50 mg / 300 mg film-coated tablets
dolutegravir / lamivudine
1. What Dovato is and what it is used for
Dovato is a medicine containing two active substances used to treat HIV – infection ( HIV = human immunodeficiency virus): dolutegravir and lamivudine. Dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI) and lamivudine belongs to a group of antiretroviral medicines called nucleoside analog reverse transcriptase inhibitors (NRTIs).
Dovato is used to treat HIV in adults and adolescents from the age of 12 weighings at least 40 kg.
Dovato not a cure for HIV – infection, but it keeps the amount of virus in the 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 is important for the body’s ability to fight infections.
Not everyone responds in the same way to treatment with Dovato. Your doctor will check the effect of the treatment on you.
What you need to know before taking Dovato
Do not take Dovato
- if you are allergic ( hypersensitive ) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).
- if you are taking another medicine called fampridine (also called dalfampridine; used for multiple sclerosis ).
→ If you think any of these apply to you, tell your doctor.
Warnings and cautions
Some people taking Dovato or other combination therapies for HIV are at greater risk of developing serious side effects. You need to know these extra risks:
- 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 consulting your doctor, as hepatitis A may recur)
- if you have kidney problems.
→ If any of these apply to you, tell your doctor before using Dovato You may need extra checks, including blood tests, while you are taking this medicine. See section 4 for more information.
Allergic reactions
Dovato contains dolutegravir. Dolutegravir can cause a severe allergic reaction, a so-called hypersensitivity reaction. You need to know the important signs and symptoms to be aware of while taking Dovato.
→ Read the information under “Allergic reactions” in section 4 of this leaflet.
Pay attention to important symptoms
Some people taking medicines for HIV – infection, other problems can be serious. These are:
- symptoms of infection and inflammation
- joint pain, stiffness, and skeletal problems.
You need to know the important signs and symptoms to be aware of while taking Dovato.
→ Read the ” Other possible side effect are ” in section 4 of this leaflet.
Protect others
HIV – infection is spread by sexual contact with an infected person or by transfer via contaminated blood (such as if the same needles). Although effective antiretroviral therapy reduces the risk, you can still transmit HIV infection while taking this medicine. Discuss with your doctor what steps you need to take to avoid infecting others.
Children
This medicine is not intended for use in children or adolescents under 12 years of age as it has not been adequately studied in these patients.
Other drugs and Dovato
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Dovato with the following medicines:
- fampridine (also called dalfampridine), which is used to treat multiple sclerosis.
Some medicines may affect the way Dovato works, or increase the risk of side effects. Dovato may also affect the way some other medicines work.
Tell your doctor if you are taking any of the medicines listed below:
- metformin, for the treatment of diabetes
- drugs called antacids that are used for indigestion and heartburn. Do not take antacids for the next 6 hours before taking Dovato, or for at least 2 hours after taking Dovato (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 supplements or multivitamins that contain calcium, iron, or magnesium while you are taking Dovato. If you are not taking Dovato with food, do not take supplements or multivitamins containing calcium, iron, or magnesium for the next 6 hours before taking Dovato or for at least 2 hours after taking Dovato (see also section 3 “How to tar Dovato ”).
- emtricitabine, etravirine, efavirenz, nevirapine or tipranavir / ritonavir, for the treatment of HIV – infection
- medicines (usually liquid) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol, or maltitol) if taken regularly
- cladribine, for the treatment of leukemia or multiple sclerosis
- 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 ), an herbal remedy for mild depression and mild anxiety.
→ Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide that your dose needs to be changed or that you need to go for more check-ups.
Pregnancy
If you are pregnant, become pregnant, or planning to have children:
→ Talk to your doctor about the risks and benefits of taking Dovato.
Taking Dovato at the time of conception or during the first six weeks of pregnancy may increase the risk of a malformation called neural tube defects, e.g. spina bifida (spina bifida).
If you get pregnant while taking Dovato:
→ Talk to your doctor and discuss whether you need to use contraception, such as condoms or pills.
Talk to a 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 a doctor, as this may harm you and the fetus.
Breast-feeding
Women who are HIV- positive should not breast-feed because HIV – infection can be transmitted to the baby through breast milk.
A small amount of the ingredients in Dovato can also pass over to breast milk.
