What is it and how is it used?

Lamivudine/Zidovudine Teva belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

Lamivudine/Zidovudine Teva is used in antiretroviral combination therapy for the treatment of HIV infection in patients weighing more than 14 kg. Lamivudine/Zidovudine Teva reduces the amount of HIV virus in your body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection. Lamivudine/Zidovudine Teva has been shown to significantly reduce the risk of disease progression. Response to treatment with Lamivudine/Zidovudine Teva varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Lamivudine/Zidovudine Teva

  • if you are allergic (hypersensitive) to lamivudine or zidovudine or any of the other ingredients of Lamivudine/Zidovudine Teva.
  • if you have very low red blood cell count (severe anaemia) or very low white blood cell count (neutropenia).

If you are not sure please ask your doctor.

Take special care with Lamivudine/Zidovudine Teva

Discuss the use of Lamivudine/Zidovudine Teva with your doctor if you have kidney or liver disease to ensure the doses of the active substances in Lamivudine/Zidovudine Teva are suitable for you.

It is important that your doctor knows about all your symptoms even if you think they are not related to HIV infection. Your doctor may decide to prescribe lamivudine or zidovudine as separate medicines instead of Lamivudine/Zidovudine Teva.

Anaemia (low red blood cell count) and neutropenia/leucopenia (low white blood cell count) may occur within 4-6 weeks due to treatment with zidovudine, one of the active substances in Lamivudine/Zidovudine Teva. If severe, your physician may stop treatment with
Lamivudine/Zidovudine Teva. This has occurred more commonly in patients with advanced HIV disease and with higher doses of zidovudine than the dose in Lamivudine/Zidovudine Teva. Regular blood tests will be arranged to check whether there is a problem with your white and red blood cell count. This adverse reaction is infrequent in patients with early HIV disease and blood tests may be performed less frequently.

If you take ribavirin and zidovudine together it may cause or worsen anaemia. Please contact your doctor if you notice symptoms of anaemia (such as tiredness and shortness of breath). Your doctor will advise you whether you should stop taking Lamivudine/Zidovudine Teva.

The class of medicines to which Combivir belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis. This rare, but serious side effect occurs more often in women, particularly if very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Lamivudine/Zidovudine Teva, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.

If you have a chronic hepatitis B infection, you should not stop your treatment without instructions from your doctor, as you may have a recurrence of your hepatitis. This recurrence may be more severe if you have serious liver disease.

You will need to take Lamivudine/Zidovudine Teva every day. This medicine helps to control your condition and delay disease progression, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor. Do not stop taking your medicine without first talking to your doctor.

Treatment with Lamivudine/Zidovudine Teva has not been shown to reduce the risk of passing HIV infection on to others by unprotected sexual contact or by blood transfer (for example, blood transfusions or sharing needles). You should continue to use appropriate precautions to prevent this.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself. These may affect the action of Lamivudine/Zidovudine Teva, or Lamivudine/Zidovudine Teva may affect their action. Lamivudine/Zidovudine Teva should not be taken with high doses of co-trimoxazole, or injections of ganciclovir or foscarnet, as lamivudine, one of the active substances in Lamivudine/Zidovudine Teva may interact with these. Lamivudine/Zidovudine Teva should also not be taken with stavudine, as zidovudine the other active substance in Lamivudine/Zidovudine Teva may reduce the action of this medicinal product.

Zidovudine, may also interact with the following medicines and may make any side effects worse: Phenytoin, probenecid, rifampicin, atovaquone, valproic acid, methadone, dapsone, pentamidine, pyrimethamine, co-trimoxazole, fluconazole, amphotericin, flucytosine, ganciclovir, interferon, clarithromycin, vincristine, vinblastine and doxorubicin.

Pregnancy and breast-feeding

If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.

If you have taken Lamivudine/Zidovudine Teva during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

If you are breast-feeding please inform your doctor before taking any medicines.
Lamivudine/Zidovudine Teva is not recommended if you are breast-feeding. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

Ask your doctor or pharmacist for advice before taking any medicine.

How is it used?

Always take Lamivudine/Zidovudine Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow Lamivudine/Zidovudine Teva tablets with water. The tablets can be taken with or without food.

If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink and take all the dose immediately.

The usual dose of Lamivudine/Zidovudine Teva for adults and adolescents weighing at least 30 kg is one tablet twice a day.

For children weighing between 21 kg and 30 kg the recommended oral dose of
Lamivudine/Zidovudine Teva is one-half tablet taken in the morning and one whole tablet taken in the evening.

For children weighing 14 kg to 21 kg the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken twice daily.

Each dose of Lamivudine/Zidovudine Teva should be taken approximately 12 hours apart.

For children weighing less than 14 kg, lamivudine and zidovudine should be taken as separate formulations according to the prescribed dosing for these products.

A liquid formulation is available for both lamivudine and zidovudine for the treatment of patients unable to take tablets.

If your doctor wishes to reduce your dose of Lamivudine/Zidovudine Teva, for example if you have kidney problems, then your medicine may be changed to lamivudine and zidovudine taken as separate medicines, which are available as tablets or liquid.

If you take more Lamivudine/Zidovudine Teva than you should
Accidentally taking too much Lamivudine/Zidovudine Teva is unlikely to cause any serious problems. However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Lamivudine/Zidovudine Teva
If you forget to take a dose of Lamivudine/Zidovudine Teva, take is as soon as you remember and then continue as before.
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Lamivudine/Zidovudine Teva can cause side effects, although not everybody gets them.

When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Lamivudine/Zidovudine Teva, by other medicines you are taking at the same time or by the HIV disease. For this reason it is very important that you inform your doctor about any changes in your health. Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly), and other internal organs, breast enlargement and fatty lumps on the back of the neck (?buffalo hump?). The cause and long-term health effects of these conditions are not known at this time.

Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

Very common side effects (affect more than 1 user in 10)

Headache and nausea.

Common side effects (affects 1 to 10 users in 100)

Vomiting, stomach pain, diarrhoea, increase in certain liver enzymes, joint pain, muscle pain and other muscle disorders, dizziness, tiredness, difficulty sleeping, hair loss, anaemia (low red blood cell count) and neutropenia (low white blood cell count). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infection.

Uncommon side effects (affects 1 to 10 users in 1,000)

Flatulence, breathlessness, rash (red, raised or itchy), fever, general aches and pains and reduction in platelets (blood cells important for blood clotting). If you have a low platelet count you may notice that you bruise more easily.

Rare side effects (affects 1 to 10 users in 10,000)

Cough, nasal symptoms, patchy colour changes inside the mouth, heartburn, chest pain (possibly indicating a heart muscle disease called cardiomyopathy), breakdown of muscle tissue, liver disorders such as enlarged liver, fatty liver, inflammation of the liver (hepatitis), inflammation of the pancreas, nail and skin colour changes, sweating, flu-like feeling, drowsiness, passing urine more frequently, breast enlargement in male patients, chills, loss of appetite, taste changes, tingling in the limbs, seizures, inability to concentrate, depression and feeling anxious, increase of lactic acid in the body known as lactic acidosis (see Take special care with Lamivudine/Zidovudine Teva).

While many of the side effects that have been reported occur with both lamivudine and zidovudine when given as separate medicines, some are more likely to occur with one of the medicines only. Your doctor may decide that you need to stop taking Lamivudine/Zidovudine Teva and take lamivudine and zidovudine separately. This will allow your doctor to vary the dose or stop one of the active substances if it is considered that this will help manage any side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Lamivudine/Zidovudine Teva after the expiry date which is stated on the blister or container. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

Further information

What Lamivudine/Zidovudine Teva contains

  • The active substances are lamivudine 150 mg and zidovudine 300 mg.
  • The other ingredients are: Tablet core: Cellulose microcrystalline, sodium starch glycolate (Type A), sodium stearyl fumarate. Tablet film-coat: Hypromellose 3cP, hypromellose 6cP, polysorbate 80, macrogol 400, titanium dioxide E171.
What Lamivudine/Zidovudine Teva looks like and contents of the pack

White, capsule shaped, biconvex, film-coated scored tablet ? engraved with ?L/Z? on one side and ?150/300? on the other side.

The tablet is a breakable tablet.

Lamivudine/Zidovudine Teva is available in aluminium blisters or HDPE containers containing 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Autnorisation Holder

TEVA Pharma B.V.
Computerweg 10, 3542DR Utrecht,
The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllö

Táncsics Mihály út 82

Hungary

TEVA UK Ltd
Brampton Road
Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

TEVA Santé SA

Rue Bellocier

89107 Sens

France

Pliva Krakow

Zaklady Farmaceutyczne S.A.

80 Mogilska St.

31-546 Krakow

Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. Tél 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Eesti Teva Eesti esindus UAB Sicor Biotech Österreich ratiopharm Arzneimittel Vertriebs-GmbH

Tel 43 1 97007 Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Pharma, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 212 08 90

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

This leaflet was last approved in {MM/YYYY}.

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