0.5 mg and 1 mg film-coated tablets
entecavir
1. What Entecavir STADA is and what it is used for
Entecavir STADA tablets are anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults.
Entecavir Stada 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 Stada tablets are also used to treat chronic (long-term) HBV infections in children and adolescents between 2 and 18 years of age.
Entecavir Stada 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 Stada reduces the amount of virus in your body and improves the condition of the liver.
Entecavir contained in Entecavir Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Entecavir STADA
Do not use Entecavir STADA
- 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 Stada.
- If you have ever had kidney problems, tell your doctor. This is important because Entecavir Stada is excreted from the body through the kidneys and your dose or dosing schedule may need to be adjusted.
- Do not stop taking Entecavir Stada without your doctor’s advice, as your hepatitis B infection may get worse after stopping treatment. When your treatment with Entecavir Stada is stopped, 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 Stada treatment.
- if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Stada to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effect of future HIV treatment may be reduced. Entecavir STADA will not control your HIV – infection under control.
- Use of Entecavir Stada 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 Stada 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 Stada.
- Tell your doctor if you have previously been treated for chronic hepatitis B.
Children and young people
Entecavir Stada should not be used in children under 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Entecavir STADA with food, drink, and alcohol
In most cases, you can take Entecavir Stada 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 Stada treatment because the treatment with lamivudine has not had sufficient effect, Entecavir Stada 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 Stada 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 Entecavir Stada 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 Stada during pregnancy. Entecavir Stada should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with Entecavir Stada must use an effective method of contraception to avoid becoming pregnant.
Breast-feeding mothers should not breast-feed during treatment with Entecavir Stada. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Entecavir Stada, 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 STADA 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.
How to use Entecavir STADA
Not all patients need to take the same dose of Entecavir Stada.
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 daily.
- the condition of your liver.
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 Stada on an empty stomach (see Entecavir Stada with food and drink in section 2 ). If your doctor instructs you to take Entecavir Stada on an empty stomach, fasting means at least 2 hours after a meal and at least two hours before the next meal.
The tablet can be divided into two equal doses.
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. Entecavir should not be used in children under 2 years of age and weighing less than 10 kg.
For children and adolescents weighing less than 32.6 kg and for doses below 0.5 mg, an entecavir oral solution may be available.
Your child’s doctor will determine the correct dose based on the child’s weight.
If you use more Entecavir STADA 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 use Entecavir STADA
You mustn’t forget to take a dose. If you forget to take a dose of Entecavir Stada, 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 using Entecavir STADA
Some people get very severe hepatitis symptoms when they stop taking Entecavir Stada. 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 Stada have reported the following side effects:
- Common (may affect up to 1 in 10 people): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (digestive problems that cause stomach and intestinal discomfort after meals), and 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.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
5. How to store Entecavir STADA
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 blister or carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package.
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 Stada 0.5 mg film-coated tablets
The active substance is entecavir. Each film-coated tablet contains 0.5 mg entecavir.
Other ingredients are
Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone (type A) (E1202), and magnesium stearate.
Tablet cover: titanium dioxide (E171), hypromellose (E464), macrogol 400, and polysorbate 80.
Entecavir Stada 1 mg film-coated tablets
The active substance is entecavir. Each film-coated tablet contains 0.5 mg entecavir.
Other ingredients are
Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone (type A) (E1202), and magnesium stearate.
Tablet cover: titanium dioxide (E171), hypromellose (E464), macrogol 400, polysorbate 80, and red iron oxide (E172).
What the medicine looks like and the contents of the pack
Entecavir Stada 0.5 mg film-coated tablets are white and oval with a scoreline on both sides.
Entecavir Stada 1 mg film-coated tablets are pink and oval with a scoreline on both sides.
Entecavir Stada 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 Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Medis International as
virtuoso zavod Bolatice
Prumyslová 961/16, 747 23 Bolatice
Czech Republic
Centrafarm Services BV
New Donk 9
NL-4879 AC Etten-Leur
Netherlands
STADA Nordic ApS.
Marielundvey 46A
2730 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark