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ALENDRONIC ACID AND CALCIUM/CHOLECALCIFEROL 70MG+1000MG/880 IU FILM-COATED TABLETS+ EFFERVESCENT TAB

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL / SODIUM ALENDRONATE / CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL / SODIUM ALENDRONATE / CALCIUM CARBONATE / CHOLECALCIFEROL / COLECALCIFEROL / SODIUM ALENDRONATE

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Sandoz Ltd.
Page 1 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

Package leaflet: Information for the user
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets
Alendronic acid+calcium/Cholecalciferol
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 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. See section 4.
What is in this leaflet
1. What Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is and what it is
used for
2. What you need to know before you take Alendronic Acid Tablets + Calcium Cholecalciferol
Effervescent Tablets
3. How to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
4. Possible side effects
5. How to store Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
6. Contents of the pack and other information

1. What Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is and what it
is used for
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is used to treat osteoporosis
in women after menopause who also need daily calcium and vitamin D3 supplementation. This
combination medicine reduces the risk of spinal and hip fractures.
a) Alendronate belongs to a group of medicines called bisphosphonates. It prevents the loss of bone
that occurs in women after they have been through the menopause, and helps to rebuild bone.
b) Calcium/vitamin D3 provides the calcium and the vitamin D3 that your body may need to harden
new bone.

2. What you need to know before you take Alendronic Acid Tablets + Calcium Cholecalciferol
Effervescent Tablets
Do not take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets if you
are/have
 allergic to alendronate sodium trihydrate, calcium carbonate, vitamin D3, soya, peanut or any of
the other ingredients of this medicine (listed in section 6)
 certain problems with your gullet such as narrowing or difficulty swallowing
 cannot stand or sit upright for at least 30 minutes
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
Page 2 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets






blood calcium levels which are below or above normal
urine calcium levels which are above normal
blood vitamin D levels which are above normal
increased levels of calcium in the kidneys, kidney stones

Warnings and precautions
Talk to your doctor before taking this medicine if any of the following conditions apply to you:
 you suffer from kidney problems,
 you have 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 low blood calcium ,
 you have sarcoidosis, a disorder mainly affecting the lungs, which causes shortness of breath and
coughing,
 you are already taking vitamin D,
 you had or have pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a
tooth,
 you have poor dental health, gum disease or you don't receive routine dental care.
You may be advised to have a dental check-up before starting treatment.
 you are under dental treatment or will undergo dental surgery.
Tell your dentist that you are being treated with Alendronic Acid Tablets + Calcium
Cholecalciferol Effervescent Tablets.
 you have cancer,
 you are undergoing chemotherapy or radiotherapy,
 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).
It is important to maintain good oral hygiene when being treated with Alendronic Acid Tablets +
Calcium Cholecalciferol Effervescent Tablets. 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, often with symptoms of chest pain, heartburn, or
difficulty or pain upon swallowing, may occur. This applies 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 Tablets +
Calcium Cholecalciferol Effervescent Tablets. These side effects may worsen if patients continue to
take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets after developing these
symptoms.
Children and adolescents
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets should not be given to
children and adolescents.
Other medicines and Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
a) Medicines containing any of the following reduce the effect of Alendronate if taken at the same
time:
 calcium
PIL 1162.009.0d

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Sandoz Ltd.
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PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets




antacids, medicines to treat heartburn
some oral medicines, such as medicines to treat pain, inflammation or rheumatism

Take these medicines at least 30 minutes after your Alendronate tablet.
b) Calcium/vitamin D3 is known to affect or be affected by the following medicines:
 digitalis: a medicine to treat heart disorders
 antibiotics with active substance names ending in “cycline”
 medicines to reduce inflammation or prevent organ transplant rejection, such as cortisone
 sodium fluoride: used to strengthen tooth enamel or to treat osteoporosis
 medicines to increase water output through your kidneys with active substance names ending in
“zide”
 cholestyramine: a medicine to reduce blood fat levels
 laxatives, such as paraffin oil
Your doctor will give you further instructions, if you take any of the above-mentioned medicines.

Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets with food and drink
a) Do not take your Alendronate tablet with food or drinks, other than plain water, to ensure that it
works properly. This particularly applies to dairy products, such as milk, as they contain calcium.
Food and drinks, other than plain water, may only be taken at least 30 minutes after your Alendronate
tablet.
b) Do not take the dissolved Calcium/vitamin D3 effervescent tablets with foods containing high
amounts of
 oxalic acid, such as spinach and rhubarb, or
 phytic acid, such as whole cereals
Take the dissolved tablets at least 2 hours after eating such foods.

