Sandoz Ltd    Page 1 of 8

Risedronate sodium and Calcium / Cholecalciferol 35 mg + 1000 mg / 880 IU Film    22/01/2016

coated Tablets + Effervescent Tablets

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

•    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

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

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.

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

•    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.

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,

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