245 mg film-coated tablets
tenofovir disoproxil
What Tenofovir disoproxil Teva is and what it is used for
Tenofovir disoproxil Teva 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 nucleotide-type reverse transcriptase inhibitor, commonly called an NRTI drug, and it 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). When treating HIV should Tenofovir disoproxil Teva always is taken in combination with other medicines against HIV?
Tenofovir disoproxil Teva is intended for the treatment of HIV (human immunodeficiency virus) infection. The tablets are suitable for:
- adults
- young people aged 12 to 18 years who have already been treated with other HIV medicines which no longer have a satisfactory effect due to the development of resistance or which have caused side effects.
Tenofovir disoproxil Teva is also intended for the treatment of chronic hepatitis B, i.e. an infection caused by HBV ( hepatitis B virus ). The tablets are suitable for:
- adults
- young people aged 12 to 18 years.
You do not need to have HIV to be treated with Tenofovir disoproxil Teva for HBV.
This medicine does not cure HIV infection. While taking Tenofovir disoproxil Teva 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 Teva may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before you use Tenofovir disoproxil Teva
Do not use Tenofovir disoproxil Teva
- 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 Teva.
Warnings and precautions
Talk to your doctor or pharmacist before using Tenofovir disoproxil Teva.
- 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 the necessary measures to avoid infecting others with your doctor. Tenofovir disoproxil Teva 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 Teva should not be given to adolescents with kidney problems. Before starting treatment, your doctor may order some blood tests to assess whether your kidneys are working normally. Tenofovir disoproxil Teva 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 Teva is usually not taken together with other medicines that can damage the kidneys (see Other medicines and Tenofovir disoproxil Teva ). If this cannot be avoided, your doctor will have your kidney function checked once a week. - Skeletal problems. Some adult patients with HIV receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue 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 a high body mass index. Signs of osteonecrosis are joint stiffness, aches, and pains (especially in the hips, knees, and shoulders), and difficulty moving. Tell your doctor if you experience any of these symptoms.
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 or your child’s doctor if you or your child 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 or your child’s doctor if you know you or your child suffers from osteoporosis. Patients with osteoporosis are at higher risk of fracture. - Inform the doctor if you already have or have had any 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 any 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 symptoms of an existing infection when treatment with Tenofovir disoproxil Teva 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 Teva. If you detect signs of inflammation or 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 appear several months after treatment has begun. If you notice any symptoms of infection or other symptoms such as muscle weakness, a 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 Teva has not been studied in patients over 65 years of age. If you are older than that and have been prescribed Tenofovir disoproxil Teva, your doctor will closely monitor your treatment.
Children and young people
Tenofovir disoproxil Teva tablets are suitable for:
- HIV -1-infected young people aged 12 to 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which no longer have a satisfactory effect due to the development of resistance or which have caused side effects.
- HBV-infected young people aged 12 years up to 18 years who weigh at least 35 kg.
Tenofovir disoproxil Teva tablets are not suitable for the following groups:
- HIV -1-infected children under 12 years of age
- HBV-infected children under 12 years of age.
For dosage, see section 3, How to use Tenofovir disoproxil Teva.
Other medicines and Tenofovir disoproxil Teva
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Do not stop taking any anti-HIV medicine prescribed by your doctor when you start taking Tenofovir disoproxil Teva if you have both HBV and HIV.
Do not take Tenofovir disoproxil Teva if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Teva with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
You must tell your doctor if you are taking other medicines that can damage your kidneys.
Such drugs are:
- aminoglycosides, pentamidine, or vancomycin (against a bacterial infection )
- amphotericin B (for fungal infection)
- foscarnet, ganciclovir, or cidofovir (for viral infection)
- interleukin-2 (for treating cancer)
- adefovir dipivoxil (for HBV)
- tacrolimus (drugs that suppress the immune system)
- non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve bone or muscle pain).
- Medicines containing didanosine (against HIV infection ). If you take Tenofovir disoproxil Teva together with 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/voxilprevir to treat hepatitis C infection .
Tenofovir disoproxil Teva with food, drink, and alcohol
Take Tenofovir disoproxil Teva with food (eg a meal or a snack).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 have been taking Tenofovir disoproxil Teva during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check the baby’s development. For children of a mother who took NRTI drugs 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 infant. This is to avoid transmission of the virus et to the child through breast milk.
Children and young people:
- 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 her baby but talk to your baby’s doctor first for more information.
- If your child has HIV, she should not breastfeed her infant to avoid transmission of the virus et to the baby through breast milk.
Driving ability and use of machinery
Tenofovir disoproxil Teva may cause dizziness. Do not drive, cycle or use tools or machines if you feel dizzy while taking Tenofovir disoproxil Teva.
You 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. A 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 Teva contains lactose and sodium
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) per dose, i.e. is almost sodium-free.
How to use Tenofovir disoproxil Teva
Always use 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 years up to 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 your doctor to ensure that the drug treatment is effective and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to do so.
- If you are an adult and have kidney problems, your doctor may advise you to take Tenofovir disoproxil Teva 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 used too much Tenofovir disoproxil Teva
- If you accidentally take too many Tenofovir disoproxil Teva tablets, you may be at 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 medication packaging with you to the reception so that the healthcare staff can easily see which medication you have taken.
If you forget to use Tenofovir disoproxil Teva
You mustn’t miss a dose of Tenofovir disoproxil Teva. If you miss a dose, calculate how long it has been since you should have taken it.
- If it is less than 12 hours after the time the medicine is usually taken, take the missed dose as soon as possible, and then take the next dose at its regular time.
- If more than 12 hours have passed since you should have taken your dose, 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 taking a dose of Tenofovir disoproxil Teva; take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Teva.
If you stop using Tenofovir disoproxil Teva
Do not stop using Tenofovir disoproxil Teva without first talking to your doctor. Stopping treatment with Tenofovir disoproxil Teva may result in a reduced effect of the treatment recommended by your doctor.
If you have hepatitis B or a simultaneous HIV and hepatitis B infection, you mustn’t stop Tenofovir disoproxil Teva treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened after stopping treatment with Tenofovir disoproxil Teva. You may need to provide blood samples for several months after the end of treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to a worsening of your hepatitis infection.
- Talk to your doctor before you stop taking Tenofovir disoproxil Teva for any reason, especially if you experience any side effects or have another illness.
- Immediately inform the doctor of any new or unexpected symptoms that appear after stopping treatment; especially symptoms that you usually associate with your hepatitis B infection.
- Consult a doctor before you start using Tenofovir disoproxil Teva again.
If you have further questions about this medicine, contact 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 HIV drugs. Your 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
- deep, rapid breathing
- drowsiness
- nausea, vomiting, and abdominal pain.
- If you think you may have lactic acidosis, you should immediately contact a doctor.
Other possible serious side effects are
The following side effects are less common (may affect up to 1 in 100 users):
- pain in the stomach
- damage to the kidney (renal tubule cells)
The following side effects are rare (may affect up to 1 in 1,000 patients):
- kidney inflammation, that you urinate a lot and 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 the kidney (to the renal tubule cells).
- fatty liver
- If you think you may have any of the serious side effects mentioned above, talk to your doctor.
The most common side effects
The following side effects are very common (may affect more than 1 in 10 users):
- diarrhea, vomiting, nausea, dizziness, skin rash, feeling weak
Test results can also indicate:
- lowered phosphate level in the blood
Other possible side effects are
The following side effects are common (may affect up to 1 in 10 users):
- headache, stomach pain, feeling tired, feeling bloated, flatulence
Test results can also indicate:
- liver problems
The following side effects are less common (may affect up to 1 in 100 users):
- muscle breakdown, muscle pain, or muscle weakness
Test results can also indicate:
- lowered potassium levels in the blood
- increased creatinine level in the blood
- pancreatic disorders
The breakdown of muscles, reduced bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and lowered potassium or phosphate levels in the blood can occur due to damage to the kidney (to the 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 Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister, can, or carton after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the 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. Each tablet contains tenofovir disoproxil phosphate in an amount equivalent to 245 mg of tenofovir disoproxil.
- Other) ingredients are:
- Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, hydrogenated vegetable oil, and sodium lauryl sulfate.
- Film coating: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminum lake (E132), carminic acid (E120).
See also section 2. “Tenofovir disoproxil Teva contains lactose”.
Appearance and package sizes of the medicine
Tenofovir disoproxil Teva film-coated tablets are light blue to blue, oval tablets, 16.6 mm long and 8.9 mm wide, marked with “T” on one side of the tablet and unmarked on the other side.
Tenofovir disoproxil Teva film-coated tablets are available in blister packs of 30 or 90 tablets, in single-dose blisters of 30×1 and 90×1 tablets, and in hospital packs of 10×1 tablets, as well as in packs of tablet jars with 30 or 90 tablets (3×30). The tablet jars contain one or two containers of desiccant (silica gel). These containers must not be swallowed.
Not all pack sizes may be marketed.