Label: information for the patient

Dovato50mg/300mg film-coated tablets

dolutegravir/lamivudine

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should 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 not listed in this label. See section 4.

6. Contents of the pack and additional information

Dovato is a medication that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of antiretroviral medications called integrase inhibitors (INI) and lamivudine belongs to a group of antiretroviral medications called nucleoside reverse transcriptase inhibitors (NRTIs).

Dovato is used to treat HIV infection in adults and adolescents 12 years of age or older who weigh at least 40 kg.

Dovato does not cure HIV infection; it maintains the amount of virus in the body at a low level. This helps to maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important for helping the body to fight off infections.

Not all people respond to Dovato treatment in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Dovato

• if you areallergic(hypersensitive) to dolutegravir or lamivudine or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking a medicine calledfampridina(also known as dalfampridina; used to treatmultiple sclerosis).

_If you think this applies to you,consult your doctor.

Warnings and precautions

Some people taking Dovato or other combined HIV treatments have a higher risk of developing serious side effects. You need to know that there is a higher risk:

• if you have moderate or severe liver disease
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B do not stop takingDovatowithout consulting your doctor, as this could make it worse)
• if you have a kidney problem.

• Consult your doctor before starting to take Dovatoif any of these conditions apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.

Allergic reactions

Dovato contains dolutegravir. Dolutegravir can cause a severe allergic reaction known ashypersensitivity reaction. You need to know what important signs and symptoms to look out for while taking Dovato.

• Read the information“Allergic reactions” in section 4 of this leaflet.

Be aware of important symptoms

Some people taking HIV medicines develop other conditions, which can be serious. These include:

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

You need to know what important signs and symptoms to look out for while taking Dovato.

• Read the information about “Other possible side effects” in section 4of this leaflet.

Children and adolescents

This medicine is not indicated in children under 12 yearsand adolescentswho weigh less than 40 kg, because it has not been studied in these patients.

Other medicines and Dovato

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

Do not take Dovato with the following medicine:

• fampridina (also known as dalfampridina),used to treatmultiple sclerosis.

Some medicines can affect the way Dovato works or increase the chance of side effects.Dovato can also affect the way some other medicines work.

Inform your doctorif you are taking any of the following medicines:

• metformin, to treatdiabetes
• medicines calledantacids, to treatindigestionandheartburn.Do not take an antacidwithin 6 hours of taking Dovato, or at least 2 hours after taking it (see also section 3, “How to take Dovato”).
• supplements or multivitamins that contain calcium, iron or magnesium.If you take Dovato with food, you can take the supplements or multivitamins that contain calcium, iron or magnesium at the same time as Dovato.If you do not take Dovato with food, you cannot take a supplement or multivitamin that contains calcium, iron or magnesiumwithin 6 hours of taking Dovato, or at least 2 hours after taking it(see also section 3, “How to take Dovato”).
• emtricitabine, etravirina, efavirenz, nevirapina or tipranavir/ritonavir, to treatHIV infection
• medicines (usually liquids) that contain sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• cladribina, used to treatleukaemiaormultiple sclerosis
• rifampicina, to treat tuberculosis (TB) and otherbacterial infections
• phenitoína and phenobarbital, to treatepilepsy
• oxcarbazepina and carbamazepina, to treatepilepsyorbipolar disorder
• St. John’s Wort(Hypericum perforatum), a herbal medicine to treatdepression.

• Inform your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide to adjust your dose or that you need additional checks.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to become pregnant:

Consult your doctorabout the risks and benefits of taking Dovato.

Inform your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking Dovato without consulting your doctor, as this could harm you and your baby.

Breast-feeding

It is not recommendedthat women with HIV breast-feed because the HIV infection can be transmitted to the baby through breast milk.

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

If you are breast-feeding or plan to breast-feed,you must consult your doctor as soon as possible.

Driving and using machines

Dovatomay make you feel dizzy and may have other side effectsthat reduce your attention.

• Do not drive or operate machinery, unless you are sure you are not affected.

Dovato contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose of Dovato isone tablet once a day.

Swallow the tablet with a little liquid.Dovatocan be taken with or without food.

The Dovato packaging is for 30 days; it contains four blisters of 7 tablets and one blister of 2 tablets. To help you track the medication intake for 30 days, the blisters of 7 tablets include printed days of the week and the blister of 2 tablets includes two empty boxes where you can write the corresponding day.

Use inadolescents

Adolescents between 12 and 17 years old and weighing at least40 kgcan take the adult dose of one tablet once a day.

Antacids

Antacids to treat indigestion and stomach heartburn may make Dovato not be absorbed by your body and make it less effective.

Do not take an antacidwithin 6 hours before taking Dovato, or at least 2 hours after taking it.

Other medications that reduce acidity, such as ranitidine and omeprazole, can be taken at the same time asDovato.

_Consult with your doctor to advise you on which acidity medications

can be taken withDovato.

Supplements or multivitamins containing calcium, iron, or magnesium

Supplements or multivitamins containing calcium, iron, or magnesium may make Dovato not be absorbed by your body and make it less effective.

If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Dovato. If you do not take Dovato with food, you cannot take a supplement or multivitamin containing calcium, iron, or magnesium within 6 hours before taking Dovato, or at least 2 hours after taking it.

