RISEDRONATE CINFAMED 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Cinfamed 75 mg Film-Coated Tablets EFG

Sodium Risedronate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Risedronate Cinfamed and what is it used for
2. What you need to know before taking Risedronate Cinfamed
3. How to take Risedronate Cinfamed
4. Possible side effects
5. Storage of Risedronate Cinfamed
6. Package Contents and Additional Information

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

What is Risedronate Cinfamed

This medication belongs to a group of non-hormonal medications called bisphosphonates, which are used to treat bone diseases. This medication acts directly on the bones, strengthening them and 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 the bone begins to weaken, becoming more fragile and prone to fractures 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. 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 Cinfamed used for

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

2. What you need to know before taking Risedronate Cinfamed

Do not take Risedronate Cinfamed

• if you are allergic to sodium risedronate or any of the other components of this medication (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 could 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 Cinfamed:

• 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 esophagitis (inflammation of the esophagus) or esophageal stricture (narrowing of the esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "severe jaw discomfort" or have a loose tooth.
• If you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are receiving treatment with sodium risedronate.

Your doctor will advise you what to do if you take this medication 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.

Other Medications and Risedronate Cinfamed

Medications containing any of the following substances reduce the effect of sodium risedronate when taken at the same time:

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

Take these medications at least 30 minutes after taking Risedronate Cinfamed.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Risedronate Cinfamed with Food and Drinks

It is very important that you DO NOT take sodium risedronate with food or drinks (other than plain water) because they may interfere. In particular, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2, "Other Medications and Risedronate Cinfamed").

Take food and drinks (other than plain water) at least 30 minutes after taking this medication.

Pregnancy, Breastfeeding, and Fertility

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

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

DO NOT take sodium risedronate if you are breastfeeding (see section 2, "Do not take Risedronate Cinfamed"). Sodium risedronate can only be used in postmenopausal women.

Driving and Using Machines

It is unknown whether sodium risedronate affects the ability to drive and use machines.

Risedronate Cinfamed contains Sodium

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

3. How to take Risedronate Cinfamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

The sodium risedronate tablets should be taken on the SAME two consecutive days of each month, for example, on days 1 and 2 or 15 and 16 of the month.

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

WHEN to take Risedronate Cinfamed tablets

Take the sodium risedronate tablet at least 30 minutes before the first meal, drink of the day (except for plain water) or other medication of the day.

HOW to take Risedronate Cinfamed tablets

• Take the tablet while standing or sitting upright to avoid heartburn.

Swallow the tablet with at least one glass (120 ml) of plain water. Do not take the tablet with mineral water or other drinks that are not 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 indicate whether you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you take more Risedronate Cinfamed than you should

If you or someone else has accidentally taken more sodium risedronate 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 medication and the amount ingested.

If you forget to take Risedronate Cinfamed

In any case:

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

If you stop taking Risedronate Cinfamed

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking sodium risedronate 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.
  • Hives and difficulty breathing.

The frequency of this side effect is unknown (cannot be estimated from available data).

• Severe skin reactions that can cause blisters on the skin. The frequency of this side effect is unknown (cannot be estimated from available data).

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

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light. The frequency of this side effect is unknown (cannot be estimated from available data).
• Orbital inflammation - inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball, and vision changes. The frequency of this side effect is unknown (cannot be estimated from available data).
• Jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, "Warnings and Precautions"). The frequency of this side effect is unknown (cannot be estimated from available data).
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, and worsening of heartburn. This side effect is uncommon (may affect up to 1 in 100 people).

Atypical fractures of the femur (thigh bone) may 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, vomiting, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in your 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.

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 through blood tests.

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

• Very rare: Consult 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.
• Frequency not known:
• • 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Risedronate Cinfamed

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Risedronate Cinfamed

• The active ingredient is sodium risedronate. Each film-coated tablet contains 75 mg of sodium risedronate (in the form of hemipentahydrate).
• The other ingredients (excipients) are:

Core of the tablet: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, povidone, sodium stearyl fumarate, and magnesium stearate.

Coating of the tablet: hypromellose, macrogol, polysorbate 80, titanium dioxide (E171), and red iron oxide (E172).

Appearance of the Product and Package Contents

Round, bisected, biconvex film-coated tablets, pink in color with the inscription "75" on one side and smooth on the other, with a diameter of approximately 9 mm. The tablets are presented in blisters, in boxes of 2 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral 22,

Alcobendas, 28108

Madrid, Spain

Date of the Last Revision of this Package Leaflet: July 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90449/P_90449.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90449/P_90449.html