Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking, filmomhulde tabletten

What Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking is

A combination medicine: the weekly therapy consists of 1 tablet of Risedronate sodium (orange tablet) and 6 tablets of Calcium (white to off-white tablets).

What Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking is used for

Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking is used to treat osteoporosis, even if severe, in women after menopause who also need daily calcium supplementation as assessed by their doctor. This combination medicine reduces the risk of spinal and hip fractures.

a) Risedronate sodium 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.

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

Do not take Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking if you are/have:

• allergic to risedronate sodium, calcium carbonate 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
• pregnant, may be pregnant or planning to become pregnant
• breast-feeding
• severe kidney problems, including kidney stones

Warnings and precautions

Talk to your doctor before taking Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking if any of the following conditions apply to you:

• 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.

• if you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may 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).
• 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 Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking.

• have mild to moderate kidney problems. Your doctor may want to monitor levels of calcium and phosphate in your blood and urine.

Your doctor will advise you on what to do when taking Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking 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 Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking

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 Risedronate sodium 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 sodium tablet.

b) Calcium is known to affect or be affected by the following medicines:

• digitalis (used to treat heart disorders)
• tetracycline antibiotics
• steroids (such as cortisone, used to reduce inflammation or prevent organ transplant rejection)
• sodium fluoride (used to strengthen tooth enamel)
• thiazides diuretics (used to remove water from the body by increasing urine production)

Your doctor will give you further instructions, if you take any of the above-mentioned medicines.

Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking with food and drink

1. Do not take your Risedronate sodium 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, Taking other medicines. Food and drinks, other than plain water, may only be taken at least 30 minutes after your Risedronate sodium tablet.
2. Do not take the Calcium tablets with foods containing high amounts of

• oxalic acid, such as spinach and rhubarb, or
• phytic acid, such as whole cereals

Take the Calcium tablets at least 2 hours after eating such foods.

Pregnancy and breast-feeding

Pregnancy

Do NOT take Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking if you are pregnant, think you may be pregnant or are planning to have a baby.

The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Breastfeeding

Do NOT take Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking if you are breast-feeding (see section 2, “Do not take Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking”).

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking is not known to affect your ability to drive or use machines.

The Risedronate sodium tablets contain lactose.

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.

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

Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking is a weekly therapy of:

1. 1 blister strip containing 1 Risedronate sodium tablet (orange tablet)
2. 1 blister strip containing 6 Calcium tablets (white to off-white tablets)

Usual dose per weekly cycle:

• Day 1 1 Risedronate sodium tablet (orange tablet) Take one risedronate sodium tablet once a week. 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 sodium tablet on your chosen “Day 1”.
• Days 2 to 7 1 Calcium tablet (white to off-white tablet) per day for the next 6 days Take one calcium tablet each day for the next 6 days, beginning on the day after the Risedronate sodium tablet has been taken.

Do not take the Risedronate sodium tablet and the Calcium tablet on the same day.

Every 7 days start a new set of blisters beginning with the Risedronate sodium tablet on your chosen “Day 1”.

Method of use

a) Take your Risedronate sodium tablet (orange tablet) whole:

• in the morning at least 30 minutes before your first food, drink or other medicine
• whilst you are in an upright position (you may sit or stand) to avoid heartburn
• with at least one glass of plain water (>120 ml)

Swallow it whole, do not suck or chew the tablets. Do not lie down for 30 minutes after taking your tablet.

b) Take one Calcium tablet (white or off-white tablet):

• Each day for the next 6 days, beginning on the day after the risedronate sodium tablet has been taken.
• Swallow it whole.
• It is recommended to take the calcium tablet with a meal.

Duration of use

This will be decided by your doctor.

If you take more Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking than you should

1. Drink one glass of milk and seek medical attention if you have taken more Risedronate sodium tablets (orange tablets) than prescribed.
2. Please contact your doctor if you have taken more Calcium tablets than you should.

If you forget to take Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking

a) If you have forgotten to take your Risedronate sodium tablet on your chosen day “Day 1”:

1. Take it on the day you remember. Do not take two Risedronate sodium tablets in one day to make up for the tablet you missed.
2. On the following day take your Calcium tablet. Do not take your Risedronate sodium tablet and the Calcium tablet on the same day.
3. Continue taking one Calcium tablet each day until the end of the weekly cycle.
4. Discard any remaining calcium tablets at the end of the weekly cycle.
5. Then start a new weekly cycle: take one Risedronate sodium tablet once a week on your chosen “Day 1”.

b) If you have forgotten to take a Calcium tablet:

1. Take it on the day you remember, but do not take two Calcium tablets on the same day. Do not take the Calcium tablet on the same day as the Risedronate sodium tablet.
2. Continue taking one Calcium tablet each day until the end of the weekly cycle.
3. Discard the forgotten Calcium tablet.

If you stop taking Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking

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 product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

a) Possible side effects caused by Risedronate sodium

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

Symptoms of a severe allergic reaction such as

• Swelling of the face, tongue or throat
• Difficulties in swallowing
• Hives and difficulties in breathing
• Severe skin reactions that can include blistering of the skin

Inform your doctor immediately if you experience the following side effects:

• Eye inflammation, usually with pain, redness and light sensitivity
• Degeneration of the jaw bone associated with delayed healing and infection, often following tooth extraction (see section 2, “Warnings and precautions”)
• 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. 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.

Other side effects:

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 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 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.

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

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

Rare: may affect up to 1 in 1,000 people

• Wind, constipation, feeling sick, abdominal pain, diarrhoea
• Rash, red raised itchy skin

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.

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.

Do not store above 30 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.

What Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking contains

Risedronate sodium tablets (orange 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, crospovidone, cellulose, microcrystalline and magnesium stearate. Film-coating: Hypromellose, titanium dioxide (E171), macrogol 400, iron oxide, yellow (E172) and iron oxide, red (172).

Calcium tablets (white to off-white tablets):

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

The other ingredients are:

Tablet core: Starch, pregelatinised, polysorbate 80, sodium starch glycolate (type A), sodium laurilsulfate and magnesium stearate.

Film-coating: Hypromellose, titanium dioxide (E171), macrogol 400 and polysorbate 80

What Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking looks like and contents of the pack

The therapy for one week consists of :

• 1 Risedronate sodium tablet (orange, oval shaped, biconvex film-coated tablet, encoded “35” on one side) presented in one blister strip (PVC/aluminium) and
• 6 Calcium tablets (white to off-white, capsule–shaped, biconvex film-coated tablets, plain on both the sides) presented in a second blister strip (PVC/aluminium).

Packsizes:

1 week combination pack: 1 Risedronate sodium tablet + 6 Calcium tablets

4 weeks combination pack: 4x1 Risedronate sodium tablet + 4x6 Calcium tablets 12 weeks combination pack: 12x1 Risedronate sodium tablet + 12x6 Calcium tablets 16 weeks combination pack: 16x1 Risedronate sodium tablet + 16x6 Calcium tablets 24 weeks combination pack: 24x1 Risedronate sodium tablet + 24x6 Calcium tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Nederland

Manufacturer

Lek Pharmaceuticals d.d. Verovškova 57

1526 Ljubljana Slovenië

Lek Pharmaceuticals d.d. Trimlini 2D

9220 Lendava Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

In het Register ingeschreven onder:

RVG 110662

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

NL: Risedronaatnatrium 35 mg en Calcium 500 mg Sandoz combinatieverpakking, filmomhulde tabletten

UK: Risedronate Sodium and Calcium 35mg + 500 mg Film Coated Tablets

This leaflet was last revised in augustus 2013