Pregnancy and breast-feeding
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is only intended for use in
postmenopausal women.
Do not take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets if you are
pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint
pain) reported with Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets that may
affect your ability to drive or operate machinery. Individual responses to Alendronic Acid Tablets +
Calcium Cholecalciferol Effervescent Tablets may vary (See “4. Possible side effects”.)
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets contains sodium,
lactose monohydrate, sucrose and hydrogenated soya oil.
The Calcium/vitamin D3 effervescent tablets contain lactose monohydrate and sucrose. If you have
been told by your doctor that you have an intolerance to some sugars, contact your doctor before you
taking this medicinal product.
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
Page 4 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

The Calcium/vitamin D3 effervescent tablets contain soya oil. If you are allergic to peanut or soya, do
not use this medicinal product.
The Calcium/vitamin D3 effervescent tablets contain 4.2 mmol (96 mg) sodium per tablet. To be taken
into consideration by patients on a controlled sodium diet.

3. How to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets is a weekly therapy of:
a) 1 Alendronate tablet and
b) 6 Calcium/vitamin D3 effervescent tablets
Usual dose per weekly cycle:
 Day 1
1 Alendronate tablet
Choose one day of the week that best fits your schedule. This will be “Day 1” of your weekly cycle.
Every week, take the Alendronate tablet on your chosen “Day 1”.
 Days 2 to 7
1 Calcium/vitamin D3 effervescent tablet per day for the next 6 days
Start Calcium/vitamin D3 intake on the day after the Alendronate tablet has been taken.
Do not take the Alendronate tablet and the Calcium/vitamin D3 effervescent tablet on the same day.
Every 7 days start a new weekly cycle beginning with the Alendronate tablet on your chosen “Day 1”.

Method of use
a) Take your Alendronate tablet whole:
It is very important to follow these instructions to help the tablet reach your stomach quickly and help
reduce the chance of irritating your gullet.
 after getting up for the day and before taking any food, drink, or other medicine, swallow your
Alendronate tablet with a full glass of water only (not less than 200 ml).
- 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 chew the tablet or allow it to dissolve in your mouth.
 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.
 Do not take the tablet at bedtime or before getting up for the day.
 If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop
taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets and contact your
doctor.
 After swallowing your tablet, wait at least 30 minutes before taking your first food, drink, or
other medicine of the day, including antacids, calcium supplements and vitamins. The
Alendronate tablet is effective only if taken when your stomach is empty.

PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
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PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

b) Take the Calcium/vitamin D3 effervescent tablet after dissolving it in a glass of water.
Duration of use
This will be decided by your doctor.

If you take more Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets than
you should
a) Drink one glass of milk and inform your doctor if you have taken more Alendronate tablets than
prescribed. Do not make yourself vomit, and do not lie down.
b) Please contact your doctor if you have taken more Calcium/vitamin D3 effervescent tablets than
you should.

If you forget to take Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
a) If you have forgotten to take your Alendronate tablet on your chosen day “Day 1”:
1. Take it on the day you remember. Do not take two Alendronate tablets in one day to make up for
the tablet you missed.
2. On the following day take your Calcium/vitamin D3 effervescent tablet. Do not take your
Alendronate tablet and the effervescent tablet on the same day.
3. Continue taking one Calcium/vitamin D3 effervescent tablet each day until the end of the weekly
cycle.
Then start a new weekly cycle: take one Alendronate tablet once a week on your chosen “Day 1”.
b) If you have forgotten to take a Calcium/vitamin D3 effervescent tablet:
1. Take it on the day you remember, but do not take two effervescent tablets on the same day. Do
not take the effervescent tablet on the same day as the Alendronate tablet.
2. Continue taking one effervescent tablet each day until the end of the weekly cycle.
3. Discard the forgotten effervescent tablet.

If you stop taking Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets
If you stop treatment you may worsen your osteoporosis. Please talk to your doctor before you
consider stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Possible side effects caused by Alendronate
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
 headache
 dizziness
 abdominal pain, uncomfortable feeling in the stomach or belching after eating
 constipation, full or bloated feeling in the stomach
 diarrhoea, flatulence
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
Page 6 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets










heartburn,
difficulty swallowing, pain upon swallowing
ulcer in the gullet which can cause chest pain, heartburn or difficulty or pain upon swallowing
joint swelling
hair loss
itching
feeling of weakness
swelling in the hands or legs.

Uncommon, may affect up to 1 in 100 people
 taste disturbance
 nausea
 vomiting
 irritation or inflammation of the gullet or stomach
 black or tarlike stools
 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
 blurred vision, pain or redness in the eye
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
 narrowing of the gullet
 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.
 mouth ulcers when the tablets have been chewed or sucked
 stomach or bowel ulcers (sometimes severe or with bleeding)
 severe bone, muscle and/or joint pain
 severe skin reactions due to an allergic reaction (toxic epidermal necrolysis, erythema
multiforme), symptoms include fever, general ill feeling, itching of the skin, joint aches, multiple
skin lesions or blisters, which may involve the face or lips
 rash made worse by sunlight
 symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling
sensation in the fingers or around the mouth.
 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.
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.
b) Possible side effects caused by Calcium/vitamin D3
Uncommon, may affect up to 1 in 100 people
 blood calcium levels above normal
 Symptoms are excessive thirst, loss of appetite, fatigue and in severe cases irregular heart beat.
 urine calcium levels above normal
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
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PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

Rare, may affect up to 1 in 1,000 people
 allergic reactions
 constipation, wind, nausea, vomiting, abdominal pain, diarrhoea
 skin reactions such as itching, rash and hives

Very rare, may affect up to 1 in 10,000 people
 serious allergic reaction which causes difficulty in breathing or dizziness, swelling of the face or
throat
Special patient group
If you suffer from kidney problems you may get high levels of phosphate in your blood, kidney stones
or increased levels of calcium in the kidneys.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly via yellow Card Scheme:
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 Tablets + Calcium Cholecalciferol Effervescent Tablets
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 after EXP. The expiry date
refers to the last day of that month.
Do not store above 25 °C. Store in the original package in order to protect from light and moisture!
Effervescent tablets
Shelf life after first opening: 1 month
Do not throw away any medicines of via wastewater 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 Tablets + Calcium Cholecalciferol Effervescent Tablets contains
a) Alendronate film-coated tablets
The active substance is alendronate sodium trihydrate.
One film-coated tablet contains 70 mg alendronic acid (as 91.35 mg sodium alendronate trihydrate).
The other ingredients are:
 Tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium,
magnesium stearate.
 Film coating: microcrystalline cellulose, carrageenan, polyethylene glycol.
b) Calcium/vitamin D3 effervescent tablets
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
Page 8 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

The active substances are calcium carbonate and Cholecalciferol (vitamin D3).
One effervescent tablet contains:
- 2500 mg calcium carbonate, equivalent to 1000 mg calcium.
- 22 microgramms (880 International Units [IU]) Cholecalciferol (vitamin D3).
The other ingredients are: citric acid anhydrous, simeticone, gelatine, lactose monohydrate, macrogol
6000, maize starch, methylcellulose, sodium cyclamate, sodium hydrogen carbonate, povidone K25,
saccharin sodium, hydrogenated soya oil, sucrose, alpha-tocopherol, orange juice flavour (PHS133147).
What Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets looks like and
contents of the pack
a) Alendronate film-coated tablets: White, round film-coated tablet, rounded on the upper and lower
side (diameter 10 mm), encoded „ALN 70“ on one side. The tablets are packed in a plastic/aluminium
blister.
b) Calcium/vitamin D3 effervescent tablets: White, round effervescent tablets, flat on both sides
(diameter 30 mm). The tablets are packed in a tube.
Alendronic Acid Tablets + Calcium Cholecalciferol Effervescent Tablets are available in packs
containing
 1 Alendronate film-coated tablet + 6 Calcium/vitamin D3 effervescent tablets or
 2 Alendronate film-coated tablets + 12 Calcium/vitamin D3 effervescent tablets or
 4 Alendronate film-coated tablets + 24 (2 x 12) Calcium/vitamin D3 effervescent tablets or
 3 x [4 Alendronate film-coated tablets + 24 (2 x 12) Calcium/vitamin D3 effervescent tablets] or
 4 x [4 Alendronate film-coated tablets + 24 (2 x 12) Calcium/vitamin D3 effervescent tablets] or
 6 x [4 Alendronate film-coated tablets + 24 (2 x 12) Calcium/vitamin D3 effervescent tablets].
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturers

Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

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Sandoz Ltd.
Page 9 of 9
PL 04416/1162
Alendronic acid and Calcium / Cholecalciferol 70 mg + 1000 mg / 880 IU Film-coated Tablets +
Effervescent Tablets

Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1,
39179 Barleben
Germany
This leaflet was last revised in 01/2017

PIL 1162.009.0d

31/01/2017

P001: To adapt the shelf-life after first opening 1 month,
accordingly in the PIL and outer packaging.

IS

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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