100 mg nintedanib soft capsules
What Ofev is and what it is used for
Ofev contains the active substance nintedanib, a drug belonging to the group of so-called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases (ILDs) that are exacerbated (with progressive disease progression), and systemic sclerosis-systemic sclerosis. lung disease (SSc-ILD) in adults.
Idiopathic pulmonary fibrosis (IPF)
IPF is a disease in which the tissue in the lungs gradually becomes thickened, stiff, and scarred. The scarring leads to a reduced ability to transfer oxygen from the lungs to the blood, and it becomes difficult to take deep breaths. Ofev slows down the increasing scarring and stiffness of the lungs.
Other chronic fibrosing interstitial lung diseases (ILDs) with progressive disease course
In addition to IPF, other diseases mean that the tissue in the lungs over time becomes thickened, stiff, and scarred ( pulmonary fibrosis ) and continues to worsen (progressive disease course). Examples of these diseases are hypersensitivity pneumonitis, autoimmune ILD diseases (eg ILD in rheumatoid arthritis ), idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILD diseases. Ofev slows down the increasing scarring and stiffness of the lungs.
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Systemic sclerosis (SSc), also called scleroderma, is a rare chronic autoimmune disease that affects the connective tissue in many parts of the body. SSc causes fibrosis (scarring and stiffness) in the skin and other internal organs such as the lungs. When the lungs suffer from fibrosis, it is called interstitial lung disease (ILD) and thus the disease is called SSc-ILD. Fibrosis in the lungs reduces the ability to transfer oxygen to the blood and the respiratory capacity decreases. Ofev slows down the increasing scarring and stiffness of the lungs.
What you need to know before taking Ofev
Do not take Ofev
- if you are pregnant,
- if you are allergic to nintedanib, peanuts or soy or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Ofev
- if you have or have had liver problems,
- if you have or have had kidney problems, or if an increased amount of protein has been detected in your urine ( proteinuria ),
- if you have or have had bleeding problems,
- if you are taking blood-thinning medicines (eg warfarin , fenprocumon or heparin ) to prevent blood clots,
- if you are taking pirfenidone as this may increase the risk of diarrhea, nausea, vomiting and liver problems,
- if you have or have had heart problems (eg heart attack),
- if you have recently had surgery. Nintedanib may affect wound healing. Therefore, a break in the treatment with Ofev is usually made before an operation. Your doctor will decide when you can resume 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 vessel wall) or a rupture in a vessel wall.
Based on what you have told your doctor, he/she may take blood samples, for example, to check your liver function. The doctor will discuss the results of the tests with you and decide if you can get Ofev.
When taking this medicine, tell your doctor immediately if:
- you get diarrhea. It is important to treat diarrhea as soon as possible (see section 4);
- if you vomit or feel unwell;
- if have unexplained symptoms such as yellowing of the skin or whites of the eyes (jaundice), dark or brown (tea-colored) urine, right-sided pain in the upper abdomen (abdomen), increased tendency to bleed or bruise or feeling tired. This can be a sign of serious liver problems;
- if you experience severe pain in the abdomen, fever, chills, nausea, vomiting, hard abdominal wall or feeling of bloating, as this may be a symptom of a hole in the intestinal wall (“gastrointestinal perforation”). Also tell your doctor if you have a history of stomach ulcers or diverticular disease or if you are being treated with anti-inflammatory drugs ( NSAIDs commonly used to treat pain and swelling) or corticosteroids (commonly used for inflammation and allergies ). ), as this may increase this risk;
- if you have a combination of severe pain or cramping in the stomach, red blood in the stool or diarrhea, as these may be symptoms of intestinal inflammation as a result of insufficient blood supply;
- if you experience pain, swelling, redness , feeling of heat in an arm or leg, as it may be a symptom of a blood clot in a vein (a type of blood vessel);
- if you experience pressure or pain in the chest, especially on the left side, pain in the neck, jaw, shoulder or arm, rapid heartbeat, shortness of breath, nausea, vomiting, as it may be a symptom of a heart attack;
- if you experience major bleeding.
- if you get bruises, bleeding, fever, feel tired and confused. This may be a sign of an injury to the blood vessels called thrombotic microangiopathy (TMA).
Children and young people
Ofev should not be taken by children and adolescents under 18 years of age.
Other drugs and Ofev
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and over-the-counter medicines.
Ofev may affect, or be affected by, certain other medicines. The following medicines are examples of medicines that may increase the levels of nintedanib in the blood and thus increase the risk of side effects (see section 4):
- a medicine for fungal infections ( ketoconazole )
- a drug for bacterial infections (erythromycin)
- a drug that affects your immune system (cyclosporine)
The following drugs are examples of drugs that can lower the levels of nintedanib in the blood and thus lead to Ofev having a worse effect:
- an antibiotic for tuberculosis (rifampicin)
- anticonvulsants (carbamazepine, phenytoin )
- a (traditional) herbal remedy for mild depression ( St. John’s wort )
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 use this medicine during pregnancy, as it may harm your unborn baby and cause birth defects.
You must take a pregnancy test to make sure you are not pregnant before starting treatment with Ofev. Talk to your doctor.
Preventive method
- Women who may become pregnant must use a very effective method of contraception to prevent pregnancy when they start taking Ofev, while taking Ofev and for at least 3 months after the end of treatment.
- You should consult your doctor about which contraceptive methods are best for you.
- Vomiting and / or diarrhea or other gastrointestinal disorders may affect the uptake of hormonal contraceptives taken by mouth, e.g. on pills , and may reduce their effect. If you experience this, you should therefore 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 Ofev.
Breast-feeding
You should not breastfeed during treatment with Ofev, as there may be a risk of injury to the breast-fed baby.
Driving and using machines
Ofev may have a minor effect on the ability to drive and use machines. Do not drive or use machines if you feel sick.
Ofev contains soy lecithin
If you are allergic to soy or peanuts, do not take this medicine (see section 2).
How to take Ofev
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one capsule of 100 mg twice a day (total 200 mg per day). Take the capsules twice daily at about 12-hour intervals, at about the same time each day, for example, one capsule in the morning and one capsule in the evening. This way, you are sure to have an even amount of nintedanib in your blood at all times. Swallow the capsules whole with water. You must not chew them. Preferably take the capsules with food, ie during or immediately before or after a meal. The capsule must not be opened or crushed (see section 5).
Do not take more than the recommended dose of one of two Ofev 100 mg soft capsules per day.
If you do not take the recommended dose of one of two capsules of Ofev 100 mg per day (see possible side effects in section 4), your doctor may tell you to stop taking the medicine. Do not reduce the dose and do not stop the treatment yourself without first consulting your doctor.
If you take more Ofev than you should
Contact a doctor or pharmacist immediately.
If you forget to take Ofev
Do not take two capsules at the same time if you have forgotten to take your previous dose. Take the next dose of 100 mg Ofev as planned at the next regular appointment as recommended by your doctor or pharmacist.
If you stop taking Ofev
Do not stop taking Ofev without first consulting your doctor. You must take this medicine every day for as long as your doctor prescribes it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must pay special attention if you experience the following side effects during treatment with Ofev:
Diarrhea (very common, may affect more than 1 user in 10):
Diarrhea can lead to dehydration: the body loses fluid and important salts ( electrolytes, such as sodium or potassium ). At the first sign of diarrhea, drink plenty of fluids and contact your doctor immediately. Initiate appropriate treatment for diarrhea, e.g. with loperamide, as soon as possible.
The following other side effects were observed during treatment with this drug.
If you get any side effects, talk to your doctor.
Idiopathic pulmonary fibrosis (IPF)
Very common side effects (may affect more than 1 user in 10 )
- Nausea
- Abdominal pain
- Abnormal liver samples
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 colon
- Serious liver problems
- Low platelet count ( thrombocytopenia )
- High blood pressure ( hypertension )
- Jaundice, ie yellowing of the skin and whites of the eyes due to high levels of bilirubin
- Itching
- Myocardial infarction
- Hair loss ( alopecia )
- Increased amount of protein in your urine ( proteinuria )
Has been reported (occurs in an unknown number of users)
- Kidney failure
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
Other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
Very common side effects (may affect more than 1 user in 10)
- Nausea
- Vomiting
- Loss of appetite
- Abdominal pain
- Abnormal liver samples
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 colon
- Low platelet count ( thrombocytopenia )
- Jaundice, ie yellowing of the skin and whites of the eyes due to high levels of bilirubin
- Itching
- Myocardial infarction
- Hair loss ( alopecia )
- Increased amount of protein in your urine ( proteinuria )
Has been reported (occurs in an unknown number of users)
- Kidney failure
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).
Systemic sclerosis-associated interstitial lung disease (SSc ‑ ILD)
Very common side effects (may affect more than 1 user in 10 )
- Nausea
- Vomiting
- Abdominal pain
- Abnormal liver samples
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 colon
- Serious liver problems
- Kidney failure
- Low platelet count ( thrombocytopenia )
- Rash
- Itching
Has been reported (occurs in an unknown number of users)
- Myocardial infarction
- Pancreatitis
- Jaundice, ie yellowing of the skin and whites of the eyes due to high levels of bilirubin
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections)
- Hair loss ( alopecia )
- Increased amount of protein in your urine ( proteinuria )
How to store Ofev
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Do not use this medicine if you notice that the blister containing the capsules is open or a capsule is broken.
If you come into contact with the contents of the capsule, wash your hands immediately with plenty of water (see section 3).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is nintedanib. Each capsule contains 100 mg of nintedanib (as esilate).
- Other ingredients are:
- Capsule content: Medium chain triglycerides , hard fat, soy lecithin (E322) (see section 2)
- Capsule shell: Gelatin, glycerol (85%), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
- Ink: Shellac glaze, black iron oxide (E172), propylene glycol (E1520)
What the medicine looks like and contents of the pack
Ofev 100 mg capsules are peach-colored, opaque, elongated soft gelatin capsules with the Boehringer Ingelheim company symbol and “100” printed in black on one side.
There are two different pack sizes of Ofev 100 mg:
- 30 x 1 soft capsules in perforated single-dose aluminum / aluminum blisters
- 60 x 1 soft capsules in perforated single-dose blisters of aluminum / aluminum
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France
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