Baraclude (Entecavir) 30 Tablets

Active ingredient
0.5 mg entecavir in each film-coated tablet.

Excipients
Lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, titanium dioxide, hypromellose, macragol 400, polysorbate 80
2. What is BARACLUDE and what is it used for?

BARACLUDE belongs to a group of drugs called antivirals. BARACLUDE is used in the treatment of hepatitis B virus (HBV) infection in adults.

BARACLUDE 0.5 mg Film Tablets each contain 0.5 mg entecavir as an active ingredient.

BARACLUDE 0.5 mg Film Tablet is in the form of triangular, white to white, film-coated tablets with "BMS" on one side and "1611" on the other side. There are 30 tablets in each box.

BARACLUDE is used in the treatment of hepatitis B virus (HBV) infection in adults.

Infection caused by the hepatitis B virus can damage your liver. BARACLUDE reduces the amount of viruses in your body and improves the condition of your liver.
3. How to use BARACLUDE?
Instructions for proper use and dose / frequency of administration

Always use BARACLUDE as directed by your doctor. If you are not sure, you should definitely consult your doctor or pharmacist.

The usual dose of BARACLUDE is 0.5 mg or 1 mg once a day.

Depending on whether you have received HBV treatment before and the medication you have taken or your kidney problems or depending on; Your doctor may decide that you need to take lower doses or take BARACLUDE as often as less than a day. The dose to be given to you will also be determined according to the condition of your liver.

Your doctor will tell you the right dose for you. Always take the dose recommended by your doctor in order to get the full effect of your medication and reduce the development of resistance to treatment. Take BARACLUDE for the duration recommended by your doctor. Your doctor will tell you when to stop treatment.

Application route and method

Take the tablets with a sufficient amount of water (eg a glass).

BARACLUDE can be taken on an empty or full stomach in many cases. If you have previously been treated with a drug containing lamivudine, but this treatment was unsuccessful and

If you have switched to BARACLUDE treatment, take BARACLUDE once a day on an empty stomach. If you have advanced liver disease, your doctor will recommend that you take BARACLUDE on an empty stomach (about 2 hours before or about 2 hours after a meal).

Use in children

Use in the elderly

Use in the elderly

The dose of BARACLUDE does not need to be adjusted according to the age.

Special use cases

The dose of BARACLUDE may need to be changed in patients with renal insufficiency. There is no need to adjust the dose of BARACLUDE in patients with hepatic insufficiency.

If you have the impression that the effect of BARACLUDE is too strong or too weak, talk to your doctor or pharmacist.

If you use more BARACLUDE than you should

If you have used more than you should use from BARACLUDE, talk to a doctor or pharmacist.

If you forgot to use BARACLUDE

It is important to remember to take any dose. If you forget to take a dose of BARACLUDE, take that dose as soon as you realize that you have forgotten. If it is time for your next dose, do not take the missed dose and take your next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

Effects that may occur when treatment with BARACLUDE is terminated

Some people may experience very serious liver inflammation symptoms when BARACLUDE treatment is discontinued. If you notice any change in symptoms after stopping treatment, tell your doctor immediately.

Do not discontinue BARACLUDE treatment unless your doctor recommends it; Your liver inflammation may get worse when you stop treatment. When your treatment with BARACLUDE is terminated, your doctor will continue to monitor you and perform blood tests for several months.
4. What are the possible side effects?

Like all medicines, people who are sensitive to the ingredients of BARACLUDE may have side effects.

Stop using BARACLUDE and IMMEDIATELY inform your doctor or go to the nearest emergency department if any of the following occur:

Sudden hypersensitivity reaction,

Rash

Itching

- rash on the skin.

These are all very serious side effects. If you have one of these, you have a serious allergy to BARACLUDE. You may need urgent medical attention or hospitalization.

All of these very serious side effects are very rare.

If you notice any of the following, tell your doctor:

Side effects are listed according to their frequency as follows:

Common: (at least one in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, nausea, diarrhea, indigestion, vomiting, increased liver enzymes

Uncommon (at least one in 1,000 patients): rash, hair loss

- Rare: (at least one in 10,000 patients): severe allergic reactions