RISEDRONATE NORMON 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Normon 75 mg Film-Coated Tablets EFG

Sodium risedronate

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Risedronate Normon is and what it is used for
2. What you need to know before taking Risedronate Normon
3. How to take Risedronate Normon
4. Possible side effects
5. Storage of Risedronate Normon
6. Contents of the pack and further information.

1. What Risedronate Normon is and what it is used for

What is Risedronate Normon

Risedronate belongs to a group of non-hormonal medications 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 occurs in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely 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. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What Risedronate Normon is used for

This medication is used to treat osteoporosis in postmenopausal women.

2. What you need to know before taking Risedronate Normon

Do not take Risedronate Normon

• If you are allergicto sodium risedronate 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 may be pregnantor if you 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 Normon:

• If you cannot remain upright, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, both causing low calcium levels in the blood).
• If you have had problems with your esophagus (the tube that connects the mouth to the stomach) in the past. You may have had pain or difficulty swallowing food, or you may have been previously diagnosed with Barrett's esophagus (a disease associated with changes in the cells that line the lower esophagus).
• If you have had or have pain, swelling, or numbness in the jaw or "a strong discomfort in the 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 receiving treatment with this medication.

Your doctor will advise you what to do if you take this medication and have any of the above problems.

Children and adolescents

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) due to insufficient data on its safety and efficacy.

Taking Risedronate Normon with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication. Medications containing any of the following substances reduce the effect of risedronate sodium when taken at the same time:

• Calcium.
• Magnesium.
• Aluminum (e.g., some medications for indigestion).
• Iron.

Take these medications at least 30 minutes after taking Risedronate Normon.

Taking Risedronate Normon with food and drinks

It is very important that you do not take Risedronate Normon with food or drinks (other than tap water) as they may interfere. 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 Risedronate Normon with other medications).

Take food and drinks (other than tap water) at least 30 minutes after taking this medication.

Pregnancy and breastfeeding

Do not take this medication if you may be pregnant, are pregnant, or plan to become pregnant (see section 2, Do not take Risedronate Normon). The potential risk associated with the use of risedronate sodium (the active ingredient in Risedronate Normon) in pregnant women is unknown.

Do not take this medication if you are breastfeeding (see section 2, Do not take Risedronate Normon).

This medication should only be used in postmenopausal women.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It is unknown whether Risedronate Normon affects the ability to drive and use machines.

Risedronate Normon contains sodium

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

3. How to take Risedronate Normon

Follow the instructions for administration of this medication indicated by your doctor. If you are in doubt, consult your doctor again.

The recommended dose is:

Risedronate Normon tablets should be taken two days a month, and always on the SAME two consecutive 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. Take ONE Risedronate Normon 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 a sticker.

You can also write the date on the space provided on the back of the medication package.

When to take Risedronate Normon tablets

Take the risedronate tablet at least 30 minutes before the first meal, drink of the day (except if it is tap water) or other medication of the day.

How to take your Risedronate Normon tablet

• Take the tablet while in an upright position, either sitting or standing, to avoid heartburn.
• 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 chew or suck it.
• Do not lie down for at least 30 minutesafter taking 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 Risedronate Normon than you should

If you or someone else has accidentally taken more Risedronate Normon tablets than prescribed, drink a full glass of milkand consult your doctor.

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 ingested.

If you forget to take Risedronate Normon

In any case:

• If you forget your Risedronate Normon dose 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 Normon

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

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

4. Possible side effects

Like all medications, Risedronate Normon can cause side effects, although not everyone will experience them.

• Stop taking Risedronate Normon and consult your doctor immediately if you experience any of the following symptoms:
• Symptoms of a severe allergic reaction such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

• Severe skin reactions such as:

• Blisters on the skin, mouth, eyes, and other moist surfaces of the body (genital areas) (Stevens-Johnson syndrome).
• Red patches on the skin (leucocytoclastic vasculitis).
• Rash on many parts of the body and/or loss of the outer layer of the skin (toxic epidermal necrolysis)

Tell your doctor promptlyif you experience 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 tooth extraction (see section 2, "Warnings and Precautions").
• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or worsening of heartburn.

Atypical fractures of the femur (thigh bone) can occur rarely, 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 these may be early symptoms of a possible femur fracture.

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

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

Indigestion, nausea, vomiting, stomach pain, discomfort or cramps in the stomach, heavy digestion, constipation, feeling of fullness, abdominal distension, diarrhea.

Pain in 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 (intestine where the stomach empties).

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

Fever and/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 tests have been reported. This can only be diagnosed through blood tests.

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

• Cases of hair loss.
• Liver disorders, in some cases severe.
• Inflammation of small blood vessels.

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

Very rare side effects

Consult 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.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medicines and Healthcare Products Agency Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Risedronate Normon

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Risedronate Normon

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

The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and red iron oxide (E172).

Appearance of the product and contents of the pack

Risedronate Normon is presented in the form of film-coated tablets, pink in color and marked. Each package contains 2 tablets.

Other presentations

Risedronate Normon weekly 35 mg film-coated tablets EFG.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of the package leaflet: March 2022

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