Label: information for the patient

Tivicay 5 mg dispersible tablets

dolutegravir

Read this label carefully before starting to take this medicine (or your child, if the patient), because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Additionally, step-by-step usage instructions are provided.

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 4 weeks old and weighing at least 3 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:

• symptoms of infections and inflammation
• joint pain, stiffness, and bone problems.

You need to know what important signs and symptoms to be aware of while taking (or your child, if the patient) Tivicay.

• Read the information in section 4 of this prospectus.

Children

Do not give this medication to children under 4 weeks of age, weighing less than 3 kg, or with HIV infection resistant to other similar medications to Tivicay. The use of Tivicay tablets in children under 4 weeks or weighing less than 3 kg has not yet been studied.

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

Other medications and Tivicay

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

Do not take Tivicaywith the following medication:

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

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

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

• metformin, to treatdiabetes.
• medications calledantacids, to treatindigestionandheartburnof the stomach.Do not take an antacidwithin 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 may 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 hoursbefore taking Tivicay, or at least 2 hours after taking it (see also section 3)
• etravirina, efavirenz, fosamprenavir/ritonavir, nevirapina, or tipranavir/ritonavir, to treatHIV infection.
• rifampicina, to treat tuberculosis (TB) and otherbacterial infections.
• phenytoin and phenobarbital, to treatepilepsy.
• oxcarbazepina and carbamazepina, to treatepilepsyorbipolar disorder.
• St. John's Wort(Hypericum perforatum), a plant-based medication to treatdepression.

• Inform your doctor or pharmacistif you are taking (or your child) 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 pregnant, or intend to become pregnant:

• Consult your doctorabout the risks and benefits of taking Tivicay.

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 amount of the 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 effects that 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.

Adults

• The recommended dose in adults is 30 mg (taken as six dispersible tablets of 5 mg)once a day.
• If you are also takingother medications, the dose is 30 mg (taken as six dispersible tablets of 5 mg)twice a day.
• For HIV resistantto other similar medications to Tivicay, the recommended dose is 30 mg (taken as six dispersible tablets of 5 mg)twice a day.

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

Children and adolescents

• The infant doseof Tivicay should be adjusted as they grow or increase in weight.

• Therefore, it is essential that children attend scheduled medical appointments.

• Children and adolescents weighing at least 20 kg can take the adult dose of 30 mg, once a day or 15 mg twice a day. Your doctor will decide how Tivicay should be administered.
• For children of at least 4 weeks and weighing between 3 and 20 kg, your doctor will decide the correct dose of Tivicay, depending on the weight and age of your child.
• If they swallow the whole tablets with water, childrenshould not swallow more than one tablet at a time,to reduce the risk of choking.
• Tivicayshould notbe used in children and adolescents withHIV resistantto other similar medications to Tivicay.

How to take the dispersible tablets

• The dispersible tablets can be dispersed in water or swallowed whole with water. When dispersed, the amount of water will depend on the number of tablets prescribed. The tablets must be dispersed completely before swallowing.

Consult the usage instructionsregarding how to disperse and administer the tablets using the dosing cup and oral syringe provided in this package.

• Do not chew, cut or crush the tablets.
• 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 infilm-coated tablets. Film-coated tablets and dispersible tablets are not the same, therefore,do not changebetween film-coated tablets and dispersible tablets without consulting your doctor first.

Antacids

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

Do not take an antacidwithin 6 hours of 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 preparationscontaining calcium, iron, or magnesiummay interrupt the absorption of Tivicay in your body and make it less effective.

Take Tivicay with food, you can take supplements or multivitamin preparations containing calcium, iron, or magnesium at the same time as Tivicay.Do not take a supplement or multivitamin preparation containing calcium, iron, or magnesiumwithin 6 hours of 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 package.

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 missed dose 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 treatment with Tivicay

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:

• skin rash
• a high temperature (fever)
• lack of energy (fatigue)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• muscle or joint pain.

• 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

These may affectmore than 1 in 10 people:

• headache
• diarrhea
• nausea.

Common side effects

These may affectup to 1 in 10 people:

• skin rash
• itching (pruritus)
• vomiting
• stomach pain (abdominal pain)
• discomfort in the stomach (abdomen)
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feeling of deep sadness and low self-esteem)
• anxiety
• lack of energy (fatigue)
• gas (flatulence)
• increase in liver enzymes
• increase in muscle enzymes (creatine phosphokinase).

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

These may affectup to 1 in 10,000 people:

• liver insufficiency (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). Such infections may have developed in a "silent" manner, not being detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and may fight these infections, causing symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

• headache
• stomach pain
• difficulty breathing.

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 months after starting to take medications to treat HIV infection. The symptoms may include:

• palpitations (irregular or rapid heartbeats) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and ascending to the body trunk.

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 other medications for the infection without

consulting with 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 medications called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

The signs of osteonecrosis include:

• stiffness in the joints
• joint pain and 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, 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 treatment medications themselves. Your doctor will evaluate these changes.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification 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 box and bottle after CAD.

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

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

Composition of Tivicay

• The active ingredient is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 5 mg of dolutegravir.
• The other components are mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethylcellulose, colloidal silicon dioxide, microcrystalline cellulose, crospovidone, sodium stearate fumarate, calcium dihydrogen sulfate, sucralose, strawberry cream flavor, titanium dioxide (E171), hypromellose, and macrogol.

Appearance of the product and contents of the package

Tivicay 5 mg dispersible tablets are white, round, biconvex, and engraved with "SV H7S" on one face and "5" on the other. The bottle contains a desiccant to reduce humidity. Once opened, keep the desiccant in the bottle, do not discard it.

Tivicay 5 mg dispersible tablets are supplied in bottles containing 60 tablets.

A measuring cup and an oral syringe are supplied with the package.

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 medication, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {month} {year}

Other sources of information

For more detailed information about this medication, please visit the website of the European Medicines Agency:https://www.ema.europa.eu.

Step-by-step instructions for use