RISEDRONATE WEEKLY NORMON 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Weekly Normon 35 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 doubts, 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.

Contents of the Package Leaflet:

1. What is Risedronate Weekly Normon and what is it used for
2. What you need to know before taking Risedronate Weekly Normon
3. How to take Risedronate Weekly Normon
4. Possible side effects
5. Storage of Risedronate Weekly Normon
6. Package Contents and Additional Information

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

What is Risedronate Weekly Normon

Risedronate Weekly Normon 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, becoming more fragile and prone to fractures after a fall or twist.

Men can also suffer from osteoporosis 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. 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 is Risedronate Weekly Normon used for

This medication is used to treat osteoporosis:

• in women after menopause, even if the osteoporosis is severe. It reduces the risk of vertebral and hip fractures;
• in men.

2. What you need to know before taking Risedronate Weekly Normon

• Do not take Risedronate Weekly Normon

• If you are allergic (hypersensitive) to sodium risedronate 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 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 Weekly Normon:

• If you cannot remain upright (sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders, which can cause 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. At some point, 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 that line the lower part of the esophagus).
• If your doctor has informed you that you have an intolerance to certain sugars (such as lactose).
• If you have had or have jaw pain, swelling, or numbness, or tooth loss.
• If you are undergoing dental treatment or will undergo dental surgery, inform your dentist that you are being treated with this medication.

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

• Taking Risedronate Weekly Normon with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

• calcium
• magnesium
• aluminum (e.g., some medication for indigestion)
• iron

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

• Taking Risedronate Weekly Normon with food and drinks

It is very important that you do not take Risedronate Weekly Normon with food or drinks (other than water). In particular, do not take this medication at the same time as dairy products (such as milk), as they contain calcium (see section 2, Use of other medications).

Do not consume food, drinks (except water), or other medications for at least 30 minutes after taking this medication.

• Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Only women after menopause and men can take Risedronate Weekly Normon.

• Driving and using machines

It is unknown whether this medication affects the ability to drive or use machines.

• Risedronate Weekly Normon contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Risedronate Weekly Normon

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

The normal dose is 1 tablet of Risedronate Weekly Normon (35 mg of sodium risedronate) once a week.

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

To facilitate taking the tablet on the same day each week, there are boxes on the outer packaging of this medication for you to mark the day of the week you have chosen to take the Risedronate Weekly Normon tablet. Also, write down the dates you will take the tablet.

When to take your Risedronate Weekly Normon tablet

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

How to take your Risedronate Weekly Normon tablet

• Take the tablet while standing or sitting upright to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water. It is very important that you do not take Risedronate Weekly Normon with food or drinks (except plain water), so that the medication works correctly.
• Swallow the tablet whole (without chewing or sucking it).
• Do not lie down for at least 30 minutes after taking the tablet.

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

• Use in children and adolescents

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

• Use in people over 65 years

No dose modification is required.

• Patients with kidney problems

If you have mild to moderate kidney function problems, no dose modification is required. If you have severe kidney problems, you should not take this medication (see section 2, Do not take Risedronate Weekly Normon).

If you take more Risedronate Weekly Normon 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 someone else has accidentally taken more Risedronate Weekly Normon tablets than prescribed, drink a full glass of milk and consult your doctor. The symptoms of overdose include a decrease in the amount of calcium in the body, whose signs and symptoms include tingling in the fingers of the hands and feet and around the mouth, muscle spasms, convulsions, and life-threatening situations such as spasms of the vocal cords and irregular heartbeat.

• If you forget to take Risedronate Weekly Normon

If you have forgotten to take the tablet on the chosen day, take it on the day you remember. And 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 stop treatment with Risedronate Weekly Normon

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

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

4. Possible side effects

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

Stop treatment with sodium risedronate and inform your doctor immediatelyif you experience any of the following:

• Characteristic symptoms of allergic inflammation (angioedema):
  • 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 (genitals) (Stevens-Johnson syndrome),
  • Red patches on the skin (leukocytoclastic 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 immediatelyif you experience any of the following side effects:

• Eye inflammation, 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, "Be careful and consult your doctor before starting to take Risedronate Weekly Normon").
• Symptoms in the esophagus such as pain and difficulty swallowing, chest pain, and heartburn (or worsening of heartburn if it already exists).

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, stomach pain, upset stomach or discomfort, constipation, feeling of fullness, 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 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 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 through blood tests.

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.

During post-marketing experience, the following side effects have been reported (frequency unknown):

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

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.

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 (AEMPS) Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Risedronate Weekly Normon

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Risedronate Weekly Normon

The active ingredient is sodium risedronate. Each tablet contains 35 mg of sodium risedronate (equivalent to 32.5 mg of risedronic acid).

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

Appearance and package contents

Risedronate Weekly Normon is presented in the form of orange film-coated tablets marked with R35. Each package contains 4 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this package leaflet:January 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/