Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dovato

Document Subject

Generated Narrative: MedicinalProductDefinition mp6eb523b7a88cd6dcee848368833cbd08

identifier: http://ema.europa.eu/identifier/EU/1/19/1370/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Dovato 50 mg/300 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6eb523b7a88cd6dcee848368833cbd08

identifier: http://ema.europa.eu/identifier/EU/1/19/1370/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - dovato

Attesters

What is in this leaflet

1. What Dovato is and what it is used for
2. What you need to know before you take Dovato
3. How to take Dovato
4. Possible side effects
5. How to store Dovato
6. Contents of the pack and other information

Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and lamivudine belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Dovato is used to treat HIV in adults and adolescents over 12 years old 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 your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

Not everyone responds to treatment with Dovato in the same way. Your doctor will monitor the effectiveness of your treatment.

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 a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).

  If you think any of these apply to you, tell your doctor.

Warnings and precautions
Some people taking Dovato or other combination treatments for HIV are more at risk of serious side effects than others. You need to be aware of the 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 infection, don t stop Dovato without your doctor s advice, as your hepatitis may come back)
• if you have a kidney problem. Talk to your doctor before using Dovato if any of these apply to you. You may need extra check- ups, including blood tests, while you re taking your medicine. See section 4 for more information.

Allergic reactions Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about important signs and symptoms to look out for while you re taking Dovato. Read the information Allergic reactions in section 4 of this leaflet.

Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness and bone problems. You need to know about important signs and symptoms to look out for while you re taking Dovato.
  Read the information Other possible side effects in section 4 of this leaflet.

Children This medicine is not for use in children under 12 years of age, because it has not been studied in these patients.

Other medicines and Dovato Tell your doctor if you are taking, have recently taken or might take any other medicines.

Don't take Dovato with the following medicine:

• fampridine (also known as dalfampridine), used in multiple sclerosis.

Some medicines can affect how Dovato works or make it more likely that you will have side effects. Dovato can also affect how some other medicines work. Tell your doctor if you are taking any of the medicines in the following list:

• metformin, to treat diabetes

• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, How to take Dovato )

• supplements or multivitamins containing calcium, iron or magnesium. 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, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take 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, to treat leukaemia 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 to treat depression.

  Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra check ups.

Pregnancy
If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Talk to your doctor about the risks and benefits of taking Dovato.

Taking Dovato at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).

If you could get pregnant while taking Dovato:

Talk to your doctor and discuss whether there is a need for contraception, such as condom or pills.

Tell 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 may harm you and your unborn child.

Breast-feeding
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

A small amount of the ingredients in Dovato can also pass into your breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines
Dovato can make you dizzy, and have other side effects that make you less alert.

Don t drive or operate machinery unless you are sure you re not affected.

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 of Dovato is one tablet once a day.

Swallow the tablet with some liquid. Dovato can be taken with or without food.

Use in adolescents Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.

Antacid medicines Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.

Talk to your doctor for further advice on taking acid-lowering medicines with Dovato.

Supplements or multivitamins containing calcium, iron or magnesium Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into 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, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it. Talk to your doctor for further advice on taking supplements or multivitamins containing calcium, iron or magnesium with Dovato.

If you take more Dovato than you should
If you take too many tablets of Dovato contact your doctor or pharmacist for advice. If possible, show them the Dovato pack.

If you forget to take Dovato
If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

Do not take a double dose to make up for a forgotten dose.

Don t stop taking Dovato without advice from your doctor
Take Dovato for as long as your doctor recommends. Don t stop unless your doctor tells you to. Stopping Dovato can affect your health and how future treatment works.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.

Allergic reactions Dovato contains dolutegravir. Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction. This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir. If you get any of the following symptoms: skin rash a high temperature (fever) lack of energy (fatigue) swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing muscle or joint aches. See a doctor straight away. Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Dovato.

Very common side effects
These may affect more than 1 in 10 people: headache diarrhoea feeling sick (nausea).

Common side effects
These may affect up to 1 in 10 people: depression (feelings of deep sadness and unworthiness) rash itching (pruritus) being sick (vomiting) stomach (abdominal) pain or discomfort weight gain wind (flatulence) dizziness feeling drowsy difficulty sleeping (insomnia) abnormal dreams lack of energy (fatigue) hair loss anxiety joint pain muscle pain.

Common side effects that may show up in blood tests are: increase in the level of liver enzymes (aminotransferases) increase in the level of enzymes produced in the muscles (creatine phosphokinase).

Uncommon side effects
These may affect up to 1 in 100 people: inflammation of the liver (hepatitis) suicidal attempt (particularly in patients who have had depression or mental health problems before) suicidal thoughts (particularly in patients who have had depression or mental health problems before). panic attack

Uncommon side effects that may show up in blood tests are: a decreased number of cells involved in blood clotting (thrombocytopenia) a low red blood cell count (anaemia) or low white blood cell count (neutropenia).

Rare side effects
These may affect up to 1 in 1000 people: liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine) swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing inflammation of the pancreas (pancreatitis) breakdown of muscle tissue. suicide (particularly in patients who have had depression or mental health problems before)

Tell your doctor immediately if you experience any mental health problems (see also other mental health problems above).

Rare side effects that may show up in blood tests are: increase in bilirubin (a test of liver function) increase in an enzyme called amylase.

Very rare side effects These may affect up to 1 in 10,000 people: lactic acidosis (excess lactic acid in the blood) numbness, tingly feelings in the skin (pins and needles) sensation of weakness in the limbs.

Very rare side effects that may show up in blood tests are: a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

Other possible side effects People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation
People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been silent and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following: headache stomach ache difficulty breathing. In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include: palpitations (rapid or irregular heartbeat) or tremor hyperactivity (excessive restlessness and movement) weakness beginning in the hands and feet and moving up towards the trunk of the body.

If you get any symptoms of infection or if you notice any of the symptoms above:

Tell your doctor immediately. Don t take other medicines for the infection without your doctor s advice.

Joint pain, stiffness and bone problems Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue are permanently damaged because of reduced blood supply to the bone. 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 systems are very weak if they are overweight.

Signs of osteonecrosis include: stiffness in the joints aches and pains in the joints (especially in the hip, knee or shoulder) difficulty moving. If you notice any of these symptoms:

Tell your doctor.

Weight, blood lipid and blood glucose effects:
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Reporting of side effects
If you get 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.

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 or blister strips after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Dovato contains

• The active substances are dolutegravir and lamivudine. Each 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, that is to say essentially sodium- free .

What Dovato looks like and contents of the pack

Dovato film-coated tablets are oval, biconvex, white tablets debossed with 'SV 137' on one face.

The film-coated tablets are provided in bottles closed with child-resistant closures or in child-resistant blister strips.

Bottle pack Each bottle contains 30 film-coated tablets.

Multipacks containing 90 film-coated tablets (3 bottle packs of 30 film-coated tablets) are also available.

Blister pack Each blister pack contains 30 film-coated tablets consisting of 4 blister strips containing 7 film-coated tablets and 1 blister strip containing 2 film-coated tablets.

Multipacks containing 90 film-coated tablets (3 blister packs of 30 film-coated tablets) are also available.

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, S.A.
Avda. Extremadura, 3 09400 Aranda De Duero Burgos Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien ViiV Healthcare srl/bv
T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV Tel: + 370 80000
ViiV Healthcare BV Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv
Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com Magyarorsz g ViiV Healthcare BV Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta ViiV Healthcare BV Tel: + 356 80065Deutschland ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com

Nederland ViiV Healthcare BV
Tel: + 31 (0)33 2081Eesti ViiV Healthcare BV Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 es-ci@viivhealthcare.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS
T l.: + 33 (0)1 39 17 69 Infomed@viivhealthcare.com

Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com

Hrvatska ViiV Healthcare BV Tel: + 385 800787Rom nia ViiV Healthcare BV Tel: + 40800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV Tel: + 386 80688 sland Vistor hf. S mi: +354 535 7Slovensk republika ViiV Healthcare BV Tel: + 421 800500Italia ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
ViiV Healthcare BV

Sverige GlaxoSmithKline AB : + 357 80070Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija ViiV Healthcare BV Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: