Leaflet: information for the user

risedronate weekly cinfa 35 mg film-coated tablets

Risedronate sodium

Read this 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 you must 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 weekly cinfa is and what it is used for

2. What you need to know before you start taking risedronate weekly cinfa

3. How to take risedronate weekly cinfa

4. Possible side effects

5. Storage of risedronate weekly cinfa

6. Contents of the pack and additional information

What is weekly risedronate cinfa

Weekly risedronate cinfa 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 their 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 twist.

Osteoporosis can also be suffered by men due to numerous causes, including aging and/or low levels of 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. Osteoporosis-related fractures 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 is weekly risedronate cinfa used

This medicationis indicated for the treatment of osteoporosis:

• In women after menopause, even if osteoporosis is severe. Reduces the risk of vertebral and hip fractures.
• men

Do not take risedronate weekly cinfa

-if you are allergic to risedronate sodium or 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 (you have low levels of calcium in your blood)

-if you could be pregnant, are pregnant, or plan to become pregnant

-if you are breastfeeding

-if you have severe kidney disease

Warnings and precautions

Consult your doctor or pharmacist before starting to take risedronate weekly cinfa:

-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 or have had problems with your esophagus (the tube that connects the mouth to the stomach). At some point, you might have or have had difficulty swallowing food or have been previously informed that you have Barrett's esophagus (a condition 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, swelling, or numbness, or a strong pain in the jaw or a tooth that moves.

-if you are undergoing dental treatment or will be undergoing a dental procedure, inform your dentist that you are being treated with risedronate weekly.

Your doctor will advise you what to do if you take risedronate weekly 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 are not enough data on its safety and efficacy.

Taking risedronate weekly cinfa with other medicines

Medicines that contain any of the following substances reduce the effect of risedronate weekly when taken at the same time:

• calcium
• magnesium
• aluminum (for example, some indigestion medication)
• iron

Take these medicines at least 30 minutes after taking risedronate weekly.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Taking risedronate weekly cinfa with food and drinks

It is very important that you DO NOT take risedronate weekly with food or drinks (other than water) because they may interfere. In particular, do not take this medicine at the same time as dairy products (such as milk) because they contain calcium (see section 2, “Taking risedronate weekly cinfa with other medicines”).

Take food and drinks (other than water) at least 30 minutes after taking risedronate weekly.

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 medicine.

DO NOT take risedronate weekly if you could be pregnant, are pregnant, or plan to become pregnant (see section 2, “Do not take risedronate weekly cinfa”). The potential risk associated with the use of risedronate sodium (active ingredient of risedronate weekly) in pregnant women is unknown.

DO NOT take risedronate weekly if you are breastfeeding (see section 2, “Do not take risedronate weekly cinfa”). Risedronate weekly can only be used in postmenopausal women and men.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

No effects on the ability to drive and use machines have been observed.

Risedronate weekly cinfa contains lactose

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

Risedronate weekly cinfa contains sodium

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

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

The recommended dose is:

One Risedronate Weekly (35 mg of Risedronate Sodium) tablet once a week.

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

When to take Risedronate Weekly

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

How to take Risedronate Weekly

• 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 plain water.
• 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 inform you if you need to take calcium and vitamin supplements, if the amount you take from your diet is not sufficient.

If you take more Risedronate Weekly Cinfa than you should

If you or someone accidentally takes more Risedronate Weekly tablets than prescribed, drink a full glass of milk and see 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 forget to take Risedronate Weekly Cinfa

If you forget to take the tablet on the chosen day, take the tablet on the day you remember. And take the next tablet the following week on the day you normally take the tablet.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Risedronate Weekly Cinfa

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them

Stop taking risedronate weekly and see your doctor immediatelyif 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 reactions that may include the appearance of blisters on the skin.

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 a dental extraction (see section 2, "Warnings and precautions").

-Esophageal symptoms such as difficulty swallowing, chest pain, and worsening or appearance of stomach acid.

Atypical femoral 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 they may be early signs of a possible femoral fracture.

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 patients):

-Indigestion, nausea, stomach pain, discomfort, or cramps, heavy digestion, constipation, feeling full, abdominal distension, diarrhea.

-Bone, muscle, and joint pain.

-Headache.

Less frequent side effects(may affect up to 1 in 100 patients)

-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/or duodenum (the intestine where the stomach empties).

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

Rare side effects(may affect up to 1 in 1,000 patients)

-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 side effects have been reported:

Very rare (may affect up to 1 in 10,000 patients):

See 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 the ear.

Unknown frequency(cannot be estimated from available data):

• hair loss cases.
• Alterations of the liver, in some cases severe.

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.

Reporting of 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 Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.esBy 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.

Do not usethis medicationafter 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.

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

Composition of risedronate weekly cinfa

• The active ingredient is risedronate sodium. Each film-coated tabletcontains 35 mg of risedronate sodium (equivalent to 32.5 mg of risedronic acid).

• The other components are:

Core tablet:Lactose monohydrate, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-470b) and anhydrous colloidal silica.

Coating:Opadry OY-L28900 white (lactose monohydrate, 15 cP hypromellose (E-464), titanium dioxide (E-171), macrogol 4000), yellow iron oxide and brown iron oxide.

Appearance of the product and contents of the packaging

Risedronate weekly cinfa 35 mg film-coated tabletsare cylindrical, biconvex, yellowish-browntablets, marked with the code “35” on one face.

They are presented in PVC-PVDC/aluminium blisters. Each package contains 4 film-coated tablets.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73191/P_73191.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73191/P_73191.html