Nintedanib Teva

Package Leaflet: Information for the Patient

Nintedanib Teva, 150 mg, Soft Capsules

Nintedanib

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What Nintedanib Teva is and what it is used for
• 2. Important information before taking Nintedanib Teva
• 3. How to take Nintedanib Teva
• 4. Possible side effects
• 5. How to store Nintedanib Teva
• 6. Contents of the pack and other information

1. What Nintedanib Teva is and what it is used for

Nintedanib Teva 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 and progressive 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 medication reduces further scarring and stiffness of the lungs.

Other Chronic and Progressive 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 worsens continuously (progressive phenotype). Examples of these diseases include allergic alveolitis, autoimmune ILD (e.g., ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other ILDs. This medication helps reduce further scarring and stiffness 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 stiffness) 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, making breathing difficult. This medication helps reduce further scarring and stiffness of the lungs.

2. Important Information Before Taking Nintedanib Teva

When Not to Take Nintedanib Teva

• if the patient is allergic to nintedanib or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant.

Warnings and Precautions

Before starting to take Nintedanib Teva, the patient should discuss it with their doctor or pharmacist if:

• the patient has or has had liver problems,
• the patient has or has had kidney problems or has been found to have an increased level of protein in their urine,
• the patient has or has had bleeding problems,
• the patient is taking blood-thinning medications (such as warfarin, phenprocoumon, or heparin) to prevent blood clotting,
• the patient is taking pirfenidone, as this may increase the risk of diarrhea, nausea, vomiting, and liver problems,
• the patient has or has had heart problems (e.g., heart attack),
• the patient has recently undergone surgery. Nintedanib may affect wound healing. Therefore, treatment with this medication is usually suspended for a while if the patient undergoes surgery. The doctor will decide when to resume treatment with this medication.
• the patient has high blood pressure,
• the patient has high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• the patient has or has 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, the doctor may perform blood tests, for example, to check liver function. The doctor will discuss the results of these tests with the patient and decide whether the patient can take Nintedanib Teva.

The patient should immediately inform their doctor if they experience any of the following while taking this medication:

• diarrhea. Early treatment of diarrhea is important (see section 4);
• vomiting or nausea;
• unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (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 symptoms of severe liver problems;
• severe stomach pain, fever, chills, nausea, vomiting, or a hard stomach or bloating, as these may be symptoms of a hole in the wall of the intestine (gastrointestinal perforation). The patient should also inform their doctor if they have had stomach ulcers or intestinal diverticulitis in the past or if they are taking nonsteroidal 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;
• severe abdominal pain or cramps, bloody stools, or diarrhea, as these may be symptoms of intestinal ischemia;
• pain, swelling, redness, and increased temperature of a limb, as these may be symptoms of a blood clot in a vein;
• chest pain or discomfort, 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 symptoms of a heart attack;
• severe bleeding;
• bruising, bleeding, fever, fatigue, and confusion. This may be a sign of a blood vessel disorder called thrombotic microangiopathy;

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3. How to Take Nintedanib Teva

Take this medication always exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Take the capsules twice a day, approximately 12 hours apart, for example, one capsule in the morning and one capsule in the evening. This will ensure that the amount of nintedanib in your blood remains constant. Swallow the capsules whole with water; do not chew the capsules. It is recommended to take the capsules with food, i.e., during or immediately before or after a meal.

Adults

The recommended dose is one 150 mg capsule twice a day (a total of 300 mg per day). Do not take more than the recommended dose of two 150 mg Nintedanib Teva capsules per day.

If the patient does not tolerate the recommended dose of two 150 mg Nintedanib Teva capsules per day (see possible side effects in section 4), the doctor may reduce the daily dose of Nintedanib Teva. Do not reduce the dose or stop treatment without consulting a doctor first.

The doctor may reduce the recommended dose to 100 mg twice a day (a total of 200 mg per day). In such a case, the doctor will prescribe 100 mg Nintedanib Teva soft capsules for further treatment. Do not exceed the recommended dose of two 100 mg Nintedanib Teva capsules per day if the patient's daily dose has been reduced to 200 mg per day.

Overdose of Nintedanib Teva

Contact a doctor or pharmacist immediately.

Missed Dose of Nintedanib Teva

Do not take two capsules at once if a dose is missed. Take the next 150 mg dose of Nintedanib Teva as scheduled, at the usual time recommended by the doctor or pharmacist.

Stopping Nintedanib Teva Treatment

Do not stop taking Nintedanib Teva without consulting a doctor first. It is important to take the medication regularly, every day, for as long as the doctor recommends.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Nintedanib Teva can cause side effects, although not everybody gets them.

Pay particular attention to the following side effects when taking Nintedanib Teva.

Diarrhea Very Common(may affect more than 1 in 10 people)

Diarrhea can lead to dehydration: loss of water and important salts (electrolytes, such as sodium or potassium) from the body. If the first symptoms of diarrhea occur, drink plenty of fluids and contact a 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 Medication)

If the patient experiences any side effects, they should inform their doctor.

Idiopathic Pulmonary Fibrosis (IPF)

Very Common Side Effects(may affect more than 1 in 10 people)

• nausea
• 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
• severe liver problems
• low platelet count (thrombocytopenia)
• high blood pressure (hypertension)
• jaundice
• 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 arms or legs, with high blood pressure or without high blood pressure (posterior reversible encephalopathy syndrome)

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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

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 medication.

5. How to Store Nintedanib Teva

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

There are no special storage instructions for this medication.

Do not use this medication 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 Pack and Other Information

What Nintedanib Teva Contains

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as nintedanib esylate).
• The other ingredients are:
• capsule content: medium-chain triglycerides, solid fat, polyglyceryl-3 diolein
• capsule shell: gelatin, glycerol, titanium dioxide (E 171), iron oxide red (E 172), and iron oxide yellow (E 172), purified water
• ink: shellac, iron oxide black (E 172), and propylene glycol (E 1520)

What Nintedanib Teva Looks Like and Contents of the Pack

Nintedanib Teva 150 mg is a non-transparent, elongated capsule with a brown color, approximately 17 mm in length, containing a yellow viscous suspension, with a black ink imprint "NT 150".

Nintedanib Teva 150 mg soft capsules are available in single-dose blisters made of OPA/Aluminum/PVC/Aluminum in a cardboard box.

Package sizes:

30 x 1 soft capsules

60 x 1 soft capsules

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel: +48 22 345 93 00

Manufacturer/Importer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Adalvo Limited

Malta Life Sciences Park Building 1 Level 4

Sir Temi Zammit Buildings

San Gwann Industrial Estate

San Gwann, SGN 3000

Malta

QUALIMETRIX S.A.

579 MESOGEION AVENUE AGIA PARASKEVI,

Athens, 15343, Greece

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria:

Nintedanib ratiopharm 150 mg – Weichkapseln

Belgium:

Nintedanib Teva 150 mg zachte capsules/capsules molles/Weichkapseln

Czech Republic:

Nintedanib Teva

Germany:

Nintedanib-ratiopharm 150 mg Weichkapseln

Denmark:

Nintedanib Teva

Estonia:

Nintedanib Teva

Greece:

Nintedanib/Teva

Spain:

Nintedanib Teva 150 mg cápsulas blandas EFG

Finland:

Nintedanib ratiopharm 150 mg kapseli, pehmeä

France:

NINTEDANIB TEVA 150mg, capsule molle

Croatia:

Nintedanib Teva 150 mg, meke kapsule

Iceland:

Nintedanib Teva

Italy:

Nintedanib Teva

Lithuania:

Nintedanib Teva 150 mg minkštosios kapsulės

Latvia:

Nintedanib Teva 150 mg mīkstās kapsulas

Luxembourg:

Nintedanib Teva 150 mg capsules molles

Netherlands:

Nintedanib Teva 150 mg, zachte capsules

Norway:

Nintedanib Teva

Poland:

Nintedanib Teva

Portugal:

Nintedanib Zidrium

Romania:

Nintedanib Teva 150 mg, capsule moi

Sweden:

Nintedanib Teva

Slovakia:

Nintedanib Teva 150 mg mäkké kapsuly

Date of Last Revision of the Package Leaflet: May 2025