Risedronate Combix 35 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Risedronato Semanal Combix 35 mg Film-Coated Tablets EFG

Sodium Risedronate

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

2. What you need to know before taking Risedronato Semanal Combix

3. How to take Risedronato Semanal Combix

4. Possible adverse effects

5. How to store Risedronato Semanal Combix

6. Contents of the pack and other information

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

This medicine belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It 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 minor injury.

Osteoporosis can also affect men, due to various causes including aging and/or low levels of the male hormone testosterone.

The most common bone fractures associated with osteoporosis are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures 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 Risedronate Semanal Combix is used for

This medicine is indicated for the treatment of osteoporosis

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

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

Do not take Risedronate Weekly 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 might be pregnant, are pregnant, or are planning to become pregnant
• if you are breastfeeding
• if you have severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Risedronate Weekly 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 problems with mineral metabolism (for example, vitamin D deficiency, parathyroid hormone disorders, both of which can cause low blood calcium levels).
• If you have or have previously had problems with your esophagus (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 severe jaw discomfort, or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled for a dental procedure, inform your dentist that you are being treated 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 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 if you are taking, have recently taken, or might need to take any other medicines.

Taking Risedronate Weekly Combix with food and drinks

It is very important NOT to take this medicine 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 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

DO NOT take this medicine if you might 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 may 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 or operate machinery.

Risedronate Weekly Combix contains sodium

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

3. How to take Risedronato Semanal Combix

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One Risedronato Semanal Combix tablet (35 mg of sodium risedronate) once a week.

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

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

When to take Risedronato Semanal Combix tablets

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

How to take Risedronato Semanal 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.
• 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 advise you whether you should take calcium and vitamin supplements if the amount you obtain from your diet is insufficient.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

If you take more Risedronato Semanal Combix than you should

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

In case of overdose or accidental ingestion, contact 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 Risedronato Semanal Combix

If you forgot to take the tablet on your chosen day, take it on the day you remember. Then take the next tablet the following week on your usual tablet-taking day.

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

If you stop taking Risedronato Semanal Combix

If you stop treatment, you may begin to lose bone mass. Please consult your doctor before deciding to discontinue 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 Risedronate Weekly Combix and see 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 include blistering of the skin.

Tell your doctor immediately if you experience any of the following adverse effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis), associated with delayed healing and infection, often following a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms related to the oesophagus, such as pain when swallowing, difficulty swallowing, chest pain, and 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 lead patients to discontinue treatment.

Frequent adverse effects (may affect up to 1 in 10 people):

• Indigestion, nausea, stomach pain, stomach discomfort or cramps, feeling of fullness, bloating, constipation, diarrhoea
• Bone, muscle, and joint pain
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people):

• Inflammation or ulceration of the oesophagus (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/or duodenum (the intestine into which the stomach empties).
• Inflammation of the coloured part of the eye (iris) (painful, red eyes with possible changes in vision).

Rare adverse effects (may affect up to 1 in 1,000 people):

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach).
• Abnormal liver function tests have been reported. These can only be diagnosed by blood tests.

During post-marketing use, the following adverse effects have been reported:

• Very rare: Consult your doctor if you have ear pain, ear discharge, 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 beginning of treatment, a mild 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 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 via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point in your pharmacy. If you are unsure, 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 Risedronato Semanal 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 components (excipients) are:

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

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

Nature of the product and contents of the container

Risedronato Semanal Combix 35 mg film-coated tablets are round, bevelled, biconvex, orange-coloured tablets with the inscription “35” on one side and smooth on the other. The tablets are supplied in blisters, in packs of 4 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer 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

Date of the most recent revision of this leaflet: May 2022

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