_Consult with your doctor to advise you on how to take supplements or

multivitamins containing calcium, iron, or magnesium withDovato.

If you take moreDovatothan you should

If you exceed the number of Dovato tablets,contact your doctor or pharmacist for advice. If possible, show them the Dovato box.

If you forgot to takeDovato

If you forget a dose, take it as soon as you remember. But if there are less than 4 hours until your next dose, skip that dose you forgot and take the next one at the usual time. Then continue your treatment as before.

• Do not take a double doseto compensate for the missed doses.

Do not interrupt the treatment with Dovato without your doctor's recommendation

Take Dovatountil your doctor tells you to. Do not stop taking it unless your doctor advises you to. Stopping treatment with Dovato may affect your health and future treatment performance.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them,so it is very important that you tell your doctor about any changes in your health status.

Allergic reactions

Dovato contains dolutegravir. Dolutegravir can cause a severe allergic reaction known ashypersensitivity reaction.This is a rare reaction (can affect up to 1 in 100 people) in people taking dolutegravir. If you have any of the following symptoms:

• skin rash
• high temperature (fever)
• fatigue (fatigue)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• muscle or joint pain.

?Go to a doctor immediately.Your doctor may decide to perform liver, kidney or blood tests and may tell you to stop taking Dovato.

Very common side effects

Thesecan affect more than 1 in 10people:

• headache
• diarrhea
• nausea.

Common side effects

Thesecan affectup to 1 in 10people:

• depression (feeling of deep sadness and lack of self-esteem)
• skin rash
• itching (pruritus)
• vomiting
• stomach pain (abdominal)
• weight gain
• gas (flatulence)
• dizziness
• drowsiness
• difficulty falling asleep (insomnia)
• abnormal dreams
• fatigue (fatigue)
• hair loss
• anxiety
• joint pain
• muscle pain.

The common side effects that can appear in blood tests are:

• an increase in liver enzymes (aminotransferases)
• an increase in muscle enzymes (creatine phosphokinase).

Rare side effects

These can affectup to 1 in 100people:

• inflammation of the liver (hepatitis)
• suicidal attempt(especially in patients who have previously had depression or mental health problems)
• suicidal thoughts(especially in patients who have previously had depression or mental health problems)
• panic attack.

The rare side effects that can appear in blood tests are:

• a decrease in cells involved in blood clotting (thrombocytopenia)
• a low count of red blood cells (anemia) or a low count of white blood cells (neutropenia).

Very rare side effects

Thesecan affectup to1 in 10000people:

• liver failure (the signs may include yellowing of the skin and eyes or dark-colored urine)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• inflammation of the pancreas (pancreatitis)
• muscle tissue rupture
• suicide (especially in patients who have previously had depression or mental health problems).

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

The very rare side effects that can appear in blood tests are:

• an increase in bilirubin (liver function test)
• an increase in an enzyme calledamylase.

Very rare side effects

Thesecan affectup to1 in 10000people:

• lactic acidosis (excess lactic acid in the blood)
• numbness, tingling sensation in the skin (pinpricks)
• sensation of weakness in the limbs.

The very rare side effects that can appear in blood tests are:

• a failure of the bone marrow to produce new red blood cells (aplastic anemia).

Other possible side effects

People taking combination therapy for HIV may have other side effects.

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 developed in a "silent" way, not being detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and may fight these infections, causing 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 may also attack healthy tissues (autoimmune disorders).The symptoms ofautoimmune disorders can appear many monthsafterstarting to take medicines to treat HIV infection. The symptoms may include:

• palpitations (rapid or irregular heartbeat) orshakiness
• hyperactivity (excessive restlessness and movement)
• weaknessthat startsin the hands and feet and ascends to the trunk of the body.

If you have any symptoms of infectionor if you notice any of the above symptoms:

_Consult your doctor immediately.Do not take other medicines for the infection without consulting your doctor first.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV developosteonecrosis. In this condition, parts of the bone tissue are permanently damaged due to reduced blood supply to the bones. People may be more prone to 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 severely weakened
• if they are overweight.

The signs of osteonecrosis include:

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

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine..

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottleor blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.By doing so, you will help protect the environment.

Composition of Dovato

• The active ingredients are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir and 300 mg of lamivudine.
• The other components are microcrystalline cellulose, sodium carboxymethylstarch, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearoyl fumarate, hypromellose (E464), macrogol, and titanium dioxide (E171).

Appearance of the product and contents of the package

The Dovato film-coated tablets are oval, biconvex, white with "SV 137" engraved on one side.

The film-coated tablets are supplied in child-resistant bottles or in child-resistant blisters.

Bottle

Each bottle contains 30 film-coated tablets.

Also available are clinical packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets, in bottles).

Blister

Each pack contains 30 film-coated tablets and consists of 4 blisters with 7 film-coated tablets and 1 blister with 2 film-coated tablets. Only for the 2-tablet blister, an intentionally empty space is included in each half of the blister.

Also available are clinical packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets, in blisters).

Only some package sizes may be marketed.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands

Responsible for manufacturing

Glaxo Wellcome, S.A.

Avda. Extremadura, 3

09400 Aranda de Duero (Burgos)

Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:MM/YYYY

Other sources of information

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.