Emtricitabine/tenofovir disoproxil Mylan: detailed information

Package leaflet: Information for the user

Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets

emtricitabine/tenofovir disoproxil
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for
What you need to know before taking Emtricitabine/Tenofovir disoproxil Mylan
How to take Emtricitabine/Tenofovir disoproxil Mylan
Possible side effects
How to store Emtricitabine/Tenofovir disoproxil Mylan
Contents of the pack and other information

1. What Emtricitabina/Tenofovir disoproxil Mylan is and what it is used for

Emtricitabina/Tenofovir disoproxil Mylan contains two active substances, emtricitabine and tenofovir disoproxil.
Both active substances are antiretroviral medicines used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor
and tenofovir is a nucleotide reverse transcriptase inhibitor. However, they are generally known as NRTIs and work by interfering with the normal activity of an enzyme (reverse transcriptase) that is essential for the virus to replicate.

Emtricitabina/Tenofovir disoproxil Mylan is used to treat human immunodeficiency virus 1 (HIV-1) infection in adults.
It is also used to treat HIV in adolescents aged 12 to < 18 years with a body weight of at least 35 kg, who have previously been treated with other HIV medicines that are no longer effective or have caused undesirable effects.
- Emtricitabina/Tenofovir disoproxil Mylan must always be used in combination with other medicines for the treatment of HIV infection.
- Emtricitabina/Tenofovir disoproxil Mylan may be administered as a substitute for separate emtricitabine and tenofovir disoproxil given at the same doses.

This medicine is not a cure for HIV infection. While taking Emtricitabina/Tenofovir disoproxil Mylan, you may still develop infections or other diseases associated with HIV infection.

Emtricitabina/Tenofovir disoproxil Mylan is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years with a body weight of at least 35 kg, when used as a daily treatment together with safe sexual practices. For a list of precautions to prevent HIV infection, see section 2.

2. What you need to know before taking Emtricitabine/Tenofovir disoproxil Mylan

Do not take Emtricitabine/Tenofovir disoproxil Mylan to treat HIV infection or to reduce the risk of acquiring HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or to any of the other ingredients of this medicine (listed in section 6).
If this applies to you, inform your doctor immediately.
Before taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV:

This medicine can only help reduce the risk of acquiring an HIV infection before you become infected.

You must be HIV negative before starting this medicine to reduce the risk of acquiring HIV. You will need to be tested to confirm that you do not already have an HIV infection. Do not take this medicine for risk reduction unless it has been confirmed that you are HIV negative. People with HIV infection must take this medicine in combination with other antiretroviral drugs.
Many HIV tests may not detect a recent infection. If you have flu-like symptoms, this could mean you have recently acquired an HIV infection. The following may be signs of HIV infection:
fatigue
fever
joint or muscle pain
headache
vomiting or diarrhoea
rash
night sweats
swollen lymph nodes in the neck or groin
Inform your doctor of any flu-like illness – both in the month before starting this medicine and at any time during treatment.

Warnings and precautions
While taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV:

Take this medicine every day to reduce your risk, not only when you think you may have been exposed to HIV. Do not miss any dose of Emtricitabine/Tenofovir disoproxil Mylan, nor stop taking this medicine. Missing doses may increase your risk of acquiring HIV infection.
Get tested for HIV regularly.
If you think you may have acquired an HIV infection, inform your doctor immediately. Your doctor may ask you to undergo further testing to confirm that you are still HIV negative.
Taking Emtricitabine/Tenofovir disoproxil Mylan alone may not prevent you from acquiring an HIV infection.
Always practice safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
Do not share personal items that could have traces of blood or body fluids, such as toothbrushes or razors.
Do not share or reuse needles or other injection or medication delivery devices.
Get tested for other sexually transmitted infections, such as syphilis and gonorrhoea. These infections make you more susceptible to acquiring HIV.

Talk to your doctor if you have further questions about how to avoid acquiring or transmitting HIV.
While taking Emtricitabine/Tenofovir disoproxil Mylan to treat HIV infection or to reduce the risk of acquiring HIV:

Emtricitabine/tenofovir disoproxil can affect the kidneys. Before and during treatment, your doctor may prescribe blood tests to monitor proper kidney function. Inform your doctor if you have had kidney disease or if blood tests have shown kidney problems. This medicine should not be given to adolescents with kidney problems. If you have kidney problems, your doctor may advise you to stop taking emtricitabine/tenofovir disoproxil, or, if you already have HIV infection, your doctor may suggest taking emtricitabine/tenofovir disoproxil less frequently. Emtricitabine/tenofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.
Bone problems (such as persistent or worsening bone pain, and sometimes resulting in fractures) may occur due to damage to the renal tubular cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.

Tenofovir disoproxil may also cause loss of bone mineral density. The most pronounced bone loss has been observed in clinical studies in which patients with HIV were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and paediatric patients are uncertain.
Inform your doctor if you have osteoporosis. Patients with osteoporosis are at higher risk of fractures.

Inform your doctor if you have previously had liver problems, including hepatitis. HIV-infected patients with liver problems (including chronic hepatitis B or C) who are treated with antiretrovirals have a higher risk of serious liver complications, which may be fatal. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
Get tested for hepatitis B virus (HBV) infection before starting Emtricitabine/Tenofovir disoproxil Mylan. If you have an HBV infection, there is a serious risk of liver problems when you stop taking emtricitabine/tenofovir disoproxil, regardless of whether you also have HIV infection. It is important that you do not stop taking emtricitabine/tenofovir disoproxil without first talking to your doctor: see section 3, Do not stop treatment with Emtricitabine/Tenofovir disoproxil Mylan.
Inform your doctor if you are over 65 years of age. Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
Inform your doctor if you are lactose intolerant (see Emtricitabine/Tenofovir disoproxil Mylan contains lactose later in this section).

Children and adolescents
Emtricitabine/tenofovir disoproxil Mylan is not indicated 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 containing the same active ingredients (i.e., emtricitabine and tenofovir disoproxil) or any other antiviral medicine containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine/tenofovir disoproxil Mylan with other medicines that may harm the kidneys: it is particularly important to inform your doctor if you are taking any of the following 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 (for cancer treatment)
cidofovir (for viral infection)
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)

If you are taking another antiviral medicine called a protease inhibitor for HIV treatment, your doctor may prescribe blood tests to monitor your kidney function more closely.
It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C infection.
Taking Emtricitabine/Tenofovir disoproxil Mylan with other medicines containing didanosine (for the treatment of HIV infection): Taking emtricitabine/tenofovir disoproxil with other antiviral medicines containing didanosine may increase the level of didanosine in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosine have been taken together, rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have been reported, which sometimes led to death. Your doctor must carefully consider whether to treat you with tenofovir and didanosine in combination.
Inform your doctor if you are taking any of these medicines. Inform 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

Emtricitabine/Tenofovir disoproxil Mylan should be taken with food whenever possible.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you have taken Emtricitabine/Tenofovir disoproxil Mylan during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.

Do not breastfeed during treatment with Emtricitabine/Tenofovir disoproxil Mylan. The active substance of this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must speak to your doctor as soon as possible.

Driving and using machines
Emtricitabine/tenofovir disoproxil may cause dizziness. If dizziness occurs while taking this medicine, do not drive and do not operate tools or machinery.
Emtricitabine/Tenofovir disoproxil Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Emtricitabine/Tenofovir disoproxil Mylan

Always take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.

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

Adults: one tablet daily, preferably taken with food.
Adolescents aged 12 to < 18 years weighing at least 35 kg: one tablet daily, preferably taken with food.

The recommended dose of Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV is:

Adults: one tablet daily, preferably taken with food.
Adolescents aged 12 to less than 18 years weighing at least 35 kg: one tablet daily, preferably taken with food.

If you have difficulty swallowing, you may use the back of a spoon to crush the tablet. Then mix the powder in approximately 100 mL (half a glass) of water, orange juice, or grape juice and drink immediately.

Always take the dose prescribed by your doctor. This is important to ensure that your medicines are fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to do so.
If you are being treated for HIV infection, your doctor will prescribe Emtricitabine/Tenofovir disoproxil Mylan together with other antiretroviral medicines. Refer to the package leaflet of the other antiretrovirals for guidance on how to take them.
If you are an adult taking this medicine to reduce the risk of acquiring HIV infection, take this medicine every day and not only when you think you may have been exposed to HIV.

Talk to your doctor if you have questions about how to avoid acquiring HIV or how to prevent spreading HIV to others.
If you take more Emtricitabine/Tenofovir disoproxil Mylan than you should
If you accidentally take more Emtricitabine/Tenofovir disoproxil Mylan than the recommended dose, contact your doctor or the nearest emergency department immediately. Take the bottle or the tablet pack with you so that you can clearly describe what you have taken.
If you miss a dose
It is important not to miss doses of Emtricitabine/Tenofovir disoproxil Mylan.

If you remember within 12 hours of your usual dosing time, take the tablet as soon as possible, preferably with food. Then take the next dose at your usual scheduled time.
If you remember 12 hours or more after your usual dosing time, do not take the missed dose. Wait and take the next dose at your usual scheduled time, preferably with food.

If you vomit within 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan, take another tablet. You do not need to take another tablet if you vomit more than one hour after taking this medicine.
Do not stop taking Emtricitabine/Tenofovir disoproxil Mylan

If you are taking Emtricitabine/Tenofovir disoproxil Mylan for the treatment of HIV infection, stopping the tablets may reduce the effectiveness of your anti-HIV therapy as recommended by your doctor.
If you are taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of acquiring HIV infection, do not stop taking this medicine and do not miss any doses. Stopping this medicine or missing doses may increase your risk of acquiring HIV infection.

Do not stop treatment with Emtricitabine/Tenofovir disoproxil Mylan without first contacting your doctor.

If you have hepatitis B, it is especially important not to stop treatment with Emtricitabine/Tenofovir disoproxil Mylan without first talking to your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to a worsening of hepatitis, which could be potentially fatal.

Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
Other effects in children
Children who have been given emtricitabine have very commonly experienced skin pigmentation changes, including:

development of dark spots on the skin
- Children have commonly experienced low red blood cell count (anaemia)
this may cause tiredness or shortness of breath in the child
If you notice any of these symptoms, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible serious side effects:

Lactic acidosis (excess lactic acid in the blood) is a rare but potentially fatal side effect. Lactic acidosis occurs more frequently in women, especially if overweight, and in people with liver disease. The following may be signs of lactic acidosis:
shortness of breath
drowsiness
feeling sick (nausea), vomiting
stomach pain

If you think you have lactic acidosis, seek medical advice immediately.

Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections occurring in people with a weakened immune system), signs and symptoms of inflammation due to previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.
Autoimmune disorders, in which the immune system attacks healthy body tissue, may also occur after starting medicines to treat HIV infection. Autoimmune disorders may occur many months after starting treatment. Look out for symptoms of infection or other symptoms such as:
muscle weakness
weakness beginning in the hands and feet and moving up towards the trunk
palpitations, tremor or hyperactivity

If you notice these or other symptoms of inflammation or infection, seek medical advice immediately.
Possible side effects:
Very common side effects
(may occur in more than 1 in 10 patients)

diarrhoea, vomiting, nausea
dizziness, headache
rash
feeling weak, muscle weakness

Blood tests may also show:

reduced phosphate levels in the blood
elevated creatine kinase

Common side effects
(may occur in up to 1 in 10 patients)

pain, stomach ache
difficulty sleeping, nightmares
digestive problems resulting from discomfort after meals, feeling of fullness, intestinal gas
skin rashes (including red spots or pustules, sometimes with blisters and skin swelling), which may be an allergic reaction, burning, changes in skin colour with the appearance of dark patches
other allergic reactions, such as shortness of breath, swelling or light-headedness

Blood tests may also show:

decreased white blood cell count (this may make you more susceptible to infection)
increased triglycerides (fatty acids), bile or glucose in the blood
problems with liver and pancreas

Uncommon side effects
(may occur in up to 1 in 100 patients)

abdominal pain caused by inflammation of the pancreas
swelling of the face, lips, tongue or throat
anaemia (low red blood cell count)
muscle breakdown, muscle pain or muscle weakness, which may occur due to damage to renal tubular cells

Blood tests may also show:

reduced potassium levels in the blood
increased creatinine in the blood
changes in urine

Rare side effects
(may occur in up to 1 in 1,000 patients)

lactic acidosis (see Possible serious side effects)
fatty liver
yellowing of the skin and eyes, itching or abdominal pain caused by liver inflammation
kidney inflammation, excessive urination and thirst, kidney failure, damage to renal tubular cells
softening of the bones (with bone pain and sometimes fractures)
back pain caused by kidney problems

Damage to renal tubular cells may be associated with muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness and decreased potassium or phosphate levels in the blood.
If you notice any of the side effects listed above or if any of them become severe, consult your doctor or pharmacist.
The frequency of the following side effects is unknown.

Bone problems. Some patients taking combination antiretroviral medicines such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Long-term use of this type of medicine, use of corticosteroids, alcohol consumption, a very weak immune system and being overweight may be among the many risk factors for developing this condition. Signs of osteonecrosis include:
joint stiffness
joint pain (especially in the hip, knee and shoulder)
difficulty moving If you notice any of these symptoms, consult your doctor.

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to improved health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Reporting of side effects If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 bottle and carton after
{Exp.}. The expiry date refers to the last day of that month.
Bottles: use within 90 days of first opening
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emtricitabina/Tenofovir disoproxil Mylan contains

The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
The other components are microcrystalline cellulose, low-substituted hydroxypropylcellulose, red iron oxide (E172), anhydrous colloidal silica, monohydrate lactose (see section 2, "Emtricitabina/Tenofovir disoproxil Mylan contains lactose"), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, brilliant blue FCF aluminium lake (E133), yellow iron oxide (E172).

Description of the appearance of Emtricitabina/Tenofovir disoproxil Mylan and contents of the pack
The film-coated tablets of Emtricitabina/Tenofovir disoproxil Mylan are light green in colour, capsule-shaped, biconvex, measuring 19.8 mm × 9.00 mm, with 'M' engraved on one side and 'ETD' on the other.
This medicinal product is available in bottles containing a desiccant (DO NOT EAT THE DESICCANT) holding 30 or 90 film-coated tablets, in multipacks of 90 film-coated tablets consisting of 3 bottles each containing 30 film-coated tablets, or in blisters with integrated desiccant containing 30, 30 × 1, 90 × 1 or 100 × 1 film-coated tablets, and in blisters containing 30, 30 × 1 or 90 × 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft
Mylan utca 1, H-2900 Komárom,
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Medis International a.s
vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice
747 23, Czech Republic
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U Mylan Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 236 31 80

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.