200 mg / 25 mg / 245 mg film-coated tablets 
emtricitabine / rilpivirine / 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 Eviplera is and what it is used for 
2. What you need to know before taking Eviplera 
3. How to take Eviplera 
4. Possible side effects 
5. How to store Eviplera 
6. Contents of the packaging and other information 

1. What Eviplera is and what it is used for

Eviplera contains three active substances used to treat human immunodeficiency virus ( HIV ) infection :

  • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
  • Rilpivirine, a non- nucleoside reverse transcriptase inhibitor (NNRTI).
  • Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NRTI).

Each of these active substances, also called antiretroviral drugs, acts by disrupting an enzyme (a protein called “reverse transcriptase”) that is necessary for the virus to multiply.

Eviplera reduces the amount of HIV in the body. This strengthens the immune system and the risk of developing illnesses associated with HIV – infection decreases.

Eviplera is a treatment for human immunodeficiency virus ( HIV ) infection in adults aged 18 years and older.

2. What you need to know before taking Eviplera

Do not take Eviplera

  • If you are allergic to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

→ If this applies to you, tell your doctor immediately.

  • If you are currently taking any of the following medicines
    • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (medicines to treat epilepsy and to prevent seizures)
    • rifampicin and rifapentine (used to treat certain bacterial infections like tuberculosis )
    • omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole ( proton pump inhibitors which are medicines used to prevent and treat stomach ulcers, heartburn, acid reflux)
    • dexamethasone (a corticosteroid used to treat inflammation and to suppress the immune system) when taken by mouth or given as an injection (except when treated with a single dose)
    • products containing St. John’s wort (Hypericum perforatum) (a traditional herbal medicine used for mild depression and mild anxiety)

Warnings and cautions

Your treatment with Eviplera must be constantly monitored by a doctor.

  • You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection. While taking Eviplera you may still develop infections you or other illnesses associated with HIV – infection.
  • Tell your doctor if you have had kidney disease or if tests have shown that you have kidney problems. Eviplera can affect your kidneys. Before starting treatment and during treatment, your doctor may prescribe some blood tests to check if your kidneys are functioning normally. Eviplera is not recommended if you have moderate or severe kidney disease.
    Eviplera is not usually taken with other medicines that can damage the kidneys (see Other medicines and Eviplera ). If this is unavoidable, your doctor will check your kidney function once a week.
  • Tell your doctor if you have or have had liver disease, including hepatitis. HIV patients with liver disease (including chronic hepatitis B or C) treated with antiretroviral drugs are at increased risk for severe and life-threatening liver problems. If you have hepatitis B, your doctor will carefully consider the best treatment for you. Two of the active substances in Eviplera (tenofovir disoproxil and emtricitabine) show some activity against the hepatitis B virus. If you have or have had liver disease or chronic hepatitis B infection, your doctor may take blood samples to check your liver function.
    If you have a hepatitis B infection, liver problems may worsen after you stop taking Eviplera. It is important that you do not stop taking Eviplera without talking to your doctor: see section 3, Do not stop taking Eviplera.
  • Tell your doctor immediately and stop taking Eviplera if you develop a rash with the following symptoms: fever, blisters, red eyes, and swelling of the face, mouth,h, or body. This can be serious or potentially life-threatening.
  • Talk to your doctor if you are over 65 years old. Not enough patients over the age of 65 have been studied. If you are over 65 years of age and have been prescribed Eviplera, your doctor will monitor you closely.

While taking Eviplera

Once you have started taking Eviplera, you should be observant of:

  • any signs of inflammation or infection
  • leg problem

→ Contact a doctor immediately if you get any of these symptoms.

Children and young people

Do not give this medicine to children and teenagers under 18 years of age.

Other medicines and Eviplera

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines, herbal remedies, or other natural products.

Tell your doctor if you are taking any of the following:

Other medicines that contain :

  • emtricitabine
  • rilpivirine
  • tenofovir disoproxil
  • tenofoviralafenamide
  • other antiviral medicines containing lamivudine or adefovir dipivoxil

Eviplera may interact with other medicines. This may affect the amount of Eviplera or other medicines in the blood. The medicines may then not work properly or any side effects may be exacerbated. In some cases, your doctor may need to change your dose or check the amount of medicine in your blood.

Drugs that can damage the kidneys, for example:

  • aminoglycosides (eg streptomycin, neomycin, and gentamicin), vancomycin (against bacterial infections )
  • foscarnet, ganciclovir, cidofovir (for viral infections)
  • amphotericin B, pentamidine (against fungal infections)
  • interleukin -2, also called aldesleukin (for the treatment of cancer)
  • non-steroidal anti-inflammatory drugs ( NSAIDs  to relieve skeletal or muscle pain)

Medicines containing didanosine (for HIV – infection ): If you take Eviplera with other antiviral medicines that contain didanosine, blood levels of didanosine increase, and CD4 + cell counts drop. 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 to treat you with other medicines used to treat HIV – infection ( see Other medicines used to treat HIV – infection ).

Other medicines used to treat HIV infection: Non-nucleoside reverse transcriptase inhibitors (NNRTIs). Eviplera contains an NNRTI (rilpivirine) and therefore Eviplera should not be combined with other medicines of this type. If necessary, your doctor will discuss another medicine.

Rifabutin, a drug used to treat certain bacterial infections. This medicine may reduce the amount of rilpivirine (an ingredient in Eviplera) in the blood. The doctor may need to give you another dose of rilpivirine to treat your HIV – infection (see section 3. How to take Eviplera).

Antibiotics used to treat bacterial infection s, including tuberculosis:

  • clarithromycin
  • erythromycin

These medicines can increase the amount of rilpivirine (a component of Eviplera) in the blood. Your doctor may need to change the dose of one of the antibiotics or give you another antibiotic.

Medicines for stomach ulcers, heartburn, or acid reflux such as:

  • antacids (aluminum/magnesium hydroxide or calcium carbonate )
  • 2 – antagonist is (famotidine, cimetidine, nizatidine, or ranitidine)

These medicines can reduce the amount of rilpivirine (an ingredient in Eviplera) in your blood. If you take any of these medicines, your doctor will either give you another medicine for stomach ulcers, heartburn, or acid reflux or recommend how and when to take it.

If you are taking an antacid (eg medicines containing magnesium or potassium ), take it at least 2 hours before or at least 4 hours after Eviplera (see section 3 How to take Eviplera).

If you take an H 2 – antagonists (used to treat stomach ulcers, heartburn, or acid reflux), take it at least 12 hours before or at least 4 hours after Eviplera. The H2 antagonist can only be taken once a day if you are taking Eviplera. H2 antagonist, you should not be taken with dosage twice a day. Talk to your doctor about an alternative treatment regimen ( see section 3 How to take Eviplera).

Methadone, a drug used to treat opiate addiction, as your doctor may need to change your methadone dose.

Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to check the levels of this medicine in your blood.

→ Tell your doctor if you are taking any of these medicines. You should not stop treatment without talking to your doctor.

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.

  • Use an effective method of contraception while taking Eviplera.
  • Tell your doctor immediately if you become pregnant or are planning to become pregnant. Pregnant women should discuss the use of Eviplera with their doctor. Your doctor will discuss the benefits and risks of taking Eviplera for you and your baby.
  • If you have taken Eviplera during your pregnancy, your doctor may ask you to have regular blood tests and other tests to check your baby’s development. For children whose mothers took NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.

Do not breast-feed during treatment with Eviplera:

  • This is because the active substances in this medicine are excreted in human breast milk.
  • If you are an HIV- infected woman, it is recommended that you do not breast-feed your baby to avoid transmitting HIV to your baby through breast milk.

Driving and using machines

Do not drive or use any tools or machines if you feel tired, drowsy, or dizzy while taking this medicine.

