Yarisen

Patient Information Leaflet

Yarisen, 35 mg, film-coated tablets
Sodium risedronate
Please read all of this leaflet carefully before 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 personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Yarisen is and what it is used for

Yarisen belongs to a group of non-hormonal medicines called bisphosphonates, which are used in the treatment of bone diseases. The medicine acts directly on the bones, making them stronger and less likely to fracture.
Bone is a living tissue. Old bone tissue is constantly being removed from the skeleton and replaced by new tissue.
Postmenopausal osteoporosis occurs in women after menopause and is characterized by increased bone fragility and a higher risk of fractures due to falls or stress. Osteoporosis may also occur in men for various reasons, including advanced age and/or low levels of the male hormone testosterone.
The spine, hip, and wrist are most susceptible to fractures, although any bone in the body may be affected. Osteoporosis-related fractures may also cause back pain, loss of height, and spinal curvature. Many patients with osteoporosis have no symptoms and may not realize they are affected.
Treatment of osteoporosis in postmenopausal women, even those with severe osteoporosis, reduces the risk of vertebral and hip fractures.
Treatment of osteoporosis in men who are at increased risk of fractures.

2. Important information before using Yarisen

When not to use Yarisen

• 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 diagnosed the patient with hypocalcaemia (low calcium levels in the blood);
• if the woman suspects she is pregnant, is pregnant, or plans to become pregnant;
• if the woman is breastfeeding;
• in case of severe renal insufficiency.

Warnings and precautions
Before starting treatment with Yarisen, discuss the following with your doctor:

• if the patient is unable to remain in an upright position (sitting or standing) for at least 30 minutes;
• if the patient has bone metabolism disorders or mineral imbalances (e.g. vitamin D deficiency, parathyroid hormone disorders) leading to low calcium levels in the blood;
• if the patient has previously had oesophageal diseases (the part of the digestive tract through which food passes from the mouth to the stomach); for example, if the patient experiences pain or difficulty when swallowing food, or has been previously diagnosed with Barrett’s oesophagus (a condition involving changes in the type of cells lining the lower oesophagus);
• if the patient has been informed by a doctor about intolerance to certain sugars (such as lactose);
• if the patient has experienced or continues to experience pain, swelling or numbness in the jaw, or a sensation of a “heavy” jaw or loose teeth;
• if the patient is undergoing or will undergo dental treatment, the dentist should be informed about treatment with Yarisen.

The doctor will advise on how to proceed when using Yarisen if any of the above conditions apply.

Children and adolescents
Yarisen is not intended for use in children under 18 years of age due to lack of data on safety and efficacy.

Yarisen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Medicines containing any of the following ingredients may reduce the effectiveness of Yarisen if taken simultaneously:

• calcium
• magnesium
• aluminium (e.g. medicines used for gastric hyperacidity, heartburn)
• iron. These medicines should be taken at least 30 minutes after taking Yarisen.

Yarisen with food and drink
It is very important not to take Yarisen with food or drink (other than plain water) to ensure proper effectiveness of the medicine.
In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2 “Yarisen with other medicines”).
Food and drinks (other than plain water) should be taken at least 30 minutes after taking a Yarisen tablet.

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 a doctor or pharmacist before using this medicine.
Yarisen must not be used if a woman may be pregnant, is pregnant, or plans to become pregnant (see section 2 “When not to use Yarisen”). The potential risk associated with the use of sodium risedronate (the active substance in Yarisen) during pregnancy is unknown.
Yarisen must not be used during breastfeeding (see section 2 “When not to use Yarisen”).

Driving and operating machinery
No effects of Yarisen on the ability to drive or operate machinery have been observed.

Yarisen contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Yarisen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet; therefore, this medicine is considered “sodium-free”.

3. How to take Yarisen

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
you should consult your doctor.
Usual dose:
Take ONE Yarisen tablet (35 mg of risedronate sodium) once a week.
Choose one day of the week that best fits your routine. Each week, take the Yarisen tablet on that
same chosen day.
To help you remember to take the medicine on the correct day of the week, the Yarisen packaging
includes a reminder system:
On the back of the cardboard box there are boxes/blanks. You should mark in them the day of the
week on which you will take Yarisen. You should also write down the dates when you will take the
tablet.

When to take Yarisen
Yarisen should be taken at least 30 minutes before the first meal, drink (other than plain water), or
other medicine of the day.

