Package leaflet: Information for the patient

V

Aetonel Combi

35 mg + 1000 mg/880 IU film-coated tablets + effervescent granules

Risedronate sodium + calcium/colecalciferol

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.

What is in this leaflet

1.    What Actonel Combi is and what it is used for

2.    What you need to know before you take Actonel Combi

3.    How to take Actonel Combi

4.    Possible side effects

5.    How to store Actonel Combi

6.    Contents of the pack and other information

1.    What Actonel Combi is and what it is used for What Actonel Combi is

A combination medicine packed as weekly units each containing 1 tablet of Actonel and 6 sachets of calcium/vitamin D3.

O Actonel tablets

Actonel tablets contain 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 fOll 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.

□ Calcium/vitamin D3 sachets

The sachets contain calcium/vitamin D3 effervescent granules which provide the calcium and the vitamin D3 that your body may need to harden new bone.

What Actonel Combi is used for

The treatment of osteoporosis, even if severe, in postmenopausal women who also need daily calcium and vitamin D3 supplementation as assessed by their doctor.

It reduces the risk of spinal and hip fractures.

2.    What you need to know before you take Actonel Combi

^jj^) Do not take Actonel Combi

•    If you are allergic to risedronate sodium, calcium carbonate, vitamin D3, peanut or soya or any of the other ingredients of this medicine (listed in section 6)

•    If your doctor has told you that you have a condition called: hypocalcaemia (a low blood calcium level), hypercalcaemia (a high blood calcium level), hypercalciuria (a high calcium level in the urine), hypervitaminosis D (a high blood vitamin D level)

•    If you may be pregnant, are pregnant or planning to become pregnant

•    If you are breast feeding

•    If you have severe kidney problems, including kidney stones.

Warnings and precautions

A Talk to your doctor or pharmacist before taking ActonelCombi

• If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes.

• If you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).

• If you have or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or have had 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).

• If you have been told by your doctor that you have an intolerance to some sugars.

• If you have a condition called sarcoidosis (an immune system disorder mainly affecting the lungs, which causes shortness of breath and cough).

• If you are already taking supplements of vitamin D.

• If you have had or have pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth.

• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Actonel Combi.

Your doctor will advise you on what to do when taking Actonel Combi if you have any of the above.

Children and adolescents

Risedronate sodium is not recommended for use in children below 18 due to insufficient data on safety and efficacy.

Other medicines and Actonel Combi

O Actonel tablets

Medicines containing one of the following lessen the effect of the Actonel tablet if taken at the same time:

•    calcium

•    magnesium

•    aluminium (for example some indigestion mixtures)

•    iron.

Take these medicines at least 30 minutes after your Actonel tablet.

□    Calcium/vitamin D3 sachets

Medicines containing calcium/vitamin D3 are known to interfere with the following:

•    digitalis (used to treat heart disorders)

•    tetracycline antibiotics

•    steroids (such as cortisone)

•    sodium fluoride (used to strengthen the tooth enamel)

•    thiazide diuretics (used to remove water from the body by increasing urine production)

•    cholestyramine (used to treat high blood cholesterol levels)

•    laxatives (such as paraffin oil).

If you are taking any of the above-mentioned medicines, your doctor will give you further instructions.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Actonel Combi with food and drink

O Actonel tablets

It is very important that you do NOT take your Actonel tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take the tablet at the same time as dairy products (such as milk) as they contain calcium (see section 2, "Other medicines and Actonel Combi").

Take food and drinks (other than plain water) at least 30 minutes after your Actonel tablet.

□    Calcium/vitamin D3 sachets

Do NOT take the dissolved calcium/vitamin D3 granules at the same time as foods containing high amounts of oxalic acid (spinach and rhubarb) or phytic acid (whole cereals).

Take the dissolved granules at least 2 hours after eating such foods.

Pregnancy and breast-feeding

Do NOT take Actonel Combi if you are pregnant, think you may be pregnant, or planning to have a baby (see section 2, "Do not take Actonel Combi"). The potential risk associated with the use of risedronate sodium (active substance in Actonel tablets) in pregnant women is unknown.

Do NOT take Actonel Combi if you are breast-feeding (see section 2, "Do not take Actonel Combi").

Driving and using machines

Actonel Combi is not known to affect your ability to drive and use machines.

Important information about some of the ingredients of Actonel Combi

The tablets contain lactose. The effervescent granules contain sorbitol, sucrose and soya-bean oil (see section 2, "Warnings and precautions" and "Do not take Actonel Combi").

The calcium/vitamin D3 granules contain potassium (163 mg per sachet). This should” be taken into consideration if you have a reduced kidney function or are on a controlled potassium diet.

