Risedronate weekly CINFA 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

risedronato semanal cinfa 35 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What risedronate cinfa weekly is and what it is used for

What risedronate cinfa weekly is

Risedronate cinfa weekly belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It 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 following a fall or twist.

Osteoporosis can also affect men, due to various causes including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in 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 risedronate cinfa weekly is used for

This medicine is indicated for the treatment of osteoporosis:

• In women after menopause, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures.
• in men

2. What you need to know before starting to take risedronate cinfa weekly

Do not take risedronate cinfa weekly

• if you are allergic to sodium risedronate or to 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 calcium levels in your blood)
• if you could be pregnant, are pregnant, or plan to become pregnant
• if you are breastfeeding
• if you have severe kidney disease

Warnings and precautions

Talk to your doctor or pharmacist before starting to take risedronate cinfa weekly:

• If you are unable to remain upright (sitting or standing) for at least 30 minutes.
• If you have bone disorders or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone disorders, both of which can cause low blood calcium levels).
• If you have or have previously had esophageal problems (the tube connecting your mouth to your stomach). At some point, you may have experienced pain or difficulty swallowing food, or you may have been previously diagnosed with Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• If your doctor has informed you that you have an intolerance to certain sugars (such as lactose).
• If you have had or currently have pain, swelling, or numbness in the jaw, severe jaw discomfort, or loose teeth.
• If you are undergoing dental treatment or are scheduled to have a dental procedure, inform your dentist that you are being treated with risedronate cinfa weekly.

Your doctor will advise you on what to do if you are taking risedronate cinfa weekly 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 safety and efficacy.

Taking risedronate cinfa weekly with other medicines

Medicines containing any of the following substances reduce the effect of risedronate cinfa weekly when taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking risedronate cinfa weekly.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking risedronate cinfa weekly with food and drinks

It is very important NOT to take risedronate cinfa weekly with food or with drinks other than plain 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, “Taking risedronate cinfa weekly with other medicines”).

Take food and drinks (other than plain water) at least 30 minutes after taking risedronate cinfa weekly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

DO NOT take risedronate cinfa weekly if you could be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take risedronate cinfa weekly”). The potential risk associated with the use of sodium risedronate (the active substance in risedronate cinfa weekly) in pregnant women is unknown.

DO NOT take risedronate cinfa weekly if you are breastfeeding (see section 2, “Do not take risedronate cinfa weekly”). Risedronate cinfa weekly may only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed.

risedronate cinfa weekly contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

risedronate cinfa weekly contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take risedronate weekly cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

The recommended dose is:

One risedronate weekly tablet (35 mg of sodium risedronate) once a week.

Choose the day of the week that best fits your schedule. Each week, take the risedronate weekly tablet on the chosen day.

When to take risedronate weekly

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

How to take risedronate weekly

• 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 plain water.
• Swallow the tablet whole (do not chew or suck it).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you need to take calcium and vitamin supplements if the amount you get from your diet is insufficient.

If you take more risedronate weekly cinfa than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take risedronate weekly cinfa

If you have forgotten to take the tablet on your chosen day, take it as soon as you remember. Then take the next tablet one week later on your usual day.

Do not take a double dose to make up for missed doses.

If you stop taking risedronate weekly cinfa

If you stop treatment, you may begin to lose bone mass. Please consult your doctor before deciding to discontinue 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 weekly risedronate and contact your doctor immediately if you experience any of the following symptoms:

• Signs of a severe allergic reaction, such as:
  • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing.
• Severe skin reactions that may include blistering of the skin.

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, often following a tooth extraction (see section 2, “Warnings and precautions”).
• Esophagus-related symptoms such as pain when swallowing, difficulty swallowing, chest pain, and onset or worsening of acid reflux.

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

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

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

• Indigestion, nausea, stomach pain, stomach discomfort or cramps, feeling of fullness, bloating, diarrhea, constipation.
• Bone, muscle, and joint pain.
• 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/or duodenum (the intestine into which the stomach empties).
• Inflammation of the colored part of the eye (iris) (painful, red eyes possibly with changes in vision).

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

• Inflammation of the tongue (swollen, red, 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 by blood tests.

During post-marketing use, the following adverse effects have been reported:

Very rare (may affect up to 1 in 10,000 patients):

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

Frequency not known (cannot be estimated from available data):

• Cases of hair loss.
• Liver disorders, in some cases severe.

Rarely, at the beginning of treatment, a slight decrease in blood phosphate and calcium levels has been observed in some patients.

These changes are usually minor and do not cause symptoms.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of risedronate cinfa weekly

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 EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the container and other information

Composition of risedronate semanal cinfa

• The active substance is sodium risedronate. Each film-coated tablet contains 35 mg of sodium risedronate (equivalent to 32.5 mg of risedronic acid).

• The other components are:

Tablet core: Monohydrate lactose, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-470b), and colloidal anhydrous silica.

Coating: Opadry OY-L28900 white (monohydrate lactose, hypromellose 15 cP (E-464), titanium dioxide (E-171), macrogol 4000), yellow iron oxide, and brown iron oxide.

Appearance of the medicine and contents of the pack

risedronate semanal cinfa 35 mg film-coated tablets are cylindrical, biconvex, ochre-colored tablets marked with the code “35” on one side.

The tablets are presented in PVC-PVDC/aluminum blisters. Each pack contains 4 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: October 2020

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/73191/P_73191.html

QR code: https://cima.aemps.es/cima/dochtml/p/73191/P_73191.html