InfoCons Consumer Protection informs you – Apretude – Package Leaflet

Before anything else

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Apretude is and what it is used for

Apretude contain s the active ingredient cabotegravir. Cabotegravir belongs to a group of anti -retroviral medicines called integrase inhibitors (INIs).

Apretude is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35kg who are at an increased risk of infection. This is called pre-exposure prophylaxis : PrEP (see section 2) .

It should be used in combination with safer sex practices, such as use of condoms.

Your doctor may advise you to take Apretude tablets before you are given a Apretude injection for the first time (called oral lead -in period, see section 3) .

If you are being given Apretude injections, but you are not able to receive your injection, your doctor may also recommend that you take Apretude tablets instead, until you can receive the injection again (see section 3) .

⚠️ 2. What you need to know before you take Apretude

Do not use Apretude

 if you have ever developed a severe skin rash, skin peeling, blistering and/or mouth sores.  if you are allergic (hypersensitive) to cabotegravir or any of the other ingredients of this medicine (listed in section 6).  If you are HIV positive or you do not know if you are HIV positive . Apretude can only help reduce your risk of getting HIV before you are infected . You must get tested to make sure you are HIV negative before taking Apretude .  if you are taking any of the following medicines : ▪ carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines to treat epilepsy and prevent fits).

72 ▪ rifampicin or rifapentine (medicines to treat some bacterial infections such as tuberculosis).

These medicines reduce the effectiveness of Apretude by decreasing the amount of Apretude in the blood ➔ If you think these apply to you, or if you are not sure, tell your doctor .

Warnings and precautions

Just taking Apretude may not prevent HIV infection .

HIV infection is spread by sexual contact with someone who is HIV positive or by transfer of infected blood. Although Apretude lowers the risk of becoming infected, you can still get HIV when taking this medicine .

Other measures should be taken to further reduce your risk of getting HIV:

• Get tested for other sexually transmitted infections when your doctor tell s you to. These infections make it easier for HIV to infect you.
• Use a condom when you have oral or penetrative sex.
• Do not share or re -use needles or other injection or drug equipment.
• Do not share personal items that may have blood or body fluids on them (such as razor blades or toothbrushes).

Discuss with your doctor the additional precautions needed to further decrease the risk getting HIV.

Reduce the risk of getting HIV:

There is a risk of resistance to this medicine if you get infected with HIV . This means that the medicine will not prevent HIV infection. To minimise this risk and to prevent infection with HIV, it is important that you:

• take Apretude tablets every day to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any doses of Apretude or stop taking it. Missing doses may increase your risk of getting HIV infection .
• get tested for HIV when your doctor tells you. You must be regularly tested to make sure that you remain HIV -1 negative while taking Apretude .
• tell your doctor straight away if you think you may have been infected with HIV (you may get a flu -like illness). They may want to do more tests to make sure you are still HIV negative.

Liver problems Let your doctor know if you have liver problems. You may need to be more closely monitored. (See also ‘ Uncommon side effects ’ in section 4) .

Adolescents Your doctor will discuss your mental health with you before and while receiving Apretude. Let your doctor know if you have mental health problems. You may need to be more closely monitored (See also section 4).

Severe skin reaction:

The s erious skin reactions , Stevens -Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with Apretude . Stop using Apretude and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions . ➔ Read the information in section 4 of this leaflet (‘Possible side effects’) .

73 Allergic reaction Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors , including cabotegravir , 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 receiving Apretude . ➔ Read the information in ‘Possible side effects’ in section 4 of this leaflet.

Children and adolescents

This medicine should not be used in children or adolescents less than 12 years of age or weighing less than 35 kg, because it has not been studied in these individual s.

Other medicines and Apretude

Tell your doctor if you are taking, have recently taken or might take any other medicines including other medicines bought without a prescription.

Some medicines can affect how Apretude works or make it more likely that you will have side effects.

Apretude can also affect how some other medicines work.

Apretude must not be given with some other medicines that may affect how well the medicine works (see ‘Do not use Apretude ’ in section 2). These include:

• carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (medicines used to treat epilepsy and prevent fits).
• rifampicin or rifapentine (medicines to treat some bacterial infections such as tuberculosis).

Tell your doctor if you are taking:

• antacids (medicines to treat indigestion and heartburn ). Antacids can stop the medicine in Apretude tablets from being absorbed into your body. Do not take these medicines in the 2 hours before you take Apretude or for at least 4 hours after you take it.

➔ Tell your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need extra check -ups.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant , or are planning to have a baby , ask your doctor for advice before receiving this medicine.

Pregnancy

Apretude is not recommended during pregnancy. The effect of Apretude on pregnancy is unknown.

Talk to your doctor: if you could get pregnant, if you are planning to have a baby or if you become pregnant. Your doctor will consider the benefit to you and the risk to your baby of starting/ continuing Apretude .

Breast -feeding It is not known whether the ingredients of Apretude can pass into breast milk.

If you are breast -feeding, or thinking about breast -feeding, check with your doctor . Your doctor will consider the benefit and risk s of breast -feeding for you and your baby.

Driving and using machines

Apretude can make you dizzy and have other side effects that make you less alert. ➔ Don’t drive or use machines unless you are sure you’re not affected.

74 Apretude contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Apretude contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take Apretude

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You must have a HIV -negative test before taking Apretude.

When you start treatment with Apretude injections, you and your doctor may decide to first start treatment with cabotegravir tablets in an oral lead -in period.

This allows your doctor to assess whether it’s appropriate to proceed with injections.

If you decide to start treatment with tablets for the oral lead -in: ▪ You should take one 30 mg Apretude tablet once a day, for approximately one month . ▪ After one month of tablets, you should receive your first injection on the same day as your last tablet or no later than 3 days after . ▪ You will then receive an injection every 2 months Oral lead -in schedule When What medicine Month 1 30 mg Apretude tablet once a day At month 2 and month 3 600 mg Apretude injection each month Month 5 onwards 600 mg Apretude injection every two months If you are not able to receive your Apretude injection, your doctor may recommend you take Apretude tablets instead, until you can receive an injection again.

How to take the tablets Apretude tablets should be swallowed with a small amount of water. They can be taken with or without food.

Do not take antacid s (medicines to treat indigestion and heartburn) during the 2 hours before you take a Apretude tablet or for at least 4 hours after you take it, as this can stop Apretude tablets being absorbed into your body and make it less effective.

If you take more Apretude than you should

If you take too many tablets of Apretude , contact your doctor or pharmacist for advice and you will be treated as needed . If possible, show them the Apretude tablet bottle.

If you forget to take Apretude

If you notice within 12 hours of the time you usually take Apretude , take the missed tablet as soon as possible. If you notice after 12 hours, then skip that dose and take the next dose as usual.

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

If you vomit less than 4 hours after taking Apretude , take another tablet. If you vomit more than 4 hours after taking Apretude you should not take another tablet until your next scheduled dose.

Don’t stop taking Apretude without advice from your doctor Take Apretude for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you have any 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 everybody gets them.

Stop using Apretude and seek medical attention immediately if you notice any of the following symptoms:

• reddish non -elevated, target -like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. These serious skin rashes can be preceded by fever and flu -like symptoms (Stevens -Johnson syndrome, toxic epidermal necrolysis).

These serious skin reactions are very rare (may affect up to 1 in 10,00 0 people).

Allergic reactions Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors including cabotegravir can cause a serious allergic reaction known as a hypersensitivity reaction.

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 Apretude .

Very common side effects

(may affect more than 1 in 10 people )

• headache
• diarrhoea
• feeling hot ( pyrexia )
• changes in liver function (transaminases increased ), as measured in blood tests

Common side effects

(may affect up to 1 in 10 people )

• depression
• anxiety
• abnormal dreams
• difficulty in sleeping (insomnia)
• dizziness
• feeling sick (nausea )
• vomiting
• stomach pain (abdominal pain)
• wind (flatulence)
• rash 76 • muscle pain (myalgia)
• lack of energy (fatigue)
• generally feeling unwell (malaise)

Uncommon side effects

(may affect up to 1 in 100 people )

• suicide attempt and suicidal thoughts (particularly in individuals who have had depression or mental health problems before)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling (angioedema), sometimes of the face or mouth, which can cause difficulty in breathing
• feeling drowsy (somnolence)
• weight gain.
• liver damage ( hepatotoxicity). S igns may include yellowing of the skin and the whites of the eyes, loss of appetite, itching, tenderness of the stomach, light -coloured stools or unusually dark urine
• Increase in blood bilirubin, a breakdown product of red blood cells, as measured in blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. 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.

🌡️ 5. How to store Apretude

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 label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature 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.

📦 6. Contents of the pack and other information

What Apretude contains

The active substance is cabotegravir. Each tablet contains 30 mg cabotegravir.

The other ingredients are:

Tablet core Lactose Monohydrate Microcrystalline Cellulose (E460) Hypromellose (E464) Sodium Starch Glycolate Magnesium Stearate Tablet coating 77 Hypromellose (E464) Titanium Dioxide (E171) Macrogol (E1521)

What Apretude looks like and contents of the pack

Apretude film-coated tablets are white, oval, film -coated tablets, debossed with ‘SV CTV’ on one side.

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

Each bottle contains 30 film -coated tablets.

Marketing Authorisation Holder

ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort Netherlands Manufacture r Glaxo Wellcome S.A.

Avenida De Extremadura 3 Aranda De Duero Burgos 09400 Spain For any information about this medicine, please 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 Teл.: + 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 hf.

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

This leaflet was last revised in {MM/YYYY }

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Apretude (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1760).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.