3. How to take Actonel Combi

Actonel Combi is a weekly therapy presented in a box containing 1 tablet (in a blister) and 6 sachets containing effervescent ranules that should be taken in a special way. Every weekly ox has dosing instructions on the back.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose:

Weekly cycle:

•    Day 1: Actonel tablet (light-orange tablet)

Take ONE Actonel tablet once a week.

Choose one day of the week that best fits your schedule. This will be your Day 1 of the weekly cycle. Every week, take the Actonel tablet on your chosen Day 1.

•    Days 2 to 7: Calcium/vitamin D₃ sachets (effervescent granules)

Beginning on the day after the Actonel tablet has been taken, Take ONE sachet of calcium/ vitamin D3 granules each day for the next 6 days.

Every 7 days start a new weekly box. You should begin a new box by taking the Actonel tablet on your chosen Day 1.

Do NOT take your Actonel tablet and the sachet on the same day.

Leaflet: Page 1		replace SAP-No.:
SAP-No.:	10001430	10000705
SAP-Title:	IS Aclonel Combi Small UK WE08
Country:	UK	MPMS-No.:
Version:	3	98911520-xxx
Constructed:	21.07.2014 s+b/khf
Modified:	11.11.2014 s+b/hp/hp	Diecut:
Size:	210 x 480 mm (80 x 105)
Smallest font size:	9,5 pt
Pages:	1 of 2
Colours:	PMS Black ■

Techn. Drawing (Size, perforation, label, Placeholder for Sticker, varnish free area)

Colours

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WHEN to take the Actonel tablet

Take your Actonel tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

HOW to take Actonel Combi

O Actonel tablets

•    Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn.

•    Swallow it with at least one glass (120 ml) of plain water.

•    Swallow it whole. Do not suck or chew it.

•    Do not lie down for 30 minutes after taking your tablet.

□    Calcium/vitamin P₃ sachets

Pour the content of the sachet into a glass of plain water and stir. Wait until the fizzing has subsided, then drink the solution.

If you take more Actonel Combi than you should

O Actonel tablets

If you have taken more tablets than you should, or if children have been taking medicine by accident, drink one full glass of milk and seek medical attention.

□    Calcium/vitamin D₃ sachets

If you have taken more sachets than you should, or if children have been taking medicine by accident, please contact your doctor.

If you forget to take Actonel Combi

O Actonel tablets

If you have forgotten to take your tablet on your chosen day (Day 1):

1.    Take it on the day you remember. Do NOT take two tablets in one day to make up for the tablet you missed.

2.    On the following day take your calcium/vitamin D3 sachet. Do NOT take your Actonel tablet and the sachet on the same day.

3.    Continue taking one sachet each day until the end of the weekly cycle.

4.    Discard any remaining sachets in the box at the end of the weekly cycle.

Then start a new weekly cycle: take one Actonel tablet once a week on your chosen Day 1.

□    Calcium/vitamin P₃ sachets

If you have forgotten to take a calcium/vitamin D3 sachet:

1.    Take it on the day you remember. Do NOT take the sachet on the same day as the Actonel tablet. Do NOT take two sachets on the same day.

2.    Continue taking one sachet each day until the end of the weekly cycle.

3.    Discard any remaining sachets in the box at the end of the weekly cycle.

If you stop taking Actonel Combi

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 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.

O Actonel tablets

Stop taking Actonel and contact a doctor immediately

if you experience any of the following:

•    Symptoms of a severe allergic reaction such as;

-    Swelling of face, tongue or throat

-    Difficulties in swallowing

-    Hives and difficulties in breathing

•    Severe skin reactions that can include blistering of the skin. Tell your doctor promptly if you experience the following side effects:

•    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 pain when you swallow, difficulties 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.

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 side effects (may affect up to 1 in 10 people)

•    Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.

•    Pain in your bones, muscles or joints.

•    Headache.

Uncommon side effects (may affect up to 1 in 100 people)

•    Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (bowel draining the stomach).

•    Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).

Rare side effects (may affect up to 1 in 1,000 people)

•    Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).

•    Abnormal liver tests have been reported. These can only be diagnosed from a blood test.

During post-marketing experience, the following have been reported (unknown frequency);

•    Hair loss

•    Liver disorders, some cases were severe

Rarely, at the beginning of treatment, a patient's blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.

□    Calcium/vitamin P₃ sachets

Uncommon side effects (may affect up to 1 in 100 people)

•    Hypercalcaemia (a high blood calcium level, with potential symptoms of excessive thirst, loss of appetite, fatigue and in severe cases irregular heart beat), hypercalciuria (a high calcium level in the urine).

