Risedronate weekly Normon 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Risedronato semanal Normon 35 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, as 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What Risedronato semanal Normon is and what it is used for
2. What you need to know before taking Risedronato semanal Normon
3. How to take Risedronato semanal Normon
4. Possible adverse effects
5. How to store Risedronato semanal Normon
6. Contents of the pack and other information

1. What Risedronato semanal Normon is and what it is used for

What Risedronato semanal Normon is

Risedronato semanal Normon 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 thereby 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 bone begins to weaken, becomes more fragile, and fractures are more likely to occur following a fall or minor injury.

Osteoporosis can also affect men due to various causes, including aging and/or low levels of the male hormone testosterone.

The most common bone fractures occur in the spine, hip, and wrist, although they can occur in any bone of the body. Osteoporosis-related fractures may also cause back pain, loss of height, and a stooped posture. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronato semanal Normon is used for

This medicine is used for the treatment of osteoporosis:

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

2. What you need to know before taking Risedronato semanal Normon

• Do not take Risedronato semanal Normon

• If you are allergic (hypersensitive) to sodium risedronate or to any of the other ingredients of this medicine (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 could be pregnant or are planning 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 semanal Normon:

• If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.
• If you have bone disorders or problems with mineral metabolism (for example, vitamin D deficiency, parathyroid hormone disorders, which may cause low blood calcium levels).
• If you have previously had problems with your esophagus (the tube connecting the mouth to the stomach). At some point, you may have experienced pain or difficulty swallowing food, or have been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining 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 currently have pain, swelling, or numbness in the jaw, jaw pain, or tooth loss.
• If you are undergoing dental treatment or are scheduled to have a dental procedure, inform your dentist that you are being treated with this medicine.

If you have any of the conditions listed above, inform your doctor before taking this medicine.

• Taking Risedronato semanal Normon with other medicines

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

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

• calcium
• magnesium
• aluminium (e.g. some medicines for indigestion)
• iron

Take these medicines at least 30 minutes after taking Risedronato semanal Normon.

• Taking Risedronato semanal Normon with food and drinks

It is very important NOT to take Risedronato semanal Normon with food or with 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, Use with other medicines).

DO NOT consume food, drinks (except water), or other medicines for at least 30 minutes after taking this medicine.

• Pregnancy and breastfeeding

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

DO NOT take this medicine if you could be pregnant or are planning to become pregnant (see section 2, Do not take Risedronato semanal Normon). The potential risk associated with the use of sodium risedronate in pregnant women is unknown.

DO NOT take this medicine if you are breastfeeding (see section 2, Do not take Risedronato semanal Normon).

Risedronato semanal Normon may only be taken by postmenopausal women and men.

• Driving and using machines

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

• Risedronato semanal Normon contains lactose and sodium

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Risedronate Weekly Normon

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Recommended dose:

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

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

To help you remember to take the tablet on the same day every week, there are boxes on the outer packaging of this medicine where you can mark the day of the week you have chosen for taking the tablet of Risedronate Weekly Normon. Also, write down the dates on which you will take the tablet.

When to take your Risedronate Weekly Normon tablet

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

How to take your Risedronate Weekly Normon tablet

• Take the tablet while in an upright position (either sitting or standing) to avoid stomach irritation.
• 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 beverages (except if this beverage is plain water), so that the medicine works properly.
• Swallow the tablet whole (do not chew or suck it).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you need to take calcium and vitamin D supplements if your dietary intake of these is insufficient.

• Use in children and adolescents

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

• Use in elderly patients over 65 years of age

No dose adjustment is required.

• Patients with kidney problems

If you have mild to moderate kidney function impairment, no dose adjustment is required. If you have severe kidney problems, you must not take this medicine (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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you or someone else has accidentally taken more tablets of Risedronate Weekly Normon than prescribed, drink a full glass of milk and seek medical attention immediately. Symptoms of overdose include decreased calcium levels in the body, whose signs and symptoms include tingling in the fingers and toes and around the mouth, muscle spasms, seizures, and life-threatening conditions such as laryngospasm and irregular heartbeat.

• If you forget to take Risedronate Weekly Normon

If you forget to take the tablet on your chosen day, take it as soon as you remember. Then take the next tablet one week later on your usual day. Do not take two tablets on the same day to make up for a missed dose.

• If you stop taking Risedronate Weekly Normon

If you stop taking this medicine, you may begin to lose bone mass. Please consult your doctor before deciding to discontinue treatment.

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

4. Possible adverse effects

Like all medicines, Risedronate Weekly Normon may cause adverse effects, although not everyone gets them.

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

• Symptoms characteristic 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),
  • Palpable red spots on the skin (leukocytoclastic vasculitis),
  • Red rash in many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor immediately if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often following dental extraction (see section 2, “Take special care with and consult your doctor before starting Risedronate Weekly Normon”).
• Esophageal symptoms such as pain and difficulty swallowing, chest pain, and heartburn (or worsening of heartburn if already present).

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

Common adverse 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 adverse effects (may affect up to 1 in 100 people)

Inflammation or ulceration of the esophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing (see also section 2, Warnings and precautions), inflammation of the stomach and duodenum (the intestine into which the stomach empties).

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

Rare adverse effects (may affect up to 1 in 1,000 people)

Inflammation of the tongue (swollen, red, possibly painful), narrowing of the esophagus (the tube connecting the mouth to the stomach).

Abnormal liver function tests, which can only be diagnosed by blood tests, have been reported.

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

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

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

Atypical femoral fractures (thigh bone) which may occur rarely, especially in patients on long-term osteoporosis treatment. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

Very rare adverse effects

Consult your doctor if you have ear pain, drainage from the ear, or suffer an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of 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 leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Semanal Normon

The active substance 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 of the product and contents of the pack

Risedronate Semanal Normon is presented as orange film-coated tablets marked with R35. Each pack contains 4 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: January 2022

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