VIREAD 245 mg Film-Coated Tablets

Зміст інструкції

1. Viread 123 mg film-coated tablets
   1. What is Viread and what is it 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
2. Viread 163 mg film-coated tablets
   1. What is Viread and what is it 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. Package contents and other information
3. Viread 204 mg film-coated tablets
   1. What is Viread and what is it 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
4. Viread 245 mg film-coated tablets
   1. What is Viread and what is it used for
   2. What you need to know before taking Viread
   3. How to take Viread
   4. Possible side effects
   5. How to store Viread
   6. Package contents and other information
5. Viread 33 mg/g granules
   1. What is Viread and what is it used for
   2. What you need to know before taking Viread
   3. How to take Viread
   4. Possible side effects
   5. How to store Viread
   6. Package contents and other information

Viread 123 mg film-coated tablets

tenofovir disoproxil

Read this leaflet carefully before your 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, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if their symptoms are the same as your child's, as it could be harmful.
• If your child gets any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Viread is and what it is used for
• 2. What you need to know before your 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 is Viread and what is it used for

Viread contains the active ingredient tenofovirdisoproxil. This active ingredient is a

antiretroviralor antiviral medicine that is used for the treatment of HIV infection, or HBV, or
both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generically known as
NRTI and works by interfering with the normal activity of enzymes (reverse transcriptasein HIV; DNA

polymerasein hepatitis B) which are essential for viruses to reproduce. Viread for the treatment
of HIV infection must always be used in association with other medicines.

Viread 123 mg tablets is a treatment forHIV(human immunodeficiency
virus) infection.
Viread 123 mg tablets is intended for use in children. It is indicated exclusively for:

• children aged between 6 and less than 12 years
• children with a body weight between 17 kg and less than 22 kg
• children who have already been treatedwith other medicines against HIV which, due to the development of resistances, are no longer fully effective or have caused undesirable effects.

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

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

The child does not necessarily have to be infected with HIV to receive therapy with Viread for
HBV.
This medicine is not a cure for HIV infection. While taking Viread, the child may
still contract infections or other diseases associated with HIV infection. The child may also
transmit the HBV virus to others, therefore it is important that they take precautions to avoid infecting
other people.

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

Do not give Viread to the child

• If the child is allergicto tenofovir, tenofovir disoproxil or to any of the other ingredients of this medicine listed in section 6.
• If this is the case , 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 is indicated exclusively forchildren who have already been treatedwith other medicines for HIV that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.
• Check the child’s age and weightto establish if Viread 123 mg tablets is suitable for him, see Children and adolescents.

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

• If the child has had kidney disease, or if tests have shown kidney problems.Viread should not be given to children who already suffer from kidney problems. Viread may have effects on 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 can damage 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 suffers from osteoporosis,has had bone fractures in the past or has bone problems.

Bone problems(which manifest as persistent or worsening bone pain and
sometimes resulting in fractures) may also occur due to damage to the cells of the kidney tubules (see section 4, Possible side effects). Tell the doctor if the child has
bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mass. The most
pronounced loss of bone mass was observed in clinical studies in which patients were treated with
tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the risk of
future fractures in adult and pediatric patients are uncertain.
Some adult patients with HIV who are taking combination antiretroviral therapy may
develop a bone disease called osteonecrosis (bone tissue death caused by a
lack of blood flow to the bone). The duration of combination antiretroviral therapy,
the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher
body mass index, among others, may be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis are joint stiffness,
discomfort and pain (especially in the hips, knees and shoulders) and difficulty in
movement. See a doctor if you notice any of these symptoms.

• Tell the doctor if the child has had liver problems in the past, 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 the child has hepatitis B, the doctor will carefully evaluate the best treatment regimen for him. If the child has had liver disease or chronic hepatitis B, the doctor may require blood tests to monitor liver function.
• Be careful of infections.If the child is affected by advanced HIV (AIDS) and presents an infection, he may develop symptoms of an infection and inflammation or a worsening of the symptoms of an existing infection when he starts treatment with Viread. These symptoms may indicate that the body's immune system is fighting the infection. Check for signs of inflammation or infection shortly after the child starts taking Viread. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy tissue in the body) may also occur after
the child has started taking medicines to treat HIV infection.
Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in the hands and feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity in the child,
tell your doctor immediately for the necessary treatment.

Children and adolescents
Viread 123 mg tablets is indicated exclusivelyfor:

• children infected with HIV, aged between 6 and less than 12 years, with a body weightbetween 17 kg and less than 22 kg, who have already been treatedwith other medicines against HIV that, due to the development of resistance, are no longer fully effective or that have caused undesirable effects.
• children infected with HBV, aged between 6 and less than 12 years, with a body weightbetween 17 kg and less than 22 kg

Viread 123 mg tablets is notindicated for the following categories:

• not indicated inchildren with a body weight less than 17 kg or equal to or greater than 22 kg. Contact your doctor if the child's weight is not within the allowed limits.
• not indicated inchildren and adolescents under 6 years of age or equal to or greater than 12 years of age.

For dosage see section 3, How to take Viread.

Other medicines and Viread
Tell your doctor or pharmacist if the child is taking, has recently taken or might
take any other medicine.

• When starting therapy with Viread, the child must not stop taking anyanti-HIV medicineprescribed by the doctor, if he has both HBV and HIV infection.
• Do not give Vireadif 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 tell the doctor if the child is taking othermedicines that can 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 immunosuppression)
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
• Other medicines that contain didanosine (for HIV infection):Taking Viread with other antiviral medicines that contain didanosine may increase levels of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely reported when medicines containing tenofovir disoproxil and didanosine have been taken together, sometimes causing death. The doctor will need to carefully consider whether to treat the child with tenofovir and didanosine in combination.
• It is also important to warn the doctorif the child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Viread with food and drink
Viread must be taken with food(e.g. a meal or a snack).

Pregnancy and breastfeeding
If the girl is pregnant, suspects she may be pregnant or is planning a pregnancy, or if she is breastfeeding, ask your doctor or pharmacist for advice before giving her this medicine.

• If the girl has already taken Vireadduring pregnancy, the doctor may require regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers have taken 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 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 more information.
• Breastfeeding is not recommended for HIV-positive mothers as HIV infection can be transmitted to the baby through breast milk. If the girl is breastfeeding or is considering breastfeeding she must talk to her doctor as soon as possible.

Driving and using machines
Viread can cause dizziness. If dizziness occurs while taking Viread, the child must not
driveor ride a bicycleand must not use tools or machinery.

Viread contains lactose
Tell the doctor before giving Viread.If the doctor has diagnosed the child with
an intolerance to certain sugars, contact him before taking this medicine.

Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
ʽsodium-free’.

3. How to take Viread

The child must take this medicine following the instructions of the
doctor or pharmacist exactly.If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

• Children aged between 6 and less than 12 yearswith a body weight between 17 kg andless than 22 kg:1 tablet each day to be taken with food (for example, a meal or a snack).

The doctor will check the child's weight.

The child must always take the dose recommended by the doctor.This is to ensure that the medicines are fully effective and to reduce the risk of developing resistance to
treatment. Do not change the dose unless your doctor tells you to.
In the treatment of HIV infection, the doctor will prescribe Viread together with other antiretroviral
medicines.

If the child takes more Viread than they should
If the child accidentally takes too many Viread tablets, it may increase the risk of
developing possible side effects from this medicine (see section 4, Possible side effects

).Contact your doctor or the nearest emergency center. Bring the bottle of
tablets with you so that you can easily describe what the child has taken.

If the child forgets to take Viread
It is important not to forget any dose of Viread. If the child forgets a dose, calculate
how much time has passed since the missed dose.

• If less than 12 hourshave passed since the usual time of taking ,the child should take the medicine as soon as possible and then take the next dose at the scheduled time.
• If more than 12 hourshave passed since the usual time of taking ,the child should not take the forgotten dose. Wait and administer the next dose regularly. Do not administer a double dose to make up for the forgotten tablet.

In case of vomiting occurring within 1 hour of taking Viread,administer another tablet to the child.
The child should not take another tablet if they have vomited more than one hour
after taking Viread.

If the child stops taking Viread
The child should not stop taking Viread without consulting the doctor. Stopping
Viread may reduce the effectiveness of the therapy prescribed by the doctor.

If the child has an infection from hepatitis B, or from HIV and hepatitis B together (co-infection),it is
particularly important not to stop treatment with Viread without first contacting the
doctor. Some patients have experienced a worsening of their hepatitis, as indicated 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 a
worsening of hepatitis in some patients.

• Talk to your doctor before the child stops taking Viread for any reason, especially if they have experienced a side effect or have another illness.
• Immediately inform your doctor of any new or unusual symptoms observed after stopping treatment, particularly symptoms that are normally associated with hepatitis B infection.
• Contact your doctor before the child starts taking Viread tablets again.

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

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check for these changes in the child.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious possible side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 patients) but serious side effect that can 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 has lactic acidosis, contact your doctor immediately.

Other serious possible side effects
The following side effects are not common(may affect up to 1 in 100 treated patients):

• stomach pain(abdomen) caused by inflammation of the pancreas
• damage to specific kidney cells (tubular cells)

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

• kidney inflammation, increased urine output and thirst
• changes in urineand back paincaused by kidney problems, including kidney failure
• softening of the bones (with bone painand sometimes fractures), which may occur due to damage to the renal tubular cells
• fatty liver
• If you think the child is experiencing any of these serious side effects, contact your doctor.

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

• diarrhea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

• reduced phosphate levels in the blood

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

• intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

• liver problems

The following side effects are not common(may affect up to 1 in 100 treated patients):

• muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

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

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 the renal tubular cells.
The following side effects are rare(may affect up to 1 in 1,000 treated patients):

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

Reporting of side effects
If you get any side effect,including any not listed in this leaflet,

talk to your doctor or pharmacist.You can also report side effects directly through the national reporting system listed 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 which is stated on the bottle and the packaging after
{Scad.}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Viread contains

• The active ingredient istenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
• The other ingredients aremicrocrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate and magnesium stearate (E572) which constitute the core of the tablet, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin (E1518) which make up the tablet coating. 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 film-coated tablets,
with a diameter of 8.5 mm, imprinted 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 must be kept in the
bottle to protect the tablets. The silica gel is contained in a separate sachet or jar
and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of
30 film-coated tablets and 3 bottles of 30 film-coated tablets. 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 on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

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

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
Further details on this medicine are available on the European Medicines Agency website, http://www.ema.europa.eu/.

Viread 163 mg film-coated tablets

tenofovir disoproxil

Read this leaflet carefully before the child takes this medicine as it contains important information for you.

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

Contents of this 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 is Viread and what is it used for

Viread contains the active ingredient tenofovir disoproxil. This active ingredient is a

antiretroviralor antiviral medicine that is used for the treatment of HIV, or HBV, or
both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generically known as
NRTI and works by interfering with the normal activity of enzymes (reverse transcriptasein HIV; DNA

polymerasein hepatitis B) that are essential for viruses to reproduce. Viread for the treatment
of HIV infection must always be used in association with other medicines.

Viread 163 mg tablets is a treatment forHIV(human immunodeficiency
virus) .
Viread 163 mg tablets is intended for use in children. It is indicated exclusively for:

• children aged between 6 and less than 12 years
• children with a body weight between 22 kg and less than 28 kg
• children who have already been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective, or that have caused undesirable effects.

Viread 163 mg tablets is also used for the treatment of chronic hepatitis B,
an HBV(hepatitis B virus) infection.
Viread 163 mg tablets is intended for use in children. It is indicated exclusively for:

• children aged between 6 and less than 12 years
• children with a body weight between 22 kg and less than 28 kg

The child does not necessarily have to be infected with HIV to receive therapy with Viread for
HBV.
This medicine is not a cure for HIV infection. While taking Viread, the child may
still contract infections or other diseases associated with HIV infection. The child may also
transmit the HBV virus to others, so it is important that they take precautions to avoid infecting
other people.

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

Do not give Viread to the child

• If the child is allergicto tenofovir, tenofovir disoproxil or to any of the other ingredients of this medicine listed in section 6.
• If this is the case , inform the doctor immediately and do not give Viread to the child.

Warnings and precautions

• In the treatment of HIV infection, Viread 163 mg tablets is indicated exclusively forchildren who have already been treatedwith other medicines for HIV that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.
• Check the child’s age and weightto establish if Viread 163 mg tablets is suitable for them, see Children and adolescents.

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

• If the child has had kidney disease, or if tests have shown kidney problems.Viread should not be given to children who already suffer from kidney problems. Viread may have effects on 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 can damage 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 suffers from osteoporosis,has had bone fractures in the past or has bone problems.

Bone problems(which manifest as persistent or worsening bone pain and
sometimes resulting in fractures) may also occur due to damage to the tubular cells of the
kidneys (see section 4, Possible side effects). Inform the doctor if the child has
bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most
pronounced loss of bone mass has been observed in clinical studies in which patients were treated with
tenofovir disoprixil 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 (bone tissue death caused by a
lack of blood flow to the bone). The duration of combination antiretroviral therapy,
the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher
body mass index, among others, may be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis are joint stiffness,
discomfort and pain (especially in the hips, knees and shoulders) and difficulty in
movement. Consult your doctor if you notice the appearance of any of these symptoms.

• Inform the doctor if the child has had liver problems in the past, 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 the child has hepatitis B, the doctor will carefully evaluate the best treatment regimen for them. If the child has had liver disease or chronic hepatitis B, the doctor may require blood tests to monitor liver function.
• Be careful with infections.If the child is affected by advanced HIV (AIDS) and presents an infection, they may develop symptoms of an infection and inflammation or a worsening of the symptoms of an existing infection when starting treatment with Viread. These symptoms may indicate that the body's immune system is fighting the infection. Check 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 that occurs when the immune system attacks the body's healthy tissue) may also occur after
the child has started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in the hands and feet that rises towards the trunk of the body, palpitations, tremor or hyperactivity in the child, inform the doctor immediately to request the necessary treatment.

Children and adolescents
Viread 163 mg tablets is indicated exclusivelyfor:

• children infected with HIV-1 aged between 6 and less than 12 years with a body weightbetween 22 kg and less than 28 kg who have already been treatedwith other medicines against HIV that, due to the development of resistance, are no longer fully effective or have caused undesirable effects
• children infected with HBV, aged between 6 and less than 12 years, with a body weightbetween 22 kg and less than 28 kg

Viread 163 mg tablets is notindicated for the following categories:

• not indicated inchildren with a body weight of less than 22 kg or equal to or greater than 28 kg. Contact your doctor if the child's weight is not within the allowed limits.
• not indicated inchildren and adolescents under 6 years of age or equal to or greater than 12 years of age.

For dosage 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 therapy with Viread, the child must not stop taking anyanti-HIV medicineprescribed by the doctor, if they have both HBV and HIV infection.
• Do not give Vireadif 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 othermedicines that can 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 immunosuppression)
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
• Other medicines that contain didanosine (for HIV infection):Taking Viread with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and may reduce the CD4 cell count. Rarely, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported when medicines containing tenofovir disoproxil and didanosine have been taken together, which sometimes have caused death. The doctor will need to carefully consider whether to treat the child with tenofovir and didanosine in combination.
• It is also important to warn the doctorif the child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Viread with food and drink
Viread must be taken with food(for example a meal or a snack).

Pregnancy and breastfeeding
If the woman is pregnant, suspects she may be pregnant or is planning a pregnancy, or if she is breastfeeding, ask the doctor or pharmacist for advice before giving this medicine to the child.

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

Driving and using machines
Viread can cause dizziness. If dizziness occurs while taking Viread, the child must not
driveor ride a bicycleand must not use tools or machinery.

Viread contains lactose
Inform the doctor before giving Viread. If the doctor has diagnosed the child with
intolerance to certain sugars, contact them before taking this medicine.

Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
ʽsodium-free’.

3. How to take Viread

The child must take this medicine following the instructions of the
doctor or pharmacist exactly.If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

• children aged between 6 and less than 12 yearswith a body weight between 22 kg andless than 28 kg:1 tablet each day to be taken with food (for example, a meal or a snack).

The doctor will check the child's weight.

The child must always take the dose recommended by the doctor.This is to ensure that the medicines are fully effective and to reduce the risk of developing resistance to
treatment. Do not change the dose unless your doctor tells you to.
In the treatment of HIV infection, the doctor will prescribe Viread together with other antiretroviral
medicines.

If the child takes more Viread than they should
If the child accidentally takes too many Viread tablets, it may increase the risk of
developing possible side effects with this medicine (see section 4, Possible side effects

undesirable).Contact your doctor or the nearest emergency center. 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 forget any dose of Viread. If the child forgets a dose, calculate
how much time has passed since the missed dose.

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

In case of vomiting occurring within 1 hour of taking Viread,administer another tablet to the child.
The child should not take another tablet if they have vomited more than one hour
after taking Viread.

If the child stops treatment with Viread
The child should not stop taking Viread without consulting the doctor. Stopping
Viread may reduce the effectiveness of the therapy prescribed by the doctor.

If the child has an infection with hepatitis B or HIV and hepatitis B together (co-infection),it
is particularly important not to stop treatment with Viread without first contacting the
doctor. Some patients have experienced a worsening of their hepatitis, as indicated 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 a
worsening of hepatitis in some patients.

• Talk to your doctor before the child stops taking Viread for any reason, especially if they have experienced a side effect or have another illness.
• Immediately inform your doctor of any new or unusual symptoms observed after stopping treatment, particularly symptoms that are normally associated with hepatitis B infection.
• Contact your doctor before the child starts taking Viread tablets again.

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

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check for these changes in the child.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious possible side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect 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 and stomach pain)
• If you think the child has lactic acidosis, contact your doctor immediately.

Other serious possible side effects
The following side effects are not common(may affect up to 1 in 100 treated patients):

• stomach pain(abdomen) caused by inflammation of the pancreas
• damage to specific kidney cells (tubular cells)

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

• inflammation of the kidneys, excessive urine and thirst
• changes in urineand back painin the child caused by kidney problems, including kidney failure
• softening of the bones (with bone painand sometimes fractures), which may occur due to damage to the renal tubular cells
• fatty liver
• If you think the child is experiencing any of these serious side effects, consult adoctor.

More frequent side effects
The following side effects are very common(affect at least 10 out of every 100 treated patients):

• diarrhea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

• reduction of phosphate in the blood

Other possible side effects
The following side effects are common(may affect up to 10 out of 100 treated patients):

• intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

• liver problems

The following side effects are not common(may affect up to 1 in 100 treated patients):

• muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

• reduction of potassium in the blood
• increased creatinine in the blood
• problems with the pancreas

Muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain,
muscle weakness and reduction of potassium or phosphate in the blood may occur due to damage
to the renal tubular cells.
The following side effects are rare(may affect up to 1 in 1,000 treated patients):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed 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 which is stated on the bottle and the packaging after
{Scad.}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient istenofovir. Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
• The other ingredients aremicrocrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate and magnesium stearate (E572) which constitute the core of the tablet, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin (E1518) which make up the tablet coating. See section 2 “Viread contains lactose”.

Description of the appearance of Viread and contents of the pack
Viread 163 mg film-coated tablets are white, round film-coated tablets,
with a diameter of 10.7 mm, imprinted on one side with “GSI” and on the other side with the
number “200”. Viread 163 mg film-coated tablets are supplied in bottles of
30 tablets. Each bottle contains silica gel as a desiccant, which must be kept in the
bottle to protect the tablets. The silica gel is contained in a sachet or a separate jar
and must not be ingested.
The following pack sizes are available: outer packaging containing 1 bottle of
30 film-coated tablets and 3 bottles of 30 film-coated tablets. 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

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

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
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/.

Viread 204 mg film-coated tablets

tenofovir disoproxil

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, ask your doctor or pharmacist.
• This medicine has been prescribed only for the child. Do not give it to other people, even if their symptoms are the same as those of the child, as it could be dangerous.
• If the child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 is Viread and what is it used for

Viread contains the active ingredient tenofovirdisoproxil. This active ingredient is a

antiretroviralor antiviral medicine that is used for the treatment of HIV infection, or HBV, or
both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generically known as
NRTI and works by interfering with the normal activity of enzymes (reverse transcriptasein HIV; DNA

polymerasein hepatitis B) that are essential for viruses to reproduce. Viread for the treatment
of HIV infection must always be used in association with other medicines.

Viread 204 mg tablets is a treatment forHIV(human immunodeficiency
virus) infection.
Viread 204 mg tablets is intended for use in children. It is indicated exclusively for:

• children aged between 6 and less than 12 years
• children with a body weight between 28 kg and less than 35 kg
• children who have already been treatedwith other medicines against HIV that, due to the development of resistance, are no longer fully effective, or that have caused undesirable effects.

Viread 204 mg tablets is also used for the treatment of chronic hepatitis B,
an HBV(hepatitis B virus) infection.
Viread 204 mg tablets is intended for use in children. It is indicated exclusively for:

• children aged between 6 and less than 12 years
• children with a body weight between 28 kg and less than 35 kg

The child does not necessarily have to be infected with HIV to receive therapy with Viread for
HBV.
This medicine is not a cure for HIV infection. While taking Viread, the child may
still contract infections or other diseases associated with HIV infection. The child may also
transmit the HBV virus to others, therefore it is important that they take precautions to avoid infecting
other people.

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

Do not give Viread to the child

• If the child is allergicto tenofovir, tenofovir disoproxil or to any of the other ingredients of this medicine listed in section 6.
• If this is the case , inform the doctor immediately and do not give Viread to the child.

Warnings and precautions

• In the treatment of HIV infection, Viread 204 mg tablets is indicated exclusively forchildren who have already been treatedwith other medicines for HIV that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.
• Check the child's age and weightto establish whether Viread 204 mg tablets is suitable for him, see Children and adolescents.

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

• If the child has had kidney disease, or if tests have shown kidney problems.Viread should not be given to children who already suffer from kidney problems. Viread may have effects on 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 can damage 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 suffers from osteoporosis,has had bone fractures in the past or has bone problems.

Bone problems (which manifest as persistent or worsening bone pain and
sometimes resulting in fractures) can also occur due to damage to the tubular cells of the
kidneys (see section 4, Possible side effects). Tell the doctor if the child has
bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most
pronounced loss of bone mass has been observed in clinical studies in which patients were treated with
tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the risk of
future fractures in adult and pediatric patients are uncertain.
Some adult patients with HIV who are taking combination antiretroviral therapy may
develop a bone disease called osteonecrosis (bone tissue death caused by
a lack of blood flow to the bone). The duration of combination antiretroviral therapy,
the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher
body mass index, among others, may be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis are joint stiffness,
discomfort and pain (especially in the hips, knees and shoulders) and difficulty in
movement. Consult your doctor if you notice the appearance of any of these symptoms.

• Tell the doctor if the child has had liver problems in the past, 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 the child has hepatitis B, the doctor will carefully evaluate the best therapeutic regimen for him. If the child has had liver disease or chronic hepatitis B, the doctor may require blood tests to monitor liver function.
• Be careful with infections.If the child is affected by advanced HIV (AIDS) and presents an infection, he may develop symptoms of an infection and inflammation or a worsening of the symptoms of an existing infection when starting treatment with Viread. These symptoms may indicate that the body's immune system is fighting the infection. Check for signs of inflammation or infection shortly after the child starts taking Viread. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks the body's healthy tissue) may also occur after
the child has started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity in the child,
immediately inform the doctor to request the necessary treatment.

Children and adolescents
Viread 204 mg tablets is indicated exclusivelyfor:

• children infected with HIV-1 aged between 6 and less than 12 years with a body weightbetween 28 kg and less than 35 kg who have already been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective or that have caused undesirable effects
• children infected with HBV aged between 6 and less than 12 years with a body weightbetween 28 kg and less than 35 kg

Viread 204 mg tablets is notindicated for the following categories:

• not indicated inchildren with a body weight less than 28 kg or equal to or greater than 35 kg. Contact your doctor if the child's weight is not within the permitted limits.
• not indicated inchildren and adolescents under 6 years of age or equal to or greater than 12 years of age.

For dosage see section 3, How to take Viread.

Other medicines and Viread
Tell your doctor or pharmacist if the child is taking, has recently taken or might
take any other medicine.

• When starting therapy with Viread, the child must not stop taking anyanti-HIV medicineprescribed by the doctor, if he has both HBV and HIV infection.
• Do not give Vireadif the child is already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not administer Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is particularly important to tell the doctor if the child is taking othermedicines that can damage his 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 immunosuppression)
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
• Other medicines that contain didanosine (for HIV infection):Taking Viread with other antiviral medicines that contain didanosine may increase levels of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely reported when medicines containing tenofovir disoproxil and didanosine have been taken together, which have sometimes caused death. The doctor will need to carefully consider whether to treat the child with tenofovir and didanosine in combination.
• It is also important to warn the doctorif the child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Viread with food and drink
Viread must be taken with food(for example a meal or a snack).

Pregnancy and breastfeeding
If the girl is pregnant, suspects or is planning a pregnancy, or if she is breastfeeding with
breast milk, ask your doctor or pharmacist for advice before giving her this medicine.

• If the girl has already taken Vireadduring pregnancy, the doctor may require regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers have taken 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, the girl may be able to breastfeed the newborn, but this should be discussed with the doctor first for more information.
• Breastfeeding is not recommended for HIV-positive mothers as HIV infection can be transmitted to the baby through breast milk. If the girl is breastfeeding or is thinking about breastfeeding she must talk to her doctor as soon as possible.

Driving and using machines
Viread can cause dizziness. If dizziness occurs while taking Viread, the child must not
driveor ride a bicycleand must not use tools or machinery.

Viread contains lactose
Tell the doctor before giving Viread. If the doctor has diagnosed the child with
intolerance to certain sugars, contact him or before taking this medicine.

Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
ʽsodium-free’.

3. How to take Viread

The child must take this medicine following the instructions of the
doctor or pharmacist exactly, always.If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

• children aged between 6 and less than 12 years with a body weight between 28 kg andless than 35 kg:1 tablet each day to be taken with food (for example, a meal or a snack).

The doctor will check your child’s weight.

The child must always take the dose recommended by the doctor.This is to ensure that the medicines are completely effective and to reduce the risk of developing resistance to
treatment. Do not change the dose unless your doctor tells you to.
In the treatment of HIV infection, the doctor will prescribe Viread together with other antiretroviral
medicines.

If the child takes more Viread than they should
If the child accidentally takes too many Viread tablets, it may increase the risk of
developing possible side effects from this medicine (see section 4, Possible side effects

).Contact your doctor or the nearest emergency center. Bring the bottle of
tablets with you so that you can easily describe what the child has taken.

If the child forgets to take Viread
It is important not to forget any dose of Viread. If the child forgets a dose, calculate
how much time has passed since the missed dose.

• If less than 12 hourshave passed since the usual time of taking ,the child should take the medicine as soon as possible and then take the next dose at the scheduled time.
• If more than 12 hourshave passed since the usual time of taking ,the child should not take the forgotten dose. Wait and administer the next dose regularly. Do not administer a double dose to make up for a missed tablet.

In case of vomiting occurring within 1 hour of taking Viread,administer another tablet to the child.
The child should not take another tablet if they have vomited more than one hour
after taking Viread.

If the child stops taking Viread
The child should not stop taking Viread without consulting the doctor. Stopping
Viread may reduce the effectiveness of the therapy prescribed by the doctor.

If the child has an infection with hepatitis B or HIV and hepatitis B together (co-infection), it
is particularly important not to stop treatment with Viread without first contacting the
doctor. Some patients have experienced worsening of their hepatitis, as indicated 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 a
worsening of hepatitis in some patients.

• Talk to your doctor before the child stops taking Viread for any reason, especially if they have experienced a side effect or have another illness.
• Immediately inform your doctor of any new or unusual symptoms observed after stopping treatment, particularly symptoms that are normally associated with hepatitis B infection.
• Contact your doctor before the child starts taking Viread tablets again.

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

4. Possible side effects

During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle and, in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check for these changes in the child.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious possible side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 patients) but serious side effect that can 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 has lactic acidosis, contact your doctor immediately.

Other serious possible side effects
The following side effects are not common(may affect up to 1 in 100 treated patients):

• stomach pain(abdomen) caused by inflammation of the pancreas
• damage to specific kidney cells (tubular cells)

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

• kidney inflammation, excessive urine and thirst
• changes in urineand back painin the child caused by kidney problems, including kidney failure
• softening of the bones (with bone painand sometimes fractures), which may occur due to damage to the renal tubular cells
• fatty liver
• If you think the child is experiencing any of these serious side effects, contact your doctor.

More frequent side effects
The following side effects are very common(may affect at least 10 patients out of every 100 treated):

• diarrhea, feeling unwell (vomiting, nausea), dizziness, skin rash, feeling weak

Laboratory tests have also shown:

• reduced phosphate in the blood

Other possible side effects
The following side effects are common(may affect up to 10 patients out of every 100 treated):

• intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

• liver problems

The following side effects are not common(may affect up to 1 in 100 treated patients):

• muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

• reduced potassium in the blood
• increased creatinine in the blood
• pancreas problems

Muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness, and reduced potassium or phosphate in the blood may occur due to damage to the renal tubular cells.
The following side effects are rare(may affect up to 1 in 1,000 treated patients):

• stomach pain (abdomen) 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, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is reported on the bottle and packaging after
{Scad.}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Viread contains

• The active ingredient istenofovir. Each Viread tablet contains 204 mg of tenofovir disoproxil (as fumarate).
• The other ingredients aremicrocrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate and magnesium stearate (E572) which constitute the core of the tablet, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin (E1518) which make up the tablet coating. See section 2 “Viread contains lactose”.

Description of Viread and contents of the pack
Viread 204 mg film-coated tablets are film-coated tablets, white in colour, capsule-shaped, measuring 15.4 mm x 7.3 mm, imprinted on one side with “GSI” and on the other side with the number “250”. Viread 204 mg film-coated tablets are supplied in bottles of 30 tablets. Each bottle contains silica gel as a desiccant, which must be kept in the bottle to protect the tablets. The silica gel is contained in a separate sachet or jar and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. 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 on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

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

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.

Viread 245 mg film-coated tablets

tenofovir disoproxil

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

If Viread has been prescribed to a child, all the information contained in this leaflet
applies to the child (in this case, “the child” is meant instead of “you”).

1. What is Viread and what is it used for

Viread contains the active ingredient tenofovir disoproxil. This active ingredient is a medicine

antiretroviralor antiviral that is used for the treatment of HIV infection, or HBV, or
both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generically known as
NRTI and works by interfering with the normal activity of enzymes (reverse transcriptasein HIV; DNA

polymerasein hepatitis B) that are essential for viruses to reproduce. Viread for the treatment
of HIV infection must always be used in association with other medicines.

Viread 245 mg tablets is a treatment for HIV(human immunodeficiency
virus) infection.The tablets are indicated for:

• adults
• adolescents aged 12 years and over, but under 18 yearswho have already been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective, or that have caused undesirable effects.

Viread 245 mg tablets is also used for the treatment of chronic hepatitis B,
an HBV(hepatitis B virus) infection.The tablets are indicated for:

• adults
• adolescents aged 12 years and over, but under 18 years.

You do not have to have HIV infection to be treated with Viread for HBV.
This medicine is not a cure for HIV infection. While taking Viread you may still
contract infections or other diseases associated with HIV infection. You can also transmit the HBV virus
to others, so it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Viread

Do not take Viread

• If you are allergicto tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
• If this is the case, tell your doctor immediately and do not take Viread.

Warnings and precautions
Viread does not reduce the risk of transmitting HBV to others through sexual contact or
blood contamination. You must continue to take precautions to avoid this.
Talk to your doctor or pharmacist before taking Viread.

• If you have had kidney disease, or if tests have shown problems with your kidneys.Viread should not be given to adolescents who already have kidney problems. Before starting treatment, your doctor may prescribe blood tests to assess kidney function. Viread may have effects on the kidneys during treatment. Your doctor may prescribe blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the prescribed dose unless you have been told to do so by your doctor.

Viread should not be taken with other medicines that can damage the kidneys (see

Other medicines and Viread). If this is unavoidable, your doctor will monitor the child's kidney function once a week.

• If you suffer from osteoporosis,have had bone fractures in the past or have bone problems.

Bone problems(which can manifest as persistent or worsening bone pain and
sometimes resulting in fractures) can also occur due to damage to the tubular cells of the
kidneys (see section 4, Possible side effects). Tell your doctor if you have bone pain or
fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most pronounced loss of bone mass was observed in clinical studies in which patients were treated with
tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the risk of
future fractures in adult and pediatric patients are uncertain.
Some adult patients with HIV who are taking combination antiretroviral therapy may
develop a bone disease called osteonecrosis (bone tissue death caused by a
lack of blood supply to the bone). The duration of combination antiretroviral therapy,
the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher
body mass index, among others, may be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis are joint stiffness,
discomfort and pain (especially in the hips, knees and shoulders) and difficulty in
movement. See your doctor if you notice any of these symptoms.

• Tell your doctor if you have had liver problems in the past, including hepatitis.Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitis B, your doctor will carefully assess the best treatment regimen for you. If you have had liver disease or chronic hepatitis B, your doctor may require blood tests to monitor liver function.
• Be careful about infections.If you have advanced HIV (AIDS) and have an infection, you may develop symptoms of an infection and inflammation or a worsening of the symptoms of an existing infection when you start treatment with Viread. These symptoms may indicate that the body's immune system is fighting the infection. Check for signs of inflammation or infection immediately after starting to take Viread. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy tissue in the body) may also occur after
you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any
symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and
feet that rises towards the trunk of the body, palpitations, tremors or hyperactivity, tell
your doctor immediately for the necessary treatment.

• Tell your doctor or pharmacist if you are over 65 years of age.Viread has not been studied in patients over 65 years of age. If you are over this age and have been prescribed Viread, your doctor will monitor you closely.

Children and adolescents
Viread 245 mg tablets is indicatedfor:

• adolescents infected with HIV-1 aged 12 years and over with a body weight ofat least 35 kg and who have already been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective or have caused side effects.
• adolescents infected with HBV, aged 12 years and over, with a body weight ofat least 35 kg.

Viread 245 mg tablets is not indicatedfor the following categories:

• not indicated in children infected with HIV-1under the age of 12
• not indicated in children infected with HBVunder the age of 12.

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

Other medicines and Viread
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• When you start therapy with Viread do not stop taking any anti-HIVmedicinesprescribed by your doctor, if you have both HBV and HIV infection.
• You should not take Vireadif you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is particularly important to tell your doctor if you are taking other medicines thatcan damage your 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 immunosuppression)
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
• Other medicines that contain didanosine (for HIV infection):Taking Viread with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), which have sometimes been fatal, have been rarely reported when medicines containing tenofovir disoproxil and didanosine have been taken together. The doctor will need to carefully consider whether to treat you with tenofovir and didanosine in combination.
• It is also important to warn your doctorif you are 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(for example a meal or a snack).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

• If you have already taken Vireadduring pregnancy, your doctor may require regular blood tests and other diagnostic tests to monitor the development of the baby. In children whose mothers have taken NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
• If you are a mother with HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed the newborn, but you should discuss this first with your doctor for more information.
• Breastfeeding is not recommended for HIV-positive women as HIV infection can be transmitted to the baby with breast milk. If you are breastfeeding or are thinking about breastfeeding you should talk to your doctor as soon as possible.

Driving and using machines
Viread can cause dizziness. If you experience dizziness while taking Viread, do not drive or
ride a bicycleand do not use tools or machinery.

Viread contains lactose
Tell your doctor before taking Viread. If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.

Viread contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
ʽsodium-free’.

3. How to take Viread

Take this medicine exactly as your doctor or pharmacist has told you.If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

• Adults:1 tablet each day to be taken with food (for example, a meal or a snack).
• Adolescents aged 12 years and over with a body weight of at least 35 kg:1 tablet each day to be taken with food (for example, a meal or a snack) .

If you have particular difficulty swallowing, you can use the end of a spoon to crush the
tablet. Then mix the powder in about 100 mL (half a glass) of water, orange juice or grape
juice and drink immediately.

• Always take the dose recommended by your doctor.This is to make sure that the medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.
• If you are an adult and have kidney problems,your doctor may prescribe you to take Viread less frequently.
• If you have HBV your doctor may suggest an HIV test to see if you have both HBV and HIV.

If you take more Viread than you should
If you accidentally take too many Viread tablets, you may increase the risk of developing
possible side effects with this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency center. Bring the tablet bottle with you so that
you can easily describe what you have taken.

If you forget to take Viread
It is important that you do not forget any dose of Viread. If you forget a dose, calculate how
much time has passed since the missed dose.

• If less than 12 hourshave passed from the usual time of taking it, take it as soon as possible and then take the next dose at the scheduled time.
• If more than 12 hourshave passed from the usual time of taking it, do not take the forgotten dose. Wait and take the next dose regularly. Do not take a double dose to make up for the missed tablet.

In case of vomiting occurring within 1 hour of taking Viread,take another tablet.
You should not take another tablet if you have vomited more than one hour after taking Viread.

If you stop taking Viread
Do not stop taking Viread without consulting your doctor. Stopping Viread may
reduce the effectiveness of the therapy prescribed by your doctor.

If you have an infection with hepatitis B or with HIV and hepatitis B together (co-infection),it is particularly
important not to stop treatment with Viread without first contacting your doctor. Some
patients have experienced a worsening of their hepatitis, as indicated by symptoms or blood
tests after stopping Viread. It may be necessary to repeat blood tests for
several months after stopping treatment. In patients with advanced liver disease or cirrhosis,
stopping treatment is not recommended as it may lead to a worsening
of hepatitis in some patients.

• Talk to your doctor before stopping taking Viread for any reason, especially if you have experienced a side effect or if you have another illness.
• Immediately inform your doctor of any new or unusual symptoms observed after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.
• Contact your doctor before starting to take Viread tablets again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.

Serious possible side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect 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, and stomach pain)
• If you think you have lactic acidosis, contact your doctor immediately.

Other serious possible side effects
The following side effects are not common(may affect up to 1 in 100 treated patients):

• stomach pain(abdomen) caused by inflammation of the pancreas
• damage to specific kidney cells (tubular cells)

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

• kidney inflammation, excessive urine and thirst
• changes in urineand back paincaused by kidney problems, including kidney failure
• softening of the bones (with bone painand sometimes fractures), which may occur due to damage to the renal tubular cells
• fatty liver
• If you think you are experiencing any of these serious side effects, see your doctor.

More frequent side effects
The following side effects are very common(may affect at least 10 patients out of every
100 treated):

• diarrhea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

• decreased phosphate in the blood

Other possible side effects
The following side effects are common(may affect up to 10 patients every 100 treated):

• headache, stomach pain, fatigue, feeling full, intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

• liver problems

The following side effects are not common(may affect up to 1 in 100 treated patients):

• muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

• decreased potassium in the blood
• increased creatinine 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 in the blood may occur due to damage
to the renal tubular cells.
The following side effects are rare(may affect up to 1 in 1,000 treated patients):

• stomach pain (abdomen) 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, see
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is stated on the bottle and the packaging after
{Scad.}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient istenofovir. Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).
• The other ingredients aremicrocrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate and magnesium stearate (E572) which constitute the core of the tablet, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518) and aluminium indigo carmine lake (E132) which make up the tablet coating. See section 2 “Viread contains lactose”.

Description of the appearance of Viread and package contents
Viread 245 mg film-coated tablets are film-coated, blue, almond-shaped tablets, measuring 16.8 mm x 10.3 mm, imprinted on one side with “GILEAD” and “4331” and
on the other side with the number “300”. Viread 245 mg film-coated tablets are supplied in
bottles of 30 tablets. Each bottle contains silica gel as a desiccant, which must be
kept in the bottle to protect the tablets. The silica gel is contained in a sachet or a
separate jar and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of
30 film-coated tablets and 3 bottles of 30 film-coated tablets. 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:
Takeda GmbH
Lehnitzstrasse 70-98
D-16515 Oranienburg
Germany
or
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

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

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/.

Viread 33 mg/g granules

tenofovir disoproxil

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

If Viread has been prescribed to a child, all the information in this leaflet applies to the child (in this case, “the child” is meant instead of “you”).

1. What is Viread and what is it used for

Viread contains the active ingredient tenofovirdisoproxil. This active ingredient is a medicine

antiretroviralor antiviral that is used for the treatment of HIV, or HBV, or
both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generically known as
NRTI and works by interfering with the normal activity of enzymes (reverse transcriptasein HIV; DNA

polymerasein hepatitis B) that are essential for viruses to reproduce. Viread for the treatment
of HIV infection must always be used in association with other medicines.

Viread 33 mg/g granules is a treatment for HIV(human immunodeficiency
virus) infection. It is indicated for:

• adults
• children and adolescents aged 2 years and over who have already been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective, or that have caused undesirable effects

Viread 33 mg/g granulesis also a treatment for chronic hepatitis B, an HBV
(hepatitis B virus) infection. It is indicated for:

• adults
• children and adolescents aged 2 years and over

You do not have to have HIV infection to be treated with Viread for HBV.
This medicine is not a cure for HIV infection. While you take Viread you may still
contract infections or other diseases associated with HIV infection. You can also transmit the HBV virus
to others, so it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Viread

Do not take Viread

• If you are allergicto tenofovir, tenofovir disoproxil or any of the other ingredients of this medicine listed in section 6.
• If this is the case , tell your doctor immediately and do not take Viread.

Warnings and precautions
Viread does not reduce the risk of transmitting HBV to others through sexual contact or contamination with blood. You must continue to take precautions to avoid this.
Talk to your doctor or pharmacist before taking Viread.

• If you have had kidney disease, or if tests have shown problems with your kidneys.Viread should not be given to children who already have kidney problems. Before starting treatment, your doctor may prescribe blood tests to assess kidney function. During treatment, Viread may have effects on the kidneys. Your doctor may prescribe blood tests during treatment to monitor kidney function. If you are an adult, your doctor may prescribe a reduction in the daily dose of granules. Do not reduce the prescribed dose unless you have been told to do so by your doctor.

Viread should not be taken with other medicines that can damage the kidneys (see

Other medicines and Viread). If this is unavoidable, your doctor will monitor the child's kidney function once a week.

• If you suffer from osteoporosis,have had bone fractures in the past or have bone problems.

Bone problems(which can manifest as persistent or worsening bone pain and sometimes resulting in fractures) can also occur due to damage to the cells of the kidney tubules (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most pronounced loss of bone mass has been observed in clinical studies in which 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 (bone tissue death caused by a lack of blood flow to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, a higher body mass index, among others, may be some of the numerous risk factors for the development of this disease. Signs of osteonecrosis are joint stiffness, discomfort and pain (especially in the hips, knees and shoulders) and difficulty moving. See your doctor if you notice any of these symptoms.

• Tell your doctor if you have had liver problems in the past, 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 you have hepatitis B, your doctor will carefully evaluate the best treatment regimen for you. If you have had liver disease or chronic hepatitis B, your doctor may require blood tests to monitor liver function.
• Be careful of infections.If you have advanced HIV (AIDS) and have an infection, you may develop symptoms of an infection and inflammation or a worsening of the symptoms of an existing infection when you start treatment with Viread. These symptoms may indicate that the body's immune system is fighting the infection. Check for signs of inflammation or infection immediately after starting to take Viread. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the body) can also occur after you have started taking medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet that rises towards the trunk of the body, palpitations, tremor or hyperactivity, tell your doctor immediately for the necessary treatment.

• Tell your doctor or pharmacist if you are over 65 years of age.Viread has not been studied in patients over 65 years of age. If you are over this age and have been prescribed Viread, your doctor will monitor you carefully.

Children and adolescents
Viread 33 mg/g granules are indicated exclusivelyfor:

• children and adolescents between the ages of 2 and less than 18 years, infected with HIV-1, who havealready been treatedwith other medicines against HIV that, due to the development of resistances, are no longer fully effective or have caused side effects
• children and adolescents, aged between 2 and less than 18 years, infected with HBV

Viread 33 mg/g granules are notindicated for the following categories:

• not indicated inchildren under 2 years of age infected with HIV
• not indicated inchildren under 2 years of age infected with HBV(hepatitis B virus)

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

Other medicines and Viread
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

• When you start therapy with Viread do not stop taking any anti-HIV medicinesprescribed by your doctor, if you have both HBV and HIV infection.
• You must not take Vireadif you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is particularly important to tell your doctor if you are taking other medicines thatcan damage your 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 immunosuppression)
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
• Other medicines that contain didanosine (for HIV infection):Taking Viread with other antiviral medicines that contain didanosine may increase the levels of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), which have sometimes been fatal, have been rarely reported when medicines containing tenofovir disoproxil and didanosine have been taken together. Your doctor will need to carefully consider whether to treat you with tenofovir and didanosine in combination.
• It is also important to warn your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Viread with food and drink
Viread granules must be mixed with a little soft food that should not be
chewed(e.g. yogurt, applesauce, purees). If chewed, the mixture
containing the granules has a strongly bitter taste.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• If you have already taken Vireadduring pregnancy, your doctor may require regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers have taken NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
• If you are a mother with HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed the newborn, but you should discuss this with your doctor first for more information.
• Breastfeeding is not recommended for HIV-positive women as HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or are planning to breastfeed you should talk to your doctor as soon as possible.

Driving and using machines
Viread can cause dizziness. If you experience dizziness while taking Viread, do not driveor
ride a bicycleand do not use tools or machinery.

Viread granules contain mannitol.
Mannitol may have a mild laxative effect.

3. How to take Viread

• Take this medicine exactly as your doctor orpharmacist has told you.If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents aged between 12 and less than 18 years, weighing at least 35 kg:245 mg, equivalent to 7.5 measuring scoops of granules, once a day.
• Children aged between 2 and less than 12 years:the daily dose in children depends on body weight. The doctor will determine the correct dose of Viread granules based on the child's weight.

Viread granules must be dosed with the measuring scoop provided (see
Figure A):
Each level measuring scoop delivers 1 g of granules, which contains 33 mg of tenofovir disoproxil (as
fumarate).

Figure A

• Fill the measuring scoop to the brim.
• Use the blade of a clean knife to level off the excess granules (see Figure B).

Figure B

• For ½ scoop:
• Fill the measuring scoop to the “½” mark on the side (see Figure C).

½ mark
Figure C

• Pour the correct number of level measuring scoops of granules into a container.
• The granules must be mixed with soft food that does not need to be chewed, such as yogurt, applesauce, or baby food. One level measuring scoop of granules must be mixed with one tablespoon (15 mL) of soft food. Do not mix the granules with liquids.
• The granules mixed with food must be taken immediately.
• Each time, all of the mixture that has been prepared must be taken.
• Always take the dose recommended by your doctor.This is to make sure the medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.
• If you are an adult and have kidney problems,your doctor may prescribe you to reduce the daily dose of granules.
• If you have HBV, your doctor may suggest you have an HIV test to see if you have both HBV and HIV.

If you take more Viread than you should
If you accidentally take too much Viread, it may increase the risk of developing possible side
effects of this medicine (see section 4, Possible side effects).Contact your doctor
or the nearest emergency center. Bring the container of granules with you so you can easily describe
what you have taken.

If you forget to take Viread
It is important that you do not forget any dose of Viread. If you forget a dose, calculate how
much time has passed since the missed dose.

• If less than 12 hourshave passed since your usual time of taking it, take it as soon as possible and then take your next dose at the scheduled time.
• If more than 12 hourshave passed since your usual time of taking it, do not take the forgotten dose. Wait and take your next dose regularly. Do not take a double dose to make up for the missed dose.

In case of vomiting occurring within 1 hour of taking Viread,take another dose. Do
not take another dose if you have vomited more than one hour after taking Viread.

If you stop taking Viread
Do not stop taking Viread without consulting your doctor. Stopping Viread may
reduce the effectiveness of the therapy prescribed by your doctor.

If you have an infection with hepatitis B or HIV and hepatitis B together (co-infection),it is particularly
important not to stop taking Viread without first contacting your doctor. Some
patients have experienced a worsening of their hepatitis, as indicated 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 a worsening
of hepatitis in some patients.

• Talk to your doctor before stopping taking Viread for any reason, especially if you have experienced a side effect or have another illness.
• Immediately tell your doctor about any new or unusual symptoms you notice after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.
• Contact your doctor before starting to take Viread granules again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During therapy for HIV, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. The doctor will check these
changes.
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.

Serious possible side effects: inform your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 patients) but serious side effect that can 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 you have lactic acidosis, contact your doctor immediately.

Other serious possible side effects
The following side effects are not common(may affect up to 1 in 100 treated patients):

• stomach pain(abdomen) caused by inflammation of the pancreas
• damage to specific kidney cells (tubular cells)

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

• kidney inflammation, increased urine output and thirst
• changesin urineand back paincaused by kidney problems, including kidney failure
• softening of the bones (with bone painand sometimes fractures), which may occur due to damage to the renal tubular cells
• fatty liver
• If you think you are experiencing any of these serious side effects, see your doctor.

More frequent side effects
The following side effects are very common(affect at least 10 patients out of every
100 treated):

• diarrhea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

• decreased phosphate in the blood

Other possible side effects
The following side effects are common(may affect up to 10 patients out of 100 treated):

• headache, stomach pain, fatigue, feeling full, intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

• liver problems

The following side effects are not common(may affect up to 1 in 100 treated patients):

• muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

• decreased potassium in the blood
• increased creatinine in the blood
• pancreas problems

Muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain,
muscle weakness, and decreased potassium or phosphate in the blood may occur due to damage
to the renal tubular cells.
The following side effects are rare(may affect up to 1 in 1,000 treated patients):

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

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, see
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 which is stated on the bottle and the packaging after
{Scad.}. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Do not dispose of any medicine in waste water 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 ingredient istenofovir. One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
• The other ingredients areethylcellulose (E462), hydroxypropylcellulose (E463), mannitol (E421) and silicon dioxide (E551). See section 2 “Viread granules contain mannitol”.

Description of the appearance of Viread and package contents
This medicine consists of a white coated granules. The granules are supplied in a bottle
containing 60 g of granules, with a dosing scoop provided with the package.

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 on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

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

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: + 44 (0) 8000 113 700
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for tenofovir disoproxil, the
PRAC’s scientific conclusions are as follows:
In light of the available data on bone mineral density reduction from clinical studies,
literature and spontaneous reports and considering the plausible mechanism of action, the
PRAC considers that a causal relationship between tenofovir disoproxil and bone mineral
density reduction is at least a reasonable possibility. The PRAC also considers that the current
warning/precaution regarding effects on bone should be further strengthened. The
PRAC concluded that the product information for medicines containing tenofovir disoproxil
should be amended accordingly.
After examining the PRAC recommendation, the CHMP agrees with the overall conclusions and
the justification for the PRAC recommendation.

Justification for the variation of the marketing authorisation(s)
Based on the scientific conclusions on tenofovir disoproxil, the CHMP considers that the benefit-risk
profile of the medicine(s) containing tenofovir disoproxil is unchanged, save for the
proposed changes to the medicine information.
The CHMP recommends the variation of the marketing authorisation(s).