Risendros 35

Patient Information Leaflet

RISENDROS 35, 35 mg film-coated tablets
(Sodium risedronate)
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any symptoms not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Risendros 35 is and what it is used for

What Risendros 35 is
Risendros 35 belongs to a group of non-hormonal medicines called bisphosphonates, which are used in the treatment of bone diseases. These medicines act directly on the bones, making them stronger and less likely to fracture.
Bone is a living tissue. The removal of old bone and its replacement with new bone tissue is a continuous process.
Postmenopausal osteoporosis is a condition occurring in women after menopause, in which bones become weaker, more fragile, and more prone to fractures due to falls or stress.
Osteoporosis may also occur in men for various reasons, including aging and/or low levels of the male hormone testosterone.
The spine, hip, and wrist are the most common sites for fractures, although fractures may occur in any bone. Osteoporotic fractures may cause back pain, loss of height, and a stooped posture. Many patients with osteoporosis have no symptoms of the disease and may therefore be unaware of its presence.

What Risendros 35 is used for
For the treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe.
Treatment with this medicine reduces the risk of vertebral and hip fractures.
For the treatment of osteoporosis in men at high risk of fractures.

2. Important information before using Risendros 35

When not to use Risendros 35

• if the patient is allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6);
• if the doctor has informed the patient that they have hypocalcemia (low calcium levels in the blood);
• if the patient suspects she is pregnant, is pregnant, or plans to become pregnant;
• if the patient is breastfeeding;
• if the patient has severe kidney function disorders.

Warnings and precautions
Before starting treatment with Risendros 35, discuss this with your doctor or pharmacist.

• if the patient has difficulty maintaining an upright position (sitting or standing) for at least 30 minutes;
• if the patient has disorders of bone metabolism and mineralization (e.g. vitamin D deficiency, parathyroid gland disorders, both leading to decreased calcium levels in the blood);
• if the patient currently has or has previously had problems with the oesophagus (the tube connecting the mouth to the stomach). For example, if the patient has experienced or is experiencing pain or difficulty swallowing food, or has previously been diagnosed with Barrett's oesophagus (a condition involving changes in the type of cells lining the lower part of the oesophagus);
• if the patient experiences or has experienced pain, swelling, or numbness in the jaw, or a sensation of "heaviness in the jaw", or if the patient has a loose tooth;
• if the patient is currently undergoing dental treatment or has a dental procedure scheduled, they should inform their dentist about taking Risendros 35.

The doctor will advise the patient on what to do if any of the above conditions occur during treatment with Risendros 35.
Children and adolescents
Sodium risedronate is not recommended for use in children under 18 years of age due to lack of data on safety and efficacy.
Risendros 35 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Medicines containing any of the following substances may reduce the effectiveness of Risendros 35 if taken at the same time:
calcium
magnesium
aluminium (e.g. some medicines used for indigestion)
iron
Such medicines should be taken at least 30 minutes after taking a tablet of Risendros 35.
Risendros 35 with food and drink
It is very important NOT to take Risendros 35 with food or drinks (other than water) so that it can work properly.
In particular, do not take this medicine at the same time as dairy products (e.g. milk), as they contain calcium (see section 2 "Risendros 35 and other medicines"). Food and drinks (other than water) may be consumed at least 30 minutes after taking Risendros 35.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine (see section 2 "When not to use Risendros 35"). The potential risk associated with the use of sodium risedronate (the active substance in Risendros 35) in pregnant women is unknown.
DO NOT use Risendros 35 if the patient is breastfeeding (see section 2 "When not to use Risendros 35").
Risendros 35 should only be used in the treatment of osteoporosis in postmenopausal women and in men.
Driving and using machines
The effect of Risendros 35 on the ability to drive and operate machinery is unknown.

3. How to use Risendros 35

This medicine should always be used exactly as instructed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.

Recommended dose
ONE tablet of Risendros 35 (35 mg of sodium risedronate) once a week. Choose a day of the week that is most convenient for you. Each week, take the Risendros 35 tablet on the chosen day.

WHEN to take the Risendros 35 tablet
Take the Risendros 35 tablet at least 30 minutes before your first meal, drink (other than plain water), or other medicines of the day.

HOW to take the Risendros 35 tablet

• Take the Risendros 35 tablet while maintaining an upright position (preferably sitting or standing) to avoid heartburn.
• Swallow the tablet whole with at least one glass of plain water (120 ml).
• Do not suck or chew the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you need to take additional calcium and vitamin supplements if your diet does not provide sufficient amounts.

Taking more Risendros 35 than recommended
If you accidentally take more than the recommended dose of Risendros 35, drink a full glass of milk and seek medical help immediately.

If you forget to take Risendros 35
If you miss a dose on your chosen day, take the tablet on the day you remember. Then return to 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.

Stopping treatment with Risendros 35
If treatment is stopped, you may gradually lose bone mass. Consult your doctor before stopping treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment with Risendros 35 must be discontinued and a doctor should be contacted immediately if the patient experiences any of the following events:

• Signs of a severe allergic reaction, such as:
  • swelling of the face, tongue or throat,
  • difficulty swallowing,
  • hives and breathing difficulties.
• Severe skin reactions, including skin blistering.

If any of the following adverse reactions occur, a doctor should be contacted immediately:

• Eye inflammation, usually with pain, redness and sensitivity to light,
• Osteonecrosis of the jaw (death of bone tissue) associated with delayed healing and infections, often following tooth extraction (see section 2, "Warnings and precautions"),
• Esophageal symptoms such as: pain when swallowing, difficulty swallowing, chest pain, new onset or worsening of heartburn.

Additionally, other adverse reactions observed in clinical trials were generally mild and did not lead to discontinuation of the medicine.
Common adverse reactions (may occur in up to 1 in 10 patients):

• headache,
• constipation, indigestion, feeling unwell, stomach pain, stomach cramps and discomfort,
• bone, muscle and joint pain.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• inflammation of the coloured part of the eye (iris) (eye redness and pain, possibly with visual disturbances),
• inflammation of the gastric and/or duodenal mucosa, oesophagitis or difficulty and pain when swallowing (oesophageal ulcer, dysphagia).

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• narrowing of the oesophagus (causing difficulty swallowing), inflammation of the tongue (red, swollen, possibly painful), and abnormal liver function test results (detectable only by blood tests),
• in rare cases, atypical femoral fractures may occur, particularly in patients receiving long-term treatment for osteoporosis. Patients should consult a doctor if they experience pain, weakness or discomfort in the thigh, hip or groin area, as these may be early signs indicating a potential femoral fracture.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• If the patient experiences ear pain, ear discharge and/or ear infection, this should be reported to a doctor. These may be symptoms of bone tissue damage in the ear.

Following the introduction of the medicine into the market, the following adverse reactions have been observed (frequency unknown):

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

In rare cases, at the beginning of treatment, a decrease in blood calcium and phosphate levels may occur. These changes are usually minor and do not cause symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland.
Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Risendros 35

Keep this medicine out of the sight and reach of children.
Do not use Risendros 35 after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice discolouration of the tablets or any other visible signs of
degradation.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Risendros 35 contains
The active substance is risedronate sodium. Each coated tablet contains 35 mg of sodium
risedronate, equivalent to 32.5 mg of risedronic acid.
The other ingredients are:
Core: microcrystalline cellulose, crospovidone, magnesium stearate
Coating: Opadry AMB Orange [(polyvinyl alcohol), talc, titanium dioxide (E171), glycerol
monocaprylocaprate, sodium lauryl sulfate, yellow iron oxide (E172), red iron oxide (E172)].

What Risendros 35 looks like and contents of the pack
Risendros 35: orange, round, biconvex coated tablets with a diameter of 9.0–9.2 mm.
Pack sizes: 4, 8, 12 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer:
Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic.

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Risendros
Poland, Slovak Republic, Lithuania, Estonia, Latvia: Risendros 35
Romania: Risedronat sodic Zentiva 35 mg