ZEFFIX 100 mg. 28 tablets
Zeffix is used to treat long-term (chronic) infection with the hepatitis B virus in adults.
The active ingredient of Zeffix is lamivudine. Zeffix is an antiviral drug that suppresses the hepatitis B virus Zeffix belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
The hepatitis B virus infects the liver, and causes a long-term (chronic) infection and can lead to liver damage. Zeffix can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function normally (decompensated liver disease).
Treatment with Zeffix can reduce the number of hepatitis B virus in the body. This reduces the damage to the liver and enhances its function. Not all people respond to treatment with Zeffix equally. Your doctor will monitor the effectiveness of your treatment.
2. What you should know before taking Zeffix
Do not take Zeffix:
• if you are allergic (hypersensitive) to lamivudine or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor if you think this applies to you.
Take special care with Zeffix
In some people, taking Zeffix, the risk of serious side effects. You should be aware of the extra risks:
• if you have ever had other type of liver disease such as hepatitis C
• if you're seriously overweight (especially if you're a woman)
Discuss with your doctor if you think any of the above statements apply to you. May need extra check-ups, including blood tests while taking the drug. See Section 4 for more information.
Do not stop taking Zeffix without checking with your doctor, as there is a risk of your hepatitis getting worse. After discontinuation of treatment should remain under medical supervision for at least four months. This will mean taking blood samples to determine whether any abnormal liver enzymes, indicating liver damage.
Watch out for important symptoms
Some people taking medicines for the treatment of hepatitis B infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for their appearance while taking Zeffix.
Read the information 'Other possible side effects of treatment for hepatitis B' in section 4 of this leaflet.
Protect other people
Hepatitis B infection is spread by sexual contact with someone who is infected, or through infected blood (for example by using the same injection needles). Zeffix can not stop the transmission of infection to others. To protect other people from becoming infected with hepatitis B virus:
• Use a condom when you have oral sex or intercourse with penetration.
• Do not create a risk of blood transfer - for example, do not share needles.
There is an effective vaccine to protect people at increased risk of infection with hepatitis B virus
Other medicines and Zeffix
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines or other medicines you bought without a prescription.
Be sure to tell your doctor or pharmacist if you begin taking a new medicine while you are being treated with Zeffix.
These medicines should not be taken simultaneously with Zeffix:
• zalcitabine or lamivudine used in the treatment of HIV infection (also known as infection with the AIDS virus)
• emtricitabine used for the treatment of HIV or hepatitis B infection.
• cladribine used for the treatment of hairy cell leukemia. Tell your doctor if you are taking any of the above drugs.
If you are pregnant, become pregnant or planning a pregnancy:
Immediately discuss with your doctor the risks and benefits of taking Zeffix during your pregnancy.
Na_Zeffix_mogat ingredients can pass into breast milk. If you are breastfeeding or plan to breast-feeding: Consult your doctor to take Zeffix Prev
Driving and using machines
Zeffix likelihood to affect your ability to drive and use machines is negligible.
3. How to take Zeffix?
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with water. Zeffix can be taken with or without food. Maintain regular contact with your doctor
Zeffix helps to control your hepatitis B infection. You should take it every day to control infection and prevent worsening of the disease.
Maintain regular contact with your doctor and do not stop taking Zeffix without consulting your doctor.
How much to take?
The usual dose of Zeffix is one tablet (100 mg lamivudine) once daily.
If you have kidney problems, your doctor may prescribe a lower dose. There Zeffix as an oral solution for those people who need a lower dose than usual or for people who can not swallow tablets.
Talk to your doctor if this applies to you.
If you are already taking other medicines containing lamivudine, to treat HIV infection, your doctor will continue treatment with the higher dose (usually 150 mg twice daily) as the dose of lamivudine in Zeffix (100 mg) is not sufficient for treatment of HIV infection. If plans change your treatment for HIV, discuss this change with your doctor beforehand.
If you take more dose of Zeffix
If you accidentally take too high a dose Zeffix, unlikely to cause any serious problems is small. If you accidentally take too high a dose, contact your doctor or pharmacist or contact your nearest hospital emergency department for further advice.
If you forget to take Zeffix
If you forget to take a dose of the drug take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up the missed dose.
Do not stop taking Zeffix
You should not stop taking Zeffix, without you consulting your doctor. If you do, there is a risk of worsening of your hepatitis (see "Take special care with Zeffix" in section 2).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In addition, side effects from taking Zeffix, listed below, during the treatment of hepatitis B can be improved and other diseases.
It is important to read the information in 'Other possible side effects of treatment for hepatitis B ".
Side effects reported commonly during Zeffix clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, abdominal discomfort and abdominal pain, nausea, vomiting and diarrhea, increases in liver enzymes and enzymes produced in the muscles (see below).
Allergic reactions are very rare in people taking Zeffix. Signs include:
• sudden shortness of breath, pain or tightness in the chest.
• swelling of eyelids, face or lips.
• skin rash or hives anywhere on the body.
Immediately contact your doctor if you experience these symptoms.
Stop taking Zeffix.
Adverse reactions which are considered to be caused by Zeffix
Very common side effects (these may affect more than 1 in 10 patients), which can be seen in blood tests is:
• an increase in the level of some liver enzymes (transaminase) that may be a sign of inflammation or liver damage.
Common side effects (these may affect up to 1 in 10 patients):
• muscle cramps and muscle pain
Common side effects that can be observed in blood tests is:
• increased levels of enzyme produced in muscle (CPK) which may be a sign of tissue damage.
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is not known.
• breakdown of muscle tissue
• worsening of liver disease after Zeffix is stopped or during treatment if hepatitis B virus become resistant to Zeffix. This can be fatal in some people.
• lactic acidosis (see the next section, 'Other possible side effects of treatment for hepatitis B ").
Adverse effects can be observed in blood tests is:
• reducing the number of cells that are involved in blood clotting (thrombocytopenia).
If you get any side effects
Tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
Other possible side effects of treatment for hepatitis B
Zeffix and similar drugs (nucleoside reverse transcriptase inhibitors, NRTIs) can lead to the development of other diseases in the treatment of hepatitis B.
Lactic acidosis is a rare but serious side effect
In some patients taking Zeffix or other similar medicines (nucleoside reverse transcriptase inhibitors, NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build up of lactic acid in the body. It is rare, and if they develop, usually several months after starting treatment. Lactic acidosis can be life-threatening, causing failure of internal organs.
The probability of occurrence of lactic acidosis is higher in patients with liver disease and in obese people (with very overweight) people, especially women.
Signs of lactic acidosis include:
• deep, rapid, difficult breathing
• numbness or weakness in the limbs
• nausea, vomiting
• stomach pain.
During treatment, your doctor will monitor you for signs of lactic acidosis. If any of the above symptoms or any other symptoms that worry you:
As quickly as possible, consult with your doctor.
5. How to store Zeffix?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the blister and carton.
Do not store above 30 ° C.
Do not dispose of medications in 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 pack and other information
The active ingredient is lamivudine. Each tablet contains 100 mg of lamivudine.
Other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide (see point 2).
What Zeffix looks like and contents of the pack?
Zeffix film-coated tablets are available in tamper packs containing foil blisters of 28 or 84 tablets. The tablets are biconvex, tan-colored, capsule-shaped and engraved with "GX CG5" on one face.