PATIENT INFORMATION LEAFLET

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1 PATIENT INFORMATION LEAFLET Page 1 of 10

2 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg * Lamivudine/Zidovudine Read all of this leaflet carefully before you start giving this medicine to your child. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, health care provider or pharmacist. - This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as those of your child. - If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your child s doctor, health care provider or pharmacist. In this leaflet: 1. What Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg is and what it is used for 2. Before your child takes Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg 3. How to take Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg 4. Possible side effects 5. How to store Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg 6. Further information 1. WHAT LAMIVUDINE / ZIDOVUDINE DISPERSIBLE TABLETS 30 MG / 60 MG IS AND WHAT IT IS USED FOR Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg 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 Dispersible Tablets 30 mg / 60 mg is used in antiretroviral combination therapy for the treatment of HIV infection. Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg reduces the amount of HIV in the body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg varies between patients. Your child s doctor or health care provider will be monitoring the effectiveness of the treatment. Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg may improve your child s condition, but it is not a cure for the HIV infection. HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 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/your child must continue to take appropriate precautions to avoid giving the virus to others. This product is intended for use in children. Safety information on use in adults is also provided. * 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

3 2. BEFORE YOUR CHILD TAKES LAMIVUDINE / ZIDOVUDINE DISPERSIBLE TABLETS 30 MG / 60 MG Your child should not be given Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg if: - he/she is hypersensitive (allergic) to lamivudine, zidovudine or any of the other ingredients of the tablets (see section 6, What Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg contains). - he/she has a very low red blood cell count (severe anaemia) or a very low white blood cell count (neutropenia). Take special care with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg It is important that your child s doctor or health care provider knows about all symptoms even when you think they are not related to HIV infection. The doctor or health care provider may decide to prescribe lamivudine or zidovudine as separate medicines instead of Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg. Blood cell count Since low red blood cell count (anaemia) as well as low white blood cell count (neutropenia/leucopenia) may occur due to treatment with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, regular blood tests will be arranged to check whether there is a problem. Liver Disease Please speak with your doctor or health care provider if your child has a history of liver disease. 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 blood tests to monitor liver function. If there is chronic hepatitis B infection, your child should not stop treatment without instructions from the doctor or health care provider, as there may be a recurrence of hepatitis. This recurrence may be more severe if there is serious liver disease. Kidney disease Discuss the use Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg with your doctor or health care provider if your child has kidney disease to ensure the doses of the active substances in Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg are suitable for your child. Lactic acidosis Females, particularly if very overweight and patients with liver disease may be more at risk of getting 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, might indicate the development of this condition (see section 3). While the child is being treated with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg the doctor or health care provider will monitor for any signs of lactic acidosis. Fat distribution Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact the doctor or health care provider if you notice changes in the child s body shape. Immune Reactivation Syndrome In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, 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 previously with no obvious symptoms. Autoimmune disorders (the immune system attacking healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. These may occur many Page 3 of 10

4 months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity in your child, please inform the doctor or health care provider immediately to seek necessary treatment. 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, e.g. when the immune system is severely compromised or when drinking alcohol regularly. So far, this disease has been reported mainly in adults. However, if your child notices joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement, inform the doctor or health care provider. General The child will need to take Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg every day. This medicine helps to control the condition, but it is not a cure for HIV infection. Your child 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 child s doctor or health care provider. Do not stop the medicine without first talking to the doctor or health care provider. Your child can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your child s doctor the precautions needed to avoid infecting other people. Important information about some of the other ingredients of Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg Each tablet contains 18 mg aspartame, which may be a source of phenylalanine. May be harmful for people with phenylketonuria. Taking other medicines Please tell your child s doctor, health care provider or pharmacist if the child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Medicines that should not be used with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg stavudine, emtricitabine to treat HIV infection. ribavirin or injections of ganciclovir to treat viral infections. high doses of trimethoprim + sulfamethoxazole, an antibiotic. cladribine, used to treat hairy cell leukaemia. Some medicines that interact with Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg valproic acid and phenytoin, to treat epilepsy interferon, to treat viral infections clarithromycin, an antibiotic take clarithromycin at least 2 hours before taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg pyrimethamine, to treat malaria and other parasitic infections dapsone (unless used for prophylaxis), to prevent pneumonia and treat skin infections amphotericin, fluconazole or flucytosine, to treat fungal infections such as Candida pentamidine, atovaquone to treat parasitic infections probenecid, to treat gout and given with some antibiotics to make them more effective methadone, used as a heroin substitute Page 4 of 10

5 vincristine, vinblastine or doxorubicin, to treat cancer Pregnancy and breast-feeding Pregnancy: If a woman becomes pregnant, or plans to become pregnant, she must contact a doctor or health care provider to discuss the benefits and risks of antiretroviral therapy. In studies of children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV was greater than the risk of suffering from side effects. Breastfeeding: Lamivudine and zidovudine, the active agents in Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, are likely to be found in human breast milk. If a mother is interested in breastfeeding her baby, she should discuss the risks and benefits with her doctor or healthcare provider. Driving and using machines Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg may cause side effects such as drowsiness or headache that can impair the ability to drive and to use machines. 3. HOW TO TAKE LAMIVUDINE / ZIDOVUDINE DISPERSIBLE TABLETS 30 MG / 60 MG Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg should be given exactly as described by the doctor or health care provider. You should check with the prescribing doctor, health care provider or pharmacist if you are not sure. Dosing for childr en aged 6 weeks and above: Number of tablets by weight band to be taken twice daily (approximately 12 hours apart). Number of tablets by weight band (twice daily) kg kg kg kg kg * 3 + This dose can be delivered as one and a half tablets twice daily, or by giving 2 tablets in the morning and one tablet in the evening. * This dose can be delivered as two and a half tablets twice daily, or by giving 3 tablets in the morning and 2 tablets in the evening. Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg may be taken with or without food. Directions for Use: Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg should be dispersed in water before administration. Please follow the following steps to disperse Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg. 1. The number of tablets to be administered to each patient will be determined by his or her body weight (as shown in table above). 2. Remove the number of tablets recommended for one dose from the bottle with dry hands. 3. Disperse the recommended number of tablets in drinking water. The minimum volume of drinking water to be used for dispersion is shown in the table below: Page 5 of 10

6 Recommended volume of drinking water to be used for dispersion of Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg Number of Tablets Recommended Per Dose of Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg Recommended Volume of Drinking Water to be Used for Dispersion 1 tablet 10 ml (approximately 2 teaspoons) 1.5 or 2 tablets 15 ml (approximately 3 teaspoons) 2.5 or 3 tablets 20 ml (approximately 4 teaspoons) 4. Swirl or stir until the tablets disperse completely. 5. Consume the entire quantity immediately. The suspension is white coloured and has a strawberry flavour. 6. Rinse the container with an additional amount of water and consume the contents to assure that the whole dose is taken. Do not disperse Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg in any liquid other than water. No attempt should be made to administer partial quantities of the dispersed tablets. Children weighing 25 kg or more, adolescents and adults: For these patient groups other fixed-dose formulations with higher amounts of the active substances are available. Dose adjustments: If the dose of Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg needs to be reduced, or if it is necessary to stop treatment with one of the active substances in Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, then the treatment may be changed to separate preparations of each component. If one takes more Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg than one should If you accidentally give the child too much medicine you should tell your child s doctor, health care provider or pharmacist, or contact your nearest hospital emergency department for further advice. Take the tablet container with you so that you can easily describe what your child has taken. If you forget to give Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg If you forget to give a dose of your child s medicine, and notice this within 6 hours, give the missed dose as soon as possible. Give the next regular dose as scheduled. If you notice later, then simply give the normal dose to the child when the next one is due. Do not give a double dose to make up for the forgotten individual doses. If your child vomits less than 1 hour after taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, give him/her another tablet. You do not need to take another tablet if your child was sick more than 1 hour after taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg. If one stops taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg Because this medicine controls and does not cure your child s condition, the child will normally need to take it continuously. You should not stop treatment unless the doctor or health care provider tells you to. If you have any further questions on the use of this product, ask the prescribing doctor, health care provider or pharmacist. Page 6 of 10

7 4. POSSIBLE SIDE EFFECTS Like all medicines, Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg 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 Dispersible Tablets 30 mg / 60 mg, by other medicines being taken at the same time, or by the HIV disease. For this reason it is very important that you inform the doctor or health care provider about any changes in your child s health. Very common side effects These affect more than 1 in 10 people: headache feeling sick (nausea) Common side effects These affect 1 in 100 to 1 in 10 people: being sick (vomiting) diarrhoea stomach pains loss of appetite feeling dizzy tiredness, lack of energy fever (high temperature) general feeling of being unwell difficulty in sleeping (insomnia) muscle pain and discomfort joint pain cough irritated or runny nose skin rash hair loss (alopecia). Common side effects that might show up in blood tests are: a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia) an increase in the level of liver enzymes an increased amount of bilirubin (a substance produced in the liver). Uncommon side effects These may affect 1 in 1000 to 1 in 100 people: feeling breathless wind (flatulence) itching muscle weakness. An uncommon side effect that may show up in blood test is: decrease in the number of cell fragments involved in blood clotting (thrombocytopenia) or in all kinds of blood cells (pancytopenia). Page 7 of 10

8 Rare side effects These may affect 1 in to 1 in 1000 people: serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis) lactic acidosis (see below, Other possible side effects of combination therapy for HIV ) inflammation of the pancreas (pancreatitis) chest pain; damage to the heart muscle (cardiomyopathy) fits (convulsions) feeling depressed or anxious, not being able to concentrate, feeling drowsy indigestion, taste disturbance changes in the colour of your nails, skin or the skin inside your mouth a flu-like feeling chills and sweating tingling in the skin ( pins and needles ) arms and legs feeling weak muscle damage numbness needing to pass urine more often enlarged breasts in men. Rare side effects that may show up in blood tests are: an increase in an enzyme called amylase inability to produce new red blood cells (pure red cell aplasia). Very rare side effects These may affect fewer than 1 in people: blood tests showing an inability to produce new red and white blood cells (aplastic anaemia). Other possible side effects of combination therapy for HIV infection Combination therapy, including Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, may cause other conditions to develop during HIV treatment. Old infections may flare up. People with advanced HIV infection (AIDS) have a weakened immune system, and can harbour germs. When these people start treatment, they may find that infections they had caught in the past, flare up. This is probably caused by the body s immune system recovering and starting to fight these infections. If your child gets any symptoms of infection while taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg: Tell your doctor immediately. Don t give other medicines for the infection without your doctor s advice. Your child s body shape may change. People taking antiretroviral medicines for HIV may find that their body shape changes, because of changes in fat distribution: Fat may be lost from the legs, arms or face Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs Fatty lumps ( buffalo hump ) may appear on the back of the neck. It is not yet known what causes these changes, or if they have any long-term effects on your child s health. Tell your doctor if you notice changes in your child s body shape. Page 8 of 10

9 Lactic acidosis, a rare but serious side effect. Some people taking Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, or other medicines like it (NRTIs), develop a rare condition called lactic acidosis, together with an enlarged liver. Lactic acidosis is caused by a build-up of lactic acid in the body and usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs. Lactic acidosis is more likely to develop in people who have liver disease, or in very overweight people, especially women. Signs of lactic acidosis include: deep, rapid, difficult breathing drowsiness numbness or weakness in the limbs feeling sick (nausea), being sick (vomiting) stomach pain. During your treatment, your doctor will monitor your child for signs of lactic acidosis. If your child has any of the symptoms listed above, or any other symptoms that worry you: See your doctor as soon as possible. Your child may have problems with his/her bones. Some people taking combination therapy, including Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg, may develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition: if they have been taking combination therapy, including Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg for a long time if they are also taking anti-inflammatory medicines called corticosteroids if they drink alcohol if their immune system is very weak if they are overweight. Signs of osteonecrosis include: stiffness in the joints aches and pains (especially in the hip, knee or shoulder) difficulty moving. If you notice any of these symptoms, tell your doctor or health care provider. Other effects may show up in blood tests. Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg can also: increase levels of sugar and fats (triglycerides and cholesterol) in the blood reduce the effect of insulin (so if your child has diabetes, you may have to change the insulin dose to control your child s blood sugar). 4. HOW TO STORE LAMIVUDINE / ZIDOVUDINE DISPERSIBLE TABLETS 30 MG / 60 MG Keep out of the reach and sight of children. Do not store above 30 C. Store in the original container. Do not use Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg after the expiry date which is stated on the bottle label. The expiry date refers to the last day of that month Do not use Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg if you notice any change in the physical description of the tablet than what is mentioned below. Page 9 of 10

10 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. FURTHER INFORMATION What Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg contains - The active ingredients are lamivudine and zidovudine. - The other ingredients are microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, croscarmellose sodium, aspartame, magnesium stearate and strawberry flavour (containing natural flavours and maltodextrin) What Lamivudine / Zidovudine Dispersible Tablets 30 mg / 60 mg looks like and contents of the pack White to off-white, round, biconvex tablet debossed with "M" on one side of the tablet and a score-line on the other side, with "LZ" debossed to the left and "1" to the right of the score-line. The tablet can be divided into equal halves. The dispersible tablets are packaged in round wide mouth opaque white HDPE bottle with white opaque polypropylene screw cap, containing absorbent cotton. Pack size: 60 tablets. Supplier Mylan Laboratories Limited Plot No. 564/A/22, Road No.92, Jubilee Hills Hyderabad , Telangana, INDIA Tel No: imtiyaz.basade@mylan.in Manufacturer Mylan Laboratories Limited Plot No. H-12 & H-13 MIDC, Waluj Industrial Area Aurangabad Maharashtra State India Mylan Laboratories Limited Plot No. 11, 12 & 13 Indore special economic zone Phase-II, Sector-III Pithampur , Dist.-Dhar, M.P., India For any information about this medicinal product, please contact the local representative of the supplier. Mylan Laboratories Limited Plot No. 564/A/22, Road No.92, Jubilee Hills Hyderabad , Telangana, INDIA Tel No: imtiyaz.basade@mylan.in This leaflet was last approved in.. Section 6 updated: February 2018 Page 10 of 10

11 Detailed information on this medicine is available on the World Health Organization (WHO) web site: Page 11 of 10