Label: information for the patient

Viread 245 mg film-coated tablets

Tenofovir disoproxil

Read this label carefully beforestartingto take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

If Viread has been prescribed to your child, note that all the information in this

label is directed at your child (in this case, read “your child” instead of “you”).

Viread contains the active ingredienttenofovir disoproxil. This active ingredient is anantiretroviralor antiviral medication that is used to treat HIV or HBV or both infections. Tenofovir is anucleotide reverse transcriptase inhibitor analog, commonly known as NtRTI, which acts by interfering with the normal function of certain enzymes (in the case of HIV, thereverse transcriptaseand in hepatitis B, theDNA polymerase) that are essential for viral replication. For the treatment of HIV infection, Viread must be used in combination with other medications.

Viread 245 mg tablets are a medication used to treatHIV infection (Human Immunodeficiency Virus). The tablets are suitable for:

• adults
• • adolescents between 12 and less than 18 years old who have already been treatedwith other HIV medications 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 medication used to treat chronic hepatitis B, an infection caused by the HBV(hepatitis B virus). The tablets are suitable for:

• adults
• adolescents between 12 and less than 18 years old

No HIV infection is required to be treated with Viread for HBV.

This medication is not a cure for HIV infection. While the child is taking Viread, they may still experience infections or other diseases associated with HIV infection. They may also continue to transmit HIV or HBV to others. Therefore, it is essential to take precautions to avoid infecting others.

Do not take Viread

• If this is the case,inform your doctor immediately and do not take Viread.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Viread.

• Be careful not to transmit your infection to others.While taking this medication, you may still be able to transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. Viread does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You should continue to take precautions to avoid it.

• If you have had kidney disease or if your tests have shown kidney problems, consult your doctor or pharmacist.Viread should not be administered to adolescents with existing kidney problems. Before starting treatment, your doctor may request that you have some blood tests to evaluate the function of your kidneys. Viread may affect your kidneys during treatment. Your doctor may request that you have some blood tests during treatment to monitor the function of your kidneys. 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 told you to do so.

Viread is normally not taken with other medications that may damage your kidneys (seeTaking Viread with other medications). If this is unavoidable, your doctor will monitor the function of your kidneys once a week.

• Bone problems.Some adult patients with HIV who receive combined antiretroviral treatment may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of combined antiretroviral treatment, the use of corticosteroids, alcohol consumption, severe immunosuppression, and a high body mass index. The symptoms of osteonecrosis are: 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.

You may also experience bone problems (sometimes leading to fractures) due to damage to renal tubular 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 a higher risk of severe 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 another type of infection, you may develop symptoms of infection and inflammation or worsening of existing infection symptoms when you start treatment with Viread. These symptoms may indicate that your improved immune system is fighting the infection. Be aware if you develop signs of inflammation or infection after starting to take Viread. If you notice signs of inflammation or infection,inform your doctor immediately.

In addition to opportunistic infections, you may also experience autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) after you start taking medications to treat 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 ascending to the trunk of the body, 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 old. If you are over this age and have been prescribed Viread, your doctor will monitor you carefully.

Children and adolescents

Viread 245 mg tablets areappropriatefor:

• adolescents infected with HIV-1 between 12 and less than 18 years old who weigh at least 35 kg and who have already been treatedwith other HIV medications that are no longer fully effective due to the development of resistance, or that have caused adverse effects.
• adolescents infected with HBV between 12 and less than 18 years old who weigh at least 35 kg.

Viread 245 mg tabletsare notappropriate for the following groups:

To know the dose, see section 3, How to take Viread.

Other medications and Viread

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Do not take Vireadif you are using medications that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Viread with medications that contain adefovir dipivoxil (a medication used to treat chronic hepatitis B).

• It is very important to tell your doctor if you are taking other medications that may damage your kidneys.

These medications include:

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

• It is also important to inform 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(e.g., a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

• If you have taken Vireadduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took tenofovir disoproxil during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects.

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

• Do not breastfeed your child if you are a woman and have HIV or HBV infection to avoid passing the virus to the child through breast milk.

Driving and operating machines

Viread may cause dizziness. If you notice dizziness during treatment with Viread,do not drive or ride a bikeor operate tools or machines.

Viread contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

If you have special 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 or grapefruit juice and drink it immediately.

• Always take the recommended dose prescribed by your doctor.This is to ensure that your medication 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 VHB, your doctor may offer you to undergo a HIV test to see if you have VHB and HIV.

Consult the prospectuses of other antiretrovirals to know how to take these medications.

If you take more Viread than you should

If you accidentally took too many Viread tablets, you may be at a higher risk of experiencing possible side effects with this medication (see section 4,Possible side effects). Consult your doctor or go to the nearest emergency service. Bring the tablet container with you so that you can easily describe what you have taken.

If you forgot to take Viread

It is important not to forget a dose of Viread. If you forget a dose, determine how long it has been since you should have taken it.

• If it is less than 12 hoursafter when you normally take it, take it as soon as you can, and then take your next dose at your usual time.

• If it is more than 12 hourssince you should have taken it, do not take the missed dose. Wait and take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

If you vomit within 1 hour after taking Viread,take another tablet. You do not need to take another tablet if you vomited more than an hour after taking Viread.

If you interrupt the treatment with Viread

Do not stop taking Viread without your doctor's permission. Stopping treatment with Viread may reduce the effectiveness of the recommended treatment by your doctor.

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

• Talk to your doctor before stopping Viread for any reason, particularly if you experience any side effect or have another disease.

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

• Contact your doctor before restarting the tablets of Viread.

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

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

Like all medications, this medication may produce side effects, although not all people will experience them.

Severe side effects: report to your doctor immediately

• Lactic acidosis(excess lactic acid in the blood) is a rare but severe side effect that can be fatal. The following side effects may be signs of lactic acidosis:

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

Other possible severe side effects

The following side effects are infrequent (may affect up to 1 in 100 patients):

• Abdominal pain(abdominal pain) caused by pancreatitis inflammation

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

• kidney inflammation, increased urine volume, and sensation of thirst

• Changes in your urineandback paindue to kidney problems, including renal failure

• bone weakening (withbone painand sometimes ending in fractures), which may occur due to kidney cell damage.

• Fatty liver

• If you think you may have any of these severe side effects, consult your doctor.

More frequent side effects

The following side effects are very frequent (may affect at least 10 in 100 patients):

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

The tests may also show:

• decreased phosphate levels in the blood

Other possible side effects

The following side effects are frequent (may affect up to 10 in 100 patients):

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

The tests may also show:

• liver problems

The following side effects are infrequent (may affect up to 1 in 100 patients):

• muscle rupture, muscle pain, or muscle weakness

The tests may also show:

• decreased potassium levels in the blood

• increased creatinine levels in the blood

• pancreas problems

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

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

Reporting side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Viread

• The active ingredient is tenofovir. Each Viread tablet contains 245 mg of tenofovir disoproxil (in the form of fumarate).

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

Appearance of the product and contents of the package

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

This medicine is available in packs of 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets. Only some 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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update date of this leaflet: {MM/AAAA}

For more detailed information about this medicine, please visit the website of the European Medicines Agency: http://www.ema.europa.eu .