Risedronate weekly Sandoz 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risedronato Semanal Sandoz 35 mg film-coated tablets EFG

sodium risedronate

Read the 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Risedronato Semanal Sandoz is and what it is used for
2. What you need to know before taking Risedronato Semanal Sandoz
3. How to take Risedronato Semanal Sandoz
4. Possible adverse effects
5. How to store Risedronato Semanal Sandoz
6. Contents of the pack and other information

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

Risedronate Sandoz Weekly is used for the treatment of osteoporosis in:

• postmenopausal women, even if osteoporosis is severe.

It reduces the risk of spinal and hip fractures,

• men at high risk of fractures.

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

2. What you need to know before taking Risedronate Weekly Sandoz

Do not take Risedronate Weekly Sandoz if

• you are allergic to sodium risedronate or to any of the components of this medicine (listed in section 6),
• you have low levels of calcium,
• you are pregnant or think you might be pregnant, or if you are planning to become pregnant,
• you are breastfeeding,
• you have severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine and if any of the following apply to you:

• if you are unable to remain in an upright position for at least 30 minutes,
• you have impaired mineral and bone absorption, conversion, and/or excretion, for example:
• vitamin D deficiency,
• disorders of parathyroid hormone.

Both conditions may lead to low calcium levels.

• if you have previously had problems with your oesophagus (the tube connecting your mouth to your stomach), such as pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett's oesophagus (a condition associated with changes in the cells lining the lower oesophagus),
• if you have had or currently have pain, swelling, or numbness in the jaw, a "heavy jaw sensation", or tooth loss,
• if you are undergoing dental treatment or are scheduled to have a dental procedure.

Inform your dentist that you are being treated with risedronate.

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

Children and adolescents

This medicine 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

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

The effect of risedronate may be reduced if taken at the same time as medicines containing any of the following ingredients:

• calcium,
• magnesium,
• aluminium, found for example in medicines used to treat heartburn,
• iron.

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

Taking Risedronate Weekly Sandoz with food and drink

Do not take Risedronate Weekly Sandoz with food or drinks other than plain water to ensure proper effectiveness. In particular, do not take this medicine with dairy products such as milk, as they contain calcium.

Wait at least 30 minutes after taking the Risedronate Weekly Sandoz tablet before consuming food or drinks other than plain water.

Pregnancy and breastfeeding

Do not take Risedronate Weekly Sandoz if you are pregnant, think you might be pregnant, or plan to become pregnant.

The potential risk associated with the use of sodium risedronate 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 medicine.

Driving and using machines

It is unknown whether risedronate affects the ability to drive or operate machinery.

Risedronate Weekly Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Risedronate Sandoz Weekly

Dosage

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 fits your schedule. Each week, take the Risedronate Sandoz Weekly tablet on the chosen day.

Instructions for use

Take the tablet whole:

• in the morning, at least 30 minutes before the first meal, drink, or other medication,
• while remaining upright, to help prevent heartburn,
• with at least one full glass (120 ml) of plain 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 advise you whether you should take calcium and vitamin supplements.

Duration of treatment

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

If you take more Risedronate Sandoz Weekly 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Risedronate Sandoz Weekly

If you forget to take your weekly dose of Risedronate Sandoz Weekly on your chosen day, take the tablet as soon as you remember. Then continue taking one tablet weekly on your usual day.

Do not take a double dose to make up for a missed dose.

If you stop taking Risedronate Sandoz Weekly

If you stop treatment, you may begin to lose bone mass. Please consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop treatment with Risedronate Sandoz Weekly and contact your doctor immediately if you experience any of the following adverse effects:

• symptoms of a severe allergic reaction characterized by:

• swelling of the face, lips, tongue, throat and/or neck,

• difficulty swallowing,

• difficulty breathing,

• hives, urticaria.

• severe skin reactions such as:

• blisters on the skin, mouth, eyes, and other moist body surfaces (genitals) (Stevens-Johnson syndrome),

• palpable red spots on the skin caused by inflammation of small blood vessels (leukocytoclastic vasculitis),

• red rash in multiple areas of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

Contact your doctor immediately if you experience any of the following adverse effects:

• eye inflammation, usually with pain, redness, and sensitivity to light,
• jaw bone deterioration associated with delayed healing, often following a dental extraction,
• pain and difficulty swallowing, chest pain, heartburn, or worsening of existing heartburn.

Common: may affect up to 1 in 10 people

• indigestion, dizziness, stomach pain, stomach cramps or discomfort, constipation, feeling of fullness, bloating, diarrhoea,
• bone, muscle or joint pain,
• headache.

Uncommon: may affect up to 1 in 100 people

• inflammation or ulceration of the oesophagus causing difficulty and pain when swallowing,
• inflammation of the stomach and duodenum (the intestine leaving the stomach),
• inflammation of the iris, presenting as red, painful eyes and possibly 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 oesophagus,
• abnormal results in liver function tests,
• reduction in blood phosphate and calcium levels (changes are usually minor, occur early in treatment, and do not cause symptoms),
• atypical fractures of the femur bone, which may rarely occur, especially in patients on long-term treatment for osteoporosis.

Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femur fracture.

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

• Consult your doctor if you have ear pain, ear discharge, 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 of which were severe.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of Risedronate Sandoz Weekly

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

Do not use this medicine after the expiry date stated on the blister, bottle, and outer packaging, following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Expiry after first opening:

Bottles: 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronato Semanal Sandoz

• The active substance is sodium risedronate. Each film-coated tablet contains 35 mg of sodium risedronate, 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 pack

Orange, oval, biconvex film-coated tablets, marked with the number “35” on one side.

The film-coated tablets are presented in Alu/PVC blisters packed in cardboard outer cartons, or packaged in HDPE bottles with polyethylene caps.

Pack 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.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states 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 the most recent review of this leaflet: February 2020.

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