What is it and how is it used?
Viread is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age.
Viread is also used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
You do not have to have HIV to be treated with Viread for HBV.
Viread contains the active substance, tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV 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 Viread should always be used combined with other medicines to treat HIV infection.
This medicine is not a cure for HIV infection. While taking Viread you may still develop infections or other illnesses associated with HIV infection.
You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
What do you have to consider before using it?
Do not take Viread
If this applies to you, tell your doctor immediately and don’t take Viread.
Take special care with Viread
Viread is not usually taken with other medicines that can damage your kidneys (see Taking other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.
Look out for possible signs of lactic acidosis (excess of lactic acid in your blood) once you start taking Viread. Possible signs of lactic acidosis are:
Other precautions
In the treatment of HIV, combination antiretroviral therapies (including Viread) may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
If you are diabetic, overweight or have high cholesterol, talk to your doctor.
Look out for infections. If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started. These symptoms may indicate that your body’s improved immune system is fighting infection. Look out for signs of inflammation or infection soon after you start taking Viread. If you notice signs of inflammation or infection, tell your doctor at once.
Bone problems. Some 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. If you notice any of these symptoms tell your doctor.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
These include:
Taking Viread with food and drink
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Viread can cause dizziness. If you feel dizzy while taking Viread, do not drive and do not use any tools or machines.
Important information about some of the ingredients of Viread
Viread contains lactose. Tell your doctor before taking Viread if you cannot tolerate lactose or if you have an intolerance to any other sugars.
How is it used?
The usual dose:
If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately.
Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
If you take more Viread than you should
If you accidentally take too many Viread tablets, contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.
If you forget to take Viread
It is important not to miss a dose of Viread.
If you miss a dose of Viread, take it as soon as you can, and then take your next dose at its regular time.
If it is almost time for your next dose anyway, forget about the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.
If you throw up less than 1 hour after taking Viread, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Viread.
If you stop taking Viread
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 product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Viread can cause side effects, although not everybody gets them.
Very common side effects
(These can affect at least 10 in every 100 patients)
Tests may also show:
Common side effects
(These can affect up to 10 in every 100 patients)
Tests may also show:
Uncommon side effects
(These can affect up to 1 in every 100 patients)
Tests may also show:
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.
Rare side effects
(These can affect up to 1 in every 1,000 patients)
If you think you may have lactic acidosis, contact your doctor immediately.
Other possible effects
In the treatment of HIV, combination antiretroviral therapy (including Viread) may change your body shape, by changing the way body fat is distributed. You may lose fat from your legs, arms and face; gain fat around the tummy (abdomen) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’). The cause and the long-term effects of these changes are not yet known.
In the treatment of HIV, combination antiretroviral therapy may also cause increased fats in the blood (hyperlipaemia) and resistance to insulin. Your doctor will test for these changes.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Viread 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.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.