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ALENDRONIC ACID/CHOLECALCIFEROL TABLET 70 MG/2800 IU

Active substance(s): ALENDRONIC ACID / CHOLECALCIFEROL / ALENDRONIC ACID / CHOLECALCIFEROL

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Package Leaflet: Information for the user
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. How to take
Alendronic acid/Cholecalciferol, before taking this medicine.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

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

1. 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 cholecalciferol 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. Alendronic acid/Cholecalciferol 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

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.

2. 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, cholecalciferol 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)
• 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).
You may be advised to have a dental check-up before starting treatment with Alendronic
acid/Cholecalciferol.
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.
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.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the
absorption of Alendronic acid/Cholecalciferol if taken at the same time. Therefore, it is
important that you follow the advice given in section 3. ‘How to take Alendronic
acid/Cholecalciferol’ 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/Cholecalciferol.
It is likely that certain medicines or food additives may prevent the vitamin D in Alendronic
acid/Cholecalciferol 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 (70 mg/2800 IU only).
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. ‘How to take Alendronic acid/Cholecalciferol’. 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 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/Cholecalciferol 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/Cholecalciferol 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/Cholecalciferol
Always take Alendronic acid/Cholecalciferol 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, Alendronic acid/Cholecalciferol 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 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.

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
• abdominal pain
• uncomfortable feeling in the stomach or belching after eating
• constipation
• full or bloated feeling in the stomach
• diarrhea
• 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 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 Alendronic acid/Cholecalciferol 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 alendronic acid (as sodium trihydrate) and
70 micrograms (2800 IU) cholecalciferol (vitamin D3).
• Each 70 mg/5600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and
140 micrograms (5600 IU) cholecalciferol (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/Cholecalciferol looks like and contents of the pack
Alendronic acid/Cholecalciferol 70 mg/2800 IU tablets are available as white caplet shaped
tablets debossed “28”on one side and plain on the other side.
Alendronic acid/Cholecalciferol 70 mg/5600 IU tablets are available as white modified
rectangle shaped tablets, debossed “56” on one side and plain on the other side.
The tablets are supplied in aluminium blisters in cartons in the following pack sizes:
• 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Welding GMBH & CO KG, Esplanade 39, Hamburg, D-20354, Germany
Manufacturer
GE Pharmaceuticals Ltd., Industrial Zone “Chekanitza-South” area, 2140 Botevgrad,
Bulgaria.

This leaflet was last revised in 05/2017

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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