0.5 mg, 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 hurt

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 Glenmark is and what it is used for 
2. What you need to know before you take Entecavir Glenmark 
3. How to take Entecavir Glenmark 
4. Possible side effects 
5. How to store Entecavir Glenmark 
6. Package contents and other information 

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

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

Entecavir Glenmark is also used to treat chronic (long-term) HBV infection in children and adolescents between 2 years of age and less than 18 years of age. Entecavir Glenmark can be used by children whose liver is damaged but still functioning properly (compensated liver disease).

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

Entecavir contained in Entecavir Glenmark 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 Glenmark

Do not take Entecavir Glenmark:

– 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 Glenmark

– if you have ever had kidney problems, tell your doctor. This is important because Entecavir Glenmark is excreted from the body by the kidneys and your dose or dosing schedule may need to be adjusted.

– Do not stop taking Entecavir Glenmark without your doctor’s advice, as your hepatitis B infection may get worse after stopping treatment. When your Entecavir Glenmark treatment is stopped, your doctor will monitor your 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 Glenmark treatment.

– if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Glenmark to treat your hepatitis B infectionunless you are taking medicines for HIV at the same time, as the effect of future HIV treatment may be reduced. Entecavir Glenmark will not control your HIV – infection under control.

– use of Entecavir Glenmark does not prevent you from infecting other people with the hepatitis B virus through sexual intercourse or body fluids (including blood infections). 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 Glenmark 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 Entecavir Glenmark.

– Tell your doctor if you have previously been treated for chronic hepatitis B.

Children and young people

Entecavir Glenmark should not be used in children under 2 years of age or weighing less than 10 kg.

Other medicines and Entecavir Glenmark

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

Entecavir Glenmark with food and drink

In most cases, you can take Entecavir Glenmark 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 switched to Entecavir Glenmark treatment because the treatment with lamivudine has not had sufficient effect, Entecavir Glenmark should be taken once daily on an empty stomach. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Glenmark 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 years of age to less than 18 years of age) can take Entecavir Glenmark with or without food.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been shown that it is safe to use Entecavir Glenmark during pregnancy. Entecavir Glenmark should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with Entecavir Glenmark must use an effective method of contraception to avoid becoming pregnant.

Breast-feeding mothers should not breast-feed during treatment with Entecavir Glenmark. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Entecavir Glenmark, 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.

Entecavir Glenmark contains lactose

This medicine 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 Entecavir Glenmark

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

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

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

Your dosage 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 years 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 between 10 kg and 32.5 kg, entecavir is recommended as an oral solution. All doses are taken orally (orally) once daily. There are no recommendations for Entecavir Glenmark for children under 2 years of age or weighing less than 10 kg.

The child’s doctor determines the correct dose 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. Take Entecavir Glenmark for as long as your doctor tells you to. Your doctor will tell you if and when to stop treatment.

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

The tablet can be divided into two equal doses.

If you take more Entecavir Glenmark 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 Glenmark

You mustn’t forget to take your medicine. If you forget to take a dose of Entecavir Glenmark, take it as soon as you can, and then take the next dose 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.

Do not stop taking Entecavir Glenmark without your doctor’s advice

Some people get very severe hepatitis symptoms when they stop taking Entecavir Glenmark. 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 Entecavir Glenmark have reported the following side effects:

Adults

  • common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (digestive problems), and elevated levels of liver enzymes in the blood.
  • uncommon (at least 1 in 1,000 patients): rash, hair loss.
  • rare (at least 1 in 10,000 patients): severe allergic reactions.

Children and young people

The side effects experienced by children and adolescents are similar to those described above for adults with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell that is important in defending against infections ).

5. How to store Entecavir Glenmark

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the blister or carton after EXP or EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Moisture sensitive.

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 Glenmark 0.5 mg:

The active substance is entecavir. One film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.

Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone (type A) (E1202), and magnesium stearate.

Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521) and polysorbate 80 (E433).

Entecavir Glenmark 1 mg:

The active substance is entecavir. One film-coated tablet contains entecavir monohydrate equivalent to 1 mg entecavir.

Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone (type A) (E1202), magnesium stearate.

Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521) and polysorbate 80 (E433), and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Entecavir Glenmark 0.5 mg:

Entecavir Glenmark film-coated tablets are white and oval with a scoreline on both sides.

Entecavir Glenmark 1 mg:

Entecavir Glenmark film-coated tablets are pink and oval with a scoreline on both sides.

Entecavir Glenmark film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablets in single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Medis International as, for example, Bolatice

Premyslov 961/16

Bolatice

74723

Czech Republic

Muhammad Nadeem

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