RISEDRONATE FARMA QUALIGEN 75 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Risedronate Farma Qualigen 75 mg film-coated tablets EFG

Sodium risedronate

Read the entire summary of product characteristics carefully before you start taking this medicine because it contains important information for you.

• Keep this summary of product characteristics, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse. This includes any possible side effects not listed in this summary of product characteristics.

Contents of the Summary of Product Characteristics

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

1. What is Risedronate Farma Qualigen and what is it 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 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 is a condition that occurs in women after menopause when the bones begin to weaken, become more fragile, and are more likely to fracture 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. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Many patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronate Farma Qualigen 75 mg used for

For the treatment of osteoporosis in postmenopausal women.

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

Do not take Risedronate Farma Qualigen 75 mg

• 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 problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Farma Qualigen 75 mg

If you cannot stay upright (either sitting or standing) for at least 30 minutes.

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

If you have had problems with your esophagus (the tube that connects your mouth to your stomach) in the past. For example, you may have had pain or difficulty swallowing food, or you may have been told that you have Barrett's esophagus (a disease associated with changes in the cells of the lower esophagus).

If you have had or have pain, swelling, or numbness in your jaw or a "heavy feeling" in your jaw, or if a tooth is loose.

• If you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are being treated with Risedronate Farma Qualigen 75 mg.

Your doctor will advise you what to do if you take Risedronate Farma Qualigen 75 mg 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 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
• aluminum (e.g., some antacids)
• iron.

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

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Taking Risedronate Farma Qualigen 75 mg with food and drinks

It is very important that you DO NOT take your Risedronate Farma Qualigen 75 mg tablet with food or drinks (other than plain water) for it to 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 may be pregnant, are pregnant, or plan 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 ingredient 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 and use machines.

Risedronate Qualigen Farma contains sodium

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

3. How to take Risedronate Farma Qualigen 75 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Usual dose:

Risedronate Farma Qualigen 75 mg tablets should be taken TWO consecutive days per MONTH, and always on the SAME two days of each month (e.g., 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 Risedronate Farma Qualigen 75 mg tablet on the morning of the first chosen day. Take the SECOND tablet on the morning of the next day.

Repeat every month, keeping 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 with stickers.

WHEN to take the Risedronate Farma Qualigen 75 mg tablet

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

HOW to take the Risedronate Farma Qualigen 75 mg tablet

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallowthe tablet with at least one glass(120 ml) of plain water.Do not take the tablet with mineral wateror other drinks that are not plain water.
• Swallow the tablet whole.Do not suck or chew it.
• Do not lie down for at least 30 minutesaftertaking the tablet.

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

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

If you or someone else has taken more Risedronate Farma Qualigen 75 mg tablets than prescribed, drink a full glass of milkand go to your 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 Farma Qualigen 75 mg

In any case:

• If you forgot 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 STOP taking Risedronate Farma Qualigen 75 mg

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

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

4. Possible side effects

Like all medicines, Risedronate Farma Qualigen 75 mg can cause side effects, although not everybody gets them.

Stop taking Risedronate and go to your doctor immediatelyif 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:
  • Blisters on the skin, mouth, eyes, or other moist surfaces of the body (Stevens-Johnson syndrome)
  • Red patches on the skin (leucocytoclastic vasculitis)
  • Red rash on many parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis).

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 in the esophagus such as pain when swallowing, difficulty swallowing, chest pain, and worsening of heartburn.

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

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

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

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

• 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"), inflammation of the stomach and duodenum (the intestine where the stomach empties).
• Inflammation of the colored part of the eye (the iris; red eyes, painful with possible change in vision).
• Fever or flu-like symptoms.

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

• Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach).
• Abnormal liver function tests have been reported. This can only be diagnosed with a blood test.

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

• Tell 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.

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

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

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

Atypical fractures of the thigh bone (femur), which can occur rarely, especially in patients on long-term treatment for osteoporosis. Tell 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.

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this summary of product characteristics.

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 carton and blister after EXP. The expiry date is the last day of the month shown.
• No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this summary of product characteristics.

You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es.

6. Contents of the pack and other information

Composition of Risedronate Farma Qualigen 75 mg

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

• The other ingredients (excipients) are:

Core of the tablet: microcrystalline cellulose, crospovidone, magnesium stearate.

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

Appearance of the product and pack contents

Risedronate Farma Qualigen 75 mg film-coated tablets are pink, oblong, film-coated tablets. They are available in blisters containing 2, 4, 6, or 8 tablets. Not all 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 Farmaceutica S.A.

Sâo Martinho do Bispo

3045-016 Coimbra

Portugal

or

LACHIFARMA S.P.A. LABORATORIO CHIMICO FARMACEUTICO SALENTINO

Zona industrial Strada statale 16

73010 Zollino

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

France Risedronate BGR 75 mg, film-coated tablet

Germany Risedronate AL 75 mg film-coated tablets

Greece Bondamax 75

Spain Risedronate Farma Qualigen 75 mg film-coated tablets EFG

Italy Risedronate DOC

Netherlands Risedronate sodium BGR 75 mg, film-coated tablets

Portugal Sodium risedronate BGR

This summary of product characteristics was last revised in:August 2025

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