Iarisen

Package Leaflet: Information for the User

Yarisen, 35 mg, Film-Coated Tablets

Sodium Risedronate

Read All of This Leaflet Carefully Before Taking This Medicine. It Contains Important Information for You.

• You Should 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. Do Not Pass It On to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• -If You Experience Any of the Following Side Effects, or Any Other Unlisted Side Effects, Tell Your Doctor or Pharmacist. See Section
• 4.

Contents of the Package Leaflet:

• 1. What Is Yarisen and What Is It Used For
• 2. Important Information Before Taking Yarisen
• 3. How to Take Yarisen
• 4. Possible Side Effects
• 5. How to Store Yarisen
• 6. Contents of the Package and Other Information

1. What Is Yarisen and What Is It Used For

Yarisen Belongs to a Group of Non-Hormonal Medicines Called Bisphosphonates, Which Are Used to Treat Bone Diseases. The Medicine Works Directly on the Bones, Making Them More Resistant to Fractures.
Bone Is a Living Tissue. Old Bone Tissue Is Constantly Being Removed from the Skeleton and Replaced with New Tissue.
Postmenopausal Osteoporosis Occurs in Women After Menopause, Characterized by Increased Bone Fragility and Susceptibility to Fractures. Osteoporosis Can 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 the Most Common Sites of Fractures, but Any Bone in the Body Can Be Affected. Osteoporosis-Related Fractures Can Also Cause Back Pain, Loss of Height, and Curvature of the Spine. Many Patients with Osteoporosis Do Not Experience Symptoms and May Not Be Aware That They Have the Condition.
Treatment of Osteoporosis in Postmenopausal Women, Even with Severe Osteoporosis, Reduces the Risk of Vertebral and Hip Fractures.
Treatment of Osteoporosis in Men at High Risk of Fracture.

2. Important Information Before Taking Yarisen

When Not to Take Yarisen

• If You Are Allergic to Sodium Risedronate or Any of the Other Ingredients of This Medicine (Listed in Section 6)
• If Your Doctor Has Diagnosed You with Hypocalcemia(Low Blood Calcium Levels);
• If You Are Pregnant, Think You May Be Pregnant, or Plan to Become Pregnant;
• If You Are Breast-Feeding;
• If You Have Severe Kidney Impairment.

Warnings and Precautions

Before Taking Yarisen, Discuss with Your Doctor:

• If You Are Unable to Stand or Sit Upright for at Least 30 Minutes;
• If You Have Bone Metabolism or Mineral Metabolism Disorders (e.g., Vitamin D Deficiency, Hormonal Disorders of the Parathyroid Gland) Leading to Low Blood Calcium Levels;
• If You Have Had Esophageal Diseases (the Part of the Gastrointestinal Tract Through Which Food Passes from the Mouth to the Stomach), Such as Difficulty Swallowing or Food Getting Stuck in the Esophagus, or If You Have Been Diagnosed with Barrett's Esophagus (a Condition Characterized by a Change in the Type of Cells in the Lower Part of the Esophagus);
• If You Have Been Informed by Your Doctor That You Have an Intolerance to Some Sugars (Such as Lactose).
• If You Have Experienced or Are Experiencing Jaw Pain, Swelling, or Numbness, or a Feeling of "Heavy" Jaw or Loose Teeth.
• If You Are Undergoing or Will Undergo Dental Treatment, Inform Your Dentist About Your Treatment with Yarisen.

Your Doctor Will Inform You How to Proceed with Taking Yarisen in Case of Any of the Above Situations.

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 and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Currently Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.
Medicines Containing Any of the Following Ingredients Reduce the Effect of Yarisen If Taken at the Same Time:

• Calcium
• Magnesium
• Aluminum (e.g., Antacids, Acid Reflux Medicines)
• 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), So That the Medicine Works Properly.
Especially, Do Not Take This Medicine at the Same Time as Dairy Products (Such as Milk), as They Contain Calcium (See Section 2, "Yarisen and Other Medicines").
Eat and Drink (Other Than Plain Water) at Least 30 Minutes After Taking a Tablet of Yarisen.

Pregnancy and Breast-Feeding

If You Are Pregnant, Think You May Be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking This Medicine.
Do Not Take Yarisen If You Are Pregnant, Think You May Be Pregnant, or Plan to Become Pregnant (See Section 2, "When Not to Take Yarisen"). The Potential Risk Associated with the Use of Sodium Risedronate (the Active Substance of Yarisen) in Pregnant Women Is Unknown.
Do Not Take Yarisen During Breast-Feeding (See Section 2, "When Not to Take Yarisen").

Driving and Using Machines

Yarisen Has Not Been Observed to Affect the Ability to Drive or Use Machines.

Yarisen Contains Lactose Monohydrate

If You Have Been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking This Medicine.

Yarisen Contains Sodium

The Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Film-Coated Tablet, Which Means It Is Essentially "Sodium-Free".

3. How to Take Yarisen

Always Take This Medicine Exactly as Your Doctor Has Told You. If You Are Not Sure, Ask Your Doctor.
Usual Dose:
Take ONE Yarisen Tablet (35 Mg Sodium Risedronate) Once a Week.
Choose a Day of the Week That Best Fits Your Schedule. Take a Tablet of Yarisen on That Chosen Day Every Week.
To Help You Remember to Take the Medicine on the Right Day, the Packaging of Yarisen Contains a Reminder:
On the Back of the Carton, There Are Boxes/Blank Spaces. Mark the Chosen Day of the Week When You Will Take Yarisen. Also, Write Down the Dates of the Days When You Will Take the Tablet.

When to Take Yarisen

Take Yarisen at Least 30 Minutes Before the First Food, Drink (Other Than Plain Water), or Other Medicine of the Day.

How to Take Yarisen

• Take the Tablet in an Upright Position(You Can Sit or Stand), to Avoid Heartburn.
• Swallowwith at Least a Full Glass of Plain Water(120 Ml).
• Swallow the Tablet Whole; Do Not Suck or Chew It.
• Do Not Lie Downfor at Least 30 Minutes After Taking the Tablet.

Your Doctor Will Inform You Whether You Need Additional Calcium and Vitamin Supplements, If You Do Not Have Enough in Your Diet. Your Diet Should Include Calcium and Vitamin D (Found in Dairy Products and Fish).

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
Stop Taking Yarisen and Tell Your Doctor ImmediatelyIf You Experience Any of the Following Side Effects:

• Symptoms of Acute Angioedema (Angioedema)
• Swelling of the Face, Tongue, and (or) Throat
• Difficulty Swallowing
• Rash and Difficulty Breathing
• Severe Skin Reactions, Including Subcutaneous Pustules

Tell Your Doctor ImmediatelyIf You Experience Any of the Following Side Effects:

• Eye Inflammation, Usually Painful, with Redness and Sensitivity to Light.

Jaw Necrosis, Particularly Difficult to Heal and with Recurring Infections, Often Occurring After Tooth Extraction (See Section 2, "Warnings and Precautions").

• Symptoms Related to the Esophagus, Such as Pain When Swallowing, Difficulty Swallowing, Chest Pain, or the Onset or Worsening of Heartburn.

Very Rare Side Effects (Less Than 1 in 10,000 Patients).
Other Side Effects Observed in Clinical Trials Were Usually Mild and Did Not Require the Patient to Stop Taking the Medicine.
Common Side Effects(1 to 10 in 100 Patients):

• Nausea, Vomiting, Stomach Pain, Abdominal Cramps or Discomfort, Constipation, Feeling of Fullness, Bloating, Diarrhea
• Bone, Muscle, or Joint Pain
• Headache.

Uncommon Side Effects(1 to 10 in 1,000 Patients):

• Inflammation of the Esophageal Mucosa or Ulceration (the Part of the Gastrointestinal 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 Gastric Mucosa and (or) Duodenum (the Initial Part of the Intestine, into Which the Stomach Contents Pass),
• Inflammation of the Colored Part of the Eye (Iritis) (Red, Painful Eyes with Possible Vision Disturbances).

Rare Side Effects(1 to 10 in 10,000 Patients):

• Inflammation of the Tongue (Swelling with Redness and Possible Pain), Narrowing of the Esophagus (the Part of the Gastrointestinal Tract Through Which Food Passes from the Mouth to the Stomach)
• Changes in Liver Function Tests. This Can Only Be Detected by a Blood Test.

The Following Additional Side Effects Have Been Reported After the Medicine Was Placed on the Market (Frequency Not Known):
Hair Loss
Liver Disorders, in Some Cases Severe.

• Hypersensitivity and Skin Reactions, Including Face, Lip, Tongue, and (or) Throat Swelling (Angioedema), Rash, and Blisters, Some Severe and Life-Threatening, Affecting the Skin and Mucous Membranes, and Vasculitis.

Very Rarely

• 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.

In Rare Cases, Atypical Fractures of the Thigh Bone May Occur, Especially in Patients 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 Already Indicate a High Risk of Thigh Bone Fracture.
Rarely, at the Beginning of Treatment, Blood Calcium and Phosphate Levels May Decrease. These Changes Are Usually Small and Do Not Cause Any Symptoms.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can Be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.
Side Effects Can Also Be Reported to the Marketing Authorization Holder.

5. How to Store Yarisen

Keep This Medicine Out of the Sight and Reach of Children.
*
Do Not Use This Medicine After the Expiration Date Stated on the Packaging After "EXP".
There Are No Special Precautions for Storage.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Package and Other Information

What Yarisen Contains

• The Active Substance of Yarisen Is Sodium Risedronate. Each Film-Coated Tablet Contains 35 Mg of Sodium Risedronate, Which Corresponds to 32.5 Mg of Risedronic Acid.
• The Other Ingredients Are: Core of the Tablet:Lactose Monohydrate, Microcrystalline Cellulose, Crospovidone (Type A), Magnesium Stearate. Coating:Yellow Iron Oxide (E172), Red Iron Oxide (E172), Hypromellose, Hydroxypropyl Cellulose, Silica Colloidal Anhydrous, Titanium Dioxide (E171), Macrogol 400, Macrogol 8000.

What Yarisen Looks Like and Contents of the Package

Yarisen 35 Mg Film-Coated Tablets Are Biconvex, Round, and Light Orange. The Medicine Is Available in Packs Containing 2, 4, or 12 Film-Coated Tablets.
Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Authorized in the Member States of the European Economic Area 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, Film-Coated Tablet}
{Ireland} {Risedronate Sodium Adamed Pharma Once a Week 35 Mg Film-Coated Tablets}

Date of Last Revision of the Leaflet: