Tivicay

Package leaflet: Information for the patient

Tivicay 10 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets

dolutegravir
Please read all of this leaflet carefully before you (or the child, if the patient is a child) start taking this medicine, because 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 (or for the child, if the patient is a child) only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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 (INI).
Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents, and children aged 6 years and older who weigh at least 14 kg.
Tivicay does not cure HIV infection, but it reduces the amount of virus in the body and keeps it at low levels.
As a result, it also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cells important in helping the body fight infection.
Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of the treatment.
Tivicay is always used in combination with other antiretroviral medicines (combination therapy). To control HIV infection and to prevent the disease from worsening, you must take all your medicines, unless your doctor tells you to stop one of them.

2. What you need to know before taking Tivicay

Do not take Tivicay

• if you (or the child, if the patient is a child) are allergic to dolutegravir or to any of the other ingredients of this medicine (listed in section 6);
• if you (or the child) are taking another medicine called fampridine (also known as dalfampridine, used for multiple sclerosis). → Consult your doctor if you think that either of these conditions applies to you (or to the child).

Warnings and precautions
Pay attention to important symptoms
Some people who take medicines for HIV infection develop other conditions that may be serious. These include:

• symptoms of infection and inflammation
• joint pain, stiffness, and bone problems. You need to be informed about important signs and symptoms so that you can recognize them while you (or the child, if the patient) are taking Tivicay. → Read the information in Section 4 of this leaflet.

Children
Do not give this medicine to children under 6 years of age, weighing less than 14 kg, or with HIV infection resistant to other medicines similar to Tivicay. The use of Tivicay film-coated tablets in children under 6 years of age or weighing less than 14 kg has not been studied.
Children must attend all scheduled appointments with the doctor (see ‘Use in children and adolescents’ in Section 3 for more information).

Other medicines and Tivicay
Inform your doctor if you (or the child) are taking, have recently taken, or plan to take any other medicines.
Do not take Tivicay with the following medicine:

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

Some medicines may affect the action of Tivicay or make it more likely that you will experience side effects.
Tivicay, in turn, may affect the action of other medicines.
Inform your doctor if you (or the 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 within at least 2 hours after taking it (see also Section 3).
• supplements or multivitamins containing calcium, iron, or magnesium. If you take Tivicay with food, you may take supplements or multivitamins 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 containing calcium, iron, or magnesium within 6 hours before taking Tivicay or within 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 to treat depression. → Inform your doctor or pharmacist if you (or the child) are taking any of these medicines. Your doctor may decide to adjust the dose or that you may need additional monitoring.

Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby: → Talk to your doctor about the risks and benefits of taking Tivicay.

Inform your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will review your treatment. Do not stop taking Tivicay without consulting your doctor, as this could harm you and the 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 components in Tivicay may 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
Tivicay may cause dizziness and other side effects that may reduce your attention.
→ Do not drive or operate machinery if you are not sure whether you are affected.

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

3. How to take Tivicay

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

• The recommended dose is 50 mg once daily.
• If you are taking certain other medicines, the dose is 50 mg twice daily.
• For HIV that is resistant to other medicines similar to Tivicay, the recommended dose is 50 mg twice daily.

Your doctor will determine the correct dose of Tivicay for you.
Swallow the tablet with liquid.
Tivicay can be taken with or without food. When Tivicay is taken twice daily, your doctor may advise you to take it with food.
Tivicay is also available as dispersible tablets. Film-coated tablets and dispersible tablets are not interchangeable; therefore, do not switch from film-coated tablets to dispersible tablets without first consulting your doctor.

Use in children and adolescents

• The dose for children with Tivicay must be adjusted as they grow or gain weight. → It is therefore important that children attend their scheduled doctor’s appointments.
• Children and adolescents weighing at least 20 kg may take the adult dose of 50 mg once daily or 25 mg twice daily. Your doctor will decide how Tivicay should be administered.
• For children aged between 6 and 12 years, the doctor will determine the correct dose of Tivicay based on the child’s body weight.
• To reduce the risk of choking, children must not swallow more than one tablet at a time.
• Tivicay must not be used in children and adolescents with HIV infection resistant to other medicines similar to Tivicay.

Antacid medicines
Antacids, used to treat indigestion and heartburn, may interfere with the absorption of Tivicay and reduce its effectiveness.
Do not take an antacid within 6 hours before taking Tivicay or within at least 2 hours after taking it.
Other medicines that reduce stomach acidity, such as ranitidine and omeprazole, may be taken at the same time as Tivicay.
→ Speak with your doctor for further advice on taking acid-reducing medicines with Tivicay.

Calcium, iron, or magnesium-containing supplements or multivitamins
Supplements or multivitamins containing calcium, iron, or magnesium may interfere with the absorption of Tivicay in your body and reduce its effectiveness. If you take Tivicay with food, you may take supplements or multivitamins 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 containing calcium, iron, or magnesium within 6 hours before taking Tivicay or within at least 2 hours after taking it.
→ Speak with your doctor for further advice on taking supplements or multivitamins containing calcium, iron, or magnesium with Tivicay.

If you take more Tivicay than you should
If you (or the child) take too many Tivicay tablets, contact your doctor or pharmacist for advice.
If possible, show them the Tivicay packaging.

If you forget to take Tivicay
If you (or the child) forget a dose, take it as soon as you remember. However, if the next dose is due within 4 hours, skip the missed dose and take the next dose at the usual time. Then continue as before.
→ Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions
These are uncommon in people taking Tivicay. Signs include:

• rash
• fever
• 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 assess liver, kidney or blood function and may tell you to stop taking Tivicay.

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

• headache
• diarrhoea
• nausea

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

• rash
• itching
• vomiting
• stomach ache (abdominal pain)
• stomach discomfort (abdominal disturbances)
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feeling deeply sad and worthless)
• anxiety
• fatigue
• flatulence (presence of intestinal gas)
• increased levels of liver enzymes
• increased levels of enzymes produced by muscles (creatine phosphokinase)

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

• inflammation of the liver (hepatitis)
• suicide attempt*
• suicidal thoughts*
• panic attack
• joint pain
• muscle pain* particularly in patients who have previously had depression or mental health problems

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)
• increased bilirubin (an indicator of liver function) in the blood
• suicide (particularly in patients who have previously had depression or mental health problems) → Contact your doctor immediately if 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 been "silent" and not detected by the weakened immune system before treatment was started. After starting treatment, the immune system becomes stronger and may react against these infections, causing symptoms of infection or inflammation. Symptoms generally include fever, together with:

• headache
• stomach ache
• difficulty breathing

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

• palpitations (fast 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 (or your child) experience any symptoms of infection and inflammation or notice any of the symptoms listed above: → Contact 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. As a result of 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 of the joints
• pain and discomfort in the joints (especially the hip, knee or shoulder)
• difficulty moving

If you notice any of these symptoms: → Contact your doctor.

Effects on body weight, lipids and blood glucose
During HIV treatment, an increase in body weight and in levels of lipids and glucose in the blood may occur. This is partly related to improved health, 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 through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 on the bottle after "Exp.".
Tivicay 10 mg film-coated tablets
Store in the original packaging to protect the medicine 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 conditions.
Tivicay 25 mg and 50 mg film-coated tablets
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tivicay contains

• The active substance is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg, or 50 mg of dolutegravir.
• The other components are mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc; and for the 25 mg and 50 mg tablets, yellow iron oxide (E172).

Description of the appearance of Tivicay and contents of the pack
Tivicay 10 mg film-coated tablets are white, round, biconvex tablets with the code ‘SV 572’ engraved on one side and ‘10’ on the other. The bottle contains a desiccant to reduce moisture. Once the bottle has been opened, keep the desiccant inside the bottle; do not remove it.
Tivicay 25 mg film-coated tablets are straw-yellow, round, biconvex tablets with the code ‘SV 572’ engraved on one side and ‘25’ on the other.
Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets with the code ‘SV 572’ engraved on one side and ‘50’ on the other.
The film-coated tablets are supplied in bottles containing 30 or 90 tablets. 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
or
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań, Poland.

For further information about this medicinal product, 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

Luxembourg/Luxemburg
България ViiV Healthcare BV
ViiV Healthcare BV Belgique/Belgien
Tel: + 359 80018205 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) 33 2081199
[email protected]

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

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: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV 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: + 40800672524

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

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

Patient Information Leaflet

Tivicay 5 mg dispersible tablets

dolutegravir
Please read this entire leaflet carefully before you (or the child, if the child is the patient) take this
medicine, because 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 (or for the child, if the child is the patient) only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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
   Detailed instructions for use 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 (INI).
Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents, and children aged 4 weeks and older who weigh at least 3 kg.
Tivicay does not cure HIV infection, but it reduces the amount of virus in the body and keeps it at low levels.
As a result, the number of CD4 cells in the blood also increases. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of the treatment.
Tivicay is always used in combination with other antiretroviral medicines (combination therapy). To control HIV infection and to prevent the disease from worsening, you must take all your medicines, unless your doctor tells you to stop one.

2. What you need to know before taking Tivicay

Do not take Tivicay

• if you (or the child, if the patient is a child) are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6);
• if you (or the child) are taking another medicine called fampridine (also known as dalfampridine, used for multiple sclerosis). → Please consult your doctor if you think that either of these conditions applies to you (or the child).

Warnings and precautions
Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions which may be serious. These include:

• symptoms of infection and inflammation
• joint pain, stiffness, and bone problems. You need to be aware of important signs and symptoms so that you can recognize them while you (or the child, if 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 that is resistant to other medicines similar to Tivicay. The use of Tivicay dispersible tablets in children younger than 4 weeks of age or weighing less than 3 kg has not been studied.
Children must attend all scheduled appointments with the doctor ( see ‘Children and adolescents’ in Section 3 for more information ).
Other medicines and Tivicay
Tell your doctor if you (or the child) are taking, have recently taken, or plan to take any other medicines.
Do not take Tivicay with the following medicine:

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

Some medicines may affect the activity of Tivicay or make it more likely that you will experience side effects.
Tivicay may in turn affect the activity of other medicines.
Tell your doctor if you (or the child) are taking any of the medicines listed below:

• metformin, to treat diabetes
• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid within 6 hours before taking Tivicay or within at least 2 hours after taking it ( see also Section 3 ).
• supplements or multivitamins containing calcium, iron, or magnesium. If you take Tivicay with food, you may take supplements or multivitamins 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 containing calcium, iron, or magnesium within 6 hours before taking Tivicay or within 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 disorders
• St. John’s wort ( Hypericum perforatum ), a herbal remedy to treat depression. → Tell your doctor or pharmacist if you (or the child) are taking any of these medicines. Your doctor may decide to adjust the dose or that you may need additional monitoring. Pregnancy If you are pregnant, think you may be pregnant, or are planning to have a baby: → Talk to your doctor about the risks and benefits of taking Tivicay.

Tell your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will review your treatment. Do not stop taking Tivicay without consulting your doctor, as this could harm you and the unborn child.
Breast-feeding
Breast-feeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.
A small amount of the components in Tivicay may pass into breast milk.
If you are breast-feeding or considering breast-feeding, you must speak to your doctor as soon as possible.
Driving and using machines
Tivicay may cause dizziness and other side effects that may reduce alertness.
→ Do not drive or operate machinery if you are not sure you are unaffected.
Tivicay contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tivicay

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Adults

• The recommended dose for adults is 30 mg (taken as six 5 mg dispersible tablets), once daily.
• If you are taking certain other medicines, the dose is 30 mg (taken as six 5 mg dispersible tablets), twice daily.
• For HIV that is 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 determine the correct dose of Tivicay for you.

Children and adolescents

• The dose of Tivicay for children must be adjusted as they grow or gain weight. → It is therefore important that children attend their scheduled doctor’s 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 aged at least 4 weeks and weighing between 3 and 20 kg, your doctor will determine the correct dose of Tivicay based on the child’s body weight and age.
• If the tablets are swallowed 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 may 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 being taken. See the separate detailed instructions on how to disperse and administer the tablets using the oral dosing cup and oral syringe provided in this pack.

• Do not chew, cut, or crush the tablets.

• Tivicay may be taken with or without food. When Tivicay is taken 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 from film-coated tablets to dispersible tablets without first speaking to your doctor.

Antacid medicines
Antacids used to treat indigestion and heartburn may interfere with the absorption of Tivicay and reduce its effectiveness.
Do not take an antacid within 6 hours before taking Tivicay or within at least 2 hours after taking it.
Other medicines that reduce stomach acidity, such as ranitidine and omeprazole, may be taken at the same time as Tivicay.
→ Speak to your doctor for further advice on taking acid-reducing medicines with Tivicay.

Calcium, iron, or magnesium supplements or multivitamins
Supplements or multivitamins containing calcium, iron, or magnesium may interfere with the absorption of Tivicay in your body and reduce its effectiveness.
If you take Tivicay with food, you may take supplements or multivitamins 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 containing calcium, iron, or magnesium within 6 hours before taking Tivicay or within at least 2 hours after taking it.
→ Speak to your doctor for further advice on taking supplements or multivitamins containing calcium, iron, or magnesium with Tivicay.

If you take more Tivicay than you should
If you (or the child) take too many Tivicay tablets, contact your doctor or pharmacist for advice. If possible, show them the Tivicay packaging.

If you forget to take Tivicay
If you (or the child) forget a dose, take it as soon as you remember. However, if the next dose is due within 4 hours, skip the missed dose and take the next dose at the usual time. Then continue as before.
→ Do not take a double dose to make up for a forgotten dose.

Do not stop taking Tivicay without consulting your doctor
Take Tivicay for the entire duration prescribed by your doctor. Do not stop treatment unless your doctor advises you to do so.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions
These are uncommon in people taking Tivicay. Signs include:

• skin rash
• fever
• 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 assess liver, kidney or blood function, and may instruct you to stop taking Tivicay.

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

• headache
• diarrhoea
• nausea

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

• rash
• itching
• vomiting
• stomach ache (abdominal pain)
• stomach discomfort (abdominal disturbances)
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feeling deeply sad and worthless)
• anxiety
• fatigue
• flatulence (presence of intestinal gas)
• increased liver enzyme levels
• increased levels of muscle enzymes (creatine phosphokinase)

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

• liver inflammation (hepatitis)
• suicide attempt*
• suicidal thoughts*
• panic attack
• joint pain
• muscle pain
  *particularly in patients who have previously had depression or mental health problems

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)
• increased bilirubin (a marker of liver function) in the blood
• suicide (particularly in patients who have previously had depression or mental health problems)
  → Contact your doctor immediately if you experience any mental health problems (see also other mental health issues 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 been "silent" and not detected by the weakened immune system before treatment was started. After starting treatment, the immune system becomes stronger and may react against these infections, causing symptoms of infection or inflammation. Symptoms usually include fever, together with:

• headache
• stomach pain
• difficulty breathing

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

• palpitations (fast 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 (or the child) experience any symptoms of infection and inflammation, or notice any of the symptoms listed above:
  → Contact your doctor immediately. Do not take any other medicines for the 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. As a result of 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
• pain and discomfort in the joints (especially in the hip, knee or shoulder)
• difficulty moving

If you notice any of these symptoms:
→ Contact your doctor.

Effects on body weight, lipids and blood glucose
During HIV treatment, an increase in body weight and in blood lipid and glucose levels may occur. This is partly due to the recovery of 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tivicay

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 on the bottle after "Exp.".
Store in the original packaging to protect the medicine 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 conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tivicay contains

• 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 starch glycolate, colloidal silicon dioxide and microcrystalline cellulose, crospovidone, sodium stearyl fumarate, calcium sulfate dihydrate, sucralose, strawberry cream flavour, titanium dioxide (E171), hypromellose and macrogol.

Description of the appearance of Tivicay and contents of the pack
Tivicay 5 mg dispersible tablets are white, round, biconvex tablets,
with the code ‘SV H7S’ engraved on one side and ‘5’ on the other side. The bottle contains a desiccant to reduce
moisture. Once the bottle has been opened, keep the desiccant in the bottle; do not remove it.
The dispersible tablets are supplied in bottles containing 60 tablets.
The pack includes a dosing cup and an oral syringe.

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) 33 2081199
[email protected]

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

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: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV 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 1 800787089 Tel: + 40800672524

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

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.

Detailed instructions for use
Read the following Instructions for Use before administering a dose of this medicine.
Follow the steps below, using drinking water to prepare and administer a dose to an infant or child who cannot swallow tablets.

Important information
Always administer this medicine exactly as directed by the doctor. Speak with your doctor if you are unsure.
Do not chew, cut or crush the tablets.
If you forget to administer a dose, give it as soon as you remember. However, if the next dose is due within 4 hours, skip the missed dose and take the next dose at the usual time. Then continue treatment as before. Do not administer two doses at the same time and do not give more doses than prescribed by your doctor.
If you administer an excessive dose, contact your doctor immediately.
If the child is able and prefers to swallow the tablets, you may skip the following steps.

Cup
Plunger
Bottle
Oral
Tip
syringe

The pack contains:

• A bottle containing 60 tablets.
• Administration kit:
  • Cup: use this to prepare and administer the medicine to children.
  • Oral syringe: use this to administer the medicine to infants.

You will also need:

• Clean drinking water.

Preparation
.

1. Pour water

Water volume
Number of
1 2 3 4 5 6
tablets
Volume of
5 mL 10 mL
water

• Pour drinking water into the cup. The water volume indication above shows the amount of water needed for the prescribed dose.

Use only drinking water.
Do not use any other beverage or food to prepare the dose.

2. Preparation of the medicine

Gently swirl
for 1 to 2
minutes

• Add the prescribed number of tablets to the water.
• Gently swirl the glass for 1 or 2 minutes to disperse the tablets. The dispersed medicine will make the water cloudy. Be careful not to spill the medicine.
• Check that the medicine is fully dispersed. If any tablet fragments remain, continue swirling the glass until they are no longer visible.

If the medicine is spilled, clean up the spilled amount immediately.
Discard any remaining prepared medicine and prepare a new dose.
You must administer the dose of medicine within 30 minutes of preparation. If more than
30 minutes have passed, discard the dose and prepare a fresh dose of medicine.

Administration of the medicine

3. Administering the medicine

Administering the medicine to a child

• Ensure the child is in an upright position. Have the child drink all of the prepared medicine.
• Add a further 5 mL of drinking water to the dosing cup, mix by swirling the cup, and have the child drink all of it.
• Repeat this step if any medicine remains, to ensure the child receives the full dose.

Administering the medicine to an infant

• Insert the tip of the oral syringe into the prepared medicine and draw up the entire amount by pulling the plunger upwards.
• Place the tip of the oral syringe against the inside of the infant’s cheek. Gently push the plunger down to slowly administer the dose.
• Add a further 5 mL of drinking water to the dosing cup and mix. Draw up the remaining medicine into the oral syringe and administer it to the infant.

Repeat this step if any medicine remains, to ensure the infant receives the full dose.
Wait to allow the infant to swallow the medicine.

Cleaning

4. Cleaning administration devices

• Wash the dosing cup with water.
• Remove the plunger from the oral syringe and wash each part of the syringe separately with water. Allow all syringe components to dry completely before reassembling and storing.
• All used components must be washed before preparing the next dose.

Storage information
Keep the tablets in the bottle. Keep the bottle tightly closed.
The bottle contains a drying agent that helps keep the tablets dry. Do not eat the drying agent.
Do not remove the drying agent.
Keep all medicines out of the sight and reach of children.

Disposal information

When all tablets have been removed from the bottle or are no longer needed, dispose of the bottle, dosing cup, and oral syringe. Dispose of them according to local guidelines for disposal of household waste.
A new dosing cup and a new oral syringe will be provided in the new package.