Nintedanib Sandoz

Package Leaflet: Information for the User

Nintedanib Sandoz, 100 mg, Soft Capsules

Nintedanib

Read All of This Leaflet Carefully Before Taking This Medicine.

• 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 Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

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

1. What Is Nintedanib Sandoz and What Is It Used For

Nintedanib Sandoz Contains the Active Substance Nintedanib, Which Belongs to a Group of Medicines Called Tyrosine Kinase Inhibitors, and Is Used to Treat Idiopathic Pulmonary Fibrosis (IPF), Other Chronic Fibrosing Interstitial Lung Diseases (ILD) with a Progressive Phenotype, and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) in Adults.

Idiopathic Pulmonary Fibrosis (IPF)

IPF Is a Disease in Which the Lung Tissue Gradually Becomes Thicker, Stiffer, and Scarred. This Scarring Reduces the Ability to Transport Oxygen from the Lungs to the Blood. Deep Breathing Is Difficult. This Medicine Reduces Further Scarring and Stiffening of the Lungs.

Other Chronic Fibrosing Interstitial Lung Diseases (ILD) with a Progressive Phenotype

Besides IPF, There Are Other Diseases in Which the Lung Tissue Becomes Thicker, Stiffer, and Scarred Over Time (Lung Fibrosis) and Continuously Worsens (Progressive Phenotype). Examples of These Diseases Include Hypersensitivity Pneumonitis, Autoimmune ILD (e.g., ILD Associated with Rheumatoid Arthritis), Idiopathic Nonspecific Interstitial Pneumonia, Unclassifiable Idiopathic Interstitial Pneumonia, and Other ILD. This Medicine Contributes to Reducing Further Scarring and Stiffening of the Lungs.

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Systemic Sclerosis (Also Known as Scleroderma) Is a Rare Autoimmune Disease That Affects the Connective Tissue in Many Parts of the Body. Systemic Sclerosis (SSc) Causes Scarring (Fibrosis and Stiffening) of the Skin and Other Internal Organs, Such as the Lungs. The Presence of Fibrosis in the Lungs Is Called Interstitial Lung Disease (ILD) and Is Referred to as SSc-ILD. Lung Fibrosis Reduces the Ability to Supply Oxygen to the Bloodstream, Reducing the Ability to Breathe. This Medicine Contributes to Reducing Further Scarring and Stiffening of the Lungs.

2. Important Information Before You Take Nintedanib Sandoz

When Not to Take Nintedanib Sandoz

• If You Are Allergic to Nintedanib or Any of the Other Ingredients of This Medicine (Listed in Section 6),
• If You Are Pregnant.

Warnings and Precautions

Before Taking Nintedanib Sandoz, Discuss with Your Doctor or Pharmacist If:

• You Have or Have Had Liver Problems,
• You Have or Have Had Kidney Problems or Have Been Found to Have Increased Protein in Your Urine,
• You Have or Have Had Bleeding Problems,
• You Are Taking Medicines to Prevent Blood Clots (Such as Warfarin, Phenprocoumon, Heparin) to Prevent Blood Clotting,
• You Are Taking Pirfenidone, as This May Increase the Risk of Diarrhea, Nausea, Vomiting, and Liver Problems,
• You Have or Have Had Heart Problems (e.g., Heart Attack),
• You Have Recently Undergone Surgery. Nintedanib May Affect Wound Healing. Therefore, Treatment with Nintedanib Sandoz Is Usually Interrupted for a Certain Period If You Undergo Surgery. Your Doctor Will Decide When to Resume Treatment with This Medicine.
• If You Have High Blood Pressure,
• If You Have High Blood Pressure in the Blood Vessels of the Lungs (Pulmonary Hypertension),
• If You Have or Have Had an Aneurysm (Enlargement and Weakening of the Wall of a Blood Vessel) or a Tear in the Wall of a Blood Vessel.

Considering This Information, Your Doctor May Perform Blood Tests, for Example, to Check Liver Function. Your Doctor Will Discuss the Results of These Tests with You and Decide Whether You Can Take Nintedanib Sandoz.

Tell Your Doctor Immediately If, While Taking This Medicine:

• You Experience Diarrhea. Early Treatment of Diarrhea Is Important (See Section 4);
• You Vomit or Feel Nauseous (Queasy);
• You Experience Unexplained Symptoms Such as Yellowing of the Skin or Whites of the Eyes (Jaundice), Dark or Tea-Colored Urine, Pain in the Upper Right Part of the Abdomen, More Frequent Than Usual Bleeding or Bruising, or Feeling Tired. These May Be Signs of Serious Liver Problems;
• You Experience Severe Stomach Pain, Fever, Chills, Nausea, Vomiting, or a Hard or Swollen Abdomen, as These May Be Signs of a Hole in the Wall of the Intestine (Gastrointestinal Perforation). You Should Also Inform Your Doctor If You Have Had Stomach Ulcers or Intestinal Diverticulitis in the Past or If You Are Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Used to Treat Pain and Swelling) or Steroids (Used to Treat Inflammatory and Allergic Conditions), as These Factors Increase the Risk;
• You Experience Severe Abdominal Pain or Cramping, Blood in Your Stool, or Diarrhea, as These May Be Signs of Intestinal Ischemia (Insufficient Blood Flow to the Intestine);
• You Experience Pain, Swelling, Redness, and Increased Temperature of a Limb, as These May Be Signs of a Blood Clot in a Vein (a Type of Blood Vessel);
• You Experience Chest Tightness or Pain, Typically on the Left Side of the Body, Pain in the Neck, Jaw, Arm, or Hand, Rapid Heartbeat, Shortness of Breath, Nausea, Vomiting, as These May Be Signs of a Heart Attack;
• You Experience Severe Bleeding;
• You Experience Bluish Discoloration, Bleeding, Fever, Fatigue, and Confusion. This May Be a Sign of Blood Vessel Damage Called Thrombotic Microangiopathy (TMA).
• You Experience Symptoms Such as Headache, Changes in Vision, Confusion, Seizures, or Other Neurological Disorders Such as Weakness of the Arm or Leg, with or Without High Blood Pressure. These May Be Signs of a Brain Disease Called Posterior Reversible Encephalopathy Syndrome (PRES).

Children and Adolescents

Nintedanib Sandoz Should Not Be Taken by Children and Adolescents Under 18 Years of Age.

Nintedanib Sandoz and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take, Including Herbal Products and Medicines Available Without a Prescription.

Nintedanib Sandoz May Interact with Certain Other Medicines. The Following Medicines May Increase the Amount of Nintedanib in Your Blood and Therefore Increase the Risk of Side Effects (See Section 4):

• A Medicine Used to Treat Fungal Infections (Ketoconazole),
• A Medicine Used to Treat Bacterial Infections (Erythromycin),
• A Medicine That Affects the Immune System (Cyclosporin).

The Following Medicines Are Examples of Medicines That May Decrease the Amount of Nintedanib in Your Blood and Therefore Decrease the Effectiveness of Nintedanib Sandoz:

• An Antibiotic Used to Treat Tuberculosis (Rifampicin),
• Medicines Used to Treat Epileptic Seizures (Carbamazepine, Phenytoin),
• A Herbal Product Used to Treat Depression (St. John's Wort).

Pregnancy and Breastfeeding

If You Are Pregnant or Breastfeeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking This Medicine.

Pregnancy

Do Not Take This Medicine During Pregnancy, as It May Harm the Unborn Child and Cause Birth Defects.

Before Starting Treatment with Nintedanib Sandoz, a Pregnancy Test Must Be Performed to Ensure You Are Not Pregnant. You Should Discuss This with Your Doctor.

Contraception

• Women Who May Become Pregnant Must Use Highly Effective Contraception to Prevent Pregnancy, When Starting Treatment with Nintedanib Sandoz, During Treatment with Nintedanib Sandoz, and for at Least 3 Months After Treatment Has Ended.
• You Should Discuss the Best Contraceptive Methods with Your Doctor.
• Vomiting and/or Diarrhea or Other Gastrointestinal Disorders May Affect the Absorption of Oral Hormonal Contraceptives, Such as the Pill, and May Reduce Their Effectiveness. In Such Cases, You Should Discuss the Use of an Alternative, More Suitable Contraceptive Method with Your Doctor.
• If You Become Pregnant or Think You May Be Pregnant While Taking Nintedanib Sandoz, Tell Your Doctor or Pharmacist Immediately.

Breastfeeding

Do Not Breastfeed While Taking This Medicine, as It May Harm the Breastfed Child.

Driving and Using Machines

This Medicine May Have a Minor Influence on the Ability to Drive and Use Machines.

If You Feel Nauseous, You Should Not Drive or Operate Machinery.

3. How to Take Nintedanib Sandoz

Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You.

In Case of Doubt, Ask Your Doctor or Pharmacist.

Take One Capsule Twice a Day, Approximately 12 Hours Apart, Every Day, at About the Same Time, for Example, One Capsule in the Morning and One Capsule in the Evening.

This Will Ensure a Steady Amount of Nintedanib in Your Bloodstream.

Swallow the Capsules Whole with Water; Do Not Suck, Chew, or Crush the Capsules.

It Is Recommended to Take the Capsules with Food, Either During or Immediately Before or After a Meal.

Do Not Open or Crush the Capsules to Avoid Unintentional Exposure to the Capsule Contents (See Section 5).

Adults

The Recommended Dose Is One 100 Mg Capsule Twice a Day (Total 200 Mg per Day).

Do Not Take More Than the Recommended Dose: Two 100 Mg Nintedanib Sandoz Soft Capsules per Day.

If You Do Not Tolerate the Recommended Dose of Two 100 Mg Nintedanib Sandoz Capsules per Day (See Possible Side Effects in Section 4), Your Doctor May Decide to Interrupt Treatment with This Medicine.

Do Not Reduce the Dose or Stop Treatment Without Consulting Your Doctor First.

Overdose of Nintedanib Sandoz

Contact Your Doctor or Pharmacist Immediately.

Missed Dose of Nintedanib Sandoz

Do Not Take Two Capsules at the Same Time If You Miss a Dose.

Take the Next 100 Mg Dose of Nintedanib Sandoz as Planned at the Usual Time and in the Dose Prescribed by Your Doctor or Pharmacist.

Stopping Treatment with Nintedanib Sandoz

Do Not Stop Taking Nintedanib Sandoz Without Consulting Your Doctor First.

It Is Important to Take This Medicine Regularly, Every Day, for as Long as Your Doctor Prescribes.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Pay Special Attention to the Following Side Effects When Taking Nintedanib Sandoz.

Diarrhea(Very Common, May Affect More Than 1 in 10 People)

Diarrhea May Lead to Dehydration: Loss of Water and Important Substances (Electrolytes, Such as Sodium or Potassium) from the Body.

If You Experience the First Symptoms of Diarrhea, Drink Plenty of Fluids and Contact Your Doctor Immediately.

Start Appropriate Anti-Diarrheal Treatment as Soon as Possible, for Example, with Loperamide.

Other Side Effects Observed with Nintedanib (the Active Substance of This Medicine)

If You Experience Any Side Effects, Tell Your Doctor.

Idiopathic Pulmonary Fibrosis (IPF)

Very Common Side Effects(May Affect More Than 1 in 10 People)

• Nausea (Queasiness),
• Abdominal Pain,
• Abnormal Liver Function Test Results.

Common Side Effects(May Affect Up to 1 in 10 People)

• Vomiting,
• Loss of Appetite,
• Weight Loss,
• Bleeding,
• Rash,
• Headache.

