Package Insert: Information for the Patient

Risedronate Combix 75 mg Film-Coated Tablets

Risedronate Sodium

Read this package insert carefully before taking this medication, as it contains important information for you.

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

What isRisedronato Combix

This medicationbelongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. This medication acts directly on the bones, strengthening them and, therefore, reduces the likelihood of fractures.

The bone is a living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis appears in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely to occur 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. Fractures associated with osteoporosis can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronato Combix used for

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

Do not takeRisedronate Combix

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

• If you cannot remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both producing low levels of calcium 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 or have had difficulty swallowing food or have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells that cover the lower part of the esophagus).
• If you have had or have jaw pain, swelling, or numbness, or a "strong pain in the jaw" or a tooth has moved.
• If you are undergoing dental treatment or are about to undergo dental surgery, inform your dentist that you are receiving treatment withrisedronate sodium.

Your doctor will advise you what to do if you takethis medicationand have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) because there is not enough data on its safety and efficacy.

Other medications andRisedronate Combix

Medications that contain any of the following substances reduce the effect ofrisedronate sodiumwhen taken at the same time:

• calcium
• magnesium
• aluminum (for example, some medication for indigestion)
• iron

Take these medications at least 30 minutes after takingRisedronate Combix.

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

TakingRisedronate Combixwith food and drinks

It is very important that you DO NOT takerisedronate sodiumwith 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 takingthis 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 takerisedronate sodiumif 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 risedronate sodium (active ingredient of Risedronate Combix) in pregnant women is unknown.

DO NOT takerisedronate sodiumif you are breastfeeding (see section 2, "Do not take Risedronate Combix").

Risedronate sodium can only be used in postmenopausal women.

Driving and operating machines

The effect ofrisedronate sodiumon the ability to drive and operate machines is unknown.

Risedronate Combix contains sodium

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

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

Recommended dose:

The risedronate sodium tablets must be taken on the SAME two consecutive days of each month, for example, the 1st and 2nd days or the 15th and 16th days 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 in the morning on the following day.

Repeat every month, maintaining 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 the risedronate Combix tablets

Take the risedronate sodium tablet at least 30 minutes before the first meal, drink (except in the case of water) or another medication of the day.

HOW to take risedronate Combix tabletstablets

• Take the tablet while standing upright, either sitting or standing, to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of tap water. Do not take the tablet with mineral water or other drinks that are not tap water.
• Swallow the tablet whole. Do not suck or chew 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 from your diet is not sufficient.

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

IF you take more risedronate Combix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

IF you forgot to take risedronate Combix

In any case:

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

IF you interrupt treatment with risedronate Combix

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop takingrisedronate sodiumand seek medical attention immediatelyif you experience any of the following symptoms:

• Severe allergic reaction symptoms, such as:
• • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing
• Severe skin reactions that may cause blisters on the skin.

Inform your doctor quicklyif you experience the following side effects:

• Eye inflammation, 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 chest pain, difficulty swallowing, or the appearance or worsening of heartburn.

Atypical femoral fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs of a possible femoral fracture.

However, in clinical studies, the side effects observed were generally mild and did not cause the patient to interrupt treatment.

Common side effects(may affect up to 1 in 10 patients):

• Indigestion, nausea, vomiting, stomach pain, discomfort, or cramps, heavy digestion, constipation, feeling full, abdominal distension, diarrhea.
• Pain in your bones, muscles, or joints.
• Headache.

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

• Inflammation or ulcer of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (see also section 2, “Warnings and precautions”), inflammation of the stomach and duodenum (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red, painful eyes with possible changes in vision).
• Fever and/or flu-like symptoms.

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

• Lingual inflammation (red, swollen, possibly painful), esophageal narrowing (the tube that connects the mouth to the stomach).
• Abnormal liver test results. 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, ear discharge, or ear infection. These may be symptoms of ear bone damage.
• Unknown frequency:
• Cases of hair loss.
• Liver alterations, in some cases severe.

Rarely, a mild decrease in blood phosphate and calcium levels has been observed in some patients at the beginning of treatment. 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 does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRisedronate Combix

• The active ingredient is risedronate sodium. Each tablet contains 75 mg of risedronate sodium(equivalent to69.6mg of risedronic acid).

• The other components (excipients) are:

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

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

Appearance of the product and content of the container

Coated tablets, round, bisected, biconvex, pink in color with the inscription “75” on one face and smooth on the other, with an approximate diameter of 9 mm. The tablets are presented in blister packs, in boxes of 2 tablets.

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: May 2022

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