Label: information for the patient

Viread 33 mg/g granules

Tenofovir disoproxil

Read this label carefully before starting to take this medicine, as 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 only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Viread is and how it is used

2. What you need to know before starting to take Viread

3. How to take Viread

4. Possible adverse effects

5. Storage of Viread

6. Contents of the package and additional information

If Viread has been prescribed for 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 infection, or HBV infection, or both. Tenofovir is anucleotide reverse transcriptase inhibitor analog, commonly known as an ITIAN, 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.

Viread should be used for the treatment of HIV infection only in combination with other medications.

Viread 33 mg/g granules is a medication used to treat HIV infection(Human Immunodeficiency Virus). It is suitable for:

• adults
• children and adolescents between 2 and less than 18 years 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 33 mg/g granules is also a medication used to treat chronic hepatitis B, an HBV infection(hepatitis B virus).It is suitable for:

It is not necessary to have HIV to be treated with Viread for HBV.

This medication is not a cure for HIV infection. While taking Viread, you may still experience infections or other diseases associated with HIV infection. You 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 your 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 transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about the necessary precautions to avoid infecting others. Viread does not reduce the risk of transmission of HCV 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 children with existing kidney problems. Before starting treatment, your doctor may request blood tests to evaluate kidney function. Viread may affect your kidneys during treatment. Your doctor may request blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise you to reduce your daily dose of granules. Do not reduce the prescribed dose unless your doctor has instructed you to do so.

Viread is usually not taken with other medications that may damage your kidneys (seeTaking Viread with other medications). If this is unavoidable, your doctor will monitor your kidney function 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 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.

You may also experience bone problems (sometimes leading to fractures) due to damage to renal tubular cells (see section 4,Adverse reactions).

• Consult 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 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 starting Viread treatment. 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 Viread. If you notice signs of inflammation or infection, inform 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 start taking medications for HIV treatment.

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 body 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 old. If you are over this age and have been prescribed Viread, your doctor will monitor you closely.

Children and adolescents

Viread 33 mg/g granulesis only suitable for:

• children and adolescents infected with HIV-1 between 2 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
• children and adolescents infected with HCV between 2 and less than 18 years old.

Viread 33 mg/g granulesis not suitable for the following groups:

• Not forchildreninfected with HIV-1under 2 years old
• Not forchildreninfected with HCV (hepatitis B virus)under 2 years old.

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 stop taking any HIV medicationprescribed by your doctor when starting Viread treatment if you have HCV and HIV.

• 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 that contain didanosine (for HIV infection):Taking Viread with other antiviral medications that contain didanosine may increase didanosine levels in your blood and reduce CD4 cell count. When taken together, medications containing tenofovir disoproxil and didanosine have rarely been associated with 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 HCV infection.

Taking Viread with food and drinks

Viread granules must be mixed with soft foods that do not require mastication(such as yogurt, compote, or puree). If you chew the granule mixture, it will have a very bitter taste.

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 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 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 Vireadduring your pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took ITIAN during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

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

• If you are a woman and have HIV or HCV infection, do not breastfeed your child to avoid passing the virus to the child through breast milk.

Driving and operating machines

Viread may cause dizziness. If you notice dizziness during Viread treatment,do not drive orride a bicycle or operate tools or machines.

Viread granules contain mannitol

Mannitol may have a mild laxative effect.

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 and adolescents between 12 and less than 18 years who weigh at least 35 kg:245 mg, equivalent to 7.5 scoops of granules, once a day.
• Children between 2 and less than 12 years:The daily dose in children depends on their weight. Your child's doctor will determine the correct dose of Viread granules based on your child's weight.

Viread granules must be measured with the dosing scoop provided (see Figure A):

Each dosing scoop level administers 1 g of granules that contain 33 mg of tenofovir disoproxil (as fumarate).

• Fill the dosing scoop to the top.
• Use the straight edge of a clean knife to level the granules with the top of the dosing scoop (see Figure B).

• For ½ dosing scoop:
• Fill the dosing scoop to the “½” line on the side (see Figure C).

• Insert the correct number of level dosing scoops of granules into a container.
• You must mix the granules with soft food that does not require chewing, for example yogurt, jam, or puree. You need 1 tablespoon (15 ml) of soft food for each level dosing scoop of granules. Do not mix the granules with liquids.
• You must take the granules mixed with food immediately.
• You must take all the mixture you prepare each time.

• Take the recommended dose as instructed 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 reduce your daily dose of granules.

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

See 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 much Viread, 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 granule bottle 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 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 hourssince when you take it normally, 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 dose. You do not need to take another dose if you vomited more than 1 hour after taking Viread.

If you interrupt the treatment with Viread

Do not stop taking Viread without your doctor's advice. Stopping the 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 that you do not interrupt your treatment with Viread without talking to your doctor first. After interrupting the 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 the 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 immediately if you experience any new or unusual symptom after interrupting your treatment, particularly those symptoms related to hepatitis B virus infection.

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 recovery of health and lifestyle, and in the case of blood lipids, sometimes to the 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: inform 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):

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 inyoururineandback paindue to kidney problems, including renal failure

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

• 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 arevery frequent(may affect at least 10 in 100 patients):

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

Analyses may also show:

• decreased level of phosphates in blood

Other possible side effects

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

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

Analyses may also show:

• liver problems

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

• muscle rupture, muscle pain or weakness

Analyses may also show:

• decreased levels of potassium in blood

• increased creatinine in blood

• pancreas problems

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

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

• abdominal pain (abdominal pain) caused by liver inflammation

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

Reporting side effects

If you 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 theAppendix 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 carton after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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. In this way, you will help protect the environment.

Composition of Viread

• The active ingredient istenofovir. One gram of Viread granules contains 33 mg of tenofovir disoproxil (in the form of fumarate).

• The other components are:ethylcellulose (E462), hydroxypropylcellulose (E463), mannitol (E421), and silicon dioxide (E551). See section 2 “Viread granules contain mannitol”.

Appearance of the product and contents of the package

This medicine is constituted by a white-coated granulate. The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing:

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 review date of this leaflet: {MM/YYYY}

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