Exviera - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Exviera 250 mg film-coated tablets

dasabuvir

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp 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 Exviera is and what it is used for

• 2. What you need to know before you take Exviera

• 3. How to take Exviera

• 4. Possible side effects

• 5. How to store Exviera

• 6. Contents of the pack and other information

1. What Exviera is and what it is used for

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.

2. What you need to know before you take Exviera

Do not take Exviera:

• 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 lifethreatening 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.

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.

Warnings and precautions

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.

Blood tests

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”).

Children and adolescents

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.

Other medicines and Exviera

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”.

Tell your doctor or pharmacist before taking Exviera, if you are taking any of the medicines in the table below. The doctor may need to change your dose of these medicines. Tell your doctor or pharmacist before taking Exviera if you are also using hormonal contraceptives. See the section on contraception be­low.

Medicines you must tell your doctor a	bout 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.

Pregnancy and contraception

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.

Breastfeeding

You should not breastfeed during treatment with Exviera. It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk.

Driving and using machines

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.

Exviera contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Exviera

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.

How much to take

The recommended dose is one tablet, twice a day. Take one tablet in the morning and one tablet in the evening.

How to take

• 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.

How long to take Exviera for

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 take more Exviera than you should

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.

If you forget to take Exviera

It is important not to miss a dose of this medicine. If you do miss a dose and it is:

• More than 6 hours until your next dose – take the missed dose with food as soon as possible.
• Less than 6 hours until your next dose – do not take the missed dose, take your next dose as usual with food.

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.

4. Possible side effects

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

Stop taking Exviera and talk to your doctor or get medical help immediately if any of the following occur:

Side effects when taking Exviera with ombitasvir/pa­ritaprevir/ri­tonavir with or without ribavirin:

Frequency not known: cannot be estimated based on available data

• Serious allergic reactions, signs may include:

o Difficulty breathing or swallowing

o Dizziness or light-headedness, which may be due to low blood pressure

o Swelling of the face, lips, tongue or throat

o Rash and itching of the skin

• Worsening liver problems. Symptoms include:

o Feel sick (nauseous), are sick (vomit) or lose your appetite

o Notice yellowing of your skin or eyes

o Your urine is darker than normal

o Confusion

o Notice swelling of your stomach area

Tell your doctor or pharmacist if you notice any of the following side effects:

Side effects when taking Exviera with ombitasvir/pa­ritaprevir/ri­tonavir:

Common: may affect up to 1 in 10 people

• Itching.

Rare: may affect up to 1 in 1,000 people

• 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)

Side effects when taking Exviera and ombitasvir/pa­ritaprevir/ri­tonavir with ribavirin:

Very common: may affect more than 1 in 10 people

• Feeling very tired (fatigue)
• Feeling sick (nausea)
• Itching
• Trouble sleeping (insomnia)
• Feeling weak or lack of energy (asthenia).
• Diarrhoea

Common: may affect up to 1 in 10 people

• Anaemia (low number of red blood cells).
• Vomiting

Uncommon: may affect up to 1 in 100 people

• Dehydration

Rare: may affect up to 1 in 1,000 people

• 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)

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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Exviera

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.

6. Contents of the pack and other information

What Exviera contains

• 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).

What Exviera looks like and contents of the pack

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).

Marketing Authorisation Holder and Manufacturer

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:

Luxembourg/Lu­xemburg

AbbVie SA

Ten.: +359 2 90 30 430	Belgique/Belgien Tél/Tel: +32 10 477811
Česká republika AbbVie s.r.o. Tel: +420 233 098 111	Magyarország AbbVie Kft. Tel.: +36 1 455 8600
Danmark AbbVie A/S Tlf: +45 72 30–20–28	Malta V.J.Salomone Pharma Limited Tel: +356 22983201
Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei)	Nederland AbbVie B.V. Tel: +31 (0)88 322 2843

Tel: +49 (0) 611 / 1720–0

Eesti AbbVie OÜ Tel: +372 623 1011	Norge AbbVie AS Tlf: +47 67 81 80 00
EZZáSa AbbVie OAPMAKEYTIKH A.E. Tql: +30 214 4165 555	Österreich AbbVie GmbH Tel: +43 1 20589–0
España AbbVie Spain, S.L.U. Tel: +34 91 384 09 10	Polska AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
France AbbVie Tél: +33 (0)1 45 60 13 00	Portugal AbbVie, Lda. Tel: +351 (0)21 1908400
Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 501	Romania AbbVie S.R.L. Tel: +40 21 529 30 35
Ireland AbbVie Limited Tel: +353 (0)1 4287900	Slovenija AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
Ísland Vistor hf. Tel: +354 535 7000	Slovenská republika AbbVie s.r.o. Tel: +421 2 5050 0777
Italia AbbVie S.r.l. Tel: +39 06 928921	Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200
Kúnpog Lifepharma (Z.A.M.) Ltd Tql: +357 22 34 74 40	Sverige AbbVie AB Tel: +46 (0)8 684 44 600
Latvija AbbVie SIA Tel: +371 67605000	United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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