123 mg film-coated tablets
tenofovir disoproxil
What Viread is and what it is used for
Viread contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine used to treat HIV infection or hepatitis B virus ( HBV) infection or both. Tenofovir is a nucleotide-type reverse transcriptase inhibitor, commonly called an NRTI, and works by affecting the normal function of an enzyme (in HIV reverse transcriptase, in hepatitis B DNA polymerase ) that viruses need for their reproduction (propagation). In the case of HIV, Viread must always be taken in combination with other medicines against HIV.
Viread 123 mg tablets are a treatment for HIV (human immunodeficiency virus) infection.
Viread 123 mg tablets are for use in children. They are only suitable for:
- children aged 6 to younger than 12 years
- weighing from 17 kg to less than 22 kg
- who has already been treated with other HIV drugs that no longer have a satisfactory effect due to the development of resistance or have caused side effects?
Viread 123 mg tablets are also used to treat chronic hepatitis B, an infection with HBV ( hepatitis B virus ).
Viread 123 mg tablets are intended for children. They are only suitable for:
- children aged 6 to younger than 12 years
- weighing from 17 kg to less than 22 kg.
Your child does not need to have HIV to be treated with Viread against HBV.
This medicine does not cure HIV infection. While your child is taking Viread, your child may still develop HIV infection or other illnesses associated with HIV infection. Your child can also pass HIV or HBV on to others, so it is important to take precautions to avoid infecting other people.
What you need to know before your child takes Viread
Do not give Viread
- If your child is allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine listed in section 6.
→ If this applies to your child, tell your child’s doctor immediately and stop giving Viread.
Warnings and precautions
- In the case of HIV, Viread 123 mg tablets are only suitable for children who have already been treated with other HIV medicines that no longer have the full effect due to the development of resistance or have caused side effects.
- Check your child’s age and weight to see if Viread 123 mg tablets are suitable, see Children and adolescents.
Talk to your doctor or pharmacist before giving your child Viread.
- Be careful not to infect other people. Your child can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment. Viread does not reduce the risk of transmitting HBV to others through sexual contact or blood infection. Discuss with your child’s doctor the necessary measures to avoid infecting others.
- Talk to your child’s doctor or pharmacist if your child has a history of kidney disease or if tests have shown that your child has kidney problems. Viread should not be given to children with kidney problems. Viread can affect your child’s kidneys during treatment. Before your child starts the treatment, your child’s doctor may order some blood tests to assess that your child’s kidneys are working normally. Your child’s doctor may also order blood tests during treatment to check how your child’s kidneys are working.
Viread is not usually taken together with other medicines that can damage your child’s kidneys (see Other medicines and Viread ). If this cannot be avoided, your child’s doctor will check your child’s kidney function once a week. - Skeletal problems. Some adult patients with HIV receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to loss of blood supply to the bone). Some of the many risk factors for developing the disease are long-term combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe impairment of the immune system, and higher body mass index. Signs of osteonecrosis are joint stiffness and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your child’s doctor if your child experiences any of these symptoms. Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures ) may also occur due to damage to renal tubule cells (see section 4, Possible side effects ). Tell your child’s doctor if your child has bone pain or a fracture.
Tenofovir disoproxil can also cause loss of bone mass. The most pronounced loss of bone mass was seen in clinical trials when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
Overall, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adults and children are uncertain. Tell your child’s doctor if your child has osteoporosis. Patients with osteoporosis are at higher risk of fracture. - Inform your child’s doctor if your child already has or has had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If your child has hepatitis B, your child’s doctor will carefully choose the best treatment for your child. If your child has or has had liver disease or chronic hepatitis B, your child’s doctor may take blood tests to check liver function.
- Be observant about infection. If your child has advanced-stage HIV infection ( AIDS ) and has an infection, your child may develop symptoms of infection and inflammation or worsening of symptoms of an existing infection when treatment with Viread is started. These symptoms may indicate that your child’s body’s improved immune system is fighting infection. Watch for signs of inflammation or infection during the first period after your child starts taking Viread. If you detect signs of inflammation or infection, you should inform your child’s doctor immediately.
In addition to opportunistic infections, autoimmune disorders (conditions where the immune system attacks healthy body tissue) can also occur after your child starts taking medicines to treat their HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice that your child has any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the trunk, palpitations, tremors, or hyperactivity, inform your child’s doctor immediately to get the necessary treatment.
Children and young people
Viread 123 mg tablets are only suitable for:
- HIV -1-infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg and who have already been treated with other HIV drugs that are no longer fully effective due to the development of resistance or have caused side effects
- HBV-infected children aged 6 to less than 12 years weighing from 17 kg to less than 22 kg.
Viread 123 mg tablets are not suitable for the following groups:
- Not for children weighing under 17 kg or 22 kg and over. Contact your child’s doctor if your child is outside the approved weight.
- Not for children and young people under 6 years or 12 years and over.
- Not for HBV ( hepatitis B virus )-infected children and adolescents of all ages.
For dosage, see section 3, How your child takes Viread.
Other medicines and Viread
Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
- Do not stop taking HIV medicines previously prescribed by the doctor when the child starts taking Viread if the child has both HBV and HIV.
- Do not give Viread if your child is already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not give Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
- You must tell your child’s doctor if your child is taking other medicines that may harm your child’s kidneys. Such drugs are:
- aminoglycosides, pentamidine, or vancomycin (against a bacterial infection ),
- amphotericin B (for fungal infection),
- foscarnet, ganciclovir, or cidofovir (for viral infection),
- interleukin-2 (for the treatment of cancer),
- adefovir dipivoxil (for HBV),
- tacrolimus (for suppressing the immune system),
- non-steroidal anti-inflammatory agents ( NSAID preparations, to relieve bone or muscle pain).
- Other medicines containing didanosine (for HIV infection ): If your child takes Viread together with other antiviral medicines containing didanosine, the blood levels of didanosine may increase and the CD4 cell count may decrease. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases with a fatal outcome, have been reported during concomitant treatment with medicines containing tenofovir disoproxil and didanosine. Your child’s doctor will carefully consider whether your child can be treated with a combination of tenofovir and didanosine.
- It is also important that you tell your doctor if your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Viread with food and drink
Give Viread food (eg a meal or a snack).
Pregnancy and breastfeeding
If your child is pregnant or breastfeeding or thinks she may be pregnant, consult a doctor or pharmacist before your child uses this medicine.
- If your child has taken Viread during pregnancy, the doctor may ask your child to have regular blood tests and other diagnostic tests to check the baby’s development. For children with a mother who took drugs such as Viread (NRTIs) during pregnancy, the benefit of protection against the virus is greater than the risk of side effects.
- If your baby has HBV and her baby has received treatment to prevent transmission of hepatitis B at birth, your baby may be able to breastfeed, but talk to your baby’s doctor first for more information.
- If your child has HIV, she should not breastfeed her infant to avoid transmission of the virus et to the baby through breast milk.
Driving ability and use of machinery
Viread can cause dizziness. Your child must not drive or cycle and must not use tools or machines if he/she feels dizzy when taking Viread.
Viread contains lactose
Talk to your child’s doctor before giving Viread. If your child has an intolerance to certain sugars, you should contact the child’s doctor before taking this medicine.
Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How your child takes Viread
Your child should always take this medicine as directed by the doctor or pharmacist. Consult your child’s doctor or pharmacist if you are unsure.
The recommended dose is:
- Children aged 6 to under 12 years weighing from 17 kg to less than 22 kg:1 tablet a day with food (e.g. a meal or a snack).
Your child’s doctor will monitor your child’s weight.
Your child must always take the dose prescribed by the doctor to ensure that the medicine is effective and to reduce the development of resistance to the treatment. Do not change the dose unless your child’s doctor tells you to.
For HIV, your child’s doctor will prescribe Viread together with other antiretroviral medicines.
Read the package leaflets of the other antiretroviral medicines for information on how to take these medicines.
If your child has taken too much Viread
→ If your child accidentally takes too many Viread tablets, your child may be at risk of possible side effects from this medicine (see section 4, Possible side effects ). Contact your child’s doctor or nearest emergency department for advice. Save the jar of tablets so you can easily describe what your child has taken.
If your child forgets to take Viread
Your child mustn’t miss a dose of Viread. If your child misses a dose, count when he/she should have taken it.
- If it has been less than 12 hours since the time it is usually taken, your child should take it as soon as possible, and then take the next dose at its regular time.
- If it has been more than 12 hours since your child should have taken it, do not take the missed dose. Wait and give the next dose at its regular time. Do not give a double dose to make up for a forgotten tablet.
If your child vomits within less than 1 hour after a dose of Viread, give your child another tablet. Your child does not need to take another tablet if your child vomits more than 1 hour after taking Viread.
If your child stops taking Viread
Your child must not stop taking Viread without consulting your child’s doctor. Discontinuing treatment with Viread may result in a reduced effect of the treatment recommended by your child’s doctor.
If your child has hepatitis B or HIV infection and hepatitis B infection at the same time, your child mustn’t stop Viread treatment without first talking to your child’s doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened after stopping treatment with Viread. Your child may need to provide blood samples for several months after finishing treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to a worsening of your child’s hepatitis.
- Talk to your child’s doctor before your child stops taking Viread for any reason, especially if your child experiences any side effects or has another illness.
- Tell your child’s doctor immediately about any new and unexpected symptoms that appear after stopping treatment, especially symptoms that you usually associate with your child’s hepatitis B infection.
- Contact your child’s doctor before your child starts taking Viread tablets again.
If you have any further questions about this medicine, ask your child’s doctor or pharmacist.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with HIV drugs. Your child’s doctor will do tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any serious side effects: inform your child’s doctor immediately
- Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 patients) but has serious side effects that can be fatal. The following side effects can be signs of lactic acidosis:
- deep, rapid breathing
- drowsiness
- nausea, vomiting, and abdominal pain
→ If you think your child may have lactic acidosis, contact your child’s doctor immediately.
Other possible serious side effects are
The following side effects are less common (they may affect up to 1 in 100 patients):
- pain in the stomach (abdomen) caused by inflammation of the pancreas
- damage to the kidney (renal tubule cells)
The following side effects are rare (these may occur in up to 1 in 1,000 patients):
- kidney inflammation, that your child urinates a lot and feels thirsty
- changes in urine and back pain caused by kidney problems, including kidney failure
- decreased bone hardness (which causes bone pain and sometimes leads to fractures ), which can occur due to damage to kidney tubule cells.
- fatty liver
→ If you think your child may have any of these serious side effects, talk to your child’s doctor.
The most common side effects
The following side effects are very common ( side effects occurring in more than 10 out of 100 patients):
- diarrhea, vomiting, nausea, dizziness, skin rash, feeling weak
Samples may also show:
- lowering the phosphate level in the blood
Other possible side effects are
The following side effects are common ( side effects occurring in up to 10 out of 100 patients):
- gas formation
Samples may also show:
- liver problems
The following side effects are less common ( side effects occurring in up to 1 in 100 patients):
- muscle breakdown, muscle pain, or muscle weakness
Samples may also show:
- lowered potassium levels in the blood
- increased creatinine level in the blood
- pancreatic disorders
The breakdown of muscles decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and lowered potassium or phosphate levels in the blood can occur due to damage to kidney tubule cells.
The following side effects are rare ( side effects occurring in up to 1 in 1,000 patients):
- pain in the stomach (abdomen) caused by inflammation of the liver
- swelling of the face, lips, tongue, or throat
How Viread should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after {EXP}. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
– The active substance is tenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
– Other ingredients are microcrystalline cellulose (E460), pregelatinized starch, croscarmellose sodium, lactose monohydrate and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate (E1518) which make up the tablet coating. See section 2 “Viread contains lactose”.
Appearance and package sizes of the medicine
Viread 123 mg film-coated tablets are white, triangular, film-coated tablets, 8.5 mm in diameter, debossed on one side with “GSI” and on the other side with “150”. Viread 123 mg film-coated tablets are supplied in bottles containing 30 tablets. Each jar contains desiccant (silica gel) which must be in the jar to protect the tablets. The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.
The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets or 3 bottles of 30 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer:
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
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