EMTRICITABINA 200 mg/245 mg Film-Coated Tablet

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1. Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma200 mg/245 mg film-coated tablets
   1. What is Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma and what is it used for
   2. What you need to know before taking Emtricitabina and Tenofovir Disoproxil Aequilibrium
   3. How to take Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma
   4. Possible side effects
   5. How to store Emtricitabina and Tenofovir disoproxil Macleods
   6. Package contents and other information

Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma200 mg/245 mg film-coated tablets

with film coating
Generic medicine

Read this leaflet carefully before taking this medicine as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma is and what it is used for
• 2. What you need to know before you take Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma
• 3. How to take Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma
• 4. Possible side effects
• 5. How to store Emtricitabina e Tenofovir Disoproxil Aequilibrium pharma
• 6. Contents of the pack and other information

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

Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma contains two active ingredients,

emtricitabinaand tenofovir disoproxil. Both active ingredients are antiretroviral medicinesthat
are used for the treatment of HIV infection. Emtricitabina is a nucleoside reverse transcriptase

inhibitorand 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) which is essential for the virus to reproduce.

• Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma is used to treatHuman Immunodeficiency Virus 1 (HIV-1) infection in adults
• It is also used to treat HIV in adolescents aged 12 to 18 years weighing at least 35 kgand who have already been treated with other HIV medicines that are no longer effective or have caused unwanted effects.
• Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma must always be used in combination with other medicines for the treatment of HIV infection.
• Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma can be administered as a replacement for emtricitabina and tenofovir disoproxil used 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 contracting HIV-1 infection in adults and adolescents aged 12 years and under 18 years weighing at least 35 kg, when taken daily, together with safe sex practices: See section 2 for a list of precautions to take against HIV infection.

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

pharma
Do not take Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmato treat HIV or
to reduce the risk of contracting HIV if you are allergicto emtricitabina, tenofovir, tenofovir
disoproxil, or to any of the other ingredients of this medicine (listed in section 6).

→ If this applies to you, tell your doctor immediately.
Before taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmato reduce the
risk of contracting HIV:
Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma can only help to reduce the risk of
contracting HIV beforeyou are infected.

• To start taking Emtricitabina and Tenofovir Disoproxil Aequilibriumtoreduce the risk of contracting HIV you must be HIV negative. You must have a test to make sure you do not already have an HIV infection. Do not take this medicine to reduce the risk unless you have been confirmed to be HIV negative. People who have HIV must take this medicine in combination with other medicines.
• Many tests for HIV may not detect a recent infection. If you get a flu-like illness, it could mean that you have recently been infected with HIV. Symptoms of HIV infection may include:
• fatigue
• fever
• joint or muscle pain
• headache
• vomiting or diarrhea
• rash
• night sweats
• swollen lymph nodes in the neck or groin →Tell your doctor if you have a flu-like illness, in the month before starting Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmaor at any time during taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma.

Warnings and precautions
While taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmato reduce the
risk of contracting HIV:

• Take this medicine every day to reduce the risk, not just when you think youhave been at risk of contracting HIV. Do not skip any doses of this medicine and do not stop taking it. Skipping doses may increase your risk of contracting HIV.
• Get tested for HIV regularly.
• If you think you have been infected with HIV, tell your doctor immediately. They may give you further tests to make sure you are still HIV negative.
• Simply taking Emtricitabina and Tenofovir Disoproxil Aequilibriumwill not prevent you from contracting HIV.Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluids, 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 equipment for injection or drug administration. Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make HIV infection easier. Ask your doctor if you have any questions about how not to contract HIV or spread HIV to others.

During the taking of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmato treat
HIV or to reduce the risk of contracting HIV:

• Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma may have effects on thekidneys. Before and during treatment, your doctor may prescribe blood tests to measure proper kidney function. Tell your doctor if you have had kidney disease, or if the tests have shown kidney problems. This medicine should not be given to adolescents who have 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.
• Tell your doctor if you have osteoporosis, have had bone fractures in the past, or havebone problems.

Bone problems

For adult patients:
Bone problems (which manifest as persistent or worsening bone pain and sometimes
resulting in fractures) can also occur due to damage to the cells of the renal tubules (see
section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most
pronounced loss of bone mass was observed in clinical studies in which patients were treated for HIV with
tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures
in adult and pediatric patients are uncertain.

For pediatric/adolescent patients:
Bone problems (which manifest as persistent or worsening bone pain and sometimes
resulting in fractures) can also occur due to damage to the cells of the renal tubules (see
section 4, Possible side effects). Tell your doctor if the child has bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most
pronounced loss of bone mass was observed in clinical studies in which patients were treated for HIV with
tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the risk of future fractures
in adult and pediatric patients are uncertain.
Tell your doctor if the child suffers from osteoporosis. Patients with osteoporosis are at higher
risk of fractures.

• Tell your doctor if you have had liver problems in the past, including hepatitis. Patients infected with HIV with also liver problems (including chronic hepatitis B or C) treated with antiretrovirals have a higher risk of severe liver complications and that can lead to death. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
• Tell your doctor if you are over 65 years of age. Emtricitabina and Tenofovir Disoproxil Aequilibrium has not been studied in patients over 65 years of age.
• Tell your doctor if you are lactose intolerant(see Emtricitabina and Tenofovir Disoproxil Aequilibrium contains lactose later in this section).

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

Other medicines and Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma
Do not take Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmaif you are already taking other
medicines that contain the components of Emtricitabina and Tenofovir Disoproxil Aequilibrium
pharma (emtricitabina and tenofovir disoproxil) or any other antiviral medicine that contains
tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma with other medicines
that can damage the kidneys: it is particularly important to tell your doctor if you are taking
any of these 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 (to treat cancer)
• 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 check your kidney function.

It is also important to tell your doctorif you are taking ledipasvir/sofosbuvir,
sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma with other medicines
that contain didanosine (for the treatment of HIV infection):
Taking this medicine with other antiviral medicines that contain didanosine may
increase the level of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), which sometimes
cause death, have been rarely reported when medicines containing tenofovir disoproxil and didanosine have been taken together. Your doctor will need to carefully consider whether to treat you with tenofovir and
didanosine in combination.
→ Tell your doctorif 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.

Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma with food and drink

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you have already taken this medicine during pregnancy, your doctor may require regular
blood tests and other diagnostic tests to monitor the development of the baby. In children whose
mothers have taken 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 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 for more information.
• If you are a mother infected with HIV, you are advised not to breastfeed, to avoid transmitting the virus to the newborn through breast milk.
• If you are breastfeeding or planning to breastfeed you should talk to your doctor assoon as possible.

For pediatric/adolescent patients:

• If the girl has HBV and the newborn received treatment to prevent transmission of hepatitis B at birth, the girl may be able to breastfeed the newborn, but you should discuss this with your doctor first for more information.
• If the girl has HIV, she should not breastfeed, to avoid transmitting the viruses to the newborn through breast milk.

Driving and using machines
Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma may cause dizziness. If you experience
dizziness while taking this medicine, do not driveand do not use tools or machinery.

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

Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma contains sodium
Emtricitabina 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 Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

The recommended dose of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma to treat HIV is:

• Adults: one tablet each day, when possible taken with food.
• Adolescents aged between 12 and 18 years with a weight of at least 35 kg: one tablet each day, when possible taken with food.

The recommended dose of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma to reduce the risk of contracting HIV is:

• Adults: one tablet each day, when possible taken with food.
• Adolescents aged between 12 and less than 18 years with a weight of at least 35 kg: one tablet each day, when possible taken with food.

If you have difficulty swallowing, you can use the end 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 recommended by your doctor. This is to make sure 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.
• If you are being treated for HIV infection, your doctor will prescribe Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma with other antiretroviral drugs. Read the leaflet of the other antiretroviral drugs as a guide on how to take these medicines.
• If you are taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma to reduce the risk of contracting HIV, take Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma every day, not just when you think you have been at risk of HIV infection.

Talk to your doctor if you have questions about how not to contract HIV or prevent the spread of HIV to other people.

If you take more Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma than you should
If you accidentally take a dose of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma higher than the recommended one, contact your doctor or the nearest emergency center. Bring the tablet bottle with you so you can easily describe what you have taken.

If you forget to take Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma
It is important not to miss doses of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma.

• If you realize it within 12 hoursof the usual time of taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma, take the tablet, preferably with food, as soon as possible. Then take the next dose at the scheduled time.
• If you realize it 12 hours or more afterthe usual time of taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma, do not take the missed dose. Wait and take the next dose, preferably with food, at the scheduled time.

In case of vomiting that occurred within 1 hour of taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma, take another tablet. You should not take another tablet if you have vomited more than one hour after taking Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma Do not stop treatment with Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma

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

→ Do not stop treatment with Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma without contacting your doctor.

• If you have hepatitis B, it is particularly important not to stop treatment with Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma without contacting your doctor first. It may be necessary to repeat blood tests 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 may be potentially fatal. Immediately tell your doctorany new or unusual symptoms observed after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible serious side effects:

• Lactic acidosis(excess of 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 pain

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

• 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 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 be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders, in which the immune system attacks healthy body tissue, can also occur after starting to take medicines to treat HIV infection. Autoimmune disorders can occur many months after starting treatment. Look for any symptoms of infection or other symptoms such as:
• muscle weakness
• weakness starting in the hands and feet and rising towards 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(may affect more than 1 in 10 people)

• diarrhoea, nausea, vomiting
• dizziness, headache
• skin rash
• feeling of weakness

Tests may also show:

• decreases in blood phosphate
• increased creatine kinase

Common(may affect up to 1 in 10 people)

• pain, stomach pain
• difficulty sleeping, nightmares
• digestive problems resulting from feeling unwell after meals, feeling of fullness, intestinal gas
• skin rashes (including red spots or pustules sometimes with blisters and swelling of the skin), which may be an allergic reaction, itching, change in skin color with the appearance of dark patches.
• other allergic reactions, such as shortness of breath, swelling or feeling of confusion.
• loss of bone mass

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 the liver and pancreas

Uncommon(may affect up to 1 in 100 people)

• abdominal pain 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, which may occur due to damage to the renal tubular cells

Tests may also show:

• decreased potassium in the blood
• increased creatinine in the blood
• changes in urine

Rare(may affect up to 1 in 1,000 people)

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

Damage to the 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 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(bone death caused by loss of blood supply to the bone).
Long-term use of this type of medicine, taking corticosteroids, alcohol, a very weakened immune system and being overweight may be some of the many risk factors
for developing this disease. Signs of osteonecrosis are:

• joint stiffness
• joint pain (especially in the hip, knee and shoulder)
• difficulty moving

→If you notice any of these symptoms, see your doctor.
During treatment for HIV, weight and levels of lipids and glucose in the blood may increase. This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will check these changes.

Additional side effects in children

• Children who have been given emtricitabine have very commonly experienced changes in skin color including the appearance of dark patches on the skin
• Children have commonly experienced a low red blood cell count (anemia). This can cause fatigue or shortness of breath in the child →If you notice any of these symptoms, see your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Emtricitabina and Tenofovir disoproxil Macleods

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 the packaging after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Store in the original packaging to protect
the medicine from humidity.
Shelf life after opening the bottle: 90 days.
Do not dispose of any medicine in 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 and Tenofovir disoproxil Macleods contains
The active ingredients areemtricitabinaand tenofovir disoproxil. Each film-coated tablet of
Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmacontains 200 mg of emtricitabina and 245 mg
of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).

The other ingredients arelactose monohydrate, microcrystalline cellulose (E460), pregelatinized starch, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E572),
ready-to-use coating material [hypromellose (E464), lactose monohydrate, triacetin (E1518),
titanium dioxide (E171), indigo carmine aluminum lake (E132)].

Description of the appearance of Emtricitabina and Tenofovir Disoproxil Aequilibrium pharma and
package contents
Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmacocoated tablets are
film-coated tablets, blue in color, capsule-shaped, biconvex with “L 24” imprinted on one
side and smooth on the other surface.
Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmais available in bottles containing 30 or 90
film-coated tablets. Each bottle contains a silica gel desiccant in a sachet
Available pack sizes are: 30 film-coated tablets (1 bottle of 30) and 90 [(1 bottle of

• 90) or (3 bottles of 30)].

Emtricitabina and Tenofovir Disoproxil Aequilibrium pharmais also available in unit dose
blisters
Available pack sizes of 30, 35, 84 and 90 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation 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 Nürnberg, Germany
Or
Pharmadox Healthcare Ltd.
KW20A, Kordin Industrial Park,
Paola , PLA3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: