Vocabria 30 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
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 rapid identification of new information on its safety. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Vocabria is and what it is used for
- What you need to know before taking Vocabria
- How to take Vocabria
- Possible side effects
- How to store Vocabria
- Contents of the pack and other information
1. What Vocabria is and what it is 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 rilpivirine 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 maintain the number of CD4+ cells in the blood. CD4+ cells are a type of white blood cells that are important in helping your body fight infections.
Your doctor may advise you to take Vocabria tablets before you are given Vocabria injectable for the first time.
If you are already receiving Vocabria injectable but cannot receive your injection, your doctor may also recommend that you take Vocabria tablets instead, until you can receive the injection again.
Vocabria tablets are always administered in combination with another antiretroviral medicine called rilpivirine tablets to treat HIV infection. Vocabria and rilpivirine tablets will replace your current antiretroviral medicines. Please refer to the rilpivirine package leaflet for more information about that medicine.
2. What you need to know before taking Vocabria
Do not take Vocabria tablets
-
if you have ever developed a severe skin rash, peeling of the skin, blisters and/or mouth sores.
-
if you are allergic (hypersensitive) to cabotegravir or to any of the other ingredients of this medicine (listed in section 6).
-
if you are taking any of the following medicines, as they may affect how Vocabria works:
-
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).
If you think any of these apply to you, inform your doctor.
Warnings and precautions
Severe skin reaction
Very rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with Vocabria. If you notice any symptoms related to these severe skin reactions, stop taking Vocabria and seek immediate medical attention.
Read the information in 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 serious allergic reaction known as hypersensitivity reaction. You need to be aware of the important signs and symptoms to watch for while taking Vocabria.
Read the information in section 4 of this leaflet.
Liver problems, including hepatitis B and/or C
Inform 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 whether you can take Vocabria.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other disorders, which may be serious.
You need to know the important signs and symptoms to watch for while being treated with Vocabria. These include:
- symptoms of infection
- symptoms of liver damage
Read the information in section 4 of this leaflet (“Possible side effects”).
If you experience symptoms of infection or liver damage:
Inform your doctor immediately. Do not take other medicines for infection unless advised by your doctor.
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
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.
Vocabria must not be taken with certain other medicines (see ‘Do not take Vocabria tablets’ above in section 2).
Some medicines may affect how Vocabria works or increase the likelihood of you experiencing side effects. Vocabria may also affect how other medicines work.
Inform your doctor if you are taking any of the following medicines:
- antacids, medicines used to treat indigestion and heartburn. Antacids may prevent Vocabria tablets from being absorbed into your body.
Do not take these medicines within 2 hours before or at least 4 hours after taking Vocabria.
- rifabutin (used to treat certain bacterial infections, such as tuberculosis).
Inform your doctor or pharmacist if you are taking any of these. Your doctor may decide that you need additional monitoring.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant:
Consult your doctor before taking Vocabria tablets.
Pregnancy
- Vocabria is not recommended during pregnancy. If necessary, your doctor will consider the benefit to you and the risk to your baby of taking Vocabria during pregnancy. If you are planning to become pregnant, discuss this with your doctor in advance.
- If you become pregnant, do not stop taking Vocabria without consulting your doctor.
Breastfeeding
It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.
It is unknown whether the components of Vocabria tablets pass into breast milk.
If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.
Driving and using machines
Vocabria may make you feel dizzy and may cause other side effects that could reduce your alertness.
Do not drive or operate machinery unless you are certain it does not affect you.
Important information about some of the ingredients of Vocabria
If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Vocabria
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.
Vocabria tablets must always be taken together with another HIV medicine (rilpivirine tablets). You must also carefully follow the instructions for rilpivirine. The package leaflet is provided in the rilpivirine pack.
Dosing schedule for Vocabria tablets prior to the monthly injection regimen
Which medicine | When | ||
Month 1 (at least 28 days) | Month 2 (after one month of tablets) | Month 3 onwards | |
Vocabria | 30 mg tablet once daily | 600 mg injection | 400 mg injection every month |
Rilpivirine | 25 mg tablet once daily | 900 mg injection | 600 mg injection every month |
Vocabria tablet dosing regimen prior to the every-2-month injection regimen
Which medicine | When | ||
Month 1 (at least 28 days) | Month 2 and Month 3 (after one month of tablets) | Month 5 onwards | |
Vocabria | 30 mg tablet once daily | 600 mg injection | 600 mg injection every 2 months |
Rilpivirine | 25 mg tablet once daily | 900 mg injection | 900 mg injection every 2 months |
When you start treatment with Vocabria, you and your doctor may decide to begin treatment with Vocabria tablets or opt directly for Vocabria injections. If you decide to start treatment with tablets, your doctor will instruct you:
- to take one 30 mg Vocabria tablet and one 25 mg rilpivirine tablet once daily for approximately one month
- after that, you will receive monthly or every-other-month injections.
The first month of Vocabria and rilpivirine tablets is called the oral induction period. This allows your doctor to assess whether switching to injections is appropriate.
How to take the tablets
Vocabria tablets should be swallowed with some water.
Vocabria may be taken with or without food. However, when Vocabria is taken together with rilpivirine, both tablets must be taken with food.
If you cannot receive your Vocabria injection
If you think you will be unable to receive your Vocabria injection, your doctor may recommend that you take Vocabria tablets or another HIV treatment instead, until you can resume your Vocabria injections.
Antacid medicines
Antacids, used to treat indigestion and stomach acidity, may prevent Vocabria tablets from being absorbed into your body and make them less effective.
Do not take an antacid within 2 hours before taking Vocabria or for at least 4 hours after taking it. Speak with your doctor for further advice on how to take acid-reducing medicines (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 Vocabria tablet bottle.
If you forget to take Vocabria
If less than 12 hours have passed since the time you usually take Vocabria, take the missed tablet as soon as possible. If more than 12 hours have passed, skip that dose and take the next dose at the usual time.
Do not take a double dose to make up for missed doses.
If you vomit within 4 hours after taking Vocabria, take another tablet. If you vomit more than 4 hours after taking Vocabria, there is no need to take another tablet until your next scheduled dose.
Do not stop taking Vocabria without consulting your doctor.
Continue taking Vocabria for as long as your doctor recommends. Do not stop unless instructed by your doctor.
If you have any further questions about 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 everyone experiences them.
Stop taking Vocabria and seek immediate medical attention if you notice any of the following symptoms:
- Reddish, non-elevated, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, sores in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These severe skin reactions are very rare (may affect up to 1 in 10,000 people).
Allergic reactions
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as hypersensitivity reaction. These hypersensitivity reactions are uncommon (may affect up to 1 in 100 people).
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), causing difficulty breathing
- Muscle or joint pain
Seek medical help immediately. Your doctor may consider it necessary to perform tests to monitor your liver, kidneys, or blood and may instruct you to stop taking Vocabria.
Very common adverse effects
These may affect more than 1 in 10 people:
- Headache
- Feeling of heat (pyrexia)
Common adverse effects
These may affect up to 1 in 10 people:
- 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 may affect up to 1 in 100 people:
- Suicide attempt and suicidal thoughts (especially in patients who previously had depression or mental health problems)
- Allergic reaction (hypersensitivity)
- Hives (urticaria)
- Swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
- Drowsiness
- Liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach discomfort, pale stools, or abnormally dark urine)
- Changes in liver markers in blood tests (increase in transaminases or increase in bilirubin)
Other adverse effects that may appear in blood tests
- Increase in lipase (a substance produced by the pancreas)
Other possible adverse effects
People who take HIV treatment with Vocabria and rilpivirine may experience other adverse effects.
Pancreatitis
If you have severe pain in the abdomen (stomach), this may be due to inflammation of the pancreas (pancreatitis).
Inform 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 likely to develop serious infections (opportunistic infections). When they start treatment, the immune system strengthens, so the body begins to fight these infections.
Symptoms of infection and inflammation may develop, caused by:
- Reactivation of old latent infections as the body fights them
- The immune system attacking healthy tissues (autoimmune disorders)
Symptoms of autoimmune disorders may appear many months after starting treatment for HIV infection.
Symptoms may include:
- Muscle weakness and/or muscle pain
- Pain or swelling of the joints
- Weakness starting in the hands and feet and moving upward toward the body trunk
- Palpitations or tremors
- Hyperactivity (excessive restlessness and movement)
If you have any symptoms of infection or inflammation or notice any of the symptoms listed above:
Inform your doctor immediately. Do not take any other medicines for infection without first consulting your doctor.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 help provide 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 expiry date stated on the carton and bottle after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage temperature conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vocabria
- The active substance 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)
Appearance of the product and contents of the pack
Vocabria film-coated tablets are white, oval-shaped, and marked with 'SV CTV' on one side.
Film-coated tablets are supplied in bottles closed with child-resistant caps.
Each bottle contains 30 film-coated tablets.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands
Manufacturer
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
09400 Aranda de Duero (Burgos)
Spain
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
| Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tel/Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tel.: + 33 (0)1 39 17 69 69 | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 |
Croatia ViiV Healthcare BV Tel: + 385 800787089 | Romania ViiV Healthcare BV Tel: + 40 800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor ehf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 |
Date of the most recent review of this leaflet: <{MM/YYYY}>.
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu