• Package Leaflet – Information for the user Look out for infections. If you have advanced HIV infection 3. How to take Lamivudine/Tenofovir disoproxil Tenofovir disoproxil Lamivudine/Tenofovir disoproxil 300 mg/245 mg (AIDS) and have an infection, you may develop symptoms of Tablets Very common (may affect more than 1 in 10 people) film-coated tablets infection and inflammation or worsening of the symptoms of an • diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, existing infection once treatment with this medicine is started. rash, feeling weak Lamivudine/Tenofovir disoproxil Always take this medicine exactly as your doctor or pharmacist has These symptoms may indicate that your body’s improved told you. Check with your doctor or pharmacist if you are not sure. Tests may also show: Read all of this leaflet carefully before you start taking this immune system is fighting infection. Look out for signs of Always take the dose recommended by your doctor or health care • decreases in phosphate in the blood medicine because it contains important information for you. inflammation or infection soon after you start taking this provider. This is to make sure that your medicine is fully effective, Common (may affect up to 1 in 10 people) - Keep this leaflet. You may need to read it again. medicine. If you notice signs of inflammation or infection, tell and to reduce the risk of developing resistance to the treatment. Do • headache, stomach pain, feeling tired, feeling bloated, flatulence - If you have any further questions, ask your doctor, pharmacist or your doctor at once. nurse. not change the dose unless your doctor tells you to. Tests may also show: In addition to the opportunistic infections, autoimmune disorders - This medicine has been prescribed for you only. Do not pass it The recommended dose is: • liver problems (a condition that occurs when the immune system attacks healthy on to others. It may harm them, even if their signs of illness are Adults: 1 tablet each day with food (for example, a meal or a body tissue) may also occur after you start taking medicines for Uncommon (may affect up to 1 in 100 people) the same as yours. snack). the treatment of your HIV infection. Autoimmune disorders may • breakdown of muscle, muscle pain or weakness - If you get any side effects, talk to your doctor or pharmacist. occur many months after the start of treatment. If you notice any If you are an adult and have problems with your kidneys, your Tests may also show: This includes any possible side effects not listed in this leaflet. symptoms of infection or other symptoms such as muscle doctor may advise you to take this medicine less frequently. • decreases in potassium in the blood See section 4. weakness, weakness beginning in the hands and feet and moving Use in children and adolescents • increased creatinine in your blood What is in this leaflet up towards the trunk of the body, palpitations, tremor or Lamivudine/Tenofovir disoproxil Tablets is not for use in children • pancreas problems 1. What Lamivudine/Tenofovir disoproxil Tablets is and what it is and adolescents under 18 years. hyperactivity, please inform your doctor immediately to seek The breakdown of muscle, softening of the bones (with bone pain used for necessary treatment. If you take more Lamivudine/Tenofovir disoproxil Tablets and sometimes resulting in fractures), muscle pain, muscle 2. What you need to know before you take Lamivudine/Tenofovir • Talk to your doctor or pharmacist if you are over 65. This than you should weakness and decreases in potassium or phosphate in the blood disoproxil Tablets medicine has not been studied in patients over 65 years of age. If If you accidentally take too many this medicine, you may be at may occur due to damage to kidney tubule cells. 3. How to take Lamivudine/Tenofovir disoproxil Tablets you are older than this and are prescribed this medicine, your increased risk of experiencing possible side effects with this Rare (may affect up to 1 in 1,000 people) 4. Possible side effects doctor will monitor you carefully. medicine (see section 4, Possible side effects). Contact your doctor • pain in the tummy (abdomen) caused by inflammation of the 5. How to store Lamivudine/Tenofovir disoproxil Tablets • if you are seriously overweight (especially if you are a woman) or nearest emergency department for advice. Keep the tablet bottle liver 6. Contents of the pack and other information or pack with you so that you can easily describe what you have Protect other people • swelling of the face, lips, tongue or throat HIV infection is spread by sexual contact with someone who has taken. 1. What Lamivudine/Tenofovir disoproxil Tablets is Reporting of side effects the infection, or by transfer of infected blood (for example, by If you forget to take Lamivudine/Tenofovir disoproxil Tablets and what it is used for If you get any side effects, talk to your doctor or pharmacist. This sharing injection needles). You can still pass on HIV when taking If you forget to take a dose, take it as soon as you remember. Then includes any possible side effects not listed in this leaflet. You can this medicine, although the risk is lowered by effective Lamivudine/Tenofovir disoproxil Tablets contains two active continue your treatment as before. also report side effects directly via the national reporting system antiretroviral therapy. Discuss with your doctor the precautions substances lamivudine and tenofovir disoproxil. These active Do not take a double dose to make up for a forgotten dose. listed in Appendix V. By reporting side effects you can help needed to avoid infecting other people. substances are antiretroviral or antiviral medicines which are used If you have any further questions on the use of this medicine, ask provide more information on the safety of this medicine. Children and adolescents to treat HIV infection. Lamivudine is a nucleoside reverse your doctor or pharmacist. transcriptase inhibitor. Tenofovir is a nucleotide reverse Lamivudine/Tenofovir disoproxil Tablets is not for use in children 5. How to store Lamivudine/Tenofovir disoproxil transcriptase inhibitor. Both active substances interfere with and adolescents under 18 years. Ask your doctor or pharmacist for 4. Possible side effects Tablets enzymes used by HIV for making copies of itself and, by doing so, advice before taking this medicine. block the reproduction of the virus. Other medicines and Lamivudine/Tenofovir disoproxil Tablets During HIV therapy there may be an increase in weight and in • Keep this medicine out of the sight and reach of children. This medicine is a treatment for Human Immunodeficiency Virus Tell your doctor or pharmacist if you are taking, have recently levels of blood lipids and glucose. This is partly linked to restored • Do not use this medicine after the expiry date which is stated on (HIV) infection in adults over 18 years of age. taken or might take any other medicines. health and life style, and in the case of blood lipids sometimes to the bottle, label and carton after EXP. The expiry date refers to • Don’t stop any anti-HIV medicines prescribed by your doctor the last day of the month. Antiviral medicines used for HIV infection are known as the HIV medicines themselves. Your doctor will test for these when you start this medicine if you have both HBV and HIV. • Blister: This medicine does not require any special temperature antiretrovirals. To prevent the virus become resistant, this medicine changes. • Do not take this medicine if you are already taking other storage conditions. should always be given as part of antiretroviral combination Like all medicines, this medicine can cause side effects, although medicines containing tenofovir disoproxil, tenofovir alafenamide • HDPE bottles: This medicine does not require any special therapy when treating HIV. not everybody gets them. or lamivudine (used to treat HIV infection or hepatitis B temperature storage conditions. Store in the original bottle in This medicine is not a cure for HIV infection. While taking infection). Do not take this medicine together with medicines Some side effects may be serious. Tell your doctor straight order to protect from moisture. Keep the bottle tightly closed. Lamivudine/Tenofovir disoproxil Tablets you may still develop containing adefovir dipivoxil (a medicine used to treat chronic away if you get any of the following: • Do not throw away any medicines via wastewater or household infections or other illnesses associated with hepatitis B). Lamivudine waste. Ask your pharmacist how to throw away medicines you HIV infection. You can also pass on HIV to others, so it is • It is very important to tell your doctor if you are taking other Rare (may affect up to 1 in 1,000 people) no longer use. These measures will help protect the environment. important to take precautions to avoid infecting other people. medicines that may damage your kidneys. • serious allergic reaction causing swelling of the face, tongue or These include: throat which may cause difficulty in swallowing or breathing 6. Contents of the pack and other information 2. What you need to know before you take • aminoglycosides, pentamidine or vancomycin (for bacterial inflammation of the pancreas (pancreatitis) Lamivudine/Tenofovir disoproxil Tablets o infection), Very rare (may affect up to 1 in 10,000 people) What Lamivudine/Tenofovir disoproxil Tablet contains • lactic acidosis (excess lactic acid in the blood) • The active substances are lamivudine and tenofovir. Each o amphotericin B (for fungal infection), Do not take Lamivudine/Tenofovir disoproxil Tablets film-coated tablet contains 300 mg lamivudine and 300 mg o foscarnet, ganciclovir, or cidofovir (for viral infection), Tenofovir disoproxil • if you are allergic to lamivudine, tenofovir disoproxil or any of tenofovir disoproxil fumarate equivalent to 245 mg tenofovir o interleukin-2 (to treat cancer), Uncommon (may affect up to 1 in 100 people) the other ingredients of this medicine (listed in section 6).