Package leaflet: Information for the patient

Optinate Combi 35 mg + 500 mg film-coated tablets

risedronate sodium + calcium

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 Optinate Combiis and what it is used for

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

3. How to take Optinate Combi

4. Possible side effects

5. How to store Optinate Combi

6. Contents of the pack and other information

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

What Optinate Combi is

A combination medicine packed as weekly units each containing 1 tablet of Optinate (light-orange tablet) and 6 tablets of calcium (blue tablets).

⃝ Optinate tablets

Optinate 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 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.

 Calcium tablets

The tablets contain calcium carbonate which provide the calcium that your body may need to harden new bone.

What Optinate Combi is used for

The treatment of osteoporosis in postmenopausal women who also need daily calcium supplementationas assessed by their doctor.

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

Do not take Optinate Combi

• If you are allergic to risedronate sodium, calcium carbonate 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)

• 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

Talk to your doctor or pharmacist before taking Optinate Combi:

• 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 (such as lactose).

• 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 Optinate Combi.

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

Children and adolescents

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

Other medicines and Optinate Combi

⃝ Optinate tablets (light-orange tablets):

Medicines containing one of the following lessen the effect of the Optinate 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 Optinate tablet.

 Calcium tablets (blue tablets):

Medicines containing calcium 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).

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.

Optinate Combi with food and drink

⃝ Optinate tablets (light-orange tablets):

It is very important that you do NOT take your Optinate tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Other medicines and Optinate Combi”). Take food and drinks (other than plain water) at least 30 minutes after your Optinate tablet.

 Calcium tablets (blue tablets):

Do NOT take your calcium tablet at the same time as foods containing high amounts of oxalic acid (spinach and rhubarb) or phytic acid (whole cereals).

Take your calcium tablet at least 2 hours after eating such foods.

Pregnancy and breast-feeding

Do NOT take Optinate Combi if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Optinate Combi”). The potential risk associated with the use of risedronate sodium (active substance in Optinate tablets) in pregnant women is unknown.

Do NOT take Optinate Combi if you are breast-feeding (see section 2, “Do not take Optinate Combi”).

Driving and using machines

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

Optinate tablets contain lactose(see section 2, “Warnings and precautions).

3. How to take Optinate Combi

Optinate Combi is a weekly therapy presented in a blister pack containing 1 Optinate once a week 35 mg tablet and 6 calcium 500 mg tablets. Every weekly blister pack 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:

Take ONE Optinate 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 Optinate tablet on your chosen Day 1.

Beginning on the day after the Optinate tablet has been taken,

Take ONE tablet of calcium each day for the next 6 days.

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

WHEN to take the Optinate tablet

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

HOW to take Optinate Combi

⃝ Optinate tablets (light-orange 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 tablets (blue tablets)

• Take one calcium tablet each day for the next 6 days.

• Swallow it whole.

• It is recommended to take the calcium tablet with a meal.

If you take more Optinate Combi than you should

⃝ Optinate tablets (light-orange tablets):

If you have taken more Optinate tablets than you should, or if children have been taking medicine by accident, drink one fullglass of milkand seek medical attention..

 Calcium tablets (blue tablets):

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

If you forget to take Optinate Combi

⃝ Optinate tablets (light-orange tablets)

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

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

 Calcium tablets (blue tablets)

If you have forgotten to take a calcium tablet:

If you stop taking Optinate 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.

⃝ Optinate tablets (light-orange tablets):

Stop taking Optinate and contact a doctor immediately if you experience any of the following:

• Swelling of the face, tongue or throat

• Difficulties in swallowing

• Hives and difficulties in breathing

Tell your doctor promptlyif 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

• 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 tablets (blue tablets):

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

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

 Wind

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Optinate 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 carton and blisters after EXP. The expiry date refers to the last day of that month.

Store below 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 Optinate Combi contains

⃝ Optinate tablets (light-orange tablets):

The active substance isrisedronate 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, hydroxypropylcelluloseand colloidal anhydrous silica, titanium dioxide [E171], iron oxide yellow [E172], iron oxide red [E172].

 Calcium tablets (blue tablets):

The active substance is calcium carbonate. Each tablet contains 1250 mg calcium carbonate, equivalent to 500 mg elemental calcium.

The other ingredients are:

Tablet core: pre-gelatinised maize starch, sodium starch glycollate, indigo carmine (E132) and magnesium stearate.

Film-coating: macrogol, hypromellose, polysorbate 80, titanium dioxide (E171), indigo carmine (E132), hydroxypropylcellulose.

What Optinate Combi looks like and contents of the pack

Optinate Combi consists of weekly units containing:

• 1 Optinate 35 mg 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 calcium carbonate 1250 mg film-coated tablets which is a capsule-shaped blue tablet with the characters “NE 2” on both sides.

The above weekly therapy is supplied in pack of 2, 4, 12 and 16 weekly units. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completely nationally]

Manufacturer:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Röhm-Str. 2-4,

64331 Weiterstadt, Germany

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

Germany: Actonel plus Calcium 35 mg + 500 mg Filmtabletten

Ireland: Actonel Combi 35 mg + 500 mg film-coated tablets

The Netherlands: Actokit, combinatieverpakking

Sweden: Optinate Combi 35 mg + 500 mg filmdragerade tabletter

This leaflet was last revised in:

14 January 2016