Rare side effects (may affect up to 1 in 1,000 people)

•    Constipation, wind, nausea, abdominal pain, diarrhoea.

•    Skin reactions such as itching, rash and hives.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

5.    How to store Actonel Combi

•    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 cartons after EXP. The expiry date refers to the last day of that month.

•    This medicine does not require any special storage conditions.

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 Actonel Combi contains

O Film-coated tablets

The active substance is risedronate sodium. Each tablet contains 35 mg risedronate sodium, equivalent to 32.5 mg risedronic acid.

The other ingredients are:

Tablet core: lactose monohydrate (see section 2), crospovidone A, magnesium stearate and cellulose microcrystalline.

Film coating: hypromellose, macrogol, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow [E172], iron oxide red [E172].

□    Effervescent granules sachets

The active substances are calcium carbonate and colecalciferol (vitamin D3). Each sachet of effervescent granules contains 1000 mg calcium (as 2500 mg calcium carbonate) and 22 micrograms (880 International Units [IU]) of colecalciferol (vitamin D3).

The other ingredients are: citric acid anhydrous, malic acid, gluconolactone, maltodextrin, sodium cyclamate, saccharin sodium, sorbitol [E420], mannitol [E421], dextrin, acacia, natural lemon oils, natural lime flavour, rice starch, potassium carbonate, all-rac-a-tocopherol, soya-bean oil (hydrogenated), gelatin, sucrose, maize starch.

What Actonel Combi looks like and contents of the pack

The combination pack is constituted of an outer carton pack containing weekly unit(s) (carton boxes).

Each weekly unit contains:

•    one film-coated tablet which is an oval light-orange tablet with the letters "RSN" on one side and "35 mg" on the other side, packaged in a blister card.

•    6 sachets of effervescent granules of calcium and vitamin D3. Pack sizes: 1,2, 4, 12 (3x4) and 16 (4x4) weekly units.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Warner Chilcott UK Ltd.,

Old Belfast Road,

Millbrook, Larne, County Antrim,

BT40 2SH, United Kingdom

Manufacturer:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Rohm-Str. 2-4,

64331 Weiterstadt, Germany

This medicine is authorised in the Member States of the EEA under the following names:

Belgium: Actonel Combi D 35 mg + 1000 mg / 880 IE

filmomhulde tabletten + bruisgranulaat, 35 mg +

1000 mg / 880 Ul comprime pellicule et granules effervescents en sachet-dose, 35 mg + 1000 mg / 880 I.E. Filmtabletten + Brausegranulat Finland: Optinate Combi D 35 mg + 1000 mg / 880 IU kalvopaallysteiset tabletit + porerakeet France: Actonel combi 35 mg + 1000 mg / 880 Ul comprime pellicule et granules effervescents en sachet-dose

Germany: Actonel plus Calcium D

35 mg + 1000 mg/880 I.E.

Filmtabletten + Brausegranulat

Ireland: Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg / 880 i.u. effervescent granules Lithuania: Actonel Combi 35 mg plevele dengtos tabletes + 1000 ma / 880 TV snypsciosios granules Malta: Actonel Pius Ca & D 35 mg film-coated tablets + 1000 mg / 880 i.u. effervescent granules The Netherlands: Actokit D 35 mg + 1000 mg/880 IE filmomhulde tabletten + bruisgranulaat Slovenia: Actonel Combi 35 mg + 1000 mg/880 IE filmsko oblozena tableta + sumeca zrnca Sweden: Optinate Combi D 35 mg + 1000 mg / 880 IE filmdragerade tabletter + brusgranulat United Kingdom: Actonel Combi 35 mg film-coated tablets + 1000 mg / 880 IU effervescent granules

This leaflet was last approved in: November 2014

Leaflet: Page 2		replace SAP-No.:
SAP-No.:	10001430	10000705
SAP-Title:	IS Aclonel Combi Small UK WE08
Country:	UK	MPMS-No.:
Version:	3	98911520-xxx
Constructed:	21.07.2014 s+b/khf
Modified:	11.11.2014 s+b/hp/hp	Diecut:
Size:	210 x 480 mm (80 x 105)
Smallest font size:	9,5 pt
Pages:	2 of 2
Colours:	PMS Black ■

Techn. Drawing (Size, perforation, label, Placeholder for Sticker, varnish free area)

Colours

Pharma Code (Laetus), Placement

Code of goods

Version

Braille

Barcode (EAN, ...) approved QA-Label Control

Reason for change:

Datum/Date: Unterschrift/Sign: