Tenovid

Tenofovir disoproxil fumarate.

Tenovid Tablets 300 mg are Light blue almond shaped film coated tablets, engraved 'SJ' on one side and 300 on the other.
The active substance is tenofovir. Each Tenovid tablet contains 300 mg of tenofovir disoproxil fumarate.
Excipients/Inactive Ingredients: The other ingredients are Lactose hydrate, Microcrystalline cellulose, Pregelatinized starch, Colloidal silicon dioxide, Croscarmellose sodium, Hydroxypropyl cellulose, Magnesium stearate and Opadry II blue (32K605003).
Opadry II blue (32K605003) contains HPMC 2910/Hypromellose, Lactose hydrate, Titanium Dioxide (77891), Triacetin, Indigo Carmine Aluminum Lake (73015), Sunset Yellow FCF Aluminum Lake (15985).

Tenovid contains the active substance tenofovir disoproxil fumarate. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves. In HIV Tenovid should always be used combined with other medicines to treat HIV infection.

Tenovid tablets 300 mg are a treatment for HIV (Human Immunodeficiency Virus) infection. The tablets are suitable for: adults; adolescents aged 12 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Tenovid tablets 300 mg are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus). The tablets are suitable for: adults.
The patient does not have to have HIV to be treated with Tenovid for HBV.
This medicine is not a cure for HIV infection. While taking Tenovid the patient may still develop infections or other illnesses associated with HIV infection.
The patient can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.

Always take this medicine exactly as prescribed. Patients must be advised.
The recommended dose is: Adults: 1 tablet each day with food (for example, a meal or a snack).
Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).
Always take the dose as recommended. This is to make sure that the medicine is fully effective, and to reduce the risk of developing resistance to the treatment. The dose should not be changed unless prescribed.
If the patient is an adult and has problems with the kidneys, Tenovid may be taken less frequently.
Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Forgotten intake of Tenovid: It is important not to miss a dose of Tenovid. For missed doses, the patient should work out how long since they should have taken it.
If it is less than 12 hours after it is usually taken, it should be taken as soon as the patient can, and the next dose should be taken at its regular time.
If it is more than 12 hours since the patient should have taken it, the missed dose should be forgotten. The patient should wait and the next dose should be taken at the regular time. A double dose should not be taken to make up for a forgotten tablet.
If the patient throws up less than 1 hour after taking Tenovid, another tablet should be taken. There's no need to take another tablet if the patient is sick more than 1 hour after taking Tenovid.
Stopping intake of Tenovid: Advise the patient not to stop taking Tenovid without the doctor's advice. Stopping treatment with Tenovid may reduce the effectiveness of the treatment as recommended.
If the patient has hepatitis B or HIV and hepatitis B together (co-infection), it is very important to advise the patient not to stop the Tenovid treatment without talking to the doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has gotten worse after stopping Tenovid. The patient 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 hepatitis.
Advise the patient to talk to the doctor before stopping Tenovid for any reason, particularly if the patient is experiencing any side effects or has another illness.
Advise the patient to inform the doctor immediately about new or unusual symptoms after stopping treatment, particularly symptoms the patient associates with hepatitis B infection.
Advise the patient to contact the doctor before restarting Tenovid tablets.
Patients must be advised regarding further questions on the use of this medicine.

If too many Tenovid tablets have been taken, the patient may be at increased risk of experiencing possible side effects with this medicine (see Side Effects). Advise the patient to contact the doctor or nearest emergency department for advice. The tablet bottle should be kept so that the patient can easily describe what has been taken.

Tenovid should not be taken: if the patient is allergic to tenofovir, tenofovir disoproxil fumarate or any of the other ingredients of this medicine listed in Description.
If this applies, advise the patient to inform the doctor immediately.

Patients must be advised before taking Tenovid.
Patients should take care not to infect other people. HIV can still be passed when taking this medicine, although the risk is lowered by effective antiretroviral therapy. The precautions needed should be discussed to avoid infecting other people. Tenovid does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. The patient must continue to take precautions to avoid this.
Advise the patient to inform the doctor or pharmacist if the patient has had kidney disease or if tests have shown problems with the kidneys. Tenovid should not be given to adolescents with existing kidney problems. Before starting treatment, blood tests may be ordered to assess the kidney function. Tenovid may affect the kidneys during treatment. Blood tests may be ordered during treatment to monitor how the kidneys work. If the patient is an adult, the patient may be advised to take the tablets less often. Advise the patient not to reduce the prescribed dose, unless the doctor has told the patient to do so. Tenovid is not usually taken with other medicines that can damage the kidneys (see Interactions). If this is unavoidable, the kidney function should be monitored once a week.
Bone problems: Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. Advise the patient to inform the doctor in case of any of these symptoms.
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see Side Effects). Advise the patient to inform the doctor if the patient has bone pain or fractures.
Tenofovir disoproxil fumarate may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil fumarate in combination with a boosted protease inhibitor.
Overall, the effects of tenofovir disoproxil fumarate on long term bone health and future fracture risk in adult and paediatric patients are uncertain. Advise the patient to inform the doctor if the patient is suffering from osteoporosis. Patients with osteoporosis are at a higher risk for fractures.
Advise the patient to talk to the doctor if the patient has a history of liver disease, including hepatitis. Patients with 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 the patient has hepatitis B infection, the best treatment should be carefully considered for the patient. If the patient has a history of liver disease or chronic hepatitis B infection, blood tests may be conducted to monitor the liver function.
Look out for infections. If the patient has advanced HIV infection (AIDS) and has an infection, symptoms of infection and inflammation may be developed or symptoms of an existing infection may be worsened once treatment with Tenovid is started. These symptoms may indicate that the body's improved immune system is fighting infection. Look out for signs of inflammation or infection soon after the patient starts taking Tenovid. Advise the patient to inform the doctor at once in case of signs of inflammation or infection.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after the patient starts taking medicines for the treatment of their HIV infection. Autoimmune disorders may occur many months after the start of treatment. Patients must be advised to seek medical attention immediately in case of 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.
Advise the patient to talk to the doctor or pharmacist if the patient is over 65. Tenovid has not been studied in patients over 65 years of age. If the patient is older than this and is prescribed Tenovid, the patient should be carefully monitored.
Tenovid contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving and using machines: Tenovid can cause dizziness. If the patient feels dizzy while taking Tenovid, the patient should not drive or ride a bicycle and use any tools or machines.
Use in Children: Tenovid tablets 300 mg are suitable for: HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Tenovid tablets 300 mg 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.

If the patient is pregnant or breastfeeding, thinks she may be pregnant or are planning to have a baby, she must be advised before taking this medicine.
If the patient has taken Tenovid during her pregnancy, regular blood tests and other diagnostic tests may be requested to monitor the development of the child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
If the patient is a mother with HBV, and her baby has been given treatment to prevent hepatitis B transmission at birth, she may be able to breastfeed her infant, but patients must be advised first.
If the patient is a mother with HIV, advise her not to breastfeed, to avoid passing the virus to the baby in breast milk.

During HIV therapy 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 medicines themselves. These changes would be tested.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients must be advised to inform the doctor immediately in case of possible serious side effects: Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every 1,000 patients) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis: deep, rapid breathing; drowsiness; feeling sick (nausea), being sick (vomiting) and stomach pain.
Advise the patient to contact the doctor immediately in case of lactic acidosis.
Other possible serious side effects: The following side effects are uncommon (this can affect up to 1 in every 100 patients): pain in the tummy (abdomen) caused by inflammation of the pancreas; damage to kidney tubule cells.
The following side effects are rare (these can affect up to 1 in every 1,000 patients): inflammation of the kidney, passing a lot of urine and feeling thirsty; changes to the urine and back pain caused by kidney problems, including kidney failure; softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells; fatty liver.
Advise the patient to talk to the doctor in case of any of these serious side effects.
Most frequent side effects: The following side effects are very common (these can affect at least 10 in every 100 patients): diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak.
Tests may also show: decreases in phosphate in the blood.
Other possible side effects: The following side effects are common (these can affect up to 10 in every 100 patients): headache, stomach pain, feeling tired, feeling bloated, flatulence.
Tests may show: liver problems.
The following side effects are uncommon (these can affect up to 1 in every 100 patients): breakdown of muscle, muscle pain or weakness.
Tests may also show: decreases in potassium in the blood; increased creatinine in the blood; pancreas problems.
The 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 may occur due to damage to kidney tubule cells.
The following side effects are rare (these can affect up to 1 in every 1,000 patients): pain in the tummy (abdomen) caused by inflammation of the liver; swelling of the face, lips, tongue or throat.
Reporting of side effects: Patients must be advised in case of any side effects.

Advise the patient to inform the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Anti-HIV medicines should not be stopped when the patient starts Tenovid if the patient has both HBV and HIV.
Tenovid should not be taken if the patient is already taking other medicines containing tenofovir disoproxil fumarate or tenofovir alafenamide. Tenovid should not be taken together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Advise the patient to inform the doctor if the patient is taking other medicines that may damage the kidneys. These include: aminoglycosides, pentamidine or vancomycin (for bacterial infection); amphotericin B (for fungal infection); foscarnet, ganciclovir, or cidofovir (for viral infection); interleukin-2 (to treat cancer); adefovir dipivoxil (for HBV); tacrolimus (for suppression of the immune system); non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
Other medicines containing didanosine (for HIV infection): Taking Tenovid with other antiviral medicines that contain didanosine can raise the levels of didanosine in the blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil fumarate and didanosine were taken together. Carefully consider whether to treat the patient with combinations of tenofovir and didanosine.
Advise the patient to inform the doctor if the patient is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Tenovid with food and drink: Tenovid should be taken with food (for example, a meal or a snack).

Store below 25°C.

Antivirals

J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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