Risedronate Normon 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronate Normon 75 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, consult 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 adverse effects

5. Storage of Risedronate Normon

6. Contents of the pack and other information

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

What Risedronato Normon is

Risedronate belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It works directly on the bones by strengthening them, 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, becoming more fragile and more prone to fractures following a fall or twist.

The most common bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronato Normon is used for

This medicine is used for the treatment of osteoporosis in postmenopausal women.

2. What you need to know before starting to take Risedronate Normon

Do not take Risedronate Normon

• If you are allergic 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 if you 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 Normon:

• If you are unable to remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone problems or disorders in mineral metabolism (for example, vitamin D deficiency, parathyroid hormone disorders, both of which may cause low blood calcium levels).
• If you have previously had esophageal problems (the tube connecting the mouth to the stomach). This includes having experienced pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett’s esophagus (a condition involving changes in the cells lining the lower esophagus).
• If you have had or currently have pain, swelling, or numbness in the jaw, or a “severe jaw discomfort,” or if a tooth becomes loose.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are receiving treatment with this medicine.

Your doctor will advise you on what to do if you are taking this medicine and have any of the conditions mentioned above.

Children and adolescents

The use of sodium risedronate is not recommended in children and adolescents (under 18 years of age) due to insufficient data on its safety and efficacy.

Taking Risedronate Normon with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines. Medicines containing any of the following substances may 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 Risedronate Normon.

Taking Risedronate Normon with food and drinks

It is very important NOT to take Risedronate Normon with food or with drinks (other than plain water), as they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2, Taking Risedronate Normon with other medicines).

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

Pregnancy and breastfeeding

DO NOT take this medicine if you could 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 sodium risedronate (the active substance in Risedronate Normon) in pregnant women is unknown.

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

This medicine should only be used in postmenopausal women.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unknown whether Risedronate Normon affects the ability to drive or operate machinery.

Risedronate Normon contains sodium

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

3. How to take Risedronate Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

Risedronate Normon tablets should be taken two days per month, always on the SAME two consecutive days each month (for example, 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 in the morning on the first chosen day. Take the SECOND tablet in the morning on the following day.

Repeat this every month, maintaining the same two consecutive days. To help you remember when to take the tablets again, you may mark them on your calendar with a pen or a sticker.

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

When to take Risedronate Normon tablets

Take the risedronate tablet at least 30 minutes before the first food, drink of the day (except if that drink is tap water), or any other medicine of the day.

How to take your Risedronate 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 tap water. Do not take the tablet with mineral water or other beverages that are not plain tap water.
• Swallow the tablet whole. Do not suck or chew it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you should take calcium and vitamin supplements if the amount you obtain from your diet is insufficient.

If you take more Risedronate Normon than you should

If you or someone accidentally takes more risedronate tablets than prescribed, drink a full glass of milk and seek medical advice immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Risedronate Normon

In any case:

• If you have forgotten your morning dose of risedronate, DO NOT take it later during the day.
• DO NOT take three tablets in the same week.

If you stop treatment with Risedronato Normon

If you stop taking this medication, you may begin to lose bone mass. Please consult your doctor before deciding to stop 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 Normon can cause adverse effects, although not everyone will experience them.

• Stop taking Risedronate Normon and contact 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 (genitals) (Stevens-Johnson syndrome).

• Palpable red spots on the skin (leukocytoclastic vasculitis).

• Rash affecting many parts of the body and/or shedding of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor promptly if you experience 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 tooth extraction (see section 2, “Warnings and Precautions”).
• Symptoms affecting the esophagus such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

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

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, vomiting, stomach pain, stomach discomfort or cramps, indigestion, constipation, feeling of fullness, bloating, diarrhea.

Pain in bones, muscles, or joints.

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).

Fever and/or flu-like symptoms.

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 have been reported. This can only be diagnosed by 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 beginning of treatment, a mild decrease in blood phosphate and calcium levels has been observed in some patients. These changes are usually minor and do not cause symptoms.

Very rare adverse 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 of adverse effects

If you experience any type of adverse effect, talk to 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 Normon

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Normon

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

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

Appearance of the product and contents of the pack

Risedronate Normon is presented as pink, film-coated tablets with markings. Each pack 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 most recent review of the package leaflet: March 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/