VIREAD 245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Viread 245 mg Film-Coated Tablets

Tenofovir Disoproxil

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

If Viread has been prescribed to your child, note that all the information in this leaflet is intended for your child (in this case, read “your child” instead of “you”).

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 function of an enzyme (in the case of HIV, reverse transcriptase, and in hepatitis B, DNA polymerase) 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 245 mg film-coated tablets are a medicine used to treat HIV (Human Immunodeficiency Virus) infection.The tablets are suitable for:

• adults
• • adolescents between 12 and less than 18 years 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 245 mg film-coated tablets are also a medicine used to treat chronic hepatitis B, an infection caused by the hepatitis B virus (HBV).The tablets are suitable for:

• adults
• adolescents between 12 and less than 18 years

You do 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 infection. They may also continue to transmit HIV or HBV to others. Therefore, it is important that they take precautions to avoid infecting others.

2. What you need to know before you take 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

Talk to your doctor or pharmacist before you start taking Viread.

• Be careful not to transmit your infection to others.While you are taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces the risk. Talk to 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 avoid this.

• If you have had kidney disease or if your blood tests have shown kidney problems, talk to your doctor or pharmacist.Viread should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask for blood tests to check your kidney function. Viread can affect your kidneys during treatment. Your doctor may ask for blood tests during treatment to check your kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the dose prescribed, unless your doctor tells you to.

Viread is not normally taken with other medicines that can damage 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 patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by 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, tell your 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 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 a higher risk of serious and potentially life-threatening 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 you have another type of infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection when you start treatment with Viread. These symptoms may indicate that your improved immune system is fighting the infection. Be aware of the signs of inflammation or infection after starting 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 body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection.

Autoimmune disorders may occur many months after starting treatment. If you observe 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 your doctor immediately to receive the necessary treatment.

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

Children and adolescents

Viread 245 mg film-coated tablets are suitablefor:

• adolescents infected with HIV-1 between 12 and less than 18 years who weigh at least 35 kg and 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.
• adolescents infected with HBV between 12 and less than 18 years who weigh at least 35 kg.

Viread 245 mg film-coated tablets are notsuitable for the following groups:

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

• not for children infected with HBVunder 12 years of age.

For dosing 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 take any other medicines.

• Do not stop taking any anti-HIV medicinesprescribed by your doctor when you start treatment with Viread if you have HBV and HIV.

• Do not take Vireadif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Viread with medicines that contain 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 can damage your 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, 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 your 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 fatally. Your doctor will carefully consider whether you should be treated with combinations of tenofovir and didanosine.

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

Taking Viread with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Do not take Viread during pregnancyunless you have specifically discussed this with your doctor. Although there are limited clinical data on the use of Viread in pregnant women, it is not normally used unless absolutely necessary.

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

• If you have taken Vireadduring your pregnancy, your doctor may ask for regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NtRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

• Do not breastfeed your child during treatment with Viread.This is because the active substance 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 to your child through breast milk.

Driving and using machines

Viread may cause dizziness. If you feel dizzy while taking Viread, do not drive or ride a bicycleor use tools or machines.

Viread contains lactose

Tell your doctor before taking Viread.If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Viread

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

• Adults:1 tablet a day with food (for example, a meal or snack).
• Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet a day with food (for example, a meal or snack).

If you have difficulty swallowing, you can 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 it immediately.

• Always take the dose recommended by your doctor.This is to ensure that your medicine is completely 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 advise you to take Viread less frequently.

• If you have HBV, your doctor may offer you an HIV test to see if you have HBV and HIV.

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

If you take more Viread than you should

If you have accidentally taken too many Viread tablets, you may have a higher risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Talk to your doctor or go to the nearest emergency department. Take the pack of tablets 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 miss a dose of Viread. If you miss a dose, determine how long ago you should have taken it.

• If it is less than 12 hourssince you were supposed to take it, take it as soon as you can, and then take your next dose at the usual time.

• If it is more than 12 hourssince you were supposed to take 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 within 1 hour of taking Viread,take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Viread.

If you stop taking Viread

Do not stop taking Viread without talking to your doctor. 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 (co-infection),it is very important that you do not stop your treatment with Viread without first talking to your doctor. After stopping treatment with Viread, some patients have had blood tests or symptoms indicating that their hepatitis had worsened. You may need 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 hepatitis.

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

• Talk to your doctor immediately if your child experiences any new or unusual symptoms after stopping treatment, especially those symptoms related to hepatitis B virus infection.

• Contact your doctor before restarting Viread.

If you have any further questions on the use of this medicine, ask your 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. Your doctor will monitor these changes.

Like all medications, this medication can cause adverse effects, although not all people experience them.

Possible Serious Adverse Effects: Report to 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 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 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(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 your 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 you may have any of these serious adverse effects, consult your 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):

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

Lab tests may also show:

• decreased blood potassium levels

• increased blood creatinine

• 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 you experience any adverse effects, 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 included 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 through 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 245 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), triacetin (E1518), and aluminum lake indigo carmine (E132) which make up the tablet coating. See section 2 "Viread contains lactose".

Product Appearance and Package Contents

Viread 245 mg film-coated tablets are light blue, almond-shaped tablets, 16.8 mm x 10.3 mm in size, marked with "GILEAD" and "4331" on one side and "300" on the other. Viread is 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 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:

Takeda GmbH

Lehnitzstrasse 70-98

D-16515 Oranienburg

Germany

or

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/YYYY}

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