245 mg film-coated tablets
tenofovir disoproxil
What Tenofovir disoproxil Sandoz is and what it is used for
Tenofovir disoproxil Sandoz contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine used to treat HIV or HBV infection or both. Tenofovir is a reverse transcriptase inhibitor of the nucleotide type, generally called an NRTI, and works by affecting the normal function of enzymes (in the case of HIV reverse transcriptase; in the case of HBV DNA polymerase ) that the virus needs for its reproduction (propagation). In the case of HIV , Tenofovir disoproxil Sandoz should always be taken in combination with other medicines against HIV .
Tenofovir disoproxil Sandoz is a treatment for HIV (human immunodeficiency virus) infection. The tablets are suitable for:
- adults
- young people aged 12 to younger than 18 who have already been treated with other HIV drugs that no longer have a satisfactory effect due to the development of resistance or have caused side effects.
Tenofovir disoproxil Sandoz is also used as a treatment for chronic hepatitis B, infection with HBV ( hepatitis B virus ). The tablets are suitable for:
- adults
- young people aged 12 to younger than 18 years.
You do not need to have HIV to be treated with Tenofovir disoproxil Sandoz for HBV.
This medicine does not cure HIV infection. While taking Tenofovir disoproxil Sandoz, you may still develop an infection or other diseases associated with HIV infection. You can also pass HIV or HBV on to others, so you must take precautions to avoid infecting other people.
Tenofovir disoproxil contained in Tenofovir disoproxil Sandoz may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you take Tenofovir disoproxil Sandoz
Do not take Tenofovir disoproxil Sandoz
- if you are allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
If this applies to you, tell your doctor immediately and stop taking Tenofovir disoproxil, Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil, Sandoz.
- Be careful not to infect other people. You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiretroviral treatment. Discuss with your doctor the necessary measures to avoid infecting others. Tenofovir disoproxil Sandoz does not reduce the risk of transmitting HBV to others through sexual contact or blood infection. You still need to take precautions to avoid this.
- Talk to your doctor or pharmacist if you have had kidney disease in the past or if tests have shown that you have problems with your kidneys. Tenofovir disoproxil Sandoz should not be given to adolescents with kidney problems. Before starting the treatment, your doctor may order some blood tests to assess that your kidneys are working normally. Tenofovir disoproxil Sandoz may affect your kidneys during treatment. Your doctor may order blood tests during treatment to check how your kidneys are working. If you are an adult, your doctor may advise you to take the tablets less often. Do not reduce the prescribed dose by one unless your doctor has told you to do so.
Tenofovir disoproxil Sandoz is usually not taken together with other medicines that can damage the kidneys (see Other medicines and Tenofovir disoproxil, Sandoz ). If this cannot be avoided, your doctor will check your kidney function once a week.
- Skeletal problems. Some adult patients with HIV receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to loss of blood supply to the bone). Some of the many risk factors for developing the disease are long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe impairment of the immune system, and higher body mass index. Signs of osteonecrosis are joint stiffness and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
For adult and young patients: Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures ) may also occur due to damage to renal tubule cells (see section 4, Possible side effects ). Tell your doctor if you have bone pain or a fracture. Tenofovir disoproxil can also cause loss of bone mass. The most pronounced loss of bone mass was seen in clinical trials 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 adults and children are uncertain. Tell your doctor or your child’s doctor if you know you or your child has osteoporosis. Patients with osteoporosis are at higher risk of fracture . - Inform your doctor if you already have or have had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you. If you have or have had liver disease or chronic hepatitis B, your doctor may take blood tests to check liver function.
- Be observant about infection . If you have advanced stage HIV infection ( AIDS ) and have an infection, you may develop symptoms of infection and inflammation or worsening of symptoms of an existing infection when treatment with Tenofovir disoproxil Sandoz is started. These symptoms may indicate that your body’s improved immune system is fighting an infection . Watch for signs of inflammation or infection during the first period after you start taking Tenofovir disoproxil Sandoz. If you detect signs of inflammationor infection , you should immediately inform your doctor.
In addition to opportunistic infections , autoimmune disorders (conditions where the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection . Autoimmune disorders may occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands or feet and moves to the trunk, palpitations, tremors or hyperactivity, inform your doctor immediately to get the necessary treatment. - Talk to your doctor or pharmacist if you are over 65. Tenofovir disoproxil Sandoz has not been studied in patients over 65 years of age. If you are older than this and have been prescribed Tenofovir disoproxil Sandoz, your doctor will monitor you closely.
Children and young people
Tenofovir disoproxil Sandoz is suitable for:
- HIV -1-infected young people aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines that no longer have a satisfactory effect due to the development of resistance or have caused side effects .
- HBV-infected adolescents aged 12 years to younger than 18 years who weigh at least 35 kg .
Tenofovir disoproxil Sandoz is 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 disoproxil Sandoz.
Other medicines and Tenofovir disoproxil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Do not stop taking any anti- HIV medicine prescribed by your doctor when you start taking Tenofovir disoproxil Sandoz, if you have both HBV and HIV .
- Do not take Tenofovir disoproxil Sandoz if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Sandoz together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
- It is very important that you tell your doctor if you are taking other medicines that can damage your kidneys.
Such drugs are:
- aminoglycosides , pentamidine or vancomycin (against bacterial infection )
- amphotericin B (for fungal infection)
- foscarnet, ganciclovir or cidofovir (for viral infection)
- interleukin-2 (for treating cancer)
- adefovir dipivoxil (for HBV)
- tacrolimus (for suppression of the immune system)
- non-steroidal anti-inflammatory drugs ( NSAIDs , to relieve bone or muscle pain).
- Other medicines containing didanosine (for HIV infection ): If you take Tenofovir disoproxil Sandoz together with other antiviral medicines containing didanosine, the blood levels of didanosine may increase and the CD4 cell count may decrease. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases with a fatal outcome, have been reported during concomitant treatment with medicines containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether you can be treated with a combination of tenofovir and didanosine.
- It is also important that you tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection .
Tenofovir disoproxil Sandoz with food and drink
Take Tenofovir disoproxil Sandoz with food (eg a meal or a snack).
Pregnancy and breastfeeding
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 using this medicine.
- If you are pregnant, you must not take Tenofovir disoproxil Sandoz until you have specifically discussed this with your doctor. Although there are limited clinical data on the use of Tenofovir disoproxil Sandoz during pregnancy, it is usually not used unless absolutely necessary.
- If you become or are planning to become pregnant , you must contact your doctor to discuss the potential benefits and risks of your antiretroviral treatment for you and your baby.
- If you have taken Tenofovir disoproxil Sandoz during your pregnancy, the doctor may request that you regularly submit blood samples and undergo other diagnostic tests to check the baby’s development. For children of a mother who took NRTIs during pregnancy, the benefit of protection against HIV is greater than the risk of side effects .
For adult patients:
- If you are a mother and you have HBV and your baby has received treatment to prevent the transmission of hepatitis B at birth, you may be able to breastfeed your baby, but talk to your doctor first for more information.
- If you are an HIV -infected mother , you should not breastfeed your baby to avoid transmission of the virus et to the baby through the breast milk.
For young patients:
- If your baby has HBV and her baby has received treatment to prevent transmission of hepatitis B at birth, your baby may be able to breastfeed, but talk to your baby’s doctor first for more information.
- If your child has HIV , she should not breastfeed to avoid transmission of the virus to the child through breast milk.
Driving ability and use of machinery
Tenofovir disoproxil Sandoz may cause dizziness. Do not drive or cycle or use tools or machines if you feel dizzy while taking Tenofovir disoproxil Sandoz.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tenofovir disoproxil Sandoz contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tenofovir disoproxil Sandoz
Always take this medicine as directed by your doctor or pharmacist . Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
- Adults: 1 tablet a day with food (e.g. a meal or a snack).
- Adolescents aged 12 to less than 18 years weighing at least 35 kg: 1 tablet a day with food (eg a meal or a snack).
If you have particular difficulty swallowing, you can crush the tablet with the tip of a spoon. Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately.
- Always take the dose prescribed by the doctor to ensure that the treatment is effective and to reduce the development of resistance to the treatment. Do not change the dose unless your doctor tells you to.
- If you are an adult and have kidney problems, your doctor may advise you to take Tenofovir disoproxil Sandoz less often.
- If you have HBV, your doctor may offer you an HIV test to see if you have both HBV and HIV .
Read the package leaflets of the other antiretroviral medicines for information on how to take these medicines.
If you have taken too much Tenofovir disoproxil Sandoz
If you accidentally take too many Tenofovir disoproxil Sandoz tablets, you may have a higher risk of possible side effects from this medicine (see section 4, Possible side effects ) .
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medicine packaging with you to be able to more easily describe what you have taken.
If you forget to take Tenofovir disoproxil Sandoz
It is important that you do not miss a dose of Tenofovir disoproxil Sandoz. If you miss a dose , work out when you should have taken it.
- If it is less than 12 hours after the time it is usually taken, take it as soon as possible, then take the next dose at its regular time.
- If it has been more than 12 hours since you should have taken it, do not take the missed dose . Wait and take the next dose at its regular time. Do not take a double dose to make up for a missed tablet.
If you vomit within less than 1 hour after a dose of Tenofovir disoproxil Sandoz , take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Sandoz.
If you stop taking Tenofovir disoproxil Sandoz
Do not stop taking Tenofovir disoproxil without consulting a doctor. Discontinuing treatment with Tenofovir disoproxil Sandoz may result in a reduced effect of the treatment recommended by your doctor.
If you have hepatitis B or HIV infection and hepatitis B infection at the same time, it is very important that you do not stop treatment with Tenofovir disoproxil Sandoz without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened after stopping treatment with this medicine. You may need to provide blood samples for several months after the end of treatment. In patients with advanced liver disease or cirrhosis , discontinuation of treatment is not recommended as this may lead to a worsening of the hepatitis infection in some patients.
- Talk to your doctor before you stop taking Tenofovir disoproxil Sandoz for any reason, especially if you experience any side effects or have another illness.
- Tell your doctor immediately about any new and unexpected symptoms that appear after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection .
- Contact your doctor before you start taking Tenofovir disoproxil Sandoz again.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids there can sometimes be a connection with the HIV drugs. The doctor will do tests to find such changes.
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Any serious side effects: inform your doctor immediately
- lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 users) but serious side effect that can be fatal. The following side effects can be signs of lactic acidosis:
- deep, rapid breathing
- drowsiness
- nausea, vomiting and abdominal pain.
If you think you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effects ar
The following side effects are less common (may affect up to 1 in 100 users):
- pain in the stomach (abdomen) caused by inflammation of the pancreas
- damage to the kidney (renal tubule cells).
The following side effects are rare (may affect up to 1 in 1,000 users):
- kidney inflammation, that you urinate a lot and that you feel thirsty
- changes in urine and back pain caused by kidney problems, including kidney failure
- decreased bone hardness (causing bone pain and sometimes leading to fractures ), which may occur due to damage to renal tubule cells
- fatty liver .
If you think you may have any of these serious side effects , talk to your doctor.
The most common side effects
The following side effects are very common (may affect more than 1 in 10 users):
- diarrhoea, vomiting, nausea, dizziness, skin rash, feeling weak.
Samples may also show:
- lowering of the phosphate level in the blood.
Other possible side effects ar
The following side effects are common (may affect up to 1 in 10 users):
- headache, stomach pain, feeling tired, feeling bloated, flatulence.
Samples may also show:
- liver problems.
The following side effects are less common (may affect up to 1 in 100 users):
- muscle breakdown, muscle pain or muscle weakness.
Samples may also show:
- lowered potassium levels in the blood
- increased creatinine level in the blood
- pancreatic disorders.
The breakdown of muscles, decreased bone hardness (which causes bone pain and sometimes leads to fracture ), muscle pain, muscle weakness and lowered potassium or phosphate levels in the blood can occur due to damage to kidney tubule cells.
The following side effects are rare (may affect up to 1 in 1,000 users):
- pain in the stomach (abdomen) caused by inflammation of the liver
- swelling of the face, lips, tongue or throat.
How to store Tenofovir disoproxil Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can, carton or blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Opened can must be used within 30 days.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tenofovir disoproxil. Each film-coated tablet contains 245 mg tenofovir disoproxil.
- Other ingredients are:Tablet core: microcrystalline cellulose, lactose monohydrate , pregelatinized corn starch, crospovidone (type B), magnesium stearate.Film coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80.
See section 2 “Tenofovir disoproxil Sandoz contains lactose”.
Appearance and package sizes of the medicine
White, almond-shaped, biconvex film-coated tablets with dimensions 16 mm x 10 mm, marked on one side with “H” and on the other side with “T11”.
OPA-Al-PVC/Al single-dose blister packs.
Pack sizes: 30×1, 60×1 and 90×1 film-coated tablets.
White, opaque HDPE jar with white, opaque, child-resistant polypropylene screw cap. The jar contains desiccant (silica gel capsule) and purified rayon.
Pack sizes: 30, 60 (2×30) and 90 (3×30) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Pharmadox Ltd., KW20A Kordin Industrial Park, Paola PLA 3000, Malta