you think any of these apply to you, do not take
the tablets. Talk to your doctor first and follow
the advice given.
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Alendronic Acid/Colecalciferol if:
• you suffer from kidney problems
• you have, or have recently had, any
swallowing or digestive problems
• 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 been told you have trouble
absorbing minerals in your stomach or
intestines (malabsorption syndrome)

Product Title
Strength
Leaflet Format
Printcode:
No of Colours

Alendronate/Colecalciferol
70 mg/2800IU tabs Date
160 x 520 mm
Client
A20012362
Country
4
Job No.

Alendronic Acid/Colecalciferol is effective only if
taken when your stomach is empty.
If you take more Alendronic
Acid/Colecalciferol 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.
If you forget to take Alendronic Acid/
Colecalciferol
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.

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

If you stop taking Alendronic Acid/
Colecalciferol
It is important that you continue taking
Alendronic Acid/Colecalciferol for as long as your
doctor prescribes the medicine. Since it is not
known for how long you should take Alendronic
Acid/Colecalciferol, you should discuss the need
to stay on this medicine with your doctor
periodically to determine if Alendronic
Acid/Colecalciferol is still right for you.

Children and adolescents
Alendronic Acid/Colecalciferol should not be
given to children and adolescents less than 18
years of age.
Other medicines and Alendronic Acid/
Colecalciferol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

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

4. Possible side effects

It is likely that calcium supplements, antacids,
and some oral medicines will interfere with the
absorption of Alendronic Acid/Colecalciferol if
taken at the same time. Therefore, it is important
that you follow the advice given in Section 3,
“How to take Alendronic Acid/Colecalciferol”, and
wait at least 30 minutes before taking any other
oral medicines or supplements.
Certain medicines for rheumatism or long-term
pain called NSAIDs (e.g. acetylsalicylic acid or
ibuprofen) might cause digestive problems.
Therefore, caution should be used when these
drugs are taken at the same time as Alendronic
Acid/Colecalciferol.
It is likely that certain medicines or food additives
may prevent the vitamin D in Alendronic
Acid/Colecalciferol from getting into your body,
including artificial fat substitutes, mineral oils,
the weight loss medicine, orlistat, and the
cholesterol-lowering medicines, cholestyramine
and colestipol. Medicines for fits (seizures) (like
phenytoin or phenobarbital) may decrease the
effectiveness of vitamin D. Additional vitamin D
supplements may be considered on an individual
basis.

Pregnancy and breast-feeding
Alendronic Acid/Colecalciferol is only intended
for use in postmenopausal women. You should
not take Alendronic Acid/Colecalciferol if you
are or think you may be pregnant, or if you are
breast-feeding.
Driving and using machines
There have been side effects (for example
blurred vision, dizziness and severe bone,
muscle or joint pain) reported with Alendronic
Acid/Colecalciferol that may affect your ability
to drive or operate machinery (see “Possible side
effects”). If you experience any of these side
effects you should not drive until you feel
better.
Alendronic Acid/Colecalciferol contains
lactose and sucrose.
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Alendronic Acid/
Colecalciferol
Always take Alendronic Acid/Colecalciferol
exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
Take one Alendronic Acid/Colecalciferol tablet
once a week.
Follow these instructions carefully.
1) Choose the day of the week that best fits your
schedule. Every week, take one Alendronic
Acid/Colecalciferol tablet on your chosen day.
It is very important to follow instructions 2), 3),
4) and 5) to help the Alendronic
Acid/Colecalciferol tablet reach your stomach
quickly and help reduce the chance of
irritating your gullet (oesophagus - the tube
that connects your mouth with your stomach).
2) After getting up for the day and before taking
any food, drink, or other medicine, swallow
your Alendronic Acid/Colecalciferol tablet
whole with a full glass of water only (not
mineral water and not less than 200 ml), so
that Alendronic Acid/Colecalciferol is
adequately absorbed.
• 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 because of the
possibility of mouth ulceration.

