Leaflet: information for the user

RisedronateStada75 mg film-coated tablets

risedronate sodium

1. What is Risedronate Stada and what is it used for.

2. What you need to know before you start taking Risedronate Stada.

3. How to take Risedronate Stada.

4. Possible side effects.

5. Storage of Risedronate Stada.

6. Contents of the pack and additional information.

What isRisedronato

Risedronatobelongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases.Risedronatoacts directly on the bones strengthening them and, therefore, reduces the probability of fractures.

The bone is a living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis appears in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely to occur after a fall or twist.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Fractures associated with osteoporosis can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what risedronato is used

This medication is indicated for the treatment of osteoporosis inwomen after menopause.

Do not takeRisedronate Stada

• If you are allergic to risedronate sodium 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 hypocalcemia (low levels of calcium in the blood).
• If you could be pregnant, if you are pregnant or if you plan to become pregnant.
• If you are breastfeeding.
• If you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Be especially careful and consult your doctor BEFORE starting to take Risedronate Stada.

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both producing low blood calcium levels).
• If you have had problems with your esophagus (the tube that connects the mouth to the stomach) in the past. You may have had difficulty swallowing food or been told you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus).
• If you have had or have jaw pain, swelling, or numbness, or a "strong jaw pain" or a tooth that moves.
• If you are undergoing dental treatment or are about to undergo dental surgery, inform your dentist that you are receiving treatment with risedronate.
• Your doctor will advise you what to do if you take risedronate and have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) because there is not enough data on its safety and efficacy.

Other medicines and Risedronate Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. The medicines that contain any of the following substances reduce the effect of risedronate when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (for example, some antacids).
• Iron.

Take these medicines at least 30 minutes after taking risedronate.

Taking Risedronate Stada with food and drinks

It is very important that you DO NOT take risedronate with food or with drinks (other than tap water) because they may interfere. 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 Risedronate Stada").

Take food and drinks (other than tap water) at least 30 minutes after taking your risedronate tablet.

Pregnancy and breastfeeding

DO NOT take risedronate if you are pregnant, think you may be pregnant or intend to become pregnant (see section 2, "Do not take Risedronate Stada"). The potential risk associated with the use of risedronate sodium (active ingredient of risedronate) in pregnant women is unknown.

DO NOT take risedronate if you are breastfeeding (see section 2, "Do not take Risedronate Stada").

Risedronate sodium should only be used in women after menopause.

Driving and operating machinery

The effect of risedronate on the ability to drive and use machines is unknown.

Risedronate Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

The risedronate tablets should be taken two days a month, and always the same two consecutive days of each month (for example, the 1st and 2nd days or 15th and 16th of the month).

Choose the two consecutive days that best fit your schedule. Take one risedronate tablet in the morning of the first chosen day. Take the second tablet in the morning of the following day.

Repeat each month keeping the same two consecutive days. To help you remember when to take the tablets again, you can mark it on your calendar with a pen or a sticker. You can also write the date in the space behind the box of this medication.

WHEN to take the risedronate tablets

Take the risedronate tablet at least 30 minutes before the first meal, drink of the day (except in the case of tap water) or another medication of the day.

HOW to take the risedronate tablets

• Take the tablet while standing upright (either sitting or standing), to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other drinks that are not tap water.
• Swallow the tablet whole.Do not chew or crush it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will indicate if you should take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

IF you take MORE Risedronate Stada than prescribed

If you or someone accidentally took more risedronate tablets than prescribed, drink a full glass of milk andconsult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the name of the medication and the amount taken.

IF you FORGET to take Risedronate Stada

In any case:

• If you forgot your risedronate dose in the morning, DO NOT take it later in the day.
• DO NOT take three tablets in the same week.

IF you INTERRUPT the treatment with Risedronate Stada

If you stop taking the treatment, you may start losing bone mass. Please consult your doctor before deciding to interrupt the treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,thismedicationcan cause side effects, although not everyone will experience them.

Stop takingrisedronateand seek medical attention immediatelyif you experience any of the following symptoms:

Severe allergic reaction symptoms, such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

Severe skin reactions, such as:

Inform your doctor quicklyif you experience the following side effects:

However, in clinical studies, the side effects observed were generally mild and did not cause patients to interrupt treatment.

Frequent side effects(may affectup to1in10 patients)

Uncommon side effects(mayaffectup to1in100 patients)

Rare side effects(mayaffectup to1in1,000 patients)

During post-marketing use, the following have been reported (frequency unknown):

Atypical femur fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, groin, as these may be early signs and indicative of a possible femur fracture.

Rarely, a slight decrease in blood phosphate and calcium levels has been observed in some patients at the beginning of treatment. These changes are usually small and do not cause symptoms.

Very rare side effects:

• Consult your doctor if you have ear pain, discharge from the ear, or ear infection. These may be symptoms of damage to the bones of the ear.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanishMedicines Adverse Reactions Monitoring System, website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthismedicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Risedronate Stada

• The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium (as hemi-pentahydrate), being equivalent to 69.6 mg of risedronic acid.
• The other components (excipients) are: microcrystalline cellulose type 101, lactose monohydrate, crospovidone (type A) and magnesium stearate in the tablet core, and hypromellose, hydroxypropylcellulose, macrogol (type 400), macrogol (type 8000), titanium dioxide (E171), anhydrous colloidal silica, and iron oxide red (E172) in the coating.

Appearance of the product and contents of the packaging

Pale pink film-coated, round, biconvex tablet, engraved with “75” on one side.

The tablets are presented in blisters of 2 film-coated tablets.

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Adamed Pharma S.A

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet: July 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/