Nintedanib soft capsules 150 mg

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Talk to your doctor or pharmacist before taking Nintedanib,

• if you have or have had liver problems,
• if you have or have had problems with your kidneys, or if an increased amount of protein has been detected in your urine,
• if you have or have had bleeding problems,
• if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting,
• if you take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems,
• if you have or have had problems with your heart (for example a heart attack),
• if you have recently had surgery. Nintedanib may affect the way your wounds heal.

Therefore, your treatment with Nintedanib will usually be stopped for a while if you are having surgery. Your doctor will decide when to resume your 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 (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.

Based on this information your doctor may do some blood tests, for example to check your liver function. Your doctor will discuss the results of these tests with you and decide whether you may receive Nintedanib.

Inform your doctor immediately while taking this medicine,

• if you get diarrhoea. Treating diarrhoea early is important (see section 4);
• if you vomit or feel sick (nausea);
• if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, or feeling tired. This could be symptoms of serious liver problems;
• if you have severe pain in your stomach, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation’). Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, or are concomitantly treated with anti-inflammatory drugs (NSAIDs) (used to treat pain relief and swelling) or steroids (used for 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).

Nintedanib should not be taken by children and adolescents under 18 years of age.

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

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):

• 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 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)

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.

Nintedanib may have minor influence on your ability to drive and use machines. You should not drive or use machines if you feel sick.

If you are allergic to soya or peanut, do not take this medicine (see section 2).

Contact your doctor or pharmacist immediately.

Do not take two capsules together if you have forgotten to take your earlier dose. You should take your next dose of Nintedanib as planned at the next scheduled time recommended by your doctor or pharmacist.

For 150 mg:

Adults

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

If you do not tolerate the recommended dose of two Nintedanib 150 mg capsules per day (see possible side effects in section 4) your doctor may reduce the daily dose of Nintedanib. Do not reduce the dose or stop the treatment by yourself without consulting your doctor first.

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

Contact your doctor or pharmacist immediately.

Do not take two capsules together if you have forgotten to take your earlier dose. You should take your next 150 mg dose of Nintedanib as planned at the next scheduled time recommended by your doctor or pharmacist.

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.

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)

• 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)

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

Capsules, Soft

Nintedanib 100 mg capsules, soft:

Nintedanib 100 mg capsules are peach opaque colour oblong shape soft gelatin capsule imprinted in black ink with “N100” containing bright yellow suspension.

Nintedanib 150 mg capsule, soft:

Nintedanib 150 mg capsules are brown opaque colour oblong shape soft gelatin capsule imprinted in black with “N150” containing bright yellow suspension

Nintedanib 100 mg, 150 mg capsules, soft

Nintedanib 100 mg and 150 mg capsules, soft are available in blister pack containing pack sizes of 30, 60, 120 capsules, soft and perforated unit dose blister pack containing 60x1 cpasules, soft.

Not all pack sizes may be marketed.

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