What Viekirax Tablets is used for and how to use it
Россия
  • Россия
  • Украина

Viekirax Tablets - Consumer Medicine Information

Manufacture: AbbVie
Country: Great Britain
Condition: Hepatitis C, Chronic (Hepatitis C)
Class: Antiviral agents
Form: Tablets
Ingredients: Ombitasvir, paritaprevir, ritonavir.

What Viekirax is and What it is Used For

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

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.

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 Contents of the pack and other information).
  • If you have severe liver problems other than hepatitis
  • 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
Medicines you must not take with Viekirax
Medicine or active substance Purpose of the medicine
alfuzosin for an enlarged prostate
amiodarone used to correct irregular heartbeats
astemizole, terfenadine for allergy symptoms. These medicines may be available without a prescription
atorvastatin, lovastatin, simvastatin 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
enzalutamide for prostate cancer
ergotamine, dihydroergotamine for migraine headaches
ergonovine, methylergometrine used in childbirth
ethinylestradiol-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 for schizophrenia
quetiapine for schizophrenia, bipolar disorder and major depressive disorder
quinidine for abnormal heart rhythms or malaria
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.

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.

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
  • Confirm if your treatment has worked and if you are free of the hepatitis C
  • 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, 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 for heart problems or high blood pressure
furosemide for the build-up of too much fluid in the body
hydrocodone For pain
levothyroxine for thyroid problems
rilpivirine, darunavir, atazanavir for HIV infection
omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems
imatinib for the treatment of some cancers of the blood
fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol
dabigatran, warfarin 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

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 ethinyl estradiol cannot be used in combination with Viekirax. Ask your doctor about the best contraception for

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
  • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes
  • Read the “Contraception” section of the package leaflet for ribavirin very carefully. It is important that both men and women read the
  • If you or your partner becomes pregnant during treatment with Viekirax and ribavirin or in the months that follow, you must contact your doctor

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.

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
  • Swallow the tablets
  • Do not chew, crush or break the tablets as they may have a bitter

How Long to Take Viekirax For

You will take Viekirax for either 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
  • Less than 12 hours until your next dose - do not take the missed dose, take your next dose as usual with

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.

Possible Side Effects

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).
Common: may affect up to 1 in 10 people

  • Anaemia (low number of red blood cells).
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Malta

ADR Reporting http://www.medicinesauthority.gov.mt/adrportal

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.

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
  • The other ingredients are:
    • Tablet core: copovidone, vitamin E, polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl
    • Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).

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

AbbVie Ltd Maidenhead SL6 4UB

United Kingdom

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:

United Kingdom

AbbVie Ltd

Tel: +44 (0)1628 561090