Risedronate Cinfamed 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronato cinfamed 75 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, because 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What is Risedronato cinfamed

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

Bone is 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.

The most common fractures due to osteoporosis occur in the spine, 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 cinfamed is used for

This medicine 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 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 levels of calcium 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 taking Risedronate cinfamed:

• If you are unable to remain in an upright position (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 calcium levels in the blood).
• If you have or have previously had esophageal problems (the tube connecting the mouth to the 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 "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 being treated with sodium risedronate.

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

Other medicines and Risedronate cinfamed

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

• calcium
• magnesium
• aluminium (for example, some medicines for indigestion)
• iron

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

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

Taking Risedronate cinfamed with food and drinks

It is very important NOT to take sodium risedronate with food or 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), which contain calcium (see section 2, "Other medicines and Risedronate cinfamed").

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

Pregnancy, breastfeeding, and fertility

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

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 substance 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 may only be used in postmenopausal women.

Driving and using machines

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

Risedronate cinfamed contains sodium

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

3. How to take Risedronate cinfamed

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

Recommended dose:

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

Choose the TWO consecutive days that best suit your schedule. Take ONE Risedronate cinfamed tablet in the morning on the first chosen day. Take the SECOND tablet the following morning.

Repeat this every month, maintaining 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.

WHEN to take Risedronate cinfamed tablets

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

HOW to take Risedronate cinfamed 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 plain water. Do not take the tablet with mineral water or other beverages that are not plain water.
• Swallow the tablet whole. Do not suck or chew it.
• You must 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 the amount you obtain from your diet is insufficient.

Follow exactly the administration instructions for this medicine provided in this leaflet or those given 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 accidentally took more sodium risedronate tablets than prescribed, drink a full glass of milk and go to the 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 cinfamed

In any case:

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

If you interrupt treatment with Risedronato cinfamed

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

Stop taking sodium risedronate and see a 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.

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

• Severe skin reactions that may cause blistering of the skin. The frequency of this adverse effect is unknown (cannot be estimated from available data).

Tell your doctor immediately if you experience any of the following adverse effects:

• Inflammation of the eyes, usually with pain, redness and sensitivity to light. The frequency of this adverse 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 disturbances. The frequency of this adverse effect is unknown (cannot be estimated from available data).
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2 “Warnings and precautions”). The frequency of this adverse effect is unknown (cannot be estimated from available data).
• Oesophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn. This adverse effect is uncommon (may affect up to 1 in 100 people).

Atypical femur fractures (thigh bone) which may rarely occur, especially 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 femur fracture.

However, in clinical studies, 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, stomach discomfort or cramps, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhoea.
• Pain in your bones, muscles or joints.
• Headache.

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

• Inflammation or ulceration of the oesophagus (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 into which the stomach empties).
• Inflammation of the coloured part of the eye (iris) (painful red eyes with possible changes in vision).
• Fever and/or flu-like symptoms.

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

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (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 have been reported:

• Very rare: 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.
• Frequency not known:
  • Cases of hair loss.
  • Liver disorders, in some cases serious.

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 type of adverse effect, talk to 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 cinfamed

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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. 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 cinfamed

• The active substance is sodium risedronate. Each film-coated tablet contains 75 mg of sodium risedronate (as hemipentahydrate).
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, povidone, sodium stearyl fumarate and magnesium stearate.

Tablet coating: hypromellose, macrogol, polysorbate 80, titanium dioxide (E171) and red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Film-coated, round, bevelled, biconvex tablets, pink in colour, marked with the inscription “75” on one side and smooth on the other, with an approximate diameter of 9 mm. The tablets are presented in blisters, in packs of 2 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: July 2025

Detailed information on this medicinal product 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 up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may 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