Tenofovir Disoproxil 245 mg Film-coated Tablets

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

What is in this leaflet:

1.    What Tenofovir Disoproxil is and what it is used for

2.    What you need to know before you take Tenofovir Disoproxil

3.    How to take Tenofovir Disoproxil

4.    Possible side effects

5.    How to store Tenofovir Disoproxil

6.    Contents of the pack and other information

If Tenofovir Disoproxil 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”).

1.    What Tenofovir Disoproxil is and what it is used for

This medicine contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves. In HIV Tenofovir Disoproxil should always be used combined with other medicines to treat HIV infection.

Tenofovir Disoproxil tablets are a treatment for HIV (Human Immunodeficiency Virus) infection. The tablets are suitable for:

•    adults

•    adolescents aged 12 to less than 18 years who already have been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.

Tenofovir Disoproxil tablets are also used to treat chronic hepatitis B, an infection with HBV

(hepatitis B virus). Tablets are suitable for:

•    adults

•    adolescents aged 12 to less than 18 years.

You do not have to have HIV to be treated with Tenofovir Disoproxil for HBV.

This medicine is not a cure for HIV infection. While taking Tenofovir Disoproxil you may still develop infections or other illnesses associated with HIV infection.

You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.

2.    What you need to know before you take Tenofovir Disoproxil Do not take Tenofovir Disoproxil 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 do not take Tenofovir Disoproxil.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tenofovir Disoproxil

•    Take care not to infect other people. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. Tenofovir Disoproxil 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 if you have had kidney disease or if tests have shown problems with your kidneys. Tenofovir Disoproxil should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may order blood tests to assess your kidney function. Tenofovir Disoproxil may affect your kidneys during the 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 take the tablets less often. Do not reduce the prescribed dose, unless your doctor has told you to do so.

Tenofovir Disoproxil is not usually taken with other medicines that can damage your kidneys (see “Other medicines and Tenofovir Disoproxil”). If this is unavoidable, your doctor will monitor your kidney function once a week.

•    Bone problems. 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.

Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule 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 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 possible signs of lactic acidosis (excess of lactic acid in your blood) once you start taking Tenofovir Disoproxil. Possible signs of lactic acidosis are:

•    deep, rapid breathing

•    drowsiness

•    nausea, vomiting and stomach pain

This rare but serious side effect can cause enlargement of the liver and has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Tenofovir Disoproxil, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

•    In the treatment of HIV, combination antiretroviral therapies (including Tenofovir Disoproxil) may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, “Possible side effects”).

If you are diabetic, overweight or have high cholesterol, talk to your doctor.

•    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 Tenofovir Disoproxil 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 Tenofovir Disoproxil. 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 disorder 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. Tenofovir Disoproxil has not been studied in patients over 65 years of age. If you are older than this and are prescribed Tenofovir Disoproxil, your doctor will monitor you carefully.

Children and adolescents

Tenofovir Disoproxil tablets are suitable for:

•    HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and 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 adolescents aged 12 to less than 18 years who weigh at least 35 kg.

Tenofovir Disoproxil tablets are not suitable for the following groups:

•    Not for HIV-1 infected children under 12 years of age.

•    Not for HBV infected children under 12 years of age.

For dosage see section 3, “How to take Tenofovir Disoproxil”.

Other medicines and Tenofovir Disoproxil

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

•    Do not stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir Disoproxil if you have both HBV and HIV.

•    Do not take Tenofovir Disoproxil if you are already taking other medicines containing tenofovir disoproxil. Do not take Tenofovir Disoproxil 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 Tenofovir Disoproxil 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.

Tenofovir Disoproxil with food and drink

Take Tenofovir Disoproxil with food (for example, a meal or a snack).

Pregnancy and breast-feeding

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

•    You must not take Tenofovir Disoproxil during pregnancy unless specifically discussed with your doctor. Although there are limited clinical data on the use of Tenofovir Disoproxil in pregnant women, it is not usually used unless absolutely necessary.

•    Try to avoid getting pregnant during treatment with Tenofovir Disoproxil. You must use an effective method of contraception to avoid becoming pregnant.

