Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten

What Natriumrisedronaat Sandoz 75 mg is

Natriumrisedronaat Sandoz 75 mg belongs to a group of non-hormonal medicines called bisphosphonates which 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.

What Natriumrisedronaat Sandoz 75 mg is used for

The treatment of osteoporosis in postmenopausal women.

• if you are allergic to risedronate sodium or any of the other ingredients of Natriumrisedronaat Sandoz 75 mg (see section 6)
• if your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)
• if you may be pregnant, are pregnant or planning to become pregnant
• if you are breast-feeding
• if you have severe kidney problems.

Warnings and precautions

Talk to your doctor before taking Natriumrisedronaat Sandoz 75 mg

• 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 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).
• 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 Natriumrisedronaat Sandoz 75 mg.

Your doctor will advise you on what to do when taking Natriumrisedronaat Sandoz 75 mg 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 Natriumrisedronaat Sandoz 75 mg

Medicines containing one of the following lessen the effect of Natriumrisedronaat Sandoz 75 mg if taken at the same time:

• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron.

Take these medicines at least 30 minutes after your Natriumrisedronaat Sandoz 75 mg tablet.

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

Natriumrisedronaat Sandoz 75 mg with food and drink

It is very important that you do NOT take your Natriumrisedronaat Sandoz 75 mg 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, “Taking other medicines”).

Take food and drinks (other than plain water) at least 30 minutes after your Natriumrisedronaat Sandoz 75 mg tablet.

Pregnancy and breast-feeding

Do NOT take Natriumrisedronaat Sandoz 75 mg if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Natriumrisedronaat Sandoz 75 mg”). The potential risk associated with the use of risedronate sodium (active substance in Natriumrisedronaat Sandoz 75 mg) in pregnant women is unknown.

Do NOT take Natriumrisedronaat Sandoz 75 mg if you are breast-feeding (see section 2, “Do not take Natriumrisedronaat Sandoz 75 mg”).

Natriumrisedronaat Sandoz 75 mg should only be used to treat postmenopausal women.

Driving and using machines

Natriumrisedronaat Sandoz 75 mg is not known to affect your ability to drive and use machines.

Natriumrisedronaat Sandoz 75 mg contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Dosage

Always take Natriumrisedronaat Sandoz 75 mg exactly as your doctor has told you. You should check with your doctor if you are not sure.

The recommended dose is:

Natriumrisedronaat Sandoz 75 mg tablets should be taken on the SAME two consecutive dates each month, e.g. on the 1st and 2nd of the month, or the 15th and 16th.

Choose TWO dates in a row that best fit your schedule to take your Natriumrisedronaat Sandoz 75 mg. Take ONE Natriumrisedronaat Sandoz 75 mg tablet in the morning of your first chosen date. Take the SECOND tablet in the morning of the following day.

Repeat every month keeping the same two consecutive dates. To help you remember when to take your tablets next, you can mark your calendar ahead of time with a pen or stickers.

When to take the Natriumrisedronaat Sandoz 75 mg tablet

Take your Natriumrisedronaat Sandoz 75 mg tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.

How to take the Natriumrisedronaat Sandoz 75 mg tablet

• 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. Do not take your tablet with mineral water or drinks other than plain water.
• Swallow it whole. Do not suck or chew it.
• Do not lie down for 30 minutes after taking your tablet.

Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.

If you take more Natriumrisedronaat Sandoz 75 mg than you should

If you or somebody else has accidentally taken more Natriumrisedronaat Sandoz 75 mg tablets than prescribed, drink one full glass of milk and seek medical attention (for national requirements see blue box).

If you forget to take Natriumrisedronaat Sandoz 75 mg

You forgot	When	What to do
	Next monthly dose is more	Take 1st tablet the next
1st and 2nd tablets	than 7 days ahead	morning and 2nd tablet the
	morning of the following day
	Next monthly dose is within 7	Do not take the tablets you
	days	have forgotten
	Next monthly dose is more	Take 2nd tablet the next
2nd tablet only	than 7 days ahead	morning
Next monthly dose is within 7	Do not take the tablets you
	days	have forgotten

The next month, take your tablets again as usual

In any case:

• If you miss your dose of Natriumrisedronaat Sandoz 75 mg in the morning, do NOT take it later in the day.
• Do NOT take three tablets within the same week.

If you stop taking Natriumrisedronaat Sandoz 75 mg

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.

Stop taking Natriumrisedronaat Sandoz 75 mg 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.

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, vomiting, 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).
• Fever and/or flu-like symptoms

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.

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.

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 Bijwerkingen Centrum Lareb. Website: www.lareb.nl. 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 blister after EXP. The expiry date refers to the last day of that month.

This medicinal product 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.

What Natriumrisedronaat Sandoz 75 mg contains

• The active substance is risedronate sodium. Each tablet contains 75 mg risedronate sodium, equivalent to 69.6 mg risedronic acid.
• The other ingredients are lactose monohydrate, maize starch, sarch pregelatinized (maize), silica colloidal anhydrous (E551), sodium stearyl fumarate (E470a) and magnesium stearate (E572) in the tablet core, and Opadry Pink 03B34103 containing hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 400 and iron oxide red (E172) in the film-coating.

What Natriumrisedronaat Sandoz 75 mg looks like and contents of the pack

• Film-coated tablet
• Pink, round, biconvex, film-coated tablet engraved “R 75” on one side and plain on the other.
• The tablets are supplied in blister packs of 2, 4, 6, 8 or 12 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V., Veluwezoom 22, Almere

Correspondentie: Postbus 10332, 1301 AH Almere

Manufacturers:

Pharmachemie B,V, Swensweg 5, 2301 GA Haarlem, The Netherlands

Teva Sante, Tue Bellocier, 89107 Sens, Immeuble Palatin 1, 1 Cour de Triangle, 92936 Paris La Défense Cedex, France

Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debreccen, Hungary

Teva Pharmaceutical Works Private Limited Company, Táncsics Mihály út 82, H-2100 Gödöllö, Hungary

Lek d.d., Verovškova 57, 1526 Ljubljana, Slovenia

Lek S.A., UL. Domaniewska 50 C, 02-672 Warszawa, Poland

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany

S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania Natriumrisedronaat Sandoz 75 mg is in het register ingeschreven onder RVG 107940.

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

names:

DE: Risedronsäure – 1A Pharma 75 mg Filmtabletten

NL : Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten

This leaflet was last approved per November 2013