Patient Information Leaflet: Product Information

Risedronate Weekly Normon 35 mg Film-Coated Tablets

Risedronate sodium

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, 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.

What is Weekly Risedronate Normon

Weekly Risedronate Normon belongs 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.

Osteoporosis can also be suffered by men due to numerous 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 of the body. Fractures associated with osteoporosis can also produce back pain, height loss, and curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

For what Weekly Risedronate Normon is used

This medication is used for the treatment of osteoporosis:

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

• Do not take Risedronato semanal Normon

• If you are allergic (hypersensitive) to 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 called hypocalcemia (low levels of calcium 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 Risedronato semanal Normon:

• If you cannot remain in an upright position (sitting or standing) for at least 30 minutes.
• If you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations, which may produce 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 told you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus).
• If your doctor has informed you that you have an intolerance to some sugars (such as lactose).
• If you have had or have jaw pain, inflammation, or numbness, maxillary pain, or tooth loss.
• If you are undergoing dental treatment or will be undergoing a dental procedure, inform your dentist that you are being treated with this medication.

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

• Taking Risedronato semanal Normon with other medications

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

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 antacid medication)
• Iron

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

• Taking Risedronato semanal Normon with food and drinks

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

DO NOT consume food, beverages (except water), and other medications for at least 30 minutes after taking this medication.

• Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 Risedronato semanal Normon). The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

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

This medication should only be taken by women after menopause and men.

• Driving and operating machinery

The effect of this medication on the ability to drive or operate machinery is unknown.

• Risedronato semanal 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 him before taking this medication.

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

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

Recommended dose:

The usual dose is 1 Risedronate weekly Normon tablet (35 mg of risedronate sodium) 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 every 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 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 the first meal, drink of the day (except in the case of water), or another medication of the day.

How to take your Risedronate weekly Normon tablet

• Take the tablet while standing upright (either sitting or standing), to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of water. It is very important that you DO NOT take Risedronate weekly Normon with food or drinks (except in the case of water), so that the medication acts correctly.
• Swallow the tablet whole (do not crush or chew it).
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin D supplements, if the amount you take from your diet is not enough.

• Use in children and adolescents

Risedronate weekly Normon is not recommended for use in children and adolescents (under 18 years), as there is not enough data on its safety and efficacy.

• Use in people over 65 years

No dose adjustment is required.

• Patients with kidney problems

If you have mild to moderate kidney function problems, no dose adjustment is required. If you have severe kidney problems, do 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 another person have accidentally taken more Risedronate weekly Normon tablets than prescribed, drink a full glass of milk and see a 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 vocal cord spasms and irregular heartbeat.

• If you forgot to take Risedronate weekly Normon

If you forgot to take the tablet on the chosen day, take the tablet on the day you remember. And take the next tablet a week later, 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 interrupt treatment with Risedronate weekly Normon

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

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

Like all medicines, Risedronate weekly Normon may cause side effects, although not everyone will experience them.

Stop treatment with sodium risedronate and inform your doctor quicklyif 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 body surfaces (genitals) (Stevens-Johnson syndrome),

- Red, palpable spots on the skin (leucocytoclastic 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:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.

• Jaw osteonecrosis (bone death) associated with delayed healing and infection, often after a dental extraction (see section 2, "Be especially 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 stomach burning (or worsening of burning if already present).

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

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

Indigestion, nausea, stomach pain, stomach upset or discomfort, constipation, feeling full, abdominal distension, diarrhea.

Bone, muscle, or joint pain.

Headache.

Uncommon side effects(may affect up to 1 in 100 people)

Inflammation or ulcer of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing (also see 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).

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, which can only be diagnosed through blood tests.

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.

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

• Hair loss

• Liver disorders, which in some cases were severe

• Inflammation of small blood vessels.

Atypical femoral fractures that may occur in rare cases, especially in patients on prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early signs of a possible femoral fracture.

Very rare side effects

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

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 that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Risedronate weekly Normon

The active ingredient is risedronate sodium. Each tablet contains 35 mg of risedronate sodium (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, iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:January 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/