Exviera
dasabuvir
dasabuvir
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 Exviera is and what it is used for
What you need to know before you take Exviera
How to take Exviera
Possible side effects
How to store Exviera
Contents of the pack and other information
Exviera contains the active substance dasabuvir. Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Exviera works by stopping the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Exviera tablets do not work on their own. They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritonavir. Some patients may also take an antiviral medicine called ribavirin. Your doctor will talk with you about which of these medicines to take with Exviera.
It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera. If you have any questions about your medicines, please ask your doctor or pharmacist.
If you are allergic to dasabuvir or any of the other ingredients of this medicine (listed in section 6).
If you have moderate to severe liver problems other than hepatitis C.
If you are taking any of the medicines listed in the following table. This is because serious or life- threatening effects can occur when Exviera and ombitasvir/paritaprevir/ritonavir are taken with these medicines. These medicines can affect the way Exviera and ombitasvir/paritaprevir/ritonavir work and Exviera and ombitasvir/paritaprevir/ritonavir can affect the way these other medicines
work.
Medicines you must not take with Exviera | |
Medicine or active substance | Purpose of the medicine |
carbamazepine, phenytoin, phenobarbital | for epilepsy |
efavirenz, etravirine, nevirapine | for HIV infection |
Apalutamide, enzalutamide | for prostate cancer |
ethinyloestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception | for contraception |
gemfibrozil | to lower cholesterol and other fats in the blood |
mitotane | for some tumours of the adrenal glands |
rifampicin | for bacterial infections |
St. John’s Wort (hypericum perforatum) | a herbal medicine for anxiety and mild depression. This medicine is available without a prescription |
Do not take Exviera if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Exviera.
Talk to your doctor or pharmacist before taking Exviera if you:
- have liver disease other than hepatitis C;
have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
have diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Exviera. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Exviera.
When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems:
Feel sick (nauseous), are sick (vomit) or lose your appetite.
Notice yellowing of your skin or eyes.
Your urine is darker than normal.
Confusion
Notice swelling of your stomach area
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera.
Tell your doctor if you have a history of depression or psychiatric illness. Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness or in patients taking ribavirin with this medicine. You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Your doctor will test your blood before, during and after your treatment with Exviera. This is so that your doctor can:
Decide what other medicines you should take with Exviera and for how long.
Confirm if your treatment has worked and if you are free of the hepatitis C virus.
Check for side effects of Exviera or other antiviral medicines your doctor has prescribed for you to
use with Exviera (such as “ombitasvir/paritaprevir/ritonavir” and “ribavirin”).
Do not give Exviera to children and adolescents under 18 years of age. The use of Exviera in children and adolescents has not yet been studied.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are some medicines you must not take with Exviera - see the previous table “Medicines you must not take with Exviera”.
Medicines you must tell your doctor about before taking Exviera | |
Medicine or active substance | Purpose of the medicine |
alprazolam, diazepam | for anxiety, panic attacks and trouble sleeping |
ciclosporin, everolimus, sirolimus, tacrolimus | to suppress the immune system |
cyclobenzaprine, carisoprodol | for muscle spasms |
dabigatran | to thin the blood |
deferasirox | to help reduce iron levels in the blood |
digoxin, amlodipine | for heart problems or high blood pressure |
furosemide | for the build-up of too much fluid in the body |
hydrocodone | for pain |
imatinib | for the treatment of some cancers of the blood |
levothyroxine | for thyroid problems |
darunavir/ritonavir, atazanavir/ritonavir, rilpivirine | for HIV infection |
omeprazole, lansoprazole, esomeprazole | for stomach ulcers and other stomach problems |
rosuvastatin, pravastatin, fluvastatin, pitavastatin | to lower blood cholesterol |
s-mephenytoin | for epilepsy |
teriflunomide | for multiple sclerosis |
sulfasalazine | to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis |
warfarin and other similar medicines called vitamin K antagonists* | to thin the blood |
*Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera.
The effects of Exviera during pregnancy are not known. Exviera should not be used during pregnancy or in women of childbearing potential not using effective contraception.
You or your partner must use an effective method of contraception during treatment.
Contraceptive medicines that contains ethinyloestradiol cannot be used in combination with Exviera. Ask your doctor about the best contraception for you.
Extra precautions are needed if Exviera is taken together with ribavirin. Ribavirin may cause severe birth defects. Ribavirin stays for a long time in the body after treatment is stopped, and effective contraception is therefore needed both during treatment and for some time afterwards.
There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Read the “Contraception” section of the package leaflet for ribavirin very carefully. It is important that both men and women read the information.
If you or your partner becomes pregnant during treatment with Exviera and ribavirin or in the months that follow, you must contact your doctor immediately.
You should not breastfeed during treatment with Exviera. It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk.
Some patients have reported feeling very tired when taking Exviera with other medicines for their hepatitis C infection. If you feel tired, do not drive or use any machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Exviera tablets do not work on their own. They are always taken with other antiviral medicines such as ombitasvir/paritaprevir/ritonavir. Your doctor may also give you an antiviral medicine called ribavirin.
The recommended dose is one tablet, twice a day. Take one tablet in the morning and one tablet in the evening.
Take the tablets with food. The type of food is not important.
Swallow the tablets whole with water.
Do not chew, crush or break the tablets as they may have a bitter taste.
You will take Exviera for 8, 12 or 24 weeks. Your doctor will tell you how long your treatment will last. Do not stop taking Exviera unless your doctor tells you to. It is very important that you complete the full course of treatment. This will give the medicines the best chance to clear the hepatitis C virus infection.
If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away. Keep the medicine pack with you so you can easily describe what you have taken.
It is important not to miss a dose of this medicine. If you do miss a dose and it is:
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions, signs may include:
Difficulty breathing or swallowing
Dizziness or light-headedness, which may be due to low blood pressure
Swelling of the face, lips, tongue or throat
Rash and itching of the skin
Worsening liver problems. Symptoms include:
Feel sick (nauseous), are sick (vomit) or lose your appetite
Notice yellowing of your skin or eyes
Your urine is darker than normal
Confusion
Notice swelling of your stomach area
Itching.
Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
Feeling very tired (fatigue)
Feeling sick (nausea)
Itching
Trouble sleeping (insomnia)
Feeling weak or lack of energy (asthenia).
Diarrhoea
Anaemia (low number of red blood cells).
Vomiting
Dehydration
Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
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 nationalreportingsystem listedin AppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 to protect the environment.
Each tablet contains 250 mg of dasabuvir (as sodium monohydrate).
The other ingredients are:
Tablet core: microcrystalline cellulose (E 460(i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Tablet film-coating: poly(vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (3350), talc (E 553b), iron oxide yellow (E 172), iron oxide red (E 172) and iron oxide black (E 172).
Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”. Exviera tablets are packed into foil blisters containing 2 tablets. Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets).
AbbVie Deutschland GmbH & Co. KG Knollstrasse
67061 Ludwigshafen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AbbVie SA
Tél/Tel: +32 10 477811
AbbVie UAB
Tel: +370 5 205 3023
АбВи ЕООД
Тел.: +359 2 90 30 430
Tél/Tel: +32 10 477811
AbbVie s.r.o.
Tel: +420 233 098 111
AbbVie Kft.
Tel.: +36 1 455 8600
AbbVie A/S
Tlf: +45 72 30-20-28
V.J.Salomone Pharma Limited Tel: +356 22983201
AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0
AbbVie B.V.
Tel: +31 (0)88 322 2843
AbbVie OÜ
Tel: +372 623 1011
AbbVie AS
Tlf: +47 67 81 80 00
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. Τηλ: +30 214 4165 555
AbbVie GmbH
Tel: +43 1 20589-0
AbbVie Spain, S.L.U. Tel: +34 91 384 09 10
AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
AbbVie
Tél: +33 (0)1 45 60 13 00
AbbVie, Lda.
Tel: +351 (0)21 1908400
AbbVie d.o.o.
Tel: +385 (0)1 5625 501
AbbVie S.R.L.
Tel: +40 21 529 30 35
AbbVie Limited
Tel: +353 (0)1 4287900
AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
Vistor hf.
Tel: +354 535 7000
AbbVie s.r.o.
Tel: +421 2 5050 0777
AbbVie S.r.l.
Tel: +39 06 928921
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200
Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
AbbVie AB
Tel: +46 (0)8 684 44 600
AbbVie SIA
Tel: +371 67605000
Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final study report for the medicinal product(s) mentioned above, the scientific conclusions of CHMP are as follows:
The observational study and the systematic review/ meta-analysis did not show an increased risk of hepatocellular carcinoma recurrence in patients treated with direct-acting antivirals. The DAA-PASS study commitment is considered fulfilled and the respective products should be removed from the list of medicines under additional monitoring.
Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the product information were warranted.
The CHMP agrees with the scientific conclusions made by the PRAC.
On the basis of the scientific conclusions for the results of the study for the medicinal product(s) mentioned above, the CHMP is of the opinion that the benefit-risk balance of these medicinal product(s) is unchanged, subject to the proposed changes to the product information.
The CHMP is of the opinion that the terms of the marketing authorisation(s) of the medicinal product(s) mentioned above should be varied.