RISEDRONATE COMBIX 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

What isRisedronate Combix

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, height loss, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What Risedronate Combix is used for

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

2. What you need to know before taking Risedronate Combix

Do not takeRisedronate Combix

• if you are allergic to sodium risedronate or any of the other ingredients 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 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 Combix:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone problems or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both causing 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 or Barrett's esophagus (a condition associated with changes in the cells lining the lower esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "a strong discomfort in the jaw" or a tooth becomes loose.
• 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 above problems.

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 andRisedronate Combix

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 Combix.

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

TakingRisedronate Combixwith 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 Combix").

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

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

Sodium risedronate can only be used in postmenopausal women.

Driving and using machines

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

Risedronate Combixcontains sodium

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

3. How to take Risedronate Combix

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended dose:

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 Combix tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next 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 takeRisedronate Combixtablets

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

HOW to takeRisedronate Combixtablets

• Take the tablet while in an upright position, either sitting or standing, 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 if you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

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

If you take moreRisedronate Combixthan you should

If you or someone accidentally takes more tablets of sodium risedronate 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 takeRisedronate Combix

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 takingRisedronate Combix

If you stop taking the treatment, you may start to lose 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 takingrisedronatesodiumand 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
• Severe skin reactions that can cause blisters on the skin.

Tell your doctor promptlyif 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 tooth extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or appearance or worsening of heartburn.

Atypical fractures of the femur (thigh bone) 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, vomiting, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.
• Pain in 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, your ear is suppurating, or you have 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance 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 Combix

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition ofRisedronate Combix

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

• The other ingredients (excipients) are:

Core of the tablet: microcrystalline cellulose, crospovidone A, anhydrous colloidal silica, povidone, sodium 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 contents of the pack

Film-coated tablets are round, bisected, biconvex, 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

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 the last revision of this package leaflet: May 2022

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