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Ofev (nintedanib) – Package leaflet - L01XE

Updated on site: 08-Oct-2017

Medication nameOfev
ATC CodeL01XE
Substancenintedanib
ManufacturerBoehringer Ingelheim International GmbH

Package leaflet: Information for the patient

Ofev 100 mg soft capsules

Nintedanib

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

-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.

What is in this leaflet

1.What Ofev is and what it is used for

2.What you need to know before you take Ofev

3.How to take Ofev

4.Possible side effects

5.How to store Ofev

6.Contents of the pack and other information

1.What Ofev is and what it is used for

Ofev contains the active substance nintedanib and it is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply. Ofev helps to reduce scarring and stiffening of the lungs.

2. What you need to know before you take Ofev

Do not take Ofev:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ofev,

-if you have or ever had liver problems,

-if you have or ever had bleeding problems,

-if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting,

-if you have or ever had problems with your heart (for example a heart attack),

-if you have recently had surgery. Nintedanib may affect the way your wounds heal. Therefore your treatment with Ofev 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.

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 Ofev.

Inform your doctor immediately while taking this medicine,

-if you get diarrhoea. Treating diarrhoea early is important (see section 4);

-if you vomit or feel sick (nausea);

-if you 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’);

-if you 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);

-if you 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;

-if you have any major bleeding.

Children and adolescents

Ofev should not be taken by children and adolescents under 18 years of age.

Other medicines and Ofev

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.

Ofev 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 Ofev:

-an antibiotic used to treat tuberculosis (rifampicin)

-medicines to treat seizures (carbamazepine, phenytoin)

-a herbal medicine to treat depression (St. John’s Wort)

Pregnancy and breast-feeding

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.

Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.

Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Ofev and for at least 3 months after stopping treatment. You should discuss the most appropriate methods of contraception for you with your doctor.

Tell your doctor or pharmacist immediately if you become pregnant during treatment with Ofev.

Do not breastfeed during the treatment with Ofev since there may be a risk for harm to the breast- feeding child.

Driving and using machines

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

Ofev contains soya lecithin

If you are allergic to soya or peanut, do not take this medicine (see section 2).

3.How to take Ofev

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

The recommended dose is one capsule of 100 mg twice daily (a total of 200 mg per day). Take the capsules 12 hours apart at about the same time every 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 blood stream. Swallow the whole capsules with water and do not chew or crush the capsules. It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.

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

If you do not tolerate the recommended dose of two Ofev 100 mg capsules 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 the treatment by yourself without consulting your doctor first.

If you take more Ofev than you should

Contact your doctor or pharmacist immediately.

If you forget to take Ofev

Do not take two capsules together if you have forgotten to take your earlier dose. You should take your next 100mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.

If you stop taking Ofev

Do not stop taking Ofev without consulting your doctor first. It is important to take this medicine every day, as long as your doctor prescribes it for you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You need to pay special attention if you get the following side effects during treatment with Ofev:

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body. At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible.

The following other side effects were observed during treatment with this medicine:

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

Uncommon side effects (may affect up to 1 in 100 people)

-Pancreatitis

-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

Side effects with frequency not known (frequency cannot be estimated from the available data)

- Serious liver problems

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.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 the blister. The expiry date refers to the last day of that month.

Do not store Ofev above 25°C.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ofev contains

-The active substance is nintedanib. Each capsule contains 100 mg nintedanib (as esilate).

-The other ingredients are:

Capsule fill:

Triglycerides, medium-chain, hard fat, soya lecithin (E322)

Capsule shell:

Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron

 

oxide yellow (E172)

Printing ink:

Shellac glaze, iron oxide black (E172), propylene glycol (E1520)

What Ofev looks like and contents of the pack

Ofev 100 mg capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.

Two pack-sizes of Ofev 100 mg capsules are available:

-30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters

-60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters

Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH Binger Strasse 173

D-55216 Ingelheim am Rhein Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173

D-55216 Ingelheim am Rhein Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

България

Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ - клон България Тел: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Eesti

Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal

Tel: +372 612 8000

Ελλάδα

Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300

España

Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas

Tel: +370 37 473922

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Magyarországi Fióktelepe

Tel: +36 1 299 8900

Malta

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Österreich

Polska

Boehringer Ingelheim Sp. z o.o.

Tel: +48 22 699 0 699

Portugal

Boehringer Ingelheim, Unipessoal, Lda.

Tel: +351 21 313 53 00

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena - Sucursala Bucuresti

Tel: +40 21 302 2800

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Slovenská republika

Vistor hf.

Boehringer Ingelheim RCV GmbH & Co KG

Sími: +354 535 7000

organizačná zložka

 

Tel: +421 2 5810 1211

Italia

Suomi/Finland

Boehringer Ingelheim Italia S.p.A.

Boehringer Ingelheim Finland Ky

Tel: +39 02 5355 1

Puh/Tel: +358 10 3102 800

Κύπρος

Sverige

Boehringer Ingelheim Ellas A.E.

Boehringer Ingelheim AB

Tηλ: +30 2 10 89 06 300

Tel: +46 8 721 21 00

Latvija

United Kingdom

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Ltd.

Latvijas filiāle

Tel: +44 1344 424 600

Tel: +371 67 240 011

 

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the patient

Ofev 150 mg soft capsules

Nintedanib

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

-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.

What is in this leaflet

1.What Ofev is and what it is used for

2.What you need to know before you take Ofev

3.How to take Ofev

4.Possible side effects

5.How to store Ofev

6.Contents of the pack and other information

1. What Ofev is and what it is used for

Ofev contains the active substance nintedanib and it is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a condition in which the tissue in your lungs becomes thickened, stiff and scarred over time. As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply. Ofev helps to reduce scarring and stiffening of the lungs.

2. What you need to know before you take Ofev

Do not take Ofev:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ofev,

-if you have or ever had liver problems,

-if you have or ever had bleeding problems,

-if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting,

-if you have or ever had problems with your heart (for example a heart attack),

-if you have recently had surgery. Nintedanib may affect the way your wounds heal. Therefore your treatment with Ofev 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.

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 Ofev.

Inform your doctor immediately while taking this medicine,

-if you get diarrhoea. Treating diarrhoea early is important (see section 4);

-if you vomit or feel sick (nausea);

-if you 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’);

-if you 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);

-if you 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;

-if you have any major bleeding.

Children and adolescents

Ofev should not be taken by children and adolescents under 18 years of age.

Other medicines and Ofev

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.

Ofev 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 Ofev:

-an antibiotic used to treat tuberculosis (rifampicin)

-medicines to treat seizures (carbamazepine, phenytoin)

-a herbal medicine to treat depression (St. John’s Wort)

Pregnancy and breast-feeding

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.

Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.

Women who can become pregnant must use an effective combination of birth control methods, including barrier methods as a second form of contraception, while they are taking Ofev and for at least 3 months after stopping treatment. You should discuss the most appropriate methods of contraception for you with your doctor.

Tell your doctor or pharmacist immediately if you become pregnant during treatment with Ofev.

Do not breastfeed during the treatment with Ofev since there may be a risk for harm to the breast- feeding child.

Driving and using machines

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

Ofev contains soya lecithin

If you are allergic to soya or peanut, do not take this medicine (see section 2).

3. How to take Ofev

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

The recommended dose is one capsule of 150 mg twice daily (a total of 300 mg per day). Take the capsules twice daily approximately 12 hours apart at about the same time every 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 blood stream. Swallow the whole capsules with water and do not chew or crush the capsules. It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.

Do not take more than the recommended dose of two Ofev 150 mg capsules per day.

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

Your doctor may reduce your recommended dose to two times 100 mg per day (a total of 200 mg per day). In this case your doctor will prescribe Ofev 100 mg capsules for your treatment. Do not take more than the recommended dose of two Ofev 100 mg capsules per day if your daily dose was reduced to 200 mg per day.

If you take more Ofev than you should

Contact your doctor or pharmacist immediately.

If you forget to take Ofev

Do not take two capsules together if you have forgotten to take your earlier dose.You should take your next 150 mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.

If you stop taking Ofev

Do not stop taking Ofev without consulting your doctor first. It is important to take this medicine every day, as long as your doctor prescribes it for you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You need to pay special attention if you get the following side effects during treatment with Ofev:

Diarrhoea (very common, may affect more than 1 in 10 people):

Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body. At the first signs of diarrhoea drink plenty of fluids and contact your doctor immediately. Start appropriate anti-diarrhoeal treatment, e.g. with loperamide, as soon as possible.

The following other side effects were observed during treatment with this medicine:

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

Uncommon side effects (may affect up to 1 in 100 people)

-Pancreatitis

-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

Side effects with frequency not known (frequency cannot be estimated from the available data)

- Serious liver problems

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 the blister. The expiry date refers to the last day of that month.

Do not store Ofev above 25°C.

Store in the original package in order to protect from moisture.

Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ofev contains

-The active substance is nintedanib. Each capsule contains 150 mg nintedanib (as esilate).

-The other ingredients are:

Capsule fill:

Triglycerides, medium-chain, hard fat, soya lecithin (E322)

Capsule shell:

Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron

 

oxide yellow (E172)

Printing ink:

Shellac glaze, iron oxide black (E172), propylene glycol (E1520)

What Ofev looks like and contents of the pack

Ofev 150 mg capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.

Two pack-sizes of Ofev 150 mg capsules are available:

-30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters

-60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters

Not all pack-sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

SCS Boehringer Ingelheim Comm.V

Boehringer Ingelheim RCV GmbH & Co KG

Tél/Tel: +32 2 773 33 11

Lietuvos filialas

 

Tel: +370 37 473922

България

Luxembourg/Luxemburg

Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ -

SCS Boehringer Ingelheim Comm.V

клон България

Tél/Tel: +32 2 773 33 11

Тел: +359 2 958 79 98

 

Česká republika

Magyarország

Boehringer Ingelheim spol. s r.o.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +420 234 655 111

Magyarországi Fióktelepe

 

Tel: +36 1 299 8900

Danmark

Malta

Boehringer Ingelheim Danmark A/S

Boehringer Ingelheim Ltd.

Tlf: +45 39 15 88 88

Tel: +44 1344 424 600

Deutschland

Nederland

Boehringer Ingelheim Pharma GmbH & Co. KG

Boehringer Ingelheim b.v.

Tel: +49 (0) 800 77 90 900

Tel: +31 (0) 800 22 55 889

Eesti

Norge

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Norway KS

Eesti filiaal

Tlf: +47 66 76 13 00

Tel: +372 612 8000

 

Ελλάδα

Österreich

Boehringer Ingelheim Ellas A.E.

Boehringer Ingelheim RCV GmbH & Co KG

Tηλ: +30 2 10 89 06 300

España

Polska

Boehringer Ingelheim España, S.A.

Boehringer Ingelheim Sp. z o.o.

Tel: +34 93 404 51 00

Tel: +48 22 699 0 699

France

Portugal

Boehringer Ingelheim France S.A.S.

Boehringer Ingelheim, Unipessoal, Lda.

Tél: +33 3 26 50 45 33

Tel: +351 21 313 53 00

Hrvatska

România

Boehringer Ingelheim Zagreb d.o.o.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +385 1 2444 600

Viena - Sucursala Bucuresti

 

Tel: +40 21 302 2800

Ireland

Slovenija

Boehringer Ingelheim Ireland Ltd.

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +353 1 295 9620

Podružnica Ljubljana

 

Tel: +386 1 586 40 00

Ísland

Slovenská republika

Vistor hf.

Boehringer Ingelheim RCV GmbH & Co KG

Sími: +354 535 7000

organizačná zložka

 

Tel: +421 2 5810 1211

Italia

Suomi/Finland

Boehringer Ingelheim Italia S.p.A.

Boehringer Ingelheim Finland Ky

Tel: +39 02 5355 1

Puh/Tel: +358 10 3102 800

Κύπρος

Sverige

Boehringer Ingelheim Ellas A.E.

Boehringer Ingelheim AB

Tηλ: +30 2 10 89 06 300

Tel: +46 8 721 21 00

Latvija

United Kingdom

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Ltd.

Latvijas filiāle

Tel: +44 1344 424 600

Tel: +371 67 240 011

 

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for nintedanib (respiratory indication), the scientific conclusions of CHMP are as follows:

Following a cumulative review of all reported cases of DILI, a total number of 10 cases was identified in the MAH’s safety database: 2 cases from clinical trials, 2 from compassionate use programme, 5 from observational studies and one case from spontaneous reporting. All 10 cases were reported as serious including 3 fatal cases. Out of the 10 cases, two from post-marketing were well described cases with significant elevation of liver enzymes (> 5 upper limit of normal (ULN)), positive dechallenge and exclusion of other possible cause of DILI. In 7 other cases, DILI could not be excluded as not sufficient information is available. Finally one case was excluded based on the low level of liver enzymes. A search in EudraVigilance was also performed by the PRAC Rapporteur which identified 5 additional cases, all reported after this PSUR’s data lock point. One of the additional case is a well documented case from the literature which also described an extensive elevation of liver enzymes (ALT and ASAT elevated 11.8 and 5.5 times the ULN respectively and a positive dechallenge excluded other possible causes of DILI. Liver enzyme and bilirubin elevation is a listed adverse reaction for Ofev and is well described in the SmPC and in the RMP. Based on the available evidence, the PRAC considered that DILI should be added to sections 4.4 and 4.8 of the SmPC.

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing nintedanib (respiratory indication) were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for nintedanib (respiratory indication) the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing nintedanib (respiratory indication) is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation should be varied.

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    prescription drugs listed