VOCABRIA 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vocabria 30 mg Film-Coated Tablets

cabotegravir

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will include 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 Vocabria and what is it used for
2. What you need to know before you take Vocabria
3. How to take Vocabria
4. Possible side effects
5. Storage of Vocabria
6. Contents of the pack and other information

1. What is Vocabria and what is it used for

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

Vocabria tablets are used to treat HIV (Human Immunodeficiency Virus) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg), who are also taking another antiretroviral medicine called rilpivirina and whose HIV-1 infection is under control.

Vocabria tablets do not cure HIV infection; they keep the amount of virus in your body at a low level. This helps to keep the number of CD4+ cells in your blood at a high level. CD4+ cells are a type of white blood cell that is important for helping your body to fight infections.

Your doctor may advise you to take Vocabria tablets before you are given Vocabria injections for the first time.

If you are already being given Vocabria injections, but you are unable to receive your injection, your doctor may also recommend that you take Vocabria tablets instead, until you can receive your injection again.

Vocabria tablets are always taken in combination with another antiretroviral medicine called rilpivirina tabletsto treat HIV infection. Vocabria and rilpivirina tablets will replace your current antiretroviral medicines. See the package leaflet for rilpivirina for more information about this medicine.

2. What you need to know before you take Vocabria

Do not take Vocabria tablets

• 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 taking any of these medicines as they may affect how Vocabria works:

• carbamazepine, oxcarbazepine, phenytoin, phenobarbital(medicines to treat epilepsy and prevent seizures)
• rifampicinor rifapentine(medicines to treat some bacterial infections, such as tuberculosis).

If you think this applies to you, tell your doctor.

Warnings and precautions

Severe skin reaction

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

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

Allergic reaction

Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, may 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 Vocabria.

Read the informationin section 4 of this leaflet.

Liver problems including hepatitis B and/or C

Tell your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor will assess the severity of your liver disease before deciding if you can take Vocabria.

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions, which can be serious.

You need to know what the important signs and symptoms are to look out for while you are being treated with Vocabria. These include:

• symptoms of infection
• symptoms of liver damage

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

If you have symptoms of infection or liver damage:

Tell your doctor immediately.Do not take other medicines for infection unless your doctor advises you to.

Children and adolescents

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

Other medicines and Vocabria tablets

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

Vocabria must not be takenwith other medicines (see ‘Do not take Vocabria tablets’ above in section 2).

Some medicines may affect how Vocabria worksor increase the chance of you having side effects. Vocabria may also affect how other medicines work.

Tell your doctorif you are taking any of the medicines on the following list:

• medicines called antacids, to treat indigestion and stomach acid. Antacids may stop Vocabria tablets from being absorbed into your body.

Do not take these medicinesin the 2 hours before taking Vocabria or until at least 4 hours after taking it.

• rifabutin(to treat some bacterial infections, such as tuberculosis).

Tell your doctoror pharmacist if you are taking any of these. Your doctor may decide that you need extra checks.

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 doctorfor advice before taking Vocabria tablets.

Pregnancy

• Vocabria is not recommended during pregnancy.If necessary, your doctor will consider the benefits and risks of taking Vocabria while you are pregnant. If you are planning to become pregnant, talk to your doctor first
• If you become pregnant, do not stop taking Vocabria without talking to your doctor.

Breast-feeding

It is not recommendedthat HIV-infected women breast-feed their babies because HIV infection can be passed to the baby through breast milk.

It is not knownwhether the components of Vocabria tablets can pass into breast milk.

If you are breast-feeding or think you may want to breast-feed, talk to your doctor as soon as possible.

Driving and using machines

Vocabria may make you feel dizzyand have other side effects that make you less alert.

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

Important information about some of the ingredients of Vocabria

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

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

3. How to take Vocabria

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

Vocabria tablets must always be taken with another HIV medicine (rilpivirina tablets). You must also carefully follow the instructions for rilpivirina. The package leaflet is provided in the rilpivirina pack.

