Nintedanib Accordpharma

Package Leaflet: Information for the Patient

Nintedanib Accordpharma, 150 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. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Package Leaflet

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

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

Nintedanib Accordpharma Soft Capsules Contain the Active Substance Nintedanib. Nintedanib Blocks the Activity of a Certain Group of Proteins Involved in the Development of New Blood Vessels, Which Are Needed to Supply Cancer Cells with Nutrients and Oxygen. By Blocking the Activity of These Proteins, Nintedanib Can Inhibit the Growth and Spread of Cancer Cells.
This Medicine Is Used in Combination with Another Anti-Cancer Medicine (Docetaxel) for the Treatment of a Type of Lung Cancer Called Non-Small Cell Lung Cancer (NSCLC). It Is Intended for Adult Patients with NSCLC of a Certain Type ("Adenocarcinoma") and Who Have Already Received Chemotherapy.

2. Important Information Before You Take Nintedanib Accordpharma

When Not to Take Nintedanib Accordpharma

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

Warnings and Precautions

Before Taking Nintedanib Accordpharma, Tell Your Doctor or Pharmacist If:

• You Have or Have Had Liver Problems, Have or Have Had Bleeding Problems, or Have Recently Had Bleeding in the Lung;
• You Have or Have Had Kidney Problems or Have Had High Levels of Protein in Your Urine;
• You Are Taking Medicines to Prevent Blood Clots (Such as Warfarin, Phenprocoumon, Heparin, or Acetylsalicylic Acid (Aspirin)). Treatment with Nintedanib Accordpharma May Increase the Risk of Bleeding;
• You Have Recently Had Surgery or Are Planning to Have Surgery. Nintedanib May Affect Wound Healing. Therefore, Treatment with Nintedanib Accordpharma Is Usually Stopped If You Are Going to Have an Operation. Your Doctor Will Decide When to Restart Treatment with This Medicine;
• You Have Cancer That Has Spread to the Brain;
• You Have High Blood Pressure;
• 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 Your Liver Function or to Check How Quickly Your Blood Clots. Your Doctor Will Discuss the Results of These Tests with You and Decide Whether You Can Take Nintedanib Accordpharma.
Tell Your Doctor Immediately If You Experience:

• Diarrhea. It Is Important to Treat Diarrhea Immediately After the First Symptoms Appear (See Section 4);
• Vomiting or Nausea;
• Unexplained Symptoms Such as Yellowing of the Skin or the 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;
• Fever, Chills, Rapid Breathing or Rapid Heartbeat. These May Be Signs of Infection or Blood Infection (Septicaemia) (See Section 4);
• Severe Abdominal 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);
• Several or All of the Following Symptoms: Sudden Severe Abdominal Pain or Cramps, Blood in the Stool, Diarrhea or Constipation, Nausea and Vomiting, as These May Be Signs of Inflammation of the Intestine Due to Reduced Blood Flow (Ischaemic Colitis);
• Pain, Swelling, Redness, and Increased Temperature of a Limb or Chest Pain and Difficulty Breathing, as These May Be Signs of a Blood Clot in a Vein;
• Severe Bleeding;
• Chest Pain or Pressure, Typically on the Left Side of the Body, Pain in the Neck, Jaw, Arm, or Back, Rapid Heartbeat, Shortness of Breath, Nausea, Vomiting, as These May Be Signs of a Heart Attack;
• Any Side Effects That Become Serious.

Children and Adolescents

This Medicine Has Not Been Studied in Children and Adolescents for the Treatment of Lung Cancer (NSCLC) and Is Not Intended for Use in Children and Adolescents Under 18 Years of Age.

Nintedanib Accordpharma and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, Including Herbal Products and Medicines You Can Buy Without a Prescription.
This Medicine May Interact with Certain Other Medicines. The Following Medicines May Increase the Levels of Nintedanib in the Blood and May Increase the Risk of Side Effects (See Section 4):

• Ketoconazole (a Medicine Used to Treat Fungal Infections);
• Erythromycin (a Medicine Used to Treat Bacterial Infections). The Following Medicines May Decrease the Levels of Nintedanib in the Blood and May Decrease the Effectiveness of Nintedanib Accordpharma:
• Rifampicin (an Antibiotic Used to Treat Tuberculosis);
• Carbamazepine, Phenytoin (Medicines Used to Treat Epilepsy);
• St. John's Wort (a Herbal Product Used to Treat Depression).

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 If You Are Pregnant, as It May Harm the Unborn Child and Cause Birth Defects.
Contraception

• Women Who Can Become Pregnant Must Use Effective Contraception to Prevent Pregnancy, When Starting Treatment with Nintedanib Accordpharma, During Treatment, and for at Least 3 Months After Treatment Has Stopped.
• Discuss the Best Method of Contraception 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 Case of Such Disorders, Discuss the Use of an Alternative, More Suitable Method of Contraception with Your Doctor.
• If You Become Pregnant or Think You May Be Pregnant While Taking Nintedanib Accordpharma, Tell Your Doctor or Pharmacist Immediately.

Breastfeeding
It Is Not Known Whether This Medicine Passes into Human Milk and Whether It May Harm the Breastfed Child.
Therefore, Women Must Not Breastfeed While Taking Nintedanib Accordpharma.

Fertility

The Effect of Nintedanib Accordpharma on Fertility in Humans Has Not Been Studied.

Driving and Using Machines

Nintedanib Accordpharma May Have a Minor Influence on the Ability to Drive and Use Machines. If You Feel Nauseous, Do Not Drive or Use Machines.

Nintedanib Accordpharma Contains Soybean Lecithin

The Capsules Contain Soybean Lecithin. Do Not Take If You Are Allergic to Peanuts or Soy.

3. How to Take Nintedanib Accordpharma

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Ask Your Doctor or Pharmacist.
Do Not Take Nintedanib Accordpharma on the Same Day That You Receive Docetaxel Chemotherapy.
Swallow the Capsules Whole with Water; Do Not Chew Them. It Is Recommended to Take the Capsule with Food, Either During or Immediately Before or After a Meal.
Do Not Open or Crush the Capsules (See Section 5).
The Recommended Dose Is Two Capsules per Day (Which Gives a Total of 300 Mg of Nintedanib per Day). Do Not Take More Than This Dose.
This Daily Dose Should Be Divided into Two Doses of One Capsule, Approximately 12 Hours Apart, for Example One Capsule in the Morning and One Capsule in the Evening. These Two Doses Should Be Taken at Approximately the Same Time Every Day. Taking the Medicine in This Way Will Ensure That You Always Have a Steady Amount of Nintedanib in Your Body.

Dose Reduction

If You Cannot Tolerate the Recommended Dose of 300 Mg per Day Due to Side Effects (See Section 4), Your Doctor May Reduce the Daily Dose of Nintedanib Accordpharma. Do Not Reduce the Dose or Stop Treatment Yourself Without Consulting Your Doctor First.
Your Doctor May Reduce the Daily Dose of Nintedanib Accordpharma to 200 Mg per Day (Two Capsules of 100 Mg). In This Case, Your Doctor Will Prescribe Nintedanib Accordpharma 100 Mg Soft Capsules for Further Treatment.
Take One Capsule of This Strength Twice a Day, Approximately 12 Hours Apart, with Food (for Example in the Morning and in the Evening), at Approximately the Same Time of Day.
If Your Doctor Stops Docetaxel Chemotherapy, You Should Continue to Take Nintedanib Accordpharma Twice a Day.

Taking More Than the Recommended Dose of Nintedanib Accordpharma

Contact Your Doctor or Pharmacist Immediately.

Forgetting to Take a Dose of Nintedanib Accordpharma

Do Not Take a Double Dose to Make Up for a Forgotten Dose. Take the Next Dose of Nintedanib Accordpharma as Planned at the Usual Time and in the Dose Recommended by Your Doctor or Pharmacist.

Stopping Treatment with Nintedanib Accordpharma

Do Not Stop Taking Nintedanib Accordpharma Without Consulting Your Doctor First.
It Is Important to Take This Medicine Every Day, as Long as Your Doctor Recommends. If You Do Not Take This Medicine as Your Doctor Recommends, the Treatment of Your Cancer May Not Be Effective.
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 Accordpharma.

• Diarrhea(Very Common, May Affect More Than 1 in 10 People)Diarrhea May Lead to 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, After Consulting Your Doctor.
• Neutropenic FeverandSepticaemia(Common, May Affect Up to 1 in 10 People)Treatment with Nintedanib Accordpharma May Lead to a Decrease in the Number of a Certain Type of White Blood Cell (Neutropenia), Which Are Important for Fighting Bacterial or Fungal Infections. As a Result of Neutropenia, Fever (Neutropenic Fever) and Blood Infection (Septicaemia) May Occur. If You Experience Fever, Chills, Rapid Breathing or Rapid Heartbeat, Tell Your Doctor Immediately. During Treatment with Nintedanib Accordpharma, Your Doctor Will Regularly Check Your Blood Cell Count and Observe You for Signs of Infection, Such as Inflammation, Fever, or Fatigue.

The Following Side Effects Have Been Observed with This Medicine:
Very Common Side Effects (May Affect More Than 1 in 10 People)

• Diarrhea - See Above
• Pain, Numbness, and/or Tingling of the Fingers and Toes (Peripheral Neuropathy)
• Nausea (Feeling Sick)
• Vomiting
• Abdominal Pain
• Bleeding
• Decreased White Blood Cell Count (Neutropenia)
• Inflammation of the Mucous Membranes of the Gastrointestinal Tract, Including Mouth Ulcers and Ulcers (Mucositis, Including Oral Mucositis)
• Rash
• Decreased Appetite
• Electrolyte Imbalance
• Increased Activity of Liver Enzymes (Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase) in the Blood
• Hair Loss (Alopecia)

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

• Septicaemia (See Above)
• Decreased White Blood Cell Count with Fever (Neutropenic Fever)
• Formation of Blood Clots in the Veins (Venous Thromboembolic Disease), in Particular in the Legs (Symptoms Are: Pain, Redness, Swelling, and Increased Temperature of the Limb), Which Can Travel Through the Bloodstream to the Lungs, Causing Chest Pain and Difficulty Breathing (If You Experience Any of These Symptoms, Seek Medical Attention Immediately).
• High Blood Pressure (Hypertension)
• Loss of Fluid from the Body (Dehydration)
• Abscesses
• Low Platelet Count (Thrombocytopenia)
• Jaundice (Hyperbilirubinemia)
• Increased Activity of the Liver Enzyme Gamma-Glutamyltransferase in the Blood
• Weight Loss
• Itching
• Headache
• Increased Amount of Protein in the Urine (Proteinuria)

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

• Formation of a Hole in the Wall of the Intestine (Gastrointestinal Perforation)
• Severe Liver Problems
• Pancreatitis
• Heart Attack
• Kidney Failure

Rare Side Effects (Frequency Cannot Be Estimated from the Available Data)

• Inflammation of the Large Intestine
• Enlargement and Weakening of the Wall of a Blood Vessel or a Tear in the Wall of a Blood Vessel (Aneurysms and Arterial Dissections)
• A Brain Disease with Symptoms Such as Headache, Changes in Vision, Disorientation, Seizures, or Other Neurological Disorders, Such as Weakness of the Arms or Legs, with High Blood Pressure or Without High Blood Pressure (Posterior Reversible Encephalopathy Syndrome)

Reporting of Side Effects

If You Experience Any Side Effects, Tell Your Doctor or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. You Can Also Report Side Effects Directly to the National Agency Responsible for the Registration of Medicinal Products. By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Nintedanib Accordpharma

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton and Blister. The Expiry Date Refers to the Last Day of the Month.
There Are No Special Storage Instructions for This Medicine.
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 to Protect the Environment.

6. Contents of the Package and Other Information

What Nintedanib Accordpharma Contains

• The Active Substance Is Nintedanib. Each Soft Capsule Contains Nintedanib Esylate Equivalent to 150 Mg of Nintedanib.
• The Other Ingredients Are: Capsule Contents: Triglycerides of Fatty Acids with a Medium Chain Length, Macrogolglycerides of Lauric Acid, Lecithin (E322) (See Section 2) Capsule Shell: Gelatin, Glycerol, Titanium Dioxide (E171), Iron Oxide Red (E172), Iron Oxide Yellow (E172) Printing Ink: Shellac, Iron Oxide Black (E172), Ammonium Hydroxide, and Propylene Glycol (E1520)

What Nintedanib Accordpharma Looks Like and Contents of the Package

Nintedanib Accord 150 Mg Soft Capsules Are Brown, Non-Transparent, Cylindrical Soft Capsules with a Length of Approximately 18 Mm, with "JF2" Printed in Black Ink, Containing a Suspension with a Color Ranging from Bright Yellowish Green to Pale Yellow.
Nintedanib Accord 100 Mg Soft Capsules Are Available in:

• Aluminum/PVC-Aluminum Blisters with 60 and 120 Soft Capsules (Packaging Containing 2 Boxes of 60 Capsules) in a Cardboard Box.
• Aluminum/PVC-Aluminum Blisters, Divided into Single Doses and Perforated, with 60 × 1 and 120 × 1 Soft Capsules (Packaging Containing 2 Boxes of 60 Capsules), in a Cardboard Box.

Not All Pack Sizes May Be Marketed.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. Z O.O.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. Z O.O.
Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009, Greece

This Medicinal Product Is Authorised in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: