Nintedanib Advanz Pharma 150 mg soft capsules – patient leaflet, side effects, dosage

1. What Nintedanib Advanz P

Nintedanib Advanz Pharma conta a medicine belonging to the clas inhibitors, and it is used for the tr fibrosis (IPF), other chronic fibros with a progressive phenotype an

interstitial lung disease (SSc-ILD) Idiopathic pulmonary fibrosis (IPF

in adults.

)

sue in your lungs becomes ime. As a result, scarring reduces the lungs into the bloodstream e deeply. This medicine helps to ning of the lungs.

lung diseases (ILDs) with a

IPF is a condition in which the tis thickened, stiff and scarred over t the ability to transfer oxygen from and it becomes difficult to breath reduce further scarring and stiffe Other chronic fibrosing interstitial

progressive phenotype

Besides IPF, there are other cond lungs becomes thickened, stiff, a and keeps worsening (progressiv conditions are hypersensitivity pn as rheumatoid arthritis associate interstitial pneumonia, unclassifia pneumonia, and other ILDs. This scarring and stiffening of the lung Systemic sclerosis associated int

itions in which the tissue in your nd scarred over time (lung fibrosis) e phenotype). Examples of these eumonitis, autoimmune ILDs (such d ILD), idiopathic nonspecific ble idiopathic interstitial

medicine helps to reduce further s.

erstitial lung disease (SSc-ILD) own as scleroderma, is a rare

Systemic sclerosis (SSc), also kn

chronic autoimmune disease that parts of the body. SSc causes fib skin and other internal organs su are affected by fibrosis, it is calle so the condition is called SSc-ILD ability to transfer oxygen into the capacity is reduced. This medicin and stiffening of the lungs.

affects connective tissue in many rosis (scarring and stiffening) of the ch as the lungs. When the lungs d interstitial lung disease (ILD), and . Fibrosis in the lungs reduces the bloodstream, and breathing e helps to reduce further scarring

know before you take

2. What you need to Nintedanib A

Do not take Nintedanib Advanz

dvanz Pharma

Pharma

• 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

  Talk to your doctor or pharmacist b

  Pharma if you:

  • have or have had liver problems
  • have or have had problems with amount of protein has been dete
  • have or have had bleeding prob

  • take blood-thinning medicines (

    efore taking Nintedanib Advanz

    ,

    your kidneys, or if an increased cted in your urine,

    lems,

    such as warfarin, phenprocoumon

    or heparin) to prevent blood clot

  • take pirfenidone as this may incr nausea, vomiting and liver probl
  • have or have had problems with attack),

  • have recently had surgery. Ninte wounds heal. Therefore, your tre usually be stopped for a while if doctor will decide when to resu

    ting,

    ease the risk of having diarrhoea, ems,

    your heart (for example a heart

    danib may affect the way your atment with this medicine will you are having a surgery. Your me your treatment with this

    medicine.

  • have high blood pressure,
  • have abnormally high blood pre lungs (pulmonary hypertension)

  • have or have had an aneurysm (

    blood vessel wall) or a tear in a Based on this information your do example to check your liver functio results of these tests with you and

    ssure in the blood vessels of the ,

    enlargement and weakening of a blood vessel wall.

    ctor may do some blood tests, for n. Your doctor will discuss the decide whether you may receive

Nintedanib Advanz Pharma. Inform your doctor immediately wh

• get diarrhoea. Treating diarrhoea
• vomit or feel sick (nausea);

• have unexplained symptoms su

  white part of your eyes

  (jaundice), dark or brown (tea c

  right side of your stomach area more easily than normal, or feeli

  ile taking this medicine if you: early is important (see section 4);

  ch as yellowing of your skin or the

  oloured) urine, pain on the upper (abdomen), bleeding or bruising ng tired. This could be symptoms

  of serious liver problems;

• have severe pain in your stomac

  vomiting, or abdominal rigidity o symptoms of a hole in the wall o perforation’). Also, tell your doct diverticular disease in the past, anti-inflammatory drugs (NSAID swelling) or steroids (used for in may increase this risk;

• have a combination of severe pa

  h, fever, chills, sickness,

  r bloating, as these could be f your gut (‘gastrointestinal or if you had peptic ulcers or or are concomitantly treated with

  1. s)

     (used to treat pain relief and flammation and allergies), as this

     in or cramping in your stomach,

red blood in your stool or diarrh of a bowel inflammation from ina

• have pain, swelling, reddening,

  symptoms of a blood clot in one vessel);

• have chest pressure or pain, typ

  pain in the neck, jaw, shoulder o of breath, nausea, vomiting, as t attack;

  ea as these could be symptoms dequate blood supply; -

  warmth of a limb as this could be of your veins (a type of blood

  ically on the left side of the body, r arm, a fast heartbeat, shortness his could be symptoms of a heart

• have any major bleeding.

