Tenofovir Disoproxil 30 tablets

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 agent or an antiviral medicine that is used to treat HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, and acts as an inhibitor of the normal functioning of enzymes (HIV reverse transcriptase, hepatitis B DNA polymerase) that are essential for self-replication of viruses. In HIV Tenofovir disoproxil Mylan should always be used with other medicines to treat HIV infection.

Tenofovir disoproxil Mylan 245 mg tablets are used to treat HIV infection (human immunodeficiency virus). The tablets are suitable for:

adults;
adolescents aged 12 to under 18 years previously treated with other HIV medicines that are not already fully effective due to resistance development or have led to side effects.
Tenofovir disoproxil Mylan 245 mg tablets are also used for the treatment of chronic hepatitis B infection with hepatitis B virus (CBV). The tablets are suitable for:
adults;
adolescents aged 12 to under 18.

You should not have HIV to be treated with tenofovir disoproxil Mylan for HBV.
This drug does not cure HIV infection. While you are taking Tenofovir disoproxil Mylan you may still develop infections or other illnesses associated with HIV infection. It is possible to pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.

2. 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 do not take Tenofovir disoproxil Mylan.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil Mylan.

Be careful not to infect other people. When you are taking this medicine, you can still pass HIV even though the risk is reduced by effective antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid infecting other people. Tenofovir disoproxil Mylan does not reduce the risk of transmission of HBV to others through sexual contact or blood circulation. You must continue to take appropriate precautions to avoid this;
Talk to your doctor or pharmacist if you have or have kidney disease, or if studies have shown problems with your kidneys. Tenofovir disoproxil Mylan should not be given to adolescents with kidney problems. Before you start treatment, your doctor may appoint blood tests to evaluate your kidney activity. Tenofovir disoproxil Mylan may affect your kidneys during treatment. Your doctor may appoint blood tests during your treatment to monitor how your kidneys work. If you are an adult, your doctor may advise you to take your tablets less often. Do not reduce your prescribed dose unless your doctor tells you to do so;
Typically, Tenofovir disoproxil Mylan is not taken together with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan). If this is unavoidable, your doctor will monitor your kidneys once a week.

Bone problems. In some adult HIV patients who are receiving combination antiretroviral therapy, a bone disease called osteonecrosis (bone tissue dies due to interruption of blood flow to the bone) may develop. The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and higher body mass index may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, joint pain (especially in the hip, knee and shoulder) and difficulty in movement. If you notice any of these signs, please tell your doctor;
Bone problems (sometimes leading to fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects);

Talk to your doctor if you have had or have a liver disease, including hepatitis. The risk of severe and potentially fatal liver complications is increased in patients with hepatic disease, including chronic hepatitis B or C, treated with antiretroviral drugs. If you have a hepatitis B infection, your doctor will carefully evaluate what is the best treatment for you. If you have, or have a liver disease or chronic hepatitis B infection, your doctor may
Talk to your doctor or pharmacist if you are over 65 years old. Tenofovir disoproxil Mylan has not been studied in patients over 65 years of age. If you are older and have been prescribed Tenofovir disoproxil Mylan, your doctor will monitor your condition carefully.
Children and adolescents
Tenofovir disoproxil Mylan 245 mg tablets are suitable for:

HIV-1 adolescents aged 12 to under 18 years of age, weighing at least 35 kg, who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development or have led to adverse reactions;
HBV infected adolescents aged 12 to under 18 years of age, weighing at least 35 kg.
Tenofovir disoproxil Mylan 245 mg tablets are not suitable for the following groups:

For children not infected with HIV-1 under 12 years of age;
For children not infected with HBV under 12 years of age.
For dosing, 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 other anti-HIV medicines 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. Do not take Tenofovir disoproxil Mylan concomitantly 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 can damage your kidneys. They include:
aminoglycosides, pentamidine or vancomycin (for bacterial infections);
amphotericin B (for fungal infections);
foscarnet, ganciclovir or cidofovir (for viral infections);
interleukin-2 (for cancer treatment);
adefovir dipivoxil (for HBV);
tacrolimus (to suppress the immune system);
non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone and muscle pain).
Other medications containing didanosine (for HIV infection): Taking Tenofovir disoproxil Mylan with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and may decrease the number of CD4 cells. There have been rare reports of inflammation of the pancreas and lactic acidosis (excess of lactic acid in the blood), which sometimes caused death when taking medicines containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether to treat you with a combination of tenofovir and didanosine.
Tenofovir disoproxil Mylan with food and beverages
Take Tenofovir disoproxil Mylan with food (for example, with a main meal or snack).

Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Tenofovir disoproxil Mylan during pregnancy unless specifically discussed with your doctor. Although there is limited clinical data on the use of Tenofovir disoproxil Mylan in pregnant women, it is usually not used unless it is absolutely necessary.
Avoid becoming pregnant during treatment with Tenofovir disoproxil Mylan. You must use an effective method of contraception to avoid becoming pregnant.
If you become pregnant or plan to become pregnant, ask your doctor about the possible benefits and risks of your antiretroviral therapy for you and your child.
If you have taken Tenofovir disoproxil Mylan during your pregnancy, your doctor may appoint regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of HIV protection is greater than the risk of side effects.
Do not breast-feed during treatment with Tenofovir disoproxil Mylan. This is because the active substance of this medicine goes into breast milk.
If you are a woman infected with HIV or HBV, you should not breast-feed to avoid passing the infected virus through breast milk.
Driving and using machines
Tenofovir disoproxil Mylan may cause dizziness. If you feel dizzy while taking Tenofovir disoproxil Mylan, do not drive or drive a bicycle and do not use any tools or machines.

Tenofovir disoproxil Mylan contains lactose
Tell your doctor before taking Tenofovir disoproxil Mylan if you have an intolerance to lactose or some other sugars.

3. How to take Tenofovir disoproxil Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet daily with food (for example, with main meal or breakfast);
Adolescents 12 to under 18 years of age, weighing at least 35 kg: 1 tablet daily with food (eg with main
If you forget to take Tenofovir disoproxil Mylan
It is important that you do not miss a dose of Tenofovir disoproxil Mylan. If you miss a dose, find out how long it has been since you were supposed to take it.

If it is less than 12 hours from the usual time to take it, take it as soon as possible and then take the next dose at the usual time;
If it is more than 12 hours from the time you should have taken it, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.
If you vomit less than 1 hour after taking Tenofovir disoproxil Mylan, take another tablet. You do not need to take another tablet if you have vomited more than 1 hour after taking Tenofovir disoproxil Mylan.

If you stop taking Tenofovir disoproxil Mylan
Do not stop taking Tenofovir disoproxil Mylan without consulting your doctor. Stopping treatment with Tenofovir disoproxil Mylan may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B or both HIV and hepatitis B (coinfection), it is especially important not to stop your treatment with Tenofovir disoproxil Mylan before consulting your doctor. Blood tests or symptoms in some patients have shown worsening of hepatitis following discontinuation of Tenofovir disoproxil Mylan. It is possible that blood tests are required for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as in some patients this may lead to a worsening of hepatitis.

Talk to your doctor before stopping taking Tenofovir disoproxil Mylan for any reason, especially if you have any side effects or if you have another illness.
Tell your doctor immediately if, after discontinuation of treatment, you notice any new or abnormal events, especially those that you might have associated with hepatitis B infection.
Contact your doctor before you start taking the Tenofovir disoproxil Mylan tablets again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
During HIV treatment, an increase in weight and lipid and blood glucose values ​​may occur. This is partly related to the restoration of health and lifestyle, and in the case of lipids in the blood it is sometimes linked to HIV drugs themselves. Your doctor will investigate these changes.

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible serious side effects: Tell your doctor immediately

Lactic acidosis (excess of lactic acid in the blood) is rare (may affect up to 1 in every 1,000 patients) but a serious side effect that may be life-threatening. The following side effects may be signs of lactic acidosis:
deep, rapid breathing;
drowsiness;
nausea, vomiting and stomach pain.
If you think you may have lactic acidosis, contact your doctor immediately.

Other possible serious side effects
The following side effects are uncommon (may affect up to 1 in every 100 patients):

abdominal pain caused by inflammation of the pancreas;
damage to kidney tubules.
The following side effects are rare (may affect up to 1 in every 1,000 patients):

inflammation of the kidneys, increased urine output and feeling thirsty;
changes in urine and back pain caused by kidney problems including kidney failure;
softening of the bones (with bone pain and sometimes leading to fractures) that may occur due to damage to the tubular kidney cells;
obesity of the liver.
If you think you may have any of these serious side effects, talk to your doctor.

Very common side effects
The following side effects are very common (may affect at least 10 in every 100 patients):

diarrhea, vomiting, nausea, dizziness, rash, feeling weak.
Research may also show:

decreased phosphate levels in the blood.
Other possible side effects:
The following side effects are common (may affect up to 10 in every 100 patients):

headache, abdominal pain, fatigue, abdominal discomfort, gas.
Research may also show:

liver problems.
The following side effects are uncommon (may affect up to 1 in every 100 patients):

muscle tissue destruction, muscle pain or muscle weakness.
Research may also show:

decrease of potassium in the blood;
increased creatinine in the blood;
problems with the pancreas.
Muscle tissue breakdown, bone softening (with bone pain and sometimes fracture), muscle pain, muscle weakness, and decreased potassium or phosphate in the blood may occur,
The following side effects are rare (may affect up to 1 in every 1,000 patients):

abdominal pain caused by inflammation of the liver;
swelling of the face, lips, tongue or throat.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Mylan
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original package in order to protect from moisture. After first opening, use within 30 days.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Tenofovir Disoproxil Mylan Contains
The active substance is tenofovir disoproxil. Each tablet Tenofovir disoproxil Mylan contains 245 mg of tenofovir disoproxil (as maleate).
The other ingredients are: microcrystalline cellulose, lactose monohydrate (see section 2), hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminum lag (E132), tetanofovir disoproxil Mylan.

What tenofovir disoproxil Mylan looks like and contents of the pack
Tenofovir disoproxil Mylan 245 mg film-coated tablets are light blue, round, biconvex, debossed with "TN245" on one side and "M" on the other side.
This medicine is available in bottles with a child resistant closure and a sealant containing 30 tablets and desiccant.

 

 

 

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