APRETUDE 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Apretude 30 mg Film-Coated Tablets

cabotegravir

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Apretude and what is it used for

Apretude contains cabotegravir as the active substance. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI).

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

It must be used in combination with safer sex practices, such as using condoms.

Your doctor may advise you to take Apretude tablets before you are given Apretude injections for the first time (called an oral induction period, see section 3).

If you are already being given Apretude injections, but you are unable to receive your injection, your doctor may also recommend that you take Apretude tablets instead, until you can receive your injection again (see section 3).

2. What you need to know before you take Apretude

Do not take Apretude

• if you have ever developed a severe skin rash, skin peeling, blisters and/or sores in the mouth.
• if you are allergic(hypersensitive) to cabotegravir or any of the other ingredients of this medicine (listed in section 6).
• If you are HIV positiveor do not know if you are HIV positive. Apretude can only help reduce the risk of getting HIV before you become infected. You must get testedto make sure you are HIV negative before taking Apretude.
• if you are taking any of the following medicines:

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

These medicines reduce the effectiveness of Apretude by decreasing the amount of Apretude in your blood.

If you think this applies to you, or if you are not sure, tell your doctor.

Warnings and precautions

Taking Apretude alone may not be enough to prevent HIV infection.

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

Other measures must be taken to reduce the risk of HIV infection further:

• Get testedfor other sexually transmitted diseases when your doctor tells you to. These infections make it easier for you to get infected with HIV.
• Use condomswhen you have oral or penetrative sex.
• Do not share or reuse needles or other injection equipment or medical equipment.
• Do not share personal items that may contain blood or body fluids (such as razors or toothbrushes).

Talk to your doctor about what additional precautions are necessary to reduce the risk of HIV infection further.

Reduce the risk of HIV infection:

There is a risk of developing resistance to this medicine if you become infected with HIV. This means that the medicine may not prevent you from getting infected with HIV. To minimize this risk and prevent HIV infection, it is important that:

• you take Apretude tablets every dayas directed to reduce your risk, not just when you think you have been at risk of HIV infection. Do not miss any dose of Apretude or stop taking it. Missing a dose can increase the risk of getting an HIV infection.
• you get tested for HIVwhen your doctor tells you to. You should get tested regularly to make sure you remain HIV-1 negative while taking Apretude.
• tell your doctor immediatelyif you think you may have been infected with HIV (you may have a flu-like illness). You may need to have more tests to make sure you remain HIV negative.

Liver problems

Tell your doctor if you have liver problems. You may need to be monitored more closely. (See also "Rare side effects" in section 4).

Adolescents

Your doctor will talk to you about your mental health before and while you are taking Apretude. Tell your doctor if you have mental health problems. You may need to be monitored more closely (see also section 4).

Severe skin reaction

Very rare cases of severe skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in association with Apretude. If you notice any of the symptoms related to these severe skin reactions, stop taking Apretude and seek medical attention immediately.

Read the informationin section 4 of this leaflet ("Possible side effects").

Allergic reaction

Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a severe allergic reaction known as hypersensitivity reaction. You need to know what the important signs and symptoms are to look out for while you are taking Apretude.

Read the information in‘Possible side effects’ in section 4 of this leaflet.

Children and adolescents

This medicine must not be used in children or adolescents under 12 years of age or weighing less than 35 kg, as it has not been studied in these users.

Other medicines and Apretude

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

Some medicines may affect how Apretude works or increase the chance of you having side effects. Apretude may also affect how other medicines work.

Apretude must not be takenwith other medicines that may affect the effectiveness of the medicine (see "Do not take Apretude" in section 2). These include:

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

Tell your doctorif you are taking:

• antacids(medicines used to treat indigestion and stomach acid). Antacids may prevent Apretude tablets from being absorbed into your body. Do not take these medicinesin the 2 hours before taking Apretude or until at least 4 hours after taking it.

Tell your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide that you need extra monitoring.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Apretude is not recommended during pregnancy. The effect of Apretude on pregnancy is not known. Talk to your doctor: if you can become pregnant, if you plan to have a baby, or if you become pregnant. Your doctor will consider the benefit to you and the risk to your baby before you start/continue taking Apretude.

Breastfeeding

It is not known whether the components of Apretude can pass into breast milk.

If you are breastfeeding or think you may be breastfeeding, talk to your doctor. Your doctor will consider the benefits and risks of breastfeeding for you and your baby.

Driving and using machines

Apretude may cause dizziness and have other effects that may make you less alert.

Do not drive or use machinesunless you are sure that you are not affected.

Apretude contains lactose

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Apretude contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Apretude

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

You must have an HIV test and be negativebefore you start taking Apretude.

Before you start treatment with Apretude injections, you and your doctor may decide to start treatment with cabotegravir tablets first (called an oral induction period). This will allow your doctor to check if it is suitable for you to switch to injections.

If you decide to start treatment with tablets for oral induction:

• You must take one Apretude 30 mg tablet once a day for about a month.
• After one month of tablets,you must receive your first injection on the same day that you take your last tablet or at the latest 3 days after.
• After that, you will receive an injection every 2 months.

Oral Induction Schedule

If you are unable to receive your Apretude injection, your doctor may recommend that you take Apretude tablets instead, until you can receive your injection again.

How to take the tablets

Apretude tablets should be swallowed with a little water. They can be taken with or without food.

Do not take antacids (medicines used to treat indigestion and stomach acid) during the 2 hours before taking an Apretude tablet or until at least 4 hours after taking it, as this may prevent the Apretude tablets from being absorbed into your body and make them less effective.

If you take more Apretude than you should

If you take too many Apretude tablets, contact your doctor or pharmacistand you will receive the necessary treatment. If possible, show them the pack of Apretude tablets.

If you forget to take Apretude

If it has been less than 12 hours since the time you normally take Apretude, take the missed tablet as soon as possible. If it has been more than 12 hours, skip that dose and take the next dose as usual.

Do not take a double doseto make up for forgotten doses.

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

Do not stop taking Apretude without your doctor’s advice

Keep taking Apretude for as long as your doctor recommends. Do not stop taking it unless your doctor tells 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 taking Apretude and seek medical attention immediatelyif you notice any of the following symptoms:

• red patches, target-like marks or circular patches on the trunk, often with blisters in the center, skin peeling, sores in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These severe skin reactions are very rare (they may affect up to 1 in 10,000people).

Allergic reactions

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

If you have any of the following symptoms:

• skin rash
• high temperature (fever)
• lack of energy (fatigue)
• swelling, sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• muscle or joint pain.

See a doctor immediately. Your doctor may decide that you need to have 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
• diarrhea
• feeling hot (pyrexia)
• changes in liver function (increased transaminases), measured in blood tests.

Common side effects

(may affect up to 1 in 10 people)

• depression
• anxiety
• abnormal dreams
• difficulty sleeping (insomnia)
• dizziness
• feeling sick (nausea)
• vomiting
• stomach pain (abdominal pain)
• gas (flatulence)
• rash
• muscle pain (myalgia)
• lack of energy (fatigue)
• general malaise.

Uncommon side effects

(may affect up to 1 in 100 people)

• attempted suicide and suicidal thoughts (especially in users with a history of depression or mental health problems)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• feeling sleepy (somnolence)
• weight gain
• liver damage (hepatotoxicity). Signs can include yellowing of the skin and the whites of the eyes, loss of appetite, itching, stomach tenderness, pale stools, or dark urine
• increase in bilirubin in the blood, a breakdown product of red blood cells, measured in blood tests.

Reporting of side effects

If you experience 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.

5. Storage of 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 carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Package Contents and Additional Information

Apretude Composition

• The active ingredient is cabotegravir. Each tablet contains 30 mg of cabotegravir.

The other components are:

Tablet core

Lactose monohydrate

Microcrystalline cellulose (E460)

Hypromellose (E464)

Sodium carboxymethyl starch

Magnesium stearate

Tablet coating

Hypromellose (E464)

Titanium dioxide (E171)

Macrogol (E1521)

Product Appearance and Package Contents

Apretude film-coated tablets are white, oval, and engraved with 'SV CTV' on one side.

The film-coated tablets are supplied in child-resistant bottles.

Each bottle contains 30 film-coated tablets.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H,

3811 LP Amersfoort

Netherlands

Manufacturer

Glaxo Wellcome S.A.

Avenida de Extremadura 3

09400 Aranda de Duero (Burgos)

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/AAAA}.

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu