Tivicay 5 mg dispersible tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Tivicay 5 mg dispersible tablets

dolutegravir

Read the entire leaflet carefully before you start taking this medicine (or your child, if they are the patient), as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you (or your child, if they are the patient). Do not give it to others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

Step-by-step usage instructions are also provided.

1. What Tivicay is and what it is used for

Tivicay contains the active substance dolutegravir. Dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).

Tivicay is used to treat HIV infection (human immunodeficiency virus) in adults, adolescents, and children at least 4 weeks of age and older who weigh at least 3 kg.

Tivicay does not cure HIV infection; it reduces the amount of virus in your 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 important in helping your body fight infections.

Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor how well your treatment is working.

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

2. What you need to know before taking Tivicay

Do not take Tivicay:

• if you (or your child, if they are the patient) are allergic to dolutegravir or to any of the other components of

• this medicine (listed in section 6).

• if you (or your child, if they are the patient) are taking another medicine called fampridine (also known as dalfampridine; used to treat multiple sclerosis).

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

Warnings and precautions

Be alert for important symptoms

Some people who take medicines for HIV infection develop other disorders, which may be serious. These include:

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

You need to know which important signs and symptoms to watch for while you (or your child, if they are the patient) are taking Tivicay.

• Read the information in section 4 of this leaflet.

Children

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

Children should attend scheduled medical appointments (see "Children and adolescents" in section 3 for more information).

Other medicines and Tivicay

Tell your doctor if you are taking (or your child is taking), have recently taken, or might need to take any other medicine.

Do not take Tivicay with the following medicine:

• fampridine (also known as dalfampridine), used to treat multiple sclerosis.

Some medicines may affect how Tivicay works, or increase the likelihood of experiencing side effects. Tivicay may also affect how some other medicines work.

Tell your doctor if you (or your child) are taking any of the following medicines:

• metformin, to treat diabetes

• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid within 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 magnesium within 6 hours before taking Tivicay, or at least 2 hours after taking it (see also section 3)

• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine, or tipranavir/ritonavir, to treat HIV infection

• rifampicin, to treat tuberculosis (TB) and other bacterial infections

• phenytoin and phenobarbital, to treat epilepsy

• oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder

• St. John’s wort (Hypericum perforatum), a herbal remedy used to treat depression.

• Tell your doctor or pharmacist if you (or your child) are taking any of these medicines. Your doctor may decide to adjust your dose or that you need additional monitoring.

Pregnancy

If you are pregnant, think you might be pregnant, or plan to become pregnant:

• Consult your doctor about the risks and benefits of taking Tivicay.

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

Breast-feeding

It is not recommended that women living with HIV breastfeed because HIV 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 considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Tivicay may cause dizziness and has other side effects that may reduce your attention.

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

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

3. How to take Tivicay

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

• The recommended dose in adults is 30 mg (taken as six 5 mg dispersible tablets) once daily.
• If you are also taking other medicines, the dose is 30 mg (taken as six 5 mg dispersible tablets) twice daily.
• For HIV resistant to other medicines similar to Tivicay, the recommended dose is 30 mg (taken as six 5 mg dispersible tablets) twice daily.

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

Children and adolescents

• The paediatric dose of Tivicay should be adjusted as children grow or gain weight.

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

• Children and adolescents weighing at least 20 kg may take the adult dose of 30 mg once daily or 15 mg twice daily. Your doctor will decide how Tivicay should be administered.

• For children at least 4 weeks old and weighing between 3 and 20 kg, your doctor will determine the correct dose of Tivicay, depending on your child’s weight and age.

• If swallowing the tablets whole with water, children must not swallow more than one tablet at a time, to reduce the risk of choking.

• Tivicay must not be used in children and adolescents with HIV infection resistant to other medicines similar to Tivicay.

How to take the dispersible tablets

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

See the instructions for use on 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 taken with or without food. When taking Tivicay twice daily, your doctor may advise you to take it with food.

Tivicay is also available as film-coated tablets. Film-coated tablets and dispersible tablets are not the same; therefore, do not switch between film-coated tablets and dispersible tablets without first consulting your doctor.

Antacids

Antacids, used to treat indigestion and heartburn, may interfere with the absorption of Tivicay in your body and make it less effective.

Do not take an antacid within 6 hours before taking Tivicay, or wait at least 2 hours after taking Tivicay. Other medicines that reduce acidity, such as ranitidina and omeprazol, may be taken at the same time as Tivicay.

• Consult your doctor for advice on which acid-reducing medicines you can take with Tivicay.

Multivitamin supplements or preparations containing calcium, iron, or magnesium

Multivitamin supplements or preparations containing calcium, iron, or magnesium may interfere with the absorption of Tivicay in your body and make it less effective.

• If you take Tivicay with food, you may take multivitamin supplements or 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 magnesium within 6 hours before taking Tivicay, or for at least 2 hours after taking it.

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

If you take more Tivicay than you should

If you (or your child) take more Tivicay tablets than prescribed, contact your doctor or pharmacist for advice. If possible, show them the Tivicay pack.

If you forget to take Tivicay

If you (or your child) forget a dose, take it as soon as you remember. However, if less than 4 hours remain before your next dose, skip the missed dose and take the next dose at the usual time. Then continue your treatment as before.

• Do not take a double dose to make up for missed doses.

Do not stop treatment with Tivicay

Take Tivicay for as long as your doctor tells you to. Do not stop taking it unless your doctor advises you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Allergic reactions

These are uncommon in people taking Tivicay. Signs include:

• skin rash

• high temperature (fever)

• lack of energy (fatigue)

• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing

• muscle or joint pain.

• Seek medical help immediately. Your doctor may decide to carry out liver, kidney, or blood tests and may instruct you to stop taking Tivicay.

Very common adverse effects

These may affect more than 1 in 10 people:

• headache
• diarrhoea
• nausea.

Common adverse effects

These may affect up to 1 in 10 people:

• skin rash
• itching (pruritus)
• vomiting
• stomach pain (abdominal pain)
• stomach discomfort (abdomen)
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feeling deeply sad and lacking self-worth)
• anxiety
• lack of energy (fatigue)
• gas (flatulence)
• increased levels of liver enzymes
• increased levels of enzymes produced in the muscles (creatine phosphokinase).

Uncommon adverse effects

These may affect up to 1 in 100 people:

• liver inflammation (hepatitis)
• suicide attempt*
• suicidal thoughts*
• panic attack
• joint pain
• muscle pain.

*especially in patients who previously had depression or mental health problems.

Rare adverse effects

These may affect up to 1 in 1000 people:

• liver failure (signs may include yellowing of the skin and whites of the eyes, or unusually dark urine)

• increased bilirubin (liver function test) in your blood

• suicide (especially in patients who previously had depression or mental health problems).

• Tell your doctor immediately if you experience any mental health problems (see also other mental health problems listed above).

Frequency not known – Cannot be estimated from available data:

• a condition in which red blood cells do not form properly (sideroblastic anaemia).

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 "silently," not detected by the weakened immune system before treatment started. After starting treatment, the immune system becomes stronger and may begin to fight these infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, along with 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). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:

• palpitations (irregular or rapid heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and moving up toward the trunk of the body.

If you (or your child) have any symptoms of infection and inflammation, or if you notice any of the symptoms listed above:

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

Joint pain, stiffness, and bone problems

Some people receiving combination treatment for HIV develop osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones. People may be more likely to develop this condition:

• if they have been on combination treatment for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

Signs of osteonecrosis include:

• stiffness in the joints
• discomfort and pain in the joints (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 in levels of lipids and blood glucose. This is partly related to improved health, lifestyle, and sometimes to the HIV medicines themselves. Your doctor will assess these changes.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tivicay

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 following EXP.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tivicay

• The active substance is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 5 mg of dolutegravir.
• The other components are mannitol (E421), microcrystalline cellulose, povidone, sodium carboxymethyl starch, colloidal silicon dioxide and microcrystalline cellulose, crospovidone, sodium stearyl fumarate, calcium sulfate dihydrate, sucralose, strawberry cream flavour, titanium dioxide (E171), hypromellose and macrogol.

Appearance of the product and contents of the pack

Tivicay 5 mg dispersible tablets are white, round, biconvex tablets, marked with “SV H7S” on one side and “5” on the other. The bottle contains a desiccant to reduce moisture. After opening, keep the desiccant in the bottle; do not discard it.

Dispersible tablets are supplied in bottles containing 60 tablets.

A dosing cup and an oral syringe are provided with the pack.

Marketing Authorization 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 Authorization Holder:

Date of the most recent review of this leaflet: {month YYYY}

Other sources of information

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

Step-by-step instructions for use