5 mg dispersible tablets
dolutegravir
What Tivicay is and what it is used for
Tivicay contains the active substance dolutegravir. Dolutegravir belongs to a group of antiretroviral drugs called integrase inhibitors.
Tivicay is used to treat HIV infection ( HIV = human immunodeficiency virus) in adults, adolescents, and children from 4 weeks of age weighing at least 3 kg.
Tivicay does not cure HIV – infection but it reduces the amount of virus in the body and keeps it at a low level. A consequence of this is that it also increases the number of CD4 cells in your blood. CD4 cells are a type of white blood cell that is important for the body’s ability to fight infection.
Not everyone reacts to treatment with Tivicay in the same way. Your doctor will check the effect of the treatment on you.
Tivicay is always used in combination with other antiretroviral drugs ( combination therapy ). To keep your HIV infection under control and prevent the disease from getting worse, you must take all your medicines, unless your doctor tells you to stop taking any of them.
What you need to know before you take Tivicay
Do not take Tivicay:
- if you (or your child, if the patient) are allergic (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 called dalfampridine; used in multiple sclerosis ).
- If you think any of these apply to you (or your child), tell your doctor.
Warnings and precautions
Pay attention to important symptoms
Some people who take medicines for HIV infection develop other problems, which can be serious. These are:
- symptoms of infection and inflammation
- joint pain, stiffness, and bone problems.
You need to know the important signs and symptoms to look out for while you (or your child, if the patient) are taking Tivicay.
- Read the information under section 4 of this leaflet.
Protect others
HIV – infection is spread through sexual contact with someone who is infected, or through transmission via infected blood (e.g. if you share the same injection needles). You can still transmit HIV when taking this medicine, although the risk is reduced with effective antiviral treatment. Discuss with your doctor the necessary measures to avoid infecting others.
Children
Do not give this medicine to children under 4 weeks of age, with a body weight of less than 3 kg, or with HIV – infection that is resistant to other medicines of the same type as Tivicay. The use of Tivicay dispersible tablets in children under 4 weeks of age or weighing less than 3 kg has not yet been studied.
Children must come to scheduled medical appointments ( see “Children and young people” in section 3 for more information ).
Other medicines and Tivicay
Tell your doctor if you (or your child) are taking, have recently taken, or plan to take any other medicines.
Do not take Tivicay together with the following medicines:
- fampridine (also called dalfampridine), is used to treat multiple sclerosis.
Some medicines can affect how Tivicay works, or increase the risk of side effects. Tivicay can also affect how some other medicines work.
Tell your doctor if you (or your child) are taking any of the medicines listed below:
- metformin, for the treatment of diabetes
- antacids, medicines to treat indigestion and heartburn. Do not take antacids for 6 hours before taking Tivicay, or for the next 2 hours after taking Tivicay ( see also section 3 ).
- calcium supplements, iron supplements, and multivitamins. Do not take calcium supplements, iron supplements, or multivitamins for 6 hours before taking Tivicay, or for the next 2 hours after taking Tivicay (see also section 3).
- etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
- rifampicin, for the treatment of tuberculosis and other bacterial infections
- phenytoin and phenobarbital, for the treatment of epilepsy
- oxcarbazepine and carbamazepine, for the treatment of epilepsy or bipolar disorder
- St. John’s wort ( Hypericum perforatum ) is, traditional herbal medicine used for mild depression and mild anxiety.
- Tell your doctor or pharmacist if you (or your child) are taking any of these medicines. The doctor may decide that the dose needs to be changed or that you need to go for more checks.
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 Tivicay.
Taking Tivicay at the time of conception or during the first six weeks of pregnancy may increase the risk of a type of malformation called a neural tube defect, e.g. spina bifida (deformed spinal cord).
If you could become pregnant while receiving Tivicay:
- Talk to your doctor and discuss whether you need to use contraception, such as condoms or birth control pills.
Tell your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop taking Tivicay without talking to your doctor as this may harm you and your unborn baby.
Breast-feeding
Women who are HIV positive should not breastfeed because HIV infection can be transmitted to the child through breast milk.
A small amount of the ingredients in Tivicay can pass into breast milk.
If you are breastfeeding or thinking about starting to breastfeed:
- Talk to your doctor immediately
Driving ability and use of machinery
Tivicay can make you dizzy and have other side effects that reduce your attention.
- Do not drive vehicles or use machines if you are not sure that the medicine does not affect you.
Tivicay contains sodium
Tivicay contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Tivicay
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Adults
- The usual adult dose 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.
- When treating HIV that is resistant to other medicines of the same type as Tivicay, the usual dose is one Tivicay 30 mg (taken as six 5 mg dispersible tablets) twice daily.
The doctor will decide which dose of Tivicay is suitable for you.
Children and young people
- The children’s dose of Tivicay must be adjusted as the child gets older or gains weight.
- It is therefore important that children attend scheduled doctor’s appointments.
- Children and adolescents weighing at least 20 kg can take the adult dose, 30 mg, once daily or 15 mg twice daily. Your doctor will decide how Tivicay should be taken.
- For children from the age of 4 weeks who weigh between 3 and 20 kg, the doctor determines the correct dose of Tivicay based on the child’s weight and age.
- If the tablets are swallowed whole, children must not swallow more than one tablet at a time. This is to reduce the risk of choking.
- Tivicay should not be given to children and adolescents with HIV – infection that is resistant to other medicines of the same type as Tivicay.
How to take the dispersible tablets
- The dispersible tablets can be dispersed in drinking water or swallowed whole with drinking water. When the tablets are dispersed, the volume of water depends on the number of tablets prescribed. The tablet(s) must be completely dissolved before being swallowed. See the separate instructions for use on how to dissolve and administer tablets using the dosing cup and oral syringe provided in the package
- The tablets should not be chewed, crushed, or split.
- Tivicay can be taken with or without food. When Tivicay is taken twice daily, the doctor may advise you to take the tablets with food.
Tivicay is also available as film-coated tablets. Film-coated tablets and dispersible tablets are not interchangeable. Therefore, do not switch between film-coated tablets and dispersible tablets without first talking to the doctor.
Antacid drugs
Antacids, which are used for indigestion and heartburn, can make Tivicay not absorbed by the body and therefore have a worse effect.
Do not take antacids for 6 hours before taking Tivicay, or for the next 2 hours after taking Tivicay. Other antacids such as ranitidine and omeprazole can be taken at the same time as Tivicay.
- Talk to your doctor to get more information about antacids with Tivicay.
Calcium supplements, iron supplements, or multivitamins
Calcium supplements, iron supplements, or multivitamins can mean that Tivicay is not absorbed by the body and therefore has a worse effect.
Do not take calcium, iron supplements, or multivitamins for 6 hours before taking Tivicay, or for the next 2 hours after taking it.
- Talk to your doctor for more information about calcium supplements, iron supplements, or multivitamins along with Tivicay.
If you have taken too much Tivicay
If you (or your 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 your child) have missed a dose, take it as soon as you remember. If it is time for the next dose within 4 hours, however, you should skip the dose you have missed and take the next dose at the usual time. Then continue with your treatment as before.
- Do not take a double dose to make up for a missed dose.
Do not stop taking Tivicay without talking to your doctor
Take Tivicay for as long as your doctor recommends. Do not stop unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
This is uncommon in people taking Tivicay. Signs of an allergic reaction are:
- rash
- high temperature ( fever )
- lack of energy ( powerlessness )
- swelling, sometimes of the face and mouth ( angioedema ), which can cause breathing difficulties
- muscle or joint pain.
- Seek medical attention immediately. Your doctor may decide to take liver, kidney, or blood tests and you may have to stop taking Tivicay.
Very common side effects are
These may occur in more than 1 in 10 users :
- headache
- diarrhea
- nausea.
Common side effects are
These may occur in up to 1 in 10 users :
- rash
- itching
- vomiting
- stomach pains ( abdominal pains )
- discomfort from the stomach ( abdomen )
- sleep difficulties
- dizziness
- abnormal dreams
- depression (feelings of deep sadness and worthlessness)
- concern
- lack of energy ( powerlessness )
- flatulence ( flatulence )
- elevated liver enzyme levels
- the increased amount of enzymes produced in the muscles ( creatine phosphokinase ).
Less common side effects are
These may occur in up to 1 in 100 users :
- inflammation of the liver ( hepatitis )
- suicide attempt*
- suicidal thoughts*
- panic attack
- joint pain
- muscle pain.
* especially in patients who previously had depression or mental problems.
Rare side effects ar
These may occur in up to 1 in 1,000 users
- liver failure (signs of this may be yellowing of the skin and whites of the eyes or unusually dark urine)
- increased levels of bilirubin (a test of liver function) in your blood
- suicide (especially in patients who previously had depression or mental problems).
→ Talk to your doctor immediately if you experience mental health problems (see also other mental health problems above).
Symptoms of infection and inflammation
People with advanced HIV infection ( AIDS ) have a weak immune system and the risk is greater that they will get serious infections ( opportunistic infections ). Such infections may have been “silent” and not detected by the weak immune system before treatment began. Once treatment has started, the immune system becomes stronger and can fight infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever and any of the following:
- headache
- gripe
- breathing difficulties
In rare cases, when the immune system becomes stronger, it can also attack healthy body tissue ( autoimmune diseases ). The symptoms of autoimmune diseases can develop several months after you start taking medicines for your HIV infection. Symptoms may include:
- palpitations (fast or irregular heartbeats) or tremors
- hyperactivity (excessive restlessness and excessive movements)
- weakness that starts in the hands and feet and moves up the trunk.
If you (or your child) develop symptoms of an infection and inflammation or if you notice any of the symptoms mentioned above:
- Talk to your doctor immediately. Do not take other anti-infection medicines unless the doctor has recommended them.
Joint pain, stiffness, and bone problems
Some people taking combination anti-HIV therapy develop osteonecrosis. This means that parts of the bone tissue die because the blood supply to the bone is reduced. The risk of being affected by this increases if:
- you have been taking the combination treatment for a long time
- you also take anti-inflammatory drugs called corticosteroids
- you drink alcohol
- the immune system is very weak
- you are overweight.
Signs of osteonecrosis are:
- stiffness in the joints
- aches and pains in the joints (especially in the hips, knees, or shoulders)
- difficulty moving.
If you get any of these symptoms:
- Tell your doctor about it
Effects on weight, blood lipids, and blood sugar
During HIV treatment, weight gain and increased levels of blood fats and blood sugar may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
How to store Tivicay
Keep this medicine out of the sight and reach of children.
Use before the expiry dais stated on the carton and can after “EXP”.
Store in the original packaging. Moisture sensitive. Close the jar well. Do not remove the desiccant. Do not swallow the desiccant. No special temperature instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispo ofse of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dolutegravir. One tablet contains dolutegravir sodium equivalent to 5 mg of dolutegravir.
- Other ingredients are mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, crospovidone, sodium stearyl fumarate, calcium sulfate dihydrate, sucralose, strawberry cream flavor, titanium dioxide (E171), hypromellose and macrogol.
Appearance and package sizes of the medicine
Tivicay 5 mg dispersible tablets are white, round, biconvex tablets debossed with “SV H7S” on one side and “5” on the other side. The jar contains a desiccant to reduce moisture. Leave the desiccant in the can after opening, do not take it out.
The dispersible tablets are available in cans containing 60 tablets.
A dosing cup and oral syringe are included in the package.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
Manufacturer
Glaxo Wellcome, SA, Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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