Uncommon Side Effects(May Affect Up to 1 in 100 People)

• Pancreatitis,
• Colitis,
• Serious Liver Problems,
• Low Platelet Count (Thrombocytopenia),
• High Blood Pressure (Hypertension),
• Jaundice (Yellowing of the Skin and Whites of the Eyes Due to High Bilirubin Levels),
• Itching,
• Heart Attack,
• Excessive Hair Loss (Alopecia),
• Increased Protein in the Urine (Proteinuria).

Frequency Not Known(Frequency Cannot Be Estimated from the Available Data)

• Kidney Failure,
• Enlargement and Weakening of the Wall of a Blood Vessel or Tear in the Wall of a Blood Vessel (Aneurysm and Arterial Dissection),
• Brain Disease with Symptoms Such as Headache, Changes in Vision, Confusion, Seizures, or Other Neurological Disorders, Such as Weakness of the Arm or Leg, with or Without High Blood Pressure (Posterior Reversible Encephalopathy Syndrome).

Other Chronic Fibrosing Interstitial Lung Diseases (ILD) with a Progressive Phenotype

Very Common Side Effects(May Affect More Than 1 in 10 People)

• Nausea (Queasiness),
• Vomiting,
• Loss of Appetite,
• Abdominal Pain,
• Abnormal Liver Function Test Results.

Common Side Effects(May Affect Up to 1 in 10 People)

• Weight Loss,
• High Blood Pressure (Hypertension),
• Bleeding,
• Serious Liver Problems,
• Rash,
• Headache.

Uncommon Side Effects(May Affect Up to 1 in 100 People)

• Pancreatitis,
• Colitis,
• Low Platelet Count (Thrombocytopenia),
• Jaundice (Yellowing of the Skin and Whites of the Eyes Due to High Bilirubin Levels),
• Itching,
• Heart Attack,
• Excessive Hair Loss (Alopecia),
• Increased Protein in the Urine (Proteinuria).

Frequency Not Known(Frequency Cannot Be Estimated from the Available Data)

• Kidney Failure,
• Enlargement and Weakening of the Wall of a Blood Vessel or Tear in the Wall of a Blood Vessel (Aneurysm and Arterial Dissection),
• Brain Disease with Symptoms Such as Headache, Changes in Vision, Confusion, Seizures, or Other Neurological Disorders, Such as Weakness of the Arm or Leg, with or Without High Blood Pressure (Posterior Reversible Encephalopathy Syndrome).

Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

Very Common Side Effects(May Affect More Than 1 in 10 People)

• Nausea (Queasiness),
• Vomiting,
• Abdominal Pain,
• Abnormal Liver Function Test Results.

Common Side Effects(May Affect Up to 1 in 10 People)

• Bleeding,
• High Blood Pressure (Hypertension),
• Loss of Appetite,
• Weight Loss,
• Headache.

Uncommon Side Effects(May Affect Up to 1 in 100 People)

• Colitis,
• Serious Liver Problems,
• Kidney Failure,
• Low Platelet Count (Thrombocytopenia),
• Rash,
• Itching.

Frequency Not Known(Frequency Cannot Be Estimated from the Available Data)

• Heart Attack,
• Pancreatitis,
• Jaundice (Yellowing of the Skin and Whites of the Eyes Due to High Bilirubin Levels),
• Enlargement and Weakening of the Wall of a Blood Vessel or Tear in the Wall of a Blood Vessel (Aneurysm and Arterial Dissection),
• Excessive Hair Loss (Alopecia),
• Increased Protein in the Urine (Proteinuria),
• Brain Disease with Symptoms Such as Headache, Changes in Vision, Confusion, Seizures, or Other Neurological Disorders, Such as Weakness of the Arm or Leg, with or Without High Blood Pressure (Posterior Reversible Encephalopathy Syndrome).

