ODEFSEY 200 mg/25 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Odefsey 200mg/25mg/25mgfilm-coated tablets

emtricitabine/rilpivirine/tenofovir alafenamide

This medicine is subject to additional monitoring, which will help to quickly identify new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

Contents of the pack and other information

1. What is Odefsey and what is it used for
2. What you need to know before you take Odefsey
3. How to take Odefsey
4. Possible side effects
5. Storing Odefsey
6. Contents of the pack and other information

1. What is Odefsey and what is it used for

Odefsey is an antiviral medicine used to treat human immunodeficiency virus (HIV) infection. It is a single tablet that contains a combination of three active substances: emtricitabine, rilpivirine, and tenofovir alafenamide. Each of these active substances works by interfering with an enzyme called "reverse transcriptase", which is essential for the HIV-1 virus to multiply.

Odefsey reduces the amount of HIV in your body. This improves your immune system and reduces the risk of developing diseases associated with HIV infection.

Odefsey is used in adults and adolescents aged 12 years and older, weighing at least 35 kg.

2. What you need to know before you take Odefsey

Do not takeOdefsey:

• or any of the other ingredients of this medicine (listed in section 6).

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin(used to treat epilepsy and prevent seizures)
• rifabutin, rifampicin, andrifapentine(used to treat some bacterial infections such as tuberculosis)
• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole(used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)
• dexamethasone(a corticosteroid used to treat inflammation and suppress the immune system) when taken orally or injected (except as a single-dose treatment)
• products containing St. John's Wort(Hypericum perforatum, a medicinal plant used for depression and anxiety)

? If you are in any of these situations, do not take Odefsey and consult your doctor immediately.

Warnings and precautions

You must remain under the supervision of your doctor while taking Odefsey.

While taking this medicine you can still transmit HIV to others,even if effective antiretroviral treatment reduces the risk. Consult your doctor about what precautions are necessary to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking Odefsey, you may still experience infections or other diseases associated with HIV infection.

Consult your doctor before starting Odefsey:

• Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious and potentially life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B infection, liver problems may worsen after stopping Odefsey. It is important that you do not stop taking Odefsey without talking to your doctor first: see section 3, Do not stop taking Odefsey.

While takingOdefsey

Once you start taking Odefsey, be aware of:

• signs of inflammation or infection
• joint pain, stiffness, or bone problems

? If you notice any of these symptoms, inform your doctor immediately.For more information, see section 4, Possible side effects.

It is possible that you may experience kidney problems if you take Odefsey for a long time.

Children and adolescents

Do not give this medicine to children aged 11years or younger or weighing less than 35kg. Odefsey has not been studied in children aged 11 years or younger or weighing less than 35 kg.

Other medicines and Odefsey

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Odefsey may interact with other medicines. As a result, the blood levels of Odefsey or other medicines may be affected. This may prevent your medicines from working properly or worsen their possible side effects. In some cases, your doctor may need to adjust the dose or check your blood levels.

Medicines that must not be taken with Odefsey:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin(used to treat epilepsy and prevent seizures)
• rifabutin, rifampicin, andrifapentine(used to treat some bacterial infections such as tuberculosis)
• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole(used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)
• dexamethasone(a corticosteroid used to treat inflammation and suppress the immune system) when taken orally or injected (except as a single-dose treatment)
• products containing St. John's Wort(Hypericum perforatum, a medicinal plant used for depression and anxiety)

? If you are taking any of these medicines, do not take Odefsey and consult your doctor immediately.

Other types of medicines:

Consult your doctor if you are taking:

• any medicine used to treat HIV

• any medicine that contains:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

• antibiotics used to treat bacterial infectionsthat contain:

• clarithromycin
• erythromycin

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• antifungals used to treat fungal infections:

• ketoconazole
• fluconazole
• itraconazole
• posaconazole
• voriconazole

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• medicines for stomach ulcers, heartburn, or acid refluxsuch as:

• antacids(aluminum/magnesium hydroxide or calcium carbonate)
• H2antagonists(famotidine, cimetidine, nizatidine, or ranitidine)

These medicines may decrease the levels of rilpivirine (a component of Odefsey) in the blood. If you are taking one of these medicines, your doctor will prescribe a different medicine or recommend how and when to take this medicine:

• If you are taking an antacid,take it at least 2 hours before or at least 4 hours after Odefsey.

• If you are taking an H2antagonist, take it at least 12 hours before or at least 4 hours after Odefsey. H2 antagonists should only be taken once a day if you are taking Odefsey. H2 antagonists should not be taken twice a day. Talk to your doctor to find an alternative regimen (see How to take Odefsey).

• cyclosporin,a medicine used to reduce the activity of the body's immune system:

This medicine may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• methadone,a medicine used to treat opioid addiction, as your doctor may need to change your methadone dose.

• dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.

? Consult your doctor if you are taking any of these medicines. Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
• use effectivecontraceptionwhile you are taking Odefsey.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.

If you have taken Odefsey 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 nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Do not breastfeed your child while taking Odefsey. This is because some of the active substances in this medicine pass into breast milk. It is recommended that you do not breastfeed to avoid transmitting the virus to your child through breast milk.

Driving and using machines

Do not drive or operate machinery if you feel tired, sleepy, or dizzy after taking your medicine.

Odefsey contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

? If you are in any of these situations, consult your doctor before starting Odefsey.

3. How to take Odefsey

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 is:

Adults:one tablet once daily with food

Adolescents aged 12years or older, weighing at least 35kg:one tablet once daily with food

Do not chew, crush, or split the tablet.

If you are taking an antacid, such as aluminum/magnesium hydroxide or calcium carbonate, take it at least 2 hours before or at least 4 hours after Odefsey.

If you are taking an H2antagonistsuch as famotidine, cimetidine, nizatidine, or ranitidine, take it at least 12 hours before or at least 4 hours after Odefsey. H2 antagonists should only be taken once a day if you are taking Odefsey. H2 antagonists should not be taken twice a day. Talk to your doctor to find an alternative regimen.

If you are on dialysis, take your daily dose of Odefsey after dialysis.

If you take more Odefsey than you should

If you accidentally take more than the recommended dose of Odefsey, you may be at greater risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).

Consult your doctor immediately or go to the emergency department at your nearest hospital. Keep the bottle of tablets with you so that you can easily describe what you have taken.

If you forget to take Odefsey

It is important that you do not miss a dose of Odefsey.

If you miss a dose:

• If you notice within 12hoursof the time you normally take Odefsey, you should take the tablet as soon as possible. Take the tablet with food. Then take the next dose as usual.
• If you notice 12hoursor moreafter the time you normally take Odefsey, do not take the missed dose. Wait and take the next dose with food at the usual time.

If you vomit within 4hoursafter taking Odefsey, take another tablet with food. If you vomit more than 4hours after taking Odefsey, you do not need to take another tablet until your next scheduled dose.

Do not stop taking Odefsey

Do not stop taking Odefseywithout talking to your doctor first.Stopping Odefsey may seriously affect your response to future treatments. If Odefsey is stopped for any reason, consult your doctor before restarting Odefsey.

When you notice that you have little Odefsey left, make an appointment with your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medicine is stopped, even for a short period. Your disease may then become more difficult to treat.

If you have both HIV and hepatitis Binfection, it is especially important not to stop your treatment with Odefsey without first talking to your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment, as this may cause your hepatitis to worsen, which can be life-threatening.

? Talk to your doctorimmediatelyabout new or unusual symptoms after stopping treatment, particularly symptoms that 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible Adverse Effects: Inform a Doctor 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 due to previous infections may occur shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight infections that may have been present without obvious symptoms.

• There may also be autoimmune disorders, in which the immune system attacks the body's healthy tissues, after starting HIV medication. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms, such as:

• muscle weakness
• weakness that starts in the hands and feet and moves towards the trunk
• palpitations, tremors, or hyperactivity

If you notice any of these symptoms or any symptoms of inflammation or infection, inform your doctor immediately.

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• difficulty sleeping (insomnia)
• headache
• dizziness
• nausea (nausea)

Tests may also show:

• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
• increased levels of liver enzymes in the blood

Common Adverse Effects

(may affect up to 1 in 10 people)

• decreased appetite
• depression
• abnormal dreams
• sleep disorders
• depressed mood
• drowsiness (somnolence)
• fatigue
• stomach pain or discomfort
• vomiting (vomit)
• bloating
• dry mouth
• gas (flatulence)
• diarrhea
• rash

Tests may also show:

• low white blood cell count (a reduced number of white blood cells can make you more prone to infection)

• low platelet count (a type of blood cell involved in blood clotting)

• decreased hemoglobin in the blood
• increased levels of fatty acids (triglycerides), bilirubin, or lipase in the blood

Uncommon Adverse Effects

(may affect up to 1 in 100 people)

• signs or symptoms of inflammation or infection
• low red blood cell count (anemia)
• severe skin reactions, including rash accompanied by fever, swelling, and liver problems
• digestive problems that cause discomfort after meals
• swelling of the face, lips, tongue, or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)

If you consider any of the adverse effects you are experiencing to be serious, inform your doctor.

Other Effects that May be Observed During HIV Treatment

The frequency of the following adverse effects is unknown (the frequency cannot be estimated from the available data).

• Bone Problems. Some patients treated with combination antiretroviral medications like Odefsey may develop a bone disease called osteonecrosis(death of bone tissue due to a loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, drinking alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. The signs of osteonecrosis are:

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

If you notice any of these symptoms, inform your doctor.

During HIV treatment, there may be an increase in weight and glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Odefsey

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

Do not use this medicine after the expiration date that appears on the box and on the bottle after {CAD}. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Odefsey Composition

The active ingredients areemtricitabine, rilpivirine, and tenofovir alafenamide. Each Odefsey film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

The other ingredients are

Tablet core:

Croscarmellose sodium, lactose (in the form of monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.

Film coating:

Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), black iron oxide (E172).

Appearance of the Product and Package Contents

Odefsey is a gray, capsule-shaped, film-coated tablet, marked with "GSI" on one side and "255" on the other side. Odefsey is available in bottles of 30 tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that should be kept in the bottle to help protect the tablets. The silica gel desiccant is contained in a separate sachet or container and should not be swallowed.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

County Cork

Ireland

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: <{MM/AAAA}><{month AAAA}>.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.