RISEDRONATE SANDOZ 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Risedronate Sodium Sandoz 35 mg Film-Coated Tablets EFG

risedronate sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Risedronate Sodium Sandoz is and what it is used for
2. What you need to know before you take Risedronate Sodium Sandoz
3. How to take Risedronate Sodium Sandoz
4. Possible side effects
5. Storage of Risedronate Sodium Sandoz
6. Contents of the pack and other information

1. What Risedronate Sodium Sandoz is and what it is used for

Risedronate Sodium Sandoz is used for treatment of osteoporosisin:

• women who have passed the menopause, even if osteoporosis is severe.

Reduces the risk of vertebral and hip fractures,

• men with a high risk of fractures.

Risedronate belongs to a group of medicines called bisphosphonates. It works directly on the bones, strengthening them and making them less likely to fracture.

2. What you need to know before you take Risedronate Sodium Sandoz

Do not take Risedronate Sodium Sandozif

• you are allergicto risedronate sodium or any of the other ingredients of this medicine (listed in section 6),
• you have low blood calcium levels,
• you may be pregnant, if you are pregnant, or if you are planning to become pregnant,
• you are breast-feeding,
• you have severe kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if you have any of the following conditions:

• if you are unable to stand or sit upright for at least 30 minutes,
• you have impaired mineral absorption, conversion and/or excretion, for example:
• vitamin D deficiency,
• parathyroid hormone disturbances.

Both situations can lead to low calcium levels.

• if you have had problems in the past with your esophagus (the tube that connects your mouth to your stomach), such as having had pain or difficulty swallowing food or if you have been previously diagnosed with Barrett's esophagus (a disease associated with changes in the cells that line the lower esophagus),
• if you have had or have pain, swelling, or numbness of the jaw, a "heavy jaw" sensation, or tooth loss,
• if you are undergoing dental treatment or will undergo dental surgery,

Tell your dentist that you are being treated with risedronate.

• if your doctor has told you that you have an intolerance to some sugars (such as lactose).

Children and adolescents

Risedronate Sodium Sandoz is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.

Taking risedronate with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you take medicines containing any of the following ingredients at the same time, the effect of risedronate is reduced:

• calcium,
• magnesium,
• aluminum, which is contained in medicines to treat heartburn,
• iron.

Take these medicines at least 30 minutes after the Risedronate Sodium Sandoz tablet.

Taking Risedronate Sodium Sandoz with food and drinks

Do not takeRisedronate Sodium Sandoz with food or drinksother than plain water, so it can work properly. In particular, do not take this medicine at the same time as dairy products, such as milk, as they contain calcium.

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

Pregnancy and breast-feeding

Do not takeRisedronate Sodium Sandoz if you may be pregnant, are pregnant, or are planning to become pregnant.

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

Do not take Risedronate Sodium Sandoz if you are breast-feeding.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It is not known if risedronate affects the ability to drive and use machines.

Risedronate Sodium Sandoz contains lactose and sodium

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

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

3. How to take Risedronate Sodium Sandoz

Dose

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet once a week.

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

Method of administration

Take the tablet whole:

• in the morning, at least 30 minutes before the first food, drink, or other medicines,
• while standing or sitting upright, to avoid heartburn,
• with at least a full glass (120 ml) of plain water,
• swallow the tablet whole. Do not suck or chew it.

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

Your doctor will tell you if you should take calcium and vitamin supplements.

Duration of use

Consult your doctor before stopping treatment. Your doctor will decidehow long you should take it.

If you take more Risedronate Sodium 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 medicine and the amount ingested.

If you forget to take Risedronate Sodium 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 make up for forgotten doses.

If you stop taking Risedronate Sodium Sandoz

If you stop treatment, you may start losing bone mass. Please consult your doctor before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• symptoms of a severe allergic reactioncharacterized by:

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

• severe skin reactionssuch as:

• blisters on the skin, mouth, eyes, and other moist surfaces of the body (genital areas) (Stevens-Johnson syndrome),
• red 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).

Tell your doctor immediatelyif you suffer from any of the following side effects:

• inflammation in the eyes, usually with pain, redness, and sensitivity to light,
• degeneration of the jawbone associated with delayed healing, often after a tooth extraction,
• pain and difficulty swallowing, chest pain, and heartburn or worsening of heartburn if it already exists.

Common, may affect up to 1 in 10 people

• indigestion, feeling dizzy, stomach pain, cramps or discomfort in the stomach, constipation, feeling full, swelling, diarrhea,
• bone, muscle, or joint pain,
• headache.

Uncommon, may affect up to 1 in 100 people

• inflammation or ulceration of the esophagus causing difficulty and pain when swallowing,
• inflammation of the stomach and duodenum (intestine that comes out of the stomach),
• inflammation of the iris, presenting with red eyes, painful sensation, and possible changes in vision.

Rare, may affect up to 1 in 1,000 people

• inflammation of the tongue, with swelling and possible pain,
• narrowing of the esophagus,
• altered liver test results,
• reduction in phosphate and calcium levels in blood tests (the changes are usually small, occur at the beginning of treatment, and do not cause any symptoms),
• atypical fractures of the thigh bone that can occur rarely, especially in patients on long-term treatment for osteoporosis.

Tell your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible fracture of the femur.

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 could be symptoms of damage to the bones of the ear.

During post-marketing experience, the following have been reported (frequency not known)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Sodium Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister, bottle, and carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Shelf life after first opening:

Bottles: 6 months.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Sodium Sandoz

• The active substance is risedronate sodium. Each film-coated tablet contains 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.

• The other ingredients are:
• • Core of the tablet:microcrystalline cellulose, crospovidone, lactose monohydrate, and magnesium stearate.
  • Coating:hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance and packaging of the product

Orange, oval, biconvex film-coated tablets with "35" engraved on one side.

The film-coated tablets are presented in Alu/PVC blisters inserted into a cardboard box or packaged in HDPE bottles with a polyethylene cap.

Package sizes:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 under the following names:

Austria: Risedronat Sandoz 35 mg einmal wöchentlich - Filmtabletten

Denmark: Risedronatnatrium Sandoz

Finland: Risedronate Sandoz 35 mg tabletti, kalvopäällysteinen

Portugal: Risedronato Sandoz

Slovenia: Natrijev risedronat 35 mg filmsko obložene tablete

Date of last revision of this leaflet: February 2020.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/