What is Lamivudine / Zidovudine Teva?
Lamivudine / Zidovudine Teva is a medicine containing two active substances: lamivudine (150 mg) and zidovudine (300 mg). It is available as white, capsule-shaped tablets.
Lamivudine / Zidovudine Teva is a "generic medicine". This means that Lamivudine / Zidovudine Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Combivir.
What is Lamivudine / Zidovudine Teva used for?
Lamivudine / Zidovudine Teva is used in combination with at least one other antiviral medicine to treat patients with human immunodeficiency virus (HIV) infection, the virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Lamivudine / Zidovudine Teva used?
Treatment with Lamivudine / Zidovudine Teva should be started by a doctor who has experience in the treatment of HIV infection. The recommended dose of Lamivudine / Zidovudine Teva for patients over 12 years of age weighing at least 30 kg is one tablet twice a day. In children (under the age of 12) weighing between 14 and 30 kg, the number of tablets and half-tablets to be taken depends on the weight. Children weighing less than 14 kg should use separate oral solutions containing lamivudine and zidovudine. Children taking Lamivudine / Zidovudine Teva should be monitored carefully for any side effects.
We recommend swallowing the tablets without crushing them. Patients who are unable to do so can crush the tablets and add them to a small amount of food or drink immediately before ingesting them. In the case of patients who have to stop taking lamivudine or zidovudine or who have to change doses due to problems with their kidneys, liver or blood, it is necessary to use medicines containing lamivudine or zidovudine separately.
For more information, see the package leaflet.
How does Lamivudine / Zidovudine Teva work?
Both active substances in Lamivudine / Zidovudine Teva are nucleoside reverse transcriptase inhibitors (NRTIs). They exert a similar action, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and reproduce. Lamivudine / Zidovudine Teva, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Lamivudine / Zidovudine Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Both active substances have been available in the European Union (EU) for several years: lamivudine has been authorized as Epivir since 1996 and zidovudine has been available in the EU since the mid-1980s.
What studies have been performed on Lamivudine / Zidovudine Teva?
Because Lamivudine / Zidovudine Teva is a generic medicine, studies in patients have been limited to tests to show that the drug is bioequivalent to the reference medicines, Combivir. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the risks and benefits of Lamivudine / Zidovudine Teva?
Because Lamivudine / Zidovudine Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Lamivudine / Zidovudine Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Lamivudine / Zidovudine Teva has been shown to have comparable quality and to be bioequivalent to Combivir. Therefore, the CHMP considered that, as in the case of Combivir, the benefits outweighed the identified risks. The Committee recommended the granting of a marketing authorization for Lamivudine / Zidovudine Teva.
More information on Lamivudine / Zidovudine Teva
On 28 February 2011, the European Commission granted Teva Pharma BV a marketing authorization for Lamivudine / Zidovudine Teva, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
Last update of this summary: 12/2010.
