Tenofovir 245 mg. 30 tablets
Tenofovir contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine that is used to treat HIV, HBV or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as NRTI, and acts by disrupting the normal action of enzymes (HIV reverse transcriptase, hepatitis B DNA polymerase) that are essential for self-replication of viruses. In HIV treatment of HIV infection, Tenofovir Sandoz should always be used with other medicines.
Tenofovir is a treatment for HIV infection (human immunodeficiency virus).
The tablets are suitable for:
adolescents aged 12 to less than 18 years who have already taken other anti-HIV medicines that are no longer fully effective due to resistance development or have caused undesirable effects.
Tenofovir Sandoz is also a treatment for chronic hepatitis B infection with HBV (hepatitis B virus).
The tablets are suitable for:
adolescents aged 12 to under 18 years old.
You do not need HIV to take Tenofovir treatment for HBV.
This drug does not cure HIV infection. Even when taking Tenofovir Sandoz you may develop infections or other illnesses associated with HIV infection. It is possible to pass HIV or HBV to others, so it is important to take precautions to avoid infection.
2. What you need to know before taking Tenofovir Sandoz
Do not take Tenofovir :
If you are allergic to tenofovir, tenofovir disoproxil fumarate 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 Sandoz.
Warnings and precautions
Tell your doctor or pharmacist before taking Tenofovir
Be careful not to infect other people. Even if you take this medicine you can pass HIV, although the risk is reduced with effective antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid contracting other people. Tenofovir Sandoz does not reduce the risk of transmission of HBV to other people through sexual contact or blood circulation. You must continue the precautions to avoid it.
Talk to your doctor or pharmacist if you have or have kidney disease, or if studies have shown problems with your kidneys. Tenofovir Sandoz should not be used in adolescents with kidney problems. Before starting treatment, your doctor may appoint blood tests to assess your kidney function. Tenofovir Sandoz may affect the kidneys during treatment. Your doctor may also appoint blood tests during your treatment to monitor your kidney function. If you are an adult, your doctor may advise you to take your tablets at a lower rate. Do not reduce your prescribed dose unless instructed by your doctor.
Usually, Tenofovir Sandoz is not taken together with other medicines that can harm the kidneys (see "Other medicines and Tenofovir Sandoz") .If this is inevitable, your doctor will monitor your kidney function once a week.
Bone problems. Some of the adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue is dying due to discontinuation of blood supply to the bone). The duration of combination antiretroviral therapy, corticosteroid use, 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, 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 liver 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 a chronic hepatitis B infection, your doctor may order blood tests to monitor your liver function.
Watch out for infections. If you have an advanced HIV infection (AIDS) as well as another infection, it may be possible to develop signs of infection and inflammation or worsening when initiating treatment with Tenofovir
In addition to opportunistic infections, autoimmune diseases (disorders in which the immune system attacks healthy tissues in the body) may also occur after you start taking the HIV infection. Autoimmune diseases can occur many months after the start of treatment. If you notice symptoms of infection or other symptoms such as muscle weakness, weakness starting from the palms and feet and continuing to the torso, palpitations, trembling or overactive, tell your doctor immediately to seek appropriate treatment.
Talk to your doctor or pharmacist if you are over 65 years old. Tenofovir Sandoz has not been studied in patients over 65 years of age. If you are older and have been prescribed Tenofovir , your doctor will monitor your condition with caution.
Children and adolescents
Tenofovir is suitable for:
HIV-1 infected adolescents aged 12 to less than 18 years of age, weighing at least 35 kg, have received treatment with other HIV medicines that no longer work completely efficiently due to resistance or adverse reactions;
HBV-infected adolescents aged 12 to under 18 years of age, weighing at least 35 kg.
Tenofovir Sandoz is not suitable for the following groups:
HIV-1 infected children under 12 years of age;
HBV-infected children under 12 years of age. For the posology, see section 3 "How to take Tenofovir ".
Other drugs and Tenofovir Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not stop taking HIV medicines prescribed by your doctor when you start taking Tenofovir if you have HBV and HIV.
Do not take Tenofovir Sandoz if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Sandoz together with medicines containing adefovir dipivoxil (medicines to treat chronic hepatitis B).
It is very important to tell your doctor if you are already taking other medicines that can harm your kidneys.
Yeah, they're like that:
aminoglycosides, pentamidine or vancomycin (against bacterial infections);
amphotericin B (against fungal infections);
foscarmet, ganciclovir or cidofovir (against viral infections);
interleukin-2 (for cancer treatment);
adefovir dipivoxil (versus HBV);
tacrolimus (to suppress the immune system);
non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone and muscle pain).
Other medications containing didanosine (to treat HIV infection): Taking Tenofovir Sandoz with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and 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 in some cases has led to death when both medicines containing tenofovir disoproxil and didanosine have been concomitantly taken. Your doctor will carefully evaluate whether to give you treatment with a combination of tenofovir and didanosine.
It is also important to tell your doctor if you are taking levodipaverin / sophosbivir for the treatment of hepatitis B infection.
Tenofovir with food and beverages
Take Tenofovir Sandoz with food (for example, 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 during pregnancy. Although there are limited clinical data on the use of Tenofovir Sandoz in pregnant women, this drug is usually only used when there is a clear need.
Try to avoid becoming pregnant while taking Tenofovir Sandoz. 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 anti-retroviral therapy with Tenofovir Sandoz for you and your child.
If you have taken Tenofovir Sandoz during your pregnancy, your doctor may arrange regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers have taken NRTIs during pregnancy, the benefit of protection against HIV is greater than the risk of adverse reactions.
Do not breastfeed while taking Tenofovir . This is because the active substances of this medicine are excreted with human milk.
If you are infected with HIV or HBV, you should not breast-feed to avoid passing the infected virus through the breast milk.
Driving and using machines
Tenofovir Sandoz may cause dizziness. If you feel dizzy while taking Tenofovir Sandoz, you should not drive or ride a bicycle and do not use tools or machines.
Tenofovir Sandoz contains lactose
Tell your doctor before taking Tenofovir if you have an intolerance to lactose or other sugars.
3. How to take Tenofovir
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 taken with food (for example, main meal or snack).
Adolescents 12 to under 18 years of age, weighing at least 35 kg: 1 tablet daily taken with food (for example, main meal or snack).
If you have a swallowing problem, you may crush the tablet with the tip of the spoon. Mix the powder in about 100 ml (half a glass) of water, orange or grape juice and drink it right away.
Always take the dose recommended by your doctor. This ensures full effectiveness of the drug and reduces the risk of developing resistance to treatment. Do not change the dose unless instructed by your doctor.
If you are elderly and have kidney problems, your doctor may recommend that you take Tenofovir Sandoz at a lower rate.
If you have HBV, your doctor may suggest you take an HIV test to see if you have both HBV and HIV.
Refer to the patient information leaflet of other antiretroviral medicines for their intake.
If you take more Tenofovir than you need
If you accidentally take too many Tenofovir tablets, you may have an increased risk of possible side effects with this medicine (see section 4, Possible side effects). Consult your doctor or go to the nearest emergency center. Take the package with you to make it easier to find out what medication you have taken.
If you forget to take Tenofovir Sandoz
It is important that you do not miss a dose of Tenofovir Sandoz. If you miss a dose, see how much time has passed since the time you were supposed to take it.
If it is less than 12 hours after the usual time to take, take the tablet as soon as possible and then continue taking the next dose at the usual time.
If it has been more than 12 hours since you had to take the missed dose, do not take it. 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 within 1 hour after taking Tenofovir Sandoz, take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir Sandoz.
If you stop taking Tenofovir
Do not stop taking Tenofovir without consulting your doctor. When stopping treatment with Tenofovir Sandoz, the effectiveness of the course of treatment recommended by your doctor may be less.
If you have hepatitis B or HIV and hepatitis B together (concomitant infection), it is important that you do not stop taking Tenofovir Sandoz before consulting your doctor. In some patients, the results of blood tests or the presence of symptoms indicate a worsening of their disease after stopping treatment with this medicine. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended due to a possible worsening of hepatitis.
Check with your doctor before stopping taking Tenofovir Sandoz, no matter what, especially if you experience side effects or other health problems.
Immediately tell your doctor about new or unusual symptoms after stopping treatment, especially symptoms that you think are related to hepatitis B infection.
Contact your doctor before resuming taking Tenofovir Sandoz tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
During treatment of HIV, weight, blood fats and blood glucose levels may increase. This is partly related to the recovery of health and lifestyle, and sometimes the increase in fat is associated with HIV drugs themselves. Your doctor will do research to track these changes.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible serious undesirable
How to Keep Tenofovir
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle, carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. After first opening the bottle, 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 contains:
The active substance is tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil.
The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, crospovidone (type B), magnesium stearate.
Film coating: Hypromellose, Titanium dioxide (E171), Macrogol 400, Polysorbate 80. See section "Tenofovir Sandoz contains lactose" at point 2.
What Tenofovir Sandoz looks like and what the package contains
White, almond-shaped, biconvex film-coated tablets, measuring 16 mm x 10 mm, engraved with "H" on one side and "T11" on the other side.
Blisters of OPA-Al-PVC / Al.
Pack sizes: 30 x 1, 60 x 1 and 90 x 1 film-coated tablets.
A white, opaque HDPE bottle containing a silicone gel packet such as a desiccant and a viscous swab, with a white, opaque polypropylene screw cap that is childproof.
Pack sizes: 30, 60 (2 x 30) and 90 (3 x 30) film-coated tablets.
Not all pack sizes may be marketed.