Package Insert: Information for the Patient

Risedronate Farma Qualigen75 mg Film-Coated Tablets

Risedronate sodium

Read this entire 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, pharmacist, or nurse.

-This medication has been prescribed for you only, 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, pharmacist, or nurse, even if they are not listed in this package insert.

1. What Risedronate Farma Qualigen 75 mg is and what it is used for

2. What you need to know before starting to 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 additional information

Risedronato Farma Qualigen 75 mg

Risedronato Farma Qualigen 75 mg 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 fractures.

The 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 appears in women after menopause when 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. Fractures related to osteoporosis 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 Risedronato Farma Qualigen 75 mg used for

For the treatment of osteoporosis in women after menopause.

Do not take Risedronato Farma Qualigen 75mg

• If you are allergic to risedronate sodium or any of the other components of this medication (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 may be pregnant, if you are pregnant, or if you 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 Risedronato Farma Qualigen 75mg

?If you cannot 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 alterations, which cause low blood calcium levels).

?If you have had problems with the esophagus (the tube that connects the mouth to the stomach) in the past. For example, you may have had difficulty swallowing food or if you have been previously informed that you haveBarrett's esophagus (a disease associated with changes in the cells of the lower part of the esophagus).

?If you have had or have jaw pain, swelling, or numbness, or a “heavy feeling in the jaw” or if a tooth has moved.

• If you are undergoing dental treatment or are about to undergo a dental surgical intervention, inform your dentist that you are receiving treatment with Risedronato Farma Qualigen 75 mg.

Your doctor will advise you what to do if you take Risedronato Farma Qualigen 75 mg and have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for children under 18 years of age due to a lack of safety and efficacy data.

Taking Risedronato Farma Qualigen 75mg with other medications

Medications that contain any of the following substances reduce the effect of Risedronato Farma Qualigen 75 mg if taken at the same time:

• calcium
• magnesium
• aluminum (for example, some antacids)
• iron.

Take these medications at least 30 minutes after taking your Risedronato Farma Qualigen 75 mg tablet.

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

Taking Risedronato Farma Qualigen 75mg with food and drinks

It is very important that you DO NOT take your Risedronato Farma Qualigen 75mg tablet with food or drinks (other than water) so that it can work correctly. In particular, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Taking Risedronato Farma Qualigen 75mg with other medications”).

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

Pregnancy and breastfeeding

DO NOT take Risedronato Farma Qualigen 75mg if you may be pregnant, if you are pregnant, or if you plan to become pregnant (see section 2, “Do not take Risedronato Farma Qualigen 75mg”). The risk associated with the use of risedronate sodium (active ingredient of Risedronato Farma Qualigen 75mg) in pregnant women is unknown.

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

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

Driving and operating machinery

Risedronato Farma Qualigen 75mg has no known effect on the ability to drive and use machines.

Risedronato Qualigen Farma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Usual dose:

Risedronato Farma Qualigen 75mg tablets should be taken TWO days in a row per MONTH, and always on the SAME two days of each month (for example, the 1st and 2nd days or 15th and 16th of the month).

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

Repeat every month maintaining 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 stickers.

WHEN to take the Risedronato Farma Qualigen 75 mg tablet

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

HOW to take the Risedronato Farma Qualigen 75 mg tablet

• Take the tablet while inan upright position(either sitting or standing) to avoid stomach burning.
• Swallowthe tablet with at least oneglass(120ml)of tap water.Do not take the tablet with mineral wateror 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 minutesaftertaking the tablet.

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

IF you take MORE Risedronato Farma Qualigen 75mg than you should

If you or someone else has accidentally taken more Risedronato Farma Qualigen 75mg tablets than prescribed, drink aglass of milkfull andconsult 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 Farma Qualigen 75mg

In any case:

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

IF you INTERRUPT the treatment with Risedronato Farma Qualigen 75mg

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

If you have any other questions about the use of this medication, ask your doctoror pharmacist.

Like all medications, Risedronate Farma Qualigen 75 mg may cause side effects, although not everyone will experience them.

Stop taking Risedronate and seek medical attention immediatelyif you experience any of the following symptoms:

•Severe allergic reaction symptoms, 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 areas of the body (Stevens-Johnson syndrome)

-Red, palpable spots 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).

Inform your doctor quicklyif you experience any of the following side effects:

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

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

Frequent 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.
• Bone, muscle, or joint pain.
• 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 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 (iris; red, painful eyes with possible vision changes).
• Fever or symptoms similar to the flu.

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).
• Abnormalities in liver tests. This can only be diagnosed by blood tests.

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

• Consult your doctor if you have ear pain, discharge from the ear, or ear infection. These may be symptoms of bone damage in the ear.

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

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

•Hair loss

•Liver disorders, in some cases severe

•Inflammation of small blood vessels

Atypical femoral fractures, which can occur in rare cases, especially 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 of a possible femoral fracture.

If you experience side effects, consult your doctor, pharmacist, or nurse,even if they are side effects that do not appear in this leaflet.

• 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 and on the blister pack after CAD. The expiration date is the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Reporting Adverse Effects

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

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.

Composition of Risedronate Farma Qualigen 75mg

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

- The other components (excipients) are:

Tablet core: microcrystalline cellulose, crospovidone, magnesium stearate.

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

Appearance of the product and contents of the packaging

Risedronate Farma Qualigen 75mg film-coated tablets are film-coated, oblong, and pink. They are presented in a blister pack containing 2, 4, 6, or 8 tablets. Some pack sizes may only be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

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

Spain

Responsible for manufacturing:

Bluepharma Industria Farmaceutica S.A.Sâo Martinho do Bispo

3045-016 Coimbra

Portugal

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

FranceRisedronate BGR 75 mg, coated tablet

GermanyRisedronat AL 75 mg Filmtabletten

GreeceBondamax 75

SpainRisedronate Farma Qualigen 75 mg film-coated tablets EFG

ItalyRisedronate DOC

NetherlandsRisedrinaatnatrium BGR 75 mg, film-coated tablets

PortugalRisedronate sodium BGR

This leaflet has been revised in:December 2020

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