Emtricitabine + Tenofovir disoproxil Tillomed

Leaflet accompanying the packaging: patient information

Emtricitabine + Tenofovir disoproxil Tillomed, 200 mg + 245 mg, film-coated tablets

Emtricitabine + Tenofovir disoproxil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1.

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

2.

Important information before taking Emtricitabine + Tenofovir disoproxil Tillomed

3.

How to take Emtricitabine + Tenofovir disoproxil Tillomed

4.

Possible side effects

5.

How to store Emtricitabine + Tenofovir disoproxil Tillomed

6.

Contents of the packaging and other information

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

Emtricitabine + Tenofovir disoproxil Tillomed 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, but both substances are generally referred to as NRTIs and work by disrupting the normal functioning of the enzyme (reverse transcriptase) that is essential for the replication of the virus.

• 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 less than 18 years, weighing at least 35 kg, who have previously taken other HIV medicines that are no longer effective or have caused side effects.
• In the treatment of HIV infection, Emtricitabine + Tenofovir disoproxil Tillomed should always be used in combination with other medicines.
• Emtricitabine + Tenofovir disoproxil Tillomed can be taken instead of emtricitabine and tenofovir disoproxil taken separately at the same doses.

People who are HIV-positive can still transmit HIVwhile taking this medicine, but the risk is lower due to effective antiretroviral therapy. The patient should discuss with their doctor the precautions necessary to avoid infecting others.
This medicine does not cure HIV infection.While taking Emtricitabine + Tenofovir disoproxil Tillomed, patients can still develop infections or other diseases related to HIV infection.

• Emtricitabine + Tenofovir disoproxil Tillomed is also used to reduce the risk of HIV-1 infectionin adults and adolescents aged 12 to less than 18 years, weighing at least 35 kg, if taken daily with safe sex practices. See section 2, which lists the precautions to be taken to protect against HIV infection.

18 years, weighing at least 35 kg, if taken daily with safe sex practices. See section 2, which lists the precautions to be taken to protect against HIV infection.

2. Important information before taking Emtricitabine + Tenofovir disoproxil Tillomed

Do not take Emtricitabine + Tenofovir disoproxil Tillomed to treat or 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).

The patient should immediately inform their doctor.

Before taking Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection:

Emtricitabine + Tenofovir disoproxil Tillomed can only help reduce the risk of HIV infection beforethe patient becomes infected.

• Before starting Emtricitabine + Tenofovir disoproxil Tillomed, the patient must be HIV-negativeto reduce the risk of HIV infection. The patient must undergo tests to confirm that they have not already been infected with HIV. Do not take Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection if it has not been confirmed that the patient is HIV-negative. People with HIV infection must take Emtricitabine + Tenofovir disoproxil Tillomed in combination with other medicines.
• Many HIV tests may not detect recent infection.If the patient has flu-like symptoms, they may indicate recent HIV infection. Possible symptoms of HIV infection:
• fatigue,
• fever,
• joint or muscle pain,
• headache,
• nausea or vomiting,
• rash,
• night sweats,
• enlarged lymph nodes in the neck or armpits. Tell your doctor about any flu-like illness- either in the month before starting Emtricitabine + Tenofovir disoproxil Tillomed or at any time while taking Emtricitabine + Tenofovir disoproxil Tillomed.

Warnings and precautions

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

• Emtricitabine + Tenofovir disoproxil Tillomed should be taken every day, to reduce the risk, and not just when the patient thinks they may have been exposed to HIV.Do not miss any dose of Emtricitabine + Tenofovir disoproxil Tillomed or stop taking it. If a dose is missed, the risk of HIV infection may be higher.
• Regular HIV tests should be performed.
• If the patient thinks they have been infected with HIV, they should immediately inform their doctor. The doctor may order further tests to rule out HIV infection.
• Taking Emtricitabine + Tenofovir disoproxil Tillomed may not prevent HIV infection.Always follow safe sex practices. Use condoms to limit contact with semen, vaginal secretions, or blood. Do not share personal items that may have blood or bodily fluids on them, such as toothbrushes or razor blades. Do not share or reuse needles or other equipment for injecting or administering drugs. Regularly test for sexually transmitted infections, such as syphilis and gonorrhea, as these infections can increase the risk of HIV infection.

Tell your doctor if you have any further questions about methods to prevent HIV infection or prevent transmission of HIV to others.

Taking Emtricitabine + Tenofovir disoproxil Tillomed to treat HIV infection or reduce the risk of HIV infection:

• Emtricitabine + Tenofovir disoproxil Tillomed may harm the kidneys.Before and during treatment, the doctor may order blood tests to assess kidney function. Tell your doctor if you have had kidney disease or if tests show kidney disease. Emtricitabine + Tenofovir disoproxil Tillomed should not be given to adolescents with kidney disease. If the patient has kidney disease, the doctor may recommend stopping Emtricitabine + Tenofovir disoproxil Tillomed or, if the patient has HIV infection, taking Emtricitabine + Tenofovir disoproxil Tillomed less frequently. It is not recommended to take Emtricitabine + Tenofovir disoproxil Tillomed if the patient has severe kidney disease or is undergoing dialysis.
• Bone disorders(manifested as persistent or worsening bone pain, and sometimes leading to fractures) can also occur due to damage to the kidney tubule cells (see section 4, Possible side effects). If the patient experiences bone pain or fractures, they should tell their doctor.

Tenofovir disoproxil can also cause a decrease in bone mass.
The most significant bone loss was observed in clinical trials in which patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
Generally, the long-term effect of tenofovir disoproxil on bone health and the risk of fractures in the future in adult patients, as well as in children and adolescents, is not clear.
If the patient has osteoporosis, they should tell their doctor. Patients with osteoporosis are more prone to fractures.

• Patients who have had liver disease, including hepatitis, should consult their doctor.Patients with HIV infection who also have liver disease (including chronic viral hepatitis B or C) and are taking antiretroviral medicines are at increased risk of severe and potentially life-threatening side effects affecting the liver. In the case of patients with hepatitis B or C, the doctor will determine the most appropriate treatment regimen.
• It is essential to know the status of hepatitis B virus (HBV) infectionbefore starting Emtricitabine + Tenofovir disoproxil Tillomed. If the patient has HBV, there is a high risk of liver disease after stopping Emtricitabine + Tenofovir disoproxil Tillomed, regardless of whether the patient has HIV infection. It is crucial not to stop taking Emtricitabine + Tenofovir disoproxil Tillomed without consulting a doctor: see section 3, Do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed.
• Patients over 65 years of age should consult their doctor.There have been no studies on the use of emtricitabine with tenofovir disoproxil in patients over 65 years of age.

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 Tillomedif you are already taking other medicines that contain the active ingredients of Emtricitabine + Tenofovir disoproxil Tillomed (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine, or adefovir dipivoxil.

Taking Emtricitabine + Tenofovir disoproxil Tillomed with other medicines that

can 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),
• cidofovir (for viral infections),
• non-steroidal anti-inflammatory drugs (NSAIDs, to reduce bone or muscle pain). If you are taking another antiviral medicine called a protease inhibitor used to treat HIV, your doctor may order blood tests to closely monitor kidney function.

You should also inform your doctorif 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):taking Emtricitabine + Tenofovir disoproxil Tillomed and other antiviral medicines that contain didanosine can increase the level of didanosine in the blood and may also decrease the number of CD4 cells. When taking medicines containing tenofovir disoproxil and didanosine, rare cases of pancreatitis and lactic acidosis (excessive lactic acid in the blood) have been observed, sometimes leading to death. The treating doctor will carefully consider whether to use tenofovir with didanosine.
Tell your doctorif you are taking any of these medicines.
Tell your doctor or pharmacist about all the 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

If you have taken Emtricitabine + Tenofovir disoproxil Tillomed during pregnancy, your doctor may order regular blood tests and other diagnostic tests to monitor the development of the child. 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 of this medicine pass into human milk.
• It is recommended that women with HIV infection do not breastfeed to avoid transmitting the virus to the child through milk.

Driving and using machines

Emtricitabine + Tenofovir disoproxil Tillomed can cause dizziness. If you experience dizziness while taking Emtricitabine + Tenofovir disoproxil Tillomed, do not drivevehicles, do not use any tools, and do not operate any machines.

