Ofev 150 Mg 60 Soft Capsules

Product description

Ofev contains the active substance nintedanib, a drug that belongs to the class of so-called tyrosine kinase inhibitors, and is used to treat idiopathic pulmonary fibrosis (ipf), other chronic fibrosing interstitial lung diseases (ild) with a progressive phenotype and systemic sclerosis-associated interstitial lung disease (ssc-ild) in adults.
Idiopathic Pulmonary Fibrosis (Ipf):

ipf is a condition where the tissue in the lungs becomes thick, stiff and scarred over time.
The scarring reduces the ability to transport oxygen from the lungs into the bloodstream, making it difficult to breathe deeply.
Ofev helps to reduce further scarring and stiffness in the lungs.
Other Chronic Fibrosing Interstitial Lung Diseases (Ild) With A Progressive Phenotype:

in addition to ipf, there are other conditions where the tissue in your lungs becomes thick, stiff and scarred over time ( pulmonary fibrosis ) and gets progressively worse (progressive phenotype). 
Examples of these conditions are hypersensitivity pneumonitis, autoimmune ild (eg, ild associated with arthritis ), idiopathic nonspecific interstitial pneumonia , unclassifiable idiopathic interstitial pneumonia , and other forms of ild.
Ofev helps to reduce further scarring and stiffness in the lungs.
Systemic Sclerosis-Associated Interstitial Lung Disease (Ssc-Ild):

Systemic sclerosis (ssc), also known as scleroderma , is a rare, chronic, autoimmune disease that affects the connective tissue in many parts of the body.
Ssc causes fibrosis (scarring and stiffness) of the skin and other internal organs, such as the lungs. 
When the lungs are attacked by fibrosis, it is called interstitial lung disease (ild), and therefore the condition is called ssc-ild. 
Fibrosis in the lungs reduces the ability to transport oxygen to the bloodstream, and breathing capacity is reduced.
Ofev helps to reduce further scarring and stiffness in the lungs.

How To Use:

Always use this medicine exactly as your doctor or pharmacist has told you.
Contact a doctor or pharmacist if you are unsure.
The recommended dose is one 150 mg capsule twice daily (total of 300 mg daily). 
Take the capsules twice a day with approx. 
12 hours apart at approximately the same time each day, for example one capsule in the morning and one capsule in the evening. 
This ensures that a steady amount of nintedanib is maintained in your bloodstream. 
The capsules are swallowed whole with water and must not be chewed. 
It is recommended that you take the capsules with food, i.e. During or immediately before or after a meal. 
Do not open or crush the capsule.
Do not take more than the recommended dose of two 150 mg capsules of Ofev daily.
Your doctor may reduce the daily dose of Ofev if you cannot tolerate the recommended dose of two 150 mg capsules of Ofev daily.
Do not reduce the dose or stop treatment without first contacting a doctor.
Your doctor may reduce your dose to 100 mg twice daily (total of 200 mg daily).
In this case, the doctor will prescribe Ofev 100 mg capsules for your treatment. 
Do not take more than the recommended dose of two 100 mg capsules of Ofev daily if the daily dose was reduced to 200 mg daily.
If you take too much Ofev:

Contact your doctor or pharmacist immediately.
If you have forgotten to take Ofev:

You must not take two capsules at the same time if you have forgotten to take the previous dose.
You should take the next 100 mg dose of Ofev as scheduled at the next time recommended by your doctor or pharmacist.
If you interrupt treatment with Ofev:

Consult a doctor before stopping treatment with Ofev.
It is important to use this medicine every day, as long as your doctor prescribes it.
Warnings And Precautions:

Do not use Ofev:

If you are pregnant
If you are allergic to nintedanib, peanuts or soya, or any of the other ingredients of this medicine.
Talk to your doctor or nurse before using Ofev:

If you have or have had liver problems
if you have or have had kidney problems, or if you have been diagnosed with an increased amount of protein 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 clots
If you are taking pirfenidone as this may increase the risk of diarrhoea , nausea , vomiting and liver problems
If you have or have had problems with your heart (such as a heart attack )
If you have recently undergone an operation. 
Nintedanib can affect the way your wounds heal. Therefore, treatment with ofev will normally be interrupted if you are to have surgery. Your doctor will decide when to resume treatment with this medicine.
If you have high blood pressure
If you have abnormally high blood pressure in the blood vessels in the lungs (pulmonary hypertension )
If you have or have had an aneurysm (enlargement and weakening of the blood vessel wall) or a tear in the blood vessel wall
Based on this information, the doctor can take certain blood tests, for example to examine liver function. 
Your doctor will talk to you about the results of these tests and decide whether you can use Ofev.
Tell your doctor immediately when you take this medicine
If you get diarrhoea:

Early treatment of diarrhea is important.
If you vomit or feel sick:

If you have unexplained symptoms such as the skin or the white part of your eyes turning yellowish ( jaundice ), dark or brown (tea-coloured) urine, pain in the upper right side of the stomach area ( abdomen ), bleeding or bruising more easily than normal, or feel tired. 
These can be symptoms of serious liver problems.
If you have severe abdominal pain, fever , chills, nausea , vomiting or a tight stomach or bloating, as these may be symptoms of a hole in the intestinal wall ("gastrointestinal perforation"). 
Also tell your doctor if you have previously had stomach ulcers or diverticular disease or if you are simultaneously being treated with anti-inflammatory drugs ( nsaids ) (used to treat pain and swelling) or steroids (used to treat inflammation and allergies ), then these can increase the risk.
If you have a combination of severe pain or cramps in the stomach, red blood in the stool or diarrhoea , as these may be symptoms of intestinal inflammation due to insufficient blood supply
If you have pain, swelling, redness, heat in a leg, as these may be symptoms of a blood clot in one of the veins (a type of blood vessel)
If you have pressure in your chest or pain, especially on the left side of your body, pain in your neck, jaw, shoulder or arm, fast heartbeat, shortness of breath, nausea or vomiting, as these may be symptoms of a heart attack
If you have heavy bleeding:

If you get bruises, bleeding, fever , fatigue and confusion.
This may be a sign of damage to the blood vessels called thrombotic microangiopathy (TMA).
Children And Youth:

Ofev should not be used by children and adolescents under 18 years of age.
Other medicines and Ofev:

Talk to your doctor or pharmacist if you are using, have recently used or plan to use other medicines, including herbal medicines and over-the-counter medicines.
Ofev can react with other medicines.
 The following are examples of medicines that can increase the amount of nintedanib in the blood and thus increase the risk of side effects :

A medicine used to treat fungal infections (ketoconazole)
A medicine used to treat bacterial infections (erythromycin)
A medicine that affects your immune system (ciclosporin)
The following are examples of medicines that can reduce the amount of nintedanib in your blood, thereby reducing the effect of Ofev:

An antibiotic used to treat tuberculosis (rifampicin)
Medicines used to treat epilepsy (carbamazepine, phenytoin)
A plant-based medicine for the treatment of depression (St. John's wort)
Pregnancy And Breastfeeding:

Talk to your doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.
Pregnancy:

Do not take this medicine during pregnancy as it may harm the unborn child and cause birth defects.
You must take a pregnancy test to make sure you are not pregnant before starting treatment with Ofev. Talk to the doctor.
Contraception:

Women of childbearing potential must use a highly effective method of contraception to avoid pregnancy when starting Ofev, while taking Ofev and for at least 3 months after treatment ends.
You should talk to your doctor about which birth control methods are best for you.
Vomiting and/or diarrhea or other stomach/intestinal conditions can affect the uptake of oral hormonal contraception, such as birth control pills, and can reduce their effectiveness.
If you experience this, you must talk to your doctor about an alternative, more suitable contraceptive method.
Consult your doctor or pharmacist immediately if you become pregnant or think you may be pregnant during treatment with Ofev.
Breastfeeding:

You should not breastfeed during treatment with Ofev, as there may be a risk of injury to the child who is breastfed.
Driving and using machines:

Ofev has little influence on the ability to drive and use machines. 
You should not drive or use machines if you feel unwell.
Ofev contains soy lecithin:

If you are allergic to soya or peanuts, you should not use this medicine.
How To Store

Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "exp". The expiration date is the last day of the specified month.
Store at a maximum of 25ºc.
store in the original packaging to protect against moisture.
Do not use this medicine if you discover that the blister pack containing the capsules has been opened or a capsule is broken.
if you come into contact with the contents of the capsule, immediately wash your hands with plenty of water.
Medicines must not be thrown into waste water or together with household waste. 
Ask the pharmacy how to dispose of medicines that you no longer use.
these measures will help to protect the environment.
Ingredients:

Ofev 150 mg soft capsules are brown, opaque, oblong soft gelatin capsules, marked with the Boehringer Ingelheim company logo and the number "150" in black on one side.
pack size of Ofev 150 mg soft capsules:

60 × 1 soft capsules in perforated aluminium/aluminium end-dose blister packs