TIVICAY 50 mg FILM-COATED TABLETS

2. What you need to know before you take Tivicay

Do not take Tivicay:

• 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, 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 these apply to you (or your child), tell your doctor.

Warnings and precautions

Be aware of important symptoms

Some people taking medicines for HIV infection develop other conditions that can be serious. These include:

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

You need to know what important symptoms to look out for while you 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 or weighing less than 14 kg has not been studied.

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

Other medicines and Tivicay

Tell your doctor if you are taking (or your child, if they are the patient), have recently taken, or might take any other medicines.

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 chance of side effects. Tivicay may also affect how some other medicines work.

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

• metformin, to treat diabetes
• medicines called antacids, to treat indigestionand heartburn. Do not take an antacidduring the 6 hours before taking Tivicay, or for at least 2 hours after taking it (see also section 3)
• supplements or multivitamins that contain calcium, iron, or magnesium. If you take Tivicay with food, you can take supplements or multivitamins that contain 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 that contains calcium, iron, or magnesiumduring the 6 hours before taking Tivicay, or for 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 epilepsyor bipolar disorder
• St. John's Wort(Hypericum perforatum), a herbal medicine to treat depression.

• Tell your doctor or pharmacistif you are taking (or your child) any of these medicines. Your doctor may decide to adjust your dose or that you need extra checks.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby:

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

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 first, as this may harm you and your baby.

Breast-feeding

It is not recommended that HIV-infected women breast-feed their babies because HIV infection can be passed to the baby through breast milk.

A small amount of the components of Tivicay may pass into breast milk.

If you are breast-feeding or think you may want to breast-feed, you should talk to your doctor as soon as possible.

Driving and using machines

Tivicay may make you feel dizzy and have other side effects that reduce your attention.

• Do not drive or use machines unless you are sure you are not affected.

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

3. How to take Tivicay

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is 50 mg once a day.
• If you are also taking other medicines, the dose is 50 mg twice a day.
• For HIV infection resistantto other medicines similar to Tivicay, the recommended dose is 50 mg, twice a day.

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

Swallow the tablet(s) with a little water.

Tivicay can be taken with or without food. When you take Tivicay twice a day, 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 the same, so do not switch between film-coated tablets and dispersible tablets without first talking to your doctor.

Use in children and adolescents

• The child's doseof Tivicay should be adjusted as they grow or gain weight.

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

• Children and adolescents who weigh at least 20 kg can take the adult dose of 50 mg, once a day or 25 mg twice a day. Your doctor will decide how Tivicay should be given.
• For children between 6 and 12 years, your doctor will decide the correct dose of Tivicay based on your child's weight.
• To reduce the risk of choking, children should not swallow more than one tablet at a time.
• Tivicay must notbe used in children and adolescents with HIV infection resistantto other medicines similar to Tivicay.

Antacid medicines

Antacids, used to treat indigestionand heartburn, can interfere with the absorption of Tivicay into your body and make it less effective.

Do not take an antacidduring the 6 hours before taking Tivicay, or for at least 2 hours after taking it. Other medicines that reduce stomach acid, such as ranitidine and omeprazole, can be taken at the same time as Tivicay.

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

Supplements or multivitamins that contain calcium, iron, or magnesium

Supplements or multivitamins that contain calcium, iron, or magnesium can interfere with the absorption of Tivicay into your body and make it less effective.

If you take Tivicay with food, you can take supplements or multivitamins that contain 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 that contains calcium, iron, or magnesiumduring the 6 hours before taking Tivicay, or for at least 2 hours after taking it.

• Talk to your doctor for advice on how to take supplements or multivitamins that contain calcium, iron, or magnesium with Tivicay.

If you take more Tivicay than you should

If you (or your child) take more Tivicay than you should, 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) miss a dose, take it as soon as you remember. But if it is less than 4 hours until 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 doseto make up for a forgotten dose.

Do not stop taking Tivicay

Take Tivicay until your doctor tells you to stop. Do not stop taking it unless your doctor has told you to.

If you have any further questions on the use of 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. The signs include:

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

• See a doctor immediately. Your doctor may decide to do liver, kidney, or blood tests and may tell you to stop taking Tivicay.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• diarrhea
• nausea.

Common side effects

These may affect up to 1 in 10 people:

• rash
• itching (pruritus)
• vomiting
• stomach pain (abdominal pain)
• stomach discomfort (abdomen)
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feeling of deep sadness and loss of self-worth)
• anxiety
• lack of energy (fatigue)
• gas (flatulence)
• increase in liver enzyme levels
• increase in muscle enzyme levels (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.

1. *especially 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 (the signs can include yellowing of the skin and the whites of the eyes or unusually dark urine)
• increase in bilirubin (a liver function test) in your blood
• suicide (especially in patients who have previously had depression or mental health problems).

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

Signs 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 being detected by the weakened immune system before treatment started. After starting treatment, the immune system becomes stronger and can fight off these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, as well as some of the following:

• headache
• stomach pain
• difficulty breathing.

In rare cases, as the immune system becomes stronger, it can also attack healthy tissue (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting treatment for HIV infection. The symptoms can include:

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

If you (or your child) have any symptoms of infection or inflammationor if you notice any of the above symptoms:

• See a doctor immediately. Do not take any other medicines for the infection without talking to your doctor first.

Joint pain, stiffness, and bone problems

Some people being treated for HIV infection 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 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 system is very weakened
• if they are overweight.

The signs of osteonecrosis include:

• joint stiffness
• joint pain or discomfort (especially in the hip, knee, or shoulder)
• difficulty moving.

If you notice any of these symptoms:

• Tell your doctor.

Effects on weight, lipids, and glucose in the blood

During HIV treatment, there may be an increase in weight and levels of lipids and glucose in the blood. This is partly due to the recovery of health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Reporting of side effects

If you experience 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.

5. Storing 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 bottle after EXP.

Tivicay 10 mg film-coated tablets

Store in the original package to protect from moisture. Keep the bottle tightly closed. Do not throw away the desiccant. Do not take the desiccant. This medicine does not require any special storage conditions.

Tivicay 25 mg and 50 mg film-coated tablets

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Tivicay Composition

• The active ingredient 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 carboxymethyl starch, sodium stearyl fumarate, partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, and for the 25 mg and 50 mg tablets, yellow iron oxide (E172).

Product Appearance and Package Contents

The 10 mg Tivicay film-coated tablets are white, round, biconvex, engraved with “SV 572” on one side and “10” on the other. The bottle contains a desiccant to reduce moisture. Once opened, keep the desiccant in the bottle, do not discard it.

The 25 mg Tivicay film-coated tablets are pale yellow, round, biconvex, engraved with “SV 572” on one side and “25” on the other.

The 50 mg Tivicay film-coated tablets are yellow, round, biconvex, engraved with “SV 572” on one side and “50” on the other.

The film-coated tablets are supplied in bottles containing 30 or 90 tablets. Only certain package sizes may be marketed.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands

Manufacturer

Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda de Duero, Burgos, Spain

or

Delpharm Poznan Spólka Akcyjna, ul., Grunwaldzka 189, 60-322 Poznan, Poland.

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: {month YYYY}.

Other sources of information

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