200 mg / 245 mg film-coated tablets 
emtricitabine / tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Emtricitabine / Tenofovir disoproxil Sandoz is and what it is used for 
2. What you need to know before taking Emtricitabine / Tenofovir disoproxil Sandoz 
3. How to take Emtricitabine / Tenofovir disoproxil Sandoz 
4. Possible side effects 
5. How to store Emtricitabine / Tenofovir disoproxil Sandoz 
6. Contents of the packaging and other information 

What Emtricitabine / Tenofovir disoproxil Sandoz is and what it is used for

Emtricitabine / Tenofovir disoproxil Sandoz contains two active substances,  emtricitabine and tenofovir disoproxil . Both of these active substances are antiretroviral drugs used to treat HIV – infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are commonly called NRTIs and act by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction (propagation).

  • Emtricitabine / Tenofovir disoproxil Sandoz is a treatment for human immunodeficiency virus infection ( HIV- 1 )  in adults.
  • It is also used to treat HIV in adolescents aged 12 to 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines that are no longer effective or that have caused side effects.
    • Emtricitabine / Tenofovir disoproxil Sandoz should always be taken in combination with other anti- HIV medicines.
    • Emtricitabine / Tenofovir disoproxil Sandoz can be used instead of separate administration of emtricitabine and tenofovir disoproxil at the same dose .

People who are HIV -positive can still transmit HIV -smitten when taking this medicine, even though the risk is reduced with effective antiretroviral treatment. Discuss the necessary steps to avoid infecting others with your doctor.

This medicine does not cure HIV – infection. While taking emtricitabine/tenofovir disoproxil Sandoz may still develop infections you or other illnesses associated with HIV – infection.

  • Emtricitabine / Tenofovir disoproxil Sandoz is also used to reduce the risk of HIV- 1 infection in adults and adolescents 12 years of age and up to 18 years of age weighing at least 35 kg, when taken daily with safe sex: See Section 2 for a list of precautions that can be taken against HIV – infection.

Emtricitabine and tenofovir disoproxil contained in Emtricitabine / Tenofovir disoproxil Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Emtricitabine / Tenofovir disoproxil Sandoz

Do not take Emtricitabine / Tenofovir disoproxil Sandoz 

for the treatment of HIV or to reduce the risk of HIV infection if you are allergic to emtricitabine, 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.

Before you take Emtricitabine / Tenofovir disoproxil, Sandoz, to reduce your risk of getting HIV:

Emtricitabine / Tenofovir disoproxil Sandoz can only help reduce the risk of getting HIV before you become infected.

  • To reduce your risk of getting HIV you must be HIV negative before starting Emtricitabine / Tenofovir disoproxil, Sandoz. You must be tested to ensure that you do not already have HIV – infection. Do not take Emtricitabine / Tenofovir disoproxil, Sandoz, to reduce your risk of infection unless you have been confirmed to be HIV- negative. People with HIV must take Emtricitabine / Tenofovir disoproxil, Sandoz, in combination with other medicines.
  • Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean that you have recently been infected with HIV. These may be signs of HIV infection:
  • fatigue
  • fever
  • joint or muscle pain
  • headache
  • vomiting or diarrhea
  • rash
  • night sweats
  • enlarged lymph nodes in the throat or groin.
    → Tell your doctor about any flu-like symptoms – either during the month before starting treatment with Emtricitabine / Tenofovir disoproxil Sandoz or at any time while you are taking Emtricitabine / Tenofovir disoproxil, Sandoz.

Warnings and cautions

While taking Emtricitabine / Tenofovir disoproxil Sandoz to reduce your risk of getting HIV:

  • Take emtricitabine/tenofovir disoproxil, Sandoz, every day to reduce the risk, not just when you think you have been exposed to the risk of getting HIV – infection. Do not miss any dose of Emtricitabine / Tenofovir disoproxil Sandoz or stop taking it. If you miss the dose you may be more likely that you suffer from HIV – infection increase.
  • Get tested regularly for HIV.
  • If you think you have been infected with HIV, tell your doctor immediately. Your doctor may want to perform several tests to make sure you are still HIV- negative.
  • Taking Emtricitabine / Tenofovir disoproxil Sandoz alone may not prevent you from getting HIV.
    • Always exercise safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
    • Do not share personal items where there may be blood or body fluids, e.g. toothbrushes and razor blades.
    • Do not share or reuse needles or other injection or drug equipment.
    • Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for you to get infected with HIV.

