250 mg film-coated tablets 
dasabuvir

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, which eventually removes the virus from the blood.

Exviera tablets do not work alone. They are always taken together with other antiviral medicines containing ombitasvir/paritaprevir/ritonavir. Some patients may also need to take an antiviral medicine called ribavirin. Your doctor will tell you 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 are taking with Exviera. If you have any further questions on the use of this product, ask your doctor or pharmacist.

2. What you need to know before using Exviera

Do not use 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 disease in addition to hepatitis C.
  • If you are taking any of the medicines listed in the following table. This is because serious or life-threatening side effects may occur when Exviera and ombitasvir / paritaprevir/ritonavir are taken with these medicines. These medicines may affect the way Exviera and ombitasvir / paritaprevir/ritonavirork and Exviera and ombitasvir / paritaprevir/ritonavir may affect the way these medicines work.

Medicines you are not allowed to take Exviera
Drug or active substance Purpose of the drug
carbamazepine, phenytoin , phenobarbital against epilepsy
efavirenz, etravirine, nevirapine against HIV – infection
apalutamide, enzalutamide against prostate cancer
ethinyl estradiol – containing drugs such as those found in most birth control pills or vaginal rings used as contraceptives contraceptive
gemfibrozil is used to lower cholesterol and other fats in the blood
mitotane against certain tumors you in the adrenal glands
rifampicin against bacterial infection er
St. John’s wort (Hypericum perforatum) an herbal remedy for mild depression and mild anxiety. 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.

Warnings and cautions

Talk to your doctor or pharmacist before taking Exviera if you:

  • have liver disease in addition to hepatitis C;
  • have or have previously had an infection with the hepatitis B virus, as your doctor may want to follow you up more closely.
  • have diabetes. Your blood sugar levels may need to be monitored more closely and/or adjustment of your diabetes medications may be needed after you start taking Exviera. In some diabetic patients, blood sugar levels have dropped (hypoglycemia) after starting treatment with medicines such as Exviera.

When taking Exviera and ombitasvir / paritaprevir/ritonavir, tell your doctor if you get the following symptoms as it may be a sign of worsening liver problems:

  • nausea, vomiting, or loss of appetite.
  • gets yellow skin or yellow eyes.
  • your urine is darker than usual.
  • confusion.
  • marks of swelling of the abdominal 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 previously been depressed or mentally ill. Suicidal ideation depression and suicidal ideation have been reported by some patients taking this medicine, especially those who have previously been depressed or mentally ill, or by those who have taken ribavirin with this medicine. You or your healthcare provider should also immediately tell your doctor if your behavior or mood changes and if you have suicidal thoughts.

Blood tests

Your doctor will take blood samples before, during, and after your treatment with Exviera. This is so that your doctor can:

  • Decide which other medicines to take with Exviera and for how long.
  • Confirm that the treatment has worked and that you no longer carry the hepatitis C virus.
  • Discover side effects of Exviera or other antiviral medicines (such as ‘ombitasvir/paritaprevir/ritonavir’ and ‘ribavirin’) that your doctor has prescribed for you to use with Exviera.

Children and young people

Do not give this medicine 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 certain medicines that you are not allowed to take with Exviera – see the previous table “Medicines that you are not allowed to take with Exviera”.

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

Medicines that you need to tell your doctor about before taking Exviera
Drug or active substance Purpose of the drug
alprazolam, diazepam against anxiety, panic attacks, and sleep problems
cyclosporin, everolimus, sirolimus, tacrolimus to inhibit the immune system
cyclobenzaprine, carisoprodol against muscle cramps
dabigatran to thin the blood
deferasirox helps to lower the iron value in the blood
digoxin, amlodipine against heart problems or high blood pressure
furosemide against fluid accumulation in the body
hydrocodone against pain
imatinib for the treatment of certain types of blood cancer
levothyroxine against thyroid problems
darunavir / ritonavir, atazanavir / ritonavir, rilpivirine against HIV – infection
omeprazole, lansoprazole, esomeprazole against stomach ulcers or other stomach problems
rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol
s-mephenytoin against epilepsy
teriflunomide against multiple sclerosis
sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis
warfarin and other similar drugs called vitamin K antagonists * to thin the blood

* Your doctor may need to take blood samples from you more often to see how well your blood is clotting.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera.

