Viread 245 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Viread 245 mg film-coated tablets

Tenofovir disoproxil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Viread is and what it is used for
2. What you need to know before your child starts taking 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 for your child, please note that all the information in this leaflet refers to your child (in this case, read “your child” instead of “you”).

1. What Viread is and what it is used for

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

Viread 245 mg tablets are a medicine used to treat infection with HIV (Human Immunodeficiency Virus). The tablets are suitable for:

• adults
  • adolescents aged 12 to less than 18 years who have previously been treated with other anti-HIV medicines that are no longer fully effective due to the development of resistance, or that have caused adverse effects.

Viread 245 mg tablets are also a medicine used to treat chronic hepatitis B, an infection caused by HBV (hepatitis B virus). The tablets are suitable for:

• adults
• adolescents aged 12 to less than 18 years

You do not need to have HIV in order 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. They may also continue to transmit HIV or HBV to others. Therefore, it is important to take precautions to avoid infecting other people.

2. What you need to know before the child starts taking Viread

Do not take Viread

• If you are allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (incl uded in section 6).

• If this applies to you, inform your doctor immediately and do not take Viread.

Warnings and precautions

Talk to your doctor or pharmacist before starting Viread.

• Be careful not to transmit your infection to other people. While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Ask your doctor about the precautions needed to avoid infecting others. Viread does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You must continue to take precautions to prevent this.

• If you have had kidney disease or if your blood tests have shown kidney problems, consult your doctor or pharmacist. Viread should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may request blood tests to assess how well your kidneys are working. Viread may affect your kidneys during treatment. Your doctor may request regular 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 your doctor has instructed you to do so.

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

• Bone problems. Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, inform your doctor.

Bone problems (sometimes leading to fractures) may also occur due to damage to renal tubule cells (see section 4, Possible side effects).

• Talk to your doctor if you have a history of liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection, your doctor may perform blood tests to monitor your liver function.

• Infections. If you have advanced HIV infection (AIDS) and have another type of infection, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when you start treatment with Viread. These symptoms may indicate that your improved immune system is fighting the infection. Be alert for signs of inflammation or infection after starting Viread. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection.

Autoimmune disorders may appear many months after starting treatment. If you experience any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

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

Children and adolescents

Viread 245 mg tablets are suitable for:

• HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have previously been treated with other HIV medicines that are no longer fully effective due to resistance development, or that have caused adverse effects.
• HBV-infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.

Viread 245 mg tablets are not suitable for the following groups:

• not for HIV-1 infected children under 12 years of age.

• not for HBV-infected children under 12 years of age.

For dosage information, 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 need to take any other medicines.

• Do not stop taking any anti-HIV medicines prescribed by your doctor when starting Viread treatment if you have HBV and HIV.

• Do not take Viread if you are using medicines that already contain 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 very important that you tell your doctor if you are taking other medicines that may harm your 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),

• tacrolimus (used to suppress the immune system),

• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines containing didanosine may increase levels of didanosine in your blood and may reduce CD4 cell count. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been reported when tenofovir disoproxil-containing and didanosine-containing medicines are taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

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

Taking Viread with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• You should not take Viread during pregnancy unless specifically discussed with your doctor. Although there is limited clinical data on the use of Viread in pregnant women, it is generally not used unless absolutely necessary.

• If you become pregnant or plan to become pregnant, ask your doctor about the potential risks and benefits of your antiretroviral therapy for you and your child.

• If you have taken Viread during your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took antiretrovirals during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects occurring.

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

• If you are a woman with HIV or HBV infection, do not breastfeed your child to avoid transmitting the virus through breast milk.

Driving and using machines

Viread may cause dizziness. If you experience dizziness during treatment with Viread, do not drive or ride a bicycle and do not operate tools or machinery.

Viread contains lactose

Inform your doctor before taking Viread. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Viread

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults: 1 tablet daily with food (for example, a meal or a snack).
• Adolescents aged 12 to less than 18 years weighing at least 35 kg: 1 tablet daily with food (for example, a meal or a snack).

If you have particular difficulty swallowing, you may use the tip of a spoon to crush the tablet. Then mix the powder with approximately 100 ml of water (half a glass), orange juice, or grape juice and drink immediately.

• Always take the dose recommended by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

• If you are an adult and have kidney problems, your doctor may advise you to take Viread less frequently.

• If you have HBV, your doctor may offer you an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of other antiretrovirals for instructions on how to take those medicines.

If you take more Viread than you should

If you accidentally took too many Viread tablets, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible side effects). Contact your doctor or go to the nearest emergency department. Take the bottle of tablets with you so you can easily describe what you have taken.

If you forget to take Viread

It is important not to miss a dose of Viread. If you forget a dose, determine how long it has been since you were supposed to take it.

• If it is less than 12 hours after the usual time, take it as soon as possible, then take your next dose at the usual time.

• If it is more than 12 hours since you should have taken it, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you vomit before 1 hour has passed after taking Viread, take another tablet. You do not need to take another tablet if you vomited more than one hour after taking Viread.

If you stop taking Viread

Do not stop taking Viread without your doctor telling you to do so. Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection), it is very important not to stop your treatment with Viread without first speaking to your doctor. After stopping treatment with Viread, some patients have had blood tests or symptoms indicating that their hepatitis has worsened. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may lead to a worsening of hepatitis.

• Talk to your doctor before stopping Viread for any reason, especially if you are experiencing any adverse effects or have another illness.

• Contact your doctor immediately if the child experiences any new or unusual symptoms after stopping treatment, particularly symptoms related to hepatitis B virus infection.

• Contact your doctor before restarting Viread tablets.

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

4. Possible adverse effects

During HIV treatment, there may be an increase in body weight and in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious possible adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare adverse effect (may affect up to 1 in 1,000 patients) but serious, and can be life-threatening. The following symptoms may be signs of lactic acidosis:

• deep, rapid breathing

• drowsiness

• nausea, vomiting, and stomach pain

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

Other possible serious adverse effects

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

• abdominal pain caused by inflammation of the pancreas

• damage to renal tubular cells

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

• inflammation of the kidney, increased urine volume and feeling thirsty

• changes in your urine and back pain due to kidney problems, including kidney failure

• weakening of the bones (with bone pain, sometimes leading to fractures), which may occur due to damage to renal tubular cells.

• fatty liver

• If you think you may be experiencing any of these serious adverse effects, consult your doctor.

More common adverse effects

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

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

• Blood tests may also show:*

• decreased blood phosphate levels

Other possible adverse effects

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

• headache, stomach pain, feeling tired, feeling bloated, flatulence

• Blood 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 weakness

• Blood tests may also show:*

• decreased blood potassium levels

• increased blood creatinine

• pancreas problems

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

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

• abdominal pain (stomach pain) caused by inflammation of the liver

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your 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 detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viread

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the carton following EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

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

6. Package contents and other information

Composition of Viread

• The active substance is tenofovir. Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).

• The other components are: microcrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, lactose monohydrate, and magnesium stearate (E572), which constitute the tablet core; and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glyceryl triacetate (E1518), and indigo carmine aluminum lake (E132), which constitute the film coating of the tablet. See section 2, “Viread contains lactose”.

Appearance of the medicinal product and contents of the pack

Viread 245 mg film-coated tablets are light blue, almond-shaped film-coated tablets measuring 16.8 mm x 10.3 mm, marked on one side with “GILEAD” and “4331” and on the other side with “300”. Viread is available in bottles containing 30 film-coated tablets. Each bottle contains a silica gel desiccant which should be kept inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

This medicine is available in packs containing either 1 bottle of 30 film-coated tablets or 3 bottles of 30 film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}

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