Patient information leaflet: information for the user

Viread 123 mg film-coated tablets

tenofovir disoproxil
Please read this leaflet carefully before the child takes this medicine because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for the child only. Do not give it to other people, even if their symptoms are the same as the child's, because it could be harmful.
If the child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Viread is and what it is used for
What you need to know before the child takes Viread
How to take Viread
Possible side effects
How to store Viread
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 HIV infection, HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, which works by interfering with the normal activity of certain enzymes (reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for viruses to replicate. Viread must always be used in combination with other medicines when treating HIV infection.
Viread 123 mg tablets is a treatment for HIV (human immunodeficiency virus) infection.
Viread 123 mg tablets is intended for use in children. It is indicated exclusively for:

children aged 6 to less than 12 years
children with body weight between 17 kg and less than 22 kg
children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance or that have caused undesirable effects.

Viread 123 mg tablets is also used for the treatment of chronic hepatitis B,
a HBV infection (hepatitis B virus).
Viread 123 mg tablets is intended for use in children. It is indicated exclusively for:

children aged 6 to less than 12 years
children with body weight between 17 kg and less than 22 kg

The child does not need to be infected with HIV to receive Viread treatment for HBV.
This medicine is not a cure for HIV infection. While taking Viread, the child may still develop infections or other illnesses associated with HIV infection. The child may also transmit the HBV virus to others, so it is important to take precautions to avoid infecting other people.

2. What you should know before the child takes Viread

Do not give Viread to the child

If the child is allergic to tenofovir, tenofovir disoproxil, or to any of the other ingredients of this medicine listed in section 6.

If this applies, inform the doctor immediately and do not give Viread to the child.
Warnings and precautions

In the treatment of HIV infection, Viread 123 mg tablets are indicated only for children who have previously been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.
Check the child’s age and weight to determine whether Viread 123 mg tablets are appropriate for him/her; see Children and adolescents.

Viread does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. You must continue to take precautions to prevent this.
Please consult the doctor or pharmacist before giving Viread to the child.

If the child has had kidney disease, or if blood tests have shown kidney problems. Viread must not be administered to children who already have kidney problems. Viread may cause kidney-related effects during treatment. Before starting treatment, the doctor may order blood tests to assess kidney function. The doctor may also order blood tests during treatment to monitor kidney function.

Viread should not be taken together with other medicines that may harm the kidneys (see
Other medicines and Viread ). If this is unavoidable, the doctor will monitor the child’s kidney function once a week.

If the child has osteoporosis, has had bone fractures in the past, or has bone problems.

Bone problems (manifesting as persistent or worsening bone pain, and sometimes resulting in fractures) may occur due to damage to the renal tubular cells (see section 4, Possible side effects ). Inform the doctor if the child experiences bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. More pronounced bone loss has been observed in clinical studies where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients are uncertain.
Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact the doctor if you notice any of these symptoms.

Inform the doctor if the child has previously had liver problems, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of severe and potentially fatal liver complications. If the child has hepatitis B, the doctor will carefully evaluate the most appropriate treatment regimen for him/her. If the child has had liver disease or chronic hepatitis B, the doctor may request blood tests to monitor liver function.
Be cautious about infections. If the child has advanced HIV (AIDS) and has an infection, he/she 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 the body’s immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after the child starts taking Viread. If you notice signs of inflammation or infection, inform the doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after the child starts taking medicines for HIV infection.
Autoimmune disorders may occur many months after starting treatment. If you notice in the child any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremor, or hyperactivity, inform the doctor immediately to receive necessary treatment.
Children and adolescents
Viread 123 mg tablets are indicated exclusively for:

HIV-infected children aged 6 to less than 12 years, weighing between 17 kg and less than 22 kg, who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development or that have caused side effects.
HBV-infected children aged 6 to less than 12 years, weighing between 17 kg and less than 22 kg

Viread 123 mg tablets are not indicated for the following categories:

Not indicated in children weighing less than 17 kg or weighing 22 kg or more. Contact the doctor if the child’s weight is outside the permitted range.
Not indicated in children and adolescents under 6 years of age or aged 12 years or older.

For dosage information, see section 3, How to take Viread.
Other medicines and Viread
Inform the doctor or pharmacist if the child is taking, has recently taken, or might take any other medicine.

When starting Viread therapy, the child must not stop taking any anti-HIV medicines prescribed by the doctor, especially if infected with both HBV and HIV.
Do not administer Viread if the 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).
It is particularly important to inform the doctor if the child is taking other medicines that may harm 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 (for cancer treatment)
adefovir dipivoxil (for HBV)
tacrolimus (for immune system suppression)
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes resulting in death. The doctor must carefully consider whether to treat the child with tenofovir and didanosine in combination.
It is also important to inform the doctor if the child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Viread with food and drink
Viread must be taken with food (e.g., a meal or snack).
Pregnancy and breastfeeding
If the girl is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, ask the doctor or pharmacist for advice before giving this medicine to the child.

If the girl has taken Viread during pregnancy, the doctor may request regular blood tests and other diagnostic examinations to monitor the child’s development. In children whose mothers took medicines like Viread (NRTIs) during pregnancy, the benefit of protection against the virus has outweighed the risk of side effects.
If the girl has HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, the girl may be able to breastfeed the newborn, but this should be discussed with the doctor first for further information.
Breastfeeding is not recommended for HIV-positive mothers because HIV infection can be transmitted to the child through breast milk. If the girl is breastfeeding or considering breastfeeding, she must discuss this with the doctor as soon as possible.

Driving and using machines
Viread may cause dizziness. If dizziness occurs while taking Viread, the child must not drive or ride a bicycle, and must not operate tools or machinery.
Viread contains lactose
Inform the doctor before administering Viread. If the doctor has diagnosed the child with an intolerance to certain sugars, contact the doctor before the child takes this medicine.
Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Viread

The child must take this medicine exactly as prescribed by the
doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended dose is:

Children aged 6 to less than 12 years with a body weight between 17 kg and less than 22 kg: 1 tablet daily, taken with food (for example, a meal or a snack).

The doctor will monitor the child's weight.
The child must always take the dose prescribed by the doctor. This is important to ensure that the
medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change
the dose unless instructed by the doctor.
In the treatment of HIV infection, the doctor will prescribe Viread together with other antiretroviral
medicines.
Please refer to the package leaflet of the other antiretrovirals for guidance on how to take these
medicines.

If the child takes more Viread than they should
If the child accidentally takes too many Viread tablets, the risk of experiencing possible side effects
from this medicine may increase (see section 4, Possible side effects). Contact the doctor or the
nearest emergency department. Bring 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 not to miss any doses of Viread. If the child misses a dose, consider how much time has
passed since the missed dose.

If less than 12 hours have passed since the usual dosing time, the child should take the medicine as soon as possible, then take the next dose at the usual scheduled time.
If more than 12 hours have passed since the usual dosing time, the child should not take the missed dose. Wait and administer the next dose as scheduled. Do not give a double dose to make up for the missed tablet.

If the child vomits within 1 hour after taking Viread, give another tablet. The child should not be
given another tablet if vomiting occurs more than 1 hour after taking Viread.

If the child stops treatment with Viread
The child must not stop taking Viread without consulting the doctor. Stopping Viread may reduce the
effectiveness of the treatment prescribed by the doctor.
If the child has hepatitis B infection, or both HIV and hepatitis B (co-infection), it is particularly
important not to stop treatment with Viread without first contacting the doctor. Some patients have
experienced worsening of hepatitis, as shown by symptoms or blood tests, after stopping Viread. Blood
tests may need to be repeated for several months after stopping treatment. In patients with advanced
liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of
hepatitis in some patients.

Talk to the doctor before the child stops taking Viread for any reason, especially if a side effect has occurred or if the child has another illness.
Inform the doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact the doctor before the child restarts taking Viread tablets.

If you have any questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes in the child.

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

Serious possible side effects: inform your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may occur in up to 1 in 1,000 patients), but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:
- deep and rapid breathing
- drowsiness
- feeling unwell (nausea, vomiting, stomach pain)

If you think the child may have lactic acidosis, contact your doctor immediately.

Other possible serious side effects

The following side effects are uncommon (occur in up to 1 in 100 patients treated):

stomach (abdominal) pain caused by inflammation of the pancreas
damage to certain kidney cells (tubular cells)

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

kidney inflammation, excessive urination and thirst
changes in urine and back pain due to kidney problems, including kidney failure
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells
fatty liver

If you think the child is experiencing any of these serious side effects, consult your doctor.

More frequent side effects

The following side effects are very common (occur in at least 10 out of 100 patients treated):

diarrhoea, feeling unwell (vomiting, nausea), dizziness, skin rash, feeling weak

Laboratory tests have also shown:

reduced phosphate levels in the blood

Other possible side effects

The following side effects are common (occur in up to 10 in 100 patients treated):

intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

liver problems

The following side effects are uncommon (occur in up to 1 in 100 patients treated):

muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

reduced potassium levels in the blood
increased creatinine levels in the blood
problems with the pancreas

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

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

stomach (abdominal) pain caused by inflammation of the liver
swelling of the face, lips, tongue or throat

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 packaging following
{Exp.}. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Viread contains

The active substance is tenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
The other ingredients are microcrystalline cellulose (E460), pregelatinized starch, croscarmellose sodium, monohydrate lactose and magnesium stearate (E572) which constitute the tablet core, and monohydrate lactose, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate (E1518) which form the film coating of the tablet. See section 2 “Viread contains lactose”.

Description of the appearance of Viread and contents of the pack
Viread 123 mg film-coated tablets are white, triangular-shaped film-coated tablets with a diameter of 8.5 mm, marked on one side with “GSI” and on the other side with the number “150”. Viread 123 mg film-coated tablets are supplied in bottles of 30 tablets. Each bottle contains silica gel as a desiccant, which should be kept in the bottle to protect the tablets. The silica gel is contained in a separate sachet or container and must not be ingested.
The following pack sizes are available: outer packaging containing 1 bottle of 30 film-coated tablets and packs containing 3 bottles of 30 film-coated tablets each. Not all 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 24 01 35 50 Tel: + 353 (0) 1 686 1888

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50

Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel.: + 353 (0) 1 686 1888

Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888

Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98

Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: + 30 210 8930 100 Tel: + 43 1 260 830

España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel.: + 48 22 262 8702

France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: + 40 31 631 18 00

Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888

Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o.
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210

Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888 Tel: + 44 (0) 8000 113 700

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.

Package leaflet: information for the user

Viread 163 mg film-coated tablets

tenofovir disoproxil
Please read this leaflet carefully before the child takes this medicine because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for the child only. Do not give it to other people, even if their symptoms are the same as the child's, as it may be harmful.
If the child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Viread is and what it is used for
What you need to know before the child takes Viread
How to take Viread
Possible side effects
How to store Viread
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 HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, which works by interfering with the normal activity of enzymes (reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for viruses to replicate. Viread must always be used in combination with other medicines when treating HIV infection.
Viread 163 mg tablets are a treatment for HIV (human immunodeficiency virus) infection.
Viread 163 mg tablets are intended for use in children. They are indicated exclusively for:

children aged 6 to less than 12 years
children weighing between 22 kg and less than 28 kg
children who have already been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

Viread 163 mg tablets are also used to treat chronic hepatitis B,
an HBV infection (hepatitis B virus).
Viread 163 mg tablets are intended for use in children. They are indicated exclusively for:

children aged 6 to less than 12 years
children weighing between 22 kg and less than 28 kg

The child does not need to be infected with HIV to receive Viread treatment for HBV.
This medicine is not a cure for HIV infection. While taking Viread, the child may still develop infections or other illnesses associated with HIV infection. The child may also transmit the HBV virus to others; therefore, it is important that precautions are taken to avoid infecting other people.

2. What you need to know before your child takes Viread

Do not give Viread to your child

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

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

In the treatment of HIV infection, Viread 163 mg tablets are indicated only for children who have previously been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused side effects.
Check your child’s age and weight to determine whether Viread 163 mg tablets are appropriate for them; see Children and adolescents.

Viread does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. Discuss with your doctor the necessary precautions to avoid transmitting the infection to other people.
Talk to your doctor or pharmacist before giving Viread to your child.

If your child has had kidney disease, or if blood tests have shown kidney problems. Viread must not be given to children who already have kidney problems. Viread may affect the kidneys during treatment. Before starting treatment, the doctor may prescribe blood tests to assess kidney function. The doctor may also prescribe blood tests during treatment to monitor kidney function.

Viread should not be taken with other medicines that may damage the kidneys (see Other medicines and Viread). If this is unavoidable, the doctor will monitor your child’s kidney function once a week.

If your child has osteoporosis, has had bone fractures in the past, or has bone problems.

Bone problems (manifesting as persistent or worsening bone pain, and sometimes leading to fractures) may occur due to damage to the kidney tubular cells (see section 4, Possible side effects). Inform the doctor if your child experiences bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. More pronounced bone loss has been observed in clinical studies where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients are uncertain.
Some adult HIV patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the numerous risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, pain (especially in hips, knees, and shoulders), and difficulty moving. Contact the doctor if you notice the onset of any of these symptoms.

Inform the doctor if your child has previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If your child has hepatitis B, the doctor will carefully evaluate the most appropriate treatment regimen for them. If your child has had liver disease or chronic hepatitis B, the doctor may request blood tests to monitor liver function.
Be cautious about infections. If your child has advanced HIV (AIDS) and has an 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 the body's immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after your child starts taking Viread. If you notice signs of inflammation or infection, inform the 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 occur several months after starting treatment. If you notice any signs of infection or other symptoms in your child such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremors, or hyperactivity, inform the doctor immediately to receive necessary treatment.
Children and adolescents
Viread 163 mg tablets are indicated exclusively for:

HIV-1 infected children aged 6 to less than 12 years with body weight between 22 kg and less than 28 kg who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development or that have caused side effects
HBV-infected children aged 6 to less than 12 years with body weight between 22 kg and less than 28 kg

Viread 163 mg tablets are not indicated for the following categories:

Not indicated in children with body weight below 22 kg or equal to or above 28 kg. Contact the doctor if your child's weight is outside the permitted range.
Not indicated in children and adolescents under 6 years of age or equal to or above 12 years of age.

For dosage instructions, see section 3, How to take Viread.
Other medicines and Viread
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

When starting therapy with Viread, your child must not stop taking any anti-HIV medicines prescribed by the doctor, especially if infected with both HBV and HIV.
Do not administer 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).
It is particularly important to inform the doctor if your child 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 immune system suppression)
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines containing didanosine may increase blood levels of didanosine and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes resulting in death. The doctor must carefully consider whether to treat your child with tenofovir and didanosine in combination.
It is also important to inform the doctor if your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Viread with food and drink
Viread must be taken with food (e.g., a meal or snack).
Pregnancy and breastfeeding
If the girl is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, ask your doctor or pharmacist for advice before giving this medicine to her.

If the girl has taken Viread during pregnancy, the doctor may regularly request blood tests and other diagnostic examinations to monitor the child's development. In children whose mothers took medicines such as Viread (NRTIs) during pregnancy, the benefit of protection against the virus has outweighed the risk of side effects.
If the girl has HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, she may be able to breastfeed, but this should be discussed with the doctor first to obtain further information.
Breastfeeding is not recommended for HIV-positive mothers because HIV infection can be transmitted to the child through breast milk. If the girl is breastfeeding or considering breastfeeding, she must talk to her doctor as soon as possible.

Driving and using machines
Viread may cause dizziness. If dizziness occurs while taking Viread, your child must not drive, ride a bicycle, or operate tools or machinery.
Viread contains lactose
Inform the doctor before administering Viread. If the doctor has diagnosed your child with an intolerance to certain sugars, contact the doctor before your child takes this medicine.
Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Viread

The child must take this medicine exactly as instructed by the
doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended dose is:

Children aged 6 to less than 12 years with body weight between 22 kg and less than 28 kg: 1 tablet daily, taken with food (for example, a meal or a snack).

The doctor will monitor the child's body weight.
The child must always take the dose prescribed by the doctor. This is important to ensure that the
medicine remains fully effective and to reduce the risk of developing resistance to treatment. Do not
change the dose unless instructed by the doctor.
In the treatment of HIV infection, the doctor will prescribe Viread together with other antiretroviral
medicines.
Please refer to the package leaflets of the other antiretrovirals for guidance on how to take these
medicines.

If the child takes more Viread than they should
If the child accidentally takes too many tablets of Viread, the risk of experiencing possible side effects
from this medicine may increase (see section 4, Possible side effects). Contact the doctor or the
nearest emergency centre immediately. Bring 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 no dose of Viread is missed. If the child forgets a dose, consider how much time has
passed since the missed dose.

If less than 12 hours have passed since the usual dosing time, the child should take the medicine as soon as possible, then take the next dose at the usual time.
If more than 12 hours have passed since the usual dosing time, the child should not take the missed dose. Wait and administer the next dose at the regular time. Do not give a double dose to make up for the forgotten tablet.

If the child vomits within 1 hour of taking Viread, give another tablet. The child should not be given
another tablet if vomiting occurs more than one hour after taking Viread.

If the child stops taking Viread
The child must not stop taking Viread without consulting the doctor. Stopping Viread may reduce the
effectiveness of the treatment prescribed by the doctor.
If the child has hepatitis B infection or both HIV and hepatitis B (co-infection), it is especially
important not to stop treatment with Viread without first contacting the doctor. Some patients have
experienced worsening of hepatitis, as shown by symptoms or blood tests, after stopping Viread. Blood
tests may need to be repeated for several months after stopping treatment. In patients with advanced
liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of
hepatitis in some patients.

Talk to the doctor before the child stops taking Viread for any reason, especially if they have experienced a side effect or have another illness.
Inform the doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact the doctor before the child restarts taking Viread tablets.

If you have any questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes also to the HIV medicines themselves. Your doctor will monitor these changes in the child.

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

Serious possible side effects: inform your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may occur in up to 1 in 1,000 patients), but serious side effect, which may be fatal. The following side effects may be signs of lactic acidosis:
- deep and rapid breathing
- drowsiness
- feeling unwell (nausea, vomiting, and stomach pain)

If you think the child may have lactic acidosis, contact your doctor immediately.

Other possible serious side effects

The following side effects are uncommon (occur in up to 1 in 100 patients treated):

abdominal pain caused by inflammation of the pancreas
damage to certain kidney cells (tubular cells)

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

kidney inflammation, excessive urination and thirst
changes in urine and back pain in the child due to kidney problems, including kidney failure
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells
fatty liver

If you think the child may be experiencing any of these serious side effects, consult your doctor.

More frequent side effects

The following side effects are very common (occur in at least 10 out of every 100 patients treated):

diarrhoea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

decreased phosphate levels in the blood

Other possible side effects

The following side effects are common (occur in up to 10 in every 100 patients treated):

intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

liver problems

The following side effects are uncommon (occur in up to 1 in 100 patients treated):

muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

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

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

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

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

Reporting of side effects

If you notice any side effect, including any not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Viread

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the outer carton after
{Exp.}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Package contents and other information

What Viread contains

The active substance is tenofovir. Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
The other components are microcrystalline cellulose (E460), pregelatinized starch, croscarmellose sodium, monohydrate lactose and magnesium stearate (E572) which constitute the tablet core, and monohydrate lactose, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate (E1518) which form the tablet coating. See section 2 “Viread contains lactose”.

Description of the appearance of Viread and the contents of the pack
The film-coated tablets of Viread 163 mg are white, round, film-coated tablets with a diameter of 10.7 mm, marked on one side with “GSI” and on the other side with the number “200”. The film-coated tablets of Viread 163 mg are supplied in bottles containing 30 tablets. Each bottle contains a silica gel desiccant as a drying agent, which should be kept in the bottle to protect the tablets. The silica gel is contained in a separate sachet or small container and must not be ingested.
The following pack sizes are available: outer packaging containing 1 bottle of 30 film-coated tablets and packs containing 3 bottles of 30 film-coated tablets each. Not all 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