Dovato 50 mg/300 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Dovato 50 mg/300 mg film-coated tablets
dolutegravir/lamivudine
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Dovato is and what it is used for
- What you need to know before taking Dovato
- How to take Dovato
- Possible adverse effects
- How to store Dovato
- Contents of the pack and other information
1. What Dovato is and what it is used for
Dovato is a medicine that contains two active substances used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI), and lamivudine belongs to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTI).
Dovato is used to treat HIV infection in adults and adolescents over 12 years of age who weigh at least 40 kg.
Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important in helping your body fight infections.
Not all people respond to treatment with Dovato in the same way. Your doctor will monitor how well your treatment is working.
2. What you need to know before starting to take Dovato
Do not take Dovato
-
if you are allergic (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 called fampridine (also known as dalfampridine; used to treat multiple sclerosis).
-
If you think any of these apply to you, consult your doctor.
Warnings and precautions
Some people who take Dovato or other combination treatments for HIV are at higher risk of developing serious side effects than others. You should be aware that the risk is higher:
-
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 taking Dovato without medical advice, as your condition may worsen)
-
if you have a kidney problem.
-
Consult your doctor before starting Dovato if 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 may cause a serious allergic reaction known as hypersensitivity reaction. You need to know which important signs and symptoms to watch for while taking Dovato.
Read the information on “Allergic reactions” in section 4 of this leaflet.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other disorders, which may be serious. These include:
- symptoms of infections and inflammation
- joint pain, stiffness, and bone problems.
You need to know which important signs and symptoms to watch for while taking Dovato.
- Read the information on “Other possible side effects” in section 4 of this leaflet.
Children and adolescents
This medicine is not indicated for children under 12 years of age and adolescents weighing less than 40 kg, as it has not been studied in these patients.
Other medicines and Dovato
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Do not take Dovato with the following medicine:
- fampridine (also known as dalfampridine), used to treat multiple sclerosis.
Some medicines may affect how Dovato works or increase the likelihood of side effects. Dovato may also affect how some other medicines work.
Tell your doctor if you 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 Dovato, or at least 2 hours after taking it (see also section 3, “How to take Dovato”).
-
supplements or multivitamins containing calcium, iron, or magnesium. If you take Dovato with food, you may take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Dovato. If you do not take Dovato with food, you must not take a supplement or multivitamin containing calcium, iron, or magnesium within 6 hours before taking Dovato, or at least 2 hours after taking it (see also section 3, “How to take Dovato”).
-
emtricitabine, etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, to treat HIV infection
-
medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
-
cladribine, used to treat leukemia or multiple sclerosis
-
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 used to treat depression.
-
Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide to adjust your dose or that you need additional monitoring.
Pregnancy
If you are pregnant, think you may be pregnant, or plan to become pregnant:
- Consult your doctor about the risks and benefits of taking Dovato.
Inform your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop treatment with Dovato without consulting your doctor, as this could harm you and your baby.
Breast-feeding
Breast-feeding is not recommended for women living with HIV because HIV infection can be passed 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 considering breast-feeding, you must consult your doctor as soon as possible.
Driving and using machines
Dovato may make you feel dizzy and may cause other side effects that reduce your alertness.
- 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”.
3. How to take Dovato
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
- The recommended dose of Dovato is one tablet once daily.
Swallow the tablet with some liquid. Dovato can be taken with or without food.
The 30-day blister pack of Dovato contains four blisters of 7 tablets and one blister of 2 tablets. To help you keep track of taking your medicine over 30 days, the 7-tablet blisters include the days of the week printed on them, and the 2-tablet blister has two blank boxes where you can write in the corresponding days.
Use in adolescents
Adolescents aged 12 to 17 years who weigh at least 40 kg can take the adult dose of one tablet once daily.
Antacid medicines
Antacids used to treat indigestion and heartburn may prevent Dovato from being absorbed by your body, making it less effective.
Do not take an antacid within 6 hours before taking Dovato, or wait at least 2 hours after taking Dovato before taking an antacid.
Other medicines that reduce acidity, such as ranitidine and omeprazol, can be taken at the same time as Dovato.
- Consult your doctor for advice on which acid-reducing medicines you can take with Dovato.
Calcium, iron, or magnesium supplements or multivitamins
Supplements or multivitamins containing calcium, iron, or magnesium may prevent Dovato from being absorbed by your body, making it less effective.
If you take Dovato with food, you may take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Dovato. If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron, or magnesium within 6 hours before taking Dovato, or wait at least 2 hours after taking Dovato before taking such supplements.
- Consult your doctor for advice on how to take supplements or multivitamins containing calcium, iron, or magnesium with Dovato.
If you take more Dovato than you should
If you take more tablets than prescribed, contact your doctor or pharmacist for advice. If possible, show them the Dovato package.
If you forget to take Dovato
If you miss a dose, take it as soon as you remember. However, if it is less than 4 hours before 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 dose to make up for a missed dose.
