Emtricitabine and tenofovir disoproxil Teva: detailed information

Patient Information Leaflet: Information for the User

Emtricitabine and Tenofovir Disoproxil Teva 200 mg/245 mg Film-coated Tablets

emtricitabine/tenofovir disoproxil
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emtricitabina e Tenofovir disoproxil Teva is and what it is used for

Emtricitabina e Tenofovir disoproxil Teva 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.
Together, 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 e Tenofovir disoproxil Teva is used to treat human immunodeficiency virus type 1 (HIV-1) infection in adults.
It is also used to treat HIV in adolescents aged between 12 and 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 e Tenofovir disoproxil Teva must always be used in combination with other medicines for the treatment of HIV infection.
Emtricitabina e Tenofovir disoproxil Teva may be administered as a replacement for emtricitabine and tenofovir disoproxil given separately at the same doses.

People who are HIV-positive can still transmit HIV even while taking this medicine, although the risk is reduced by effective antiviral therapy. Discuss with your doctor the necessary precautions to avoid transmitting the infection to others.
This medicine is not a cure for HIV infection. While taking Emtricitabina e Tenofovir disoproxil Teva, you may still develop infections or other illnesses associated with HIV infection.

Emtricitabina e Tenofovir disoproxil Teva 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 daily treatment, along with safe sexual practices: See section 2 for a list of precautions to take against HIV infection.

2. What you need to know before taking Emtricitabine and Tenofovir Disoproxil Teva

DO NOT take Emtricitabine and Tenofovir Disoproxil Teva to treat HIV or to reduce the risk of
contracting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil fumarate, or any of
the other ingredients of this medicine (listed in section 6).
If this applies to you, inform your doctor IMMEDIATELY.
Before taking Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk of contracting HIV:
Emtricitabine and Tenofovir Disoproxil Teva can only help reduce the risk of contracting HIV before you
are infected.

To start taking Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk of contracting HIV, you must be HIV-negative. You must undergo an HIV test to ensure you do not already have an HIV infection. Do not take Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk unless you have been confirmed to be HIV-negative. People who have HIV must take Emtricitabine and Tenofovir Disoproxil Teva in combination with other medicines.
Many HIV tests may not detect a recent infection. If you develop an illness resembling the flu, it could mean you have recently been infected with HIV. Possible signs of HIV infection include:
fatigue
fever
joint or muscle pain
headache
vomiting or diarrhea
rash
night sweats
swollen lymph nodes in the neck or groin
Inform your doctor if you experience flu-like illness, either within the month before starting Emtricitabine and Tenofovir Disoproxil Teva or at any time during treatment with Emtricitabine and Tenofovir Disoproxil Teva.

Warnings and precautions
While taking Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk of contracting HIV:

Take Emtricitabine and Tenofovir Disoproxil Teva every day to reduce the risk—not only when you think you may have been exposed to HIV. Do not skip any doses of Emtricitabine and Tenofovir Disoproxil Teva and do not stop taking it. Skipping doses may increase the risk of contracting HIV.
Get tested for HIV regularly.
If you think you may have been infected with HIV, inform your doctor immediately. Additional tests may be performed to confirm you are still HIV-negative.
Simply taking Emtricitabine and Tenofovir Disoproxil Teva may not prevent you from contracting HIV.
Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluid, or blood.
Do not share personal items that may have blood or body fluids on them, such as toothbrushes or razors.
Do not share or reuse needles or other injection or medication administration equipment.
Get tested for other sexually transmitted infections (STIs), such as syphilis and gonorrhea. These infections can increase the risk of HIV infection. Talk to your doctor if you have further questions about how to avoid contracting or spreading HIV.

While taking Emtricitabine and Tenofovir Disoproxil Teva to treat HIV or to reduce the risk of contracting HIV:

Emtricitabine and Tenofovir Disoproxil Teva may affect the kidneys. Before and during treatment, your doctor may order blood tests to monitor proper kidney function. Inform your doctor if you have had kidney disease or if blood tests have shown kidney problems. Emtricitabine and Tenofovir Disoproxil Teva must not be administered to adolescents with kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine and Tenofovir Disoproxil Teva or, if you already have HIV, to take it less frequently. Emtricitabine and Tenofovir Disoproxil Teva is not recommended if you have severe kidney disease or are on dialysis.
Bone problems
Bone issues (manifesting as persistent or worsening bone pain, and sometimes resulting in fractures) may occur due to damage to 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 loss of bone density
has been observed in clinical studies where patients 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 risk of future fractures
in adult and pediatric 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 disease (including chronic hepatitis B or C) treated with antiretrovirals have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully evaluate the most appropriate treatment regimen for you.
Get tested for hepatitis B virus (HBV) infection before starting Emtricitabine and Tenofovir Disoproxil Teva. If you have HBV infection, there is a serious risk of liver problems if you stop taking Emtricitabine and Tenofovir Disoproxil Teva, whether or not you have HIV. It is important that you do not stop taking Emtricitabine and Tenofovir Disoproxil Teva without speaking to your doctor: see section 3, Do not stop treatment with Emtricitabine and Tenofovir Disoproxil Teva.

Inform your doctor if you are over 65 years old. The combination of emtricitabine and tenofovir disoproxil has not been studied in patients over 65 years of age.
Children and adolescents
Emtricitabine and Tenofovir Disoproxil Teva is not indicated for children under 12 years of age.
Other medicines and Emtricitabine and Tenofovir Disoproxil Teva
DO NOT take Emtricitabine and Tenofovir Disoproxil Teva if you are already taking other medicines containing emtricitabine and tenofovir disoproxil or any other antiviral medicine containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Emtricitabine and Tenofovir Disoproxil Teva with other medicines that may damage your 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 for HIV called a protease inhibitor, your doctor may order 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 to treat hepatitis C infection.
Taking Emtricitabine and Tenofovir Disoproxil Teva with other medicines containing
didanosine (for treatment of HIV infection): Taking Emtricitabine and Tenofovir Disoproxil Teva 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), sometimes fatal, have been reported. 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 and Tenofovir Disoproxil Teva with food and drink

Emtricitabine and Tenofovir Disoproxil Teva 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, consult your doctor or pharmacist before taking this medicine.
If you have taken Emtricitabine and Tenofovir Disoproxil Teva during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV infection has outweighed the risk of side effects.

DO NOT breastfeed during treatment with Emtricitabine and Tenofovir Disoproxil Teva. The active substance of this medicine is excreted in breast milk.
If you are an HIV-infected woman, you are advised NOT to breastfeed to avoid transmitting HIV to your newborn through breast milk.
Driving and using machines
The combination of emtricitabine and tenofovir disoproxil may cause dizziness. If dizziness occurs while taking Emtricitabine and Tenofovir Disoproxil Teva, do not drive and do not operate tools or machinery.
Emtricitabine and Tenofovir Disoproxil Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

3. How to take Emtricitabine and Tenofovir Disoproxil Teva

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose of Emtricitabine and Tenofovir Disoproxil Teva 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 and Tenofovir Disoproxil Teva 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 about 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 medicine remains fully effective and to reduce the risk of developing treatment resistance. DO NOT change your dose unless instructed by your doctor.
If you are being treated for HIV infection, your doctor will prescribe Emtricitabine and Tenofovir Disoproxil Teva 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 Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk of acquiring HIV, take Emtricitabine and Tenofovir Disoproxil Teva every day, not only when you think you may have been exposed to HIV.

Talk to your doctor if you have questions about how to avoid getting HIV or preventing its spread to others.
If you take more Emtricitabine and Tenofovir Disoproxil Teva than you should
If you accidentally take more Emtricitabine and Tenofovir Disoproxil Teva than recommended, contact your doctor or the nearest emergency department immediately. Take the medicine container with you so you can clearly describe what has been taken.
If you miss a dose
It is important not to miss any doses of Emtricitabine and Tenofovir Disoproxil Teva.

If you remember within 12 hours of your usual dosing time, take the tablet as soon as possible, preferably with food. Then take your next dose at the usual 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 the usual time, preferably with food.

If you vomit within 1 hour after taking Emtricitabine and Tenofovir Disoproxil Teva,
take another tablet. Do not take an additional tablet if you vomit more than 1 hour after taking Emtricitabine and Tenofovir Disoproxil Teva.
Do not stop taking Emtricitabine and Tenofovir Disoproxil Teva

If you are taking Emtricitabine and Tenofovir Disoproxil Teva for the treatment of HIV infection, stopping the tablets may reduce the effectiveness of your prescribed anti-HIV therapy.
If you are taking Emtricitabine and Tenofovir Disoproxil Teva to reduce the risk of acquiring HIV, do not stop taking Emtricitabine and Tenofovir Disoproxil Teva and do not miss doses. If you stop taking Emtricitabine and Tenofovir Disoproxil Teva or miss doses, your risk of acquiring HIV infection may increase.

Do not stop taking Emtricitabine and Tenofovir Disoproxil Teva without first contacting your doctor.

If you have hepatitis B, it is especially important NOT to stop treatment with Emtricitabine and Tenofovir Disoproxil Teva without first consulting your doctor. Your 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 worsening of hepatitis, which could be potentially fatal.

Inform your doctor IMMEDIATELY about any new or unusual symptoms occurring after stopping treatment, particularly symptoms typically associated with hepatitis B infection.
If you have any questions about the use of this medicine, consult 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 fatal side effect. Lactic acidosis occurs more frequently in women, especially if overweight, and in people with liver disease. The following side effects may be signs of lactic acidosis:
shortness of breath
drowsiness
nausea, vomiting
stomach pain

If you think you have lactic acidosis, seek immediate medical help.

Any sign 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 prior infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing 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 can occur many months after treatment initiation. Watch for symptoms of infection or other symptoms such as:
muscle weakness
weakness starting in the hands and feet and moving upward toward the trunk
palpitations, tremor, or hyperactivity

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

diarrhoea, vomiting, nausea
dizziness, headache
rash
feeling weak

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 allergic reactions, burning sensation, change in skin colour with appearance of dark patches
other allergic reactions, such as shortness of breath, swelling, or light-headed feeling

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, contact your
doctor or pharmacist.
The frequency of the following side effects is not known.

Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine and Tenofovir disoproxil Teva 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 severely weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:
joint stiffness
joint pain (especially of the hip, knee, and shoulder)
difficulty moving If you notice any of these symptoms, contact your doctor.

During HIV treatment, an increase in weight and in blood lipid and glucose levels 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.
Other effects in children

Children who have been given emtricitabine have very commonly developed changes in skin pigmentation, including the appearance of dark patches on the skin.
Children have commonly developed a low red blood cell count (anaemia). This may cause tiredness or shortness of breath in the child.

If you notice any of these symptoms, contact your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Emtricitabine and Tenofovir Disoproxil Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after {Exp.}.
The expiry date refers to the last day of that month.
Blister packs: Do not store above 30°C. Keep in the original packaging to protect
the medicine from moisture.
HDPE bottle:

Store in the original bottle to protect from moisture. Keep the bottle tightly closed.
The product has been shown to remain stable for 30 days after first opening of the bottle.

Do not dispose of medicines 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 Emtricitabine and Tenofovir Disoproxil Teva contains

The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet of Emtricitabine and Tenofovir Disoproxil Teva contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
The excipients are mannitol, sodium stearyl fumarate, microcrystalline cellulose (E460), hydroxypropylcellulose-low substituted (E463), and hypromellose (E464).
The other ingredients in the film coating are partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172), and indigo carmine aluminium lake (E132).

Description of the appearance of Emtricitabine and Tenofovir Disoproxil Teva and contents of the pack
The film-coated tablets of Emtricitabine and Tenofovir Disoproxil Teva are green to light green in colour, oval-shaped, approximately 18 mm x 10 mm in size, with "E T" engraved on one side and smooth on the other side.
Each bottle contains a silica gel desiccant, which must be kept inside the bottle to help protect the tablets. The silica gel desiccant is contained in a separate sachet or container and must not be ingested.
The following pack sizes are available:
Blister packs: packs of 30, 30x1, and 90 film-coated tablets.
Bottle: pack of 30 and 3x30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy

Manufacturer:
Teva Pharma B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Krakow
Poland
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
10000
Croatia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Emtricitabin/Tenofovir disoproxil ratiopharm 200 mg/245 mg Filmtabletten
Belgium: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Cyprus: Emtricitabine + Tenofovir disoproxil/Teva (200+245) mg Film-coated Tablets
Czech Republic: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg
Germany: Emtricitabin/Tenofovir disoproxil ratiopharm 200 mg/245 mg Filmtabletten
Denmark: Emtricitabine/Tenofovir disoproxil Teva
Estonia: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg
Greece: Emtricitabine + Tenofovir disoproxil/Teva (200+245) mg Film-coated Tablets
Spain: Emtricitabina/Disoproxilo de tenofovir Teva 200 mg/245 mg comprimidos recubiertos con película EFG
Finland: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg tabletti, kalvopäällysteinen
France: Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg, comprimé pelliculé
Croatia: Emtricitabin/Tenofovir dizoproksil Pliva 200 mg/245 mg filmom obložene tablete
Hungary: Emtricitabine/Tenofovir-disoproxil Teva 200 mg/245 mg filmtabletta
Ireland: Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg Film-coated Tablets
Iceland: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg filmuhúðaðar töflur
Italy: Emtricitabina e Tenofovir disoproxil Teva
Latvia: Emtricitabine/Tenofovir disoproxil Teva 200mg/245mg apvalkotas tabletes
Malta: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets
The Netherlands: Emtricitabine/Tenofovir disoproxil Teva 200/245 mg, filmomhulde tabletten
Poland: Emtricitabine/Tenofovir disoproxil Teva
Portugal: Emtricitabina + Tenofovir disoproxil Teva
Romania: EMTRICITABINĂ/TENOFOVIR DISOPROXIL TEVA 200mg/245mg comprimate filmate
Sweden: Emtricitabine/Tenofovir disoproxil Teva
Slovenia: Emtricitabin/dizoproksil tenofovirat Teva 200 mg/245 mg filmsko obložene tablete
United Kingdom: Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets