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RISEDRONATE SODIUM AND CALCIUM / CHOLECALCIFEROL 35 MG + 1000 MG / 880 IU TABLETS

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

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Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 1 of 8
22/01/2016

Package leaflet: Information for the user
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets
Risedronate sodium+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. Do not pass it on to others. It may harm them, even if
their symptoms 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 Risedronate sodium and Calcium / Cholecalciferol is and what it is used for
2. What you need to know before you take Risedronate sodium and Calcium / Cholecalciferol
3. How to take Risedronate sodium and Calcium / Cholecalciferol
4. Possible side effects
5. How to store Risedronate sodium and Calcium / Cholecalciferol
6. Contents of the pack and other information

1. What Risedronate sodium and Calcium / Cholecalciferol is and what it is used for
Risedronate sodium and Calcium / Cholecalciferol is used to treat osteoporosis, even if severe, 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) Risedronate tablets contains risedronate sodium which belongs to a group of non-hormonal
medicines called bisphosphonates. These medicines are used to treat bone diseases. It works directly
on your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new
bone.
Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones
become weaker, more fragile and more likely
to break after a fall or strain.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in
your body. Osteoporosis related fractures can also cause back pain, height loss and a curved back.
Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
b) Calcium/vitamin D3 effervescent tablets provide the calcium and the vitamin D3 that your body
may need to harden new bone.
2. What you need to know before you take Risedronate sodium and Calcium / Cholecalciferol
Do not take Risedronate sodium and Calcium / Cholecalciferol
If you are/have
• allergic to risedronate sodium, calcium carbonate, vitamin D3, soya, peanut or any of the other
ingredients of this medicine (listed in section 6)
• blood calcium levels which are below or above normal
• urine calcium levels which are above normal
• blood vitamin D levels which are above normal
PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets





Page 2 of 8
22/01/2016

pregnant, may be pregnant or planning to become pregnant
breast-feeding
severe kidney problems, including increased levels of calcium in the kidneys, or kidney stones

Warnings and precautions
Talk to your doctor or pharmacist before taking Risedronate sodium and Calcium / Cholecalciferol, if
you are/have: =
• unable to stand or sit upright for at least 30 minutes
• abnormal bone and mineral absorption, conversion and/or excretion, for example:
- lack of vitamin D
- parathyroid hormone abnormalities
Both of which lead to below normal calcium levels.
• previous problems with your oesophagus (the tube that connects your mouth with your stomach),
such as pain or difficulty in swallowing food or you have previously been told that you have Barrett's
oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• sarcoidosis, a disorder mainly affecting the lungs, which causes shortness of breath and coughing
• already taking vitamin D
• had or have pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth
• under dental treatment or will undergo dental surgery
Tell your dentist that you are being treated with Risedronate sodium and Calcium /
Cholecalciferol.
Your doctor will advise you on what to do when taking Risedronate sodium and Calcium /
Cholecalciferol if you have any of the above.
Children and adolescents
Risedronate is not recommended for use in children below age 18 due to insufficient data on safety
and efficacy.
Other medicines and Risedronate sodium and Calcium / Cholecalciferol
Talk to your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
a) Medicines containing any of the following reduce the effect of Risedronate if taken at the same
time:
• calcium
• magnesium
• aluminium, contained for example in medicines to treat heartburn
• iron
Take these medicines at least 30 minutes after your Risedronate tablet.
b) Calcium/vitamin D3 is known to affect or be affected by the following medicines:
• digitalis: a medicine to treat heart weakness
• tetracycline antibiotics
• medicines to reduce inflammation or prevent organ transplant rejection, such as cortisone
• sodium fluoride: used to strengthen tooth enamel or to treat osteoporosis
• thiazides diuretics: medicines to increase water output through your kidneys
• cholestyramine: a medicine to reduce blood fat levels
• laxatives, such as paraffin oil
• aluminium, contained for example in medicines to treat heartburn
Your doctor will give you further instructions, if you take any of the above-mentioned medicines.
Risedronate sodium and Calcium / Cholecalciferol with food and drink
PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 3 of 8
22/01/2016

a) Do not take your Risedronate 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, (see
section 2, “Other medicines and Risedronate sodium and Calcium / Cholecalciferol”).
Food and drinks, other than plain water, may only be taken at least 30 minutes after your Risedronate
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
Do not take Risedronate sodium and Calcium / Cholecalciferol if you are, may be pregnant or plan to
become pregnant.
The risk associated with the use of risedronate sodium in pregnant women is unknown.
Do not take Risedronate sodium and Calcium / Cholecalciferol if you are breast-feeding.
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
Risedronate sodium and Calcium / Cholecalciferol is not known to affect your ability to drive or use
machines.
Risedronate sodium and Calcium / Cholecalciferol contain lactose, sucrose and sodium
The Risedronate tablets contain lactose. The Calcium/vitamin D3 effervescent tablets contain lactose
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.
One effervescent tablet contains 4.18 mmol sodium (or 96.12 mg sodium). To be taken into
consideration by patients on a controlled sodium diet.

3. How to take Risedronate sodium and Calcium / Cholecalciferol
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Risedronate sodium and Calcium / Cholecalciferol is a weekly therapy of:
a) 1 Risedronate tablet
b) 6 Calcium/vitamin D3 effervescent tablets
The recommended dose per weekly cycle is:
 Day 1
1 Risedronate tablet (orange 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 Risedronate tablet on your chosen “Day 1” at the position of the strip which
is marked with the corresponding week (e.g. week 1).


Days 2 to 7
1 Calcium/vitamin D3 effervescent tablet per day for the next 6 days

PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 4 of 8
22/01/2016

Start Calcium/vitamin D3 intake on the day after the Risedronate tablet has been taken.
Do not take the Risedronate tablet and the Calcium/vitamin D3 effervescent tablet on the same day.
Every 7 days start a new weekly box beginning with the Risedronate tablet on your chosen “Day 1”.
Method of use
Oral use
a) Take your Risedronate tablet whole:
• in the morning at least 30 minutes before your first food, drink or other medicine
• whilst you sit or stand, to avoid heartburn
• with at least one glass of plain water
Do not lie down for 30 minutes after taking your tablet. Swallow it whole, do not suck or chew the
tablets.
b) Take the Calcium/vitamin D3 effervescent tablet after dissolving it in a glass of water.
If you take more Risedronate sodium and Calcium / Cholecalciferol than you should
a) Drink one glass of milk and seek medical attention if you have taken more Risedronate tablets than
prescribed or if children have been taking this medicine by accident.
b) Please contact your doctor if you have taken more Calcium/vitamin D3 effervescent tablets than you
should or if children have been taking this medicine by accident.
If you forget to take Risedronate sodium and Calcium / Cholecalciferol
a) If you have forgotten to take your Risedronate tablet on your chosen day “Day 1”:
1. Take it on the day you remember. Do not take two Risedronate 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
Risedronate 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.
4. Discard any remaining calcium/vitamin D tablets in the box at the end of the weekly cycle.
Then start a new weekly cycle: take one Risedronate tablet once a week on your chosen “Day1”.
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 Risedronate tablet.
2. Continue taking one effervescent tablet each day until the end of the weekly cycle.
3. Discard any remaining calcium/vitamin D effervescent tablet s in the box at the end of the weekly
cycle.
4. .
If you stop taking Risedronate sodium and Calcium / Cholecalciferol
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider
stopping treatment.
If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.

PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 5 of 8
22/01/2016

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Possible side effects caused by Risedronate
Stop taking Risedronate and contact a doctor immediately if you experience any of the following:




Symptoms of severe allergic reaction such as:
- swelling of face, tongue or throat
- difficulties in swallowing
- hives and difficulties in breathing
severe skin reactions such as:
- Blistering of the skin, mouth, eyes and other moist body surfaces (genitals) (Stevens
Johnson syndrome)
- Palpable red spots on the skin (leukocytoclastic vasculitis)
- Red rash over many parts of the body and/or loss of the outer layer of the skin (toxic
epidermal necrolysis)

Inform your doctor immediately if you have:
• eye inflammation, usually with pain, redness and light sensitivity

bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often
following tooth extraction (see section 2, “Warnings and precautions”)
• symptoms from oesophagus such as difficulty and pain in swallowing, chest pain, or new or
worsened heartburn

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 necrosis of the external auditory canal (osteonecrosis) mainly in patients on long-term treatment
for osteoporosis may occur very rarely. 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.
However, in clinical studies the other side effects that were observed were usually mild and did not
cause the patient to stop taking their tablets.
Common, may affect up to 1 in 10 people
• indigestion, feeling sick, stomach pain, stomach cramps or discomfort, constipation, feelings of
fullness, bloating, diarrhoea
• pain in your bones, muscles or joints
• headache
Uncommon, may affect up to 1 in 100 people
• inflammation or ulcer of the gullet (the tube that connects your mouth with your stomach) causing
- difficulty and pain in swallowing
- inflammation of the stomach and the first part of the small bowel immediately beyond the
stomach
• inflammation of the coloured part of the eye (iris) causing red, painful eyes and visual
disturbances
Rare, may affect up to 1 in 1,000 people
PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets






Page 6 of 8
22/01/2016

tongue inflammation with swelling and possible pain
narrowing of the gullet
abnormal liver blood tests
reduced blood calcium and phosphate levels
These changes are usually small, occur at the beginning of treatment and cause no symptoms.


During post-marketing experience, the following have been reported (Not known, frequency cannot
be estimated from the available data
• hair loss
• liver disorders, some cases were severe

b) Possible side effects caused by Calcium/vitamin D3
In very rare cases (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 has been reported. Contact a doctor
immediately if you experience any of above mentioned symptoms.
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 heartbeat.
• urine calcium levels above normal
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

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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the 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 Risedronate sodium and Calcium / 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 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!
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.

PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 7 of 8
22/01/2016

6. Contents of the pack and other information
What Risedronate sodium and Calcium / Cholecalciferol contains
a) Risedronate film-coated tablets
The active substance is risedronate sodium.
One film-coated tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.
The other ingredients are:
• Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate, magnesium stearate
• Film coating: hypromellose, macrogol 400, titanium dioxide (E171), ferric oxide yellow (E172),
ferric oxide red (E172)
b) Calcium/vitamin D3 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 micrograms (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, aromatics (orange juice flavour,
PHS-133147 (containing maltodextrin, orange flavouring substances and hydroxyethyl starch)).
What Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film coated
Tablets + Effervescent Tablets looks like and contents of the pack
a) Risedronate film-coated tablets: oval biconvex, orange, encoded 35 on one side. It is packed in a
plastic/aluminium strip.
b) Calcium/vitamin D3 effervescent tablets: cylindrical, white or off-white coloured biplane
effervescent tablets with bevel-edges on both sides. It is packed in a tube.
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film coated Tablets +
Effervescent Tablets is available in packs containing
• 4 film-coated tablets + 24 (2 x 12) effervescent tablets
A single carton box contains both the film-coated tablet blister (placed in a carton box) and the
effervescent tablets in tubes for one month use
• 3 x (4 film-coated tablets + 24 (2 x 12) effervescent tablets)
A single carton box contains both the film-coated tablet blister (placed in carton boxes) and the
effervescent tablets in tubes for three months use
• 4 x (4 film-coated tablets + 24 (2 x 12) effervescent tablets)
A single carton box contains both the film-coated tablet blister (placed in carton boxes) and the
effervescent tablets in tubes for four months use.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd
Frimley Business Park,
PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

Sandoz Ltd
Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film
coated Tablets + Effervescent Tablets

Page 8 of 8
22/01/2016

Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer:
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1,
39179 Barleben
Germany
This leaflet was last revised in 05/2016.

PIL.1091.008.2d

V016: SPC and PIL update in line with reference texts + RFI + second update

JG

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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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