Reporting Side Effects

If You Experience Any Side Effects, Tell Your Doctor or Pharmacist.

Side Effects Can Be Reported Directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw,

Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl

Side Effects Can Also Be Reported to the Marketing Authorization Holder.

By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Nintedanib Sandoz

Keep This Medicine Out of the Sight and Reach of Children.

Do Not Use This Medicine After the Expiry Date Stated on the Carton and Blister.

The Expiry Date Refers to the Last Day of the Month Stated.

Store in the Original Package to Protect from Moisture.

Do Not Use This Medicine If You Notice That the Blister Containing the Capsules Is Open or That the Capsule Is Broken.

If You Come into Contact with the Contents of the Capsule, Wash Your Hands Immediately with Plenty of Water (See Section 3).

Medicines Should Not Be Disposed of via Wastewater or Household Waste.

Ask Your Pharmacist How to Dispose of Medicines No Longer Required.

These Measures Will Help Protect the Environment.

6. Contents of the Package and Other Information

What Nintedanib Sandoz Contains

• The Active Substance Is Nintedanib. Each Capsule Contains 100 Mg of Nintedanib Esylate, Which Corresponds to 100 Mg of Nintedanib.
• The Other Ingredients Are:

Capsule Contents:

Medium-Chain Triglycerides, Hardened Fat,

Polyglyceryl 3-Dioleate (E475)

Capsule Shell:

Gelatin (E441), Glycerol (85%) (E422), Titanium Dioxide (E171), Iron Oxide Red (E172), Iron Oxide Yellow (E172)

Ink Used for Printing: Shellac (E904), Carmine (E120), Propylene Glycol (E1520), and Simethicone

What Nintedanib Sandoz Looks Like and Contents of the Package

Nintedanib Sandoz, 100 Mg, Soft Capsules (Capsules) Are Oblong, Non-Transparent Soft Gelatin Capsules, Peach-Colored, 13.5-17.5 Mm in Length, with Red Printing "NT 100", Containing a Yellow, Sticky Suspension.

Nintedanib Sandoz, 100 Mg, Soft Capsules Are Available in a Carton Containing 30 x 1 and 60 x 1 Soft Capsules, in Aluminum Perforated Blister Packs OPA/Aluminum/PVC.

Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

Sandoz Poland Sp. z o.o.

ul. Domaniewska 50C

02-672 Warsaw

Poland

Phone: 22 209 70 00

Manufacturer/Importer

Adalvo Limited

Malta Life Sciences Park Building 1 Floor 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate, SGN 3000

Malta

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Lek Pharmaceuticals d.d

Verovškova ulica 57

1526 Ljubljana

Slovenia

Qualimetrix S.A.

Mesogeion Avenue 579

Agia Paraskevi

Athens

153 43

Greece

This Medicine Is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands

Nintedanib Esylate Sandoz 100 Mg, Soft Capsules

Austria

Nintedanib Sandoz 100 Mg, Soft Capsules

Czech Republic

Nintedanib Sandoz

Denmark

Nintedanib Sandoz

Estonia

Nintedanib Sandoz

Spain

Nintedanib Sandoz 100 Mg, Soft Capsules EFG

Finland

Nintedanib Sandoz 100 Mg, Soft Capsules

France

NINTEDANIB SANDOZ 100 Mg, Soft Capsules

Hungary

Nintedanib Sandoz 100 Mg, Soft Capsules

Iceland

Nintedanib Sandoz

Italy

Nintedanib Sandoz

Lithuania

Nintedanib Sandoz 100 Mg, Soft Capsules

Latvia

Nintedanib Sandoz 100 Mg, Soft Capsules

Norway

Nintedanib Sandoz

Portugal

Nintedanib Sandoz 100 Mg, Soft Capsules

Sweden

Nintedanib Sandoz

Greece

Nintedanib/Sandoz

Date of Last Revision of the Package Leaflet:

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