RISEDRONATE SANDOZ

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Risedronate Sandoz 35 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Risedronate Sandoz 35 mg is and what it is used for
2. What you need to know before taking Risedronate Sandoz 35 mg
3. How to take Risedronate Sandoz 35 mg
4. Possible side effects
5. How to store Risedronate Sandoz 35 mg
6. Contents of the pack and other information

1. WHAT RISEDRONATE SANDOZ 35 MG IS AND WHAT IT IS USED FOR

Risedronate Sandoz is used to treat osteoporosis:

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

Postmenopausal osteoporosis is a condition occurring in women after menopause, in which bones become weaker, more fragile and more prone to fracture as a result of falls or stress. Osteoporosis can also occur in men due to a variety of causes, including aging and/or low levels of the male hormone testosterone.
The spine, hip and wrist are the bones most likely to fracture, although fractures may occur in any bone of the body. Fractures associated with osteoporosis can also cause back pain, loss of height and curvature of the spine. Many patients with osteoporosis have no symptoms and are unaware they have the disease.
Risedronate Sandoz belongs to a group of non-hormonal medicinal products called bisphosphonates, which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to fracture.
Bone is living tissue. Old bone tissue is constantly removed from the skeleton and replaced with new bone tissue.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RISEDRONATE SANDOZ 35 MG

Do not take Risedronate Sandoz 35 mg
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in the following cases:

• if you are allergic to sodium risedronate or to any of the excipients of this medicine (listed in section 6).
• if you have low levels of calcium in the blood
• if you may be pregnant, are pregnant, or are planning a pregnancy
• if you are breastfeeding
• if you have severe kidney problems.

Warnings and precautions
If any of the following conditions apply to you, inform your doctor before taking this
medicine:

• if you are unable to remain upright (sitting or standing) for at least 30 minutes
• if you have disorders in the absorption, conversion, and/or bone and mineral excretion, for example:
  • vitamin D deficiency
  • parathyroid hormone disorders. Both of these conditions cause low calcium levels below normal;
• if you have previously had esophageal problems (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or you may have been diagnosed with Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).
• you have had or currently have pain, swelling or numbness in the jaw, a sensation of “heaviness” in the jaw, or loosening of a tooth
• dental treatment or an upcoming dental surgical procedure. Inform your dentist that you are being treated with Risedronate Sandoz.
• your doctor has informed you that you have an intolerance to certain sugars (such as lactose)

Children and adolescents
Sodium risedronate is not recommended in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Risedronate Sandoz 35 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Medicines containing any of the following substances reduce the effect of Risedronate Sandoz if taken
at the same time:

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

Take these medicines at least 30 minutes after taking the Risedronate Sandoz tablet.
Risedronate Sandoz 35 mg with food and drinks
Do not take the Risedronate Sandoz tablet with food or drinks other than plain water, so that the
medicine can work properly. This is especially important for dairy products such as milk, as they
contain calcium (see section 2, “Other medicines and Risedronate Sandoz”).
Food and drinks other than plain water may be consumed only at least 30 minutes after
taking the Risedronate Sandoz tablet.
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Pregnancy and breastfeeding
Do not take Risedronate Sandoz if you may be pregnant, are pregnant, or are planning a
pregnancy (see section 2, “Do not take Risedronate Sandoz”).
The risk associated with the use of Risedronate Sandoz in pregnant women is unknown.
Do not take Risedronate Sandoz if you are breastfeeding (see section 2, “Do not take Risedronate
Sandoz”).
Risedronate is used only for the treatment of post-menopausal women and men.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Risedronate Sandoz has no known effects on the ability to drive or use machines.
Risedronate Sandoz 35 mg contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine (see section 2, “Warnings and precautions”).
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. HOW TO TAKE RISEDRONATE SANDOZ 35 MG

Dosage
Always take Risedronate Sandoz 35 mg exactly as your doctor or pharmacist has instructed you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet once a week.
Choose the day of the week that is most convenient for you. Take the Risedronate Sandoz tablet every week on the chosen day.

Instructions for use
Take the tablet whole:

• in the morning, at least 30 minutes before taking the first food, drink (except plain water), or other medication of the day
• while sitting upright or standing, to help prevent stomach irritation
• with at least one glass (120 ml) of plain water.
• Swallow the tablet whole. Do not suck or chew it.

Do not lie down for 30 minutes after taking the tablet.
Your doctor will advise you whether you need calcium or vitamin supplements.

Duration of treatment
Consult your doctor before stopping treatment. The duration of treatment will be determined by your doctor.

If you take more Risedronate Sandoz 35 mg than you should
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Drink a glass of milk and contact your doctor if you have taken more tablets than prescribed.

If you forget to take Risedronate Sandoz 35 mg
If you forget to take the tablet on the scheduled day, take it on the day you remember. Then continue taking one tablet once a week on your usual day.
Do not take two tablets on the same day to make up for a missed dose.

If you stop taking Risedronate Sandoz 35 mg
If you stop treatment, you may begin to lose bone mass. Consult your doctor before considering 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.
If you experience any of the following, stop taking Risedronate Sandoz and contact a doctor immediately:

• symptoms of severe allergic reactions such as:
  • swelling of the face, lips, tongue, throat and/or neck
  • difficulty swallowing
  • breathing difficulties
  • hives, skin rash

The frequency of this adverse effect is not known (cannot be estimated from the available data).

• severe skin reactions such as:
  • blistering of 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 affecting many parts of the body and/or loss of the outer layer of skin (toxic epidermal necrolysis).

The frequency of this adverse effect is not known (cannot be estimated from the available data).
Contact your doctor immediately if you develop:

• eye inflammation, usually associated with pain, redness, and light sensitivity. The frequency of this adverse effect is not known (cannot be estimated from the available data).
• orbital inflammation – inflammation of the structures surrounding the eyeball. Symptoms may include: pain, swelling, redness, protrusion of the eyeball, and vision disturbances. The frequency of this adverse effect is not known (cannot be estimated from the available data).

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• jaw bone deterioration (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, "Warnings and precautions"). The frequency of this adverse effect is not known (cannot be estimated from the available data).
• difficulty and pain when swallowing, chest pain, onset or worsening of heartburn. This adverse effect is uncommon (may affect up to 1 in 100 people).

However, in clinical studies, other adverse effects observed were generally mild in severity and did not lead patients to discontinue treatment.

Common – may affect up to 1 in 10 patients

• indigestion, nausea, stomach pain, stomach cramps or discomfort, constipation, sensation of fullness, abdominal bloating, diarrhoea
• bone, muscle or joint pain
• headache.

Uncommon – may affect up to 1 in 100 patients

• inflammation or ulceration of the oesophagus, causing difficulty and pain when swallowing (see also section 2, "Warnings and precautions")
• inflammation of the stomach and the first part of the small intestine, just beyond the stomach
• inflammation of the iris, causing redness, eye pain and visual disturbances.

Rare – may affect up to 1 in 1,000 patients

• inflammation of the tongue, with swelling and possible pain
• narrowing of the oesophagus
• changes in liver function tests
• decreased levels of calcium and phosphate in the blood (these changes are usually mild, occur at the beginning of treatment, and do not cause symptoms)
• Rarely, an unusual femur fracture may occur, particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible femur fracture.

Very rare – may affect up to 1 in 10,000 patients

• Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These symptoms could be signs of bone damage in the ear.

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

• hair loss
• liver disorders, in some cases severe

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RISEDRONATE SANDOZ 35 MG

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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, the bottle and the packaging after the term “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Shelf life after first opening:
Bottle: 6 months
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Risedronato Sandoz 35 mg contains
The active substance is sodium risedronate.
Each film-coated tablet contains 35 mg of risedronate, equivalent to 32.5 mg of risedronic acid.
The other components are as follows:

• In the tablet core: microcrystalline cellulose, crospovidone, monohydrate lactose, magnesium stearate
• In the coating: hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)

Description of the appearance of Risedronato Sandoz 35 mg and pack contents
Oval-shaped, orange-coloured tablets, rounded at the upper and lower edges, marked with the number "35" on one side.
The film-coated tablets are packaged in PVC/Al blisters and placed in cardboard boxes, or
packaged in HDPE bottles with polyethylene caps.
Pack sizes:
Blister packs: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.
Bottles: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 – 39179 Barleben, Germany
Lek Pharmaceuticals d.d - Verovskova 57 - 1526 Ljubljana, Slovenia
Lek S.A. - ul. Domaniewska 50 C - 02-672 Warsaw, Poland
Lek Pharmaceuticals d.d. - Trimlini 2D - 9220 Lendava, Slovenia
S.C. Sandoz S.R.L. - 7A Livezeni Street, 540472, Targu Mures, Jud Mures - Romania

This medicinal product has been authorised in the Member States of the European Economic Area and
in the United Kingdom (Northern Ireland) under the following names:
Austria: Risedronat Sandoz 35 mg einmal wöchentlich - 35 mg Filmtabletten
Belgium: Risedronat Sandoz 35 mg Filmomhulde tabletten
Finland: Risedronat Sandoz 35 mg kalvopäällysteinen tabletti
France: Risédronate Sandoz 35 mg, comprimé pelliculé
Italy: Risedronato Sandoz 35 mg compresse rivestite con film
Netherlands: Natriumrisedronaat Sandoz Wekelijks 35 mg, filmomhulde tabletten
Portugal: RISEDRONATO DE SÓDIO SANDOZ
Spain: Risedronato Semanal Sandoz 35 mg comprimidos recubiertos con película EFG
Sweden: Risedronat Sandoz 35 mg filmdragerade tabletter
UK: Risedronate Sodium 35 mg Film-coated Tablets

This summary of product characteristics was last approved in 02/2026
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