Pregnancy, breastfeeding, and fertility

Pregnancy and contraception

The effect of Exviera on pregnancy is unknown. Exviera should not be used during pregnancy or by women of childbearing potential not using effective contraception.

  • You or your partner must use an effective method of contraception during treatment. Contraceptives containing ethinylestradiol can not be used with Exviera. Ask your doctor which contraceptive method is best for you.

Extreme caution is required if Exviera is taken with ribavirin. Ribavirin can cause serious birth defects. Ribavirin remains in the body for a long time after the end of treatment and an effective method of contraception is required both during treatment and for some time afterward.

  • There is a risk of birth defects when ribavirin is used by female patients who become pregnant.
  • There is also a risk of birth defects if ribavirin is used by a male patient, whose female partner becomes pregnant.
  • Read the section on contraception in the package leaflet of ribavirin very carefully. Both men and women must read the information.
  • If you or your partner become pregnant during treatment with Exviera and ribavirin or in the months that follow, contact your doctor immediately.

Breast-feeding

You should not breast-feed during treatment with Exviera. It is not known if the active substance in Exviera (dasabuvir) is excreted in human milk.

Driving and using machines

Some patients have reported fatigue when using Exviera with other medicines for hepatitis C infection. If you feel tired, do not drive or use 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 use Exviera

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Exviera tablets do not work alone. 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 daily. 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.
  • The tablets should not be chewed, crushed, or divided as they may have a bitter taste.

How long to use Exviera

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. You must complete the entire treatment. This will give the drug the best chance to cure the hepatitis C virus infection.

If you use more Exviera than you should 

If you accidentally take more than the recommended dose, contact your doctor or nearest hospital immediately. Take the medicine pack with you so that you can easily describe what you have taken.

If you forget to use Exviera

You mustn’t miss a dose of this medicine. If you miss a dose and it is:

  • more than 6 hours until the next dose – take the missed dose one with food as soon as possible.
  • less than 6 hours until the next dose – do not take the missed dose one, 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 product, 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 contact a doctor immediately or seek medical attention if any of the following happens:

An adverse reaction is  when Exviera used with ombitasvir / paritaprevir/ritonavir with or without ribavirin:

No known frequency: can not be calculated from the available data

  • The severe allergic reaction may include signs such as:
    • Difficulty breathing or swallowing
    • Dizziness or intoxication that may be due to low blood pressure
    • Swelling of the face, lips, tongue, or throat
    • Rash and itching of the skin
  • Exacerbated liver problems. Symptoms include:
    • Nausea, vomiting, or loss of appetite
    • Yellowing of the skin or eyes
    • Your urine is darker than normal
    • Confusion
    • Noted swelling of your stomach area

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

Side effects when Exviera is used 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 skin layers can affect all parts of the body including the face, tongue, or throat, and can make it difficult to swallow or breathe ( angioedema )

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

Very common: may affect more than 1 in 10 people

  • Feeling tired
  • Nausea
  • Itching
  • Sleep problems ( insomnia )
  • The feeling of weakness or lack of energy ( asthenia )
  • Diarrhea

Common: may affect up to 1 in 10 people

  • Anemia (low red blood cell count )
  • Vomiting

Uncommon: may affect up to 1 in 100 people

  • Dehydration

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

  • Swelling of the skin layers can affect all parts of the body including the face, tongue, or throat, and can make it difficult to swallow or breathe ( angioedema )

5. How to store Exviera

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 after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • One tablet contains 250 mg dasabuvir (as sodium monohydrate).
  • Other ingredients are:
  • Tablet core: microcrystalline cellulose (E 460 (i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal silica (E 551), magnesium stearate (E 470b).
  • Tablet film-coating: poly (vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (3350), talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172).

What the medicine looks like and the contents of the pack

Exviera tablets are beige, oval film-coated tablets, with dimensions 14.0 mm x 8.0 mm, embossed with “AV2”. Exviera tablets are packaged in blisters containing 2 tablets. One carton contains 56 tablets (multipack cartons of 4 inner cartons of 14 tablets each).

Marketing Authorization Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Information provided by:

AbbVie AB

Tel: +46 (0) 8 684 44 600

Muhammad Nadeem

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