If you are breast-feeding or considering starting breastfeeding:
→ Talk to a doctor immediately.
Driving and using machines
Dovato may make you dizzy and have other side effects that diminish your attention.
→ Do not drive or use machines unless you are sure that the medicine will not affect you in that way.
3. How to take Dovato
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose of Dovato is one tablet daily.
Swallow the tablet with a little liquid. Dovato can be taken with or without food.
Use for young people
Young people between the ages of 12 and 17 who weigh at least 40 kg can take the adult dose, ie. one tablet once a day.
Antacids
Antacids, which are used for indigestion and heartburn, can prevent Dovato from being absorbed by the body and therefore have a worse effect.
Do not take antacids for the next 6 hours before taking Dovato or for at least 2 hours after taking Dovato. You can take other antacids such as ranitidine and omeprazole at the same time as Dovato.
→ Talk to a doctor for more information on taking antacids and Dovato.
Dietary supplements or multivitamins that contain calcium, iron, or magnesium
Dietary supplements or multivitamins that contain calcium, iron, or magnesium can prevent Dovato from being absorbed by the body and therefore have a worse effect.
If you take Dovato with food, you can take supplements or multivitamins that contain calcium, iron, or magnesium while you are taking Dovato. If you are not taking Dovato with food, do not take supplements or multivitamins containing calcium, iron, or magnesium for the next 6 hours before taking Dovato or at least 2 hours after taking Dovato (see also section 3 “How to take Dovato ”).
→ Talk to your doctor for more information on taking supplements or multivitamins that contain calcium, iron, or magnesium and Dovato.
If you take more Dovato then you should
If you take more Dovato than you should, contact your doctor or pharmacist for advice. Show them the package with Dovato if possible.
If you forget to take Dovato
If you miss a dose, take it as soon as you remember. If it is time for the next dose within 4 hours, you, skip the dose you missed and take your next dose at the usual time. Then continue with your treatment as before.
→ Do not take a double dose to make up for a forgotten dose.
Do not stop taking Dovato without talking to a doctor
Take Dovato for as long as your doctor prescribes it. Do not stop unless your doctor tells you to. If you stop taking Dovato, it may affect your health and how future treatment works.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is therefore very important that you talk to your doctor about any changes in your health.
Allergic reactions
Dovato contains dolutegravir. Dolutegravir can cause a severe allergic reaction, a so-called hypersensitivity reaction. This is a less common reaction (which may affect up to 1 in 100 people) in people taking dolutegravir. If you get any of the following symptoms:
- rash
- high temperature ( fever )
- lack of energy ( fatigue )
- swelling, sometimes in the face and mouth ( angioedema ), which causes difficulty breathing
- muscle or joint pain.
→ Seek medical attention immediately. Your doctor may decide to take samples of your liver, kidneys, or blood and you may want to stop taking Dovato.
Very common side effects are
These can occur in more than 1 in 10 people:
- headache
- diarrhea
- nausea.
Common side effects are
These can occur in up to 1 in 10 people:
- depression (deep sadness and feelings of inferiority)
- rash
- itching ( pruritus )
- vomiting
- pain or discomfort from the stomach ( abdomen )
- gas production ( flatulence )
- dizziness
- drowsiness
- difficulty sleeping ( insomnia )
- abnormal dreams
- lack of energy ( fatigue )
- hair loss
- anxiety
- joint pain
- muscle pain.
Common side effects that can show up in blood tests are:
- elevated liver enzyme values ( aminotransferases )
- the increased amount of enzymes produced in the muscles ( creatine phosphokinase).
Uncommon side effects are
These can occur in up to 1 in 100 people:
- inflammation of the liver ( hepatitis )
- suicide attempts (especially in patients who have previously had depression or mental health problems)
- suicidal ideation (especially in patients with a history of depression or mental health problems).
Uncommon side effects that may show up in blood tests are:
- decreased number of cells involved in blood coagulation ( thrombocytopenia )
- a small number of red blood cells ( anemia ) or a small number of white blood cells ( neutropenia ).
Rare side effects are
These can occur in up to 1 in 1,000 people:
- liver failure (signs may be yellowing of the skin and whites of the eyes or abnormally dark urine)
- swelling, sometimes in the face or mouth ( angioedema ), which causes difficulty breathing
- inflammation of the pancreas ( pancreatitis )
- degradation of muscle tissue.
Rare side effects that may show up in blood tests are:
- elevated levels of an enzyme called amylase.
Very rare side effect s
These can occur in up to 1 in 10,000 people:
- lactic acidosis (excess lactic acid in the blood)
- numbness and tingling in the skin
- the feeling of weakness in arms and legs.
Very rare side effects that may show up in blood tests are:
- the inability of bone marrow to form new red blood cells ( pure erythrocyte plasma ).
Other possible side effects are
People taking combination drugs for HIV may experience other side effects.
Symptoms of infection you and inflammation you
People with advanced HIV – infection ( AIDS ) have weak immune systems, and the risk is greater than they develop a serious infection (opportunistic infection s). Such infections may have been “silent” and not detected by the weak immune system before starting treatment. Once treatment has begun, the immune system becomes stronger and can attack the infections, which can cause symptoms of infection or inflammation. The symptoms usually consist of fever plus some of the following:
- headache
- gripe
- breathing difficulties.
When the immune system becomes stronger, it can also in rare cases attack healthy body tissue ( autoimmune diseases ). The symptoms of autoimmune diseases may develop several months after you start your treatment against HIV – infection a. The symptoms can be:
- palpitations (rapid or irregular heartbeat) or tremors
- hyperactivity (excessive restlessness and excessive movement)
- weakness that begins in the hands and feet and moves upwards towards the torso.
If you get symptoms of infection or if you notice any of the symptoms mentioned above:
→ Tell your doctor immediately. Do not take other medicines for infection without your doctor’s recommendation.
Joint pain, stiffness, and skeletal problems
Some people who take combination drugs for HIV suffer from osteonecrosis. Osteonecrosis means that parts of the skeletal tissue are permanently damaged because the blood supply to the skeleton decreases. The risk of suffering from this increases in people who:
- have been treated for a long time with combination drugs
- also taking anti-inflammatory medicines called corticosteroids s
- drinking alcohol
- has a very weak immune system
- are overweight.
Signs of osteonecrosis are:
- stiffness in the joints
- aches and pains (especially in the hips, knees, or shoulders)
- difficulty moving.
If you get any of these symptoms:
→ Tell your doctor.
Effects on weight and blood fats 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 when it comes to blood fats, there can sometimes be a connection with HIV drugs. Your doctor will prescribe tests to find such changes.
Reporting of side effects
5. How to store Dovato
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 can after “EXP” or “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are dolutegravir and lamivudine. Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
- The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29 / 32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
- This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
What the medicine looks like and the contents of the pack
Dovato film-coated tablets are oval, biconvex, white tablets debossed with “SV 137” on one side.
The film-coated tablets are available in jars that are closed with a child-resistant lid.
Each jar contains 30 film-coated tablets.
There are also multiple packs of 90 film-coated tablets (3 packs of 30 film-coated tablets).
Not all pack sizes may be available in your country.
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 to find out more about this medicine:
| Belgium / Belgique / BelgienViiV Healthcare srl / bv Tel: + 32 (0) 10 85 65 00 | LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com |
| BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 | Luxembourg / LuxemburgViiV Healthcare srl / bv Belgium / BelgiumTel: + 32 (0) 10 85 65 00 |
| Czech RepublicGlaxoSmithKline, sroTel: + 420 222 001 111cz.info@gsk.com | HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300 |
| DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com | MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131 |
| GermanyViiV Healthcare GmbHTel .: + 49 (0) 89 203 0038-10viiv.med.info@viivhealthcare.com | The NetherlandsViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
| EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com | NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00 |
| GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainLaboratories ViiV Healthcare, SLTel: + 34 900 923 501 es-ci@viivhealthcare.com | PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000 |
| FranceViiV Healthcare SASTel .: + 33 (0) 1 39 17 69 69Infomed@viivhealthcare.com | PortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDATel: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com |
| CroatiaGlaxoSmithKline dooTel: + 385 16051 999 | RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208 |
| IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 | SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com |
| ItalyViiV Healthcare Srl Tel: + 39 (0) 45 9212611 | Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com |
| LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com | United KingdomViiV Healthcare UK LimitedTel: + 44 (0) 800 221441customercontactuk@gsk.com |