Product Information for the Patient

Risedronate Weekly Sandoz 35 mg Film-Coated Tablets

risedronate sodium

Read this 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. 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 is Risedronate Weekly Sandoz and what it is used for

2.What you need to know before starting to take Risedronate Weekly Sandoz

3.How to take Risedronate Weekly Sandoz

4.Possible side effects

5.Storage of Risedronate Weekly Sandoz

6.Contents of the pack and additional information

Risedronato Semanal Sandoz is used fortreatment of osteoporosisin:

• women who have gone through menopause, even if osteoporosis is severe.

Reduces the risk of spine and hip fractures,

• men with a high risk of fractures.

Risedronato belongs to a group of medications called bisphosphonates. It acts directly on the bones, strengthening them and therefore, makes fractures less likely.

Do not take Risedronate Weekly Sandozif

• youare allergicto risedronate sodium or any of the components of this medication (listed in section 6),
• you havelow calcium levels,
• you may bepregnant, if you are pregnant, or if you are planning to become pregnant,
• you arebreastfeeding,
• you havesevere kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication and if any of the following conditions occur:

• if you have difficulty staying upright for at least 30 minutes,
• you have altered mineral and bone metabolism, for example:
• vitamin D deficiency,
• parathyroid hormone alterations.

Both situations may lead to low calcium levels.

• if you have had problems with the esophagus (the tube that connects your mouth to your stomach) in the past, such as having had pain or difficulty swallowing food, or if you have 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, a "heavy jaw sensation" 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 risedronate.

• if your doctor has indicated that you have intolerance to certain sugars (such as lactose).

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age due to insufficient data on its safety and efficacy.

Risedronate use with other medications

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

If taken at the same time as medications containing any of the following components, the effect of risedronate is reduced:

• calcium,
• magnesium,
• aluminum, for example, medications to treat heartburn,
• iron.

Take these medications at least 30 minutes after taking the Risedronate Weekly Sandoz tablet.

Risedronate Weekly Sandoz with food and beverages

Do not takeRisedronate Weekly Sandozwith food or beveragesother than plain water for it to act correctly. In particular, do not take this medication at the same time as dairy products, such as milk, as they contain calcium.

Take food and beverages, other than plain water, at least 30 minutes after taking the Risedronate Weekly Sandoz tablet.

Pregnancy and breastfeeding

Do not takeRisedronate Weekly Sandozif you may be pregnant, are pregnant, or plan to become pregnant.

The potential risk associated with the use of risedronate sodium in pregnant women is unknown.

Do not take Risedronate Weekly Sandoz if you are breastfeeding.

Risedronate should only be used for the treatment of postmenopausal women and men.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It is not known if risedronate affects the ability to drive and operate machinery.

Risedronate Weekly Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

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

Dose

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.

Therecommended dose is one tablet once a week.

Choose a day of the week that best suits your schedule. Each week, take the Risedronato Semanal Sandoz tablet on the chosen day.

Method of use

Take the tablet whole:

• in the morning, at least 30 minutes before the first meal, drink, or other medications,
• while standing, to avoid heartburn,
• with at least one full glass (120 ml) of water,
• swallow the tablet whole. Do not chew or crush it.

Do not lie down until 30 minutes have passed since taking the tablet.

Your doctor will tell you if you need to take calcium supplements and vitamins.

Duration of use

Consult with your doctor before interrupting treatment. Yourdoctor will decidefor how long you should take it.

If you take more Risedronato Semanal Sandoz than you should

Drink a full glass of milk and consult your doctor if you have taken more tablets than prescribed.

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 ingested.

If you forget to take Risedronato Semanal Sandoz

If you have forgotten to take the tablet on the chosen day, take it as soon as you remember. Continue with another tablet the following week on the day you normally take your tablet.

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

If you interrupt Risedronato Semanal Sandoz treatment

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop treatment with Risedronate Weekly Sandoz and contact your doctor immediatelyif you experience any of the following side effects:

• symptoms of asevere allergic reactioncharacterized by:

• inflammation of the face, lips, tongue, throat, and/or neck,
• difficulty swallowing,
• difficulty breathing,
• hives, urticaria.

• severe skin reactionssuch as:

• blistering of the skin, mouth, eyes, and other moist areas of the body (genitals) (Stevens-Johnson syndrome),
• red, palpable patches on the skin caused by inflammation of small blood vessels (leukocytoclastic 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 in the eyes, usually with pain, redness, and sensitivity to light,
• jawbone degeneration associated with delayed healing, often after a tooth extraction,
• difficulty swallowing, chest pain, and heartburn or worsening of heartburn if you already have it.

Frequent, may affect up to 1 in 10 people

• indigestion, dizziness, stomach pain, cramps, or discomfort, constipation, feeling full, bloating, diarrhea,
• bone, muscle, or joint pain,
• headache.

Rare, may affect up to 1 in 100 people

• inflammation or ulcer of the esophagus causing difficulty and pain swallowing,
• inflammation of the stomach and duodenum (intestinal tract that exits the stomach),
• inflammation of the iris, presenting red, painful eyes with possible vision changes.

Very rare, may affect up to 1 in 1,000 people

• inflammation of the tongue, with swelling and possible pain,
• narrowing of the esophagus,
• abnormal liver test results,
• reduction in phosphate and calcium levels in blood tests (changes are usually small, occur at the beginning of treatment, and do not cause any symptoms),
• atypical fractures of the femur 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 femur fracture.

Very rare, may affect up to 1 in 10,000 people

• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be symptoms of damage to the bones of the ear.

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

• hair loss,
• liver disorders, some cases were severe.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 blister pack, bottle, and packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Expiration after first opening:

Bottles: 6 months.

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

Composition of Risedronate Weekly Sandoz

• Theactive ingredientisrisedronate sodium. Each film-coated tablet contains 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.

• The other components are:
• • Tablet core:microcrystalline cellulose, crospovidone, lactose monohydrate, and magnesium stearate.
  • Film coating:hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the package

Orange film-coated, oval, rounded on both sides, and with the mark “35” on one of them.

Film-coated tablets are presented in Alu/PVC blisters inserted in cardboard packaging, or packaged in HDPE bottles with a polyethylene closure.

Package sizes:

Blisters: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.

Bottles: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

LEK Pharmaceuticals d.d

Trimlini 2D

9220 Lendava

Slovenia

or

LEK Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

or

LEK S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

S.C. Sandoz S.R.L.

7A Livezeni Street, 540472, Targu Mures,

Jud Mures

Romania

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Risedronat Sandoz 35 mg once a week -Filmtabletten

Denmark:Risedronate sodium Sandoz

Finland:Risedronate Sandoz 35 mg tablets, film-coated

Portugal:Risedronate Sandoz

Slovenia:Natrium risedronate 35 mg film-coated tablets

Last review date of this leaflet: February 2020.

The 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/