20/06/2017
Creo Pharma
UK
CRE-ALD-PIL-313

Black
Typefaces
Myriad Pro, Nimbus Sans
Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

No. of Draft
_01
_02
_03

Date
20/06/2017
27/06/2017
27/06/2017

Reason for Draft
New file
Corrections
Corrections

Keep this medicine out of the sight and reach of
children.

Store in the original blister in order to protect
from moisture and light.
Do not store above 25°C.
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
What Alendronic Acid/Colecalciferol contains
The active substances are alendronic acid and
colecalciferol (vitamin D3). Each tablet contains
70 mg alendronic acid (as sodium trihydrate) and
70 micrograms (2800 IU) colecalciferol (vitamin
D3).
The other ingredients are: microcrystalline
cellulose (E460), lactose anhydrous, medium
chain triglycerides, gelatin, croscarmellose
sodium, sucrose, silica, colloidal anhydrous,
magnesium stearate (E572), butyl
hydroxytoluene (E321), pregelatinized starch
(maize).
What Alendronic Acid/Colecalciferol looks like
and contents of the pack
Alendronic Acid/Colecalciferol 70 mg/2800 IU
tablets are available as white caplet shaped
tablets debossed “28” on one side and plain on
the other side.
The tablets are supplied in aluminium blisters in
cartons in the following pack sizes
• 2 tablets (1 blister containing 2 tablets)
• 4 tablets (1 blister containing 4 tablets)
• 6 tablets (3 blisters each containing 2 tablets)
• 12 tablets (3 blisters each containing 4 tablets).

Like all medicines, Alendronic Acid/
Colecalciferol can cause side effects, although
not everybody gets them.

Not all pack sizes may be marketed.

See your doctor immediately if you notice any of
the following side effects, which may be serious,
and for which you may need urgent medical
treatment:

Marketing Authorisation Holder
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex CM6 3LY, UK

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
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;
severe skin reactions
• 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
• bone, muscle and/or joint pain which is severe

Marketing Authorisation Holder &
Manufacturer

Manufacturer
GE Pharmaceuticals Ltd
Industrial Zone
‘Chekanitza-South’ area
Botevgrad 2140
Bulgaria
This leaflet was last revised in June 2017

Other side effects include
Very common (may affect more than 1 in 10
people):
• bone, muscle and/or joint pain which is
sometimes severe

Pharmacode: 9694

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.

Do not use Alendronic Acid/Colecalciferol after
the expiry date which is stated on the carton and
the blister after EXP.
The expiry date refers to the last day of that
month.

6) After swallowing your Alendronic Acid/
Colecalciferol tablet, wait at least 30 minutes
before taking your first food, drink, or other
medicine of the day, including antacids,
calcium supplements and vitamins.

You may be advised to have a dental check-up
before starting treatment with Alendronic Acid/
Colecalciferol.
It is important to maintain good oral hygiene
when being treated with Alendronic
Acid/Colecalciferol. 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.

Alendronic Acid/Colecalciferol with food and
drink
It is likely that food and beverages (including
mineral water) will make Alendronic Acid/
Colecalciferol 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/Colecalciferol”. You must wait at
least 30 minutes before taking any food and
beverages except water.

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

60mm

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.

• 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 angiogenesis inhibitors (such as
bevacizumab, or thalidomide)
• 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)

5. How to store Alendronic Acid/
Colecalciferol

Common (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 100 people):
• 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):
• 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
• mouth ulcers
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
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 MHRA 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.

Important
Please ensure that the texts and layout are to
your satisfaction as the studio cannot accept
liability for any errors overlooked.
All Bar Codes and Braille text must be verified
by the client/manufacturer/printer. The studio is
unable to do this and cannot accept liability for
any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

Printcode: A20012362/01
Pharmacode: 9694

CRE-ALD-PIL-313_03
27/06/2017

A20012362/01

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you, even if this is a
repeat prescription.
• 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.
• It is particularly important to understand the
information in Section 3, “How to take
Alendronic Acid/Colecalciferol”, before taking
this medicine.

3) 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.

+ 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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