0.5 mg, 1 mg film-coated tablets
entecavir
1. What Entecavir Sandoz is and what it is used for
Entecavir Sandoz t tablets is an antiviral treatment of chronic (long term) hepatitis B virus (HBV) in adults. Entecavir Sandoz 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 Sandoz such tablets are also used to treat chronic (long-term) HBV infection in children and adolescents aged 2 to under 18 years. Entecavir Sandoz 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 Sandoz reduces the amount of virus in your body and improves the condition of the liver.
Entecavir contained in Entecavir Sandoz 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 Sandoz
Do not take Entecavir Sandoz
- 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 Sandoz
- If you have ever had kidney problems, tell your doctor. This is important because Entecavir Sandoz is excreted from the body through the kidneys and your dose or dosing schedule may need to be adjusted.
- Do not stop taking Entecavir Sandoz without your doctor’s advice, as your hepatitis B infection may worsen after stopping treatment. When your treatment with Entecavir Sandoz 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 Sandoz treatment.
- if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Sandoz 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. Entecavir Sandoz will not control your HIV – infection under control.
- Using Entecavir Sandoz 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 Sandoz 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 while you are taking Entecavir Sandoz.
- Tell your doctor if you have previously been treated for chronic hepatitis B.
Children and young people
Entecavir Sandoz should not be used in children under 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Entecavir Sandoz with food and drink
In most cases, you can take Entecavir Sandoz 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 Sandoz because the treatment with lamivudine has not had sufficient effect, Entecavir Sandoz 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 Sandoz on an empty stomach. Fasting means at least 2 hours after one meal and at least 2 hours before your next meal.
Entecavir Sandoz 0.5 mg film-coated tablets
Children and adolescents (from 2 to younger than 18 years) can take Entecavir Sandoz 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 entecavir is safe to use during pregnancy. Entecavir Sandoz should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with Entecavir Sandoz must use an effective method of contraception to avoid becoming pregnant.
Breast-feeding mothers should not breast-feed during treatment with Entecavir Sandoz. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Entecavir Sandoz, 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 Sandoz 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 take Entecavir Sandoz
Ll patients need to take the same dose of Entecavir Sandoz.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
F ear adults the recommended dose either 0.5 mg or 1 mg once daily orally (by mouth).
D In 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 prescribe a lower dose or instruct you to take dose one less often than once a day.
- the condition of your liver.
Entecavir Sandoz 0.5 mg film-coated tablets
F ear children and adolescents (from 2 to under 18 years) determines the child’s doctor, the correct dosage one based on the weight of the child. Children weighing at least 32.6 kg may take the 0.5 mg tablet or entecavir may be available as an oral solution. Entecavir is an oral solution is recommended for patients weighing from 10 kg to 32.5 kg. All doses are taken orally (orally) once daily. There are no recommendations for entecavir in 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.
Entecavir Sandoz 1 mg film-coated tablets
F ear children and adolescents (2 to under 18 years) are Entecavir Sandoz, 0.5 mg tablets available, and entecavir as the oral solution can be provided. 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. Take Entecavir Sandoz for as long as your doctor tells you. Your doctor will tell you if and when to stop treatment.
Some patients have to take Entecavir Sandoz on an empty stomach (see Entecavir Sandoz with food and drink in section 2 ). If your doctor instructs you to take Entecavir Sandoz 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 Sandoz then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Entecavir Sandoz
You mustn’t forget to take your medicine. If you forget to take a dose of Entecavir Sandoz, 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 Sandoz
Do not stop taking Entecavir Sandoz without your doctor’s advice. Some people get very severe hepatitis symptoms when they stop taking Entecavir Sandoz. 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 Sandoz 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.
5. How to store Entecavir Sandoz
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, pressure pack, or carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
After first opening the jar: used within 6 months.
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
- The active substance is entecavir (as monohydrate).
- Other ingredients are T ablettkärna: lactose monohydrate, microcrystalline cellulose, crospovidone (type A), magnesium stearate. Film coating: hypromellose 2910, macrogol 6000, titanium dioxide (E171), talc. Entecavir Sandoz 1 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Entecavir Sandoz 0.5 mg film-coated tablets
White, round film-coated tablets marked with “SZ” on one side and “108” on the other side, with a diameter of approx. 8.0 mm.
Entecavir Sandoz 1 mg film-coated tablets
Light red, round film-coated tablets marked with “SZ” on one side and “109” on the other side, with a diameter of approx. 10.0 mm.
OPA / Aluminum / PVC-Aluminum – pressure packaging
Pack sizes: 30 and 90 film-coated tablets.
White HDPE jar with child-resistant polypropylene screw cap.
Pack sizes: 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
T il l verkare
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia