Nintedanib Advanz Pharma 150 mg soft capsules

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

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

Talk to your doctor or pharmacist before taking Nintedanib Advanz Pharma if you:

• have or have had liver problems,
• have or have had problems with your kidneys, or if an increased amount of protein has been detected in your urine,
• have or have had bleeding problems,
• take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting,
• take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems,
• have or have had problems with your heart (for example a heart attack),
• have recently had surgery. Nintedanib may affect the way your wounds heal. Therefore, your treatment with this medicine will usually be stopped for a while if you are having a surgery. Your doctor will decide when to resume your treatment with this medicine.
• have high blood pressure,
• have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• 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 Advanz Pharma.

Inform your doctor immediately while taking this medicine if you:

• get diarrhoea. Treating diarrhoea early is important (see section 4);
• vomit or feel sick (nausea);
• 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;
• 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;
• have a combination of severe pain or cramping in your stomach, red blood in your stool or diarrhea as these could be symptoms of a bowel inflammation from inadequate blood supply; -
• 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);
• 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;
• have any major bleeding.
• experience bruising, bleeding, fever, fatigue and confusion. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).

Nintedanib Advanz Pharma 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 Advanz Pharma 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 Advanz Pharma:

• 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 this medicine. 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 Advanz Pharma, while they are taking Nintedanib Advanz Pharma 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 this medicine.

Breast-feeding

Do not breast-feed during the treatment with this medicine since there may be a risk of harm to the breast-fed child.

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

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 Advanz Pharma 150 mg capsules per day.

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

Your doctor may reduce your recommended dose to 100 mg two times per day (a total of 200 mg per day). In this case your doctor will prescribe Nintedanib Advanz Pharma 100 mg capsules for your treatment. Do not take more than the recommended dose of two Nintedanib Advanz Pharma 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 Advanz Pharma as planned at the next scheduled time recommended by your doctor or pharmacist.

Do not stop taking Nintedanib Advanz Pharma 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 (frequency 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)

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 (frequency 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)

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 (frequency 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)

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

Nintedanib Advanz Pharma 150 mg are brown, opaque and oblong soft capsules containing yellow viscous suspension, imprinted with “NT 150” in blackink and approximately 17 mm in length.

Nintedanib Advanz Pharma 150 mg capsules are available in carton box with OPA/Al/PVC-Aluminum perforated unit dose blisters.

Pack sizes:

60 x 1 soft capsules