Viread 33 mg/g granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Viread 33 mg/g granules

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 could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 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 applies 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 infection, HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, commonly known as NRTI, which works by interfering with the normal function of 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 33 mg/g granules is a medicine used to treat HIV infection (Human Immunodeficiency Virus). It is suitable for:

• adults
• children and adolescents aged 2 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 33 mg/g granules is also a medicine used to treat chronic hepatitis B, an infection caused by HBV (hepatitis B virus). It is suitable for:

• adults
• children and adolescents aged 2 to 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 taking Viread, you may still develop infections or other illnesses associated with HIV infection. You may also continue to transmit HIV or HBV to others. Therefore, it is important that you take precautions to avoid infecting other people.

2. What you need to know before taking Viread

Do not take Viread

• If you are allergic to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed 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 to take Viread.

• Take care not to transmit your infection to others. While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Consult 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 must not be given to children 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 reducing your daily dose of granules. 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 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 HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Numerous risk factors for developing this condition include length of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include: 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 leading to fractures) may also occur due to damage to the cells of the renal tubule (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 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 starting 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 notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up toward the trunk, palpitations, tremor, 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 closely.

Children and adolescents

Viread 33 mg/g granules is only suitable for:

• HIV-1 infected children and adolescents aged 2 to less than 18 years 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
• Hepatitis B virus (HBV) infected children and adolescents aged 2 to less than 18 years.

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

• Not for children infected with HIV-1 under 2 years of age
• Not for children infected with HBV (hepatitis B virus) under 2 years of age.

For dosage information, see section 3, How to take Viread.

Other medicines and Viread

Inform 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 treatment with Viread if you have both 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 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)

• tacrolimus (used to suppress the immune system)

• non-steroidal anti-inflammatory drugs (NSAIDs, used 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), some fatal, have been reported when medicines containing tenofovir disoproxil and didanosine are taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important to 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 baby.

• If you have taken Viread during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby's development. In babies whose mothers took antiretroviral drugs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

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

• If you are a woman with HIV or HBV infection, do not breastfeed your baby 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 or operate tools or machinery.

Viread granules contain mannitol

Mannitol may have a mild laxative effect.

3. How to take Viread

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

The recommended dose is:

• Adults and adolescents aged 12 to under 18 years weighing at least 35 kg: 245 mg, equivalent to 7.5 dosing scoops, once daily.
• Children aged 2 to under 12 years: The daily dose in children depends on body weight. Your child's doctor will determine the correct dose of Viread granules based on your child's weight.

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

Each level dosing scoop delivers 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 off the granules with the top of the scoop (see Figure B).

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

• Place the correct number of level scoops of granules into a container.

• Mix the granules with soft food that does not require chewing, such as yoghurt, apple puree, or baby food. Use one tablespoon (15 ml) of soft food per level scoop of granules. Do not mix the granules with liquids.

• The mixture of granules and soft food must be taken immediately.

• Take the entire mixture each time.

• Always take the dose prescribed 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 with kidney problems, your doctor may advise you to reduce your daily dose of granules.

• 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 take too much Viread, 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 granules 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 since you were due to take it, take it as soon as possible, then take your next dose at the usual time.

• If it is more than 12 hours since you were due 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 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 unless your doctor tells 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 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 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 you experience any new or unusual symptoms after stopping treatment, particularly symptoms related to hepatitis B virus infection.

• Contact your doctor before restarting Viread granules.

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

4. Possible side effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of 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 may cause side effects, although not everybody gets them.

Possible serious side effects: tell 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 side effect that can be life-threatening. The following side effects 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 side effects

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

• abdominal pain caused by inflammation of the pancreas
• damage to the cells of the renal tubule

The following side 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 and which sometimes leads to fractures), which may occur due to damage to the cells of the renal tubule

• fatty liver

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

More frequent side effects

The following side 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:

• decrease in blood phosphate levels

Other possible side effects

The following side effects are common (may affect up to 10 out of 100 patients):

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

Blood tests may also show:

• liver problems

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

• muscle rupture, muscle pain or weakness

Blood tests may also show:

• decrease in blood potassium levels
• increase in blood creatinine
• problems with the pancreas

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

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

• abdominal pain caused by inflammation of the liver
• swelling of the face, lips, tongue, or throat

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side 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 carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viread

• The active substance is tenofovir. One gram of Viread granules contains 33 mg of tenofovir disoproxil (as 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 medicine and contents of the pack

This medicine is a white-coated granule. The granules are supplied in a bottle containing 60 g of granules and are packaged with a dosing scoop.

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

Further information on this medicine can be obtained by contacting 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 European Medicines Agency website: http://www.ema.europa.eu.