Emtricitabine + tenofovir disoproxil tillomed: detailed information

Package leaflet: Information for the user

Emtricitabine + Tenofovir disoproxil Tillomed, 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Emtricitabine + Tenofovir disoproxil Tillomed is and what it is used for

Emtricitabine + Tenofovir disoproxil Tillomed contains two active substances:
emtricitabine and tenofovir disoproxil. Both active substances are antiretroviral medicines used in the treatment of HIV infections. Emtricitabine is a nucleoside reverse transcriptase inhibitor, and tenofovir is a nucleotide reverse transcriptase inhibitor; however, both substances are generally referred to as NRTIs and work by interfering with the normal function of an enzyme (reverse transcriptase), which is essential for viral replication.

Emtricitabine + Tenofovir disoproxil Tillomed is used to treat adults infected with human immunodeficiency virus type 1 (HIV-1).
It is also used to treat HIV in adolescents aged 12 to below 18 years, weighing at least 35 kg, who have previously received other anti-HIV medicines that are no longer effective or have caused side effects.
- In the treatment of HIV infection, Emtricitabine + Tenofovir disoproxil Tillomed must always be used in combination with other antiretroviral medicines.
- Emtricitabine + Tenofovir disoproxil Tillomed may be administered instead of separate emtricitabine and tenofovir disoproxil taken at the same doses.

People who are HIV-positive can still transmit HIV while taking this medicine,
but the risk is reduced by effective antiretroviral therapy. You should discuss with your doctor the precautions necessary to avoid infecting others.
This medicine does not cure HIV infection. While taking Emtricitabine + Tenofovir
disoproxil Tillomed, infections or other conditions associated with HIV infection may still develop.

Emtricitabine + Tenofovir disoproxil Tillomed is also used to reduce the risk of HIV-1 infection in adults and adolescents aged 12 to below 18 years, weighing at least 35 kg, when taken daily in combination with safe sex practices.
See section 2 for a list of precautions to take to protect against HIV infection.

2. What you need to know before taking Emtricitabine + Tenofovir disoproxil Tillomed

Do not take Emtricitabine + Tenofovir disoproxil Tillomed for the treatment of HIV infection or to reduce the risk of HIV infection if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
If this applies to you, you must inform your doctor immediately.
Before taking Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection:
Emtricitabine + Tenofovir disoproxil Tillomed can only help reduce your risk of HIV infection before you become infected.

Before starting Emtricitabine + Tenofovir disoproxil Tillomed, you must test HIV-negative to reduce the risk of HIV infection. You must have tests to confirm that you are not already infected with HIV. Do not take Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection unless it has been confirmed that you are HIV-negative. People infected with HIV must take Emtricitabine + Tenofovir disoproxil Tillomed in combination with other antiretroviral medicines.
Many HIV tests may not detect recent infection. If you have flu-like symptoms, they may indicate a recent HIV infection. Possible symptoms of HIV infection include:
feeling tired,
fever,
joint or muscle pain,
headache,
vomiting or diarrhoea,
rash,
night sweats,
swollen neck or groin lymph nodes.
You must inform your doctor of any flu-like illness – either within one month before starting Emtricitabine + Tenofovir disoproxil Tillomed or at any time during treatment with Emtricitabine + Tenofovir disoproxil Tillomed.

Warnings and precautions
While taking Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Tillomed must be taken every day, to reduce risk, not only when you think you were exposed to HIV. Do not miss any doses of Emtricitabine + Tenofovir disoproxil Tillomed or stop taking it. Missing doses may increase the risk of HIV infection.
You should have regular HIV testing.
If you think you may have been infected with HIV, you must inform your doctor immediately. Your doctor may order further tests to rule out HIV infection.
Taking Emtricitabine + Tenofovir disoproxil Tillomed may not prevent HIV infection.
o Always follow safe sex practices. 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 razor blades.
o Do not share or reuse needles or other injection or drug administration equipment.
o Have regular testing for sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier to become infected with HIV.

Contact your doctor if you have further questions about methods of preventing HIV infection or transmitting HIV to others.
Taking Emtricitabine + Tenofovir disoproxil Tillomed for the treatment of HIV infection or to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Tillomed may harm your kidneys. Before and during treatment, your doctor may order blood tests to assess kidney function. Inform your doctor if you have had kidney disease or if tests indicate kidney problems. Emtricitabine + Tenofovir disoproxil Tillomed should not be given to adolescents with kidney disease. If you have kidney disease, your doctor may advise stopping Emtricitabine + Tenofovir disoproxil Tillomed or, if you are HIV-infected, taking it less frequently. Emtricitabine + Tenofovir disoproxil Tillomed is not recommended if you have severe kidney disease or are undergoing dialysis.
Bone problems (manifesting as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to renal tubular cells (see section 4, Possible side effects). If you experience bone pain or fractures, tell your doctor.

Tenofovir disoproxil may also cause a decrease in bone mineral density.
The most significant bone loss was observed in clinical studies where
patients were treated with tenofovir disoproxil in combination with a boosted
protease inhibitor.
In general, the long-term impact of tenofovir disoproxil on bone health and
the future risk of fractures in adult patients, as well as in children and adolescents,
is not fully clear.
If you have osteoporosis, tell your doctor. Patients with osteoporosis are at higher risk of fractures.

Patients with a history of liver disease, including hepatitis, should consult their doctor. HIV-infected patients who also have liver disease (including chronic viral hepatitis B or C) and are taking antiretroviral medicines are at increased risk of severe, potentially fatal, liver-related side effects. For patients with hepatitis B or C, your doctor will determine the most appropriate treatment regimen.
You should know your hepatitis B virus (HBV) status before starting Emtricitabine + Tenofovir disoproxil Tillomed. If you have HBV, there is a significant risk of liver disease after stopping Emtricitabine + Tenofovir disoproxil Tillomed, regardless of whether you are HIV-infected. It is important not to stop taking Emtricitabine + Tenofovir disoproxil Tillomed without consulting your doctor: see section 3, Do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed.
Patients over 65 years of age should consult their doctor. Studies on the use of emtricitabine with tenofovir disoproxil in patients over 65 years of age have not been conducted.

Children and adolescents
Emtricitabine + Tenofovir disoproxil Tillomed is not intended for use in children under 12 years of age.
Emtricitabine + Tenofovir disoproxil Tillomed and other medicines
Do not take Emtricitabine + Tenofovir disoproxil Tillomed if you are already taking other medicines containing the components of Emtricitabine + Tenofovir disoproxil Tillomed (emtricitabine and tenofovir disoproxil) or any other antiviral medicines containing tenofovir alafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine + Tenofovir disoproxil Tillomed with other medicines that may harm the kidneys: it is particularly important to inform your doctor if you are taking medicines such as:

aminoglycosides (for bacterial infections),
amphotericin B (for fungal infections),
foscarnet (for viral infections),
ganciclovir (for viral infections),
pentamidine (for infections),
vancomycin (for bacterial infections),
interleukin-2 (for cancer treatment),
cidofovir (for viral infections),
non-steroidal anti-inflammatory drugs (NSAIDs, for reducing bone or muscle pain).
If you are taking another antiviral medicine called a protease inhibitor for HIV treatment, your doctor may order blood tests to closely monitor kidney function.

You should also inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir used to treat hepatitis C virus infection.
Taking Emtricitabine + Tenofovir disoproxil Tillomed with other medicines containing didanosine (used to treat HIV infection): concomitant use of Emtricitabine + Tenofovir disoproxil Tillomed and other antiviral medicines containing didanosine may increase blood levels of didanosine and may also reduce CD4 cell counts. Pancreatitis and lactic acidosis (excess lactic acid in the blood), sometimes fatal, have been rarely observed with concomitant use of tenofovir disoproxil and didanosine. Your treating doctor will carefully consider whether tenofovir can be used together with didanosine.
Inform your doctor if you are taking any of these medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Taking Emtricitabine + Tenofovir disoproxil Tillomed with food and drink

Emtricitabine + Tenofovir disoproxil Tillomed should be taken with food, if possible.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
If you took Emtricitabine + Tenofovir disoproxil Tillomed during pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of HIV infection outweighs the risk of side effects.

Do not breastfeed while taking Emtricitabine + Tenofovir disoproxil Tillomed, as the active substances pass into human milk.
Women infected with HIV are advised not to breastfeed to avoid transmitting the virus to the baby through breast milk.

Driving and using machines
Emtricitabine + Tenofovir disoproxil Tillomed may cause dizziness. If you feel dizzy while taking Emtricitabine + Tenofovir disoproxil Tillomed, do not drive or operate tools or machinery.
Emtricitabine + Tenofovir disoproxil Tillomed contains soya lecithin
Do not use this medicine if you are allergic to peanuts or soya.
Emtricitabine + Tenofovir disoproxil Tillomed contains sodium
Emtricitabine + Tenofovir disoproxil Tillomed contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Emtricitabine + Tenofovir disoproxil Tillomed

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose of Emtricitabine + Tenofovir disoproxil Tillomed for the treatment of HIV infection:

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

Recommended dose of Emtricitabine + Tenofovir disoproxil Tillomed for reducing the risk of HIV infection:

Adults: one tablet once daily, preferably with food.
Adolescents aged 12 to under 18 years, weighing at least 35 kg: one tablet once daily, preferably with food. If swallowing is difficult, the tablet may be crushed with the back of a spoon. The resulting powder should then be mixed with approximately 100 ml (half a glass) of water, orange juice, or grape juice and taken immediately.
Always take the dose prescribed by your doctor. This is essential to ensure full effectiveness of the medicine and to reduce the risk of developing drug resistance. Do not change the dose of this medicine unless instructed by your doctor.
When treating HIV infection, your doctor will prescribe Emtricitabine + Tenofovir disoproxil Tillomed to be used in combination with other antiretroviral medicines. Please read the patient information leaflets of the respective antiretroviral medicines to understand how they should be taken.
When taking Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection, this medicine must be taken every day, not only when the patient believes they may have been exposed to HIV.

Please contact your doctor if you have further questions about methods of preventing HIV infection or preventing transmission of HIV to others.

Taking more than the recommended dose of Emtricitabine + Tenofovir disoproxil Tillomed
If you accidentally take more Emtricitabine + Tenofovir disoproxil Tillomed than prescribed, contact your doctor or the nearest hospital emergency department for advice. Take the medicine packaging with you so that you can show which medicine has been taken.

Missed dose
It is important not to miss any dose of Emtricitabine + Tenofovir disoproxil Tillomed.

If you realize within 12 hours of your usual dosing time, take the tablet as soon as possible, preferably with food. Take your next dose at the usual time.
If you realize more than 12 hours 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 vomiting occurs within 1 hour after taking Emtricitabine + Tenofovir disoproxil Tillomed, take another tablet. Do not take another tablet if vomiting occurs more than 1 hour after taking the medicine.

Do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed

When using Emtricitabine + Tenofovir disoproxil Tillomed for the treatment of HIV infection, stopping the tablets may reduce the effectiveness of the HIV treatment prescribed by your doctor.
When using Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection, do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed or miss any dose. Stopping Emtricitabine + Tenofovir disoproxil Tillomed or missing a dose may increase the risk of HIV infection.
- Do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed without consulting your doctor.
It is especially important that patients infected with hepatitis B virus do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed without first consulting their doctor. Blood tests may be required for several months after stopping the medicine. In some patients with advanced liver disease or cirrhosis, discontinuation of the medicine is not recommended, as it may lead to a severe flare-up of hepatitis B, which could be life-threatening.
Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, especially symptoms typically associated with hepatitis B infection. If you have any further doubts 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 life-threatening side effect. Lactic acidosis occurs more frequently in women, especially those who are overweight, and in people with liver disease. Symptoms which may indicate lactic acidosis include:
deep, rapid breathing,
drowsiness,
nausea, vomiting,
abdominal pain. If the patient suspects they have developed lactic acidosis, they should seek immediate medical help.
Any symptom 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 related to previous infections may occur shortly after starting HIV treatment. These symptoms are believed to be due to an improved immune response, enabling the body to fight infections that may have been present but not causing obvious symptoms.
Autoimmune disorders, where the immune system attacks healthy tissues of the body, may also occur after starting treatment with medicines used for HIV infection. Autoimmune disorders may occur many months after starting treatment. The patient should monitor their health for any signs of infection or other symptoms such as:
muscle weakness,
weakness starting in the hands and feet and moving upwards,
palpitations, tremor or excessive activity.

If these or any other symptoms of inflammation or infection are observed,
immediate medical help should be sought.
Possible side effects:
Very common side effects
(may affect more than 1 in 10 people)

diarrhoea, vomiting, nausea,
dizziness, headache,
rash,
feeling of weakness.

Tests may also show:

decreased phosphate levels in the blood,
increased creatine kinase activity.

Common side effects
(may affect up to 1 in 10 people)

pain, stomach ache,
difficulty sleeping, unusual dreams,
digestive problems leading to discomfort after meals, feeling of bloating, flatulence,
rashes (including red spots or patches, sometimes with blistering and skin swelling), which may be allergic reactions, itching, skin discolouration, including dark spots on the skin,
other allergic reactions such as wheezing, swelling or feeling of emptiness in the head.

Tests may also show:

reduced white blood cell count (reduced white blood cells may increase susceptibility to infections),
increased blood levels of triglycerides (fatty acids), bilirubin or glucose,
liver and pancreas function disorders.

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

abdominal pain due to pancreatitis,
swelling of the face, lips, tongue or throat,
anaemia (reduced number of red blood cells),
muscle cell breakdown, muscle pain or muscle weakness, which may occur due to damage to kidney tubule cells.

Tests may also show:

decreased potassium levels in the blood,
increased creatinine levels in the blood,
changes in urine test results.

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 due to hepatitis,
kidney inflammation, excessive urination and thirst, kidney failure, damage to kidney tubule cells,
bone softening (manifesting as bone pain and sometimes leading to fractures),
back pain due to kidney dysfunction. Damage to kidney tubule cells may lead to muscle cell breakdown, bone softening (manifesting as bone pain and sometimes leading to fractures), muscle pain, muscle weakness and decreased blood potassium or phosphate levels.

If any of the side effects listed above occur, or if any of these side effects worsen,
tell a doctor or pharmacist.
The frequency of the following side effects is unknown

Bone disorders. In some patients taking combination antiretroviral medicines such as emtricitabine with tenofovir disoproxil, a bone disease called avascular necrosis (death of bone tissue due to lack of blood supply to the bone) may develop. Long-term use of such medicines, corticosteroid use, alcohol consumption, a weakened immune system and being overweight may be among the many risk factors for developing this condition.

Symptoms of avascular necrosis include:

joint stiffness,
joint pain (especially in the hip, knee and shoulder),
difficulty moving. Contact a doctor if any of these symptoms are observed.

During HIV treatment, an increase in body weight and blood lipid and glucose levels may occur. This is partly related to improved health and lifestyle, and sometimes, in the case of blood lipid levels, to the effect of HIV treatment medicines. The doctor will order tests to detect these changes.
Other effects in children

In children receiving emtricitabine, skin discolouration changes, including darker spots on the skin, occurred very commonly.
In children, low red blood cell count (anaemia) occurred commonly. This may cause fatigue or shortness of breath in the child.

Contact a doctor if any of these symptoms are observed.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder. Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Emtricitabine + Tenofovir disoproxil Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package and blister.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture. Keep the bottle tightly closed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Emtricitabine + Tenofovir disoproxil Tillomed contains

The active substances are emtricitabine and tenofovir disoproxil. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). The other ingredients are: sodium croscarmellose, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, soy lecithin (E 322), partially hydrolysed polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc, xanthan gum (E 415).

What Emtricitabine + Tenofovir disoproxil Tillomed looks like and contents of the pack
Film-coated tablets, white to off-white in colour, in modified capsule shape,
with the imprint "EM" on one side and "144" on the other side of the tablet.
The tablet measures approximately 19.20 mm x 9.70 mm.
Blister:
Film-coated tablets in single-dose perforated blisters, made of aluminium/aluminium foil,
packaged in a cardboard box.
Pack sizes: 30 x 1 and 90 x 1 film-coated tablets.
Bottle:
30 film-coated tablets in an HDPE bottle with a moisture-absorbing agent, closed with a child-resistant PP cap,
packaged in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Tillomed Pharma GmbH
Mittelstrasse 5/5a
12529 Schönefeld
Germany
Tel: +48 509 368 531
E-mail: [email protected]
Importer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Emtricitabin Tenofovirdisoproxil Tillomed 200 mg/245 mg
Filmtabletten
Denmark Emtricitabin/Tenofovirdisoproxil Tillomed
Finland Emtricitabine / Tenofovir disoproxil Tillomed 200 mg/245 mg
kalvopäällysteiset tabletit
Ireland Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-
coated tablets
Netherlands Emtricitabine/Tenofovirdisoproxil Tillomed 200 mg/245 mg
filmomhulde tabletten
Norway Emtricitabin/Tenofovirdisoproxil Tillomed
Poland Emtricitabine + Tenofovir disoproxil Tillomed
Portugal Emtricitabina/Tenofovir disoproxil Tillomed 200 mg/245 mg
comprimidos revestidos por película
Romania Emtricitabină/tenofovir disoproxil Tillomed 200 mg/245 mg
comprimate filmate
Spain Emtricitabina/tenofovir disoproxil Tillomed 200 mg/245 mg
comprimidos recubiertos con película EFG
Sweden Emtricitabin/Tenofovirdisoproxil Tillomed