50 mg / 25 mg film-coated tablets
dolutegravir / rilpivirine
What Juluca is and what it is used for
Juluca is a medicine that contains two active substances that are used to treat human immunodeficiency virus ( HIV ) infection: dolutegravir and rilpivirine. Dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI ) and rilpivirine belongs to a group of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Juluca is used to treat HIV in adults from the age of 18 who are taking other antiretroviral medicines and whose HIV- 1 infection has been under control for at least 6 months. Juluca replaces the antiretroviral medicines you are taking now.
Juluca keeps the amount of HIV – the virus in the body at a low level. It helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cell that is important for the body’s ability to fight infections.
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 as they may affect the way Juluca works:
- fampridine (also called dalfampridine; used for multiple sclerosis ).
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and to prevent seizures)
- rifampicin, rifapentine (medicines used to treat certain bacterial infections, such as tuberculosis )
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (medicines to prevent and treat stomach ulcers , heartburn or reflux disease )
- dexamethasone (a corticosteroid used in many conditions such as inflammation and allergic reactions) when taken orally or injected, with the exception of treatment as a single dose
- herbal medicines containing St. John’s wort ( Hypericum perforatum ) (used for mild depression and mild anxiety).
If you are taking any of the above medicines, ask your doctor for alternatives.
Warnings and cautions
Talk to your doctor or pharmacist before taking Juluca.
Allergy to reactions
Juluca contains dolutegravir. Dolutegravir can cause a severe allergic reaction, a so-called hypersensitivity reaction. You need to know the important signs and symptoms to be aware of while taking Juluca.
→ Read the information under “Allergic reactions” in section 4 of this leaflet.
Liver problems including hepatitis B and/or C
Tell your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may need to assess the severity of your liver disease before deciding if you can be treated with Juluca.
Pay attention to important symptoms
Some people take medicines for HIV – infection, other problems can be serious. These include:
- Symptoms of infection you and inflammation you
- joint pain, stiffness and skeletal problems.
You need to know the important signs and symptoms to be aware of while taking Juluca.
→ Read the ” Other possible side effect are ” in section 4 of this leaflet.
Protect others
HIV – infection is spread by sexual contact with an infected person, or by transfer of infected blood (e.g., by sharing needles). You can still transmit HIV infection when you take this medicine, even if the risk is reduced with effective antiretroviral therapy. Discuss with your doctor what steps you need to take to avoid infecting others.
Children and young people
This medicine is not intended for use in children or adolescents below 18 years of age as it has not been studied in these patients.
Other drugs and Juluca
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Juluca must not be taken with certain other medicines (see “Do not take Juluca” above in section 2).
Some medicines may affect the way Juluca works, or increase the risk of side effects. Juluca may also affect the way some other medicines work.
Tell your doctor if you are taking any of the medicines listed below :
- Metformin , for the treatment of diabetes .
- Drugs that can cause life-threatening irregular heartbeat ( torsade de pointes ) . As many different medicines can cause this condition, you should ask your doctor or pharmacist if you are unsure.
- Medicines called antacids and used for indigestion and heartburn . Do not take antacids for 6 hours before taking Juluca, or for the next 4 hours after taking Juluca (see also section 3, “How to take Juluca”).
- Calcium supplements, iron supplements and multivitamins should be taken at the same time as Juluca with meals. If you can not take these supplements at the same time as Juluca , do not take calcium supplements, iron supplements or multivitamins for 6 hours before taking Juluca, or for the next 4 hours after taking Juluca (see also section 3 “How to take Juluca” ).
- Drugs called H 2 -receptor antagonists (eg cimetidine, famotidine, nizatidine, ranitidine) to treat stomach ulcers or to relieve heartburn caused by reflux disease . Do not take these medicines for 12 hours before taking Juluca, or for the next 4 hours after taking Juluca (see also section 3, “How to take Juluca”).
- Any medicine to treat HIV – infection .
- Rifabutin, for the treatment of tuberculosis (TB) and other bacterial infections. If you take rifabutin, your doctor may give you another dose of rilpivirine to treat your HIV – infection (see section 3, “How to take Juluca”).
- Artemeter / lumefantrine used to prevent malaria .
- Clarithromycin and erythromycin, for the treatment of bacterial infections.
- Methadone , which is used to treat opioid addiction.
- Dabigatran etexilate, which is used to treat or prevent blood clots .
→ Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide that you need to have more check-ups.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby:
→ The use of Juluca is not recommended. Consult a doctor.
Taking Juluca at the time of conception or during the first six weeks of pregnancy can also increase the risk of a type of malformation called a neural tube defect, e.g. spina bifida (malformed spinal cord).
If you could get pregnant while getting Juluca:
→ Talk to your doctor and discuss whether you need to use contraception, such as condoms or pills.
Tell your doctor immediately if you become pregnant or are planning 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 unborn baby.
Breast-feeding
Women who are HIV -positive must not breastfeed because HIV – infection can be transferred to the baby through breast milk.
A small amount of the ingredient dolutegravir in Juluca may pass into your breast milk. It is not known if the other ingredient rilpivirine can pass into your breast milk.
If you are breast-feeding or considering starting breastfeeding:
→ Talk to your doctor immediately.
Driving and using machines
Juluca can make you dizzy, tired, or drowsy and cause other side effects that diminish your attention.
→ Do not drive or use machines unless you are sure you are affected by them.
Juluca contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Juluca
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose of Juluca is one tablet daily . Juluca must be taken with a meal . The meal is important for you to get the right level of medicine in your body. A protein-rich nutritional drink alone does not replace a meal.
- Do not chew, crush or divide the tablet, to ensure that the full dose is taken.
Rifabutin
Rifabutin, a drug used to treat certain bacterial infections, can reduce the amount of Juluca in the body so that it has a worse effect.
If you are taking rifabutin, your doctor may need to give you an extra dose of rilpivirine. Take the rilpivirine tablet while you are taking Juluca.
→ Talk to your doctor for more information about treatment with rifabutin with Juluca.
Antacids
Antacids, which are used for indigestion and heartburn, can prevent Juluca from being absorbed by the body and therefore have a worse effect.
Do not take antacids for 6 hours before taking Juluca, or for the next 4 hours after taking Juluca.
→ Talk to your doctor for further information about taking antacids with Juluca.
Calcium supplements, iron supplements, and multivitamins
Calcium and iron supplements or multivitamins can prevent Juluca from being absorbed by the body and therefore have a worse effect.
Calcium and iron supplements or multivitamins should be taken at the same time as Juluca. Juluca should be taken with a meal.
If you can not take these supplements at the same time as Juluca, do not take calcium – or iron supplements or multivitamins for 6 hours before taking Juluca, or for the next 4 hours after taking Juluca.
→ Talk to your doctor for more information on how to take calcium supplements, iron supplements, or multivitamins with Juluca.
H 2 -receptor antagonists (eg cimetidine, famotidine, nizatidine, ranitidine)
H 2 -receptor antagonists can prevent Juluca from being absorbed by the body and therefore have a worse effect.
Do not take such medicines for 12 hours before taking Juluca, or for the next 4 hours after taking Juluca.
→ Talk to your doctor for more information on how to take these medicines with Juluca.
If you take more Juluca than you should
If you have taken too many Juluca tablets, contact your doctor or pharmacist immediately. Show them if possible the Juluca packaging.
If you forget to take Juluca
If you notice that you have missed a dose within 12 hours from the time you usually take Juluca, you must take the tablet as soon as possible. You must take Juluca with a meal. Then take the next dose as usual. If you notice it later than after 12 hours, skip the missed dose and take the next dose as usual.
→ Do not take a double dose to make up for a forgotten dose.
If you vomit less than 4 hours after taking Juluca, take a new tablet with a meal. If you vomit more than 4 hours after taking Juluca, you do not need to take a new tablet until you take the next scheduled dose.
Do not stop taking Juluca without talking to your doctor
Take Juluca for as long as your doctor recommends. Do not stop unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Therefore, it is very important that you talk to your doctor if your health should change in any way.
Allergic reactions
Juluca contains dolutegravir. Dolutegravir can cause a severe allergic reaction called a hypersensitivity reaction. It is a less common (may affect up to 1 in 100 people) reaction in people taking raltegravir. If you get any of the following symptoms:
- rash
- high temperature ( fever )
- lack of energy ( weakness )
- swelling, sometimes in the face and mouth ( angioedema ), which causes difficulty breathing
- muscle or joint pain.
→ Seek medical attention immediately. Your doctor may decide to take samples to check your liver, kidneys, or blood and possibly to stop taking Juluca.
Very common side effects are
These can occur in more than 1 in 10 users :
- headache
- dizziness
- diarrhea
- nausea
- difficulty sleeping ( insomnia ).
Very common side effects that may show up in blood tests are:
- elevated liver enzyme values (aminotransferases)
- elevated cholesterol
- elevated pancreatic amylase (a digestive enzyme).
Common side effects are
These can occur in up to 1 in 10 users :
- loss of appetite
- rash
- itching ( pruritus )
- vomiting
- abdominal pain (abdominal pain ) or stomach upset
- gas production ( flatulence )
- drowsiness
- difficulty sleeping
- abnormal dreams
- lack of energy ( weakness )
- depression (deep sadness and feelings of inferiority)
- Depression
- anxiety
- dry mouth .
Common side effects that can show up in blood tests are:
- increased amount of enzymes produced in the muscles (creatine phosphokinase)
- decreased number of platelets involved in blood coagulation
- decreased white blood cell count
- decreased hemoglobin value
- increased content of triglycerides (a type of fat)
- increased content of lipase (an enzyme involved in fat breakdown)
- increased levels of bilirubin (a test of liver function) in the blood.
Uncommon side effects are
These can occur in up to 1 in 100 users :
- allergic reaction ( hypersensitivity ) (see “allergic reactions” earlier in this section)
- inflammation of the liver ( hepatitis )
- suicidal ideation and behavior (especially in patients with a history of depression or mental health problems)
- joint pain
- muscle pain.
Rare side effects are
These can occur in up to 1 in 1000 users :
- liver failure (signs include yellow skin and whites of the eyes or unusually dark-colored urine).
Has been reported
Occurs in an unknown number of users:
- signs or symptoms of inflammation or infection , such as fever, chills, sweating ( immune reactivation syndrome ).
Other possible side effects are
People taking combination therapy for HIV may experience other side effects.
Symptoms of infection you and inflammation you
People with advanced HIV – infection ( AIDS ) have weak immune systems, and the risk is greater that they have a serious infection ( opportunistic infection s ). Infectious symptoms can develop caused by old infections that flare up again when the body begins to fight them. The symptoms usually consist of fever and some of the following:
- headache
- abdominal pain
- breathing difficulties.
When the immune system becomes stronger, it can even in rare cases attack healthy body tissues ( autoimmune disease). Symptoms of autoimmune disease can develop several months after starting treatment for your HIV – infection. Symptoms may include:
- palpitations (rapid or irregular heartbeat) and tremors
- hyperactivity (excessive restlessness and movement)
- weakness that begins in the hands and feet and then moves towards the torso.
If you get symptoms of an infection or if you notice any of the symptoms mentioned above:
→ Tell your doctor immediately. Do not take other medicines for infection without your doctor’s recommendation.
Joint pain, stiffness, and bone problems
Some people who take combination therapy for HIV suffer from osteonecrosis. This means that parts of the skeletal tissue die because the blood supply to the skeleton decreases. People are at increased risk of developing this condition:
- if they have been taking the combination treatment for a long time
- if they are also taking anti-inflammatory medicines called corticosteroids s
- if they drink alcohol
- if their immune system is very weak
- if they are overweight.
Signs of osteonecrosis are:
- stiffness in the joints
- aches and pains in the joints (especially in the hips, knees or shoulders)
- difficulty moving.
If you get any of these symptoms:
→ Tell your doctor.
Effects on weight, blood fats, and blood sugar
During HIV treatment, weight gain and increased levels of blood fats and blood sugar may occur. This is partly related to restored health and lifestyle, but when it comes to blood fats, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
How to store Juluca
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 jar after “EXP”. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive. Keep the jar tightly closed. Do not remove the desiccant.
No special temperature instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are dolutegravir and rilpivirine. Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
- The other ingredients are mannitol (E421), magnesium stearate, microcrystalline cellulose, povidone (K29 / 32), sodium starch glycolate , sodium stearyl fumarate, lactose monohydrate , croscarmellose sodium, povidone (K30), polysorbate 17, titanium dioxide, microhydrolene cellulose macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).
- This medicine contains less than 1 mmol sodium (23 mg) per dose , which is essentially ‘sodium-free’.
What the medicine looks like and contents of the pack
Juluca film-coated tablets are pink, oval, biconvex tablets marked with SV J3T ”on one side.
The film-coated tablets are supplied in jars with child-resistant lids.
Each jar contains 30 film-coated tablets and a desiccant to reduce moisture. Once the jar has been opened, leave the desiccant in the jar, do not remove it.
There are also multi-packs of 90 film-coated tablets (3 packs of 30 film-coated tablets).
Not all pack sizes may be available in your country.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
Manufacturer
Glaxo Wellcome, SA
Avda. Extremadura, 3
09400 Aranda De Duero
Burgos
Spain
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