Viread 123 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Viread 123 mg Film-Coated Tablets

Tenofovir Disoproxil

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Viread and what is it used for
2. What you need to know before your child takes Viread
3. How to take Viread
4. Possible side effects
5. Storage of Viread
6. Contents of the pack and other 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 123 mg film-coated tablets is a medicine used to treat HIV (Human Immunodeficiency Virus) infection.

Viread 123 mg film-coated tablets is for use in children. It is only suitable for:

• children between 6 and less than 12 years of age
• who weigh between 17 kg and less than 22 kg
• • who have already been treatedwith other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.

Viread 123 mg film-coated tablets is also a medicine used to treat chronic hepatitis B, an infection caused by the hepatitis B virus (HBV).

Viread 123 mg film-coated tablets is for use in children. It is only suitable for:

• children between 6 and less than 12 years of age
• who weigh between 17 kg and less than 22 kg

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

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

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

Do not give Viread

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

• If this is the case for your child, tell their doctor immediately and do not give them Viread.

Warnings and precautions

• In the case of HIV, Viread 123 mg film-coated tablets is only suitable for children who have already been treatedwith other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.

• Check your child's age and weightto see if Viread 123 mg film-coated tablets is suitable, see Children and adolescents.

Consult your child's doctor or pharmacist before starting treatment with Viread.

• Be careful not to pass on your infection to others.While taking this medicine, your 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. Consult your child's doctor about what precautions are necessary to avoid infecting others.

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

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

• Bone problems.Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are: stiffness in the joints, pain and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your child's doctor.

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

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

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

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

Autoimmune disorders may occur many months after starting treatment. If you notice that your 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, tremors, or hyperactivity, inform their doctor immediately to receive the necessary treatment.

Children and adolescents

Viread 123 mg film-coated tablets is only suitable for:

• Children infected with HIV-1 between 6 and less than 12 years of age who weigh between 17 kg and less than 22 kg and have been treatedwith other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.
• • Children infected with HBV between 6 and less than 12 years of age who weigh between 17 kg and less than 22 kg.

Viread 123 mg film-coated tablets is not suitable for the following groups:

• Not forchildren who weigh less than 17 kg or 22 kg or more. Consult your child's doctor if they are outside the permitted weight range.
• Not forchildren and adolescents under 6 years of age or 12 years of age or older.

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

Other medicines and Viread

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

• Do not stop treatment with any anti-HIV medicinesprescribed by your child's doctor when starting treatment with Viread if they have both HBV and HIV.

• Do not give Vireadif your child is using medicines that already 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 that you tell your child's doctor if your child is taking other medicines that may harm their kidneys.

These medicines include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),
• amphotericin B (used to treat fungal infections),
• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),
• interleukin-2 (used to treat cancer),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune system suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, 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 didanosine levels in the blood and may reduce 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 fatally. Your child's doctor will carefully consider whether they should be treated with combinations of tenofovir and didanosine.

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

Taking Viread with food and drinks

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

Pregnancy and breastfeeding

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

• The girl must not take Viread during pregnancyunless she has specifically discussed this with her doctor. Although there are limited clinical data on the use of Viread in pregnant women, it is not normally used unless absolutely necessary.

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

• If the girl has taken Vireadduring her pregnancy, her 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 girl must not breastfeed during treatment with Viread.This is because the active ingredient of this medicine passes into breast milk.

• The girl must not breastfeed to avoid passing on the virus to the baby through breast milk.

Driving and using machines

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

Viread contains lactose

Tell your child's doctor before giving Viread.If their doctor has told them that your child is intolerant to some sugars, consult with them before giving this medicine.

3. How to take Viread

Your child must follow their doctor's or pharmacist's instructions for taking this medicine exactly.If they are unsure, they should consult their doctor or pharmacist again.

The recommended dose is:

• Children between 6 and less than 12 years of age who weigh between 17 kg and less than 22 kg:

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

Their doctor will monitor their weight.

Your child must always take the dose 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 their doctor tells them to.

In the case of HIV, their doctor will prescribe Viread with other antiretroviral medicines.

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

If your child takes more Viread than they should

If your child accidentally takes too many Viread tablets, they may be at greater risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Consult their doctor or go to the nearest emergency department. Take the pack of tablets with them so that they can easily describe what your child has taken.

If your child forgets to take Viread

It is important that your child does not miss a dose of Viread. If they miss a dose, determine 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 missed doses.

If your child vomits before 1 hour has passed after taking Viread,give them another tablet. Your child does not need to take another tablet if they vomit more than 1 hour after taking Viread.

If your child stops taking Viread

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

If your child has hepatitis B or HIV and hepatitis B co-infection,it is very important that they do not stop their treatment with Viread without first talking to their doctor. After stopping treatment with Viread, some patients have had blood tests or symptoms indicating that their hepatitis has worsened. It may be necessary for them 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 may lead to worsening of their hepatitis.

• Talk to their doctor before they stop taking Viread for any reason, particularly if they are experiencing any side effects or have another illness.

• Talk to their doctor immediately if they experience any new or unusual symptoms after stopping their treatment, particularly those symptoms that they think may be related to their hepatitis B virus infection.

• Contact their doctor before they restart taking Viread tablets.

If you have any other questions about the use of this medicine, ask your 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 with 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) 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) 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 stated 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 123 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 triacetin (E1518), which make up the tablet coating.

See section 2 "Viread contains lactose".

Product Appearance and Package Contents

White, triangular, film-coated tablets, 8.5 mm in diameter, marked with "GSI" on one side and "150" on the other. Viread 123 mg film-coated tablets are available in bottles containing 30 tablets. Each bottle contains a silica gel desiccant that should be kept inside 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 packs of 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. Not all pack 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

For more information about this medication, contact the local representative of the Marketing Authorization Holder:

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

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