Emtricitabine + Tenofovir disoproxil Tillomed contains soya lecithin

Do not take this medicine if you are hypersensitive 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, which means it is essentially 'sodium-free'.

3. How to take Emtricitabine + Tenofovir disoproxil Tillomed

• This medicine should always be taken as directed by your doctor.If you are unsure, consult your doctor or pharmacist.

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

is:

• Adults: one tablet once a day, preferably with food.
• Adolescents aged 12 to less than 18 years, weighing at least 35 kg:one tablet once a day, preferably with food.

Recommended dose of Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection is:

• Adults: one tablet once a day, preferably with food.
• Adolescents aged 12 to less than 18 years, weighing at least 35 kg:one tablet once a day, preferably with food. If you have difficulty swallowing, the tablet can be crushed with the tip of a spoon. Then mix the powder with about 100 ml (half a glass) of water, orange juice, or grape juice and drink immediately.
• Always take the dose prescribed by your doctor.This is to ensure the full effectiveness of the medicine and to limit the development of resistance to the medicine. Do not change the dose of the medicine unless your doctor advises you to do so.
• In the treatment of HIV infection, the doctor will prescribe Emtricitabine + Tenofovir disoproxil Tillomed to be taken with other antiretroviral medicines. Read the patient information leaflets for the respective antiretroviral medicines to learn about their use.
• In the case of taking Emtricitabine + Tenofovir disoproxil Tillomed to reduce the risk of HIV infection, Emtricitabine + Tenofovir disoproxil Tillomed should be taken every day, and not just when the patient thinks they may have been exposed to HIV.

Tell your doctor if you have any further questions about methods to prevent HIV infection or prevent transmission of HIV to others.

Taking more than the recommended dose of Emtricitabine + Tenofovir disoproxil Tillomed

If you have accidentally taken a dose of Emtricitabine + Tenofovir disoproxil Tillomed that is higher than recommended, consult your doctor or the nearest hospital emergency department for advice. Take the package leaflet with you to show the medicine you have taken.

Missing a dose

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

• If you realize within 12 hoursof the usual time you take Emtricitabine + Tenofovir disoproxil Tillomed, take the tablet as soon as possible, preferably with food. Take the next dose at the usual time.
• If you realize after at least 12 hoursof the usual time you take Emtricitabine + Tenofovir disoproxil Tillomed, 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 of taking Emtricitabine + Tenofovir disoproxil Tillomed

Tillomed, take another tablet. You do not need to take another tablet if the vomiting occurs later than 1 hour after taking the medicine.

Do not stop taking Emtricitabine + Tenofovir disoproxil Tillomed

• In the case of taking Emtricitabine + Tenofovir disoproxil Tillomed to treat HIV infection, stopping the tablets may reduce the effectiveness of the HIV treatment recommended by your doctor.
• In the case of taking 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 particularly important that patients with hepatitis B virus infectiondo not stop taking Emtricitabine + Tenofovir disoproxil Tillomed without consulting their doctor. For several months after stopping the medicine, it may be necessary to perform blood tests. In some patients with advanced liver disease or liver cirrhosis, it is not recommended to stop taking the medicine, as it may lead to a life-threatening exacerbation of hepatitis B.
• Tell your doctor immediatelyabout any new or unusual symptoms you notice after stopping treatment, especially those that are typically associated with hepatitis B virus infection. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Emtricitabine + Tenofovir disoproxil Tillomed can cause side effects, although not everybody gets them.

Possible serious side effects:

• Lactic acidosis(excessive 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 that may be signs of lactic acidosis are:
• deep, rapid breathing,
• drowsiness,
• nausea, vomiting,
• abdominal pain.

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

• 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 related to previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are related to the improvement of the immune system, allowing it to fight infections that may be present but not showing symptoms.
• Autoimmune disordersin which the immune system attacks healthy tissues of the body may also occur after starting antiretroviral therapy. Autoimmune disorders can occur several months after starting treatment. You should be aware of any signs of infection or other symptoms, such as:
• muscle weakness,
• muscle weakness starting in the hands and feet and moving up the body,
• heart palpitations, tremors, or excessive activity.

