Emtricitabine/Tenofovir disoproxil Glenmark 200 mg/245 mg Film-coated Tablets

• 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 Emtricitabine/Tenofovir disoproxil Glenmark is and what it is used for
2. What you need to know before you take Emtricitabine/Tenofovir disoproxil Glenmark
3. How to take Emtricitabine/Tenofovir disoproxil Glenmark
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil Glenmark
6. Contents of the pack and other information

While taking Emtricitabine/Tenofovir disoproxil Glenmark to treat HIV:

• Emtricitabine/Tenofovir disoproxil Glenmark may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if you have had kidney disease, or if tests have shown kidney problems. Emtricitabine/Tenofovir disoproxil Glenmark should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Tenofovir disoproxil Glenmark or, if you already have HIV, to take Emtricitabine/Tenofovir disoproxil Glenmark less frequently. Emtricitabine/Tenofovir disoproxil Glenmark is not recommended if you have severe kidney disease or are on dialysis.
• 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 a 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.

Tell your doctor if you know you suffer from osteoporosis. Patients with osteoporosis are at a higher risk of fractures.

• Talk to your doctor if you have a history of liver disease, including hepatitis. Patients infected with HIV who also have 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 or C, your doctor will carefully consider the best treatment regimen for you.
• Know your hepatitis B virus (HBV) infection status before starting this medicine. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Glenmark, whether or not you also have HIV. It is important not to stop taking Emtricitabine/Tenofovir disoproxil Glenmark without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Glenmark.
• Talk to your doctor if you are over 65. Emtricitabine and tenofovir disoproxil has not been studied in patients over 65 years of age.
• Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Glenmark contains lactose later in this section).

Emtricitabine/Tenofovir disoproxil Glenmark is not for use in children under 12 years of age.

Do not take Emtricitabine/Tenofovir disoproxil Glenmark if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Glenmark (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxil Glenmark with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including:

• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (for viral infection)
• ganciclovir (for viral infection)
• pentamidine (for infections)
• vancomycin (for bacterial infection)
• interleukin-2 (to treat cancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.

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.

Taking Emtricitabine/Tenofovir disoproxil Glenmark with other medicines containing didanosine (for treatment of HIV infection): Taking emtricitabine and 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 causes 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.

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

• Whenever possible, Emtricitabine/Tenofovir disoproxil Glenmark should be taken with food.

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.

• Although there are limited clinical data on the use of emtricitabine and tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with emtricitabine and tenofovir disoproxil to you and your child.

If you have taken emtricitabine/Tenofovir disoproxil Glenmark 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 HIV outweighed the risk of side effects.

• Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Glenmark. This is because the active substances in this medicine pass into human breast milk.
• If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.

Emtricitabine and tenofovir disoproxil can cause dizziness. If you feel dizzy while taking this medicine, do not drive and do not use any tools or machines.

Emtricitabine/Tenofovir disoproxil Glenmark contains phosphate

Tell your doctor if you are on a reduced phosphate diet. Each tablet of Emtricitabine/Tenofovir disoproxil Glenmark contains 46 mg of phosphate.

Tell your doctor if you are lactose-intolerant or intolerant to other sugars.

• Adults: one tablet each day. Whenever possible, Emtricitabine/Tenofovir disoproxil Glenmark should be taken with food.
• Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.

If you have 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 being treated for HIV infection your doctor will prescribe Emtricitabine/Tenofovir disoproxil Glenmark with other antiretroviral medicines. Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.

Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.

If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Glenmark, 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.

It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Glenmark.

• If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Glenmark, take the tablet preferably with food as soon as possible. Then take the next dose at your usual time.
• If you notice 12 hours or more after the time you usually take Emtricitabine/Tenofovir disoproxil Glenmark, forget about the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Glenmark, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Glenmark.

• If you take Emtricitabine/Tenofovir disoproxil Glenmark for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.

• Do not stop taking Emtricitabine/Tenofovir disoproxil Glenmark without contacting your doctor.

• If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil Glenmark treatment without talking to your doctor first. 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, which may be life-threatening.

• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.

• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect. Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
  • deep rapid breathing
  • drowsiness
  • feeling sick (nausea), being sick (vomiting)
  • stomach pain
  • If you think you may have lactic acidosis, get medical help immediately.
• Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for 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

• If you notice these or any symptoms of inflammation or infection, get medical help immediately.

Very common side effects

(may affect more than 1 in 10 people)

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

Tests may also show:

• decreases in phosphate in the blood
• increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

• pain, stomach pain
• difficulty sleeping, abnormal dreams
• problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
• other allergic reactions, such as wheezing, swelling or feeling light-headed

Tests may also show:

• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liver and pancreas problems

Uncommon side effects

(may affect up to 1 in 100 people)

• pain in the abdomen (tummy) caused by inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells

Tests may also show:

• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine

Rare side effects

(may affect up to 1 in 1,000 people)

• Lactic acidosis (see Possible serious side effects)
• fatty liver
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
• inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
• softening of the bones (with bone pain and sometimes resulting in fractures)
• back pain caused by kidney problems

Damage to kidney tubule cells may be associated with 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.

• If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.

The frequency of the following side effects is not known.

• Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/Tenofovir disoproxil Glenmark may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
  • joint stiffness
  • joint aches and pains (especially of the hip, knee and shoulder)
  • difficulty with movement

• If you notice any of these symptoms tell your doctor.

During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

• Children given emtricitabine very commonly experienced changes in skin colour including
  • darkening of the skin in patches
• Children commonly experienced low red blood cell count (anaemia).
  • this may cause the child to be tired or breathless

• If you notice any of these symptoms tell your doctor.

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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The active substances are emtricitabine and tenofovir disoproxil (as phosphate).

Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).

The other ingredients are microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium, colloidal anhydrous silica, stearic acid (E570), lactose monohydrate, hypromellose (E464), titanium dioxide (E171),triacetin (E1518) and indigo carmoine aluminium lake (E132).

Emtricitabine/Tenofovir disoproxil Glenmark are blue coloured, oval shaped, biconvex, 18.6 mm x 9.5 mm film-coated tablets plain on both sides.

Emtricitabine/Tenofovir disoproxil Glenmark is supplied in white plastic bottles. Each bottle contains one (in 30’s pack) or three (in 90’s pack) silica gel dessicant sachets depending on the pack size. The sachets must be kept in the bottle to help protect your tablets and should not be swallowed.

The following pack sizes are available:

• 30 film-coated tablets
• 90 (3 packs of 30) film-coated tablets

Not all pack sizes may be marketed.