Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Nintedanib is a medicine belonging to the class of so-called tyrosine kinase inhibitors, and it is used for the treatment of the following diseases: Idiopathic pulmonary fibrosis (IPF) in adults IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply. Nintedanib helps to reduce further scarring and stiffening of the lungs. Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults Besides IPF, there are other conditions in which the tissue in your lungs becomes thickened, stiff, and scarred over time (lung fibrosis) and keeps worsening (progressive phenotype). Examples of these conditions are hypersensitivity pneumonitis, autoimmune ILDs (e.g. rheumatoid arthritis associated ILD), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Nintedanib helps to reduce further scarring and stiffening of the lungs. Clinically significant, progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from 6 to 17 years old Lung fibrosis may occur in patients with Childhood Interstitial Lung Disease (chILD). When this is the case, the tissue in the lungs of children and adolescents becomes thickened, stiff, and scarred over time. Nintedanib helps to reduce further scarring and stiffening of the lungs. Systemic sclerosis associated interstitial lung disease (SSc-ILD) in adults, adolescents and children aged 6 years and older Systemic sclerosis (SSc), also known as scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease that affects connective tissue in many parts of the body. SSc causes fibrosis (scarring and stiffening) 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 so the condition is called SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen into the bloodstream, and breathing capacity is reduced. Nintedanib helps to reduce further scarring and stiffening of the lungs.
inflammation and allergies), as this may increase this risk; - if you have a combination of severe pain or cramping in your stomach, red blood in your stool or diarrhoea as these could be symptoms of a bowel inflammation from inadequate blood supply; - if you have pain, swelling, reddening, warmth of a limb as this could be symptoms of a blood clot in one of your veins (a type of blood vessel); - if you have chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack; - if you have any major bleeding; - if you experience bruising, bleeding, fever, fatigue and confusion. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA); - if you experience symptoms such as headache, vision changes, confusion, seizure or other neurologic disturbances such as weakness in an arm or a leg, with or without high blood
pressure. This could be symptoms of a brain condition called Posterior Reversible Encephalopathy Syndrome (PRES). Children and adolescents Nintedanib should not be taken by children and adolescents under 6 years of age. Your doctor may perform regular dental examinations at least every 6 months until development of teeth is completed and monitor your growth annually (bone imaging) while you take this medicine. Other medicines and Nintedanib Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Nintedanib can interact with certain other medicines. The following medicines are examples that may increase the levels of nintedanib in your blood, and hence may increase the risk for side effects (see section 4, 'Possible side effects'): - a medicine used to treat fungal infections (ketoconazole) - a medicine used to treat bacterial infections (erythromycin) - a medicine that affects your immune system (cyclosporin) The following medicines are examples that may lower the levels of nintedanib in your blood and thus may reduce the effectiveness of nintedanib: - an antibiotic used to treat tuberculosis (rifampicin) - medicines to treat seizures (carbamazepine, phenytoin) - a herbal medicine to treat depression (St. John's Wort) Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 can harm your unborn baby and cause birth defects. You must have a pregnancy test done to ensure you are not pregnant before starting treatment with nintedanib. Please talk to your doctor. Contraception - Women who can become pregnant must use a highly effective method of birth control to prevent pregnancy when they start taking nintedanib, while they are taking nintedanib and for at least 3 months after stopping treatment. - You should discuss the most appropriate methods of contraception for you with your doctor. - Vomiting and/or diarrhoea or other gastrointestinal conditions can affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if experiencing these, talk to your doctor to discuss an alternative more appropriate method of contraception. - Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with nintedanib. Breast-feeding Do not breast-feed during the treatment with nintedanib since there may be a risk of harm to the breast-fed child. Driving and using machines Nintedanib may have minor influence on your ability to drive and use machines. You should not drive or use machines if you feel sick.
Weight range in kilograms (kg) Nintedanib dose in milligrams (mg)
13.5 - 22.9 kg 50 mg (two 25 mg capsules) twice daily
Nintedanib contains sorbitol (E420) This medicine contains 27.15 mg (for 100 mg) or 34.79 mg (for 150 mg) sorbitol liquid in each capsule.
23.0 - 33.4 kg 75 mg (three 25 mg capsules) twice daily
33.5 - 57.4 kg 100 mg (one 100 mg capsule or four 25 mg capsules) twice daily
57.5 kg and above 150 mg (one 150 mg capsule or six 25 mg
capsules) twice daily
If you take more nintedanib than you should If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you. If you forget to take nintedanib Take it as soon as you remember, unless it is time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose. If you stop taking nintedanib Do not stop taking nintedanib without consulting your doctor first. It is important to take this medicine every day, as long as your doctor prescribes it for you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. You need to pay special attention if you get the following side effects during treatment with nintedanib: Diarrhoea (very common, may affect more than 1 in 10 people): Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body. At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible. The following other side effects were observed during treatment with this medicine. Talk to your doctor if you get any side effects. Idiopathic pulmonary fibrosis (IPF) Very common side effects (may affect more than 1 in 10 people): - Feeling sick (nausea) - Pain in the lower body (abdomen) - Abnormal liver 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 - Inflammation of the large bowel - Serious liver problems - Low platelet count (thrombocytopenia) - High blood pressure (hypertension) - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin
- Itching - Heart attack - Hair loss (alopecia) - Increased amount of protein in your urine (proteinuria) Not known (cannot be estimated from the available data) - Renal failure - An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections) - A brain condition with symptoms such as headache, vision changes, confusion, seizure or other neurologic disturbances such as weakness in an arm or a leg, with or without high blood pressure (posterior reversible encephalopathy syndrome) Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Very common side effects (may affect more than 1 in 10 people) - Feeling sick (nausea) - Vomiting - Loss of appetite - Pain in the lower body (abdomen) - Abnormal liver 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 - Inflammation of the large bowel - Low platelet count (thrombocytopenia) - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin - Itching - Heart attack - Hair loss (alopecia) - Increased amount of protein in your urine (proteinuria) Not known (cannot be estimated from the available data) - Renal failure - An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections) - A brain condition with symptoms such as headache, vision changes, confusion, seizure or other neurologic disturbances such as weakness in an arm or a 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) - Feeling sick (nausea) - Vomiting - Pain in the lower body (abdomen) - Abnormal liver test results Common side effects (may affect up to 1 in 10 people)
o Each soft capsule contains 100 mg nintedanib (as esylate). o Each soft capsule contains 150 mg nintedanib (as esylate).
- Bleeding - High blood pressure (hypertension) - Loss of appetite - Weight loss - Headache Uncommon side effects (may affect up to 1 in 100 people) - Inflammation of the large bowel - Serious liver problems - Renal failure - Low platelet count (thrombocytopenia) - Rash - Itching Not known (cannot be estimated from the available data) - Heart attack - Pancreatitis - Jaundice, that is a yellow colour to the skin and whites of the eyes due to high levels of bilirubin - An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections) - Hair loss (alopecia) - Increased amount of protein in your urine (proteinuria) - A brain condition with symptoms such as headache, vision changes, confusion, seizure or other neurologic disturbances such as weakness in an arm or a leg, with or without high blood pressure (posterior reversible encephalopathy syndrome) Fibrosing interstitial lung diseases (ILDs) in children and adolescents Side effects in children and adolescents were similar to side effects in adult patients. Talk to your doctor if you get any side effects. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
• The other ingredients are:
Not all pack sizes or types may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Tillomed Laboratories Limited 220 Butterfield Great Marlings Luton LU2 8DL United Kingdom Manufacturers[1] Cyndea Pharma, S.L. Poligono Industrial Emiliano Revilla Sanz Avenida Agreda 31 Olvega, Soria 42110 Spain [1] Only the actual release site will be listed on the marketed product. This leaflet was last revised in December 2025.
o Capsule fill: macrogol 400. o Capsule shell: gelatin (E441), sorbitol (E420, liquid, partially dehydrated), glycerol (E422),
titanium dioxide (E171), ferric oxide red (E172) and ferric oxide yellow (E172). What Nintedanib capsules look like and contents of the pack • Nintedanib 100 mg are peach, opaque, oblong, soft capsules with an approximate size of 15.3 x 6.1 mm. • Nintedanib 150 mg are brown, opaque, oblong, soft capsules with an approximate size of 17.0 x 7.0 mm. Nintedanib is available in Nintedanib 100 mg and 150 mg soft capsules are available in perforated or non-perforated blister packs of 30 x 1 or 60 x 1 soft capsules.
Nintedanib 100 mg Soft Capsules comes as capsule containing 100 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nintedanib 100 mg Soft Capsules is nintedanib esilate.
Medicines with the same active substance include: Nintedanib 100 mg Soft Capsule, Nintedanib 100mg soft capsules, Nintedanib 150 mg Soft Capsule, Nintedanib 150mg soft capsules, Nintedanib ADVANZ PHARMA 100 mg Soft Capsules, Nintedanib Advanz Pharma 150 mg soft capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nintedanib 100 mg Soft Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Nintedanib is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Nintedanib is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1).
Nintedanib is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Treatment should be initiated by physicians experienced in the management of diseases for which nintedanib is approved.
Posology
Adults
The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart.
The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.
If a dose is missed, administration should resume at the next scheduled time at the recommended dose. If a dose is missed the patient should not take an additional dose. The recommended maximum daily dose of 300 mg should not be exceeded.
Dose adjustments
In addition to symptomatic treatment if applicable, the management of adverse reactions to nintedanib (see sections 4.4 and 4.8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy. Nintedanib treatment may be resumed at the full dose (150 mg twice daily in adult patients) or a reduced dose (100 mg twice daily in adult patients). If an adult patient does not tolerate 100 mg twice daily, treatment with nintedanib should be discontinued.
If diarrhoea, nausea and/or vomiting persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required. The treatment may be resumed at a reduced dose (100 mg twice daily in adult patients) or at the full dose (150 mg twice daily in adult patients). In case of persisting severe diarrhoea, nausea and/or vomiting despite symptomatic treatment, therapy with nintedanib should be discontinued (see section 4.4).
In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3× upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with nintedanib may be reintroduced at a reduced dose (100 mg twice daily in adult patients) which subsequently may be increased to the full dose (150 mg twice daily in adult patients) (see sections 4.4 and 4.8).
Special populations
Elderly patients (≥ 65 years)
No overall differences in safety and efficacy were observed for elderly patients. No a-priori dose adjustment is required in elderly patients. Patients ≥ 75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Renal impairment
Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (< 30 mL/min creatinine clearance).
Hepatic impairment
In adult patients with mild hepatic impairment (Child Pugh A), the recommended dose of nintedanib is 100 mg twice daily approximately 12 hours apart. In patients with mild hepatic impairment (Child Pugh A), treatment interruption or discontinuation for management of adverse reactions should be considered. The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with nintedanib is not recommended (see section 5.2).
Paediatric population
Nintedanib should not be used in children (see section 4.8 and 5.1).
Method of administration
Nintedanib is for oral use. The capsules should be taken with food, swallowed whole with water, and should not be chewed. The capsule should not be opened or crushed (see section 6.6).
• Pregnancy (see section 4.6)
• Hypersensitivity to nintedanib or to any of the excipients listed in section 6.1.
P-glycoprotein (P-gp)
Nintedanib is a substrate of P-gp (see section 5.2). Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study. In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone. If co-administered with nintedanib, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of nintedanib. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with nintedanib (see section 4.2).
Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib. Selection of an alternate concomitant medicinal product with no or minimal P-gp induction potential should be considered.
Cytochrome (CYP)-enzymes
Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways. Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies (see section 5.2). The likelihood of drug-drug interactions with nintedanib based on CYP metabolism is therefore considered to be low.
Co-administration with other medicinal products
Co-administration of nintedanib with oral hormonal contraceptives did not alter the pharmacokinetics of oral hormonal contraceptives to a relevant extent (see section 5.2).
Co-administration of nintedanib with bosentan did not alter the pharmacokinetics of nintedanib (see section 5.2).
Women of childbearing potential / Contraception
Nintedanib may cause foetal harm in humans (see section 5.3). Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nintedanib and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of nintedanib. Nintedanib does not relevantly affect the plasma exposure of ethinylestradiol and levonorgestrel (see section 5.2). The efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhoea or other conditions where the absorption may be affected. Women taking oral hormonal contraceptives experiencing these conditions should be advised to use an alternative highly effective contraceptive measure.
Pregnancy
There is no information on the use of nintedanib in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3). As nintedanib may cause foetal harm also in humans, it must not be used during pregnancy (see section 4.3) and pregnancy testing must be conducted prior to treatment with nintedanib and during treatment as appropriate.
Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with nintedanib.
If the patient becomes pregnant while receiving nintedanib, treatment must be discontinued and she should be apprised of the potential hazard to the foetus.
Breast-feeding
There is no information on the excretion of nintedanib and its metabolites in human milk.
Pre-clinical studies showed that small amounts of nintedanib and its metabolites (≤ 0.5% of the administered dose) were secreted into milk of lactating rats. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with nintedanib.
Fertility
Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3). From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily (see section 5.3).
Nintedanib has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines during treatment with nintedanib.
There is no specific antidote or treatment for nintedanib overdose. Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days. Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms. Both patients recovered from these adverse reactions. In the INPULSIS trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate
Ask anything about Nintedanib 100 mg Soft Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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