Viread 33 mg/g GRANULES

Introduction

Package Leaflet: Information for the Patient

Viread 33 mg/g Granules

Tenofovir Disoproxil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 experience 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, or both. Tenofovir is a nucleotide analogue reverse transcriptase inhibitor, commonly known as NtRTI, which works by interfering with the normal function of enzymes (in the case of HIV, reverse transcriptase, and in hepatitis B, DNA polymerase) that are essential for the viruses to reproduce.

For the treatment of HIV infection, Viread must always be used in combination with other medicines.

Viread 33 mg/g granules is a medicine 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 medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.

Viread 33 mg/g granules is also a medicine used to treat chronic hepatitis B, an infection caused by the HBV(hepatitis B virus). It is suitable for:

• adults
• children and adolescents between 2 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 you are taking Viread, you may still develop infections or other illnesses associated with HIV. You may also continue to transmit HIV or HBV to others. Therefore, it is important that you 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, inform 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 can still transmit HIV to others, although effective antiviral treatment reduces the risk. Talk to your doctor about what precautions you need to take 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 children 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 reduce your daily dose of the granules. Do not reduce the dose prescribed, unless your doctor has told you to.

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

• Bone problems.Some adult patients with HIV who are taking 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, inform your doctor.

Bone problems (sometimes resulting in fractures) may also occur due to damage to the 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, who are treated with antiretrovirals have a higher risk of serious and potentially life-threatening liver complications. If you have a 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 check 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 immune system is improving and fighting the infection. Be aware of 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 have started taking medicines for the treatment of your HIV infection.

Autoimmune disorders can 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, tremors, or hyperactivity, inform your doctor immediately to receive the 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 granules are only suitablefor:

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

Viread 33 mg/g granules are notsuitable for the following groups:

• Not forchildren infected with HIV-1under 2 years
• Not forchildren infected with HBV (hepatitis B virus)under 2 years.

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 doctorif 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)
• 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 fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important that you 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

Viread granules must be mixed with soft foods that do not require chewing(e.g., yogurt, applesauce, or mashed potatoes). If the granule mixture is chewed, it will have a very bitter taste.

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 your doctor has specifically discussed it with you. 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 pregnant,or 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 your child's development. 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 passing the virus to your child through breast milk.

Driving and using machines

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

Viread granules contain mannitol

Mannitol may have a mild laxative effect.

3. How to take Viread

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, talk to 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 daily.
• 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 level dosing scoop administers 1 g of granules containing 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 scoop (see Figure B).

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

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

• 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 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 the granules.

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

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

If you take more Viread than you should

If you have accidentally taken too much Viread, you may be at greater 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 jar of granules 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 it has been since you should have taken it.

• If it is less than 12 hourssince you normally 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 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 missed doses.

If you vomit before 1 hour has passed after taking Viread,take another dose. You do not need to take another dose 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 are experiencing any side effects or if you have another illness.

• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, especially those symptoms that you associate with hepatitis B virus infection.

• Contact your doctor before restarting Viread granules.

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 levels of glucose and lipids in the blood. This may be partly related to the recovery of health 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 can cause adverse effects, although not all people experience them.

Possible Serious Adverse Effects: Inform 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 pain) 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 feeling of thirst

• changes inyour 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 in 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 in 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 levels

• 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 pain) 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 listed 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 CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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 istenofovir. One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).

• Other ingredients are:ethylcellulose (E462), hydroxypropylcellulose (E463), mannitol (E421), and silicon dioxide (E551). See section 2 "Viread granules contain mannitol".

Product Appearance and Package Contents

This medication consists of a white, coated granule. The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing spoon.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer:

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/AAAA}

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