Tenvir-EM

Do not take Tenvir EM if you are:

• allergic to emtricitabine, tenofovir, tenofovir disoproxil or any of the other ingredients of this medicinal product (listed in section 6).

If this applies to you, tell your doctor immediately.

Before taking Tenvir EM to reduce the risk of getting HIV:
Tenvir EM can only help reduce your risk of getting HIV before you are infected.

• You must be HIV negative before you start to take Tenvir EM to reduce the risk of getting HIV. You must get tested to make sure that you do not already have HIV infection. Do not take Tenvir EM to reduce your risk unless you are confirmed to be HIV negative. People who do have HIV must take Tenvir EM in combination with other medicinal products.
• Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean you have recently been infected with HIV.
  These may be signs of HIV infection:
  • tiredness
  • fever
  • joint or muscle aches
  • headache
  • vomiting or diarrhoea
  • rash
  • night sweats
  • enlarged lymph nodes in the neck or groin

Tell your doctor about any flu-like illness – either in the month before starting Tenvir EM, or at any time while taking this medication.

Warnings and Precautions

While taking Tenvir EM to reduce the risk of getting HIV:

• Take Tenvir EM every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Tenvir EM, or stop taking it. Missing doses may increase your risk of getting HIV infection.
• Get tested for HIV regularly.
• If you think you were infected with HIV, tell your doctor straight away. They may want to do more tests to make sure you are still HIV negative.

Just taking Tenvir EM may not stop you getting HIV.

• Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
• Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.
• Do not share or re-use needles or other injection or medical equipment.
• Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how to prevent spreading infection to other people.

While taking Tenvir EM to treat HIV or to reduce the risk of getting HIV:

• Tenvir EM may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if you have had kidney disease, or if tests have shown kidney problems. This medicine should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Tenvir EM or, if you already have HIV, to take it less frequently. The use of Tenvir EM is not recommended if you have severe kidney disease or are on dialysis.
  Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see Section 4, Possible adverse reactions).
• Talk to your doctor if you have a history of liver disease, including hepatitis. Patients infected with HIV who also have liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.
• Know your hepatitis B virus (HBV) infection status before starting this medicine. If you have HBV, there is a serious risk of liver problems when you stop taking Tenvir EM, whether or not you also have HIV. It is important not to stop taking Tenvir EM without talking to your doctor: see Section 3, Do not stop taking Tenvir EM.
• Talk to your doctor if you are over 65. Tenvir EM has not been studied in patients over 65 years of age.
• Talk to your doctor if you are intolerant to lactose (see Tenvir EM contains lactose later in this section).

Paediatric population
Tenvir EM is not for use in children and adolescents under 18 years of age.

Drug-to-drug interactions

Do not take Tenvir EM if you are already taking other medicines that contain the components of this medication (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Tenvir EM with other medicinal products that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including

• aminoglycosides (for bacterial infection);
• amphotericin B (for fungal infection);
• foscarnet (for viral infection);
• ganciclovir (for viral infection);
• pentamidine (for infections);
• vancomycin (for bacterial infection);
• interleukin-2 (to treat cancer);
• cidofovir (for viral infection);
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).

If you are taking another antiviral medication called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.

It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Tenvir EM with other medicines containing didanosine (for treatment of HIV infection): taking Tenvir EM with other antiviral medications that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medications containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

Tell your doctor if you are taking any of these medicinal products. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tenvir EM with food and drink
Whenever possible, Tenvir EM should be taken with food.

Pregnancy and lactation

Pregnancy
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 taking this medicine.
If you have taken Tenvir EM during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Breast-feeding
Do not breast-feed during treatment with Tenvir EM. This is because the active substances in this medicine pass into human breast milk. HIV-infected women should not breastfeed to avoid passing the infection to the baby in breast milk.

Effects on ability to drive and use potentially dangerous machines
Tenvir EM can cause dizziness. If you feel dizzy, do not drive and do not use any tools or machines.

Tenvir EM contains lactose
This medicinal product contains lactose. Patients with rare hereditary forms of galactose intolerance, lactase deficiency syndrome or glucose-galactose malabsorption syndrome should not take Tenvir EM.

Always take Tenvir EM exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Posology
The recommended dose to treat HIV is:
Adults: One tablet each day with food.
Take tablets orally without chewing, with a glass of pre-boiled room-temperature water.
For patients who have difficulty swallowing, you can crush the tablet and mix the powder with about 100 ml of water or juice. All of this mixture should be consumed immediately.

Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

If you are being treated for HIV infection your doctor will prescribe Tenvir EM with other antiretroviral medicines. Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medications.

If you are taking Tenvir EM to reduce the risk of getting HIV, take this medicine every day, not just when you think you have been at risk of HIV infection.
Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.

If you take more Tenvir EM tablets than you should
If you accidentally take more than the recommended dose of Tenvir EM medicinal product, immediately contact specialists to provide timely medical care!

If you miss a dose of Tenvir EM
It is important not to miss a dose of Tenvir EM.
If you notice within 12 hours of the time you usually take this medicine, take the tablet preferably with food as soon as possible. Then take the next dose at your usual time.
If you notice 12 hours or more after the time you usually take this medicine, forget about the missed dose. Wait and take the next dose at your usual time.
If you vomit less than 1 hour after taking this medicine, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking this medicine.

Do not stop taking Tenvir EM

• f you take this medicine for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
• If you are taking this medicine to reduce the risk of getting HIV, do not stop taking it or miss any doses. Stopping use of this medicine, or missing doses, may increase your risk of getting HIV infection.
• Do not stop taking Tenvir EM medicinal product without contacting your doctor.
• If you have hepatitis B, it is especially important not to stop your treatment with Tenvir EM without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.

If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

Like all medications Tenvir EM can cause side effects, although not everybody gets them.

Possible serious adverse reactions:

• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect. Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
  • deep rapid breathing
  • drowsiness
  • nausea, vomiting
  • stomach pain

  If you think you may have lactic acidosis, get medical help immediately.

• Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
  • muscle weakness
  • weakness beginning in the hands and feet and moving up towards the trunk of the body;
  • palpitations, tremor or hyperactivity

  If you notice these or any symptoms of inflammation or infection, get medical help immediately.

Possible adverse reactions

Very common (may affect more than 1 in 10 people):

• diarrhoea, nausea, vomiting
• dizziness, headache
• rash
• feeling weak

Blood tests may also show very common adverse reactions:

• decreases in phosphate in the blood
• increased creatine kinase

Common (may affect up to 1-10 in 100 people):

• pain, stomach pain
• insomnia, abnormal dreams
• problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
• other allergic reactions, such as wheezing, swelling or feeling light-headed

Blood tests may also show common adverse reactions:

• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liver and pancreas problems

Uncommon (may affect up to 1-10 in 1000 people):

• pain in the abdomen (tummy) caused by inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells

Blood tests may also show uncommon adverse reactions:

• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine

Rare (may affect up to 1-10 in 10,000 people):

• lactic acidosis (see Section Possible serious side effects)
• fatty liver (hepatic steatosis)
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
• inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
• softening of the bones (with bone pain and sometimes resulting in fractures)
• back pain caused by kidney problems

Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.

If you notice any of the adverse reactions listed above or if any of the adverse reactions get serious, talk to your doctor or pharmacist.

The frequency of the following adverse reactions is not known.

• Bone tissue disorders. Some patients taking combination antiretroviral medicines such as Tenvir EM may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
  • joint stiffness
  • joint aches and pains (especially of the hip, knee and shoulder)
  • difficulty with movement

  If you notice any of these symptoms, tell your doctor.

During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medications themselves. Your doctor will test for these changes.

Reporting of adverse reactions
If you get any side effects, address your healthcare provider. This recommendation applies to any possible side effects, including those not listed in the leaflet. You can report to the information database on adverse reactions (side effects), or on inefficiency of medicinal products (Center for Examinations and Tests in Health Service: http://www.rceth.by) or to the manufacturer ACADEMPHARM via an electronic application form on their website: http://academpharm.by/en

When you report adverse reactions, you help to get more information about the safety of the medicinal product.

Do not store above 30°C. Keep away from children.
Keep the bottle tightly closed. Do not take out the bag with the desiccant.
Do not use this medicinal product after the expiry date which is stated on the carton. The expiry date refers to the last day of that month stated on the carton.

What Tenvir EM contains
One tablet contains the following active substances: 200 mg of emtricitabine, 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil).
Other ingredients: microcrystalline cellulose, lactose monohydrate, pre-gelatinized starch 1500, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, indigocarmine dye aluminum lake (E132).

What Tenvir EM looks like and contents of the package
Blue, oval biconvex film-coated tablets.
High-density polyethylene bottles containing 30 tablets and a silica gel desiccant closed with high-density polyethylene cover. One bottle with a patient information leaflet, packed in a carton.

Marketing authorization holder
State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus,
Phone / Fax +375 17 268 63 64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en