If you notice these or any other signs of inflammation or infection, seek medical help immediately.

Possible side effects:

Very common side effects

(may affect more than 1 in 10 people)

• diarrhea, vomiting, nausea,
• dizziness, headache,
• rash,
• feeling weak.

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, abdominal pain,
• difficulty sleeping, unusual dreams,
• digestive problems leading to discomfort after meals, bloating, gas,
• rash (including red spots or patches, sometimes with blistering and swelling of the skin), which can be allergic reactions, itching, changes in skin color, including darker skin patches,
• other allergic reactions, such as wheezing, swelling, or a feeling of emptiness in the head.

Tests may also show:

• decreased white blood cell count (decreased white blood cell count may increase the risk of infections),
• increased triglyceride, bilirubin, or blood sugar levels,
• liver or pancreas problems.

Uncommon side effects

(may affect up to 1 in 100 people)

• abdominal pain caused by pancreatitis,
• swelling of the face, lips, tongue, or throat,
• anemia (decreased red blood cell count),
• muscle breakdown, muscle pain, or muscle weakness, which can occur due to damage to the 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 liver inflammation,
• kidney inflammation, excessive urine production, and thirst, kidney failure, damage to the kidney tubule cells,
• bone softening (manifested as bone pain and sometimes leading to fractures),
• back pain caused by kidney problems. Damage to the kidney tubule cells can cause muscle breakdown, bone softening (manifested as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.

If you experience any of the above side effects or if they worsen

tell your doctor or pharmacist.
The frequency of the following side effects is unknown

• Bone disorders.In some patients taking combination antiretroviral therapies, such as emtricitabine with tenofovir disoproxil, a bone disease called osteonecrosis(death of bone tissue due to lack of blood supply to the bone) has developed. Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a weakened immune system, and being overweight may be some of the risk factors for this disease.

Symptoms of osteonecrosis are:

• joint stiffness,
• joint pain (especially in the hips, knees, and shoulders),
• difficulty moving.

Tell your doctor if you notice any of these symptoms.

During HIV treatment, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to the improvement in the patient's condition and lifestyle, and sometimes, in the case of lipid levels in the blood, to the effect of HIV treatment. Your doctor will order tests to detect these changes.

Other side effects in children

• In children taking emtricitabine, very common side effects included skin discoloration, including darker skin patches.
• In children, common side effects included a low red blood cell count (anemia), which can cause fatigue or shortness of breath in the child.

Tell your doctor if you notice any of these symptoms.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Emtricitabine + Tenofovir disoproxil Tillomed

Keep the medicine out of the sight and reach of children.

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

6. Contents of the packaging and other information

What Emtricitabine + Tenofovir disoproxil Tillomed contains

• The active substances areemtricitabineand 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: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, maize starch, soybean lecithin (E 322), partially hydrolyzed 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

White to off-white, modified capsule-shaped film-coated tablets with "EM" engraved on one side and "144" on the other side. The dimensions of the tablet are approximately 19.20 mm x 9.70 mm.
Blister:
Film-coated tablets in a perforated unit dose blister, made of aluminum/aluminum foil, 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 desiccant, with a PP child-resistant closure, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Tillomed Pharma GmbH
Mittelstrasse 5/5a
12529 Schönefeld
Germany
Phone: +48 509 368 531
Email: [email protected]

Importer

MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg
Filmtabletten
Denmark
Emtricitabine/Tenofovir disoproxil 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
Emtricitabine/Tenofovirdisoproxil Tillomed
Poland
Emtricitabine + Tenofovir disoproxil Tillomed
Portugal
Emtricitabina/Tenofovir disoproxil Tillomed 200 mg/245 mg
comprimidos revestidos por película
Romania
Emtricitabina/tenofovir disoproxil Tillomed 200 mg/245 mg
comprimate filmate
Spain
Emtricitabina/tenofovir disoproxil Tillomed 200 mg/245 mg
comprimidos recubiertos con película EFG
Sweden
Emtricitabine/Tenofovirdisoproxil Tillomed

Date of last revision of the leaflet: