200 mg / 245 mg film-coated tablets
emtricitabine / tenofovir disoproxil
What Emtricitabine / Tenofovir disoproxil Mylan is and what it is used for
Emtricitabine / Tenofovir disoproxil Mylan 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 Mylan is a treatment for human immunodeficiency virus 1 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 Mylan should always be taken in combination with other HIV medicines.
- Emtricitabine / Tenofovir disoproxil Mylan may 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 Mylan may still develop infections you or other illnesses associated with HIV – infection.
- Emtricitabine/tenofovir disoproxil Mylan is also used to reduce the risk of being infected with HIV -1 in adults and young people 12 years and up to less than 18 years who weigh at least 35 kg, when used daily with safe sex: See Section 2 for a list of precautions that can be taken against HIV – infection.
What you need to know before you take Emtricitabine / Tenofovir disoproxil Mylan
Do not take Emtricitabine / Tenofovir disoproxil Mylan for HIV or to reduce the risk of HIV infection if you are allergic
against 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 Mylan to reduce your risk of getting HIV:
This medicine can only help reduce the risk of getting HIV before you become infected.
- To reduce the risk of getting HIV, you must be HIV- negative before you start taking this medicine. You must be tested to ensure that you do not already have HIV – infection. Do not take this medicine to reduce your risk of infection unless you have been confirmed to be HIV- negative. People with HIV must take this medicine in combination with other medicines.
- Many HIV tests do not show 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. à Tell your doctor about any possible flu-like symptoms – either during the month before starting treatment with this medicine or at any time while you are taking this medicine.
Warnings and cautions
While you are taking Emtricitabine / Tenofovir disoproxil Mylan to reduce your risk of getting HIV:
- Take this medicine 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 Mylan 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 Mylan 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.
Talk to your doctor if you have more questions about how to prevent getting HIV or transmitting HIV to other people.
While taking Emtricitabine / Tenofovir disoproxil Mylan for treatment of HIV or to reduce the risk of getting HIV:
- Emtricitabine/tenofovir disoproxil 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 Mylan 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 or, if you already have HIV, to take the tablets less often. Emtricitabine/tenofovir disoproxil is not recommended if you have severe kidney disease or if you are on dialysis.
Skeletal problems (which sometimes lead to fractures ) can also occur due to damage to the renal tubules (see section 4, Possible side effects ). - 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 about your hepatitis B virus status (HBV status) before you start taking Emtricitabine / Tenofovir disoproxil Mylan. If you have HBV, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxil, whether you have HIV or not. It is important not to stop taking emtricitabine/tenofovir disoproxil without talking to your doctor, see section 3, “ Do not stop taking Emtricitabine / Tenofovir ET disoproxil Mylan ”.
- Talk to your doctor if you are over 65 years old. Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
- Talk to your doctor if you have lactose intolerance (see “Emtricitabine / Tenofovir disoproxil Mylan contains lactose” later in this section).
Children and young people
Emtricitabine / Tenofovir disoproxil Mylan should not be used in children under 12 years of age.
Other medicines and Emtricitabine / Tenofovir disoproxil Mylan
Do not take Emtricitabine / Tenofovir disoproxil Mylan if you are already taking other medicines that contain the components of this medicine (which are emtricitabine and tenofovir disoproxil), or other antiviral medicines that contain tenofoviralafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine / Tenofovir disoproxil Mylan 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/tenofovir disoproxil Mylan with other medicines containing didanosine (for the treatment of HIV – infection ): If you take emtricitabine/tenofovir in combination 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 Mylan with food and drink
- Whenever possible, Emtricitabine / Tenofovir disoproxil Mylan should be taken with food.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant,t 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 during pregnancy, it is not usually used unless necessary.
- If you are becoming or planning to become pregnant, you must contact your doctor to discuss the benefits and risks of emtricitabine/tenofovir disoproxil treatment for you and your baby.
If you have taken Emtricitabine / Tenofovir disoproxil Mylan 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 Emtricitabine / Tenofovir disoproxil Mylan. 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/tenofovirdisoproxil may cause dizziness. Do not drive or use any tools or machines if you feel dizzy while taking this medicine.
Emtricitabine / Tenofovir disoproxil Mylan 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.
How to take Emtricitabine / Tenofovir disoproxil Mylan
- 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 Mylan for 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 Mylan 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 Mylan together with other antiretrovirals. Read the package leaflets for these medicines for instructions on how to take them.
- If you are an adult taking this medicine to reduce the risk of getting HIV, take this medicine every day, not just when you think you have been exposed to the risk of getting 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 Mylan then you should
If you accidentally take more than the prescribed dose of one of Emtricitabine / Tenofovir disoproxil Mylan, contact your doctor or nearest emergency department for advice. Save the jar or package so you can easily describe what you have taken.
If you forget to take Emtricitabine / Tenofovir disoproxil Mylan
You mustn’t miss a dose of Emtricitabine / Tenofovir disoproxil Mylan.
- If you notice it within 12 hours from the time you usually take Emtricitabine / Tenofovir disoproxil Mylan, 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 Mylan, 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 Mylan, take a new tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking this medicine.
Do not stop taking Emtricitabine / Tenofovir disoproxil Mylan
- If you take emtricitabine/tenofovirdisoproxil Mylan to treat HIV – infection and stop taking the tablets, the effect of the anti- HIV treatment the physician has recommended reducing.
- If you are taking Emtricitabine / Tenofovir disoproxil Mylan to reduce your risk of getting HIV, do not stop taking this medicine and avoid missing out on a few doses. If you stop using dataset drugs or miss the dose you, the risk of you getting HIV – infection increase.
→ Do not stop taking Emtricitabine / Tenofovir disoproxil Mylan without first talking to your doctor.
- If you have chronic hepatitis B, you mustn’t stop taking Emtricitabine / Tenofovir disoproxil Mylan 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, ( the infection that occurs in people with a weak immune system), signs and symptoms of inflammation from previous infections 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 user in 10) :
- 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 users in 100) :
- 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 up to 1 in 1,000 users):
- lactic acidosis (see Possible serious side effects )
- 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 Mylan may develop a bone disease called osteonecrosis (bone tissue death caused by the 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 several 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 Mylan
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 can and carton after EXP. The expiration date is the last day of the specified month.
Can packaging: use within 90 days after first opening.
Do not store above 25 ° C. Store in the original package. Moisture sensitive.
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. An Emtricitabine / Tenofovir disoproxil Mylan film-coated tablet contains 200 mg emtricitabine and 245 mg tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil maleate).
- The other ingredients are microcrystalline cellulose, hydroxypropylcellulose, low-substituted red iron oxide (E172), colloidal anhydrous silica, lactose monohydrate (see section 2 “Emtricitabine / Tenofovir disoproxil Mylan contains lactose”), magnesium stearate, aluminum bleach, triacylate, FC lacquer (E133) and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Emtricitabine / Tenofovir disoproxil Mylan film-coated tablets are a light green, film-coated, capsule-shaped, biconvex tablet measuring 19.8 mm x 9.00 mm, marked with “M” on one side of the tablet and with “ETD” on the other side.
This medicine is supplied in plastic cans containing a desiccant (the desiccant must NOT be consumed) and contains 30 film-coated tablets. It is also available in multiple packs of 90 film-coated tablets comprising 3 cans containing 30 film-coated tablets each or blister packs containing incorporated desiccant and 30, 30×1, 90×1, or 100×1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MYLAN SAS
117 Allée desAd Parcs,
69 800 Saint Priest,
France
Manufacturer
Mylan Hungary Kft
Mylan utca 1, H-2900 Komárom,
Hungary
McDermott Laboratories Ltd T / A Gerard Laboratories T / A Mylan Dublin
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Medis International as
vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice
747 23, Czech Republic
Mylan Germany GmbH
Branch drop Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352,
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienMylan bvba / sprlTel: + 32 (0) 2 658 61 00 | LithuaniaBGP Products UAB Tel: +370 5 205 1288 |
| BulgariaМайлан ЕООДTel: +359 2 44 55 400 | Luxembourg / LuxemburgMylan bvba / sprlTel: + 32 (0) 2 658 61 00(Belgium / Belgium) |
| Czech RepublicMylan Healthcare CZ sroTel: +420 222 004 400400 | HungaryMylan EPD KftTel: + 36 1 465 2100 |
| DenmarkMylan Denmark ApSTel: +45 28 11 69 32 | MaltaVJ Salomone Pharma Ltd.Tel: + 356 212 01 74 |
| GermanyMylan Healthcare GmbHTel: + 49 800 0700 800 | The NetherlandsMylan BVTel: + 31 (0) 20426 3300 |
| EestiBGP Products Switzerland GmbH Eesti subsidiaryTel: +372 6363 052 | NorwayMylan Healthcare Norge ASTel: + 47 66 75 33 00 |
| GreeceGenerics Pharma Hellas ΕΠΕ:Ηλ: +30 210 993 6410 | AustriaArcana Arzneimittel GmbHTel: +43 1 416 2418 |
| SpainMylan Pharmaceuticals, SLTel: + 34 900 102 712 | PolandMylan Healthcare Sp. z ooTel: + 48 22 546 64 00 |
| FranceMylan SASTel: +33 4 37 25 75 00 | PortugalMylan, Lda.Tel: + 351 21 412 72 56 |
| CroatiaMylan Hrvatska dooTel: +385 1 23 50 599 | RomaniaBGP Products SRLTel: +40 372 579 000 |
| IrelandMylan Ireland LimitedTel: +353 (0) 87 1694982 | SloveniaMylan Healthcare dooTel: + 386 1 236 31 80 |
| IcelandIcepharma hfTel: +354 540 8000 | Slovak RepublicMylan sroTel: +421 2 32 199 100 |
| ItalyMylan Italia SrlTel: + 39 02 612 46921 | Finland / FinlandMylan Finland OYPuh / Tel: + 358 20720 9555 |
| LatviaMylan Healthcare SIATel: +371 676 055 8080 | United KingdomGenerics [UK] LtdTel: +44 1707 853000 |