Label: information for the user

Viread 204 mg film-coated tablets

Tenofovir disoproxil

Read this label carefully before the child starts taking this medicine, as it contains important information for you.

• Keep this label, 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 only for the child, and should not be given to other people even if they have the same symptoms as the child, as it may harm them.
• If the child experiences any side effects, consult the child's doctor or pharmacist, even if they are not listed in this label. See section 4.

Viread contains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral medication that is used to treat HIV or HBV or both infections. Tenofovir is anucleotide reverse transcriptase inhibitor analog, commonly known as NtRTI, which acts by interfering with the normal function of an enzyme (in HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) that are essential for viruses to replicate. For the treatment of HIV infection, Viread must be used always in combination with other medications.

Viread 204 mg tablets are a medication used to treatHIV infection (Human Immunodeficiency Virus).

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

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

Viread204 mg tablets are also a medication used to treat chronic hepatitis B, a HBV infection (hepatitis B virus).

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

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

No HIV infection is required for a child to be treated with Viread for HBV.

This medication is not a cure for HIV infection. While the child is taking Viread, they may still have infections or other diseases associated with HIV infection. The child may also continue to transmit HIV or HBV to others. Therefore, it is essential to take precautions to avoid infecting others.

Do not administer Viread

• If this is the case for the child,inform your child's doctor immediately and do not administer Viread.

Warnings and precautions

• Viread 204 mg tablets are only suitable for children who have already been treatedwith other HIV medications that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

• Check the child's age and weightto see if Viread 204 mg tablets are suitable, seeChildren and adolescents.

Consult your child's doctor or pharmacist before starting to administer Viread.

• Be careful not to transmit your infection to others.While taking this medication, the child can still transmit HIV to others, although effective antiviral treatment reduces the risk. Viread does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. Consult your child's doctor about the precautions needed to avoid infecting others.

• If the child has had kidney disease or if their tests have shown kidney problems, consult your child's doctor or pharmacist.Viread should not be administered to children with existing kidney problems. Viread can affect the child's kidneys during treatment. Before starting treatment, your child's doctor may request blood tests to evaluate kidney function. Your child's doctor may also request blood tests during treatment to monitor kidney function.

Viread is usually not taken with other medications that can damage the child's kidneys (seeTaking Viread with other medications). If this is unavoidable, your child's doctor will monitor kidney function once a week.

• Bone problems.Some adult patients with HIV who receive combination antiretroviral treatment may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Factors that increase the risk of developing this disease include the duration of combination antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a 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 tubular cells (see section 4, Possible side effects).

• Talk to your child's doctor if they have a history of liver disease, including hepatitis.Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If the child has hepatitis B infection, your child's doctor will carefully consider the best treatment for them. If the 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 the child has advanced HIV infection (AIDS) and another type of infection, they may develop symptoms of infection and inflammation or worsening of existing infection symptoms when starting Viread treatment. These symptoms may indicate that the child's improved immune system is fighting the infection. Be aware if signs of inflammation or infection appear shortly after the 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 that occurs when the immune system attacks healthy body tissue) may also occur after the child starts taking medications for HIV treatment.

Autoimmune disorders may occur many months after starting treatment. If you observe that the child is experiencing any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the body 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:

• Children infected with HIV-1 between 6 and less than 12 years old who weigh between 28 kg and less than 35 kg and who have been treatedwith other HIV medications that are no longer fully effective due to the development of resistance, or that have caused adverse effects.
• • Children infected with HBV between 6 and less than 12 years old who weigh between 28 kg and less than 35 kg.

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

To know the dose, see section 3, How to take Viread.

Other medications and Viread

Inform your child's doctor or pharmacist if the child is taking, has taken recently, or may need to take any other medication.

• Do not interrupt treatment with any prescribed HIV medicationby your child's doctor when starting Viread treatment if they have both HBV and HIV.

• Do not administer Vireadif the child is taking medications that already contain tenofovir disoproxil or tenofovir alafenamide. Do not administer Viread with medications that contain adefovir dipivoxil (a medication used to treat chronic hepatitis B).

• It is very important to tell your child's doctor if the child is taking other medications that can damage their kidneys.

These medications include:

• Other medications that contain didanosine (for HIV infection):Taking Viread with other antiviral medications that contain didanosine may increase didanosine levels in the blood and reduce CD4 cell count. When taken together, medications containing tenofovir disoproxil and didanosine have been associated with rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal. Your child's doctor will carefully consider whether to treat them with combinations of tenofovir and didanosine.

• It is also important to inform your child's doctor if they are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Viread with food and drinks

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

Pregnancy and breastfeeding

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

• The woman should not take Viread during pregnancyunless she has specifically consulted with her doctor. Although there are few clinical data on the use of Viread in pregnant women, it is generally not used unless absolutely necessary.

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

• If the woman has taken Vireadduring her pregnancy, her doctor may request periodic blood tests and other diagnostic tests to monitor the child's development. In children whose mothers took medications like Viread (ITIAN) during pregnancy, the benefit of virus protection was greater than the risk of adverse effects.

• The woman should not breastfeed during Viread treatment.This is because the active ingredient in this medication passes into breast milk.

• The woman should not breastfeed to avoid passing the virus to the child through breast milk.

Driving and using machines

Viread may cause dizziness. If the child notices dizziness during Viread treatment, they should notdrive or ride a bike,or operate tools or machines.

Viread contains lactose

Inform your child's doctor before administering Viread.If your child's doctor has indicated that the child has a intolerance to certain sugars, consult with them before taking this medication.

The child must follow exactly the administration instructions of this medication indicated by their doctor or pharmacist.In case of doubt, consult the doctor or pharmacist of the child again.

The recommended dose is:

• Children between 6 and less than 12 years old who weigh between 28 kg and less than 35 kg:

1 tablet per day 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 their medication is completely effective, and to reduce the risk of developing resistance to treatment. Do not change the dose unless the child's doctor tells them to.

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

Consult the prospectuses of the other antiretrovirals to know how to take these medications.

If the child takes more Viread than they should

If the child accidentally took too many Viread tablets, they may be at a higher risk of experiencing possible side effects with this medication (see section 4, Possible side effects). Consult the child's doctor or go to the nearest emergency service. Bring the tablet container with them so they can easily describe what the child has taken.

If the child forgets to take Viread

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

• If it is less than 12 hoursafter when they normally take it, they should take it as soon as possible, and then take their next dose at their usual time.

• If it is more than 12 hourssince the child should have taken it, they should not take the missed dose. Wait and administer the next dose at their usual time. Do not administer a double dose to compensate for the missed doses.

If the child vomits before 1 hour after taking Viread,administer another tablet to the child. The child does not need to take another tablet if they vomited more than 1 hour after taking Viread.

If the child interrupts treatment with Viread

The child should not stop taking Viread without their doctor's permission. Stopping treatment with Viread may reduce the effectiveness of the recommended treatment.

If the child has hepatitis B or HIV and hepatitis B together (coinfection),it is very important that they do not stop their treatment with Viread without first talking to their doctor. After stopping treatment with Viread, some patients have presented blood test results or symptoms indicating that their hepatitis had worsened. It may be necessary to have the child's blood tested for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may lead to worsening of the child's hepatitis.

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

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

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

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

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

Like all medications, this medication may produce side effects, although not all people will experience them.

Severe side effects: report to the child's doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare but severe side effect that can be fatal. The following side effects may be signs of lactic acidosis:

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

Other possible severe side effects

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

• abdominal pain(bloating) caused by pancreatitis

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

• kidney inflammation,increased urine volume, and sensation of thirst

• changes in the child's urine andback paindue to kidney problems, including kidney failure

• bone weakening (withbone painand sometimes leading to fractures), which may occur due to kidney cell damage.

• steatosis

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

More frequent side effects

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

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

Tests may also show:

• decreased phosphate levels in the blood

Other possible side effects

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

• flatulence

Tests may also show:

• liver problems

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

• muscle rupture, muscle pain, or muscle weakness

Tests may also show:

• decreased potassium levels in the blood

• increased creatinine levels in the blood

• pancreas problems

Muscle rupture, bone weakening (with bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood, may occur due to kidney cell damage.

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

Reporting side effects

If the child experiences any type of side effect, consult the child's doctor or pharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. This will help protect the environment.

Composition of Viread

• The active ingredient is tenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (in the form of fumarate).

• The other components are:microcrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate, and magnesium stearate (E572), which form the core of the tablet; and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), and triacetin (E1518), which form the film coating of the tablet.

See section 2 “Viread contains lactose”.

Appearance of the product and contents of the pack

White film-coated tablets, in capsule shape, 15.4 mm x 7.3 mm, marked on one face 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 that must be kept inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container and must not be taken.

This medicinal product is available in packs of 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

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For more detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.