VIREAD 123 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

What Viread is and what it is used for

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

How to take Viread

4J Possible side effects

5.1 How to store Viread

6.J Contents of the pack and other information

1. | what viread is and what it is used for

Viread contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor , generally known as an NRTI and works by interfering with the normal working of an enzyme (in HIV reverse transcriptase , in hepatitis B DNA polymerase ) that are essential for the viruses to reproduce themselves. In HIV Viread should always be used combined with other medicines to treat HIV infection.

Viread 123 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.

Viread 123 mg tablets are for use in children. They are only suitable for:

• ■ children aged 6 to less than 12 years

• ■ who weigh from 17 kg to less than 22 kg

• ■ who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.

Viread 123 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).

Viread 123 mg tablets are for use in children. They are only suitable for:

• ■ children aged 6 to less than 12 years

• ■ who weigh from 17 kg to less than 22 kg

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

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

What you need to know before your child takes Viread

Do not give Viread

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

^ If this applies to your child, tell their doctor immediately and don’t give Viread.

Warnings and precautions

• ■ For HIV, Viread 123 mg tablets are only suitable for children who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.

• ■ Check your child’s age and weight to see if Viread

123 mg tablets are suitable, see Children and adolescents.

Talk to your child’s doctor or pharmacist before giving Viread.

• ■ Take care not to infect other people. Your child can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Viread does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. Discuss with your child’s doctor the precautions needed to avoid infecting other people.

• ■ Talk to your child’s doctor or pharmacist if your child has had kidney disease or if tests have shown problems with their kidneys. Viread should not be given to children with existing kidney problems. Viread may affect your child’s kidneys during treatment. Before starting treatment, your child’s doctor may order blood tests to assess your child’s kidney function. Your child’s doctor may also order blood tests during treatment to monitor how your child’s kidne­ys work.

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

• ■ Bone problems. Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms tell your child’s doctor.

Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects ). Tell your child’s doctor if your child has bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

Overall, the effects of tenofovir disoproxil on long term bone health and future fracture risk in adult and paediatric patients are uncertain.

Tell your child’s doctor if your child suffers from osteoporosis. Patients with osteoporosis are at a higher risk for fractures.

• ■ Talk to your child’s doctor if your child has 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 severe and potentially fatal liver complications. If your child has hepatitis B infection, your child’s doctor will carefully consider the best treatment for them. If your child has a history of liver disease or chronic hepatitis B infection your child’s doctor may conduct blood tests to monitor their liver function.

• ■ Look out for infections. If your child has advanced HIV infection (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started. These symptoms may indicate that your child’s body’s im­proved immune system is fighting infection. Look out for signs of inflammation or infection soon after your child starts taking Viread. If you notice signs of inflammation or infection, tell your child’s doctor at once.

In addition to the 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 the start of treatment. If you notice that your child has any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your child’s doctor immediately to seek necessary treatment.

Children and adolescents

Viread 123 mg tablets are only suitable for:

• ■ HIV-1 infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.

• ■ HBV infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg

Viread 123 mg tablets are not suitable for the following groups:

• ■ Not for children who weigh under 17 kg or 22 kg and over. Contact your child’s doctor if your child is outside the permitted weight.

• ■ Not for children and adolescents under 6 years or 12 years and over.

For dosage see section 3, How to take Viread.

Other medicines and Viread

Tell your child’s doctor or pharmacist if they are taking, have recently taken or might take any other medicines.

• ■ Don’t stop any anti-HIV medicines prescribed by your child’s doctor when they start Viread if they have both HBV and HIV.

• ■ Do not give Viread if your child is already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not give Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

• ■ It is very important to tell your child’s doctor if your child is taking other medicines that may damage their 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 suppression of the immune system),

• ■ non-steroidal anti-inflammatory drugs

(NSAIDs, to relieve bone or muscle pains).

• ■ Other medicines containing didanosine

(for HIV infection): Taking Viread with other antiviral medicines that contain didanosine can raise the levels of didanosine in the blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your child’s doctor will carefully consider whether to treat your child with combinations of tenofovir and didanosine.

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

Viread with food and drink

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

Pregnancy and breastfeeding

If your child is pregnant or breastfeeding, or they think they may be pregnant, ask your child’s doctor or pharmacist for advice before they take this medicine.

• ■ If your child has taken Viread during their pregnancy, your child’s doctor may request regular blood tests and other diagnostic tests to monitor the development of the baby. In children whose mothers took medicines like Viread (NRTIs) during pregnancy, the benefit from the protection against the virus outweighed the risk of side effects.

• ■ If your child has HBV, and their baby has been given treatment to prevent hepatitis B transmission at birth, your child may be able to breast-feed their infant, but first talk to your child’s doctor to get more information.

• ■ If your child has HIV they must not breastfeed, to avoid passing the virus to the baby in breast milk.

Driving and using machines

Viread can cause dizziness. If your child feels dizzy while taking Viread, they must not drive or ride a bicycle and must not use any tools or machines.

Viread contains lactose

Tell your child’s doctor before giving Viread. If you have been told by your child’s doctor that your child has an intolerance to some sugars, contact your child’s doctor before they take this medicinal product.

Viread contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

How to take Viread

Your child must always take this medicine exactly as their doctor or pharmacist has told you. Check with your child’s doctor or pharmacist if you are not sure.

The recommended dose is:

• ■ Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:

1 tablet each day with food (for example, a meal or a snack).

Your child’s doctor will monitor their weight.

Your child must always take the dose recommended by their doctor. This is to make sure that their medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your child’s doctor tells you to.

For HIV, your child’s doctor will prescribe Viread with other antiretroviral medicines.

Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.

If your child takes more Viread than they should

If your child accidentally takes too many Viread tablets, they may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects ). Contact your child’s doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what your child has taken.

If your child forgets to take Viread

It is important not to miss a dose of Viread. If your child misses a dose, work out how long since they should have taken it.

• ■ If it is less than 12 hours after it is usually taken, they should take it as soon as they can, and then take their next dose at its regular time.

• ■ If it is more than 12 hours since your child should have taken it, forget about the missed dose. Wait and give the next dose at the regular time. Do not give a double dose to make up for a forgotten tablet.

If your child throws up less than 1 hour after taking Viread, give your child another tablet. Your child does not need to take another tablet if they were sick more than 1 hour after taking Viread.

If your child stops taking Viread

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

If your child has hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop theirViread treatment without talking to yourchild's doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Viread. Your child may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your child's hepatitis.

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

• ■ Tell your child's doctor immediately about new or unusual symptoms afteryour child stops treatment, particularly symptoms you associate with hepatitis B infection.

• ■ Contact your child's doctor before your child restarts taking Viread tablets.

If you have any further questions on the use of this medicine, askyour child's doctor or pharmacist.

Q Possible side effects

During HIV therapy there may bean increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your child's doctor will test for these changes.

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

Possible serious side effects: tell your child's doctor immediately

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

• ■ deep, rapid breathing

• ■ drowsiness

• ■ feeling sick (nausea), being sick (vomiting) and stomach pain

**lfyou thinkthatyour child may have lactic acidosis, contact your child's doctor immediately.

Other possible serious side effects

The following side effects are uncommon

(this can affect up to 1 in every 100 patients):

• ■ pain in the tummy (abdomen) caused by inflammation of the pancreas

• ■ damage to kidney tubule cells

The following side effects are rare (these can affect

up to 1 in every 1,000 patients):

• ■ inflammation ofthe kidney, passing a lot of urineand feeling thirsty

• ■ changes to your child's urine and back pain caused by kidney problems, including kidney failure

• ■ softening ofthe bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells

• ■ fatty liver

If you thinkthatyour child may have any of these serious side effects, talk to your child's doctor.

Most frequent side effects

The following side effects are very common (these can affect at least 10 in every 100 patients):

• ■ diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak

Tests may also show:

• ■ decreases in phosphate in the blood

Other possible side effects

The following side effects are common (these can affect up to 10 in every 100 patients):

• ■ flatulence

Tests may also show:

• ■ liver problems

The following side effects are uncommon (these can affect up to 1 in every 100 patients):

• ■ breakdown of muscle, muscle pain or weakness

Tests may also show:

• ■ decreases in potassium in the blood

• ■ increased creatinine in your child's blood

• ■ pancreas problems

The breakdown of muscle, softening ofthe bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.

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

• ■ pain in the tummy (abdomen) caused by inflammation ofthe liver

• ■ swelling of the face, lips, tongue orthroat

3 How to store Viread

Keep this medicine out ofthe sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throwaway medicines you no longer use. These measures will help protect the environment.

3 Contents ofthe pack and other information

What Viread contains

■The active substance is tenofovir. Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).

■ The other ingredients are microcrystalline cellulose (E460), starch pregelatinised, croscarmellose sodium, lactose monohydrate, and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate (El518) which make up the tablet coating. Refer to section 2 „Viread contains lactose“.

What Viread looks like and contents of the pack

Viread 123 mg film-coated tablets are white, triangle-shaped, film-coated tablets, 8.5 mm in diameter, debossed on one side with „GSI“ and on the other side with „150“. Viread 123 mg film-coated tablets are supplied in bottles containing 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

The following pack sizes are available: outer cartons 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 Ltd 280 High Holborn London

WC1V7EE

United Kingdom

Manufacturer:

Gilead Sciences Ireland UC

IDA Business &Technology Park

Carrigtohill

County Cork Ireland

For any information about this medicine, please contact the local representative ofthe Marketing Authorisation Holder:

Gilead Sciences Ltd.

Tel:+ 44 (0)8000 113 700

This leaflet was last revised in 01/2021.

[J GILEAD

04/05/2021 12:29