RISEDRONATE WEEKLY QUALIGEN 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

RisedronateWeeklyQualigen35 mg film-coated tabletsEFG

Risedronate sodium

Read the entire package leaflet carefully before starting to take thismedicine, as it contains important information for you.

• Keep this package 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 to you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

• 1.What is Risedronate Weekly Qualigen 35 mg film-coated tablets and what is it used for
• 2. What you need to know before taking Risedronate Weekly Qualigen 35 mg film-coated tablets
• 3.How to take Risedronate Weekly Qualigen 35 mg film-coated tablets
• 4.Possible side effects
• 5.Storage of Risedronate Weekly Qualigen 35 mg film-coated tablets
• 6. Package contents and further information

1. What is Risedronate Weekly Qualigen 35 mg film-coated tablets and what is it used for

What isRisedronateWeeklyQualigen35 mg

Risedronate Weekly Qualigen 35 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 thus reduces 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 the bone begins to weaken, becomes more fragile, and fractures are more likely to occur after a fall or twist.

Osteoporosis can also affect men due to various causes, including aging and/or low levels of the 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. Fractures associated with osteoporosis 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 isRisedronateWeeklyQualigen35 mgused for

Risedronate is used to treat osteoporosis in postmenopausal women and reduces the risk of fractures.

It is also used to treat osteoporosis in men with a high risk of fracture.

2. What you need to know before taking Risedronate Weekly Qualigen 35 mg film-coated tablets

Do not takeRisedronateWeeklyQualigen35 mg

• if you are allergic to risedronate sodium 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 (you have low levels of calcium in your blood),
• if you may be pregnant or plan 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 Qualigen 35 mg.

• If you cannot sit or stand up for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders) that may cause low blood calcium levels.
• If you have had esophagus problems in the past (the tube that connects the mouth to the stomach). You may have had pain or difficulty swallowing food, or you may have been diagnosed with Barrett's esophagus (a disease associated with changes in the cells of the lower esophagus).

• If you have gastritis.
• If your doctor has told you that you have an intolerance to certain sugars (such as lactose).
• If you have had jaw pain, inflammation, or numbness, or tooth loss.
• If you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are being treated with risedronate sodium.

If you have any of the above problems, tell your doctor BEFORE taking this medicine.

Taking Risedronate Weekly Qualigen 35 mg with other medicines

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

There are few medicines that interfere with the effects of risedronate sodium.

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

• calcium,
• magnesium,
• aluminum,
• iron.

Take these medicines at least 30 minutes after taking risedronate sodium.

Risedronate sodium can be used with estrogen supplements (in women).

TakingRisedronateWeeklyQualigen35 mgwith food, drinks, and alcohol

It is very important that you DO NOT take Risedronate Weekly Qualigen 35 mg with food or drinks (other than water). In particular, do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2).

DO NOT consume food, drinks (except water), or other medicines for at least 30 minutes after taking Risedronate Weekly Qualigen 35 mg.

Pregnancy, breastfeeding, and fertility

Talk to your doctor or pharmacist before taking any medicine.

Do not take risedronate sodium if you may be pregnant or plan to become pregnant (see section 2).

Do not take risedronate sodium if you are breastfeeding (see section 2).

Risedronate sodium can only be used in postmenopausal women.

Driving and using machines

Risedronate Weekly Qualigen 35 mg does not affect your ability to drive or use machines.

This medicine contains lactose

If your doctor has told you that you have an intolerance to certain sugars, talk to them before taking this medicine.

3. How to take Risedronate Weekly Qualigen 35 mg film-coated tablets

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The usual dose is one Risedronate Weekly Qualigen 35 mg tablet (35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronate Weekly Qualigen 35 mg tablet on the chosen day.

To facilitate taking the tablet on the same day each week, there are boxes on the package. Mark the day of the week you have chosen to take the Risedronate Weekly Qualigen 35 mg tablet. Also, write down the dates when you will take the tablet.

Elderly

No dose adjustment is required.

