Risedronate Stada 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

RisedronatoStada 75 mg film-coated tablets EFG

sodium risedronate

Package leaflet contents:

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

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

What is Risedronato

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

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

Postmenopausal osteoporosis occurs in women after menopause, when bone begins to weaken, becomes more fragile, and fractures are more likely to occur following a fall or minor trauma.

The most common bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronato is used for

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

2. What you need to know before starting Risedronate Stada

Do not take Risedronate Stada

• If you are allergic to sodium risedronate 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 are planning to become pregnant.
• If you are breastfeeding.
• If you have severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Take special care and consult your doctor BEFORE starting Risedronate Stada.

• If you are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders, both of which may cause low blood calcium levels).
• If you have previously had problems with your esophagus (the tube connecting your mouth to your stomach). At some point, you may have experienced pain or difficulty swallowing food, or you have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, or a "severe jaw discomfort," or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are receiving risedronate treatment.
• Your doctor will advise you on what to do if you take risedronate and have any of the conditions mentioned above.

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents (under 18 years of age) 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 need to take any other medicines. Medicines containing any of the following substances reduce the effect of risedronate when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (for example, 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 NOT to take risedronate with food or with drinks (other than plain tap water), as 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 plain tap water) at least 30 minutes after taking your risedronate tablet.

Pregnancy and breastfeeding

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

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

Risedronate should only be used in postmenopausal women.

Driving and using machines

It is unknown whether risedronate affects the ability to drive or operate machinery.

Risedronate Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 exactly the instructions for use of this medicine as given by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Risedronate tablets should be taken two days per month, always on the same two consecutive days each month (for example, days 1 and 2, or days 15 and 16 of the month).

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

Repeat this every month, keeping to the same two consecutive days. To help you remember when to take the tablets again, you may mark them on your calendar with a pen or a sticker. You may also write the date in the space provided on the back of this medicine’s package.

WHEN to take the risedronate tablets

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

HOW to take the risedronate tablets

• Take the tablet while in an upright position (either sitting or standing) to avoid stomach irritation.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other beverages instead of 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 advise you whether you should take calcium and vitamin supplements if your dietary intake of these is insufficient.

If you take MORE Risedronate Stada than you should

If you or someone else has accidentally taken more risedronate tablets than prescribed, drink a full glass of milk and consult a doctor.

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

If you FORGET to take Risedronate Stada

In any case:

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

If you INTERRUPT treatment with Risedronato Stada

If you stop taking this medication, you may begin to lose bone mass. Please consult your doctor before deciding to interrupt treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking risedronate and contact your doctor immediately if 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 (genitals) (Stevens-Johnson syndrome).
• Palpable red spots on the skin (leukocytoclastic vasculitis).
• Red rash in multiple areas of the body and/or shedding of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor promptly if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, frequently following tooth extraction (see section 2, "Take special care and consult your doctor before starting risedronate").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

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

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

• Indigestion, nausea, vomiting, stomach pain, discomfort, dyspepsia, constipation, feeling of fullness, bloating, diarrhea.
• Pain in your bones, muscles, or joints.
• Headache.

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

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

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

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

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

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

Atypical femoral fractures (thigh bone) which may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

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

Very rare adverse effects:

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronato Stada

• The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate (as hemi-pentahydrate), 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; hypromellose, hydroxypropylcellulose, macrogol (type 400), macrogol (type 8000), titanium dioxide (E171), anhydrous colloidal silica, and red iron oxide (E172) in the coating.

Appearance of the product and contents of the pack

Film-coated tablet, pale pink in color, round, biconvex, marked with "75" on one side.

The tablets are presented in blisters containing 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 the most recent revision of this leaflet: July 2014

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/