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

While taking Emtricitabine / Tenofovir disoproxil Sandoz for treatment of HIV or to reduce the risk of getting HIV:

  • Emtricitabine / Tenofovir disoproxil Sandoz may affect your kidneys. Before and during treatment, your doctor may prescribe some blood tests to measure your kidney function. Tell your doctor if you have a history of kidney disease or if tests have shown that you have kidney problems. Emtricitabine / Tenofovir disoproxil Sandoz should not be used in adolescents with pre-existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine / Tenofovir disoproxil Sandoz or, if you already have HIV, to take the tablets less often. Emtricitabine / Tenofovir disoproxil Sandoz is not recommended if you have severe kidney disease or if you are on dialysis.
    Bone problems (sometimes resulting in fractures s) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects s ).
  • Tell your doctor if you already have or have had liver disease, including hepatitis. HIV patients with liver disease (including chronic hepatitis B or C) treated with antiretroviral agents are at increased risk for severe and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully choose the best treatment for you.
  • Find out your hepatitis B virus status (HBV status) before you start taking Emtricitabine / Tenofovir disoproxil, Sandoz. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine / Tenofovir disoproxil Sandoz, whether you have HIV or not. It is important not to stop taking Emtricitabine / Tenofovir disoproxil Sandoz without talking to your doctor, see section 3, “ Do not stop taking Emtricitabine / Tenofovir disoproxil, Sandoz ”.
  • Talk to your doctor if you are over 65 years old. Emtricitabine / Tenofovir disoproxil Sandoz has not been studied in patients over 65 years of age.
  • Talk to your doctor if you have lactose intolerance (see “Emtricitabine / Tenofovir disoproxil Sandoz contains lactose” later in this section).

Children and young people

Emtricitabine / Tenofovir disoproxil Sandoz should not be used in children under 12 years of age.

Other medicines and Emtricitabine / Tenofovir disoproxil Sandoz

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

Taking Emtricitabine / Tenofovir disoproxil Sandoz 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:

  • aminoglycoside is (against a bacterial infection )
  • amphotericin B (against fungal infection)
  • foscarnet (against a viral infection)
  • ganciclovir (for virus infection)
  • pentamidine (against infection )
  • vancomycin (against a bacterial infection )
  • interleukin -2 (for the treatment of cancer)
  • cidofovir (for virus infection)
  • non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain)

If you are taking other antiviral medicines, called protease inhibitors, for the treatment of HIV, your doctor may prescribe blood tests to closely monitor your kidney function.

It is also important that you tell your doctor if you are taking ledipasvir / sofosbuvir, sofosbuvir / velpatasvir or sofosbuvir / velpatasvir / voxilaprevir to treat hepatitis C infection .

Taking emtricitabine/tenofovirdisoproxil Sandoz with other medicines containing didanosine (for the treatment of HIV – infection ): If you take emtricitabine/tenofovir disoproxil, Sandoz, together with other antiviral medicines that contain didanosine, blood levels of didanosine increase and CD4 cell counts. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases fatal, have been reported during concomitant treatment with drugs containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether you can be treated with a combination 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.

Emtricitabine / Tenofovir disoproxil Sandoz with food and drink

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

Pregnancy and breastfeeding

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 / Tenofovir disoproxil Sandoz during pregnancy, it is not usually used unless clearly necessary.
  • If you are a woman who may become pregnant during treatment with Emtricitabine / Tenofovir disoproxil Sandoz, you must use an effective method of contraception to avoid pregnancy.
  • If you are becoming or planning to become pregnant, you must contact your doctor to discuss the benefits and risks of treatment with Emtricitabine / Tenofovir disoproxil Sandoz for you and your baby.

If you have taken Emtricitabine / Tenofovir disoproxil, Sandoz, during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

  • Do not breast-feed during treatment with Emtricitabine / Tenofovir disoproxil Sandoz. This is because the active substances in this medicine are excreted in human breast milk.
  • If you are an HIV- infected woman, do not breast-feed your baby to avoid transmitting HIV to your baby through breast milk.

Driving and using machines

Emtricitabine / Tenofovir disoproxil Sandoz may cause dizziness. Do not drive or use any tools or machines if you feel dizzy while taking Emtricitabine / Tenofovir disoproxil Sandoz.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Emtricitabine / Tenofovir disoproxil contains Sandoz

Emtricitabine / Tenofovir disoproxil Sandoz contains lactose .

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Emtricitabine / Tenofovir disoproxil Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Emtricitabine / Tenofovir disoproxil Sandoz

  • Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose of Emtricitabine / Tenofovir disoproxil Sandoz for the treatment of HIV is:

  • Adults: one tablet daily, if possible with food.
  • Adolescents aged 12 to under 18 years weighing at least 35 kg: one tablet daily, if possible with food. The recommended dose of Emtricitabine / Tenofovir disoproxil Sandoz to reduce the risk of getting HIV is: 
  • Adults: one tablet daily, if possible with food. 
  • Adolescents 12 years of age and up to less than 18 years of age who weigh at least 35 kg: one tablet daily, if possible with food.
    If you have difficulty swallowing, you can crush the tablet with the tip of a spoon. 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 prescribed by your doctor to ensure that the medicine is effective and to reduce the development of resistance to treatment. Do not change the dose unless your doctor tells you to.
  • If you are being treated for HIV – infection, your doctor will write out the emtricitabine/tenofovir disoproxil Sandoz together with other antiretrovirals. Read the package leaflets for these medicines for instructions on how to take them.
  • If you are an adult taking Emtricitabine / Tenofovir disoproxil Sandoz to reduce your risk of getting HIV, take Emtricitabine / Tenofovir disoproxil, Sandoz, every day, not just when you think you are at risk of being infected with HIV.

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

If you take more Emtricitabine / Tenofovir disoproxil Sandoz then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Save the outer carton or jar so that you can easily describe what you have taken.

If you forget to take Emtricitabine / Tenofovir disoproxil Sandoz

It is important that you do not miss a dose of Emtricitabine / Tenofovir disoproxil Sandoz.

If you miss a dose

  • If you notice it within 12 hours from the time you usually take Emtricitabine / Tenofovir disoproxil Sandoz , take the tablet, preferably with food, as soon as possible. Then take the next dose at the usual time.
  • If you notice it 12 hours or more after the time you usually take Emtricitabine / Tenofovir disoproxil Sandoz, ignore the missed dose . Wait and take the next dose, preferably with food, at the usual time.

If you vomit within less than 1 hour after a dose of Emtricitabine / Tenofovir disoproxil Sandoz, take a new tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Emtricitabine / Tenofovir disoproxil Sandoz.

Do not stop taking Emtricitabine / Tenofovir disoproxil Sandoz

  • If you take emtricitabine / tenofovir disoproxil Sandoz to treat HIV – infection , if you stop taking the tablets, the effect of the anti- HIV treatment the doctor has recommended reduced.
  • If you are taking Emtricitabine / Tenofovir disoproxil Sandoz to reduce the risk of getting HIV , do not stop taking Emtricitabine / Tenofovir disoproxil Sandoz or miss any dose . If you stop using emtricitabine / tenofovir disoproxil Sandoz, or miss the dose you, the risk of you getting HIV – infection increase.
    → Do not stop taking Emtricitabine / Tenofovir disoproxil Sandoz without first talking to your doctor.
  • If you have chronic hepatitis B , it is especially important that you do not stop taking Emtricitabine / Tenofovir disoproxil Sandoz without talking to your doctor first. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis , discontinuation of treatment is not recommended as this may lead to worsening of hepatitis A, which may be life-threatening.
    → Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection .

If you have any further questions on the use of this product, 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:

  • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect . Lactic acidosis occurs more frequently in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
  • deep, rapid breathing
  • drowsiness
  • nausea, vomiting
  • abdominal pain
    → If you think you may have lactic acidosis, seek medical attention immediately.
  • Any signs of inflammation or infection . In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you ( the infection you that occurs in people with a weak immune system), signs and symptoms of inflammation from previous infections you may occur soon after the treatment against HIV begin. It is believed that these symptoms are due to an improvement in the body’s immune system and enable the body to fight infections that may have existed without any visible symptoms.
  • Autoimmune disorders, where the immune system attacks healthy body tissue, can also occur after you start taking medicines for the treatment of HIV – infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
    • muscle weakness
    • weakness that begins in the hands and feet and moves upwards towards the torso
    • palpitations, tremors or hyperactivity.
      → If you notice these or any symptoms of inflammation or infection , seek medical attention immediately.

Possible side effects:

Very common side effects are

(may affect more than 1 in 10 people)

  • diarrhea, vomiting, nausea
  • dizziness, headache
  • rash
  • feeling weak.

Samples can also show:

  • lowering of phosphate levels in the blood
  • elevated creatine kinase.

