Product Details

What you need to know before you take Tenofovir 245 mg film-coated tablets

DO NOT take Tenofovir 245 mg film-coated tablets • If you are allergic to tenofovir, tenofovir disoproxil succinate or any of the other ingredients of this medicine (listed in section 6). ➞ If this applies to you, tell your doctor immediately and don’t take Tenofovir 245 mg film-coated tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir 245 mg film-coated tablets. • Tenofovir 245 mg film-coated tablets do not reduce the risk of passing on HBV to others through sexual contact or blood contamination. You must continue to take precautions to avoid this. • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys. Tenofovir 245 mg film-coated tablets should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may order blood tests to assess your kidney function. Tenofovir 245 mg filmcoated tablets may affect your kidneys during treatment. Your doctor may order blood tests during treatment to monitor how your kidneys work. If you are an adult, your doctor may advise you to take the tablets less often. Do not reduce the prescribed dose, unless your doctor has told you to do so. Tenofovir 245 mg film-coated tablets are not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir 245 mg film-coated tablets). If this is unavoidable, your doctor will monitor your kidney function once a week. • Bone problems. Some adult patients with HIV 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 tell your doctor. Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures. Tenofovir disopraxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor. Overall, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adult and paediatric patients are uncertain. Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk for fractures. • Talk to your doctor if you have a history of liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function. • Look out for infections. If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with tenofovir is started. These symptoms may indicate that your body’s improved immune system is fighting infection. Look out for signs of inflammation or infection soon after you start taking Tenofovir 245 mg film-coated tablets. If you notice signs of inflammation or infection, tell your doctor at once. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many 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, please inform your doctor immediately to seek necessary treatment. • Talk to your doctor or pharmacist if you are over 65. Tenofovir has not been studied in patients over 65 years of age. If you are older than this and are prescribed Tenofovir 245 mg film-coated tablets, your doctor will monitor you carefully. Children and adolescents Tenofovir 245 mg tablets are suitable for: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects. • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg. Tenofovir 245 mg tablets are not suitable for the following groups: • Not for HIV-1 infected children under 12 years of age • Not for HBV infected children under 12 years of age. For dosage see section 3, How to take Tenofovir 245 mg film-coated tablets. Other medicines and Tenofovir 245 mg filmcoated tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. • Don’t stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir 245 mg film-coated tablets if you have both HBV and HIV. • Do not take Tenofovir 245 mg film-coated tablets if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir 245 mg film-coated tablets together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B). • It is very important to tell your doctor if you are taking other medicines that may damage your kidneys. These include: – aminoglycosides, pentamidine or vancomycin (for bacterial infection), – amphotericin B (for fungal infection), – foscarnet, ganciclovir, or cidofovir (for viral infection), – interleukin-2 (to treat cancer), – adefovir dipivoxil (for HBV), – tacrolimus (for suppression of the immune system), – non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains). • Other medicines containing didanosine (for HIV infection): Taking Tenofovir 245 mg filmcoated tablets with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine. • It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/ velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir to treat hepatitis C infection. Tenofovir 245 mg film-coated tablets with food and drink Take Tenofovir 245 mg film-coated tablets with food (for example, a meal or a snack). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. • If you have taken Tenofovir 245 mg filmcoated tablets during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. 92877482308 GB P18-0791R245/31B 005115 P18-0791R245/31B 005115 In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects. • If you are a mother with HBV, and your baby has been given treatment to prevent hepatitis B transmission at birth, you may be able to breast-feed your infant, but first talk to your doctor to get more information. • Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breastfeeding, you should discuss it with your doctor as soon as possible. Driving and using machines Tenofovir 245 mg film-coated tablets can cause dizziness. If you feel dizzy while taking this medicine, do not drive or ride a bicycle and do not use any tools or machines. Tenofovir 245 mg film-coated tablets contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Tenofovir 245 mg film-coated tablets contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.