Dosing schedule of Vocabria tablets before the injection schedule

Dosing schedule of Vocabria tablets before the every 2 months injection schedule

When you start treatmentwith Vocabria, you and your doctor may decide to start treatment with Vocabria tablets or go straight to Vocabria injections. If you decide to start with the tablets, your doctor will tell you:

• to take one Vocabria 30 mg tablet and one rilpivirina 25 mg tablet, once a day, for about 1 month
• after that, you will receive the injections every month or every 2 months.

The first month of Vocabria and rilpivirina tablets is called the oral lead-in period. This will allow your doctor to check if it is suitable for you to switch to the injections.

How to take the tablets

Vocabria tablets should be swallowed with a little water.

Vocabria can be taken with or without food. However, when Vocabria is taken at the same time as rilpivirina, both tablets should be taken with food.

If you are unable to receive your Vocabria injection

If you think you will not be able to receive your Vocabria injection, your doctor may recommend that you take Vocabria tablets or another treatment for HIV instead, until you can receive your injection again.

Antacid medicines

Antacids, to treat indigestionand stomach acid, may stop Vocabria tablets from being absorbed into your body and make them less effective.

Do not take an antacidin the 2 hours before taking Vocabria or until at least 4 hours after taking it. Talk to your doctor for more information about how to take medicines to reduce stomach acid (antacids) with Vocabria tablets.

If you take more Vocabria than you should

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

If you forget to take Vocabria

If it is less than 12 hours since you were supposed to take Vocabria, take the missed tablet as soon as possible. If it is more than 12 hours since you were supposed to take Vocabria, miss that dose and take the next dose as usual.

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

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

Do not stop taking Vocabria without your doctor’s advice.

Keep taking Vocabria for as long as your doctor recommends. Do not 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Vocabria and seek immediate medical attentionif you notice any of the following symptoms:

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

Allergic Reactions

Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions are uncommon (they can affect up to 1 in 100people).

If you experience any of the following symptoms:

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

See your doctor immediately. Your doctor may consider it necessary to perform tests to check your liver, kidneys, or blood and may advise you to stop taking Vocabria.

Very Common Adverse Effects

These can affect more than 1 in 10people:

• headache
• feeling of heat (pyrexia).

Common Adverse Effects

These can affect up to 1 in 10people:

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

Uncommon Adverse Effects

These can affect up to 1 in 100people:

• suicide attempts and suicidal thoughts (especially in patients who have previously had depression or mental health problems)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing.
• feeling of drowsiness
• liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach sensitivity, light-colored stools, or abnormally dark urine)
• changes in liver markers in blood tests (increased transaminases or increased bilirubin).

Other Adverse Effects that May Appear in Blood Tests

• an increase in lipase (a substance produced by the pancreas).

Other Possible Adverse Effects

People taking HIV treatment with Vocabria and rilpivirine may have other adverse effects.

Pancreatitis

If you have severe abdominal pain (stomach), this may be due to pancreas inflammation (pancreatitis).

Tell your doctor, especially if the pain spreads and worsens.

Symptoms of Infection and Inflammation

People with advanced HIV infection (AIDS) have a weakened immune system and are more prone to developing severe infections (opportunistic infections). When they start treatment, the immune system strengthens, so the body begins to fight these infections.

Symptoms of infection and inflammation can develop, caused by:

• latent old infections that reappear as the body fights them
• the immune system attacking healthy tissues (autoimmune disorders).

The symptoms of autoimmune disorders can appear many months after starting to take medications to treat HIV infection.

The symptoms may include:

• muscle weaknessand/or muscle pain
• painor swelling of the joints
• weaknessthat starts in the hands and feet and moves up to the body
• palpitationsor tremors
• hyperactivity(excessive restlessness and movement).

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

Tell your doctor immediately.Do not take other medications for the infection without consulting your doctor first.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Vocabria

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and bottle after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Vocabria Composition

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

The other ingredients 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

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

The film-coated tablets are presented in child-resistant closed 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.

Avda. Extremadura, 3

09400 Aranda de Duero (Burgos)

Spain

You can request more information about this medicine 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 about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu