Patient Information Leaflet

Risedronate Normon 75 mg Film-Coated Tablets

Risedronic acid

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Risedronate Normon

4.Possible side effects

5.Storage of Risedronate Normon

6.Contents of the pack and additional information.

Risedronato Normon

Risedronatobelongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases. It acts directly on the bones strengthening them and, therefore, reduces the probability of fractures.

The bone is a living tissue.

The old bone of the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis appears in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely to occur after a fall or a twist.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteoporosis can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Risedronato Normon is used

This medication is used for the treatment of osteoporosis inwomen after menopause.

Do not take Risedronate Normon

• If you areallergicto risedronate sodium or to any of the other components of this medication (listed in section 6).
• If your doctor has told you that you have a condition calledhypocalcemia(low levels of calcium in the blood).
• If you could bepregnantor if you plan to become pregnant.
• If you arebreastfeeding.
• If you havesevere kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Normon:

• If you cannot remain in an upright position, either sitting or standing, for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, both producing low levels of calcium 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 difficulty swallowing food or been previously informed that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower esophagus).
• If you have had or have jaw pain, swelling, or numbness, or a "strong pain in the jaw" or a tooth that moves.
• If you are undergoing dental treatment or are going to undergo dental surgeryinform 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 problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children and adolescents (under 18 years) because there is not enough data on its safety and efficacy.

Taking Risedronate Normonwith other medications

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

• Calcium.
• Magnesium.
• Aluminum (for example, some antacids).
• Iron.

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

Taking Risedronate Normonwith food and drinks

It is very important that you DO NOT takeRisedronateNormonwith food or drinks (other than plain water)because 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 Normonwith other medications).

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

Pregnancy and breastfeeding

DO NOT take this medication 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 risedronate sodium (active ingredient of 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 operating machines

The potential effect of Risedronate Normonon the ability to drive and operate machines is unknown.

Risedronate Normon contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Risedronate Normontablets should be taken two days a month, and always the SAME two consecutive days of each month,(for example, the 1st and 2nd days or 15th and 16th of the month).

Choose the TWO consecutive days that best fit your schedule. Take ONE Risedronate Normontablet in the morning of the first chosen day. Take the SECOND tablet in the morning of the following 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 thedate in the space behind the medication packaging.

When to take Risedronate Normon

Take the Risedronate tablet at least 30 minutes before the first meal, drink of the day (except in the case of tap wateroranother medication of the day).

How to take your Risedronate Normon

• Take the tablet while inan upright position, either sitting or standing, to avoid stomach burning.
• Swallow the tablet with at least oneglass(120 ml) oftap water. Do not take the tablet with mineral water or other beverages that are not 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 indicate if you should take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

If you take more Risedronate Normonthan youshould

If you or someone accidentally took more Risedronate tablets than prescribed, drink aglass of milkfull and consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Risedronate Normon

In any case:

• If you forgot your Risedronate doses in the morning, DO NOT take it later in the day.
• DO NOT take three tablets in the same week.

If you interrupt treatment with Risedronate Normon

If you stop taking the treatment you might start losing bone mass. Please consult your doctor before deciding to interrupt the treatment.

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

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

• Stop taking Risedronate Normonand seek medical attention immediately if you experience any of the following symptoms:
• Severe allergic reaction symptoms such as:

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

• Severe skin reactionssuch as:

• Blisters on the skin, mouth, eyes, and other moist areas of the body (Stevens-Johnson syndrome).
• Red, palpable rashes 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).

Inform your doctor quicklyif you experience the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after tooth extraction (see section 2, "Warnings and Precautions").
• Esophageal symptoms such as difficulty swallowing, chest pain, or the appearance or worsening of heartburn.

Atypical femur fractures that 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 these may be early signs of a possible femur fracture.

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

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

Indigestion, nausea,vomiting,stomach pain,discomfortorcrampsinthestomach, heavy digestion, constipation, feeling full, abdominal distension,diarrhea.

Pain in your 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 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, painful eyes 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 test results. This can only be diagnosed through blood tests.

During post-marketing use, the following have been reported (frequency unknown):

• Cases of hair loss.
• Alterations in the liver, in some cases severe.
• Inflammation of small blood vessels.

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

Very rare side effects

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system: Spanish Medicines and Medical Devices Agency Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Risedronate N Compositionormon

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

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

Appearance of the product and contents of the packaging

Risedronate Normonis presented in the form of coated tablets with a pink film coating and markings. Each package contains 2 tablets.

Other presentations

Risedronate weekly Normon 35 mg coated tablets EFG.

Marketing authorization holder and responsible manufacturer

Laboratorios Normon, S.A.

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

Last review date of the leaflet: March 2022

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