Emtricitabine and tenofovir disoproxil Aequilibrium Pharma: detailed information

Patient Information Leaflet: Information for the User

Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma 200 mg/245 mg film-coated tablets

Equivalent medicine
Please 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma is and what it is used for

Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma contains two active substances,
emtricitabine and tenofovir disoproxil. Both active substances are antiretroviral medicines used for the treatment of 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 e Tenofovir Disoproxil Aequilibrium pharma is used to treat infection with Human Immunodeficiency Virus type 1 (HIV-1) 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 Aequilibrium pharma must always be used in combination with other medicines for the treatment of HIV infection.
- Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma may be administered as a substitute for emtricitabine and tenofovir disoproxil given separately at the same doses.

This medicine is not a cure for HIV infection. While taking this medicine, you may still develop infections or other illnesses associated with HIV infection.

This medicine is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 years and less than 18 years with a body weight of at least 35 kg, when taken daily in combination with safe sexual practices: See section 2 for a list of precautions to prevent HIV infection.

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

pharma
Do not take Emtricitabine and Tenofovir Disoproxil Aequilibrium pharmato treat HIV or
to reduce the risk of getting 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 and Tenofovir Disoproxil Aequilibrium pharmato reduce the
risk of getting HIV:

Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma can only help reduce the risk of
contracting HIV before you become infected.

To start taking Emtricitabine and Tenofovir Disoproxil Aequilibrium pharmato reduce the risk of getting HIV, you must be HIV-negative. You must undergo a test to ensure you do not already have an HIV infection. Do not take this medicine to reduce the risk unless it has been confirmed that you are HIV-negative. People who have HIV must take this medicine in combination with other medicines.
Many HIV tests may not detect a recent infection. If you develop a flu-like illness, 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 diarrhoea
rash
night sweats
swollen lymph nodes in the neck or groin → Inform your doctor if you experience a flu-like illness within the month before starting Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma or at any time during treatment with Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma.

Warnings and precautions
While taking Emtricitabine and Tenofovir Disoproxil Aequilibrium pharmato reduce the
risk of getting HIV:

Take this medicine every day to reduce the risk, not only when you think you may have been exposed to HIV. Do not skip any doses of this medicine 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. You may be given additional tests to confirm that you are still HIV-negative.
Simply taking Emtricitabine and Tenofovir Disoproxil Aequilibrium phamacannot prevent you from contracting HIV.
o Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluid, or blood.
o Do not share personal items that may have blood or body fluids on them, such as toothbrushes or razors.
o Do not share or reuse needles or other injection or drug administration equipment.
o Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections can make it easier to contract HIV. Speak to your doctor if you have further questions about how to avoid contracting HIV or spreading HIV to others.

While taking Emtricitabine and Tenofovir Disoproxil Aequilibrium pharmato treat
HIV or to reduce the risk of getting HIV:

Emtricitabine and Tenofovir Disoproxil Aequilibrium phamacan 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 must not be administered to adolescents with kidney problems. If you have kidney problems, your doctor may advise you to stop taking this medicine or, if you already have HIV, to take this medicine less frequently. This medicine is not recommended if you have severe kidney disease or are on dialysis.
Inform your doctor if you have osteoporosis, have had bone fractures in the past, or have bone problems.

Bone problems
For adult patients:
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may occur due to damage to the kidney 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 mineral density has been observed in clinical studies where patients were treated for HIV 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 paediatric patients are uncertain.
For paediatric/adolescent patients:
Bone problems (manifesting as persistent or worsening bone pain and sometimes resulting in fractures) may occur due to damage to the kidney tubular cells (see section 4, Possible side effects). Inform your doctor if the child has bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. The most pronounced loss of bone mineral density has been observed in clinical studies where patients were treated for HIV 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 paediatric patients are uncertain.
Inform your doctor if the child has 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) treated with antiretrovirals have a higher risk of severe liver complications, which may be fatal. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
Find out your hepatitis B virus (HBV) infection status before starting Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma. If you have an HBV infection, there is a serious risk of liver problems if you stop taking this medicine, whether or not you have HIV. It is important that you do not stop taking this medicine without speaking to your doctor: see section 3, Do not interrupt treatment with Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma.
Inform your doctor if you are over 65 years of age. Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma has not been studied in patients over 65 years of age.
Inform your doctor if you are lactose intolerant (see Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma contains lactose later in this section).

Children and adolescents
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma is not indicated in children under
12 years of age.

Other medicines and Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma
Do not take Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma if you are already taking other
medicines containing the components of Emtricitabine and Tenofovir Disoproxil Aequilibrium
pharma (emtricitabine and tenofovir disoproxil) or any other antiviral medicine containing
tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Taking Emtricitabine and Tenofovir Disoproxil Aequilibrium phamawith other medicines
that may damage 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 to treat HIV, your
doctor may prescribe blood tests to better monitor your kidney function.
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 Aequilibrium phamawith other medicines
containing didanosine (for the treatment of HIV infection):
Taking this medicine 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
resulted in 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 medicine.

Emtricitabine and Tenofovir Disoproxil Aequilibrium phamawith food and drink

Whenever possible, Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma should be taken with food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you have taken this medicine 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.
For adult patients:

If you are a mother with HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed the newborn, but you should discuss this with your doctor first to obtain further information.
If you are an HIV-infected mother, you are advised not to breastfeed, to avoid transmitting the HIV virus to the newborn through breast milk.
If you are breastfeeding or considering breastfeeding, you must speak to your doctor as soon as possible.

For paediatric/adolescent patients:

If the girl has HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, the girl may be able to breastfeed the newborn, but this should be discussed with the doctor first for further information.
If the girl has HIV, she must not breastfeed, to avoid transmitting the virus to the newborn through breast milk.

Driving and using machines
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma may cause dizziness. If dizziness occurs while taking this medicine, do not drive and do not use tools or machinery.

Emtricitabine and Tenofovir Disoproxil Aequilibrium phama contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

Emtricitabine and Tenofovir Disoproxil Aequilibrium phama contains sodium
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma contains less than 1 mmol (23 mg) of sodium
per tablet, i.e. essentially ‘sodium-free’.

3. How to take Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma

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 Aequilibrium pharmafor
treating 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 Aequilibrium pharmafor
reducing 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 medication remains fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless instructed by your doctor.
If you are being treated for HIV infection, your doctor will prescribe Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma together with other antiretrovirals. Refer to the package leaflet of the other antiretrovirals for guidance on how to take them.
If you are taking Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma to reduce the risk of acquiring HIV, take Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma every day, not only when you think you may have been exposed to HIV.

Consult your doctor if you have questions about how to avoid acquiring HIV or prevent its transmission to
others.
If you take more Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma than you should
If you accidentally take more Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma than recommended, contact your doctor or the nearest emergency department immediately. Bring the bottle of tablets with you so you can easily describe what you have taken.
If you forget to take Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma
It is important not to miss doses of Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma.

If you remember within 12 hours of your usual dosing time, take the missed 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
Aequilibrium pharma, take another tablet. You do not need to take another tablet if you vomit more than one hour after taking Emtricitabine and Tenofovir Disoproxil
Aequilibrium pharma.
Do not stop taking Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma

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

→ Do not stop treatment with Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma without first consulting your doctor.

If you have hepatitis B, it is especially important not to stop treatment with Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma without first consulting 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 worsening of hepatitis, which could be potentially fatal. Inform your doctor immediately of 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 symptoms may be signs of lactic acidosis:
- shortness of breath
- drowsiness
- nausea, vomiting
- stomach ache

→ If you think you may have lactic acidosis, seek immediate medical advice.

Any sign of inflammation or infection . In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with weakened immune systems), signs and symptoms of inflammation due to previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from 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 may occur many months after starting treatment. Look out for symptoms of infection or other symptoms such as:
- muscle weakness
- weakness starting in the hands and feet and moving upwards towards the trunk
- palpitations, tremor, or hyperactivity

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

diarrhoea, nausea, vomiting
dizziness, headache
rash
feeling weak

Blood tests may also show:

reduced phosphate levels in the blood
increased creatine kinase

Common (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, itching, skin colour changes with appearance of dark patches.
other allergic reactions, such as shortness of breath, swelling, or feeling confused.
loss of bone mass

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
liver and pancreas problems

Uncommon (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 (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 Aequilibrium pharma 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 some of 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, contact your doctor.
During treatment for HIV, 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.
Additional side effects in children

Children who have been given emtricitabine have very commonly experienced skin pigmentation changes, including the appearance of dark patches 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, contact your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 Macleods

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 the outer packaging following
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Period of validity after opening the bottle: 90 days.
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 Emtricitabine and Tenofovir Disoproxil Macleods contains
The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet of
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma contains 200 mg of emtricitabine and 245 mg
of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
The other components are monohydrate lactose, microcrystalline cellulose (E460), pregelatinized starch,
sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E572), ready-to-use coating material [hypromellose (E464), monohydrate lactose, triacetin (E1518), titanium dioxide (E171), indigo carmine aluminium lake (E132)].
Description of the appearance of Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma and contents of the pack
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma film-coated tablets are blue, capsule-shaped, biconvex film-coated tablets, marked with "L 24" on one side and smooth on the other.
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma is available in bottles containing 30 or 90 film-coated tablets. Each bottle contains a silica gel desiccant in a separate sachet which must not be ingested. The bottles are packed in cartons with the package leaflet.
Pack sizes available: 30 film-coated tablets (1 bottle of 30) and 90 [(1 bottle of 90) or (3 bottles of 30)].
Emtricitabine and Tenofovir Disoproxil Aequilibrium pharma is also available in unit-dose blisters.
Pack sizes available: 30, 35, 84 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aequilibrium Pharma Srl
Via Podgora, 11 20122
Milan, Italy
Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15, 62-020
Swarzędz,
Poland
Or
Heumann Pharma GmbH & Co. Generica KG,
Südwestpark 50, 90449 Nuremberg, Germany
Or
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park,
Paola, PLA3000
Malta
This medicinal product is authorized in the European Economic Area Member States under the following names: