Risedronate Farma Qualigen 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronato Farma Qualigen 75 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 questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Contents of this leaflet

1. What Risedronato Farma Qualigen 75 mg is and what it is used for
2. What you need to know before taking Risedronato Farma Qualigen 75 mg
3. How to take Risedronato Farma Qualigen 75 mg
4. Possible side effects
5. How to store Risedronato Farma Qualigen 75 mg
6. Contents of the pack and other information

1. What Risedronate Farma Qualigen is and what it is used for

What is Risedronate Farma Qualigen 75 mg

Risedronate Farma Qualigen 75 mg 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 risk of fractures.

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

Postmenopausal osteoporosis is a condition that occurs in women after menopause, when bones begin to weaken, become more fragile, and are more likely to fracture following a fall or twist.

The most common fractures associated with osteoporosis occur in 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. Many patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronate Farma Qualigen 75 mg is used for

For the treatment of osteoporosis in women after menopause.

2. What you need to know before taking Risedronate Farma Qualigen 75 mg

Do not take Risedronate Farma Qualigen 75 mg

• 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 hypocalcemia (low calcium levels in the blood)
• If you could be pregnant, are pregnant, or are planning to become pregnant
• If you are breastfeeding
• If you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronate Farma Qualigen 75 mg

? If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.

? If you have bone or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone disorders, which cause low blood calcium levels).

? If you have previously had esophageal problems (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or have been diagnosed with Barrett's esophagus (a condition associated with changes in the cells of the lower esophagus).

? If you have had or currently have pain, swelling, or numbness in the jaw, or a "heavy sensation" in the jaw, or if a tooth becomes loose.

• If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are taking Risedronate Farma Qualigen 75 mg.

Your doctor will advise you on what to do if you are taking Risedronate Farma Qualigen 75 mg and have any of the conditions mentioned above.

Children and adolescents

Sodium risedronate is not recommended for use in individuals under 18 years of age due to lack of safety and efficacy data.

Taking Risedronate Farma Qualigen 75 mg with other medicines

Medicines containing any of the following substances reduce the effect of Risedronate Farma Qualigen 75 mg if taken at the same time:

• calcium
• magnesium
• aluminium (e.g. some antacid mixtures)
• iron.

Take these medicines at least 30 minutes after taking your Risedronate Farma Qualigen 75 mg tablet.

Inform your doctor or pharmacist if you are taking or using, have recently taken or used, or might need to take or use any other medicines.

Taking Risedronate Farma Qualigen 75 mg with food and drink

It is very important that you do NOT take your Risedronate Farma Qualigen 75 mg tablet with food or drinks (other than plain water) so that it can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, "Taking Risedronate Farma Qualigen 75 mg with other medicines").

Take food and drinks (other than plain water) at least 30 minutes after taking your Risedronate Farma Qualigen 75 mg tablet.

Pregnancy and breastfeeding

DO NOT take Risedronate Farma Qualigen 75 mg if you could be pregnant, are pregnant, or are planning to become pregnant (see section 2, "Do not take Risedronate Farma Qualigen 75 mg"). The risk associated with the use of sodium risedronate (the active substance in Risedronate Farma Qualigen 75 mg) in pregnant women is unknown.

DO NOT take Risedronate Farma Qualigen 75 mg if you are breastfeeding (see section 2, "Do not take Risedronate Farma Qualigen 75 mg").

Risedronate Farma Qualigen 75 mg should only be used to treat postmenopausal women.

Driving and using machines

Risedronate Farma Qualigen 75 mg has no known effect on the ability to drive or operate machinery.

Risedronate Farma Qualigen contains sodium

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

3. How to take Risedronate Farma Qualigen 75 mg

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

Usual dose:

Risedronate Farma Qualigen 75 mg tablets should be taken on TWO consecutive days per MONTH, always on the SAME two days each month (for example, days 1 and 2 or 15 and 16 of the month).

Choose the TWO consecutive days that best fit your schedule to take this medicine. Take ONE tablet of Risedronate Farma Qualigen 75 mg in the morning on the first chosen day. Take the SECOND tablet the following morning.

Repeat this every month, keeping the same two consecutive days. To help you remember when to take the tablets again, you may mark them on your calendar with a pen or stickers.

WHEN to take the Risedronate Farma Qualigen 75 mg tablet

Take the Risedronate Farma Qualigen 75 mg tablet at least 30 minutes before your first meal, drink (except tap water), or other medicine of the day.

HOW to take the Risedronate Farma Qualigen 75 mg tablet

• 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 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 advise you whether you should take calcium and vitamin supplements if the amount you get from your diet is not sufficient.

If you take MORE Risedronate Farma Qualigen 75 mg than you should

If you or someone else has accidentally taken more tablets of Risedronate Farma Qualigen 75 mg 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 Poison Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you FORGET to take Risedronate Farma Qualigen 75 mg

In any case:

• If you forget your dose of Risedronate Farma Qualigen 75 mg in the morning, DO NOT take it later during the day.
• DO NOT take three tablets in the same week.

If you INTERRUPT treatment with Risedronate Farma Qualigen 75 mg

If you stop taking the medication, you may begin to lose bone mass. Please consult your doctor before deciding to interrupt 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, Risedronate Farma Qualigen 75 mg can cause adverse effects, although not everyone experiences them.

Stop taking Risedronate and see a doctor immediately if you experience any of the following symptoms:

• Symptoms of a severe allergic reaction such as:
  • Swelling of the face, lips, tongue, throat or neck
  • Difficulty swallowing
  • Difficulty breathing
  • Rash, skin eruption
• Severe skin reactions such as:
  • Appearance of blisters on the skin, mouth, eyes, and other moist surfaces of the body (genitals) (Stevens-Johnson syndrome)
  • Palpable red spots on the skin (leukocytoclastic vasculitis)
  • Red rash in many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor promptly if you experience any of the following adverse effects:

• Eye inflammation, 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”).
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, and onset or worsening of heartburn.

However, in clinical studies, other adverse effects observed were generally mild and did not cause patients to discontinue treatment.

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

• Indigestion, nausea, vomiting, stomach pain, stomach discomfort or cramps, constipation, feeling of fullness, abdominal distension, diarrhea.
• Bone, muscle or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (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 duodenum (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris; painful red eyes with possible changes in vision).
• Fever or flu-like symptoms.

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

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the tube connecting the mouth to the stomach).
• Liver function test abnormalities have been reported. These can only be diagnosed by a blood test.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Consult your doctor if you have ear pain, ear discharge, or ear infection. These could be symptoms of damage to the ear bones.

Rarely, at the beginning of treatment, blood levels of calcium and phosphate may decrease in some patients. These changes are usually minor and do not cause symptoms.

During post-marketing use, the following adverse effects have been reported (frequency not known):

• Hair loss
• Liver disorders, in some cases severe
• Inflammation of small blood vessels

Atypical femoral fractures (thigh bone), which may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

5. Storage of Risedronate Farma Qualigen 75 mg

• 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 and on the blister after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet.

You may also report adverse reactions directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

6. Contents of the pack and other information

Composition of Risedronato Farma Qualigen 75mg

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

• The other components (excipients) are:

Tablet core: microcrystalline cellulose, crospovidone, magnesium stearate.

Film coating: Opadry II pink [polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), iron oxide red (E172)].

Appearance of the product and pack contents

Risedronato Farma Qualigen 75 mg film-coated tablets are pink, oblong, film-coated tablets. They are available in blister packs containing 2, 4, 6 or 8 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69. 08970 Sant Joan Despí, Barcelona

Spain

Manufacturer:

Bluepharma Industria Farmacêutica S.A. São Martinho do Bispo 3045-016 Coimbra Portugal

or

LACHIFARMA S.P.A. LABORATORIO CHIMICO FARMACEUTICO SALENTINO Zona industriale Strada statale 16 73010 Zollino Italy

This medicine is authorized in the European Economic Area member states under the following names:

France: Risedronato BGR 75 mg, comprimé pelliculé
Germany: Risedronat AL 75 mg Filmtabletten
Greece: Bondamax 75
Spain: Risedronato Farma Qualigen 75 mg comprimidos recubiertos con película EFG
Italy: Risedronato DOC
Netherlands: Risedrinaatnatrium BGR 75 mg, filmomhulde tabletten
Portugal: Risedronato de sódio BGR

This leaflet has been reviewed in: August 2025

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