Product Information for the Patient

Tivicay 10mg Film-Coated Tablets

Tivicay 25mg Film-Coated Tablets

Tivicay 50mg Film-Coated Tablets

dolutegravir

Read this entire product information carefully before starting to take this medicine(or your child, if the patient), because 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(or your child, if the patient), and should not be given to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this product information. See section 4.

1.What isTivicayand for what it is used

2.What you need to knowbefore starting to takeTivicay

3.How to takeTivicay

4.Possible adverse effects

1. Storage ofTivicay

6.Contents of the package and additional information

Tivicay contains dolutegravir as its active ingredient. Dolutegravir belongs to a group of antiretroviral medications calledintegrase inhibitors (INIs).

Tivicay is used to treathuman immunodeficiency virus (HIV) infection(HIV) in adults, adolescents, and children at least 6 years old and weighing at least 14 kg.

Tivicay does not cure HIV infection; it reduces the amount of virus in the body and keeps it at a low level. As a result, it also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important for helping the body fight off infections.

Not everyone responds to Tivicay treatment in the same way. Your doctor will monitor the effectiveness of your treatment.

Tivicay is always used in combination with other antiretroviral medications (combination therapy). To control your HIV infection and to prevent your condition from worsening, you must continue taking all your medications, unless your doctor has instructed you to stop taking one of them.

Do not take Tivicay:

• if you (or your child, if the patient) are allergic to dolutegravir or any of the other components of this medication (listed in section 6)

• if you (or your child, if the patient) are taking another medication called fampridina (also known as dalfampridina; used to treat multiple sclerosis)

• If you think this applies (or to your child), consult your doctor.

Warnings and precautions

Be aware of important symptoms

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

You need to know what important signs and symptoms to be aware of while taking Tivicay.

• Read the information in section 4 of this prospectus.

Children

Do not give this medication to children under 6 years of age, weighing less than 14 kg, or with HIV infection resistant to other similar medications to Tivicay. The use of Tivicay film-coated tablets in children under 6 years of age or weighing less than 14 kg has not yet been studied.

Children mustattend scheduled medical appointments(see “Use in children and adolescents” in section 3 for more information).

Other medications and Tivicay

Inform your doctor if you (or your child, if the patient) are taking, have taken recently, or may need to take any other medication.

Do not take Tivicay with the following medication:

• fampridina (also known as dalfampridina), used to treat multiple sclerosis.

Some medications may affect the functioning of Tivicay, orincrease the likelihood of adverse effects. Tivicay may also affect the functioning of some other medications.

Inform your doctorif you (or your child) are taking any of the following medications:

• metformin, to treat diabetes
• medications calledantacids, to treat indigestion and heartburn.Do not take an antacidat least 6 hours before taking Tivicay, or at least 2 hours after taking it (see also section 3).
• calcium supplements, iron supplements, and multivitamin preparations.Do not take a calcium supplement, iron supplementor multivitamin preparationat least 6 hours before taking Tivicay, or at least 2 hours after taking it (see also section 3).
• supplements or multivitamin preparations containing calcium, iron, or magnesium.If you take Tivicay with food, you can take supplements or multivitamin preparations containing calcium, iron, or magnesium at the same time as Tivicay.If you do not take Tivicay with food, do not take a supplement or multivitamin preparation containing calcium, iron, or magnesiumat least 6 hours before taking Tivicay, or at least 2 hours after taking it (see also section 3)
• etravirina, efavirenz, fosamprenavir/ritonavir, nevirapina, or tipranavir/ritonavir, to treat HIV infection
• rifampicina, to treat tuberculosis (TB) and other bacterial infections
• phenytoin and phenobarbital, to treat epilepsy
• oxcarbazepina and carbamazepina, to treat epilepsy or bipolar disorder
• St. John's Wort(Hypericum perforatum), a plant-based medication to treat depression.

• Inform your doctor or pharmacistif you (or your child) are taking any of these medications. Your doctor may decide to adjust your dose or that you need additional checks.

Pregnancy

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

_Consult your doctorabout the risks and benefits of takingTivicay

Inform your doctor immediately if you become pregnant or intend to become pregnant. Your doctor will review your treatment. Do not interrupt treatment with Tivicay without consulting your doctor, as this could harm you and your fetus.

Breastfeeding

It is not recommendedthat women with HIV infection breastfeed, as the infection can be transmitted to the baby through breast milk.

A small amountofthe components of Tivicay may pass into breast milk.

If you are breastfeeding or plan to breastfeed,you must consult your doctor as soon as possible.

Driving and operating machinery

Tivicay may make you feel dizzy and have other adverse effectsthat reduce your attention.

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

Tivicay contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

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 is 50mgonce a day.
• If you are also takingother medications, the dose is 50 mgtwice a day.
• For HIV resistantto other similar medications to Tivicay, the recommended dose is 50 mg,twice a day.

Your doctor will decide what is the correct dose of Tivicay for you.

Swallow the/ the tablets with a little liquid.

Tivicay can be takenwith or without food. When taking Tivicay twice a day, your doctor may advise you to take it with food.

Tivicay is also available indisintegrating tablets. Film-coated tablets and disintegrating tabletsare not the same, therefore, do not switch between film-coated tablets and disintegrating tablets without consulting your doctor first.

Use in childrenand adolescents

• The pediatric doseof Tivicay should be adjusted as they grow or gain weight.

• Therefore, it is essential that childrenattend scheduled medical appointmentsprogrammed.

• Children and adolescents weighing at least 20 kg can take the adult dose of 50 mg, once a day or 25 mg twice a day. Your doctor will decide how Tivicay should be administered.
• Your doctor will decide the correct dose of Tivicay for children between 6 and 12 years old, depending on the child's weight.
• To reduce the risk of choking, childrenshould not swallow more than one tablet at a time.
• Tivicayshould notbe used in children and adolescents withHIV resistantto other similar medications to Tivicay.

Antacids

Antacids, used to treatindigestionandheartburnofstomach, may interrupt the absorption of Tivicay in your body and make it less effective.

Do not take an antacidwithin 6 hours before taking Tivicay, or at least 2 hours after taking it. Other medications that reduce acidity, such as ranitidine and omeprazole, can be taken at the same time as Tivicay.

• Consult your doctor to advise you on which antacids you can take with Tivicay.

Supplements or multivitamin preparations containing calcium, iron, or magnesium

Supplements or multivitamin preparations containing calcium, iron, or magnesium may interrupt the absorption of Tivicay in your body and make it less effective.

If you take Tivicay with food, you can take supplements or multivitamin preparations containing calcium, iron, or magnesium at the same time as Tivicay.If you do not take Tivicay with food, do not take a supplement or multivitamin preparation containing calcium, iron, or magnesiumwithin 6 hours before taking Tivicay, or at least 2 hours after taking it.

• Consult your doctor to advise you on how to take supplements or multivitamin preparations containing calcium, iron, or magnesium with Tivicay.

If you take more Tivicay than you should

If you (or your child) exceed the number of Tivicay tablets,contact your doctor or pharmacist for advice. If possible, show them the Tivicay box.

If you forget to take Tivicay

If you (or your child) forget a dose, take it as soon as you remember. But if there are less than 4 hours until your next dose, skip the dose you forgot and take the next one at the usual time. Then continue your treatment as before.

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

Do not interrupt Tivicay treatment

Take Tivicay until your doctor tells you to. Do not stop taking it unless your doctor advises you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions

These are rare in people taking Tivicay. The signs include:

• Seek medical attention immediately.Your doctor may decide to perform liver, kidney or blood tests and may tell you to stop taking Tivicay.

Very common side effects

Thesecan affectmore than 1 in 10people:

Common side effects

Thesecan affectup to 1 in 10people:

Uncommon side effects

These may affectup to 1 in 100 people:

• • inflammation of the liver (hepatitis)
  • suicidal attempt*
  • suicidal thoughts*
  • anxiety crisis
  • joint pain
  • muscle pain.
• *especially in patients who have previously had depression or mental health problems.

Rare side effects

Thesecan affectup to 1 in 1,000 people:

• liver failure (the signs may include yellowing of the skin and eyes or dark-colored urine)
• increase in bilirubin (liver function test) in the blood
• 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 listed above).

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). These infections may have developed "silently", not being detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and can fight these infections,which can cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

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

If you (or your child) experience any symptoms of infection and inflammationor if you notice any of the above symptoms:

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

Joint pain, stiffness and bone problems

Some people taking combined HIV treatment 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 been taking combined treatment for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is very weakened
• if they are overweight.

The signs of osteonecrosis include:

• stiffness in the joints
• 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 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 doctor or pharmacist, evenif it ispossibleside effects that do not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. 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 box and bottle after CAD.

Tivicay 10mg film-coated tablets

Store in the original packaging to protect it from moisture. Keep the bottle tightly closed. Do not discard the desiccant. Do not ingest the desiccant.This medication does not require any special storage temperature.

Tivicay 25mg and 50mg film-coated tablets

This medication does not require special storage conditions.

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

Composition of Tivicay

• The active ingredient is dolutegravir. Each tablet containsdolutegravir sodium equivalent to 10mg, 25mg or 50mg of dolutegravir.
• The other components are mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethylcellulose, sodium stearate fumarate,partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, and for the 25mg and 50mg tablets, yellow iron oxide (E172).

Appearance of the product and contents of the pack

The film-coated tablets of Tivicay 10mg are white, round, biconvex, engraved with “SV572”on one side and “10” on the other. The bottle contains a desiccant to reduce humidity. Once opened, keep the desiccant in the bottle, do not discard.

The film-coated tablets of Tivicay 25mg are pale yellow, round, biconvex, engraved with “SV572”on one side and “25” on the other.

The film-coated tablets of Tivicay 50mg are yellow, round, biconvex, engraved with “SV572”on one side and “50”on the other.

The film-coated tablets are supplied inbottles containing 30 or 90 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

or

Delpharm Poznan Spólka Akcyjna, Grunwaldzka 189, 60-322 Poznan, Poland.

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

Date of the last revision of this leaflet: {month} {year}.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.