• experience bruising, bleeding, f

  may be a sign of damage to blo microangiopathy (TMA). Children and adolescents

Nintedanib Advanz Pharma should adolescents under 18 years of age Other medicines and Nintedanib

Tell your doctor or pharmacist if yo

ever, fatigue and confusion. This od vessels known as thrombotic

not be taken by children and .

Advanz Pharma

u are taking, have recently taken

or might take any other medicines medicines obtained without a pres Nintedanib Advanz Pharma can int medicines. The following medicine the levels of nintedanib in your blo risk for side effects (see section 4)

, including herbal medicines and cription.

eract with certain other

s are examples that may increase od, and hence may increase the :

• a medicine used to treat fungal in
• a medicine used to treat bacterial
• a medicine that affects your immu The following medicines are examp nintedanib in your blood and thus m Nintedanib Advanz Pharma:
• an antibiotic used to treat tubercu

• medicines to treat seizures (carba

  fections (ketoconazole) infections (erythromycin) ne system (cyclosporine) les that may lower the levels of ay reduce the effectiveness of

  losis (rifampicin)

  mazepine, phenytoin)

• a herbal medicine to treat depres Pregnancy and breast-feeding

If you are pregnant or breast-feedin are planning to have a baby, ask yo advice before taking this medicine. Pregnancy

Do not take this medicine during pr unborn baby and cause birth defect

sion (St. John’s Wort)

g, think you may be pregnant or ur doctor or pharmacist for

egnancy, as it can harm your s.

You must have a pregnancy test do pregnant before starting treatment your doctor.

Contraception

• Women who can become pregna

  method of birth control to prevent taking Nintedanib Advanz Pharm Nintedanib Advanz Pharma and f stopping treatment.

  ne to ensure you are not with this medicine. Please talk to

  nt must use a highly effective pregnancy when they start a, while they are taking

  or at least 3 months after

• You should discuss the most app

  contraception for you with your d

• Vomiting and/or diarrhoea or othe

  affect the absorption of oral horm birth control pills, and may reduc experiencing these, talk to your d more appropriate method of cont

• Tell your doctor or pharmacist imm

  or think you may be pregnant dur

  ropriate methods of

  octor.

  r gastrointestinal conditions can onal contraceptives, such as e their effectiveness.Therefore, if octor to discuss an alternative raception.

  ediately if you become pregnant ing treatment with this medicine.

Breast-feeding

Do not breast-feed during the treatm there may be a risk of harm to the b Driving and using machines

This medicine may have minor influ use machines. You should not drive

3. How to take Ninteda

Always take this medicine exactly a

ent with this medicine since reast-fed child.

ence on your ability to drive and or use machines if you feel sick.

nib Advanz Pharma

s your doctor or pharmacist has

told you. Check with your doctor or Take the capsules twice daily appro the same time every day, for examp and one capsule in the evening. Thi of nintedanib is maintained in your capsules with water and do not che recommended that you take the ca during or immediately before or afte the capsule (see section 5).

pharmacist if you are not sure. ximately 12 hours apart at about le one capsule in the morning s ensures that a steady amount blood stream. Swallow the whole w the capsules. It is

psules with food, for example r a meal. Do not open or crush

Adults

The recommended dose is one cap total of 300 mg per day).

Do not take more than the recomm Advanz Pharma 150 mg capsules p If you do not tolerate the recommen Advanz Pharma 150 mg capsules p in section 4) your doctor may reduc Advanz Pharma. Do not reduce the

sule of 150 mg twice daily (a

ended dose of two Nintedanib er day.

ded dose of two Nintedanib er day (see possible side effects e the daily dose of Nintedanib dose or stop the treatment by

yourself without consulting your do Your doctor may reduce your recom times per day (a total of 200 mg per will prescribe Nintedanib Advanz Ph treatment. Do not take more than th Nintedanib Advanz Pharma 100 mg dose was reduced to 200 mg per d

ctor first.

mended dose to 100 mg two day). In this case your doctor arma 100 mg capsules for your e recommended dose of two capsules per day if your daily ay.

Package leaflet: Information

for the patient

Nintedanib

Advanz Pharma

150 mg soft capsules

AW-LF-0001517 (v0.9)

Package leaflet: Information

for the patient Nintedanib Advanz Pharma 150 mg soft capsules

AW-LF-0001517 (v0.9)

Dimension: 558 x 395 mm Commodity No.: N/A

Print Colours: Black

AMS Component No.: AW-LF-0001517

(v0.9)

Product Description: Nintedanib esilate

Capsule, soft 150 mg

Component: Leaflet

Revision Date: 17-Nov-2025 Revised by: PSC

AW-LF-0001517 (v0.9)

If you take more Nintedanib Ad

doctor or pharmacist immediately If you forget to take Nintedanib

Do not take two capsules togethe dose. You should take your next planned at the next scheduled tim pharmacist.

vanz Pharma than you should Con .

Advanz Pharma

r if you have forgotten to take your e 150 mg dose of Nintedanib Advanz P e recommended by your doctor or

tact your

arlier

harma as

• Rash
• Headache

Uncommon side effe

• Pancreatitis
• Inflammation of the
• Low platelet count (t

• Jaundice, that is a y

  levels of bilirubin

If you stop taking Nintedanib A

Do not stop taking Nintedanib Ad first. It is important to take this m prescribes it for you.

If you have any further questions pharmacist.

dvanz Pharma

vanz Pharma without consulting you edicine every day, as long as your do

on the use of this medicine, ask you

r doctor ctor

r doctor or

everybody

• Itching
• Heart attack
• Hair loss (alopecia)
• Increased amount o Not known (frequency
• Renal failure

• An enlargement and

  vessel wall (aneurys

4. Po

ssible side effects

Like all medicines, this medicine

can cause side effects, although not

gets them.

You need to pay special attention treatment with Nintedanib Advan Diarrhoea (very common, may Diarrhoea may lead to dehydratio such as sodium or potassium) fro drink plenty of fluids and contact anti-diarrhoeal treatment, e.g. wit The following other side effects

if you get the following side effects z Pharma:

affect more than 1 in 10 people): n: a loss of fluid and important salts (e m your body. At the first signs of dia your doctor immediately. Start appro h loperamide, as soon as possible. were observed during treatment

during

lectrolytes, rrhoea

priate

with

Systemic sclerosis ass Very common side ef

• Feeling sick (nausea
• Vomiting
• Pain in the lower bo
• Abnormal liver test r Common side effects
• Bleeding
• High blood pressure

nintedanib (the active ingredien

Talk to your doctor if you get any Idiopathic pulmonary fibrosis (IPF

t in this medicine).

side effects.

)

affect more than 1 in 10 people)

en)

ct up to 1 in 10 people)

Very common side effects (may

• Feeling sick (nausea)
• Pain in the lower body (abdom
• Abnormal liver test results Common side effects (may affe
• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

Uncommon side effects (may af

• Pancreatitis

• Inflammation of the large bowe

  fect up to 1 in 100 people)

  l

• Serious liver problems
• Low platelet count (thrombocy
• High blood pressure (hyperten

• Jaundice, that is a yellow colou

  levels of bilirubin

• Itching
• Heart attack
• Hair loss (alopecia)

• Increased amount of protein in Not known (frequency cannot be

  topenia)

  sion)

  r to the skin and whites of the eyes

  your urine (proteinuria)

  estimated from the available data)

  due to high

  Reporting of side eff

  If you get any side effe possible side effects n directly via the Yellow for MHRA Yellow Card By reporting side effec this medicine.

5. H

• Renal failure

• An enlargement and weakenin

  vessel wall (aneurysms and art Other chronic fibrosing interstitial

  g of a blood vessel wall or a tear in a ery dissections)

  lung diseases (ILDs) with a progres

  blood

  sive

  Keep this medicine ou Do not use this medici

phenotype

Very common side effects (may

• Feeling sick (nausea)

• Vomiting

  affect more than 1 in 10 people)

• Loss of appetite
• Pain in the lower body (abdom
• Abnormal liver test results Common side effects (may affe
• Weight loss
• High blood pressure (hyperten
• Bleeding

• Serious liver problems

  en)

  ct up to 1 in 10 people)

  sion)

  cts (may affect up to 1 in 100 people

  large bowel

  hrombocytopenia)

  ellow colour to the skin and whites o

  )

  f the eyes due to high

  f protein in your urine (proteinuria) cannot be estimated from the availa

  weakening of a blood vessel wall or ms and artery dissections)

  ble data)

  a tear in a blood

  ociated interstitial lung disease (SSc

  -ILD) people)

  fects (may affect more than 1 in 10 )

  dy (abdomen)

  esults

  (may affect up to 1 in 10 people)

  (hypertension)

  • Loss of appetite
  • Weight loss
  • Headache

Uncommon side effe

• Inflammation of the
• Serious liver proble
• Renal failure
• Low platelet count (t

• Rash

  cts (may affect up to 1 in 100 people large bowel

  ms

  hrombocytopenia)

  )

• Itching

Not known (frequency

• Heart attack
• Pancreatitis

• Jaundice, that is a y

  levels of bilirubin

• An enlargement and

  vessel wall (aneurys

• Hair loss (alopecia)

• Increased amount o

  cannot be estimated from the availa

  ellow colour to the skin and whites o

  weakening of a blood vessel wall or ms and artery dissections)

  f protein in your urine (proteinuria)

  ble data)

  f the eyes due to high

  a tear in a blood

  ects

  cts, talk to your doctor or pharmacis ot listed in this leaflet. You can also r Card Scheme at: www.mhra.gov.uk/y in the Google Play or Apple App Sto ts, you can help provide more inform

  t. This includes any eport side effects ellowcard or search re.

  ation on the safety of

  arma

  ow to store Nintedanib Advanz Ph

  t of the sight and reach of children. ne after the expiry date which is stat

  ed on the carton and

the blister after EXP. T

he expiry date refers to the last day o

f that month.

This medicine does no

t require any special storage conditi

ons.

Do not use this medici

ne if you notice that the blister conta

ining the capsules is

opened or a capsule i If you are in contact wi

s broken.

th the content of the capsule, wash

off your hands

immediately with plent Do not throw away an pharmacist how to thr will help protect the en

y of water (see section 3).

y medicines via wastewater or house ow away medicines you no longer us vironment.

hold waste. Ask your e. These measures

6. Contents of the pack and ot

her information

sule contains 150 mg nintedanib

ard fat and polyglyceryl-3

What Ninte

• The activ (as esilat

• The other

  • Caps diolea

    danib Advanz Pharma contains

    e substance is nintedanib. Each cap e).

    ingredients are:

    ule fill: triglycerides, medium-chain, h te

  • Caps (E 17
  • Printin What Ninte

Nintedanib containing approximat Nintedanib OPA/Al/PVC

ule shell: gelatin, glycerol, titanium d

1. 2) and iron oxide yellow (E 172), wat g ink: shellac, black iron oxide (E 17 danib Advanz Pharma looks like a

Advanz Pharma 150 mg are brown, o yellow viscous suspension, imprinte ely 17 mm in length.

Advanz Pharma 150 mg capsules ar -Aluminum perforated unit dose blis

ioxide (E 171), iron oxide red er purified.

2), and propylene glycol (E 1520) nd contents of the pack

paque and oblong soft capsules d with “NT 150” in black ink and

e available in carton box with ters.

Pack sizes: 60 x 1 soft c Marketing

Advanz Pha Unit 17 Nor Northwood Dublin 9 D09 V504

apsules

Authorisation Holder

rma Limited

thwood House

Crescent

Ireland

+44 (0)208 medicalinfo Manufactu

Pharmadox KW20A Kor Paola PLA Malta

Adalvo Limi

588 9131

rmation@advanzpharma.com rer

Healthcare Limited

din Industrial Park

3000

ted

Malta Life S Sir Temi Za San Gwann Malta

QUALIMET 579 MESO Athens, 153 This leaflet

ciences Park Building 1 Level 4 mmit Buildings

Industrial Estate, SGN 3000

RIX S.A.

GEION AVENUE AGIA PARASKEVI, 43, Greece

was last revised in November 202

5.