Tivicay
dolutegravir
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you (or your child, if they are the patient) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Tivicay is and what it is used for
What you need to know before you take Tivicay
How to take Tivicay
Possible side effects
How to store Tivicay
Contents of the pack and other information
Tivicay contains the active ingredient dolutegravir. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children of at least 6 years of age or older, and who weigh at least 14 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 of that, it also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of your treatment.
Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).
To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.
if you (or your child, if they are the patient) are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).
if you (or your child) are taking another medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).
→ If you think any of these apply to you (or your child), tell your doctor.
Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:
symptoms of infections and inflammation
joint pain, stiffness and bone problems
You need to know about important signs and symptoms to look out for while you (or your child, if they are the patient) are taking Tivicay.
→ Read the information in Section 4 of this leaflet.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
Do not give this medicine to children under 6 years of age, weighing less than 14 kg or with HIV infection that is resistant to other medicines similar to Tivicay. The use of Tivicay film-coated tablets in children under
6 or weighing less than 14 kg has not yet been studied.
Children must keep planned doctor’s appointments (see ‘Use in children and adolescents’ in Section 3 for more information).
Tell your doctor if you (or your child) are taking, have recently taken or are planning to take any other medicines.
fampridine (also known as dalfampridine), used in multiple sclerosis.
Some medicines can affect how Tivicay works, or make it more likely that you will have side effects. Tivicay can also affect how some other medicines work.
metformin, to treat diabetes
medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3).
calcium supplements, iron supplements and multivitamins. Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take 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
→ Tell your doctor or pharmacist if you (or your child) are taking any of these. Your doctor may decide to adjust your dose or that you need extra check ups.
If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
→ Talk to your doctor about the risks and benefits of taking Tivicay.
Taking Tivicay at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
If you could get pregnant while receiving Tivicay:
→ Talk to your doctor and discuss whether there is a need for contraception, such as condom 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 Tivicay without consulting your doctor, as this may harm you and your unborn child.
A small amount of the ingredient in Tivicay can pass into your breast milk. If you are breast-feeding, or thinking about breast-feeding:
→ Talk to your doctor immediately.
Tivicay can make you dizzy and have other side effects that make you less alert.
→ Don’t drive or operate machinery unless you are sure you’re not affected.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you are taking certain other medicines, the dose is 50 mg twice a day.
Your doctor will decide on the correct dose of Tivicay for you. Swallow the tablet(s) with some liquid.
Tivicay can be taken with or without food. When Tivicay is taken twice a day, your doctor may advise you to take with food.
Tivicay is also available as dispersible tablets. Film-coated tablets and dispersible tablets are not the same, therefore do not switch between film-coated tablets and dispersible tablets without first talking to your doctor.
→ It is important therefore that children keep planned doctor’s appointments.
Children and adolescents weighing at least 20 kg can take the adult dose of 50 mg, once a day or 25 mg twice daily. Your doctor will decide how Tivicay should be given.
For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child.
To reduce the risk of choking, children must not swallow more than one tablet at a time.
Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.
Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective.
Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay.
→ Talk to your doctor for further advice on taking acid-lowering medicines with Tivicay.
Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective.
Tivicay, or for at least 2 hours after you take it.
→ Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay.
If you (or your child) take too many tablets of Tivicay, contact your doctor or pharmacist for advice. If possible, show them the Tivicay pack.
If you (or your child) miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.
Take Tivicay for as long as your doctor recommends. Don’t stop unless your doctor advises you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, but not everybody gets them.
These are uncommon in people taking Tivicay. Signs include:
skin rash
a high temperature (fever)
lack of energy (fatigue)
swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
muscle or joint aches.
→ See a doctor straight away. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.
These may affect more than 1 in 10 people:
headache
diarrhoea
feeling sick (nausea).
These may affect up to 1 in 10 people:
rash
itching (pruritus)
being sick (vomiting)
stomach pain (abdominal pain)
stomach (abdominal) discomfort
insomnia
dizziness
abnormal dreams
depression (feelings of deep sadness and unworthiness)
anxiety
lack of energy (fatigue)
wind (flatulence)
increase in the level of liver enzymes
increase in the level of enzymes produced in the muscles (creatine phosphokinase).
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 had depression or mental health problems before.
These may affect up to 1 in 1000 people:
liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
increase in bilirubin (a test of liver function) in your blood.
suicide (particularly in patients who have had depression or mental health problems before)
→ Tell your doctor immediately if you experience any mental health problems (see also other mental health problems above).
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:
headache
stomach ache
difficulty breathing
In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:
palpitations (rapid or irregular heartbeat) or tremor
hyperactivity (excessive restlessness and movement)
weakness beginning in the hands and feet and moving up towards the trunk of the body.
→ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s
advice.
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
if they have been taking combination therapy for a long time
if they are also taking anti-inflammatory medicines called corticosteroids
if they drink alcohol
if their immune systems are very weak
if they are overweight.
stiffness in the joints
aches and pains in the joints (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms:
→ Tell your doctor.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle. Tivicay 10 mg film-coated tablets
Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove
the desiccant. Do not swallow the desiccant. This medicine does not require any special temperature storage conditions.
Tivicay 25 mg and 50 mg film-coated tablets
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.
The other ingredients are mannitol (E421), microcrystalline cellulose, povidone, sodium starch
glycolate, sodium stearyl fumarate, poly(vinyl alcohol) partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 mg and 50 mg tablets, iron oxide yellow (E172).
Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘10’ 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.
Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘25’ on the other side.
Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘50’ on the other side.
The film-coated tablets are provided in bottles containing 30 or 90 tablets. Not all pack sizes may be available in your country.
ViiV Healthcare BV
Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands.
Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR
GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poland.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ViiV Healthcare BV Tel: + 370 80000334
ViiV Healthcare BV Teл.: + 359 80018205
Tél/Tel: + 32 (0) 10 85 65 00
ViiV Healthcare BV Tel: + 36 80088309
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
ViiV Healthcare BV Tel: + 356 80065004
ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10
viiv.med.info@viivhealthcare.com
ViiV Healthcare BV Tel: + 31 (0)33 2081199
ViiV Healthcare BV Tel: + 372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: + 385 800787089
ViiV Healthcare BV Tel: + 40800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
ViiV Healthcare BV Tel: + 386 80688869
Vistor hf.
Sími: + 354 535 7000
ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600
ViiV Healthcare BV
Τηλ: + 357 80070017
ViiV Healthcare BV Tel: + 371 80205045
ViiV Healthcare BV Tel: + 44 (0)800 221441