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ALENDRONIC ACID/CHOLECALCIFEROL TABLET 70 MG/5600 IU

Active substance(s): ALENDRONIC ACID / CHOLECALCIFEROL

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Package leaflet: Information for the patient
Alendronic acid/Cholecalciferol 70 mg/2800 IU & 70 mg/5600 IU tablets
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 before taking this
medicine.
What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Alendronic acid/Cholecalciferol is and what it is used for
What you need to know before you take Alendronic acid/Cholecalciferol
How to take Alendronic acid/Cholecalciferol
Possible side effects
How to store Alendronic acid/Cholecalciferol
Contents of the pack and other information

What Alendronic acid/Cholecalciferol is and what it is used for

What is Alendronic acid/Cholecalciferol?
Alendronic acid/Cholecalciferol is a tablet containing the two active substances, alendronic acid
(commonly called alendronate) and colecalciferol known as vitamin D3.
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.
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/Cholecalciferol used for?
Your doctor has prescribed Alendronic acid/Cholecalciferol to treat your osteoporosis and because you
are at risk of vitamin D insufficiency. It reduces the risk of spine and hip fractures in women after
menopause.
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.

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.
How can osteoporosis be treated?
As well as your treatment with Alendronic acid/Cholecalciferol, your doctor may suggest you make
changes to your lifestyle to help your condition, such as:
Stopping smoking
Exercise
Eating a balanced diet

2.

Smoking appears to increase the rate at which you lose bone and, therefore,
may increase your risk of broken bones.
Like muscles, bones need exercise to stay strong and healthy. Consult your
doctor before you begin any exercise programme.
Your doctor can advise you about your diet or whether you should take any
dietary supplements.

What you need to know before you take Alendronic acid/Cholecalciferol

Do not take Alendronic acid/Cholecalciferol

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/Cholecalciferol 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)

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), which are used in
the treatment of cancer

you are taking corticosteroids (such as prednisone or dexamethasone), which are used in the
treatment of asthma, rheumatoid arthritis and severe allergies

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/Cholecalciferol.
During treatment

It is important to maintain good oral hygiene when being treated with Alendronic acid/Cholecalciferol.
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/Cholecalciferol. These side effects may worsen if
patients continue to take Alendronic acid/Cholecalciferol after developing these symptoms.
Your doctor may give you additional vitamin D supplements if you do not receive enough from your
diet or other supplements.
Children and adolescents
Alendronic acid/Cholecalciferol should not be given to children and adolescents less than 18 years of
age.
Other medicines and Alendronic acid/Cholecalciferol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without prescription, or any of the following:












calcium supplements
antacids for indigestion
corticosteroid medicines such as prednisolone or dexamethasone, used to reduce inflammation;
as it is important that you have a good dietary intake of calcium and vitamin D
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 this medicine
artificial fat substitutes
mineral oils
orlistat, a medicine used to lose weight
medicines used to lower cholesterol such as cholestyramine or colestipol
cimetidine (a medicine that reduces the amount of acid in your stomach)
medicines used to treat fits (seizures) such as phenytoin or phenobarbital
thiazide medicines used to lower blood pressure such as hydrochlorothiazide.

It is important that you follow the advice given in section 3, ‘How to take Alendronic
acid/Cholecalciferol’ and wait at least 30 minutes after taking this medicine before taking any other
medicines.
Alendronic acid/Cholecalciferol with food and drink
It is likely that food and beverages (including mineral water) will make Alendronic
acid/Cholecalciferol less effective if taken at the same time. Therefore, it is important that you follow
the advice given in section 3. You must wait at least 30 minutes before taking any food and beverages
except water.
Pregnancy and breast-feeding
Alendronic acid/Cholecalciferol is only intended for use in postmenopausal women. You should not
take Alendronic acid/Cholecalciferol if you are or think you may be pregnant, or if you are breastfeeding.
Driving and using machines
There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint
pain) reported with alendronate/colecalciferol that may affect your ability to drive or operate

machinery (see section 4). If you experience any of these side effects you should not drive until you
feel better.
Alendronic acid/Cholecalciferol contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars such as lactose or
sucrose, contact your doctor before taking this medicine.

3.

How to take Alendronic acid/Cholecalciferol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Take one Alendronic acid/Cholecalciferol 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/Cholecalciferol tablet on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic
acid/Cholecalciferol 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/Cholecalciferol tablet whole with a full glass of water only (not mineral water)
(not less than 200 ml), so that Alendronic acid/Cholecalciferol 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.
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.

4)

Do not take Alendronic acid/Cholecalciferol 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/Cholecalciferol and contact your doctor.

6)

After swallowing your Alendronic acid/Cholecalciferol tablet, wait at least 30 minutes before
taking your first food, drink, or other medicine of the day, including antacids, calcium
supplements and vitamins.
Alendronic acid/Cholecalciferol is effective only if taken when your stomach is empty.

If you take more Alendronic acid/Cholecalciferol 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/Cholecalciferol
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.
If you stop taking Alendronic acid/Cholecalciferol

It is important that you continue taking Alendronic acid/Cholecalciferol for as long as your doctor
prescribes the medicine. Since it is not known how long you should take Alendronic
acid/Cholecalciferol, you should discuss the need to stay on this medicine with your doctor
periodically to determine if Alendronic acid/Cholecalciferol is still right for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
Common (may affect up to 1 in 10 people):

heartburn, difficulty, discomfort or pain upon swallowing (these are signs of ulceration of the
oesophagus).
Uncommon (may affect up to 1 in 100 people):

blurred vision, watery eyes, pain or redness in the eye, increased sensitivity to light, floaters
(shadows passing across your sight) or gritty eyes.

dark black or tar-like stools

inflammation, irritation, or erosion of the lining of the stomach or gullet.
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

mouth ulcers, pain in the mouth, throat, chest or stomach which may be associated with eating.
You may feel bloated, sick or be sick, have a loss of appetite or have a loss of weight. You may
also notice particles that look like coffee grounds (upper gastrointestinal bleeding) on stools.
These may be signs of inflammation, ulceration or bleeding in the digestive tract.
Very rare (may affect up to 1 in 10,000 people):

ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage
in the ear.
Other side effects include
Very common (may affect more than 1 in 10 people):

bone, muscle and/or joint pain which is sometimes severe.
Common (may affect up to 1 in 10 people):

joint swelling

stomach pain, uncomfortable feeling in the stomach or belching after eating, constipation, full or
bloated feeling in the stomach, diarrhoea, wind





hair loss, itching skin
headache, dizziness
tiredness, swelling in the hands or legs.

Uncommon (may affect up to 1 in 100 people):

feeling sick (nausea), being sick (vomiting)

rash, redness of the skin

temporary flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes
with fever usually at the start of treatment

bad taste in the mouth.
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

narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach)

rash made worse by sunlight.
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/Cholecalciferol

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 and the blister after EXP.
The expiry date refers to the last day of that month.
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/Cholecalciferol contains
The active substances are alendronic acid and cholecalciferol (vitamin D3).
• Each 70 mg/2800 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70
micrograms (2800 IU) of colecalciferol (vitamin D3).
• Each 70 mg/5600 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140
micrograms (5600 IU) of colecalciferol (vitamin D3).
The other ingredients are microcrystalline cellulose (E460), lactose, sucrose (see section 2,
‘Alendronic acid/Cholecalciferol contains lactose and sucrose’), medium chain triglycerides, gelatin,
croscarmellose sodium, colloidal anhydrous silica, magnesium stearate (E572), butylhydroxytoluene
(E321), pregelatinised maize starch.
What Alendronic acid/Cholecalciferol looks like and contents of the pack

Alendronic acid/Cholecalciferol 70 mg/2,800 IU tablets are white caplet shaped, marked “28” on one
side and plain on the other side.
Alendronic acid/Cholecalciferol 70 mg/5,600 IU tablets are white, modified rectangle shaped, marked
“56” on one side and plain on the other side.
The tablets are available in aluminium blisters containing 4 tablets.
Marketing Authorisation Holder
Welding GMBH & CO KG, Esplanade 39, Hamburg, D-20354, Germany
Manufacturer
GE Pharmaceuticals Ltd, Industrial zone, ‘Chekanitza-South’ area, Botevgrad, 2140, Bulgaria.
This leaflet was last revised in 09/2017

+ 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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