Juluca

Patient Information Leaflet

Juluca 50 mg/25 mg film-coated tablets

dolutegravir/rilpivirine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Juluca is and what it is used for

Juluca is a medicine that contains two active substances used in the treatment of human immunodeficiency virus (HIV) infection: dolutegravir and rilpivirine. Dolutegravir belongs to a group of antiretroviral medicines known as integrase inhibitors (Integrase Inhibitors, INI), and rilpivirine belongs to a group of antiretroviral medicines known as non-nucleoside reverse transcriptase inhibitors ( Non-Nucleoside Reverse Transcriptase Inhibitors , NNRTI ).
Juluca is used to treat HIV infection in adults aged 18 years and older who are taking other antiretroviral medicines and whose HIV-1 infection has been under control for at least 6 months. Juluca may replace current antiretroviral medicines.
Juluca keeps the amount of HIV virus in the body at low levels. This helps maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.

2. What you need to know before taking Juluca

Do not take Juluca

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

Do not take Juluca if you are taking any of the following medicines, because they may affect
the activity of Juluca:

• fampridine (also known as dalfampridine; used for multiple sclerosis)
• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and prevent seizures)
• rifampicin, rifapentine (medicines used to treat certain bacterial infections such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (medicines used to prevent and treat gastric ulcers, heartburn, or acid reflux disease)
• dexamethasone (a corticosteroid used in many clinical conditions such as inflammation and allergic reactions) if taken by mouth or by injection, except for a single treatment dose
• products containing St. John’s wort ( Hypericum perforatum ) (a herbal remedy used for depression).

If you are taking any of these medicines listed above, consult your doctor for alternatives.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Allergic reactions
Juluca contains dolutegravir. Dolutegravir may cause a serious allergic reaction known as hypersensitivity reaction. You need to be aware of these important signs and symptoms so that you can recognize them while taking Juluca.
→ Read the information in 'Allergic reactions' in section 4 of this leaflet.
Liver problems including hepatitis B and/or C
Consult your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may assess the severity of liver disease before deciding whether you can take this medicine.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions which may be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness and bone problems. You need to be aware of these important signs and symptoms so that you can recognize them while taking Juluca. → Read the information in the section ‘Other possible side effects’ in section 4 of this leaflet.

Children and adolescents
This medicine is not intended for children or adolescents under 18 years of age, as it has not been studied in such patients.
Other medicines and Juluca
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Juluca must not be taken with certain medicines (see 'Do not take Juluca' at the beginning of section 2).
Some medicines may affect the activity of Juluca or make it more likely that you experience side effects. Juluca may in turn affect the activity of other medicines.
Tell your doctor if you are taking any of the medicines included in the following list :

• metformin to treat diabetes
• medicines that may cause a life-threatening irregular heartbeat ( Torsades de pointes ). Since several different medicines may cause this condition, consult your doctor or pharmacist if you are unsure
• medicines called antacids used to treat indigestion and heartburn . Do not take an antacid within 6 hours before taking Juluca or for at least 4 hours after taking it (also see section 3 ‘How to take Juluca’)
• calcium supplements , iron supplements , and multivitamins should be taken at the same time as Juluca with a meal. If you cannot take these supplements at the same time as Juluca, do not take a calcium supplement, an iron supplement or a multivitamin within 6 hours before taking Juluca or for at least 4 hours after taking it (also see section 3 ‘How to take Juluca’)
• medicines called H\2-receptor antagonists (for example, cimetidine, famotidine, nizatidine, ranitidine) used to treat gastric or intestinal ulcers or to relieve heartburn due to gastric acid reflux . Do not take these medicines within 12 hours before taking Juluca or for at least 4 hours after taking it (also see section 3 ‘How to take Juluca’)
• any medicine to treat HIV infection
• rifabutin to treat tuberculosis (TB) and other bacterial infections. If you are taking rifabutin, your doctor may need to give you an additional dose of rilpivirine to treat HIV infection (see section 3, ‘How to take Juluca’)
• artemether/lumefantrine used to prevent malaria
• clarithromycin and erythromycin to treat bacterial infections
• methadone used to treat opioid dependence
• dabigatran etexilate used to treat or prevent blood clotting. → Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide that you need additional monitoring.

Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby:
→ Juluca is not recommended. Consult your doctor for advice.
Inform your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will review your treatment. Do not stop taking Juluca without consulting your doctor, as this could harm you and your unborn child.
Breast-feeding
Breast-feeding is not recommended for HIV-positive women because HIV infection can be transmitted to the child through breast milk.
A small amount of the component dolutegravir in Juluca may pass into breast milk. It is not known whether the other component, rilpivirine, can pass into breast milk.
If you are breast-feeding or considering breast-feeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Juluca may cause dizziness, fatigue or drowsiness and other side effects that may reduce alertness.
→ Do not drive or operate machinery if you are not sure you are unaffected.
Juluca contains lactose
If you have been told by your doctor that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.

3. How to take Juluca

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• The recommended dose of Juluca is one tablet once daily. Juluca must be taken with a meal. A meal is important to maintain adequate levels of the medicine in the body. A protein-rich nutritional drink alone does not replace a meal.
• Do not chew, crush, or split the tablet to ensure the entire dose is taken.

Rifabutin
Rifabutin, a medicine used to treat certain bacterial infections, may reduce the amount of Juluca in the body and make it less effective.
If you are taking rifabutin, your doctor may need to give you an additional tablet of rilpivirine. Take the rilpivirine tablet at the same time as you take Juluca.
→ Talk to your doctor for further advice on taking rifabutin with Juluca.

Antacids
Antacids used to treat indigestion and heartburn may interfere with the absorption of Juluca into the body and reduce its effectiveness.
Do not take an antacid within 6 hours before or at least 4 hours after taking Juluca.
→ Talk to your doctor for further advice on taking antacids or other acid-reducing medicines with Juluca.

Calcium supplements, iron supplements, or multivitamins
Calcium supplements, iron supplements, or multivitamins may interfere with the absorption of Juluca into the body and reduce its effectiveness.
Calcium supplements, iron supplements, or multivitamins should be taken at the same time as Juluca. Juluca must be taken with a meal.
If you cannot take these supplements at the same time as Juluca, do not take calcium supplements, iron supplements, or multivitamins within 6 hours before or at least 4 hours after taking Juluca.
→ Talk to your doctor for further advice on taking calcium supplements, iron supplements, or multivitamins with Juluca.

H2-receptor antagonists (e.g., cimetidine, famotidine, nizatidine, ranitidine)
H2-receptor antagonist medicines may interfere with the absorption of Juluca into the body and reduce its effectiveness. Do not take these medicines within 12 hours before or at least 4 hours after taking Juluca.
→ Talk to your doctor for further advice on taking these medicines with Juluca.

If you take more Juluca than you should
If you take too many Juluca tablets, contact your doctor or pharmacist immediately. If possible, show them the Juluca packaging.

If you forget to take Juluca
If you remember within 12 hours of your usual dosing time, take the missed tablet as soon as possible. The Juluca tablet must be taken with a meal. Then take your next dose at the usual time. If you remember more than 12 hours after your usual dosing time, skip the missed dose and take the next dose at the usual time.
→ Do not take a double dose to make up for a missed dose.
If you vomit within 4 hours after 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 your next scheduled dose.

Do not stop taking Juluca without consulting your doctor
Take this medicine for the entire duration prescribed by your doctor. Do not stop treatment unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Therefore, it is very important to inform your doctor about any changes in your health status.

Allergic reactions
Juluca contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in individuals taking dolutegravir. If you experience any of the following symptoms:

• skin rash
• high temperature (fever)
• lack of energy (fatigue)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• muscle or joint pain
  → Contact your doctor immediately. Your doctor may decide to carry out tests to monitor your liver, kidneys, or blood and may instruct you to stop taking Juluca.

Very common side effects
These may affect more than 1 in 10 people:

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

Very common side effects that may be detected by blood tests include:

• increased levels of liver enzymes (aminotransferases)
• increased cholesterol
• increased pancreatic amylase (an enzyme involved in digestion).

Common side effects
These may affect up to 1 in 10 people:

• loss of appetite
• skin rash
• itching
• vomiting
• stomach or abdominal pain or discomfort
• weight gain
• flatulence
• drowsiness
• sleep disorders
• abnormal dreams
• lack of energy (fatigue)
• depression (feeling deeply sad and worthless)
• depressed mood
• anxiety
• dry mouth

Common side effects that may be detected by blood tests include:

• increased levels of muscle enzymes (creatine phosphokinase)
• decreased platelet count (cells involved in blood clotting)
• low white blood cell count
• decreased haemoglobin
• increased triglycerides (a type of fat)
• increased lipase (an enzyme involved in fat digestion)
• increased blood bilirubin (a liver function test).

Uncommon side effects
These may affect up to 1 in 100 people:

• allergic reaction (hypersensitivity) (see ‘Allergic reactions’ at the beginning of this section)
• inflammation of the liver (hepatitis)
• suicidal thoughts and behaviour (particularly in patients who have previously had depression or mental health problems)
• panic attack
• joint pain
• muscle pain.

Rare side effects
These may affect up to 1 in 1,000 people:

• liver failure (signs may include yellowing of the skin and whites of the eyes, or unusually dark urine)
• suicide (particularly in patients who have previously had depression or mental health problems)
  → Inform your doctor immediately if you experience any mental health problems (see also other mental health issues listed above).

Not known
Frequency cannot be estimated from the available data:

• signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome).

Other possible side effects
People who take combination therapy for HIV may experience 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). Symptoms of infection may appear, caused by previously "silent" infections that re-emerge as the body starts fighting them. Symptoms generally include fever, together with:

• headache
• stomach pain
• difficulty breathing

In rare cases, as the immune system strengthens, it may also attack healthy tissues in the body (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting treatment for HIV infection. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive agitation and movement)
• weakness starting in the hands and feet and spreading to the trunk of the body.

If you experience any symptoms of infection or notice any of the symptoms listed above:
→ Inform your doctor immediately. Do not take any other medicines for infection without first consulting your doctor.

Joint pain, stiffness, and bone problems
Some people taking combination therapy for HIV infection develop a condition called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bones. People may be more likely to develop this condition if they:

• have been taking combination therapy for a long time
• are also taking anti-inflammatory medicines called corticosteroids
• consume alcoholic beverages
• have a very weak immune system
• are overweight.

Signs of osteonecrosis include:

• stiffness in the joints
• joint pain or discomfort (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, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to improved health status and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Juluca

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp". The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from moisture. Keep the bottle tightly closed.
Do not remove the desiccant.
This medicine does not require any special storage temperature conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Juluca contains

• The active substances 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), sodium starch glycolate, sodium stearyl fumarate, lactose monohydrate, croscarmellose sodium, povidone (K30), polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172). See section 2, ‘Do not take Juluca’ and ‘Juluca contains lactose’.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is essentially "sodium-free".

Description of the appearance of Juluca and contents of the pack
Juluca film-coated tablets are pink, biconvex, oval tablets, with the code ‘SV J3T’ engraved on one side.
The film-coated tablets are supplied in bottles with child-resistant closures.
Each bottle contains 30 film-coated tablets and a desiccant to reduce moisture. After opening the bottle, keep the desiccant in the bottle and do not remove it.
Multiple packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands

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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0)10 85 65 00 Tel: +370 80000334

България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0)10 85 65 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf.: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0) 332081199
[email protected]

Norge
Eesti GlaxoSmithKline AS
ViiV Healthcare BV Tlf: + 47 22 70 20 00
Tel: +372 8002640

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIV HIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
ViiV Healthcare BV ViiV Healthcare BV
Tel: +371 80205045 Tel: + 44 (0)800 221441
[email protected]

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