Viekirax - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/pa­ritaprevir/ri­tonavir

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 Viekirax is and what it is used for

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

• 3. How to take Viekirax

• 4. Possible side effects

• 5. How to store Viekirax

• 6. Contents of the pack and other information

1. What Viekirax is and what it is used for

Viekirax contains the active substances ombitasvir, paritaprevir and ritonavir. It 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).

The combined action of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time. Ombitasvir and paritaprevir block two proteins essential for the virus to multiply. Ritonavir acts as a ‘booster’ to prolong the action of paritaprevir in the body.

Viekirax tablets are taken with other antiviral medicines such as dasabuvir and ribavirin. Your doctor will talk with you about which of these medicines to take with Viekirax.

It is very important that you also read the package leaflets for the other antiviral medicines that you take with Viekirax. If you have any questions about your medicines, please ask your doctor or pharmacist.

2. What you need to know before you take Viekirax

Do not take Viekirax

• If you are allergic to ombitasvir, paritaprevir, ritonavir, 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 Viekirax is taken with these medicines. These medicines can affect the way Viekirax works and Viekirax can affect the way these other medicines work.

Medicines you must not take with Viekirax
Medicine or active substance	Purpose of the medicine
alfuzosin	for an enlarged prostate
amiodarone, disopyramide, dronedarone	used to correct irregular heartbeats
astemizole, terfenadine	for allergy symptoms. These medicines may be available without a prescription
atorvastatin, lovastatin, simvastatin, lomitapide	to lower blood cholesterol
carbamazepine, phenytoin, phenobarbital	for epilepsy
cisapride	for relieving certain stomach problems
clarithromycin, fusidic acid, rifampicin, telithromycin	for bacterial infections
colchicine in patients who have severe problems with their liver or kidneys	for treating gout attacks
conivaptan	for making the sodium levels in the blood normal
efavirenz, etravirine, lopinavir/rito­navir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat	for HIV infection
apalutamide,en­zalutamide	for prostate cancer
ergotamine, dihydroergotamine	for migraine headaches
ergonovine, methylergometrine	used in childbirth
ethinyloestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception	for contraception
itraconozole, ketoconozole, posaconazole, voriconazole	for fungal infections
midazolam, triazolam (when taken by mouth)	for anxiety or trouble sleeping
mitotane	for symptoms of malignant tumours of the adrenal glands
pimozide, lurasidone	for schizophrenia
quetiapine	for schizophrenia, bipolar disorder and major depressive disorder
quinidine	for abnormal heart rhythms or malaria
ranolazine	for chronic angina (chest pain)
salmeterol	for asthma
sildenafil	when used to treat a heart and lung disorder called “pulmonary arterial hypertension”’
St. John’s Wort (hypericum perforatum )	a herbal medicine for anxiety and mild depression. This medicine is available without a prescription
ticagrelor	stops blood from clotting

Do not take Viekirax if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Viekirax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Viekirax 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 Viekirax. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Viekirax.

When taking Viekirax with dasabuvir, 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 Viekirax.

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 Viekirax. This is so that your doctor can:

• Decide what other medicines you should take with Viekirax 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 Viekirax or other antiviral medicines your doctor has prescribed for you to use with Viekirax (such as “dasabuvir” and “ribavirin”).

Children and adolescents

Do not give Viekirax to children and adolescents under 18 years of age. The use of Viekirax in children and adolescents has not yet been studied.

Other medicines and Viekirax

Tell your doctor or pharmacist if you are taking, have recently taken and before starting any other medicines.

There are some medicines you must not take with Viekirax see the previous table “Medicines you must not take with Viekirax”.

Tell your doctor or pharmacist before taking Viekirax, 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 Viekirax also if you are using hormonal contraceptives. See the section on contraception be­low.

Medicines you must tell your doctor about before taking Viekirax
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
colchicine for patients whose kidney and liver function test are normal	for treating gout attacks or familial Mediterranean fever
digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan	for heart problems or high blood pressure
encorafenib	for skin cancer
furosemide	for the build-up of too much fluid in the body
fostamatinib	for low platelet counts
hydrocodone	for pain
levothyroxine	for thyroid problems
rilpivirine, darunavir, atazanavir	for HIV infection
omeprazole, lansoprazole, esomeprazole	for stomach ulcers and other stomach problems
ibrutinib, imatinib	for the treatment of some cancers of the blood
fluvastatin, pitavastatin, pravastatin, rosuvastatin	to lower blood cholesterol
dabigatran	to thin the blood
fexofenadine	for hay fever
s-mephenytoin	for epilepsy
sulfasalazine	for inflammatory bowel disease
repaglinide	for lowering blood sugar
erythromycin	for bacterial infections
steroid or corticosteroid medicines (such as fluticasone)	for many different conditions including serious illnesses and allergies
trazodone	for anxiety and depression
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 Viekirax.

Pregnancy and contraception

The effects of Viekirax during pregnancy are not known. Viekirax 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 contain ethinyloestradiol cannot be used in combination with Viekirax. Ask your doctor about the best contraception for you.

Extra precautions are needed if Viekirax 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 Viekirax and ribavirin or in the months that follow, you must contact your doctor immediately.

Breastfeeding

You should not breast-feed during treatment with Viekirax. It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.

Driving and using machines

Some patients have reported feeling very tired when taking Viekirax with other medicines for their hepatitis C infection. If you feel tired, do not drive or use machines.

3. How to take Viekirax

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

Viekirax tablets are usually taken with other anti-viral medicines such as “dasabuvir” and “ribavirin”.

How much to take

The recommended dose is two tablets taken together in the morning.

How to take

• Take the tablets in the morning 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 Viekirax for

You will take Viekirax for 8, 12 or 24 weeks. Your doctor will tell you how long your treatment will last. Do not stop taking Viekirax 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 Viekirax 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 that you can easily describe what you have taken.

If you forget to take Viekirax

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

• More than 12 hours until your next dose – take the missed dose with food as soon as possible.
• Less than 12 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

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

Side effects when taking Viekirax with or without dasabuvir and 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

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

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

Side effects when taking Viekirax with dasabuvir:

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 Viekirax with dasabuvir and 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 Viekirax

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 Viekirax contains

• Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
• The other ingredients are:

• – Tablet core: copovidone, tocofersolan, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.

• – Tablet film-coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).

What Viekirax looks like and contents of the pack

Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1’. Viekirax tablets are packed into foil blisters containing 2 tablets. Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).

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:

Belgie/Belgiqu­e/Belgien Lietuva

AbbVie SA

Tel/Tel: +32 10 477811

Luxembourg/Lu­xemburg

A6Bu EOOfl Ten.: +359 2 90 30 430	AbbVie SA 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
EMáSa 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

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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