245 mg film-coated tablets
tenofovir disoproxil
What Tenofovir disoproxil Mylan is and what it is used for
Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral drug 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 HIV should Tenofovir disoproxil Mylan always be taken in combination with other medicines against HIV?
Tenofovir disoproxil Mylan 245 mg tablets is a treatment for HIV (human immunodeficiency virus ) infection. The tablets are suitable for:
- adults
- young people aged 12 to younger than 18 years 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 Mylan 245 mg tablets are 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 Mylan for HBV.
This medicine does not cure HIV infection. While taking Tenofovir disoproxil Mylan, 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.
What you need to know before you take Tenofovir disoproxil Mylan
Do not take Tenofovir disoproxil Mylan
- 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 Mylan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil Mylan.
- Be careful not to infect other people. You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment. Discuss with your doctor the necessary measures to avoid infecting others. Tenofovir disoproxil Mylan 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 Mylan 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 Mylan 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 Mylan is usually not taken together with other medicines that can damage the kidneys (see Other medicines and Tenofovir disoproxil Mylan ). 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.
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 child’s doctor if your child has 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 child’s doctor if 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 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 Mylan is started. These symptoms may indicate that your body’s improved immune system is fighting infection. Watch for signs of inflammation or infection during the first period after you start taking Tenofovir disoproxil Mylan. 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 occur several months after starting treatment. 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 Mylan has not been studied in patients over 65 years of age. If you are older than that and have been prescribed Tenofovir disoproxil Mylan, your doctor will monitor you closely.
Children and young people
Tenofovir disoproxil Mylan 245 mg tablets are 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 drugs that no longer have the full effect due to the development of resistance or have caused side effects.
- HBV‑infected young people aged 12 years to younger than 18 years who weigh at least 35 kg.
Tenofovir disoproxil Mylan 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 disoproxil Mylan.
Other medicines and Tenofovir disoproxil Mylan
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 Mylan if you have both HBV and HIV.
- Do not take Tenofovir disoproxil Mylan if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Mylan 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 the treatment of cancer),
- adefovir dipivoxil (for HBV),
- tacrolimus (for suppressing 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 Mylan 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 Mylan with food and drink
Take Tenofovir disoproxil Mylan with food (eg a meal or a snack).
Pregnancy and breastfeeding
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.
- Try to avoid becoming pregnant while being treated with Tenofovir disoproxil Mylan. You must use an effective method of birth control to avoid pregnancy.
- If you have taken Tenofovir disoproxil Mylan during your pregnancy, the doctor may request that the baby regularly give blood samples and undergo other examinations to check the baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV is greater than the risk of side effects.
- 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 first talk to your doctor for more information.
- If you are an HIV -infected mother, you should not breastfeed your infant to avoid transmission of the virus to the baby through breast milk.
Driving ability and use of machinery
Tenofovir disoproxil Mylan may cause dizziness. Do not drive or cycle or use tools or machines if you feel dizzy while taking Tenofovir disoproxil Mylan.
Tenofovir disoproxil Mylan contains lactose
Talk to your doctor before taking Tenofovir disoproxil Mylan. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Tenofovir disoproxil Mylan
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 medicine 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 Mylan 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.
- Other formulations of this medicine may be more suitable for patients who have difficulty swallowing. Ask the doctor or pharmacist.
If you have taken too much Tenofovir disoproxil Mylan
If you accidentally take too many Tenofovir disoproxil Mylan tablets, you may be at risk of possible side effects from this medicine (see section 4, Possible side effects ). Contact your doctor or nearest emergency department for advice. Save the jar so you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil Mylan
You mustn’t miss a dose of Tenofovir disoproxil Mylan. 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 less than 1 hour after a dose of Tenofovir disoproxil Mylan, take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Mylan
If you stop taking Tenofovir disoproxil Mylan
Do not stop taking Tenofovir disoproxil Mylan without talking to your doctor. Discontinuing treatment with Tenofovir disoproxil Mylan 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, you mustn’t stop Tenofovir disoproxil Mylan treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened when treatment with Tenofovir disoproxil Mylan has stopped. 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 Mylan for any reason, especially if you experience any side effects or have another illness.
- Inform your doctor immediately of any new and unexpected symptoms that appear after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.
- Talk to your doctor before you start taking Tenofovir disoproxil Mylan 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 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 patients) 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 are
The following side effects are less common (they may affect up to 1 in 100 patients):
- pain in the stomach (abdomen) caused by inflammation of the pancreas
- damage to the kidney (renal tubule cells)
The following side effects are rare (these may occur in up to 1 in 1,000 patients):
- 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 (which causes bone pain and sometimes leads to fractures ), which can occur due to damage to kidney 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 ( side effects occurring in more than 10 out of 100 patients):
- diarrhea, vomiting, nausea, dizziness, skin rash, feeling weak
Samples may also show:
- lowering of the phosphate level in the blood
Other possible side effects are
The following side effects are common ( side effects occurring in up to 10 out of 100 patients):
- headache, stomach (abdominal) pain, feeling tired, feeling bloated, flatulence
Samples may also show:
- liver problems
The following side effects are less common ( side effects occurring in up to 1 in 100 patients):
- 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 fractures ), 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 ( side effects occurring in up to 1 in 1,000 patients):
- pain in the stomach (abdomen) caused by inflammation of the liver
- swelling of the face, lips, tongue, or throat
How to store Tenofovir disoproxil Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after (EXP). The expiration date is the last day of the specified month.
Store at a maximum of 25°C. Store in the original packaging. Light sensitive. Moisture sensitive.
For cans: Use within 90 days of the first opening.
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 Tenofovir disoproxil Mylan tablet contains 245 mg of tenofovir disoproxil.
- Other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2, Tenofovir disoproxil Mylan contains lactose ), hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine (E132).
Appearance and package sizes of the medicine
Tenofovir disoproxil Mylan 245 mg are light blue, round, biconvex film-coated tablets marked with “TN245” on one side and “M” on the other side.
This medicine is available in plastic jars with a child-resistant closure and cotton swabs containing 30 film-coated tablets and in multipacks of 90 film-coated tablets divided into 3 jars, each of which contains 30 film-coated tablets. The cans also contain a desiccant. The desiccant must not be ingested.
The tablets are also available in blister packs containing 10, 30, or 30 × 1 (single-dose) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft
Mylan utca 1,
Komarom, H-2900,
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg CEO Hoehe
Benzstrasse 1
Bad Homburg CEO Hoehe
Hesse, 61352
Germany