Emtricitabine and tenofovir disoproxil Cipla: detailed information

Package leaflet: Information for the user

Emtricitabine and Tenofovir Disoproxil Cipla

200 mg/245 mg film-coated tablets
emtricitabine/tenofovir disoproxil
Generic 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 further 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 to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emtricitabine and Tenofovir Disoproxil Cipla is and what it is used for

Emtricitabine and Tenofovir Disoproxil Cipla 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.

Emtricitabine and Tenofovir Disoproxil Cipla 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 less than 18 years of age weighing at least 35 kg, who have previously been treated with other HIV medicines that are no longer effective or have caused undesirable effects.
- Emtricitabine and Tenofovir Disoproxil Cipla must always be used in combination with other medicines for the treatment of HIV infection.
- Emtricitabine and Tenofovir Disoproxil Cipla may be administered as a substitute for emtricitabine and tenofovir disoproxil taken separately at the same doses.

This medicine is not a cure for HIV infection. While taking Emtricitabine and Tenofovir Disoproxil Cipla, you may still develop infections or other illnesses associated with HIV infection.

Emtricitabine and Tenofovir Disoproxil Cipla is also used to reduce the risk of acquiring HIV-1 infection in adults and adolescents aged 12 to less than 18 years of age weighing 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 Cipla

Do not take Emtricitabine and Tenofovir Disoproxil Cipla to treat HIV or to reduce the risk
of acquiring HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of
the other ingredients of this medicine (listed in section 6).
→ If any of these conditions apply to you, inform your doctor immediately.
Before taking Emtricitabine and Tenofovir Disoproxil Cipla to reduce the risk of acquiring
HIV:

Emtricitabine and Tenofovir Disoproxil Cipla can only help reduce the risk of acquiring HIV before
you become infected.

To start taking Emtricitabine and Tenofovir Disoproxil Cipla to reduce the risk of acquiring HIV, you must be HIV-negative . You must undergo an HIV test to confirm that you do not already have an HIV infection. Do not take Emtricitabine and Tenofovir Disoproxil Cipla for risk reduction unless it has been confirmed that you are HIV-negative. People who have HIV must take Emtricitabine and Tenofovir Disoproxil Cipla in combination with other antiretroviral medicines.
Many HIV tests may not detect a recent infection . If you develop flu-like symptoms, this could mean you have recently been infected with HIV. Signs of HIV infection may include:
fatigue
fever
joint or muscle pain
headache
vomiting or diarrhoea
rash
night sweats
swollen lymph nodes in the neck or groin

→ Tell your doctor if you experience flu-like illness within the month before starting
Emtricitabine and Tenofovir Disoproxil Cipla or at any time during treatment with
Emtricitabine and Tenofovir Disoproxil Cipla.
Warnings and precautions
While taking Emtricitabine and Tenofovir Disoproxil Cipla to reduce the risk of acquiring
HIV:

Take Emtricitabine and Tenofovir Disoproxil Cipla every day to reduce risk, not only when you think you may have been exposed to HIV infection . Do not miss any doses of Emtricitabine and Tenofovir Disoproxil Cipla and do not stop taking it. Missing doses may increase your risk of acquiring HIV infection.
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.
Taking Emtricitabine and Tenofovir Disoproxil Cipla alone may not prevent you from acquiring 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 increase the risk of acquiring HIV.
Talk to your doctor if you have further questions about how to avoid acquiring or transmitting HIV to others.
While taking Emtricitabine and Tenofovir Disoproxil Cipla to treat HIV or to reduce the risk of
acquiring HIV:

Emtricitabine and Tenofovir Disoproxil Cipla 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 Cipla should not be given to adolescents with kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine and Tenofovir Disoproxil Cipla or, if you already have HIV, to take Emtricitabine and Tenofovir Disoproxil Cipla less frequently. Emtricitabine and Tenofovir Disoproxil Cipla 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 where 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 future fracture risk in adult
and paediatric patients are uncertain.
Talk to your doctor if you have osteoporosis, a history of bone fractures, or bone-related problems.

Inform your doctor if you have previously had liver problems, including hepatitis. HIV-infected patients who also have liver problems (including chronic hepatitis B or C) and are treated with antiretrovirals have a higher risk of severe and potentially life-threatening liver complications. 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) status before starting Emtricitabine and Tenofovir Disoproxil Cipla. If you have an HBV infection, there is a serious risk of liver problems if you stop taking Emtricitabine and Tenofovir Disoproxil Cipla, whether or not you have HIV. It is important that you do not stop taking Emtricitabine and Tenofovir Disoproxil Cipla without speaking to your doctor: see section 3, Do not stop treatment with Emtricitabine and Tenofovir Disoproxil Cipla .
Inform your doctor if you are over 65 years of age. Emtricitabine and Tenofovir Disoproxil Cipla has not been studied in patients over 65 years of age.
Inform your doctor if you are lactose intolerant (see “Emtricitabine and Tenofovir Disoproxil Cipla contains lactose” later in this section).

