RISEDRONATE SEMANAL CINFA 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risedronate Weekly Cinfa 35 mg Film-Coated Tablets EFG

Sodium Risedronate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Risedronate Weekly Cinfa and what is it used for

What is Risedronate Weekly Cinfa

Risedronate Weekly Cinfa 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 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.

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

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Osteoporosis-related fractures 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 is Risedronate Weekly Cinfa used for

This medicine is indicated for the treatment of osteoporosis:

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

2. What you need to know before you take Risedronate Weekly Cinfa

Do not take Risedronate Weekly Cinfa

• 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 disease called hypocalcemia (low calcium levels in the blood)
• if you may be pregnant, are pregnant, or 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 Risedronate Weekly Cinfa:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both producing low calcium levels in the blood).
• If you have or have had problems with your esophagus (the tube that connects the mouth to the stomach). At some point, you may have had or been told you have esophageal Barrett's (a condition associated with changes in the cells lining the lower esophagus).
• If your doctor has informed you that you have an intolerance to some sugars (such as lactose).
• 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 will undergo dental surgery, inform your dentist that you are being treated with Risedronate Weekly.

Your doctor will advise you what to do if you take Risedronate Weekly and have any of the problems mentioned above.

Children and adolescents

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

Taking Risedronate Weekly Cinfa with other medicines

Medicines containing any of the following substances reduce the effect of Risedronate Weekly when taken at the same time:

• calcium
• magnesium
• aluminum (e.g., some medicine for indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronate Weekly.

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

Taking Risedronate Weekly Cinfa with food and drinks

It is very important that you do NOT take Risedronate Weekly with food or drinks (other than plain 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, "Taking Risedronate Weekly Cinfa with other medicines").

Take food and drinks (other than plain water) at least 30 minutes after Risedronate Weekly.

Pregnancy and breastfeeding

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

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

DO NOT take Risedronate Weekly if you are breastfeeding (see section 2, "Do not take Risedronate Weekly Cinfa"). Risedronate Weekly can 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 and use machines have been observed.

Risedronate Weekly Cinfa contains lactose

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

Risedronate Weekly Cinfa contains sodium

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

3. How to take Risedronate Weekly Cinfa

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, 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 suits 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 the first food, drink, or other medicine of the day (except if this drink is plain water).

How to take Risedronate Weekly

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water.
• Swallow the tablet whole (without chewing or sucking 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 in your diet is not sufficient.

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 consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 the chosen day, take it on the day you remember. And take the next tablet the following week, on the day you normally take the tablet.

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

If you stop taking Risedronate Weekly Cinfa

If you stop treatment, you may start losing 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 Weekly and consult your 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
  • Rashes and difficulty breathing
• Severe skin reactions that can include blistering of the skin.

Tell your doctor as soon as possibleif you experience 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 a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms related to the esophagus, such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of stomach acid.

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

However, in clinical studies, the side effects 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, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Bone, muscle, and joint pain.
• 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"), stomach inflammation and/or duodenum (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful with possible changes in vision).

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

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

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

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

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

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

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

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

These changes are usually small and do not cause symptoms.

Reporting of side effects

If you experience any side effects, 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 the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Cinfa

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 special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Weekly Cinfa

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

• The other ingredients are:

Core tablet:Lactose monohydrate, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-470b), and anhydrous colloidal silica.

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

Appearance of the product and contents of the pack

Risedronate Weekly Cinfa 35 mg film-coated tablets are cylindrical, biconvex, ochre-colored tablets, marked with the code "35" on one face.

They 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 last revision of this leaflet:October 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73191/P_73191.html

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