Product Information for the Patient

Juluca 50 mg/25 mg Film-Coated Tablets

dolutegravir/rilpivirina

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• Consult your doctor or pharmacist if you experience any side effects,including those not listed in this product information. See section 4.

Juluca is a medication that contains two active ingredients used to treat infection by the human immunodeficiency virus (HIV-1): dolutegravir and rilpivirine. Dolutegravir belongs to a group of medicationscalled antiretrovirals known as integrase inhibitors (INI)and rilpivirine belongs to a group of antiretroviral medications called non-nucleoside reverse transcriptase inhibitors (ITINN).

Juluca is used to treat HIV-1 infectionin adults aged 18 years and older who are taking other antiretrovirals and whose HIV-1 infection is under control sinceat least6 months. Juluca may replace current antiretroviral medications.

Juluca maintains the level of HIV-1 virus in the body at a low level. This helps to maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important for helping your body to fight off infections.

Do not take Juluca:

• if you are allergic to dolutegravir or rilpivirina or to any of the other ingredients of this medicine (listed in section 6).

Do not take Juluca if you are taking any of the following medicinesas they may affectthe way Juluca works:

• fampridina (also known as dalfampridina; used to treat multiple sclerosis)
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent seizures)
• rifampicin, rifapentine (medicines to treat some bacterial infections, such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (medicines used to prevent and treat stomach ulcers,heartburnor reflux)
• dexamethasone (a corticosteroid used in many conditions such as inflammation and allergic reactions) when taken by mouth or injection, except as a single dose treatment
• products containing St. John's Wort (Hypericum perforatum) (a plant used for depression).

If you are taking any of the above, consult your doctor about alternatives.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Allergic reactions

Juluca contains dolutegravir. Dolutegravir may cause a severe allergic reaction known as hypersensitivity reaction. You need to know the important signs and symptoms to look out for while taking Juluca.

• Read the informationon “Allergic reactions” in section 4 of this leaflet.

Liver problems including hepatitis B and/or C

Inform your doctor if you have or have hadliver problems, including hepatitis B and/or C. Your doctor will assess the severity of your liver disease before deciding if you can take this medicine.

Be aware of the important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

You need to know the important signs and symptoms to look out for while taking Juluca.

• Read the information on “Other possible side effects” in section 4 of this leaflet.

Children and adolescents

This medicine should not be used in children or adolescents under 18 years, as it has not been studied in these patients.

Other medicines and Juluca

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

Julucashould not be takenwith some other medicines (see“Do not take Juluca” in section 2):

Some medicines may affect the way Juluca works, orincrease the risk of side effects. Juluca may also affect the way some other medicines work.

Inform your doctorif you are taking any of the following medicines:

• metformin, to treatdiabetes
• medicines that may cause potentially fatal irregular heartbeats (Torsade de Pointes).Since there are several medicines that may cause this, you should ask your doctor or pharmacist if you are unsure
• medicines calledantacids, to treatindigestionandheartburn.Do not take an antacidfor at least 6 hours before taking Juluca, or at least 4 hours after taking it (see also section 3“How to take Juluca”)
• calcium supplements, iron supplements and multivitamin preparationsshould be taken at the same time as Juluca with a meal. If you cannot take them at the same time as Juluca,do not take a calcium supplement,iron supplementor multivitamin preparationfor at least 6 hours before taking Juluca or at least 4 hours after taking it (see also section 3“How to take Juluca”)
• medicines calledhistamine H2 receptor antagonists(e.g.cimetidine, famotidine, nizatidine, ranitidine)to treat stomach or intestinal ulcers or used torelieve heartburndue to reflux.Do not take these medicinesfor at least 12 hours before taking Juluca or at least 4 hours after taking it (see also section 3“How to take Juluca”)
• any medicine to treat HIV infection
• rifabutin to treat tuberculosis (TB) and otherbacterial infections.If you are taking rifabutin, your doctor may need to give you an additional dose of rilpivirina to treat HIV infection (see section 3“How to take Juluca”)
• artemether/lumefantrine to preventmalaria
• clarithromycin and erythromycin, to treatbacterial infections
• methadone, to treat opioid dependence
• dabigatran etexilate, used to treat or preventblood clots.

• Inform your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide that you need additional check-ups.

Pregnancy

If you are pregnant,think you may be pregnantor intend to become pregnant:

Juluca is not recommended for use.Consult your doctorfor advice.

Inform your doctor immediately if you become pregnant or intend to become pregnant. Your doctor will review your treatment. Do not stop taking Juluca without consulting your doctor, as this may harm you and your baby.

Breastfeeding

Juluca is not recommendedfor women with HIV as the infection can be transmitted to the baby through breast milk.

A small amount of the component, dolutegravir, in Juluca may pass into breast milk. It is unknown if the other component, rilpivirina, may pass into breast milk.

If you are breastfeeding, or think you may be breastfeeding,you should consult your doctor as soon as possible.

Driving and using machines

Julucamay make you feel dizzy, tired or drowsy and have other side effectsthat make you less alert.

• Do not drive or operate machinery unless you are sure it will not affect you.

Juluca contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose of Juluca isone tablet once a day.Julucamust be taken with a meal.It is essential to take it with food to achieve the appropriate medication levels in the body. A nutritional drink with a high protein content alone does not substitute a meal.
• Do not chew, crush, or break the tablet to ensure you take the complete dose.

Rifabutina

Rifabutina, a medication to treat some bacterial infections, may decrease the amount of Juluca in the body and make it less effective.

If you take rifabutina, your doctor may need to give you an additional dose of rilpivirina. Take the rilpivirina tablet at the same time as you take Juluca.

• Consult with your doctor to inform you about taking rifabutina with Juluca.

Antacids

Antacids, used to treat indigestion and stomach heartburn, may interrupt the absorption of Juluca in the body and make it less effective.

Do not take an antacid during the 6 hours before taking Juluca, or at least 4 hours after taking it.

• Consult with your doctor to inform you about taking antacids with Juluca.

Calcium supplements, iron supplements, or multivitamin preparations

Calcium supplements, iron supplements, or multivitamin preparations may interrupt the absorption of Juluca in the body and make it less effective.

Calcium or iron supplements, or multivitamin preparations should be taken at the same time as Juluca. Juluca should be taken with a meal.

If you cannot take these supplements at the same time as Juluca, do not take calcium, iron, or multivitamin supplements during the 6 hours before taking Juluca, or at least 4 hours after taking it.

• Consult with your doctor to inform you about taking calcium, iron, or multivitamin supplements with Juluca.

Antagonists of H2 receptors (e.g., cimetidina, famotidina, nizatidina, ranitidina)

Medications that are antagonists of H2 receptors may interrupt the absorption of Julucain the bodyand make it less effective. Do not take these medications during the 12 hours before taking Juluca, or at least 4 hours after taking it.

• Consult with your doctor to inform you about taking these medications with Juluca.

If you take more Juluca than you should

If you exceed the number of Juluca tablets,contact your doctor or pharmacist immediately. If possible, show them the Juluca packaging.

If you forget to take Juluca

If you realize you have forgotten a dose before 12 hours have passed since your usual Juluca-taking time, take it as soon as possible. The Juluca tablet should be taken with a meal, and then take the next one at your usual time. If more than 12 hours have passed since your usual Juluca-taking time, skip the missed dose and then take the next one at your usual time.

• Do not take a double doseto compensate for the missed doses.

If you vomit before 4 hours have passed since taking Juluca, take another tablet with a meal. If you vomit more than 4 hours after taking Juluca, you do not need to take another tablet until the next dose.

Do not interrupt treatment with Juluca

Takethis medicationuntil your doctor tells you to. Do not stop taking it unless your doctor tells you to.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.Therefore, it is very important that you inform your doctor of any change in your health.

Allergic reactions

Juluca contains dolutegravir. Dolutegravir can cause a severe allergic reaction known ashypersensitivity reaction. This is a rare reaction (can affect up to 1 in 100 people) that takes dolutegravir. If you have any of the following symptoms:

• Go to a doctor immediately.Your doctor may consider it necessary to perform tests to control your liver, kidneys, or blood and may tell you to stop taking Juluca.

Very common side effects

These can affectmore than 1 in 10people:

Very common side effects that can appear in your blood tests are:

• increase in liver enzymes (transaminases)
• increase in cholesterol
• increase in pancreatic amylase (a digestive enzyme).

Common side effects

These can affectup to 1 in 10people:

Common side effects that can appear in your blood tests are:

• increase in muscle enzymes (creatine phosphokinase)
• decrease in platelet count (involved in blood clotting)
• decreased white blood cell count
• decrease in hemoglobin
• increase in triglycerides (a type of fat)
• increase in lipase (an enzyme involved in fat digestion)
• increase in bilirubin (liver function test) in your blood.

Uncommon side effects

These can affectup to 1 in 100 people:

Rare side effects

These can affectup to 1 in 10,000 people:

• liver failure (signs may include yellowing of the skin and eyes or dark urine)
• suicide (especially in patients who have previously had depression or mental health problems).

• Inform your doctor immediatelyif you experience any mental health problems (see also other mental health problems that appear above)

Side effects of unknown frequency

The frequency cannot be estimated from the available data:

• signs or symptoms of inflammation or infection, such as fever, chills, sweating (immune reactivation syndrome).

Other possible side effects

People taking combination therapy for HIV may have other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). They may develop symptoms of infection, caused by old and hidden infections that become active when the body fights them. The symptoms usually includefever, as well as some of the following:

In rare cases, as the immune systembecomes stronger, it may also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders may appear many monthsafterstarting to take HIV medicines. The symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness that begins in the hands and feet and ascends to the body trunk.

If you have any symptoms of infectionor if you notice any of the above symptoms:

• Consult your doctor immediately. Do not take other medicines for the infection without consulting your doctor first.

Joint pain, stiffness, and bone problems

Some people taking combination therapy for HIV developosteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones. People may be more prone to this condition:

• if they have taken combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systemis severely weakened
• if they are overweight.

The signs of osteonecrosis include:

• joint stiffness
• joint pain (especially in the hip, knee, or shoulder)
• difficulty moving.

If you notice any of these symptoms:

• Inform your doctor.

Effects on weight, lipids, and blood glucose

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

Reporting side effects

If you experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and 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 perfectly closed. Do not remove the desiccant.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Juluca

• The active ingredients are dolutegravir and rilpivirine. Each tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir and rilpivirine hydrochloride equivalent to 25 mg of rilpivirine.
• The other components are mannitol (E421), magnesium stearate, microcrystalline cellulose, povidone (K29/32),carboxymethylcellulose sodium, stearic acid and sodium, lactose monohydrate, croscarmellose sodium, povidone (K30), polysorbate 20, microcrystalline cellulose silicified,partially hydrolyzed polyvinyl alcohol,titania dioxide (E171),macrogol,talco,yellow iron oxide (E172),red iron oxide (E172).See "Do not take Juluca" and "Juluca contains lactose" in section 2.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

Appearance of the product and contents of the pack

Juluca film-coated tablets are pink, oval, biconvex, and engraved with “SV J3T” on one side.

Film-coated tablets are presented in child-resistant containers.

Each container contains 30 film-coated tablets and a desiccant to reduce humidity. Once the container has been opened, keep the desiccant in it, do not remove it.

Multiple pack sizes are also available with 90 film-coated tablets (3 packs of 30 film-coated tablets).

Only some pack sizes may be marketed.

Marketing authorization holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands

Responsible for manufacturing

Glaxo Wellcome, S.A.
Avda. Extremadura, 3
09400 Aranda de Duero
Burgos
Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.