RISEDRONATE WEEKLY COMBIX 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Weekly Combix 35 mg Film-Coated Tablets EFG

Sodium Risedronate

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Risedronate Weekly Combix and what is it used for
2. What you need to know before you take Risedronate Weekly Combix
3. How to take Risedronate Weekly Combix
4. Possible side effects
5. Storage of Risedronate Weekly Combix

1. Contents of the pack and further information

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

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

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

Postmenopausal osteoporosis occurs in women after menopause when bone begins to weaken, becoming more fragile and prone to fractures after a fall or twist.

Osteoporosis can also affect men due to various 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 in the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What is Risedronate Weekly Combix used for

This medicine 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.

2. What you need to know before you take Risedronate Weekly Combix

Do not take Risedronate Weekly Combix

• if you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6)
• if your doctor has told you that you have a disease called hypocalcemia (low blood calcium levels)
• 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 Weekly Combix:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both causing low blood calcium levels).
• 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 (inflammation of the esophagus) or esophageal ulcers, or you may have been informed that you have 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 severe discomfort in the jaw or a tooth has become loose.
• If you are undergoing dental treatment or will undergo dental surgery, inform your dentist that you are being treated with sodium risedronate.

Your doctor will advise you what to do if you take this medicine 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 medicines and Risedronate Weekly Combix

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

• calcium
• magnesium
• aluminum (e.g., some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronate Weekly Combix.

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

Taking Risedronate Weekly Combix with food and drinks

It is very important that you do not take this medicine with food or drinks (other than plain water) because they can 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 Risedronate Weekly Combix").

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

Pregnancy and breastfeeding

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

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

Do not take this medicine if you are breastfeeding (see section 2, "Do not take Risedronate Weekly Combix"). Sodium risedronate can only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Risedronate Weekly Combix contains sodium

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

3. How to take Risedronate Weekly Combix

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

The recommended dose is:

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

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

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

When to take Risedronate Weekly Combix tablets

Take the Risedronate Weekly Combix tablet at least 30 minutes before the first food, drink of the day (except if this drink is plain water) or other medicine of the day.

How to take Risedronate Weekly Combix tablets

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water.
• Swallow the tablet whole (without chewing or sucking it).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will indicate whether you should take calcium and vitamin supplements if the amount you take in your diet is not sufficient.

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

If you take more Risedronate Weekly Combix than you should

If you or someone else has accidentally taken more tablets of sodium risedronate than prescribed, drink a full glass of milk and consult a doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Risedronate Weekly Combix

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. And take the next tablet the following week, on the day you normally take the tablet.

Do not take a double dose to make up for the forgotten dose.

If you stop taking Risedronate Weekly Combix

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Risedronate Weekly Combix and consult a 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 include blistering of the skin.

Tell your doctor immediatelyif you experience any of 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 a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms related to the esophagus, such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of heartburn.

Atypical fractures of the thigh bone (femur) can occur rarely, 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 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, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea
• Bone, muscle, and joint pain
• 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"), stomach inflammation and/or duodenal inflammation (intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris) (red eyes, painful with possible changes in vision).

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

• Inflammation of the tongue (swollen, red, 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 side effects have been reported:

• Very rare: Consult your doctor if you have ear pain, discharge from the ear, or 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 blood levels has been observed in some patients.

These changes are usually small and do not cause symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Combix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is 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 should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Risedronate Weekly Combix

• The active substance is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (equivalent to 32.5 mg of risedronic acid).

• The other ingredients (excipients) are:

Core of the tablet:microcrystalline cellulose, crospovidone A, anhydrous colloidal silica, povidone, sodium stearyl fumarate, and magnesium stearate.

Coating of the tablet:hypromellose, macrogol, polysorbate 80, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

Risedronate Weekly Combix 35 mg film-coated tablets are round, bisected, biconvex, orange 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

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 leaflet: May 2022

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