Risendros 35

Package Leaflet: Information for the Patient

RISENDROS 35, 35 mg coated tablets

(Sodium risedronate)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Risendros 35 and what is it used for
• 2. Important information 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 is Risendros 35 and what is it used for

What is Risendros 35

Risendros 35 belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. They work directly in the bones, making them stronger and less prone to fractures.
Bone is a living tissue. The process of removing old bone and replacing it with new bone tissue is continuous.
Postmenopausal osteoporosis is a condition that occurs in women after menopause, in which the bones become weaker, more brittle, and more prone to fractures due to falls or stress.
Osteoporosis can also occur in men for various reasons, including the aging process and (or) low levels of male hormone, testosterone.
The spine, hip, and wrist are the most common sites of fracture, although a fracture can occur in any bone. Osteoporotic fractures can cause back pain, loss of height, and a hunched back. Many patients with osteoporosis do not have symptoms related to the disease, so they may not be aware of its existence.

What is Risendros 35 used for

For the treatment of osteoporosis in postmenopausal women, even if the osteoporosis is severe.
Taking the medicine reduces the risk of vertebral and hip fractures.
For the treatment of osteoporosis in men with a high risk of fractures.

2. Important information before taking Risendros 35

When not to take Risendros 35

• if you are allergic to sodium risedronate or any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you have hypocalcemia (low calcium levels in the blood);
• if you suspect you are pregnant, are pregnant, or plan to become pregnant;
• if you are breastfeeding;
• if you have severe kidney problems.

Warnings and precautions

Before starting to take Risendros 35, discuss it with your doctor or pharmacist.

• if you have problems maintaining an upright position (sitting or standing) for at least 30 minutes,
• if you have disorders of bone metabolism and mineralization (e.g., vitamin D deficiency, parathyroid gland disorders, in both cases leading to decreased calcium levels in the blood),
• if you have or have had problems with the esophagus (the tube connecting the mouth to the stomach). For example, you feel or have felt pain or difficulty swallowing food or have been previously diagnosed with Barrett's esophagus (a condition in which the type of cells in the lining of the lower part of the esophagus changes),
• if you feel or have felt pain, swelling, or numbness in the jaw or a feeling of "heaviness" in the jaw, or if you have a loose tooth,
• if you are currently undergoing dental treatment or have a planned dental procedure, you should inform your dentist about taking Risendros 35.

Your doctor will tell you what to do if the above disorders occur while taking Risendros 35.

Children and adolescents

Sodium risedronate is not recommended for use in children under 18 years of age due to the lack of data on safety and efficacy.

Risendros 35 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines containing any of the following substances reduce the effect of Risendros 35 if taken at the same time:
calcium
magnesium
aluminum (e.g., some antacids)
iron
Such medicines should be taken at least 30 minutes after taking a Risendros 35 tablet.

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"). You can eat or drink (other than water) after at least 30 minutes after taking Risendros 35.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine (see section 2 "When not to take Risendros 35"). The potential risk associated with the use of sodium risedronate (the active substance of Risendros 35) in pregnant women is unknown.
Do not take Risendros 35 if you are breastfeeding (see section 2 "When not to take Risendros 35").
Risendros 35 should only be used to treat osteoporosis in postmenopausal women and men.

Driving and using machines

The effect of Risendros 35 on the ability to drive and use machines is not known.

3. How to take Risendros 35

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
ONE Risendros 35 tablet (35 mg sodium risedronate), once a week. Choose a day of the week that is most convenient for you. Take Risendros 35 on the chosen day every week.

WHEN to take the Risendros 35 tablet

Take the Risendros 35 tablet at least 30 minutes before the first meal or drink (other than plain water) or other medicines on the same 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 with at least one full glass of plain water (120 ml).
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you need to take additional calcium and vitamin supplements, if they are not provided in sufficient amounts by your diet.

Taking a higher dose of Risendros 35 than recommended

If you accidentally take a higher dose of Risendros 35 than recommended, drink a full glass of milk and seek medical attention.

Missing a dose of Risendros 35

If you miss a dose, take it on the day you remember. Then, return to taking one tablet once a week on the day you usually take it. Do not take two tablets on the same day to make up for the missed dose.

Stopping treatment with Risendros 35

If you stop treatment, you may experience a gradual loss of bone mass. Before stopping treatment, consult your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Risendros 35 can cause side effects, although not everybody gets them.
Stop taking Risendros 35 and tell your doctor immediatelyif you experience any of the following:
symptoms of a severe allergic reaction, such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

If you experience any of the following side effects, tell your doctor immediately:

• Eye inflammation, usually with pain, redness, and sensitivity to light,
• Bone necrosis (death of bone tissue) of the jaw associated with delayed healing and infection, often after tooth extraction (see section 2, "Warnings and precautions"),
• Esophageal symptoms, such as pain when swallowing, difficulty swallowing, chest pain, or heartburn.

In clinical trials, other side effects were observed, which were usually mild and did not cause the patient to stop taking the medicine.
Common side effects (may affect up to 1 in 10 people):

• headache,
• constipation, indigestion, feeling sick, stomach pain, cramps, and discomfort in the stomach, diarrhea,
• bone, muscle, and joint pain.

Uncommon side effects (may affect up to 1 in 100 people):

• inflammation of the colored part of the eye (iris) (redness and pain in the eye with possible vision problems),
• inflammation of the stomach lining and (or) duodenum, esophagitis, or difficulty and pain when swallowing (esophageal ulcer, dysphagia).

Rare side effects (may affect up to 1 in 1,000 people):

• narrowing of the esophagus (causing difficulty swallowing), inflammation of the tongue (red swelling, possibly painful), and abnormal liver function test results (can only be determined by a blood test),
• in rare cases, atypical fractures of the thigh bone may occur, especially in patients who have been treated for osteoporosis for a long time. Consult your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may indicate an increased risk of fracture.

Very rare side effects (may affect up to 1 in 10,000 people):

• If you experience ear pain, discharge from the ear, and (or) ear infection, tell your doctor. These may be symptoms of bone tissue damage in the ear.

After the medicine was placed on the market, the following side effects were observed (frequency not known):

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

In rare cases, at the beginning of treatment, a decrease in calcium and phosphate levels in the blood may occur. These changes are usually small and do not cause symptoms.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Risendros 35

Keep the medicine out of the sight and reach of children.
Do not take Risendros 35 after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Do not take this medicine if you notice discoloration on the tablets or other visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Risendros 35 contains

The active substance is sodium risedronate. Each coated tablet contains 35 mg of sodium risedronate, which corresponds 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 monocabrylate, 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 Authorization 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 authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Risendros
Poland, Slovakia, Lithuania, Estonia, Latvia:
Risendros 35
Romania:
Risedronate sodium Zentiva 35 mg
Date of last revision of the leaflet:November 2020