Risedronate Sodium And Calcium 35 Mg + 500 Mg Film-Coated Tablets
Patient Information Leaflet 22/07/2013
Sandoz Ltd PL 04416/1301
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets
Package leaflet: Information for the user
Risedronate sodium and Calcium 35 mg + 500 mg Film-coated Tablets
risedronate sodium and 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 Risedronate sodium and Calcium Film-coated Tablets are and what they are used for
2. What you need to know before you take Risedronate sodium and Calcium Film-coated Tablets
3. How to take Risedronate sodium and Calcium Film-coated Tablets
4. Possible side effects
5. How to store Risedronate sodium and Calcium Film-coated Tablets
6. Contents of the pack and other information
1. What Risedronate sodium and Calcium Film-coated Tablets are and what they are used for
What Risedronate sodium and Calcium Film-coated Tablets are
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 Risedronate sodium and Calcium Film-coated Tablets are used for
Risedronate sodium and Calcium Film-coated Tablets are 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 nonhormonal 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.
Sandoz Ltd PL 04416/1301 Patient Information Leaflet
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets 22/07/2013
2. What you need to know before you take Risedronate sodium and Calcium Film-coated Tablets
Do not take Risedronate sodium and Calcium Film-coated Tablets 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 Risedronate sodium and Calcium Film-coated Tablets 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 Risedronate sodium and Calcium Film-coated Tablets.
• 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 Risedronate sodium and Calcium Film-coated Tablets 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 Risedronate sodium and Calcium Film-coated Tablets
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)
Sandoz Ltd PL 04416/1301 Patient Information Leaflet
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets 22/07/2013
• 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. Risedronate sodium and Calcium Film-coated Tablets with food and drink
a) 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.
b) 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 Risedronate sodium and Calcium Film-coated Tablets 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 Risedronate sodium and Calcium Film-coated Tablets if you are breast-feeding (see section 2, “Do not take Risedronate sodium and Calcium Film-coated Tablets”).
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Risedronate sodium and Calcium Film-coated Tablets 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 start taking this medicinal product.
3. How to take Risedronate sodium and Calcium Film-coated Tablets
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 Film-coated Tablets is a weekly therapy of:
a) 1 blister strip containing 1 Risedronate sodium tablet (orange tablet)
b) 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
Sandoz Ltd PL 04416/1301 Patient Information Leaflet
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets 22/07/2013
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 Risedronate sodium and Calcium Film-coated Tablets than you should
a) Drink one glass of milk and seek medical attention if you have taken more Risedronate sodium tablets (orange tablets) than prescribed.
b) Please contact your doctor if you have taken more Calcium tablets than you should.
If you forget to take Risedronate sodium and Calcium Film-coated Tablets
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 Risedronate sodium and Calcium Film-coated Tablets
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.
Sandoz Ltd PL 04416/1301
Patient Information Leaflet 22/07/2013
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets
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 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
Sandoz Ltd PL 04416/1301 Patient Information Leaflet
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets 22/07/2013
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 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 Film-coated Tablets
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.
6. Contents of the pack and other information
What Risedronate sodium and Calcium Film-coated Tablets contain
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 Risedronate sodium and Calcium Film-coated Tablets look like and contents of the pack
The therapy for one week consists of :
Sandoz Ltd PL 04416/1301 Patient Information Leaflet
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets 22/07/2013
• 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).
Pack sizes:
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 Limited Frimley Business Park Frimley, Camberley, Surrey GU16 7SR United Kingdom
Manufacturer Lek Pharmaceuticals d.d. Verovskova 57, 1526 Ljubljana Slovenia
Or
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava,
Slovenia
Or
Salutas Pharma GmbH Otto-Von-Guericke-Allee 1, 39179 Barleben Germany
Or
S.C. Sandoz S.R.L.
Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania
Or
LEK S.A
Domaniewska 50 C, 02-672 Warszawa,
Poland
Sandoz Ltd PL 04416/1301
Patient Information Leaflet 22/07/2013
Risedronate Sodium and Calcium 35 mg + 500 mg Film-coated Tablets
This leaflet was last revised in 07/2013
PIL.1301.001.0d Licence Application JH