Eviplera contains lactose, para-orange aluminum lacquer (E110), and sodium

  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
  • Tell your doctor if you are allergic to para-orange aluminum paint (E110). Eviplera contains para-orange aluminum lacquer, also called “E110” which can cause allergic reactions.
  • This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

3. How to take Eviplera

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

The usual dose is one tablet taken daily by mouth. The tablet must be taken with food. This is important for you to get the right levels of the active substance in your body. A nutritional drink alone does not replace food.

Swallow the tablet whole with water.

Do not chew, crush or split the tablet – if you do, it may affect the release of one of the drugs in the body.

If your doctor decides to stop one of the components of Eviplera or change the dose of Eviplera, you may be given emtricitabine, rilpivirine, and/or tenofovir disoproxil separately or with other medicines to treat HIV – infection.

If you are taking an antacid such as medicines containing magnesium or potassium. Take it at least 2 hours before or at least 4 hours after Eviplera.

If you take an H 2 – antagonist that as famotidine, cimetidine, nizatidine, or ranitidine. Take it at least 12 hours before or at least 4 hours after Eviplera. H 2 – antagonist, you can only be taken once a day if you take Eviplera. H2 antagonists should not be taken twice a day. Talk to your doctor about an alternative treatment regimen.

If you are taking rifabutin. Your doctor may need to give you another dose of rilpivirine. Take the rilpivirine tablet while you are taking Eviplera. Ask your doctor or pharmacist if you are unsure.

If you take more Eviplera then you should

If you accidentally take more than the prescribed dose of Eviplera, the risk of side effects is with this medicine may increase (see section 4, Possible side effects s ).

Contact your doctor or nearest emergency department immediately for advice. Save the jar so you can easily describe what you have taken.

If you forget to take Eviplera

You mustn’t miss a dose of Eviplera.

If you miss a dose:

  • If you notice it within 12 hours after the time you usually take Eviplera, you must take the tablet as soon as possible. The tablet must always be taken with food. Then take the next dose as usual.
  • If you notice it 12 hours or more after the time you usually take Eviplera, do not take the missed dose. Wait and take the next dose of food at its regular time.

If you vomit within less than 4 hours after a dose of Eviplera, take a new tablet of food. If you vomit more than 4 hours after taking Eviplera, you do not need to take a new tablet until it is time to take your next dose at the usual time.

Do not stop taking Eviplera

Do not stop taking Eviplera without talking to your doctor. If you stop taking Eviplera, it may seriously affect your response to future treatment. If for any reason you stop taking Eviplera talk to your doctor before taking Eviplera tablets again. Your doctor may consider giving you the components of Eviplera individually if you have any problems or need a dose adjustment.

When your Eviplera supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The virus can then become more difficult to treat.

If you have HIV – infection and hepatitis B infection, it is especially important not to stop your Eviplera treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened when treatment with emtricitabine or tenofovir disoproxil (two of the three active substances in Eviplera) is stopped. If you stop taking Eviplera, your doctor may recommend that you resume treatment for hepatitis B. You may need to provide blood tests to check how your liver is working for 4 months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended that treatment be discontinued 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 side effects: Contact a doctor immediately

  • Lactic acidosis (too much lactic acid in the blood) is a rare but potentially life-threatening side effect of certain HIV medicines. Lactic acidosis is more common in women – especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
    • Deep, rapid breathing
    • Fatigue or drowsiness
    • Nausea, vomiting
    • Stomach pain

→ Contact a doctor immediately if you think you may have lactic acidosis.

Any sign of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) who have a history of opportunistic infection, you ( infection s that occur in people with weakened immune systems) may be signs and symptoms of inflammation from previous infections that occur shortly after HIV treatment is started. It is believed that these symptoms are because the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.

In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.

→ If you notice any symptoms of inflammation or infection, tell your doctor immediately.

Very common side effects are

(may occur in more than 1 in 10 people)

  • Diarrhea, vomiting, nausea
  • Difficulty sleeping (insomnia)
  • Dizziness, headache
  • Rash
  • Feeling weak

Samples can also show :

  • Lowering the phosphate level in the blood
  • Elevated levels of creatine kinase in the blood can cause muscle pain and muscle weakness
  • Elevated levels of cholesterol and/or pancreatic amylase ( enzyme from the pancreas) in the blood
  • Elevated levels of liver enzymes in the blood

→ Tell your doctor if any of these side effects become serious.

Common side effects are

(may occur in up to 1 in 10 people)

  • Decreased appetite
  • Depression and lowered mood
  • Fatigue, drowsiness ( somnolence )
  • Drowsiness
  • Pain, abdominal pain or discomfort, feeling of bloating, dry mouth
  • Abnormal dreams, sleep disorders
  • Indigestion which results in discomfort after meals, flatulence ( flatulence )
  • Skin rash (including red spots or 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:

  • Small white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
  • Small platelet count (a type of blood cell involved in coagulation )
  • Decreased level of hemoglobin in the blood (low number of red blood cells )
  • Elevated levels of fatty acids ( triglycerides ), bilirubin, or sugar in the blood
  • Pancreatic problems

→ Tell your doctor if any of these side effects become serious.

Uncommon side effects are

(may occur in up to 1 in 100 people)

  • Anemia ( Anemia, a small number of red blood cells )
  • Abdominal pain (stomach) caused by inflammation of the pancreas
  • Muscle breakdown, muscle pa, in or muscle weakness
  • Swelling of the face, lips, tongue, or throat
  • Signs or symptoms of inflammation or infection
  • Severe skin reactions including rash accompanied by fever, swelling, and liver problems
  • Renal injury (renal tubules)

Samples can also show :

  • Decreased potassium levels in the blood
  • Elevated creatinine content in the blood
  • Changes in urine

→ Tell your doctor if any of these side effects become serious.

Rare side effects are

(can occur in up to 1 in 1,000 people)

  • Lactic acidosis (see Possible side effects: Contact a doctor immediately)
  • Back pain is caused by kidney damage, including kidney failure. Your doctor may take blood samples to see if your kidneys are working properly.
  • Fatty liver
  • Yellow skin or yellow eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
  • Kidney inflammation, that you urinate a lot and that you feel thirsty
  • Decreased bone hardness (which causes bone pain and sometimes leads to fractures )

Muscle breakdown decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood can occur due to damage to kidney tubules.

→ Tell your doctor if any of these side effects become serious.

Other side effects are liable to occur in HIV treatment

The frequency of the following side effects is unknown (frequency cannot be calculated from the available data).

  • Leg problem. Some patients taking combination antiretroviral medicines such as Eviplera may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids, alcohol consumption, a very weak immune system, and obesity. Signs of osteonecrosis are:
    • Joint stiffness
    • Pain and pain (especially in hips, knees, and shoulders)
    • Movement difficulties
  • → Tell your doctor if you notice any of these symptoms.

During HIV treatment, weight gain and increased levels of fat and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood fats, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

5. How to store Eviplera

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 jar and carton after {EXP}. The expiration date is the last day of the specified month.

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

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, rilpivirine, and tenofovir disoproxil. One Eviplera film-coated tablet contains 200 mg emtricitabine, 25 mg rilpivirine (as hydrochloride), and 245 mg tenofovir disoproxil (as fumarate).
  • Other ingredients are Tablet core: Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinized maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate.
    Film coating: Hypromellose, indigo carmine aluminum lacquer, lactose monohydrate, polyethylene glycol, red iron oxide, para-orange aluminum lacquer (E110), titanium dioxide, and triacetin.

What the medicine looks like and the contents of the pack

Eviplera is a purple-pink, capsule-shaped, film-coated tablet, debossed on one side with “GSI” and smooth on the other side. Eviplera is supplied in cans containing 30 tablets and in packs of 3 cans each containing 30 tablets. Each jar contains desiccant (silica gel) which must be present in the jar to protect the tablets. The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Muhammad Nadeem

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