Patients with kidney problems

No dose adjustment is required if you have mild to moderate kidney function impairment. If you have severe kidney function impairment, you should not use Risedronate Weekly Qualigen 35 mg.

Children and adolescents

Risedronate Weekly Qualigen 35 mg is not recommended for use in children under 18 years of age and adolescents.

When to take your Risedronate Weekly Qualigen 35 mg tablet

Take the risedronate tablet at least 30 minutes before the first food, drink, or other medicine of the day (except for plain water).

How to take your Risedronate Weekly Qualigen 35 mg tablet

• Take the tablet while standing or sitting upright. This prevents heartburn (a burning sensation in the throat).
• Swallow the tablet with at least one glass (120 ml) of plain water. It is very important that you DO NOT take Risedronate Weekly Qualigen 35 mg with food or drinks (except for plain water), so that it can work properly.
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you need to take calcium and vitamin D supplements. This may be necessary if the amount you take in your diet is not sufficient.

If you take moreRisedronateWeeklyQualigen35 mgthan you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you or someone else has accidentally taken a large number of tablets, drink a glass of milk and go to the doctor. The symptoms of overdose include a decrease in the amount of calcium in the body, whose symptoms include muscle cramps or abdominal cramps.

If you forget to takeRisedronateWeeklyQualigen35 mg

If you have forgotten to take your tablet, simply take the tablet on the day you remember. Take the next tablet the following week, on the day you normally take the tablet. Do not take two tablets on the same day to make up for the missed dose (if you have forgotten to take a tablet for a week or more).

If you stop takingRisedronateWeeklyQualigen35 mg

Treatment of osteoporosis is usually necessary for long periods. Talk to your doctor before stopping treatment. If you stop taking the treatment, you will no longer get the benefits of it and may start losing bone mass again.

4. Possible side effects

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

Tell your doctor immediately if you experience symptoms in the esophagus, such as pain or difficulty swallowing, chest pain, or heartburn.

The 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)

Constipation, upset stomach (dyspepsia), indigestion, nausea, stomach pain, diarrhea. Bone or muscle 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 when swallowing. Inflammation or ulceration of the stomach and/or duodenum (intestine where the stomach empties).

Talk to your doctor immediately if you experience any of the following side effects:

Inflammation of the colored part of the eye (red, painful eyes with possible changes in vision).

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 tests have been reported, which can only be diagnosed with a blood test. Atypical fractures of the femur (thigh bone), 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 fracture of the femur.

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

Talk to your doctor immediately if you experience any of the following side effects:

Allergic reactions such as hives (skin rash), swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Severe skin reactions, including blisters (formation of blisters) under the skin.

Talk to 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

Talk to your doctor immediately if you experience any of the following side effects:

Osteonecrosis (death of bone tissue) in the jaw.

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 side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report side effects to the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Qualigen 35 mg film-coated tablets

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date is the last day of the month shown.

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.

6. Package contents and further information

Composition ofRisedronateWeeklyQualigen35 mg

• The active substance is risedronate sodium. Each tablet contains 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.
• The other ingredients are:

Core of the tablet: pregelatinized corn starch, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-572).

Coating of the tablet:hypromellose (E-464), lactose monohydrate, titanium dioxide (E171), Macrogol 4000 (E-1521).

Appearance of the product and package contents

Risedronate Weekly Qualigen 35 mg are film-coated tablets, biconvex, round, white, with a diameter of 11.2 mm, 5.0 mm thick, and with "35" engraved on one side.

Risedronate Weekly Qualigen 35 mg comes in a blister pack containing 4 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

Pharmathen S.A.

Dervenakion 6, Pallini

153 51, Attiki

Greece

or

Pharmathen International S.A.

Sapes Industrial Park

Block 5

69300 Rodopi

Greece

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

Denmark Ellidronat

Spain Risedronato Semanal Qualigen 35mg film-coated tablets EFG

Date of last revision of thispackage leaflet:April 2021

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