Children and adolescents
Emtricitabine and Tenofovir Disoproxil Cipla is not indicated for children under 12 years of age.
Other medicines and Emtricitabine and Tenofovir Disoproxil Cipla
Do not take Emtricitabine and Tenofovir Disoproxil Cipla if you are already taking other medicines containing the components of Emtricitabine and Tenofovir Disoproxil Cipla (emtricitabine and tenofovir disoproxil) or any other antiviral medicine containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine and Tenofovir Disoproxil Cipla 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 more closely monitor your kidney function.
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 and Tenofovir Disoproxil Cipla with other medicines containing
didanosine (for the treatment of HIV infection): Taking Emtricitabine and Tenofovir
Disoproxil Cipla 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 have 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 medicine.
Emtricitabine and Tenofovir Disoproxil Cipla with food and drink

Emtricitabine and Tenofovir Disoproxil Cipla 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 and Tenofovir Disoproxil Cipla during pregnancy, your doctor may
regularly perform blood tests and other diagnostic examinations to monitor the baby’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 and Tenofovir Disoproxil Cipla. This is because the active substances of this medicine are excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you should discuss this with your doctor as soon as possible.

Driving and using machines
Emtricitabine and Tenofovir Disoproxil Cipla may cause dizziness. If dizziness occurs while taking
Emtricitabine and Tenofovir Disoproxil Cipla, do not drive and do not operate tools or
machinery.
Emtricitabine and Tenofovir Disoproxil Cipla contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
Emtricitabine and Tenofovir Disoproxil Cipla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Emtricitabina e Tenofovir Disoproxil Cipla

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

The recommended dose of Emtricitabina e Tenofovir Disoproxil Cipla for treating 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.

The recommended dose of Emtricitabina e Tenofovir Disoproxil Cipla 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 ensures that your medicine remains fully effective and reduces 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 Emtricitabina e Tenofovir Disoproxil Cipla together with other antiretroviral medicines. Please refer to the patient information leaflet of the other antiretrovirals for instructions on how to take them.
If you are taking Emtricitabina e Tenofovir Disoproxil Cipla to reduce the risk of acquiring HIV, take Emtricitabina e Tenofovir Disoproxil Cipla 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 how to prevent transmitting HIV to others.
If you take more Emtricitabina e Tenofovir Disoproxil Cipla than you should
If you accidentally take more Emtricitabina e Tenofovir Disoproxil Cipla 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 doses of Emtricitabina e Tenofovir Disoproxil Cipla.

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 regular 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 the regular scheduled time, preferably with food.

If you vomit within 1 hour after taking Emtricitabina e Tenofovir Disoproxil Cipla, take another tablet. You do not need to take another tablet if you vomit more than one hour after taking Emtricitabina e Tenofovir Disoproxil Cipla.
Do not stop treatment with Emtricitabina e Tenofovir Disoproxil Cipla

If you are taking Emtricitabina e Tenofovir Disoproxil Cipla 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 Emtricitabina e Tenofovir Disoproxil Cipla to reduce the risk of acquiring HIV, do not stop taking Emtricitabina e Tenofovir Disoproxil Cipla and do not miss doses. If you stop taking Emtricitabina e Tenofovir Disoproxil Cipla or miss doses, your risk of acquiring HIV may increase.

→ Do not stop treatment with Emtricitabina e Tenofovir Disoproxil Cipla without first contacting your doctor.

If you have hepatitis B, it is especially important not to stop treatment with Emtricitabina e Tenofovir Disoproxil Cipla 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 potentially be 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 using 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 may be signs of lactic acidosis:
- shortness of breath
- drowsiness
- feeling sick, vomiting
- stomach ache

→ If you think you have lactic acidosis, contact a doctor 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 weakened immune systems), 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, 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. Watch for the appearance of any symptoms of infection or other symptoms such as:
- muscle weakness
- weakness beginning 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, contact a doctor immediately.
Possible side effects:
Very common side effects
(may affect more than 1 in 10 people)

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 affect up to 1 in 10 people)

pain, stomach ache
difficulty sleeping, abnormal dreams
digestive problems resulting from discomfort after meals, bloating, excess 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 wheezing, swelling, or feeling mentally confused
loss of bone mass

Blood tests may also show:

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

Uncommon side effects
(may affect up to 1 in 100 people)

abdominal pain caused by inflammation of the pancreas
swelling of the face, lips, tongue, or throat
anaemia (low red blood cell count)
muscle wasting, 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 affect up to 1 in 1,000 people)

lactic acidosis (see Possible serious side effects)
fatty liver
yellowing of the skin or 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 wasting, 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 tablets may develop a bone disease called osteonecrosis (death of bone tissue due to reduced 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 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, 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 shown changes in skin pigmentation including
- development of dark patches on the skin
Children have commonly shown 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 experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Cipla

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.
Store in the original packaging to protect the medicine from moisture. Keep the bottle
tightly closed.
After first opening of Emtricitabine and Tenofovir Disoproxil Cipla, store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Emtricitabina e Tenofovir Disoproxil Cipla contains

The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet of Emtricitabina e Tenofovir Disoproxil Cipla contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
The other excipients are: Tablet core: croscarmellose sodium, monohydrate lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch; Film coating: hypromellose, indigo carmine aluminium lake (E132), monohydrate lactose, triacetin and titanium dioxide (E171).

Description of the appearance of Emtricitabina e Tenofovir Disoproxil Cipla and contents of the pack
Emtricitabina e Tenofovir Disoproxil Cipla film-coated tablets are blue, capsule-shaped, biconvex, smooth on both sides. Emtricitabina e Tenofovir Disoproxil Cipla is supplied in bottles containing 30 tablets.
Each bottle contains a silica gel desiccant as drying agent, which should be kept in the bottle to protect the tablets. The silica gel is contained in a separate sachet or canister and must not be ingested.
The following pack sizes are available: outer packs containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder:
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium

Responsible person for batch release:
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium