sign in sign up
<<
Home , Zidovudine

Lamivudine//Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

PATIENT INFORMATION LEAFLET

Page 1 of 10 /Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg*

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your health care provider. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any , talk to your health care provider. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet: 1. What Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is and what it is used for 2. What you need to know before you take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg 3. How to take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg 4. Possible side effects 5. How to store Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg 6. Contents of the pack and other information

1. WHAT LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE TABLETS 150 + 200 + 300 MG IS AND WHAT IT IS USED FOR

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg contains lamivudine, zidovudine and nevirapine. These medicines are antiviral medicines, also known as antiretrovirals, belonging to two groups referred to as nucleoside analogues (NRTIs, lamivudine and zidovudine) and non- nucleoside inhibitors (NNRTIs, nevirapine). These are medications used to treat Human Immunodeficiency (HIV) .

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is used as antiretroviral combination therapy for the treatment of HIV infection in adults and in children that weigh at least 25 kg.

The three medicines contained in Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg can be used separately with other medicines for combination treatment of HIV infection or can be used together. The dose of each active ingredient in Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is the same as that recommended for the medicines when used separately. Treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg will only be instituted by your health care provider, when you have been shown to be stable on the three individual compounds. Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg reduces the amount of HIV in the body, and keeps it at a low level. It also increases CD4 counts. CD4 cells are a type of white blood cells that play an important role in maintaining a healthy immune system to help fight . Response to treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg varies between patients. Your health care provider will be monitoring the effectiveness of your treatment.

* Trade names are not prequalified by WHO. This is the national medicines regulatory authority's (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only.

Page 2 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg should improve your condition, but it is not a cure for the HIV infection. HIV infection is spread by contact with blood or sexual contact with an infected individual. Treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg has not been shown to eliminate the risk of passing HIV infection on to others by sexual contact or by blood transfer. Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE TABLETS 150 + 200 + 300 MG

Do not take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg: - if you are allergic (hypersensitive) to lamivudine, zidovudine, nevirapine or any of the other ingredients of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg (see section 6, “What Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg contains”) - if you have very low count (severe anaemia) or very low white blood cell count () - if you have serious disease or marked changes in liver function - if you previously experienced liver inflammation, severe skin rash or liver injury while on treatment with nevirapine-containing products - patients taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg must not take products containing rifampicin or St. John’s wort (Hypericum perforatum, a herbal remedy against depression) as this may prevent Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg from working properly.

Warnings and precautions Before using Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg you should have told the health care provider: • if you have ever had or still has a (such as hepatitis), • if you are suffering from or has ever suffered from disease. It is important that your health care provider knows about all your signs of illness, even when you think they are not related to HIV infection. Your health care provider may decide to prescribe lamivudine, zidovudine and/or nevirapine as separate medicines instead of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg. Liver disease During the first 18 weeks of treatment with medicines containing nevirapine, such as Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg the health care provider will closely monitor you for possible occurrence of severe and life-threatening skin reactions and serious liver problems. Since Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg may cause changes in liver function, the health care provider will monitor the function of your liver by blood tests before and at regular intervals during treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require additional blood tests to monitor their liver function.

You are at higher risk of severe and potentially fatal liver damage: - if you already have abnormally increased liver function tests, - if you have Hepatits B or C infection - if you are female.

Page 3 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

- if one has higher CD4 cell counts at the start of treatment with any nevirapine-containing product. If any of these possible risk factors applies to you, your health care provider will monitor you more closely.

Therapy with any nevirapine-containing product should not be started in women with CD4 cell counts greater than 250cells/mm3 or in men with CD4 cell counts greater than 400 cells/mm3, unless the benefits are considered to outweigh the risk.

If you develop clinical symptoms suggesting injury of the liver, such as loss of appetite, nausea, jaundice (yellowing of the skin and whites of the eyes), dark urine, discoloured stools (faeces), or pain and tenderness in the upper right abdomen, you should immediately stop giving Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg and must contact the health care provider immediately. If you have chronic hepatitis B infection, you should not stop your treatment without instructions from your health care provider, as you may have a recurrence of your hepatitis. This recurrence may be more severe if you have serious liver disease. Blood disorders Since low red blood cell count (anaemia) as well as low white blood cell count (neutropenia/leucopenia) may occur due to treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg, regular blood tests will be arranged to check whether there is a problem. Skin reactions Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg may cause skin reactions and allergic reactions, which in the worst case can be serious and life-threatening. Fatalities have been reported. Such reactions may appear in the form of a rash accompanied by other side effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling, muscle or joint aches, a reduction in white blood cells (granulocytopenia), general feelings of illness or severe problems with liver or kidneys.

If you experience a severe rash or any rash associated with other side effects of an allergic reaction, as described above, you should stop giving Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg right away and must contact your health care provider immediately. If you develop severe liver, skin or allergic reactions while taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg, never take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg or any other nevirapine-containing product again without asking your health care provider. Fat distribution Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your health care provider if you notice changes in your body shape. Women, particularly if very overweight and patients with liver disease may be at greater risk of developing a rare but serious side effect called lactic acidosis, a build-up of lactic acid in the body. If lactic acidosis occurs, it usually develops after a few months of treatment. Deep rapid breathing, drowsiness, and non-specific symptoms such as nausea, vomiting and stomach pain may indicate the development of this condition (see section 3). While you are being treated with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg, your health care provider will monitor you for any signs that you might be developing lactic acidosis. Immune reactivation syndrome In some patients with advanced HIV infection (AIDS) and a history of AIDS-associated (opportunistic) infections, signs and symptoms of inflammation from such previous infections may

Page 4 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

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 without obvious symptoms. If you notice any symptoms of infection, inform your health care provider immediately. Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue). The risk of developing this disease may be higher if the immune system is severely weakened, or when drinking alcohol regularly. General You will need to take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg every day. This medicine helps to control your condition, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease (e.g. opportunistic infections). These will require specific and sometimes preventive treatment. You should keep in regular contact with your health care provider. Do not stop taking the medicine without first talking to your health care provider.

You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your health care provider the precautions needed to avoid infecting other people.

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg contains lactose. If you have been told by your health care provider that you have intolerance to some sugars, contact your health care provider before taking this medicinal product.

Other medicines and Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg Tell your health care provider if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These may affect the action of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg, or Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg may affect their action.

Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg must not be taken with rifampicin. Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg must not be taken with herbal preparations containing St. John’s Wort. Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg should not be taken with the following agents: - other medicinal products containing lamivudine to treat hepatitis B infection - , , , several protease inhibitors (e.g. /rtv, /rtv , ), (antiviral agents) - ketoconazole, itraconazole (antifungals) - (uric acid lowering agent) Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg may also interact with the following medicines and may make any side effects worse or may affect the other medication’s effectiveness: - oral contraceptives (“the pill”). Therefore, you should employ an alternative contraceptive method such as barrier contraception (e.g. condoms) while taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg - fluconazole (antifungal medicine) - , rifabutin (antibiotics)

Page 5 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

- , /artesunate, quinine, lumefantrine, halofantrine, atovaquone (antimalarials) - phenytoin, valproic acid (anticonvulsants) - warfarin (medicine for preventing blood clots) - doxorubicin (anti- medicine)

Taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg with food and drink Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg may be taken with food or between meals

Pregnancy and breast-feeding Ask your health care provider for advice before taking any medicine. Be sure to tell your health care provider immediately if you are or may be pregnant.

In babies born to mothers who have taken antiretroviral medicines comprising nucleoside and nucleotide analogues, the benefit of reduced risk of becoming infected with HIV outweighs the risk of side effects of these medicines.

If you are interested in breast-feeding your baby, you should discuss the risks and benefits with your health care provider.

Driving and using machines Dizziness can occur during treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg. If you experience these symptoms you should avoid potentially hazardous tasks such as driving and operating machinery.

3. HOW TO TAKE LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE TABLETS 150 + 200 + 300 MG

Always take this medicine exactly as your health care provider told you. Check with your health care provider if you are not sure.

The recommended dose of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is adults and children with a body weight of 25kg or more is one tablet twice daily.

Tablets should be swallowed whole and neither be split nor crushed.

Children: Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is not indicated for children weighing less than 25 kg, since appropriate dose reductions cannot be made.

Dose adjustments If your dose of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg needs to be reduced, for example if you have kidney problems or discontinuation of therapy with one of the active substances of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is necessary, then your medicine may be changed to separate preparations of lamivudine, zidovudine and nevirapine, which are available as tablets/capsules and liquid formulations for oral use.

Page 6 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

If one takes more Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg than one should: If you have accidently taken too many tablets, or if someone accidentally swallows some, there is no immediate danger. However, you should contact your health care provider or the nearest hospital emergency department for further advice. Take the tablet container with you so that you can easily describe what you have taken.

If one forgets to take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg If you accidentally miss a dose and you notice within 6 hours after the missed dose, give the missed dose as soon as possible. Give the next dose as regularly scheduled. If you notice later than 6 hours after the missed dose, then only give the normal dose when the next dose is due. Do not give a double dose to make up for forgotten individual doses.

If you throw up the tablet (just after taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg) you should take another tablet. Do not wait until your next dose is due.

If one stops taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg You should not stop taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg without talking to your health care provider. Stopping Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg can seriously affect your response to future treatment. If Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg is stopped, speak to your health care provider before you restart taking Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg. Your health care provider may consider giving you the components of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg separately if you are having problems or need your dose adjusted. When your supply of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg starts to run low, get more from your health care provider. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat. If you have any further questions on the use of this product, ask your health care provider.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg can cause side effects, although not everyone may experience them. When treating HIV infection, it is not always possible to differentiate between unwanted effects caused by Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg, those caused by any other medicines you may be taking at the same time, and those caused by the HIV disease. For this reason, it is important that you inform your health care provider of any change in your health.

As mentioned above, the most important side effects of Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg are severe and life-threatening skin reactions and serious liver injuries. These occur mainly in the first 10 to 12 weeks of treatment with Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg. This is therefore an important period which requires close surveillance (see “Warnings and precautions”)

Tell your health care provider about any of the following side effects:

Common side effects (These can affect more than 1 user in 10)

Page 7 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

- fatigue (feeling ill and tired), headache, nausea (feeling sick), vomiting (being sick), dizziness - stomach pain, diarrhoea - fever - rash (red, raised or itchy) - increase in certain liver , - joint pain, muscle pain and other muscle disorders - cough, nasal symptoms - 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 signs of tiredness or breathlessness, and a reduction in your white blood cell count can make you more prone to infections.

Uncommon side effects (These can affect 1 to 10 users in 1,000) - flatulence - breathlessness - general aches and pains - decrease of 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 (These can affect 1 to 10 users in 10,000) - patchy colour changes inside the mouth - nail and skin colour changes - a blood disorder called pure red cell aplasia - heartburn - chest pain (possibly indicating a heart muscle disease called ) - breakdown of muscle tissue - liver disorders such as enlarged liver, fatty liver, inflammation of the liver (hepatitis) inflammation of the pancreas - sweating - flu-like feeling - passing urine more frequently - breast enlargement in male patients - chills - loss of appetite, taste changes - tingling in the limbs - convulsions, inability to concentrate - depression, feeling anxious - build-up of lactic acid in the body known as lactic acidosis (See section 2, What you need to know before you take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg).

Very rare side effects (These can affect less than 1 users in 10,000) - blood disorder called aplastic anaemia

Side effects with unknown frequency: - 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 around 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.

Page 8 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

- raised lactic acid and sugar in the blood, increased fats in the blood - osteonecrosis (death of bone tissue) - immune reactivation syndrome (see ”Warnings and precautions”).

Other possible side effects: Combination antiretroviral therapy may also cause increased blood sugar levels, resistance to insulin, and diabetes (see section 2, What you need to know before you take Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg).

If you get any side effects, talk to your health care provider. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE TABLETS 150 + 200 + 300 MG

Keep out of the reach and sight of children.

Do not store above 30oC, store in the original container protected from moisture.

Do not use Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg after the expiry date which is stated on the bottle and carton after {EXP}. The expiry date refers to the last day of that month.

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 PACK AND OTHER INFORMATION

What Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg contains The active ingredients are lamivudine 150 mg, zidovudine 200 mg and nevirapine 300 mg. The other ingredients are: Lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, povidone, sodium starch glycolate, magnesium stearate and Opadry 03K50731 Blue (Film coating material).

What Lamivudine, Nevirapine and Zidovudine Tablets 150 + 200 + 300 mg looks like and contents of the pack Blue coloured, capsule shaped, film coated tablets with ‘RX 922’ debossed on one side and plain on the other side. Tablets are available in white opaque HDPE bottle pack of 60’s.

Page 9 of 10 Lamivudine/Nevirapine/Zidovudine WHOPAR part 3 Updated: July 2018 150 mg/200 mg/300 mg Tablets, (Sun Pharmaceutical Industries Limited), HA323

Supplier and Manufacturer Sun Pharmaceutical Industries Limited Village: Ganguwala ,Paonta Sahib District Sirmour Himachal Pradesh – 173025 India Email: [email protected] Fax : (00-91-1704) 223492 Telephone: +91 1704 662201, +911704 662279

For any information about this medicinal product, please contact the local representative of the supplier.

Sun Pharmaceutical Industries Ltd Research & Development Centre Sarhaul, Sector-18 Gurgaon-122015, Haryana, India Telephone: +91-124-4194400 (Ext. 4217) Email: [email protected]

Ranbaxy Pharmaceuticals (Pty) Ltd a SUN PHARMA company 14 Lautre Road, Stormill,Ext 1, 1724 P.O. Box 43486, Industria, 2042 South Africa Telephone: +27 11 4950107 Fax: +27 11 4950150

This leaflet was first approved in May 2008 Section 6 updated in February 2017 All sections updated in July 2018

Detailed information on this medicine is available on the World Health Organization (WHO) web site: https://extranet.who.int/prequal

Page 10 of 10