Viread 33 mg/g granules

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Viread is and what it is used for
2. What you need to know before you take 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 is addressed to your child (in this case please read “your child” instead of “you”).

• 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, tell your doctor immediately and don’t take Viread.

Viread does not reduce the risk of passing on HBV to others through sexual contact or blood contamination. You must continue to take precautions to avoid this.

Talk to your doctor or pharmacist before taking Viread.

• If you have had kidney disease or if tests have shown problems with your kidneys. Viread should not be given to children with existing kidney problems. Before starting treatment, your doctor may order blood tests to assess your kidney function. Viread may affect your kidneys during treatment. Your doctor may order blood tests during treatment to monitor how your kidneys work. If you are an adult, your doctor may advise you to reduce your daily dose of the granules. Do not reduce the prescribed dose, unless your doctor has told you to do so.
  Viread is not usually taken with other medicines that can damage your kidneys (see Other medicines and Viread). If this is unavoidable, your doctor will monitor your kidney function once a week.
• If you suffer from osteoporosis, have a history of bone fracture or if you have problems with your bones.
  Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
  Tenofovir disoproxil may also cause loss of bone mass. The most pronounced bone loss was seen in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
  Overall, the effects of tenofovir disoproxil on long term bone health and future fracture risk in adult and paediatric patients are uncertain.
  Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms tell your doctor.
• 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 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 conduct blood tests to monitor your liver function.
• Look out for infections. If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started. These symptoms may indicate that your body’s improved immune system is fighting infection. Look out for signs of inflammation or infection soon after you start taking Viread. If you notice signs of inflammation or infection, tell your doctor at once.
  In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
• Talk to your doctor or pharmacist if you are over 65. Viread has not been studied in patients over 65 years of age. If you are older than this and are prescribed Viread, your doctor will monitor you carefully.

Viread 33 mg/g granules are only suitable for:

• HIV-1 infected children and adolescents aged 2 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
• HBV infected children and adolescents aged 2 to less than 18 years.

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

• Not for HIV-1 infected children under 2 years
• Not for HBV (Hepatitis B virus) infected children under 2 years.

For dosage see section 3, How to take Viread.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Don’t stop any anti-HIV medicines prescribed by your doctor when you start Viread if you have both HBV and HIV.
• Do not take Viread if you are already taking other medicines containing 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 to tell your doctor if you are taking other medicines that may damage your kidneys.
  These include:
  • aminoglycosides, pentamidine or vancomycin (for bacterial infection),
  • amphotericin B (for fungal infection),
  • foscarnet, ganciclovir, or cidofovir (for viral infection),
  • interleukin-2 (to treat cancer),
  • adefovir dipivoxil (for HBV),
  • tacrolimus (for suppression of the immune system),
  • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
• Other medicines containing didanosine (for HIV infection): Taking Viread with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
• It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Viread granules should be mixed with soft food which does not require chewing (for example, yoghurt, applesauce or baby food). If the granules mixture is chewed, it will taste very bitter.

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

• If you have taken Viread during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIVoutweighed the risk of side effects.
• If you are a mother with HBV, and your baby has been given treatment to prevent hepatitis B transmission at birth, you may be able to breastfeed your infant, but first talk to your doctor to get more information.
• Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Viread can cause dizziness. If you feel dizzy while taking Viread, do not drive or ride a bicycle and do not use any tools or machines.

Mannitol may have a mild laxative effect.

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

Viread granules should be measured with the supplied dosing scoop (see Figure A):

Each level dosing scoop provides 1 g of the granules which contains 33 mg tenofovir disoproxil (as fumarate).

• Fill the dosing scoop to the top.
• Use the flat edge of clean knife to make the granules even 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).

• Measure out the correct number of level scoops of granules into a container.
• You must mix the granules with soft food which does not require chewing, for example yoghurt, applesauce or baby food. One tablespoon (15 ml) of soft food per one level scoop of granules is required. Do not mix the granules with liquids.
• You must take the granules mixed with food immediately.
• Take all of the mixture you make each time.
• Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.
• If you are an adult and have problems with your kidneys, 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 both HBV and HIV.

Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.

If you accidentally take too much Viread, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Contact your doctor or nearest emergency department for advice. Keep the granules bottle with you so that you can easily describe what you have taken.

It is important not to miss a dose of Viread. If you miss a dose, work out how long since you should have taken it.

• If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
• If it is more than 12 hours since you should have taken it, forget about the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

If you throw up less than 1 hour after taking Viread, take another dose. You do not need to take another dose if you were sick more than 1 hour after taking Viread.

Don’t stop taking Viread without your doctor’s advice. 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 together (co-infection), it is very important not to stop your Viread treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Viread. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis.

• Talk to your doctor before you stop taking Viread for any reason, particularly if you are experiencing any side effects or you have another illness.
• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
• Contact your doctor before you restart taking Viread granules.

• Lactic acidosis (excess lactic acid in the blood) is a rare (can affect up to 1 in every 1,000 patients) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis:
  • deep, rapid breathing
  • drowsiness
  • feeling sick (nausea), being sick (vomiting) and stomach pain

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

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

• pain in the tummy (abdomen) caused by inflammation of the pancreas
• damage to kidney tubule cells

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

• inflammation of the kidney, passing a lot of urine and feeling thirsty
• changes to your urine and back pain caused by kidney problems, including kidney failure
• softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney tubule cells
• fatty liver

If you think that you may have any of these serious side effects, talk to your doctor.

The following side effects are very common (these can affect at least 10 in every 100 patients):

• diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak

Tests may also show:

• decreases in phosphate in the blood

The following side effects are common (these can affect up to 10 in every 100 patients):

• headache, stomach pain, feeling tired, feeling bloated, flatulence, loss of bone mass

Tests may also show:

• liver problems

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

• breakdown of muscle, muscle pain or weakness

Tests may also show:

• decreases in potassium in the blood
• increased creatinine in your blood
• pancreas problems

The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.

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

• pain in the tummy (abdomen) caused by inflammation of the liver
• swelling of the face, lips, tongue or throat

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is tenofovir. One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
• The other ingredients are ethylcellulose (E462), hydroxypropyl cellulose (E463), mannitol (E421) and silicon dioxide (E551). Refer to section 2 “Viread granules contain mannitol”.

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

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