Nintedanib Stada 150 mg soft capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Nintedanib Stada 150 mg soft capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Nintedanib Stada contains the active substance nintedanib, a medicine belonging to the class of drugs known as tyrosine kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and interstitial lung disease associated with systemic sclerosis (SSc-ILD) in adults.

Idiopathic pulmonary fibrosis (IPF)

IPF is a disease that over time causes thickening, hardening, and scarring of the lung tissue. As a result, this scarring reduces the ability to transfer oxygen from the lungs into the bloodstream, making it difficult to breathe deeply. Nintedanib helps reduce the development of further scarring and hardening in the lungs.

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype
In addition to IPF, there are other disorders in which lung tissue becomes thickened, hardened, and scarred over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Some examples of these disorders include hypersensitivity pneumonitis, autoimmune ILDs (such as ILD associated with rheumatoid arthritis), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib helps reduce new lung scarring and hardening.

Interstitial lung disease associated with systemic sclerosis (SSc-ILD)

Systemic sclerosis (SSc), also known as scleroderma, is a rare chronic autoimmune disease affecting connective tissue in many parts of the body. SSc causes fibrosis (scarring and hardening) of the skin and other internal organs, such as the lungs.

When the lungs are affected by fibrosis, it is called interstitial lung disease (ILD), and thus the condition is referred to as SSc-ILD. Lung fibrosis reduces the ability to transfer oxygen into the bloodstream and impairs breathing capacity. Nintedanib helps reduce new scarring and hardening of the lungs.

2. What you need to know before taking Nintedanib Stada

Do not take Nintedanib Stada

• if you are allergic to nintedanib or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nintedanib Stada:

• if you have or have had liver problems;
• if you have or have had kidney problems, or if you have been found to have an increased amount of protein in your urine;
• if you have or have had bleeding problems;
• if you are taking medicines to thin the blood (such as warfarin, phenprocoumon or heparin) to prevent blood clots;
• if you are taking pirfenidone, as this may increase the risk of diarrhoea, nausea, vomiting and liver problems;
• if you have or have had heart problems (such as a heart attack);
• if you have recently undergone surgery. Nintedanib may affect how wounds heal. Therefore, treatment with nintedanib is usually temporarily stopped if you undergo surgery. Your doctor will decide when to resume treatment with this medicine;
• if you have high blood pressure;
• if you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension);
• if you have or have had an aneurysm (a bulge and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may carry out certain blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide whether you can take nintedanib.

Tell your doctor immediately while you are taking this medicine:

• if you have diarrhoea. It is important to treat diarrhoea early (see section 4);
• if you have vomiting or feel sick (nausea);
• if you have unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (like tea), pain in the upper right side of the stomach area (abdomen), you bleed or bruise more easily than normal, or feel tired. These could be signs of serious liver problems;
• if you have sudden severe stomach pain, fever, chills, dizziness, vomiting or abdominal stiffness or swelling, as these could be symptoms of a hole in the wall of the intestine ("gastrointestinal perforation"). Also inform your doctor if you have previously had peptic ulcers or diverticular disease, or if you are being treated at the same time with anti-inflammatory medicines (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as these may increase this risk;
• if you have a combination of severe or colicky stomach pain, red blood in the stools or diarrhoea, as these could be symptoms of intestinal inflammation due to insufficient blood supply;
• if you have pain, swelling, redness or warmth in a limb, as these could be symptoms of a blood clot in one of your veins (a type of blood vessel);
• if you have pressure or pain in the chest, usually on the left side of the body, pain in the neck, jaw, shoulder or arm, rapid heartbeat, shortness of breath, nausea or vomiting, as these could be symptoms of a heart attack;
• if you have a serious bleeding;
• if you experience bruising, bleeding, fever, fatigue and confusion, as these may be signs of damage to blood vessels known as thrombotic microangiopathy (TMA).

Children and adolescents

Nintedanib must not be used in children and adolescents under 18 years of age.

Other medicines and Nintedanib Stada

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, including herbal medicines and those obtained without a prescription.

Nintedanib may interact with other medicines. The following medicines may increase blood levels of nintedanib 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 your immune system (cyclosporine).

The following medicines are examples that may decrease blood levels of nintedanib and thus reduce the effectiveness of nintedanib:

• an antibiotic used to treat tuberculosis (rifampicin);
• medicines used to treat seizures (carbamazepine, phenytoin);
• a herbal medicine 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy, as it may harm the unborn baby and cause birth defects.

A pregnancy test must be performed to confirm you are not pregnant before starting treatment with nintedanib. Consult your doctor.

Contraception

• Women who can become pregnant must use a highly effective method of contraception to prevent pregnancy when starting nintedanib, while taking nintedanib, and for at least 3 months after stopping treatment.
• Discuss with your doctor the most appropriate contraceptive methods for you.
• Vomiting and/or diarrhoea or other gastrointestinal disorders may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these conditions, consult your doctor to consider an alternative, more appropriate method of contraception.
• Inform your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib.

Breastfeeding

Do not breastfeed during treatment with nintedanib, as it may cause harm to the breastfed infant.

Driving and using machines

Nintedanib has little influence on the ability to drive and use machines. You should not drive or operate machinery if you feel dizzy.

3. How to take Nintedanib Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Take the capsules twice daily, approximately 12 hours apart and at approximately the same time each day; for example, one capsule in the morning and one capsule in the evening. This ensures that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without chewing them. It is recommended that you take the capsules with food, that is, during meals or immediately before or after meals. Do not open or break the capsule (see section 5).

Adults

The recommended dose is one 150 mg capsule twice daily (a total of 300 mg daily).

Do not take more than the recommended dose of two 150 mg nintedanib capsules per day.

If you do not tolerate the recommended dose of two 150 mg nintedanib capsules per day (see possible adverse effects in section 4), your doctor may reduce your daily dose of this medicine. Do not reduce the dose or stop treatment on your own without first consulting your doctor.

Your doctor may reduce the recommended dose to 100 mg twice daily (a total of 200 mg daily). In this case, your doctor will prescribe nintedanib 100 mg capsules for your treatment. Do not take more than the recommended dose of two 100 mg nintedanib capsules per day if your daily dose has been reduced to 200 mg daily.

If you take more Nintedanib Stada than you should

Contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nintedanib Stada

Do not take two capsules together if you have missed your previous dose. You should take your next dose of nintedanib 150 mg according to the schedule established and recommended by your doctor or pharmacist.

If you stop taking Nintedanib Stada

Do not stop taking nintedanib without first consulting your doctor. It is important to take this medicine every day for as long as your doctor prescribes it.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You should pay special attention if you experience the following adverse effects during treatment with nintedanib:

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of important body fluids and salts (electrolytes, such as sodium or potassium). At the first signs of diarrhoea, drink plenty of fluids and contact your doctor immediately. Start an appropriate anti-diarrhoeal treatment as soon as possible, for example, by taking loperamide.

The following adverse effects have also been observed during treatment with this medicine.

Contact your doctor if you experience any type of adverse effect.

Idiopathic pulmonary fibrosis (IPF)

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Abdominal pain
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Serious liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure (hypertension)
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Weakening and enlargement of a blood vessel wall or tear in a blood vessel wall (aneurysms and arterial dissections)

Other chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Weight loss
• High blood pressure (hypertension)
• Bleeding
• Serious liver problems
• Rash
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people)

• Pancreatitis
• Inflammation of the large intestine
• Low platelet count (thrombocytopenia)
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Kidney failure
• Weakening and enlargement of a blood vessel wall or tear in a blood vessel wall (aneurysms and arterial dissections)

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Very common adverse effects (may affect more than 1 in 10 people)

• Nausea
• Vomiting
• Abdominal pain
• Abnormal liver function test results

Common adverse effects (may affect up to 1 in 10 people)

• Bleeding
• High blood pressure (hypertension)
• Loss of appetite
• Weight loss
• Headache

Uncommon adverse effects (may affect up to 1 in 100 people)

• Inflammation of the large intestine
• Serious liver problems
• Kidney failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from available data)

• Heart attack
• Pancreatitis
• Jaundice, i.e., yellowing of the skin and whites of the eyes due to high levels of bilirubin
• Weakening and enlargement of a blood vessel wall or tear in a blood vessel wall (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased amount of protein in the urine (proteinuria)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nintedanib Stada

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 after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the blister containing the capsules is open or if a capsule is broken.

If you come into contact with the capsule contents, wash your hands immediately with plenty of water (see section 3).

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Nintedanib Stada

• The active substance is nintedanib. Each capsule contains 150 mg of nintedanib (as esilate).

• The other components are:

• Capsule contents: medium-chain triglycerides, solid semisynthetic glycerides, and glycerol dioleate.

• Capsule shell: gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and purified water.

• Printing ink: shellac, black iron oxide (E 172), and propylene glycol (E 1520).

Appearance of the product and contents of the container

Nintedanib Stada 150 mg are brown, opaque, oblong soft capsules containing a yellow viscous suspension, printed with "NT 150" in black ink, approximately 17 mm in length.

Nintedanib Stada 150 mg capsules are available in cardboard boxes with single-dose OPA/Al/PVC-Al perforated blisters.

Pack sizes:

• 30 x 1 soft capsules
• 60 x 1 soft capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

or

Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate, SGN 3000
Malta

or

QUALIMETRIX S.A.
579 MESOGEION AVENUE
AGIA PARASKEVI, Athens,
15343, Greece

or

STADA Arzneimittel AG
Stadastrasse 2 - 18,
Dortelweil,
Bad Vilbel, Hesse, 61118
Germany

or

Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814NE Breda
Netherlands

or

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Wien
Austria

This medicinal product is authorized in the European Economic Area member states under the following names:

Iceland: Nintedanib STADA 150 mg mjúk hylki
Germany: Nintedanib IPF AL 150 mg Weichkapseln
Austria: Nintedanib STADA 150 mg Weichkapseln
Belgium: Nintedanib EG 150 mg zachte capsules
Denmark: Nintedanib STADA
Spain: Nintedanib STADA 150 mg cápsulas blandas EFG
France: NINTEDANIB EG 150 mg, capsule molle
Finland: Nintedanib STADA 150 mg pehmeät kapselit
Greece: NINTEDANIB/STADA
Croatia: Nintedanib STADA 150 mg meke kapsule
Luxembourg: Nintedanib EG 150 mg capsules molles
Netherlands: Nintedanib CF 150 mg, zachte capsules
Norway: Nintedanib STADA 150 mg myke kapsler
Poland: Nintedanib STADA
Sweden: Nintedanib STADA 150 mg mjuka kapslar
Romania: Nintedanib Stada 150 mg capsule moi
Lithuania: Nintedanib STADA 150 mg minkštosios kapsules
Latvia: Nintedanib STADA 150 mg mikstas kapsulas
Estonia: Nintedanib STADA 150 mg pehmekapsel

Date of latest review of this package leaflet: December 2023

Other sources of information.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)