•    If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.

•    If you have taken Tenofovir Disoproxil 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 medicines like Tenofovir Disoproxil (NRTIs) during pregnancy, the benefit from the protection against the virus outweighed the risk of side effects.

•    Do not breast-feed during treatment with Tenofovir Disoproxil. This is because the active substance in this medicine passes into human breast milk.

•    If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.

Driving and using machines

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

Tenofovir Disoproxil contains lactose

Tell your doctor before taking Tenofovir Disoproxil if you cannot tolerate lactose or if you have an intolerance to any other sugars.

3. How to take Tenofovir Disoproxil

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

•    Adults: 1 tablet each day with food (for example, a meal or a snack).

•    Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).

If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately.

•    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 take Tenofovir Disoproxil less frequently.

•    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 take more Tenofovir Disoproxil than you should

If you accidentally take too many Tenofovir Disoproxil tablets 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 tablet bottle with you so that you can easily describe what you have taken.

If you forget to take Tenofovir Disoproxil

It is important not to miss a dose of Tenofovir Disoproxil. 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 tablet.

If you throw up less than 1 hour after taking Tenofovir Disoproxil, take another tablet. You do not

need to take another tablet if you were sick more than 1 hour after taking Tenofovir Disoproxil.

If you stop taking Tenofovir Disoproxil

Do not stop taking Tenofovir Disoproxil without your doctor’s advice. Stopping treatment with Tenofovir Disoproxil 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 Tenofovir Disoproxil treatment without talking to your doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Tenofovir Disoproxil. 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 Tenofovir Disoproxil 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 Tenofovir Disoproxil.

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

4. Possible side effects

Like all medicines, this medicine can 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 (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.

Other possible serious side effects

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

•    pain in the tummy (abdomen) caused by inflammation of the pancreas

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, damage to kidney tubule cells

•    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

•    changes in body shape

In the treatment of HIV, combination antiretroviral therapy (including Tenofovir Disoproxil) may change your body shape, by changing the way body fat is distributed. You may lose fat from your legs, arms and face; gain fat around the tummy (abdomen) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’). The cause and the long-term effects of these changes are not yet known.

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

Most frequent side effects

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.

Other possible side effects

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

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

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.

In the treatment of HIV, combination antiretroviral therapy may also cause increased fats in the blood (hyperlipaemia) and resistance to insulin. Your doctor will test for these changes.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

5.    How to store Tenofovir Disoproxil

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

Do not use this medicine after the expiry date which is stated on the blister or bottle and carton after {EXP}. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Tenofovir Disoproxil contains

•    The active substance is tenofovir. Each tablet contains tenofovir disoproxil phosphate equivalent to 245 mg of tenofovir disoproxil.

•    The other ingredients are:

•    Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, hydrogenated vegetable oil and sodium laurilsulfate.

•    Film-coating: polyvinyl alcohol - partially hydrolysed (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), indigo carmine aluminium lake (E132), carminic acid (E120).

Refer to section 2 “Tenofovir Disoproxil contains lactose”.

What Tenofovir Disoproxil looks like and contents of the pack

Tenofovir Disoproxil are light blue to blue, film coated, oval shaped tablet, 16.6 mm long and 8.9 mm wide, debossed with “T” on one side of the tablet and plain on the other side.

Tenofovir Disoproxil is available in blister packs containing 30 or 90 tablets, unit dose blister packs containing 30x1 or 90x1 tablets, bottles containing 30 tablets or 90 tablets (3 x 30) .

The bottles contain one or two canister shaped silica gel desiccants. Please do not eat these.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

TEVA Gyogyszergyar Zrt. (Teva Pharmaceutical Works Private Limited Company), Debrecen, Pallagi ut 13, H-4042, Hungary

*OR

Merckle GmbH, Ludwig-Merckle-StraBe 3, Blaubeuren, 89143, Germany *OR

Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands

This leaflet was last revised in 07/2015

PL 00289/1897

* Only the actual site of batch release will appear on the printed version of the leaflet