Do not stop treatment with Dovato without your doctor's recommendation
Keep taking Dovato for as long as your doctor tells you to. Do not stop taking it unless your doctor advises you to do so. Stopping treatment with Dovato may affect your health and the future effectiveness of treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Therefore, it is very important that you tell your doctor about any changes in your health.
Allergic reactions
Dovato contains dolutegravir. Dolutegravir may cause a serious allergic reaction known as hypersensitivity reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir. If you experience any of the following symptoms:
-
skin rash
-
high temperature (fever)
-
lack of energy (fatigue)
-
swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
-
muscle or joint pain
-
Seek medical help immediately. Your doctor may decide to perform liver, kidney, or blood tests and may instruct you to stop taking Dovato.
Very common adverse effects
These may affect more than 1 in 10 people:
- headache
- diarrhoea
- nausea
Common adverse effects
These may affect up to 1 in 10 people:
- depression (feeling deeply sad and lacking self-esteem)
- skin rash
- itching (pruritus)
- vomiting
- stomach or abdominal pain or discomfort
- weight gain
- gas (flatulence)
- dizziness
- drowsiness
- difficulty falling asleep (insomnia)
- abnormal dreams
- lack of energy (fatigue)
- hair loss
- anxiety
- joint pain
- muscle pain
Common adverse effects that may show up in blood tests include:
- increased levels of liver enzymes (aminotransferases)
- increased levels of enzymes produced in muscles (creatine phosphokinase)
Uncommon adverse effects
These may affect up to 1 in 100 people:
- inflammation of the liver (hepatitis)
- suicide attempt (especially in patients who previously had depression or mental health problems)
- suicidal thoughts (especially in patients who previously had depression or mental health problems)
- panic attack
Uncommon adverse effects that may show up in blood tests include:
- a decrease in cells involved in blood clotting (thrombocytopenia)
- low red blood cell count (anaemia) or low white blood cell count (neutropenia)
Rare adverse 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)
-
swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
-
inflammation of the pancreas (pancreatitis)
-
muscle tissue breakdown
-
suicide (especially in patients who previously had depression or mental health problems)
-
Tell your doctor immediately if you experience any mental health problems (see also other mental health issues listed above).
Rare adverse effects that may show up in blood tests include:
- increased bilirubin (liver function test)
- increased levels of an enzyme called amylase
Very rare adverse effects
These may affect up to 1 in 10,000 people:
- lactic acidosis (excess lactic acid in the blood)
- numbness, tingling sensation in the skin (pins and needles)
- feeling of weakness in the limbs
Very rare adverse effects that may appear in blood tests include:
- failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
Frequency not known – Cannot be estimated from available data:
- a condition in which red blood cells do not form properly (sideroblastic anaemia)
Other possible adverse effects
People who take combination therapy for HIV may experience other adverse 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 "silently," not detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and may start fighting these infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, along with 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). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:
- palpitations (fast or irregular heartbeat) or tremor
- hyperactivity (excessive restlessness and movement)
- weakness starting in the hands and feet and moving upward toward the body trunk
If you have any symptoms of infection 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 receiving combination HIV treatment develop osteonecrosis. In this condition, parts of the bone tissue are permanently damaged due to reduced blood supply to the bones. People may be more likely to develop this condition if they:
- have been on combination treatment for a long time
- are also taking anti-inflammatory medicines called corticosteroids
- drink alcohol
- have a severely weakened immune system
- are overweight
Signs of osteonecrosis include:
- stiffness in the joints
- discomfort and pain in the joints (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 in levels of lipids and blood glucose. This is partly related to improved health, lifestyle, and sometimes to the HIV medicines themselves. Your doctor will assess these changes.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dovato
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack after EXP. The expiry date refers to the last day of the month indicated.
This medicine requires no special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This helps protect the environment.
6. Contents of the container and additional information
Composition of Dovato
- The active substances 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 carboxymethyl starch, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
Appearance of the product and contents of the container
Dovato film-coated tablets are oval, biconvex, white tablets with "SV 137" engraved on one side.
Film-coated tablets are supplied in child-resistant bottles or in child-resistant blisters.
Bottle
Each bottle contains 30 film-coated tablets.
Clinical packs containing 90 film-coated tablets are also available (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. For the 2-tablet blister only, an intentionally blank compartment is included in each half of the blister.
Clinical packs containing 90 film-coated tablets are also available (3 packs of 30 film-coated tablets in blisters).
Only certain pack sizes may be marketed.
Marketing Authorization Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands
Manufacturer responsible for manufacturing
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
09400 Aranda de Duero (Burgos)
Spain
More information about this medicinal product can be requested by contacting the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
| Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tel/Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0)33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Mono. E.P.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 |
Croatia ViiV Healthcare BV Tel: + 385 800787089 | Romania ViiV Healthcare BV Tel: + 40800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | |
Date of the most recent review of this leaflet: MM/YYYY
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.