Viread 204 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viread 204 mg film-coated tablets

Tenofovir disoproxil

Read the entire leaflet carefully before the child starts taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult the child's doctor or pharmacist.
• This medicine has been prescribed for the child only and must not be given to other people, even if they have the same symptoms as the child, since it may harm them.
• If the child experiences any adverse effects, consult the child's doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Viread is and what it is used for
2. What you need to know before the child takes Viread
3. How to take Viread
4. Possible side effects
5. How to store Viread
6. Contents of the pack and other information

1. 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 infection with HIV or HBV, or both. Tenofovir is a nucleotide analogue reverse transcriptase inhibitor (NRTI), which acts by interfering with the normal function of an enzyme (in HIV, reverse transcriptase; in hepatitis B, DNA polymerase) that is essential for the viruses to replicate. For the treatment of HIV infection, Viread must always be used in combination with other medicines.

Viread 204 mg tablets are a medicine used to treat HIV (Human Immunodeficiency Virus) infection.

Viread 204 mg tablets are for use in children. They are only suitable for:

• children aged between 6 and less than 12 years
• who weigh between 28 kg and less than 35 kg
  • who have already been treated with other anti-HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Viread 204 mg tablets are also a medicine used to treat chronic hepatitis B, an infection caused by HBV (hepatitis B virus).

Viread 204 mg tablets are for use in children. They are only suitable for:

• children aged between 6 and less than 12 years
• who weigh between 28 kg and less than 35 kg

The child does not need to have HIV in order to be treated with Viread for HBV.

This medicine is not a cure for HIV infection. While the child is taking Viread, they may continue to experience infections or other illnesses associated with HIV infection. The child may also continue to transmit HIV or HBV to others. Therefore, it is important that precautions are taken to avoid infecting other people.

2. What you need to know before your child starts taking Viread

Do not give Viread

• If your child is allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (included in section 6).

• If this applies to your child, inform your doctor immediately and do not give Viread.

Warnings and precautions

• In the case of HIV, Viread 204 mg tablets are only suitable for children who have already been treated with other anti-HIV medicines that are no longer fully effective due to resistance development, or that have caused adverse effects.

• Check your child's age and weight to determine whether Viread 204 mg tablets are appropriate; see Children and adolescents.

Consult your child’s doctor or pharmacist before starting Viread.

• Take care not to transmit the infection to others. While taking this medicine, your child may still transmit HIV to others, although effective antiviral treatment reduces this risk. Viread does not reduce the risk of transmission of HBV to others through sexual contact or blood contamination. Consult your child’s doctor about which precautions are necessary to avoid infecting others.

• If your child has had kidney disease or blood tests have shown kidney problems, consult your child’s doctor or pharmacist. Viread must not be given to children with existing kidney problems. Viread may affect your child’s kidneys during treatment. Before starting treatment, your child’s doctor may request blood tests to assess kidney function. Your child’s doctor may also request regular blood tests during treatment to monitor kidney function.

Viread is generally not taken together with other medicines that may harm your child’s kidneys (see Taking Viread with other medicines). If this is unavoidable, your child’s doctor will monitor kidney function once a week.

• Bone problems. Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your child’s doctor.

Bone problems (sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects).

• Talk to your child’s doctor if your child has a history of liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If your child has hepatitis B infection, your child’s doctor will carefully consider the best treatment for them. If your child has a history of liver disease or chronic hepatitis B infection, your child’s doctor may perform blood tests to monitor liver function.

• Infections. If your child has advanced HIV infection (AIDS) and has another type of infection, they may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when starting treatment with Viread. These symptoms may indicate that your child’s improved immune system is fighting the infection. Be alert for signs of inflammation or infection shortly after your child starts taking Viread. If you notice signs of inflammation or infection, inform your child’s doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for HIV infection.

Autoimmune disorders may appear many months after starting treatment. If you notice your child showing any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your child’s doctor immediately to receive necessary treatment.

Children and adolescents

Viread 204 mg tablets are only suitable for:

• HIV-1 infected children aged 6 to less than 12 years weighing between 28 kg and less than 35 kg who have been treated with other anti-HIV medicines that are no longer fully effective due to resistance development, or that have caused adverse effects.
  • HBV-infected children aged 6 to less than 12 years weighing between 28 kg and less than 35 kg.

Viread 204 mg tablets are not suitable for the following groups:

• Not for children weighing less than 28 kg or 35 kg or more. Consult your child’s doctor if your child is outside the permitted weight range.
• Not for children and adolescents under 6 years of age or 12 years of age or older.

For dosage information, see section 3, How to take Viread.

Other medicines and Viread

Inform your child’s doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

• Do not stop treatment with any anti-HIV medicines prescribed by your child’s doctor when starting Viread if your child has both HBV and HIV.

• Do not give Viread if your child is taking medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not give Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

• It is very important that you tell your child’s doctor if your child is taking other medicines that may harm their kidneys.

These medicines include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),

• amphotericin B (used to treat fungal infections),

• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),

• interleukin-2 (used to treat cancer),

• adefovir dipivoxil (used to treat HBV infection),

• tacrolimus (used to induce immune system suppression),

• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines containing didanosine may increase levels of didanosine in the blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when tenofovir disoproxil and didanosine are taken together. Your child’s doctor will carefully consider whether treatment with combinations of tenofovir and didanosine is appropriate.

• It is also important that you inform your doctor if your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Viread with food and drink

Administer Viread with food (e.g., a meal or snack).

Pregnancy and breastfeeding

If the girl is pregnant or breastfeeding, or thinks she may be pregnant, consult her doctor or pharmacist before taking this medicine.

• The girl should not take Viread during pregnancy unless specifically discussed with her doctor. Although there is limited clinical data on the use of Viread in pregnant women, it is generally not used unless absolutely necessary.

• If the girl becomes pregnant, ask her doctor about the potential risks and benefits of antiretroviral therapy for her and her baby.

• If the girl has taken Viread during her pregnancy, her doctor may request periodic blood tests and other diagnostic tests to monitor the baby’s development. In children whose mothers took medicines like Viread (ITIAN) during pregnancy, the benefit of protection against the virus was greater than the risk of adverse effects occurring.

• The girl should not breastfeed during treatment with Viread. This is because the active ingredient of this medicine passes into breast milk.

• The girl should not breastfeed to avoid transmitting the virus to the child through breast milk.

Driving and using machines

Viread may cause dizziness. If your child experiences dizziness during treatment with Viread, they should not drive or ride a bicycle, or operate tools or machinery.

Viread contains lactose

Inform your child’s doctor before administering Viread. If your child’s doctor has informed you that your child has an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Viread

The child must follow exactly the administration instructions for this medicine as indicated by their doctor or pharmacist. If in doubt, consult the child's doctor or pharmacist again.

The recommended dose is:

• Children aged 6 to less than 12 years weighing between 28 kg and less than 35 kg:

1 tablet daily with food (for example, a meal or a snack).

The child's doctor will monitor their weight.

The child must always take the dose recommended by their doctor. This is to ensure that the medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless the child's doctor tells you to do so.

In the case of HIV, the child's doctor will prescribe Viread together with other antiretroviral medicines.

Please refer to the package leaflets of the other antiretrovirals for instructions on how to take those medicines.

If the child takes more Viread than they should

If the child accidentally takes too many Viread tablets, they may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible side effects). Consult the child's doctor or go to the nearest emergency department. Take the bottle of tablets with you so you can easily describe what the child has taken.

If the child forgets to take Viread

It is important that the child does not miss a dose of Viread. If the child misses a dose, determine how long it has been since it should have been taken.

• If less than 12 hours have passed since the usual time, take it as soon as possible, then take the next dose at the regular time.

• If more than 12 hours have passed since the dose was due, the missed dose should not be taken. Wait and take the next dose at the regular time. Do not give a double dose to make up for a missed dose.

If the child vomits within 1 hour after taking Viread, give another tablet. The child does not need to take another tablet if they vomit more than 1 hour after taking Viread.

If the child stops taking Viread

The child must not stop taking Viread unless instructed by their doctor. Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by the child's doctor.

If the child has hepatitis B or both HIV and hepatitis B (coinfection), it is very important not to stop treatment with Viread without first speaking to the child's doctor. After stopping Viread treatment, some patients have had blood tests or symptoms indicating that their hepatitis had worsened. The child may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

• Talk to the child's doctor before the child stops taking Viread for any reason, especially if they experience any adverse effects or have another illness.

• Contact the child's doctor immediately if the child experiences any new or unusual symptoms after stopping treatment, particularly symptoms related to hepatitis B virus infection.

• Contact the child's doctor before the child restarts taking Viread tablets.

If you have any further questions about the use of this medicine, ask the child's doctor or pharmacist.

4. Possible side effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. The child's doctor will monitor these changes.

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Possible serious side effects: inform the child's doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare but serious side effect (may affect up to 1 in 1,000 patients) that can be life-threatening. The following side effects may be signs of lactic acidosis:

• deep, rapid breathing

• drowsiness

• nausea, vomiting, and stomach pain

• If you think the child may have lactic acidosis, contact the child's doctor immediately.

Other possible serious side effects

The following side effects are uncommon (may affect up to 1 in 100 patients):

• abdominal pain caused by inflammation of the pancreas
• damage to renal tubular cells

The following side effects are rare (may affect up to 1 in 1,000 patients):

• inflammation of the kidney, increased urine volume and feeling thirsty

• changes in the child's urine and back pain due to kidney problems, including kidney failure

• weakening of the bones (with bone pain, sometimes leading to fractures), which may occur due to damage to renal tubular cells

• fatty liver

• If you think the child may have any of these serious side effects, consult the child's doctor.

More common side effects

The following side effects are very common (may affect at least 10 in 100 patients):

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

Blood tests may also show:

• decreased blood phosphate levels

Other possible side effects

The following side effects are common (may affect up to 10 in 100 patients):

• flatulence

Blood tests may also show:

• liver problems

The following side effects are uncommon (may affect up to 1 in 100 patients):

• muscle breakdown, muscle pain, or muscle weakness

Blood tests may also show:

• decreased blood potassium levels
• increased blood creatinine
• problems with the pancreas

Muscle breakdown, weakening of the bones (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may occur due to damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 patients):

• abdominal pain caused by inflammation of the liver
• swelling of the face, lips, tongue, or throat

Reporting of side effects

If the child experiences any side effect, consult the child's doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viread

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Viread

• The active substance is tenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).

• Other components are: microcrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, monohydrate lactose and magnesium stearate (E572), which make up the tablet core; and monohydrate lactose, hypromellose (E464), titanium dioxide (E171) and glyceryl triacetate (E1518), which make up the film coating of the tablet.

See section 2 “Viread contains lactose”.

Appearance of the product and contents of the container

Film-coated white capsule-shaped tablets, 15.4 mm x 7.3 mm, marked on one side with “GSI” and on the other with “250”. Viread 204 mg film-coated tablets are available in bottles containing 30 tablets. Each bottle contains a silica gel desiccant, which should remain inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

This medicine is available in pack sizes of 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer:

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.