Viread 163 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Viread 163 mg Film-Coated Tablets

Tenofovir disoproxil

Read all of this leaflet carefully before the child starts taking this medicine because it contains important information for them.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask the child's doctor or pharmacist.
• This medicine has been prescribed for the child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as the child's.
• If the child experiences any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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. Storing Viread

Contents of the pack and further information

1. What is Viread and what is it used for

Viread contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine used to treat HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NtRTI, which works by interfering with the normal functioning of an enzyme (reverse transcriptase in HIV and DNA polymerase in hepatitis B) that is essential for the viruses to reproduce. For the treatment of HIV infection, Viread must always be used in combination with other medicines.

Viread 163 mg tablets are a medicine used to treat HIV (Human Immunodeficiency Virus) infection.

Viread 163 mg tablets are for use in children. They are only suitable for:

• children between 6 and less than 12 years of age
• who weigh between 22 kg and less than 28 kg
• • who have already been treated with other HIV medicines which are no longer fully effective due to resistance, or have caused side effects.

Viread 163 mg tablets are also a medicine used to treat chronic hepatitis B, an infection caused by the hepatitis B virus (HBV).

Viread 163 mg tablets are for use in children. They are only suitable for:

• children between 6 and less than 12 years of age
• who weigh between 22 kg and less than 28 kg

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

This medicine is not a cure for HIV infection. While the child is taking Viread, they may still develop infections or other illnesses associated with HIV infection. The child can also still pass on HIV or HBV to others. Therefore, it is important that they take precautions to avoid infecting others.

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

Do not give Viread

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

• If this is the case, tell the doctor immediately and do not give Viread.

Warnings and precautions

• For HIV, Viread 163 mg tablets are only suitable for children who have already been treated with other HIV medicines which are no longer fully effective due to resistance, or have caused side effects.

• Check the child's age and weight to see if Viread 163 mg tablets are suitable, see Children and adolescents.

Talk to the child's doctor or pharmacist before starting treatment with Viread.

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

• If the child has had kidney disease or if their blood tests have shown kidney problems, talk to the child's doctor or pharmacist.Viread must not be given to children with existing kidney problems. Viread can affect the child's kidneys during treatment. Before starting treatment, the child's doctor may do blood tests to check their kidney function. The child's doctor may also do blood tests during treatment to check their kidney function.

Viread is not normally taken with other medicines that can damage the child's kidneys (see Taking other medicines). If this is unavoidable, the child's doctor will check their kidney function once a week.

• Bone problems.Some adult patients with HIV who are taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply). The risk of developing this disease is increased by long-term use of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis are joint stiffness, pain, and difficulty moving. If you notice any of these symptoms, tell the child's doctor.

Bone problems (sometimes resulting in fractures) can also occur due to damage to the kidney tubule cells (see section 4, Possible side effects).

• Tell the child's doctor if they have a history of liver disease, including hepatitis.Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals have a higher risk of serious and potentially life-threatening liver complications. If the child has hepatitis B infection, the child's doctor will carefully consider the best treatment for them. If the child has a history of liver disease or chronic hepatitis B infection, the child's doctor may do blood tests to check their liver function.

• Infections.If the child has advanced HIV infection (AIDS) and an infection, they may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection when they start treatment with Viread. These symptoms may indicate that the child's improved immune system is fighting the infection. Be aware of signs of inflammation or infection soon after the child starts taking Viread. If you notice signs of inflammation or infection, tell the child's doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) can also occur after the child starts taking medicines for the treatment of their HIV infection.

Autoimmune disorders can occur many months after starting treatment. If you notice the child has any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up towards the trunk of the body, palpitations, tremor, or hyperactivity, tell the child's doctor immediately to receive the necessary treatment.

Children and adolescents

Viread 163 mg tablets are only suitable for:

• Children with HIV-1 between 6 and less than 12 years of age who weigh between 22 kg and less than 28 kg and have been treated with other HIV medicines which are no longer fully effective due to resistance, or have caused side effects.
• • Children with HBV between 6 and less than 12 years of age who weigh between 22 kg and less than 28 kg.

Viread 163 mg tablets are not suitable for the following groups:

• Not for children who weigh less than 22 kg or 28 kg or more.Talk to the child's doctor if they are outside the allowed weight range.
• Not for children and adolescents under 6 years of age or 12 years of age or older.

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

Other medicines and Viread

Tell the child's doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.

• Do not stop any HIV medicine prescribed by the child's doctor without their advice.If the child has both HBV and HIV, do not stop taking Viread without talking to the child's doctor.

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

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

These include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),
• amphotericin B (used to treat fungal infections),
• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),
• interleukin-2 (used to treat cancer),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune system suppression),
• 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 can increase the levels of didanosine in the blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, sometimes causing death. The child's doctor will carefully consider whether to treat them with a combination of tenofovir and didanosine.

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

Taking Viread with food and drink

Give Viread with food(for example, a meal or snack).

Pregnancy and breastfeeding

If the child is pregnant or breastfeeding, or thinks they may be pregnant, talk to the doctor or pharmacist before taking this medicine.

• The child must not take Viread during pregnancyunless the doctor has specifically discussed the benefits and risks with them. Although there is limited clinical data on the use of Viread in pregnant women, it is not normally used unless absolutely necessary.

• If the child becomes pregnant, ask the doctor about the risks and benefits of antiretroviral therapy for them and their baby.

• If the child has taken Viread during pregnancy, the doctor may ask for regular blood tests and other diagnostic tests to monitor the development of the baby.In children whose mothers took medicines like Viread (NtRTI) during pregnancy, the benefit of protection against the virus was greater than the risk of side effects.

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

• The child must not breastfeed to prevent passing on the virus to the baby through breast milk.

Driving and using machines

Viread can cause dizziness. If the child feels dizzy while taking Viread, they should not drive or ride a bicycle,or use tools or machines.

Viread contains lactose

Tell the child's doctor before giving Viread.If the child's doctor has told them that the child has an intolerance to some sugars, talk to the doctor before giving this medicine.

3. How to take Viread

The child must follow the doctor's instructions for taking this medicine exactly as prescribed.If in doubt, talk to the child's doctor or pharmacist again.

The recommended dose is:

• Children between 6 and less than 12 years of age who weigh between 22 kg and less than 28 kg:

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

The child's doctor will monitor their weight.

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

For HIV infection, the child's doctor will prescribe Viread with other antiretroviral medicines.

Read the package leaflets of the other antiretrovirals to find out how to take these medicines.

If the child takes more Viread than they should

If the child accidentally takes too many Viread tablets, they may have a higher risk of experiencing possible side effects of this medicine (see section 4, Possible side effects). Talk to the child's doctor or go to the nearest emergency department. Take the pack 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 that the child does not miss a dose of Viread. If the child misses a dose, find out how long ago they should have taken it.

• If it is less than 12 hourssince they were supposed to take it, they should take it as soon as possible, and then take their next dose at the usual time.

• If it is more than 12 hourssince they were supposed to take it, they should not take the missed dose. Wait and give the next dose at the usual time. Do not give a double dose to make up for a missed dose.

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

If the child stops taking Viread

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

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

• Talk to the child's doctor before they stop taking Viread for any reason, especially if they have any side effects or other illnesses.

• Talk to the child's doctor immediately if the child experiences any new or unusual symptoms after stopping treatment, especially those symptoms that they think may be related to their hepatitis B infection.

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

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

4. Possible Adverse Effects

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

Like all medications, this medication may produce adverse effects, although not all people suffer from them.

Possible Serious Adverse Effects: Inform the Child's Doctor Immediately

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

• deep and rapid breathing
• drowsiness
• nausea, vomiting, and stomach pain

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

Other Possible Serious Adverse Effects

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

• abdominal pain(stomach pain) caused by pancreas inflammation

• kidney tubule cell damage

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

• kidney inflammation, increased urine volume, and thirst

• changes in urineand back paindue to kidney problems, including kidney failure

• bone weakening (with bone painand sometimes resulting in fractures), which may occur due to kidney tubule cell damage.

• fatty liver

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

More Frequent Adverse Effects

The following adverse effects are very common(may affect at least 10 out of 100 patients):

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

Lab tests may also show:

• decreased blood phosphate levels

Other Possible Adverse Effects

The following adverse effects are common(may affect up to 10 out of 100 patients):

• flatulence

Lab tests may also show:

• liver problems

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

• muscle rupture, muscle pain, or muscle weakness

Lab tests may also show:

• decreased blood potassium levels

• increased blood creatinine levels

• pancreas problems

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

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

• abdominal pain (stomach pain) caused by liver inflammation

• swelling of the face, lips, tongue, or throat

Reporting Adverse Effects

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

5. Storage of Viread

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Viread Composition

• The active ingredient is tenofovir. Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).

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

See section 2 "Viread contains lactose".

Product Appearance and Package Contents

White, round, film-coated tablets, 10.7 mm in diameter, marked with "GSI" on one side and "200" on the other. Viread 163 mg film-coated tablets are available in bottles containing 30 tablets. Each bottle contains a silica gel desiccant that should remain in the bottle to protect the tablets. The silica gel desiccant is contained in a separate pouch or container and should not be swallowed.

This medication is available in packages of 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer:

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medication from the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Leaflet:{MM/AAAA}

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