How to take Yarisen

• Take the tablet in an upright position (you may sit or stand), to avoid heartburn.
• Swallow with at least a full glass of plain water (120 ml).
• The tablet should be swallowed whole; do not suck or chew it.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise whether you need to take additional calcium and vitamin supplements if
your diet does not provide enough. Your diet should include calcium and vitamin D (found, for
example, in dairy products and fish).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking Yarisen immediately and contact your doctor if any of the following adverse reactions occur:

• symptoms characteristic of acute tissue swelling (angioedema)
• swelling of the face, tongue and/or throat
• difficulty swallowing
• skin rash and breathing difficulties
• severe skin reactions, including subcutaneous blisters

You should contact your doctor immediately if you experience any of the following adverse reactions:

• Eye inflammation, usually painful, with redness and sensitivity to light.

Osteonecrosis of the jaw, particularly difficult to heal and associated with recurring infections, often occurring after tooth extraction (see section 2, "Warnings and precautions").

• Esophageal symptoms such as pain when swallowing, difficulty swallowing, chest pain, or new onset or worsening heartburn.

Very rare adverse reactions (less than 1 in 10,000 patients).
Other adverse reactions observed in clinical trials were generally mild and did not lead to discontinuation of the medicine by the patient.
Common adverse reactions (1 to 10 in 100 patients):

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

Uncommon adverse reactions (1 to 10 in 1,000 patients):

• inflammation or ulceration of the oesophagus (the part of the digestive tract through which food passes from the mouth to the stomach), causing difficulty or pain when swallowing (see section 2, "Warnings and precautions"), inflammation of the stomach and/or duodenum (the initial part of the intestine into which stomach contents pass)
• inflammation of the coloured part of the eye (iris) (red, painful eyes with possible visual disturbances).

Rare adverse reactions (1 to 10 in 10,000 patients):

• inflammation of the tongue (swelling with redness and possible pain), narrowing of the oesophagus (the part of the digestive tract through which food passes from the mouth to the stomach)
• changes in liver function test parameters. These can only be detected by diagnostic blood tests.

The following additional adverse reactions have been reported after marketing authorization (frequency not known):
hair loss
liver disorders, in some cases severe.

• hypersensitivity and skin reactions, including swelling of the face, lips, tongue and/or neck (angioedema), rash and blisters, some of which are severe and life-threatening skin and mucosal reactions, and inflammation of small blood vessels.

Very rare

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

In rare cases, atypical femoral fractures may occur, particularly in patients on long-term treatment for osteoporosis. Patients should consult their doctor if they experience pain, weakness or discomfort in the thigh, hip or groin area, as this may be an early sign indicating a potential femoral fracture.
Rarely, at the beginning of treatment, a decrease in blood calcium and phosphate levels may occur. These changes are usually minor and do not cause any symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store the medicine Yarisen

Keep this medicine out of sight and reach of children.*
Do not use this medicine after the expiry date stated on the packaging after "EXP".
No special precautions for storage are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Yarisen contains

• The active substance is risedronate sodium. Each coated tablet contains 35 mg of sodium risedronate, equivalent to 32.5 mg of risedronic acid.
• Other ingredients are: Tablet core: monohydrate lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate. Coating: yellow iron oxide (E172), red iron oxide (E172), hypromellose, hydroxypropylcellulose, colloidal anhydrous silica, titanium dioxide (E171), macrogol 400, macrogol 8000.

What Yarisen looks like and contents of the pack
Yarisen 35 mg coated tablets are biconvex, round, light orange in colour. The medicine is available in packages containing 2, 4 or 12 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
One Pharma Industrial Pharmaceutical Company Societe Anonyme
60th km Athens-Lamia Highway
32009 Schimatari
Greece
This medicinal product is authorised in the European Economic Area countries under the following names:
{Poland} {Yarisen}
{Estonia} {Norifaz}
{Greece} {Bonmate}
{Lithuania} {Norifaz}
{Latvia} {Norifaz}
{Portugal} {Norifaz}
{Hungary} {Norifaz}
{Slovakia} {Norifaz 35 mg}
{France} {Risedronate Zentiva Lab 35 mg, comprimé pelliculé}
{Ireland} {Risedronate sodium Adamed Pharma Once a week 35 mg film-coated tablets}