Package Insert: Information for the Patient

Risedronate Weekly Combix 35 mg Film-Coated Tablets

Risedronate Sodium

Read this package insert carefully before starting to take 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 only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

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

The bone is a living tissue. The old bone of 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 after a fall or twist.

Osteoporosis can also be suffered by men due to numerous causes, including aging and/or low levels of male hormone, testosterone.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis can also produce back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Risedronato Semanal Combix is used

This medication is indicated for the treatment of osteoporosis

• in women after menopause, even if osteoporosis is severe. It reduces the risk of vertebral and hip fractures.
• in men.

Do not take Risedronato Semanal Combix

• if you are allergic to sodium risedronate or to 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 take Risedronato Semanal 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 pain, swelling, or numbness in the jaw or a strong pain in the jaw or a tooth that moves.
• If you are undergoing dental treatment or will be undergoing a dental intervention, inform your dentist that you are being treated 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

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Other medications and Risedronato Semanal Combix

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

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

Take these medications at least 30 minutes after taking Risedronato Semanal Combix.

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

Taking Risedronato Semanal Combix with food and drinks

It is very important that you DO NOT take this medication with food or with beverages (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 Risedronato Semanal Combix”).

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

Pregnancy and lactation

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 this medication if you may be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take Risedronato Semanal Combix”). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

DO NOT take this medication if you are breastfeeding (see section 2, “Do not take Risedronato Semanal Combix”). Risedronate sodium can only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The effect of risedronate sodium on the ability to drive and operate machinery is unknown.

Risedronato Semanal 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.

The recommended dose is:

One Risedroanto Weekly Combix tablet (35 mg of risedronate sodium) once a week.

Choose the day of the week that best fits your schedule. Each week, take the risedronate sodium tablet on the chosen day.

To facilitate taking the tablet on the same day every week, there are boxes on the back of the package. Mark the day of the week you have chosen to take the risedronate sodium tablet. Also, write the dates on which you will take the tablet.

When to take Risedronato Weekly Combix tablets

Take the Risedronato Weekly Combix tablet at least 30 minutes before the first meal, drink of the day (except in the case of water), or other medication of the day.

How to take Risedronato Weekly Combix tablets

• 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 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 tell you if you need to take calcium and vitamin supplements, if the amount you take in your diet is not enough.

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

If you take more Risedronato Weekly 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 taken.

If you forget to take Risedronato Weekly Combix

If you forgot to take the tablet on the chosen day, take the tablet on the day you remember. And take the next tablet a week later, on the day you normally take the tablet.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Risedronato Weekly Combix

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

If you have any other questions 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 taking Risedronate Weekly Combix and see your doctor 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 include the appearance of blisters on the skin.

Inform your doctor quicklyif you experience the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after a dental extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as difficulty swallowing, chest pain, and appearance or worsening of stomach acid.

Atypical femur 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 they may be early symptoms and indicative of a possible femur 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, stomach pain, discomfort, or cramps in the stomach, heavy digestion, constipation, feeling full, abdominal distension, diarrhea
• Bone, muscle, and joint pain
• 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"), stomach and/or duodenal inflammation.
• Iris inflammation (red, painful eyes with possible vision changes).

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

• Tongue inflammation (swollen, red, 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 side effects 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:
• 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Risedronate Weekly Combix

• The active ingredient is risedronate sodium.Each tablet contains 35 mg of risedronate sodium (equivalent to 32.5 mg 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), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and content of the packaging

Risedronate Weekly Combix 35 mg film-coated tablets are round, bisected, biconvex, orange-colored tablets with the inscription “35” on one face and smooth on the other.The tablets are presented in blisters, in boxes of 4 tablets.

Marketing authorization holder

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