Risedronate Combix 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronato Combix 75 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, consult 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 Combix is and what it is used for
2. What you need to know before taking Risedronato Combix
3. How to take Risedronato Combix
4. Possible adverse effects
5. How to store Risedronato Combix
6. Contents of the pack and other information

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

What Risedronato Combix is

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 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 twist.

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 Combix is used for

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

2. What you need to know before taking Risedronato Combix

Do not take Risedronato Combix

• 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 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 Risedronato Combix:

• If you are unable to remain in an upright position, either 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 the mouth to the stomach). At some point, you may have experienced pain or difficulty swallowing food, or you may 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 to have dental surgery, inform your dentist that you are receiving treatment 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 Risedronato Combix

Medicines containing any of the following substances reduce the effect of sodium 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 Risedronato Combix.

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

Taking Risedronato Combix with food and drinks

It is very important NOT to take sodium risedronate 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, "Other medicines and Risedronato Combix").

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 might be pregnant, or plan 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 Risedronato Combix"). The potential risk associated with the use of sodium risedronate (the active substance in Risedronato Combix) in pregnant women is unknown.

DO NOT take sodium risedronate if you are breastfeeding (see section 2, "Do not take Risedronato Combix").

Sodium risedronate should only be used in postmenopausal women.

Driving and using machines

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

Risedronato Combix 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 Combix

Follow exactly the dosing instructions for this medicine as 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, 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 Combix tablet in the morning on the first chosen day. Take the SECOND tablet the following morning.

Repeat this every month, keeping 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 Combix tablets

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

HOW to take Risedronate Combix 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 need to take calcium and vitamin supplements if your dietary intake of these is insufficient.

Follow exactly the dosing instructions for this medicine as contained in this leaflet or as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you take more Risedronate Combix than you should

If you or someone accidentally takes more sodium risedronate tablets than prescribed, drink a full glass of milk and contact your doctor immediately.

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

If you forget to take Risedronate Combix

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 Combix

If you stop taking the 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 sodium 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 that may cause 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, frequently following tooth extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

Atypical femoral fractures (thigh bone) may occur rarely, particularly in patients on long-term osteoporosis treatment. 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.

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, stomach discomfort or cramps, feeling of fullness, bloating, diarrhea.
• Pain in 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 into which the stomach empties).
• Inflammation of the colored part of the eye (iris) (painful red eyes possibly with 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 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 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 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 type of 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 through 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 Combix

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 refers to 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 at your pharmacy. If 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 pack and other information

Composition of Risedronate Combix

• The active substance is sodium risedronate. Each tablet contains 75 mg of sodium risedronate (equivalent to 69.6 mg of risedronic acid).

• The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

Film-coated, round, bevelled, biconvex tablets, pink in colour, 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 Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of latest revision of this leaflet: May 2022

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