Product Information for the User

Risedronate WeeklyQualigen35 mg Coated Tablets

Risedronate Sodium

Read this leaflet carefully before you start taking this medicinebecause 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 or pharmacist.
• This medicine has been prescribed for you onlyand you must not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

• 1.What Risedronate Weekly Qualigen 35 mg Coated Tablets are and what they are used for
• 2. What you need to know before you start taking Risedronate Weekly Qualigen 35 mg Coated Tablets
• 3.How to take Risedronate Weekly Qualigen 35 mg Coated Tablets
• 4.Possible side effects
• 5.Storage of Risedronate Weekly Qualigen 35 mg Coated Tablets
• 6. Contents of the pack and additional information

What isRisedronateWeeklyQualigen35 mg

RisedronateWeeklyQualigen35 mg belongs to a group of non-hormonalmedicationsdenominatedbisphosphonates, which are used for the treatment ofbonediseases.It acts directly on the bonesstrengtheningthem, and therefore, reduces the probability of fractures.

The bone is a living tissue.Theold boneof the skeleton is constantly being renewedandreplacedby new bone.

Postmenopausal osteoporosisappears in womenafter menopausewhenthe bonebegins toweaken,becomes more fragile andfractures are more likely to occur aftera falloratwist.

Osteoporosis can alsobesufferedby mendue tonumerous causes,including agingand/oralowlevelof the male hormone, testosterone.

The most likely bone fractures are those of the vertebrae,hip and wrist,althoughit canoccur in any bone of thebody.Bone fractures associated with osteoporosis can also produce back pain, height loss, and curved back.Some patients with osteoporosis do not have symptoms and maynot even know they have it.

For what it is usedRisedronateWeeklyQualigen35 mg

Risedronateis used for the treatment ofosteoporosis in women after menopause andreduces the risk of fractures.

It is also used for the treatment of osteoporosis inmenwith a high riskof fracture.

Do not takeRisedronate Weekly Qualigen 35 mg

• if you are allergic to risedronate sodium or any of the other ingredients 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 are pregnant or plan to become pregnant,
• if you are breastfeeding,
• if you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Weekly Qualigen 35 mg.

• If you cannot remain seated or standing for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations) that may cause low calcium levels in the blood.
• If in the past you have had esophagus problems (the tube that connects the mouth to the stomach).You may have haddifficulty swallowing food,or if you have previously been diagnosed with Barrett's esophagus (a disease associated with changes in the cells of the lower part of the esophagus).

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

If you have any of the problems mentioned above, inform your doctor BEFORE taking this medication.

Taking Risedronate Weekly Qualigen 35 mg with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Few medications are known to interfere with the effects of risedronate sodium.

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

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

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

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

Taking Risedronate Weekly Qualigen 35 mg with 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).Particularly, do not take this medication at the same time as dairy products (such as milk) as they contain calcium (see section 2).

Do not consume food, drinks (except water) and other medications for at least 30 minutes after taking Risedronate Weekly Qualigen 35 mg.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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 operating machinery

Risedronate Weekly Qualigen 35 mgdoes not affect the ability to drive or operate machinery.

This medication contains lactose

If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

The normal dose is one tablet of Risedronato Semanal Qualigen 35 mg (35 mg of risedronate sodium) once a week.

Choose the day of the week that best suits your schedule.Take the Risedronato Semanal Qualigen 35 mg tablet on the chosen day each week.

To facilitate taking the tablet on the same day every week, there are boxes in the packaging.Mark the day of the week that you have already chosen to take the Risedronato Semanal Qualigen 35 mg tablet.Also, write down the dates when you will take the tablet.

Seniors

No dose adjustments are required.

Patients with kidney problems

No dose adjustments are required if you have mild to moderate kidney function impairment.If you have severe kidney function impairment, you should not use Risedronato Semanal Qualigen 35 mg.

Children and adolescents

Risedronato Semanal Qualigen 35 mg is not recommended for use in children under 18 years and adolescents.

When to take your Risedronato Semanal Qualigen 35 mg tablet

Take the risedronate tablet at least 30 minutes before the first meal, drink (except in the case of water) or other medication of the day.

How to take your Risedronato Semanal Qualigen 35 mg tablet

• Take the tablet while standing upright (either sitting or standing).This prevents heartburn (sensation of burning in the throat).
• Swallow the tablet with at least one glass (120 ml) of water.It is very important that Risedronato Semanal Qualigen 35 mg not be taken with food or drinks (except in the case of water), so that it can function properly.
• Swallow the tablet whole.Do not chew or crush the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will indicate if you should take calcium and vitamin D supplements.You may need to take them if the amount you take in your diet is not sufficient.

If you take more Risedronato Semanal Qualigen 35 mg than you should

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

If you or another person have 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 or abdominal cramps.

If you forgot to take Risedronato Semanal Qualigen 35 mg

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

If you interrupt treatment with Risedronato Semanal Qualigen 35 mg

The usual treatment for osteoporosis is necessary for long periods.Speak with your doctor before interrupting treatment.If you stop taking the treatment, you will no longer receive its benefits and you may start losing bone mass again.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor quickly if you experience symptoms in the esophagus, such as pain or difficulty swallowing, chest pain or new or worsening stomach burning.

The side effects observed were generally mild and did not cause the patient to interrupt treatment.

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

Constipation, upset stomach (dyspepsia), indigestion, nausea, stomach pain, diarrhea.Bone or muscle pain.Headache.

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

Inflammation or ulcer of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing.Inflammation or ulcer of the stomach and/or duodenum (intestine where the stomach empties).

Consult 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 test results, which can only be diagnosed through a blood test. Atypical femur fractures, which may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early signs of a possible femur fracture.

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

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

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

Consult your doctor if you have ear pain, your ear is discharging, or you have an ear infection. These may be symptoms of damage to the bones of the ear.

Unknown frequency

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

Osteonecrosis (bone tissue death) in the jaw.

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

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this prospectus. You can also report side effects through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date appearing on the blister and packaging.

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

Composition ofRisedronate Weekly Qualigen 35 mg

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

Tablet core: pregelatinized cornstarch, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-572).

Tablet coating:hypromellose (E-464), lactose monohydrate, titanium dioxide (E171), Macrogol 4000 (E-1521).

Product appearance and packaging contents

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

Risedronate Weekly Qualigen 35 mg is presented in a blister pack containing 4 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona- Spain

Responsible for manufacturing

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 with the following names:

DenmarkEllidronate

SpainRisedronate Weekly Qualigen 35mg film-coated tablets EFG

Revision date of thisleaflet:April 2021

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