Puqod contains the active substance nintedanib, a medicine that belongs to the class of so-called tyrosine kinase inhibitors and is used to treat the following diseases:

Idiopathic pulmonary fibrosis (IPF) in adults:
IPF is a disease in which the tissue in your lungs thickens, hardens, and scars over time. As a result, the scarring decreases the lungs’ ability to transfer oxygen to the bloodstream, and deep breathing becomes difficult. This medicine helps to reduce further scarring and stiffening of the lungs.

Other chronic fibrosing diffuse interstitial lung diseases (DIPs) with progressive phenotype in adults:
Apart from IPF there are other conditions where the tissue in your lungs thickens, becomes stiff and scars over time (pulmonary fibrosis), and this continues to get worse (progressive phenotype).
Examples of such conditions are: hypersensitivity pneumonitis, autoimmune PID (e.g. PID associated with rheumatoid arthritis), nonspecific idiopathic interstitial pneumonia, unclassified idiopathic interstitial pneumonia, and other PIDs. This medication helps reduce scarring and stiffening of the lungs.

Clinically significant progressive fibrosing interstitial lung diseases (PID) in children and adolescents aged 6 to 17 years
Pulmonary fibrosis can occur in patients with childhood interstitial lung disease (chILD). When this happens, the tissue in the lungs of children and adolescents thickens, becomes stiff, and scars over time. This medicine helps reduce the scarring and stiffening of the lungs.

Diffuse interstitial lung disease associated with scleroderma (DIP-SSc) in adults, adolescents and children aged 6 years and older.
Systemic sclerosis (SSc), also called scleroderma (and juvenile systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease that affects connective tissue in many areas of the body.
Scleroderma causes fibrosis (scarring and stiffening) of the skin and other internal organs, such as the lungs. When the lungs are affected by fibrosis, this is called interstitial lung disease (ILD), so the condition is called PID-SSc. Fibrosis in the lungs reduces the ability to carry oxygen to the bloodstream, and breathing capacity decreases. This medicine helps reduce scarring and stiffening of the lungs.

Do not take Puqod:
- if you are allergic to nintedanib, peanut or soya or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before taking Puqod.

Pregnancy and breastfeeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Task:
You should not take this medicine during pregnancy as it may harm your unborn baby and cause birth defects.
You should have a pregnancy test to make sure you are not pregnant before starting treatment with this medicine. Ask your doctor.
Contraception:
- Women of childbearing potential must use a highly effective method of contraception to prevent pregnancy when they start taking Puqod, while they are taking Puqod, and for at least 3 months after stopping treatment.
- You should talk to your doctor about the most appropriate contraceptive methods for you.
- Vomiting and/or diarrhoea or other gastrointestinal conditions may affect the absorption of oral hormonal contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience these conditions, contact your doctor to discuss a more suitable alternative contraceptive method.
- Tell your doctor or pharmacist immediately if you become pregnant or think you may be pregnant while taking this medicine.
Breastfeeding:
Do not breast-feed while taking this medicine, as there may be a risk of harm to the infant.

Driving and using machines:
This medicine may have minor influence on the ability to drive and use machines.
You should not drive or use machines if you are not feeling well.

Always take this medicine exactly as your doctor or pharmacist has told you.
Talk to your doctor or pharmacist if you are not sure.

Take the capsules twice a day approximately 12 hours apart, at about the same time each day, for example one capsule in the morning and one capsule in the evening. This ensures that there is a constant amount of nintedanib in your blood. Swallow the capsules whole with water and do not chew the capsules. It is recommended that you take the capsules with food, for example during or immediately before or after a meal. Do not open or crush the capsules.
crush the capsule (see section 5).

To make the capsules easier to swallow, you can take them with a small amount (one teaspoon) of soft, cold or room temperature food, such as applesauce or chocolate pudding. Swallow the capsule immediately and do not chew it to ensure it remains intact.
Adults:
The recommended dose is one 100 mg capsule twice daily (a total of 200 mg per day).

Do not take more than the recommended dose of two Puqod 100 mg capsules per day.

If you do not tolerate the recommended dose of two capsules of Puqod 100 mg per day (see possible side effects in section 4), your doctor may advise you to stop taking this medicine. Do not reduce the dose or stop treatment without first talking to your doctor.

Use in children and adolescents:
The recommended dose depends on the patient's weight.
Tell your doctor if, at any time during treatment, the patient's weight is less than 13.5 kg. Tell your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose as your treatment progresses. If you do not tolerate the recommended dose of Puqod capsules for one day (see possible side effects in section 4), your doctor may reduce your daily dose of Puqod.

Do not reduce the dose or stop treatment on your own without first talking to your doctor.

- The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
- The other ingredients are:
• Capsule contents: medium chain triglycerides, solid fats and polyglyceryl-3 dioleate
• Capsule shell: gelatin, glycerol, titanium dioxide (E 171), red iron oxide (E 172) and yellow iron oxide (E 172), purified water.
• Printing ink: shellac, carmine (E 120), propylene glycol (E 1520) and simethicone

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

60 softgels