0.5 mg and 1 mg film-coated tablets 
entecavir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Entecavir Teva is and what it is used for 
2. What you need to know before taking Entecavir Teva 
3. How to take Entecavir Teva 
4. Possible side effects 
5. How to store Entecavir Teva 
6. Contents of the packaging and other information 

1. What Entecavir Teva is and what it is used for

Entecavir tablets Teva is anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults. This medicine can be used by people whose liver is damaged but still works properly (compensated liver disease) and by people whose liver is damaged and does not work properly (decompensated liver disease).

Entecavir Teva tablets are also used to treat chronic (long-term) HBV infection in children and adolescents between 2 and younger than 18 years of age. This medicine can be used by children whose liver is damaged but still works properly (compensated liver disease).

Infection with the hepatitis B virus can lead to liver damage. Entecavir Teva reduces the amount of virus in your body and improves the condition of the liver.

Entecavir contained in Entecavir Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Entecavir Teva

Do not take Entecavir Teva:

  • if you are allergic to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Entecavir Teva

  • If you have ever had kidney problems, tell your doctor. This is important because Entecavir Teva is excreted from the body through the kidneys and your dose or dosing schedule may need to be adjusted.
  • Do not stop taking Entecavir Teva without your doctor’s advice, as your hepatitis B infection may get worse after stopping treatment. When your treatment with this medicine ends, your doctor will follow up the treatment and take blood samples for several months.
  • Discuss with your doctor if your liver is working properly and if not, what effect this may have on your Entecavir Teva treatment.
  • if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Teva to treat your hepatitis B infection unless you are taking HIV at the same time, as the effect of future HIV treatment may be reduced. This medicine will not control your HIV – infection under control.
  • Using Entecavir Teva does not prevent you from infecting other people with the hepatitis B virus through sexual intercourse or body fluids (including blood transfusions). Thus, it is important to take precautions to prevent others from becoming infected with the hepatitis B virus. Some vaccines protect people who are at risk of contracting the hepatitis B virus.
  • Entecavir Teva belongs to a group of medicines that can cause lactic acidosis(too much lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This rare but serious side effect has in some cases be fatal. Lactic acidosis is more common in women, especially if they are very overweight. Your doctor will perform regular check-ups when you take this medicine.
  • Tell your doctor if you have previously received treatment for chronic hepatitis B.

Children and young people

Entecavir Teva should not be used in children under 2 years of age or weighing less than 32.6 kg.

Other medicines and Entecavir Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Entecavir Teva with food and drink

In most cases, you can take this medicine with or without food.

However, if you have previously been treated with a medicine containing the active substance lamivudine, you should consider the following. If you have been switched to treatment with this medicine because the treatment with lamivudine has not had sufficient effect, this medicine should be taken once daily on an empty stomach.

If your liver disease is very advanced, your doctor will also instruct you to take this medicine on an empty stomach. Fasting means at least 2 hours after one meal and at least 2 hours before your next meal.

Children and adolescents (from 2 to younger than 18 years) can take this medicine with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It has not been shown that it is safe to use Entecavir Teva during pregnancy. This medicine should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with this medicine must use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Entecavir Teva. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in this medicine, is excreted in human milk.

Driving and using machines

Dizziness, tiredness, and drowsiness are common side effects that can impair your ability to drive and use machines. If you have any further questions on the use of this product, ask your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Entecavir Teva

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

Not all patients need to take the same dose of Entecavir Teva.

For adults, the recommended dose is either 0.5 mg or 1 mg once daily taken orally (by mouth).

Your dose depends on:

  • if you have been treated for hepatitis B infection before and what medicine you were given.
  • if you have kidney problems. Your doctor may then prescribe a lower dose or instruct you to take a dose at longer intervals than once a day.
  • the condition of your liver.

Use for children and adolescents

For children and adolescents (from 2 to younger than 18 years), the child’s doctor determines the correct dosage based on the child’s weight. Children weighing at least 32.6 kg may take the 0.5 mg tablet or entecavir may be available as an oral solution. For patients weighing from 10 kg to 32.5 kg, entecavir is recommended as an oral solution. All doses are taken orally (orally) once daily. There are no recommendations for entecavir for children under 2 years of age or weighing less than 10 kg.

The child’s doctor determines the correct dosage based on the child’s weight.

Your doctor will prescribe a dose that is right for you. For the medicine to have full effect and to reduce the risk of developing resistance to the treatment, you should always take the dose recommended by your doctor. Your doctor will tell you if and when to stop treatment.

Some patients have to take Entecavir Teva on an empty stomach (see Entecavir Teva with food and drink in section 2 ). If your doctor instructs you to take this medicine on an empty stomach, fasting means at least 2 hours after a meal and at least two hours before the next meal.

If you take more Entecavir Teva then you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for assessment of the risk and advice.

If you forget to take Entecavir Teva

It is important that you do not forget to take any dose . If you forget to take a dose of this medicine, take it as soon as you can and then take the next dose as usual at the time you should take it. Do not take the missed dose if it is only a short time before you take your next dose . Then wait and take the next dose as usual. Do not take a double dose to make up for a forgotten dose .

If you stop taking Entecavir Teva

Do not stop taking Entecavir Teva without your doctor’s instructions

Some people get very severe hepatitis symptoms when they stop taking this medicine. Talk to your doctor immediately if you notice any changes in symptoms when you stop treatment.

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.

Patients treated with this medicine have reported the following side effects:

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

  • headache
  • insomnia
  • fatigue
  • dizziness
  • somnolence
  • vomiting
  • diarrhea
  • nausea
  • dyspepsia
  • elevated levels of liver enzymes in the blood.

Uncommon (may affect up to 1 in 100 people):

  • rash
  • hair loss.

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

  • severe allergic reactions.

5. How to store Entecavir Teva

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 can, blister or 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

Entecavir Teva 0.5 mg film-coated tablets

  • The active substance is entecavir. Each film-coated tablet contains 0.5 mg entecavir.
  • Other ingredients are:Film coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b).Tablet core: mannitol (E421), microcrystalline cellulose (E460), pregelatinized maize starch, crospovidone type A (E1202), magnesium stearate.

Entecavir Teva 1 mg film-coated tablets

  • The active substance is entecavir. Each film-coated tablet contains 1 mg entecavir.
  • Other ingredients are:Tablet core: mannitol (E421), microcrystalline cellulose (E460), pregelatinized maize starch, crospovidone type A (E1202), magnesium stearate.Film coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b), red iron oxide (E172).

What the medicine looks like and contents of the pack

Entecavir Teva 0.5 mg film-coated tablets

White to off-white, round tablet, debossed with “05” on one side of the tablet and with “E” on the other side of the tablet, with a diameter of approximately 5.96–6.26 mm.

Entecavir Teva 1 mg film-coated tablets

Light pink to pink, round tablet with a deep break, marked with “1” on one side of the tablet and with “E / E” on the other side of the tablet, with a diameter of approximately 8.42–8.86 mm.

The tablet can be divided into two equal halves.

The film-coated tablets are provided in:

PVC / PVdC aluminum blisters in cartons containing 10, 30, 60 or 90 film-coated tablets.

PVC / PVdC-aluminum single-dose blisters in cartons containing 30×1 film-coated tablets for Entecavir Teva 0.5 mg and 30×1, 60×1 or 90×1 film-coated tablets for Entecavir Teva 1 mg.

Aluminum / OPA / PVC-aluminum blisters in cartons containing 10, 30, 60 or 90 film-coated tablets.

Aluminum / OPA / PVC-aluminum single-dose blisters in cartons containing 30×1 film-coated tablets for Entecavir Teva 0.5 mg and 30×1, 60×1 or 90×1 film-coated tablets for Entecavir Teva 1 mg.

HDPE cans with child-resistant polypropylene lids in cartons containing 30 or 100 film-coated tablets.

HDPE cans with child-resistant polypropylene lids and silica gel desiccants in cartons containing 30 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Manufacturer:

Merckle GmbH, Blaubeuren, Germany

Pliva, Zagreb, Croatia

Teva Operations Poland Sp. zoo, Krakow, Poland

Muhammad Nadeem

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