RUKOBIA 600 mg Extended-Release Tablet

Зміст інструкції

1. Rukobia 600 mg prolonged-release tablets
   1. What is Rukobia and what is it used for
   2. What you need to know before taking Rukobia
   3. How to take Rukobia
   4. Possible side effects
   5. How to store Rukobia

Rukobia 600 mg prolonged-release tablets

fostemsavir

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Rukobia and what is it used for

Rukobia contains fostemsavir and is a type of medicine against HIV (antiretroviral) known as

attachment inhibitor. It works by attaching to the virus and thus blocking its entry into the blood cells.
Rukobia is used with other antiretroviral medicines (combination therapy) to treat HIV infection in adults with limited treatment options (other antiretroviral medicines are not
sufficiently effective or are not adaptable).
Rukobia does not cure HIV infection; it reduces the amount of virus in the body and keeps it
at low levels. Since HIV reduces the number of CD4 cells in the body, keeping HIV at
a low level also contributes to increasing the number of CD4 cells in the blood. CD4 cells are a type of white blood cells that are important in helping the body fight infection.

2. What you need to know before taking Rukobia

Do not take Rukobia

• If you are allergic to fostemsaviror to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of these medicines: or carbamazepine, or phenytoin(used to treat epilepsyand prevent convulsions) or mitotane(to treat various types of cancer) or enzalutamide(to treat prostate cancer) or rifampicin(to treat some bacterial infectionssuch as tuberculosis) or medicines that contain St John's wort( Hypericum perforatum) (a herbal product for depression).

➔ If you think any of these conditions apply to you, do not take Rukobiauntil you have
consulted your doctor.

Warnings and precautions
Conditions for which you need to be careful
Some people taking medicines for HIV infection develop other conditions, which
can be serious. These include:

• infections and inflammation
• joint pain, stiffness and bone problems. You need to be informed about important signs and symptoms so that you can recognise them while taking Rukobia. ➔ See Section 4 of this leaflet.

Before taking Rukobia your doctor needs to know

• if you have or have had a heart problem, or if you notice any unusual changes in your heartbeat (such as a heartbeat that is too fast or too slow). Rukobia can affect the heart rhythm.
• if you have or have had a liver diseaseincluding hepatitis B or hepatitis C. ➔ Talk to your doctorif this applies to you. You may need further checks, including blood tests while you are taking the medicines.

You will need regular blood tests
For the entire time you take Rukobia, your doctor will schedule regular blood tests to
measure the amount of HIV in your blood and to check for side effects. More information
on these side effects is provided in Section 4of this leaflet.

Stay in regular contact with your doctor
Rukobia helps to control your condition, but does not cure HIV infection. You need to
take it every day to prevent the disease from getting worse. Because Rukobia does not cure HIV
infection, you can still develop other infections and diseases related to HIV infection.
➔ Stay in contact with your doctor, and do not stop taking Rukobiawithout your doctor's
advice.

Children and adolescents
Rukobia is not recommended for people under the age of 18 because it has not been studied in
this age group.

Other medicines and Rukobia
Tell your doctor or pharmacistif you are taking other medicines, if you have taken them recently or if
you start taking any new ones.

Rukobia must not be taken with certain other medicines
Do not take Rukobia if you are taking any of these medicines:

• carbamazepineor phenytoin,to treat epilepsyand prevent convulsions
• mitotane,to treat various types of cancer
• enzalutamide,to treat prostate cancer
• rifampicin,to treat some bacterial infectionssuch as tuberculosis
• products that contain St John's wort( Hypericum perforatum) (a herbal product for depression).

This medicine is not recommended with Rukobia:

• elbasvir/grazoprevir, to treat hepatitis C virus infection.➔ Tell your doctor or pharmacistif you are being treated with this medicine.

Some medicines can affect the activity of Rukobia
Or they may make it more likely that you will experience side effects. Rukobia can also
affect the activity of other medicines.

Tell your doctorif you are taking any of the medicines listed below:

• amiodarone, disopyramide, ibutilide, procainamide, quinidine or sotalol, used to treat heart diseases
• statins(atorvastatin, fluvastatin, pitavastatin, rosuvastatin or simvastatin), used tolower cholesterol levels
• ethinyl estradiol, used as contraception
• tenofovir alafenamide, used as an antiviral➔ Tell your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide that you need further checks.

Pregnancy
If you are pregnant, if you suspect you are pregnant or are planningto become pregnant, do not
takeRukobiawithout first consulting your doctor. Your doctorwill assess the benefit to you and the
risk to your baby of taking Rukobia while you are pregnant.

Breast-feeding
Breast-feeding is not recommendedfor HIV-positive women as HIV infection can
be transmitted to the baby through breast milk.

It is not knownwhether the components of Rukobia can pass into breast milk and harm the baby.
If you are breast-feeding or are thinking about breast-feeding you should talk to your doctor as soon as possible.
Driving and using machines
Rukobia can cause dizziness and have other side effects that cause a decrease in attention.
Do not drive vehicles or operate machinery if you are not sure that your state of alertness is not
impaired.

3. How to take Rukobia

Take Rukobia following the doctor's instructions exactly at all times. If you have any doubts, consult your
doctor or pharmacist.

• The recommended doseof Rukobia is one 600 mg tablet, twice a day.
• Rukobia must be swallowed whole, with liquid. Do not chew, crush, or splitthe tablets- if you do this, there is a risk that the medicine may be released into the body too quickly.
• You can take Rukobia with or without food.

If you take more Rukobia than you should
If you take too many Rukobia tablets, contact your doctor or pharmacist.If possible, show them
the Rukobia packaging.

If you forget to take Rukobia
Take the medicine as soon as you remember. However, if it is time for the next dose, skip the
forgotten dose and return to your normal schedule. Do not take a double doseto make up for the
forgotten dose. If you are not sure what to do, ask your doctor or pharmacist.
If you stop taking Rukobia
Do not stop Rukobia without your doctor's advice.
To control HIV infection and to prevent the disease from worsening, take Rukobia for the entire
duration prescribed by your doctor. Do not stop treatment unless your doctor tells you to.
If you have 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 everyone will experience them.
Therefore, it is very important to discuss any changes in your health with your doctor.
Symptoms of infection and inflammation are common (may affect up to 1 in 10 people)
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). After starting treatment, the immune system becomes stronger, so the body begins to fight infections.
Symptoms of infection and inflammation may develop due to:

• old “silent” infections that re-emerge as the body fights them
• the immune system mistakenly attacking healthy tissues in the body (autoimmune disorders). Symptoms of autoimmune disorders can develop many months after starting to take the medicine to treat HIV infection.

Symptoms may include:

• muscle weaknessand/or pain
• painor swelling of the joints
• weaknessstarting in the hands and feet and spreading along the body
• palpitationsor tremor
• agitation and excessive movement(hyperactivity) If you experience any symptoms of infection and inflammationor notice any of the symptoms listed above: ➔ tell your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

Very common side effects(may affect more than 1 in 10people):

• nausea
• diarrhea
• vomiting
• stomach pain (abdominal pain)
• headache
• skin rash ➔ See your doctorif you experience these side effects.

Common side effects(may affect up to 1 in 10people):

• indigestion (dyspepsia)
• lack of energy (fatigue)
• heart rhythm disturbances observed with an electrocardiogram ECG (QT prolongation)
• muscle pain (myalgia)
• feeling tired (somnolence)
• dizziness
• taste disturbances (dysgeusia)
• flatulence
• difficulty sleeping (insomnia)
• itching ➔ See your doctorif you experience these side effects

Some side effects can only be detected by blood tests and may not
be immediately apparent after taking Rukobia.
Common side effects that can be detected by blood tests are:

• increased levels of enzymes produced in the muscles (creatine phosphokinase, an indicator of muscle damage)
• increased creatinine, an indicator of kidney function
• increased levels of enzymes produced by the liver (transaminases, an indicator of liver damage).

Other side effects that can be detected by blood tests
Other side effects have occurred in some people, but their exact frequency is unknown:

• increased bilirubin (a substance produced by the liver) in the blood.

Joint pain, stiffness and bone problems
Some people taking combination therapy for HIV infection develop a
condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood flow to the bones. People may be more likely to develop this
disease:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

• joint stiffness
• pain and discomfort in the joints (especially the hip, knee, or shoulder)
• difficulty moving If you notice any of these symptoms: ➔ tell your doctor.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rukobia

Keep this medicine out of the sight and reach of children.
Do not use Rukobia after the expiry date stated on the packaging, which is reported after "Exp."
on the carton and the bottle.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Rukobia contains

• The active ingredient is fostemsavir. Each tablet contains fostemsavir tromethamine equivalent to 600 mg of fostemsavir.
• The other ingredients are hydroxypropyl cellulose, hypromellose, anhydrous colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Rukobia and contents of the pack
Rukobia 600 mg extended-release tablets are beige-colored, biconvex,
oval tablets, approximately 19 mm in length, 10 mm in width and 8 mm in thickness, and with the code ‘SV
1V7’ engraved on one side.
Each pack contains one or three bottles, each containing 60 extended-release
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands

Manufacturer
GlaxoSmithKline Manufacturing S.p.A
Strada Provinciale Asolana, 90
San Polo di Torrile
Parma, 43056
Italy
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00

Lietuva
ViiV Healthcare BV
Tel: + 370 80000334

България
ViiV Healthcare BV
Тел.: + 359 80018205

Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika
GlaxoSmithKline, s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: + 356 80065004

Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
[email protected]

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 501
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 69 69
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 01
[email protected]

Hrvatska
ViiV Healthcare BV
Tel: + 385 800787089

România
ViiV Healthcare BV
Tel: + 40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
ViiV Healthcare BV
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
ViiV Healthcare BV
Tel: + 421 800500589

Italia
ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741600

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
ViiV Healthcare BV
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu/