1. What Denine is and what it is used for
Denine contains the active substance nintedanib, 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. Denine 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 lung fibrosis keeps worsening (progressive phenotype). Examples: hypersensitivity pneumonitis, autoimmune ILDs (e.g. rheumatoid arthritis associated ILD), idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs.
Clinically significant, progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from 6 to 17 years old
Denine helps to reduce further scarring and stiffening of the lungs in Childhood Interstitial Lung Disease (chILD).
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, causes fibrosis of skin and internal organs. When lungs are affected, it is called SSc-ILD. Denine helps to reduce further scarring and stiffening of the lungs.
2. What you need to know before you take Denine
Do not take Denine:
- if you are pregnant,
- if you are allergic to nintedanib or any of the other ingredients.
Warnings and precautions
Talk to your doctor or pharmacist before taking Denine, especially if you have or have had:
- liver problems,
- kidney problems or protein in urine,
- bleeding problems,
- take blood-thinning medicines (warfarin, heparin, etc.),
- take pirfenidone (increased risk of diarrhoea, nausea, liver problems),
- heart problems (e.g. heart attack),
- recent surgery (treatment usually interrupted),
- high blood pressure, pulmonary hypertension,
- aneurysm or tear in blood vessel wall.
Inform your doctor immediately while taking this medicine if you experience:
- diarrhoea (treat early), vomiting, nausea,
- yellowing of skin/eyes, dark urine, upper right abdominal pain, unusual bleeding/bruising, tiredness (possible liver problems),
- severe stomach pain, fever, chills, abdominal rigidity (possible gastrointestinal perforation),
- severe cramping, red blood in stool (bowel inflammation),
- pain/swelling/warmth of a limb (blood clot),
- chest pressure/pain, fast heartbeat, shortness of breath,
- major bleeding, bruising, fever, fatigue, confusion (thrombotic microangiopathy),
- neurological symptoms (posterior reversible encephalopathy syndrome).
Children and adolescents
Denine should not be taken by children under 6 years of age. Your doctor may perform regular dental examinations at least every 6 months and monitor growth annually.
Other medicines and Denine
Tell your doctor about all medicines you take. Medicines that may increase nintedanib levels: ketoconazole, erythromycin, cyclosporine. Medicines that may lower nintedanib levels: rifampicin, carbamazepine, phenytoin, St. John’s Wort.
Pregnancy, breastfeeding and contraception
Do not take Denine during pregnancy. It can harm your unborn baby and cause birth defects. Women who can become pregnant must use a highly effective method of birth control while taking Denine and for at least 3 months after stopping treatment. If you become pregnant, tell your doctor immediately. Do not breastfeed during treatment.
Driving and using machines
Denine may have minor influence on ability to drive. Do not drive if you feel sick.
3. How to take Denine
Always take this medicine exactly as your doctor has told you. Take the capsules twice daily approximately 12 hours apart at about the same time every day (e.g., one in the morning and one in the evening). Swallow whole with water, do not chew. Take with food (during or immediately before/after a meal). Do not open or crush the capsule. For ease of swallowing, you may take with a small amount of soft food (apple sauce or chocolate pudding) – swallow immediately without chewing.
Adults: The recommended dose is one capsule of 100 mg twice daily (total 200 mg per day). Do not exceed recommended dose. If you do not tolerate the recommended dose, your doctor may advise you to stop treatment.
Use in children and adolescents (6 years and older): The dose depends on body weight. Tell your doctor if weight falls below 13.5 kg.
| Weight range (kg) | Denine dose (twice daily) |
|---|
| 13.5 – 22.9 kg | 50 mg (two 25 mg capsules) twice daily |
| 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 forget to take Denine: Do not take two capsules together. Take your next dose as planned.
If you stop taking Denine: Do not stop without consulting your doctor first.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- Diarrhoea (drink plenty of fluids and contact your doctor immediately)
- Nausea, abdominal pain
- Hepatic enzyme increased
- Decreased appetite (very common to common depending on indication)
Common (may affect up to 1 in 10 people):
- Weight decreased, decreased appetite, headache
- Bleeding, hypertension (ranges from uncommon to common)
- Vomiting (common to very common)
- ALT increased, AST increased, GGT increased
- Rash, drug induced liver injury (uncommon to common)
Uncommon (may affect up to 1 in 100 people):
- Thrombocytopenia, dehydration, myocardial infarction
- Pancreatitis, colitis, hyperbilirubinaemia, pruritus
- Renal failure, proteinuria, blood ALKP increased
Not known (frequency cannot be estimated):
- Posterior reversible encephalopathy syndrome, aneurysms and artery dissections
- Alopecia, renal failure (not known/uncommon)
Reporting of Suspected Adverse Reactions
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects via email to: medico@zorvia.com. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Denine
- Do not store above 25°C.
- Store in the original package to protect from moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiry date stated on the pack.
6. Contents of the pack and other information
What Denine contains:
- Active substance: Nintedanib (as free base) 100 mg or 150 mg per capsule.
- Other ingredients: Capsule shell contains gelatin, titanium dioxide, iron oxide yellow, etc. (refer to pack).
What Denine looks like and contents of the pack:
Denine 100 mg and 150 mg hard capsules are available in pack sizes as prescribed. Not all pack sizes may be marketed.
Marketing Authorization Holder:
Zorvia Healthcare Limited
Suite 4, 10th Floor, Centaurus, Central Avenue, Hiranandani Estate, Ghodbunder Road, Thane West, Maharashtra – 400607, India.
This leaflet was last revised in: March 2026