Common side effects are

(may affect up to 10 in 100 patients)

  • pain, abdominal pain
  • difficulty sleeping, abnormal dreams
  • indigestion which results in discomfort after meals, feeling of bloating, flatulence
  • skin rash (including red spots or skin blemishes sometimes with blistering and swelling of the skin) which may be allergic reactions, itching , discoloration of the skin including dark spots on the skin
  • other allergic reactions, such as wheezing / wheezing, swelling or intoxication.

Samples can also show:

  • low white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
  • elevated levels of triglycerides (fatty acids) in the blood, increased amount of bile pigments in the blood or elevated blood sugar
  • liver and pancreatic disorders.

Uncommon side effects are

(may affect up to 1 in 100 people)

  • abdominal pain (stomach) caused by inflammation of the pancreas
  • swelling of the face, lips, tongue or throat
  • anemia (low red blood cell count )
  • muscle breakdown, muscle pain or muscle weakness that can occur due to damage to kidney tubules.

Samples can also show:

  • decreased potassium levels in the blood
  • elevated creatinine content in the blood
  • changes in the urine.

Rare side effects are

(may affect 1 in 1,000 patients)

  • lactic acidosis (see ” any serious adverse event is “)
  • fatty liver
  • yellow skin or yellow eyes, itching , or pain in the abdomen (stomach) caused by inflammation of the liver
  • kidney inflammation, urinating a lot and feeling thirsty, kidney failure , damage to kidney tubules
  • impaired bone hardness (which causes skeletal pain and sometimes leads to fractures )
  • back pain caused by kidney problems.

Damage to kidney tubules can be associated with muscle breakdown, decreased bone hardness (which causes skeletal pain and sometimes leads to fractures ), muscle pain, muscle weakness and decreased potassium or phosphate levels in the blood.

→ If you notice any of the above side effects or if any of the side effects gets serious , talk to your doctor or pharmacist.

The frequency of the following side effects is unknown.

  • Skeletal problem. Some patients taking combination antiretroviral medicines such as Emtricitabine / Tenofovir disoproxil Sandoz may develop a bone disease called osteonecrosis (bone tissue death caused by lost blood supply to the bone tissue). Some of the many risk factors for developing this disease are long-term use of this type of drug, use of corticosteroids , use of alcohol, very weak immune system and obesity. Signs of osteonecrosis are:
  • joint stiffness
  • joint pain and pain (especially in the hip joint, knee joint and shoulder joint)
  • difficulty moving.
    → Tell your doctor if you notice any of these symptoms.

During treatment for HIV , there may be weight gain and an increase in blood fat and blood glucose levels. This is partly related to improved health and lifestyle and as far as blood fats are concerned, sometimes with the HIV drugs themselves. Your doctor will take samples for this.

Other side effects are in children

  • Children who have been given emtricitabine have very often suffered from discoloration of the skin including
    • dark spots on the skin
  • Children are often affected by too low a number of red blood cells ( anemia ).
    • This can lead to the child becoming tired or short of breath.
      → Tell your doctor if you notice any of these symptoms.

5. How to store Emtricitabine / Tenofovir disoproxil Sandoz

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 label and carton after EXP. The expiration date is the last day of the specified month.

Tablet jar:

Store in the original package. Moisture sensitive. Close the jar tightly.

No special temperature instructions.

Opened jar should be used within 30 days.

Blister:

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are emtricitabine and tenofovir disoproxil.Each film-coated tablet contains 200 mg emtricitabine and 245 mg tenofovir disoproxil.
  • Other ingredients are:Tablet core: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, pregelatinised maize starch, lactose monohydrate .Tablet coating: hypromellose, lactose monohydrate , titanium dioxide (E171), triacetin, indigo carmine (E132).

What the medicine looks like and contents of the pack

Emtricitabine / Tenofovir disoproxil Sandoz is a blue, capsule-shaped, film-coated tablet, measuring approximately 19 mm x 9 mm, marked “H” on one side and “E29” on the other.

Emtricitabine / Tenofovir disoproxil Sandoz is supplied in OPA aluminum PVC / aluminum blister packs and in a white, opaque, HDPE can (containing 30 tablets) with a white, opaque, child-resistant polypropylene screw cap. The jar contains desiccant (silica gel capsule) which must be in the bottle to protect the tablets.

The following pack sizes are available:

Outer cartons containing 30, 60 (2 cans of 30) or 90 (3 cans of 30) film-coated tablets.

Outer cartons containing blister card with 10, 30, 60 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, Paola PLA 3000, Malta

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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