EMTRICITABINE/TENOFOVIR DISOPROXIL TILLOMED 200 MG / 245 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

□ what you need to know beforeyou take emtricitabine/ ten ofov ir d isop roxi i

3 How to take Emtricita bi ne/Tenofovi r di soproxil

□ Possible side effects

□ HowtostoreEmtri­citabine/Teno­fovir disoproxil

□ Contents ofthepackand other information

□ What Emtricitabine/Tenofovir disoproxil is and what it is used for

Emtricitabine/Te­nofovir disoproxil contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential forthe virus to reproduce itself.

• Emtrkitabine/Te­nofovir disoproxil is used to treat Human Immunodeficiency Virus 1 (HIV-1) infectionin adults
• It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or havecaused side effects.

– Emtricitabine/Te­nofovir disoproxil should always be used combined with other medicines to treat HIVinfection.

– Emtricitabine/Te­nofovir disoproxil can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.

People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid i nfecting other people.

This medicine is not a cure for HIV infection. While taking Emtricitabine/Te­nofovir disoproxil you may still develop infectionsorother illnesses associated with HIV infection.

• Emtricitabine/Te­nofovir disoproxil is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when taken daily, together with safer sex practices:

See section 2 for a list of precautions to take against HIV infection.

□ what you need to know before you take emtricitabine/tenofbvir disoproxil

Do not take Emtricitabine/Te­nofovir disoproxil to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

Ifthis applies toyou, tell your doctor immediately.

Before taking Emtricitabine/Te­nofovir disoproxil to reduce the riskof getting HIV:

Emtricita bine/Tenofovir disoproxil can only help reduce your risk of getti ng HIV beforeyou are i nfected.

• You must be HIV negative before you start to take emtricitabine/te­nofovir disoproxil to reduce the risk of getting HIV. You must get tested to make sure that you do not already have HIV infection. Do not take emtricitabine/te­nofovir disoproxil to reduce your risk unless you areconflrmed to be HIV negative. People who do have HIV must take emtricitabine/te­nofovir disoproxil in combination with other drugs.
• Many HIV tests ca n m iss a recent infection. If you get a fl u-like illness, it could mean you have recently been infected with HIV.

These may be signs of HIVinfection:

• tiredness
• fever
• jointormuscle aches
• headache
• vomiting ordiarrhoea
• rash
• night sweats
• enlarged lymph nodesin theneckorgroin

Tell your doctor about any flu-like illness - either in the month before starting Emtricitabine/Te­nofovir disoproxil, orat any time while taking Emtricitabine/Te­nofovirdisopro­xil.

Wamingsand precautions

While taking Emtricitabine/Te­nofovir disoproxil to reduce the riskof getting HIV:

• Take Emtricitabine/Te­nofovir disoproxil every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Emtricitabine/Te­nofovirdisopro­xil, or stop taki ng it. Missing doses may increase your risk of getting HIVinfection.
• Gettested for HIV regularly.
• If you think you were infected with HIV, tell your doctor straight away. They may want to do more tests to make sure you are still HIV negative.
• Just taking Emtricitabine/Te­nofovir disoproxil may not stop you getting HIV.

° Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.

° Do not share personal items that can have blood or body fluidsonthem,suchas­toothbrushesand razor blades.

° Do not share or re-use needles or other injection or drug equipment.

° Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how to prevent getti ng HIVorspreading HIVto other people.

While taking Emtricitabine/Te­nofovir disoproxil to treat HIV or to reducetheriskof getting HIV:

• Emtricitabine/te­nofovir disoproxil may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if you have had kidneydisease,o­riftests have shown kidney problems. Emtricitabine/Te­nofovirdisopro­xil should not be given to adolescents with existing kidney problems. If you have kidney problems, yourdoctor may advise you to stop taking Emtricitabine/Te­nofovir disoproxil or, if you already have HIV,to take Emtricitabine/Te­nofovir disoproxil less frequently. Emtricitabine/te­nofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.

Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).

• Talk to your doctor if you have a history of liver disease, including hepatitis. Patients infected with HIV who also have liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentiallyfatal liver complications.

If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen foryou.

• Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Te­nofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Te­nofovir disoproxil, whether or not you also have HIV. It is important not to stop taking Emtricitabine/Te­nofovir disoproxil without talking to your doctor: see section 3, Do not stop taking Emtricitabine/ Tenofovir disoproxil.
• Talk to your doctor if you are over 65. Emtricitabine/ tenofovir disoproxil has not been studied in patients over 65 years of age.

Children and adolescents

Emtricitabine/Te­nofovir disoproxil is not for use in children under 12 years of age.

Other medicines and Emtricitabine/Te­nofovir disoproxil

Do not take Emtricitabine/Te­nofovir disoproxil if you are already taking other medicines that contain the components of Emtricitabine/Te­nofovir disoproxil (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofoviralafe­namidejamivudi­ne or adefovirdipivoxil.

Taking Emtricitabine/Te­nofovir disoproxil with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including

• aminoglycosides (forbacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (forviral infection)
• ganciclovir(for­viral infection)
• pentamidine (for infections)
• vancomycin (forbacterial infection)
• interleukin-2(totreatcancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve boneor muscle pains)

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.

It is also important to tell your doctor if you are taking ledipasvir/so­fosbuvir or sofosbuvir/vel­patasvir or sofosbuvir/ velpatasvir/vo­xilaprevirto treat hepatitisC infection.

Taking Emtricitabine/Te­nofovir disoproxil with other medicines containing didanosine (for treatment of HIV infection): Taking Emtricitabine/Te­nofovir disoproxil with other antiviral med icines that contain d idanosine can raisethe levels of didanosine in your blood and may reduce CD4 cell counts. Rarely, inflammation ofthe pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully consider whether to treat you with combi nations of tenofovir and didanosine.

Tell yourdoctor if you are taking any of these medicines. Tell your doctoror pharmacist ifyouaretaking, have recently taken ormig httakeanyother medicines.

Emtricitabine/Te­nofovir disoproxil with food and drink

• Whenever possible, Emtricitabine/Te­nofovir disoproxil should betaken with food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacistforadvice before taking this medicine.

• Although there are limited clinical data on the use of Emtricitabine/Te­nofovir disoproxil in pregnant women, it is not usually used unlessabsolutely necessary.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Te­nofovir disoproxil to you and your child.

If you have taken Emtricitabine/Te­nofovir disoproxil during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

• Do not breast-feed during treatment with Emtricitabine/ Tenofovir disoproxil.This is because the active substances in this medicine pass into human breast milk.
• If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breastmilk.

Driving and using machines

Emtricitabine/Te­nofovir disoproxil can cause dizziness. If you feel dizzy while taking Emtricitabine/Te­nofovir disoproxil, do not drive and do not use any toolsor machines.

Emtricitabine/Te­nofovir disoproxil contains soya lecithin.

If you are allergic to peanut or soya do not use this medicinal product.

Emtricitabine/Te­nofovir disoproxil contains sodium.

Emtricitabine/Te­nofovir disoproxil contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‚sodium-free‘

□ How to takeEmtricitabine/Tenofovir disoproxil

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Emtricitabine/Te­nofovir disoproxil totreatHIVis:

• Adults: one tablet each day, where possible, with food.
• Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.

The recommended dose of Emtricitabine/Te­nofovir disoproxil toreducethe riskof getting HIV is:

• Adults: one tablet each day, whenever possible with food.
• Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice, and drink immediately.

• Alwaystakethedose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unlessyourdoctortel Isyou to.
• If you are being treated for HIV infection your doctor will prescribe Emtricitabine/Te­nofovir disoproxil with other antiretroviral medicines. Please refer to the patient information leaflets ofthe other antiretrovirals for guidance on howto take those medicines.
• If you are taking Emtrkitabine/Te­nofovir disoproxil to reduce the risk of getting HIV, take Emtricitabine/ Tenofovir disoproxil every day, not just when you think you have been at risk of HIV infection.

Ask your doctor if you have any questions about how to prevent getting HIV or prevent spread! ng HIV to other people.

If you take more Emtricitabine/Te­nofovir disoproxil than you should

If you accidentally take more than the recommended dose of Emtricitabine/Te­nofovir disoproxil, contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.

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Ifyoumissadose

It is important not to miss a dose of Emtricitabine/ Tenofovir disoproxil.

• If you notice within 12 hours of the time you usually take Emtricitabine/Te­nofovir disoproxil, take the tablet preferably with food as soon as possible. Then take the next dose atyour usual time.
• If you notice 12 hours or more after the time you usually take Emtricitabine/Te­nofovir disoproxil, forget about the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/ Tenofovir disoproxil, take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Emtricitabi ne/Tenofovir disoproxi I.

Do not stop taking Emtricitabine/Te­nofovirdisopro­xil

• If you take Emtricitabine/Te­nofovir disoproxil for treatment of HIV infection, stopping tablets may reduce the effectiveness of theanti-HIV therapy recommended by yourdoctor.
• If you are taking Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV, do not stop taking Emtricitabine/Te­nofovir disoproxil or miss any doses. Stopping use of Emtricitabine/Te­nofovir disoproxil, or missing doses, may increase your risk of getting HIV infection.

→ Do not stop taking Emtricitabine/Te­nofovir disoproxil without contacting your doctor.

• If you have hepatitis B, it is especially important not to stop your Emtricitabine/Te­nofovir disoproxil treatment without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.

—> Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection

If you have any further questions on the use of this medicine, ask yourdoctor or pharmacist.

□ 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 often in women, particularly if they are overweight, and in people with liver disease.The following may be signsof lactic acidosis:
• deep rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting)
• stomach pain

If you think you may have lactic acidosis, get medical help immediately.

• Any signs 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 weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
• muscleweakness
• weakness beginning in the hands and feet and moving up towardsthe trunk of the body
• palpitations»tre­mororhyperacti­vity

If you notice these or any symptoms of inflammation or infection, get medical help immediately.

Possiblesideef­fects:

Very com mon side effects

(may affect more than 1 in 10people)

• diarrhoea, bei ng sick (vomiting), feeli ng sick (nausea)
• dizziness, headache
• rash
• feeling weak

Tests may a I so sho w:

• decreases in phosphate in the blood
• increased creatine ki nase

Common side effects

(may affect up to 1 in 10people)

• pain, stomach pain
• difficultysle­eping,abnormal­dreams
• problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin i n patches
• other allergic reactions, such as wheezing, swelling or feeling light-headed

Tests may also show:

• low white blood cell count (a reduced white blood cell countcan makeyou more proneto infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liverand pancreas problems

Uncommon side effects

(may affect up to 1 in 100people)

• pain in the abdomen (tummy) caused by inflammation of the pancreas
• swelling ofthe face, lips,tongueorthroat
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness which may occur due to damageto the kidney tubule cells

Tests may a Iso show:

• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine

Rare side effects

(may affect up to 1 in 1,000people)

• Lactic acidosis (see Possible serious side effects)
• fatty liver
• yellow skin or eyes, itching, or pain i n the abdomen (tummy) caused by inflammation ofthe liver
• inflammation of the kidney, passing a lot of urine and feeling thi rsty, kid neyfai lure, damageto kidney tubule cells
• softening of the bones (with bone pain and sometimes resulting in fractures)
• backpain caused by kidney problems

Damage to kidney tubule cells may be associated with breakdown of muscle, softening ofthe bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.

If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmaci st. Thefrequency of thefollowing side effects is not known.

• Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/ Tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and bei ng overweight, may be some ofthe many risk factors for developing this disease. Signs of osteonecrosis a re:
• joint stiffness
• joint aches and pains (especially of the hip, knee and shoulder)
• difficulty with movement

If you noticeany of these symptoms tell your doctor.

During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Other effects in children

• Children given emtricitabine very commonly experienced changes in skin colour including darkening ofthe skin in patches
• Children commonly experienced low red blood cell count (anaemia). This may cause the child to be tired or breathless

If you noticeany ofthese symptoms tell 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 via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

□ how to store emtricitabine/tenofovir disoproxil

Keep this medicine out of thesight and reachof children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture. Keep bottle tig htlyclosed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measureswill help to p rotect the envi ronment.

• □ Contents ofthe packand other information

What Emtricitabine/Te­nofovirdisopro­xil contains

• The active substances are emtricitabine and tenofovir disoproxil. Each Emtricitabine/Te­nofovir disoproxil film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disop roxilfumarateor 136 mg oftenofovir).

The other ingredients are croscarmellose sodium, magnesium stearate, microcrystal line cellulose, pre gelatinized starch (maize starch), lecithin (soya) (E322), polyvinyl alcohol-partially hydrolyzed (E1203), titanium dioxide (El 71), talc, xanthangum(E415).

What Emtricitabine/Te­nofovir disoproxil looks like and contentof the pack

White to off white, modified capsule shaped, film-coated tablets, debossed with "EM"on one side and "144"on other side of the tablet. The dimensions of the tablet are approximately 19.20mm x9.70 mm.

Blisterpack:

Film-coated tablets in Aluminium plain foil as lidding material and Aluminium-Aluminium plain as forming foil, perforated unit dose blister.

Pack sizes: 30 × 1 and 90×1 film-coated tablets.

Bottles:

30 tablets in HDPE bottles containing desiccant (Canister HDPE containing silica gel), with polypropylene child resistant closure.

Notall pack sizes may be marketed.

Marketing Authorisation Holderand Manufacturer

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marling s,

Luton, LU2 8DL

United Kingdom

Manufacturer

Tillomed Laboratories Ltd.

220 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

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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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

2 What Emtricitabine/Te­nofovir disoproxil is and what it is used for

3| What you need to know before you take Emtricitabine/ Tenofovir disoproxil

3| How to take Emtricitabine/Te­nofovir disoproxil

4| Possible side effects

7| How to store Emtricitabine/Te­nofovir disoproxil

6| Contents of the pack and other information

What Emtricitabine/Tenofovir disoproxil is and what it is used for

Emtricitabine/Te­nofovir disoproxil contains two active substances , emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.

! Emtricitabine/Te­nofovir disoproxil 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 who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.

– Emtricitabine/Te­nofovir disoproxil should always be used combined with other medicines to treat HIV infection.

– Emtricitabine/Te­nofovir disoproxil can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.

People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

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

! Emtricitabine/Te­nofovir disoproxil is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg, when taken daily, together with safer sex practices:

See section 2 for a list of precautions to take against HIV infection.

3| What you need to know before you take Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Te­nofovir disoproxil to treat HIV or to reduce the risk of getting HIV 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, tell your doctor immediately.

Before taking Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV:

Emtricitabine/Te­nofovir disoproxil can only help reduce your risk of getting HIV before you are infected.

! You must be HIV negative before you start to take emtricitabine/te­nofovir disoproxil to reduce the risk of getting HIV. You must get tested to make sure that you do not already have HIV infection. Do not take emtricitabine/te­nofovir disoproxil to reduce your risk unless you are confirmed to be HIV negative. People who do have HIV must take emtricitabine/te­nofovir disoproxil in combination with other drugs.

! Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean you have recently been infected with HIV.

These may be signs of HIV infection:

! tiredness

! fever

! joint or muscle aches

! headache

! vomiting or diarrhoea

! rash

! night sweats

! enlarged lymph nodes in the neck or groin

Tell your doctor about any flu-like illness – either in the month before starting Emtricitabine/Te­nofovir disoproxil, or at any time while taking Emtricitabine/Te­nofovir disoproxil.

Warnings and precautions

While taking Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV:

! Take Emtricitabine/Te­nofovir disoproxil every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Emtricitabine/Te­nofovir disoproxil, or stop taking it. Missing doses may increase your risk of getting HIV infection.

! Get tested for HIV regularly.

! If you think you were infected with HIV, tell your doctor straight away. They may want to do more tests to make sure you are still HIV negative.

! Just taking Emtricitabine/Te­nofovir disoproxil may not stop you getting HIV.

• # Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.

• # Do not share personal items that can have blood or body fluids on them, such as toothbrushes and razor blades.

• # Do not share or re-use needles or other injection or drug equipment.

• # Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV to other people.

While taking Emtricitabine/Te­nofovir disoproxil to treat HIV or to reduce the risk of getting HIV:

! Emtricitabine/te­nofovir disoproxil may affect your kidneys. Before and during treatment, your doctor may order blood tests to measure kidney function. Tell your doctor if you have had kidney disease, or if tests have shown kidney problems. Emtricitabine/Te­nofovir disoproxil should not be given to adolescents with existing kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine/Te­nofovir disoproxil or, if you already have HIV, to take Emtricitabine/Te­nofovir disoproxil less frequently. Emtricitabine/te­nofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.

Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects ).

! Talk to your doctor if you have a history of liver disease, including hepatitis. Patients infected with HIV who also have liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.

If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.

! Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Te­nofovir disoproxil. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Te­nofovir disoproxil, whether or not you also have HIV. It is important not to stop taking Emtricitabine/Te­nofovir disoproxil without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Te­nofovir disoproxil.

• ! Talk to your doctor if you are over 65. Emtricitabine/ tenofovir disoproxil has not been studied in patients over 65 years of age.

3| How to take Emtricitabine/Tenofovir disoproxil

! Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Emtricitabine/Te­nofovir disoproxil to treat HIV is:

! Adults: one tablet each day, where possible, with food.

! Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.

The recommended dose of Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV is:

! Adults: one tablet each day, whenever possible with food.

! Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. 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 recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

! If you are being treated for HIV infection your doctor will prescribe Emtricitabine/Te­nofovir disoproxil with other antiretroviral medicines. Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.

! If you are taking Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV, take Emtricitabine/ Tenofovir disoproxil every day, not just when you think you have been at risk of HIV infection.

Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to other people.

If you take more Emtricitabine/Te­nofovir disoproxil than you should

If you accidentally take more than the recommended dose of Emtricitabine/Te­nofovir disoproxil, contact your doctor or nearest emergency department for advice. Keep the tablet bottle with you so that you can easily describe what you have taken.

If you miss a dose

It is important not to miss a dose of Emtricitabine/ Tenofovir disoproxil.

! If you notice within 12 hours of the time you usually take Emtricitabine/Te­nofovir disoproxil, take the tablet preferably with food as soon as possible. Then take the next dose at your usual time.

! If you notice 12 hours or more after the time you usually take Emtricitabine/Te­nofovir disoproxil, forget about the missed dose. Wait and take the next dose, preferably with food, at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/ Tenofovir disoproxil , take another tablet. You do not need to take another tablet if you were sick more than 1 hour after taking Emtricitabine/Te­nofovir disoproxil.

Do not stop taking Emtricitabine/Te­nofovir disoproxil

! If you take Emtricitabine/Te­nofovir disoproxil for treatment of HIV infection , stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.

! If you are taking Emtricitabine/Te­nofovir disoproxil to reduce the risk of getting HIV , do not stop taking Emtricitabine/Te­nofovir disoproxil or miss any doses. Stopping use of Emtricitabine/Te­nofovir disoproxil, or missing doses, may increase your risk of getting HIV infection.

® Do not stop taking Emtricitabine/Te­nofovir disoproxil without contacting your doctor.

! If you have hepatitis B, it is especially important not to stop your Emtricitabine/Te­nofovir disoproxil treatment without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.

® Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection

If you have any further questions on 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 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 often in women, particularly if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:

! deep rapid breathing

! drowsiness

! feeling sick (nausea), being sick (vomiting)

! stomach pain

If you think you may have lactic acidosis, get medical help immediately.

! Any signs 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 weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is thought that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

! Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:

! muscle weakness

! weakness beginning in the hands and feet and moving up towards the trunk of the body

! palpitations, tremor or hyperactivity

If you notice these or any symptoms of inflammation or infection, get medical help immediately.

Possible side effects:

Very common side effects

(may affect more than 1 in 10 people)

! diarrhoea, being sick (vomiting), feeling sick (nausea)

! dizziness, headache

! rash

! feeling weak

Tests may also show:

! decreases in phosphate in the blood

! increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

! pain, stomach pain

! difficulty sleeping, abnormal dreams

! problems with digestion resulting in discomfort after meals, feeling bloated, flatulence

! rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches

! other allergic reactions, such as wheezing, swelling or feeling light-headed

Tests may also show:

! low white blood cell count (a reduced white blood cell count can make you more prone to infection)

! increased triglycerides (fatty acids), bile or sugar in the blood

! liver and pancreas problems

Uncommon side effects

(may affect up to 1 in 100 people)

! pain in the abdomen (tummy) caused by inflammation of the pancreas

! swelling of the face, lips, tongue or throat

! anaemia (low red blood cell count)

! breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells

Tests may also show:

! decreases in potassium in the blood

! increased creatinine in your blood

! changes to your urine

Rare side effects

(may affect up to 1 in 1,000 people)

! Lactic acidosis (see Possible serious side effects )

! fatty liver

! yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver

! inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells

! softening of the bones (with bone pain and sometimes resulting in fractures)

! back pain caused by kidney problems

Damage to kidney tubule cells may be associated with breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood.

If you notice any of the side effects listed above or if any of the side effects get serious , talk to 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/ Tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are: ! joint stiffness

! joint aches and pains (especially of the hip, knee and shoulder)

! difficulty with movement

If you notice any of these symptoms tell your doctor.

During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Other effects in children

! Children given emtricitabine very commonly experienced changes in skin colour including darkening of the skin in patches

! Children commonly experienced low red blood cell count (anaemia). This may cause the child to be tired or breathless

If you notice any of these symptoms tell 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 via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5| How to store Emtricitabine/Tenofovir disoproxil

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 carton and blister. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture. Keep bottle tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help to protect the environment.

6| Contents of the pack and other information

What Emtricitabine/Te­nofovir disoproxil contains

! The active substances are emtricitabine and tenofovir disoproxil. Each Emtricitabine/Te­nofovir disoproxil 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, pregelatinized starch (maize starch), lecithin (soya) (E322), polyvinyl alcohol-partially hydrolyzed (E1203), titanium dioxide (E171), talc, xanthan gum (E415).

What Emtricitabine/Te­nofovir disoproxil looks like and content of the pack

White to off white, modified capsule shaped, film-coated tablets, debossed with“EM” on one side and“144” on other side of the tablet. The dimensions of the tablet are approximately 19.20 mm x 9.70 mm.

Blister pack:

Film-coated tablets in Aluminium plain foil as lidding material and Aluminium-Aluminium plain as forming foil, perforated unit dose blister.

Pack sizes: 30 × 1 and 90 × 1 film-coated tablets.

Bottles:

30 tablets in HDPE bottles containing desiccant (Canister HDPE containing silica gel), with polypropylene child resistant closure.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

Manufacturer

Tillomed Laboratories Ltd.

220 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany	Emtricitabin/Te­nofovirdisopro­xil Tillomed 200 mg/245 mg Filmtabletten
Austria	Emtricitabin/Te­nofovirdisopro­xil Tillomed 200 mg/245 mg Filmtabletten
Denmark	Emtricitabin/ Tenofovirdisoproxil Tillomed 200 mg/245 mg filmovertrukne tabletter
Finland	Emtricitabine/ Tenofovir disoproxil Tillomed 200 mg/245 mg kalvopaallysteiset tabletit
Ireland	Emtricitabine/Te­nofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets
Italy	Emtricitabina e Tenofovir disoproxil Tillomed
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 pelfcula
Romania	Emtricitabina/Te­nofovir disoproxil Tillomed 200 mg/245 mg comprimate filmate
Spain	Emtricitabina/te­nofovir disoproxil Tillomed 200 mg/245 mg comprimidos recubiertos con pelfcula EFG
Sweden	Emtricitabin/Te­nofovirdisopro­xil Tillomed
United Kingdom	Emtricitabine/Te­nofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets

This leaflet was last revised in 04/2020

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