RISEDRONATE STADA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

RisedronateStada75 mg film-coated tablets EFG

risedronate sodium

Contents of the package leaflet:

1. What Risedronate Stada is and what it is used for.
2. What you need to know before you take Risedronate Stada.
3. How to take Risedronate Stada.
4. Possible side effects.
5. Storage of Risedronate Stada.
6. Contents of the pack and further information.

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

What isRisedronate

Risedronate belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. Risedronate acts directly on the bones, strengthening them and thus reducing the likelihood of fractures.

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

Postmenopausal osteoporosis occurs in women after menopause when the bone begins to weaken, becomes more fragile, and is more likely to fracture 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 may not have symptoms and may not even know they have it.

What Risedronate is used for

This medicine is indicated for the treatment of osteoporosis in postmenopausal women.

2. What you need to know before you take Risedronate Stada

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 disease called hypocalcemia(low blood calcium levels).
• If you may be pregnant, if you are pregnant, or if you plan to become pregnant.
• If you are breast-feeding.
• If you have severe kidney disease.

Warnings and precautions

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

Be particularly 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 problems or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, 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. At some point, you may have had pain or difficulty swallowing food or have been told that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "a strong discomfort in the jaw" or a tooth is loose.
• If you are undergoing dental treatment or are going 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

The use of risedronate sodium is not recommended in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Other medicines and Risedronate Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Medicines that contain any of the following substances reduce the effect of risedronate when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (e.g., some medicines for indigestion).
• 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 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 it contains 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 breast-feeding

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

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

Risedronate should only be used in postmenopausal women.

Driving and using machines

It is not known if risedronate affects the ability to drive and use machines.

Risedronate Stada contains lactose and sodium

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

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

3. How to take Risedronate Stada

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

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

The recommended dose is:

Risedronate tablets should be taken two days a month, and always on the SAME two consecutive days of each month (e.g., days 1 and 2 or 15 and 16 of the month).

Choose the TWO consecutive days that best fit your schedule. Take ONE risedronate tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

Repeat every 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 on the space provided on the back of the medicine box.

WHEN to take the risedronate tablets

Take the risedronate tablet at least 30 minutes before the first food, drink, or other medicine of the day (except if it is tap water).

HOW to take the risedronate tablets

• Take the tablet while standing or sitting upright, to avoid heartburn.
• 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 suck or chew it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

If you take MORE Risedronate Stada than you should

If you or someone else has taken more risedronate tablets than prescribed, drink a full glass of milkand go to the doctor.

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

If you FORGET to take Risedronate Stada

In any case:

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

If you STOP taking Risedronate Stada

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

If you have any other questions about 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.

Stop taking risedronate and go to the doctor immediatelyif you experience any of the following symptoms:

Symptoms of a severe allergic reaction such as:

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

Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist surfaces of the body (genital areas) (Stevens-Johnson syndrome)
• Red patches on the skin (leucocytoclastic vasculitis)
• Red rash on many parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis)

Tell your doctor immediatelyif you experience any of the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, "Be particularly careful and consult your doctor before starting to take risedronate").
• Esophagus symptoms such as pain when swallowing, difficulty swallowing, chest pain, or appearance or worsening of heartburn.

However, in clinical studies, the side effects that were observed were generally mild and did not cause the patient to stop treatment.

Common side effects(may affect up to 1 in 10 patients)

• Indigestion, nausea, vomiting, stomach pain, discomfort, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in bones, muscles, or joints.
• Headache.

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

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful with possible changes in vision).
• Fever and/or flu-like symptoms (within the first five days after the first administration).

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

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• Abnormal liver tests have been reported. This can only be diagnosed with blood tests.

During post-marketing use, the following have been reported (frequency not known):

• Hair loss, skin rash.
• Liver disorders, in some cases severe.
• Inflammation of small blood vessels.

Atypical fractures of the thigh bone (femur) may occur rarely, especially in patients on long-term treatment for osteoporosis. Tell your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible fracture of the femur.

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

Very rare side effects:

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

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Stada

Keep this medicine out of the sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Risedronate Stada

• The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium (as hemi-pentahydrate), equivalent to 69.6 mg of risedronic acid.
• The other ingredients (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), colloidal anhydrous silica, and red iron oxide (E172) in the coating.

Appearance of the product and pack contents

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

The tablets are presented in blister packs of 2 film-coated tablets.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Adamed Pharma S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

Date of last revision of this package leaflet: July 2014

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/