Twinrix adultos, suspension inyectable en jeringa precargada

Label: information for the user

Twinrix Adults, Pre-filled syringe

Combined vaccine (inactivated) against hepatitis A and hepatitis B (DNA)

Read this label carefully before you start receiving this vaccine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This vaccine has been prescribedonlyto you, and you must not give it to others.
• If you experience any adverse effects, consult yourdoctor or pharmacist,even if they are not listed in this label. See section 4.

Twinrix Adult is a vaccine used in adults and adolescents 16 years of age or older to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease that can affect the liver. This disease is caused by the hepatitis A virus. Hepatitis A can be transmitted from person to person through food and drinks, or by swimming in waters contaminated with sewage. The symptoms of hepatitis A begin 3 to 6 weeks after contact with the virus. These consist of nausea (discomfort), fever, and pain. After several days, the whites of the eyes and the skin may turn yellow (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely, but the disease is usually severe enough to keep patients ill for approximately one month.

• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes inflammation of the liver. The virus is found in bodily fluids such as blood, semen, vaginal secretions, or saliva (sputum) of infected individuals.

Vaccination is the best way to protect against these diseases. None of the components of the vaccine are infectious.

Twinrix Adults should not be administered if:

• You are allergic to:

• The active principles or to any of the other components of this vaccine (listed in section 6)(including in section 6)
• Neomycin.

The signs of an allergic reaction may include skin rash with itching, difficulty breathing, and facial or tongue inflammation

• You have had a previous allergic reaction to any hepatitis A and hepatitis B vaccine
• You have a severe infection with fever (over 38°C). A minor infection, such as a cold, should not be a problem for vaccination, but inform your doctor first.

Warnings and precautions

Consult your doctor or pharmacist before receiving Twinrix Adults if:

• You have experienced any health problems after previous administration of a vaccine
• You have a weakened immune system due to a disease or pharmacological treatment
• You have any bleeding disorder or bruise easily.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

In obese individuals, a low response to the vaccine has been observed, possibly without achieving protection against hepatitis A. A low response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in elderly subjects, in men more than in women, in smokers, in obese individuals, and in people with long-term diseases, or those receiving some type of pharmacological treatment. Your doctor may recommend that you undergo a blood test after completing the vaccination cycle to check if you have achieved a satisfactory response. If not, your doctor will indicate the possibility of needing additional doses.

Other medicines and Twinrix Adults

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

The passage of Twinrix Adults to breast milk is unknown, however, it is not expected that the vaccine will cause problems for infants.

Twinrix Adults contains neomycin and sodium

Inform your doctor if you have had an allergic reaction to neomycin (antibiotic).

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

You will receive a total of three injections over a period of 6 months. Each injection will be administered in a separate visit. The first dose will be administered on the chosen date. The other two doses will be administered one month and six months after the first dose.

• First dose:on the chosen date
• Second dose:1 month after
• Third dose:6 months after the first dose

Twinrix Adults can also be administered as a total of 3 doses over 1 month. This vaccination schedule is only for adults who need rapid protection (e.g. travelers). The first dose will be administered on the chosen date. The other two doses will be administered 7 and 21 days after the first dose. A fourth dose is recommended 12 months after the first dose.

• First dose:on the chosen date
• Second dose:7 days after
• Third dose:21 days after the first dose
• Fourth dose:12 months after the first dose

Your doctor will inform you if additional doses and future booster doses are necessary.

As mentioned in section 2, it is more common for there to be a low response to the vaccine, possibly without achieving protection against hepatitis B, in older adults, in men more than in women, in smokers, in obese individuals, or in individuals with long-term illnesses, or those receiving some type of pharmacological treatment. Your doctor may recommend that you undergo a blood test after completing the vaccination cycle to check if you have achieved a satisfactory response. If not, your doctor will indicate the possibility of needing additional doses.

If you miss one of the scheduled injections, speak with your doctor to schedule another visit.

Make sure to complete the full cycle of three injections. Otherwise, you may not be fully protected against the diseases.

Your doctor will administer the Twinrix Adults injection in the upper arm muscle.

The vaccine should not be injected subcutaneously (deep) or intramuscularly in the buttock, as the protection may be lower.

The vaccine should never be injected into a vein.

If you have any other questions about the use of this vaccine, ask your doctor or pharmacist.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The side effects that may occur are as follows:

Very common(may occur in more than 1 in 10 vaccine doses): headache, pain and redness at the injection site, fatigue.

Common(may occur up to 1 in 10 vaccine doses):diarrhea, nausea, inflammation, rashes or itching at the injection site, general discomfort.

Uncommon(may occur up to 1 in 100 vaccine doses):dizziness, vomiting, stomach pain, muscle aches,upper respiratory tract infection, fever equal to or greater than 37.5°C.

Rare(may occur up to 1 in 1,000 vaccine doses): lymphadenopathy (inflammation of the lymph nodes in the neck, armpit, or groin), loss of skin sensitivity to pain or touch (hypoesthesia), tingling sensation(paresthesia), skin rash, itching, joint pain, loss of appetite, low blood pressure, flu-like symptoms such as fever, sore throat, runny nose, cough, and chills.

Very rare(may occur up to 1 in 10,000 vaccine doses):

Among the side effects that occurred very rarely during clinical trials, the routine use of the vaccine or with individual anti-hepatitis A and anti-hepatitis B vaccines include: reduction of platelets, which increases the risk of bleeding or appearance of rashes (thrombocytopenia), visible purple or brownish-red spots on the skin (purpura thrombocytopenic), inflammation or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), inflammation of the nerves (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis, convulsions or seizures, inflammation of the face, mouth, or throat (angioneurotic edema), purple or purple-red skin swelling (lichen planus), severe skin eruptions (erythema multiforme), urticarial hives, joint inflammation, muscle weakness, infection around the brain that may cause severe headache with neck stiffness and sensitivity to light (meningitis), inflammation of some blood vessels (vasculitis), abnormal liver function test results, multiple sclerosis, spinal cord inflammation (myelitis), drooping eyelids and facial muscle sagging on one side of the face (facial paralysis), temporary nerve inflammation, which causes pain, weakness, and paralysis of the limbs and often progresses to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), immediate painat the injection site, itching and burning sensation.

Severe allergic reactions (anaphylaxis, anaphylactoid reactions, and serum sickness-like reactions) may also occur very rarely (up to 1 in 10,000 vaccine doses). Some signs of severe allergic reactions may include skin rashes with itching or blisters, eye and face inflammation, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. These reactions may occur before leaving the doctor's office. In any case, if any of these symptoms appear, seek medical attention immediately.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use,https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do notuse this medicationafterthe expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C).

Store in the original packaging to protect it from light.

Do not freeze. Freezing destroys the vaccine.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Twinrix Adults

The active principles are:

Human hepatitis A virus (inactivated)1,2720 ELISA units

HBsAg (surface antigen of hepatitis B)3,420 micrograms

1Produced in diploid human cells (MRC-5)

2Adsorbed on hydrated aluminium hydroxide0.05 milligrams Al3+

3Produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)

4Adsorbed on aluminium phosphate0.4 milligrams Al3+

The other components ofTwinrix Adultsare:sodium chloride and water for injection.

Appearance ofTwinrix Adultsand contents of the container

Injectable suspension in pre-filled syringe.

Twinrix Adults is a white, slightly milky liquid.

Twinrix Adults is available in pre-filled syringe of 1 dose with or without separate needles, container sizes of 1, 10 and 25.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer responsible

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.:

Last update of this leaflet:04/2023

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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Thisinformation is intended solely for healthcare professionals:

During storage, a fine white deposit may be observed with a translucent and colourless layer on top.

The vaccine must be resuspended before use. Once resuspended, the vaccine will have a white, turbid and uniform appearance.

Resuspension of the vaccine to obtain a white, turbid and uniform suspension

The vaccine must be resuspended by following the steps outlined below.

1. Hold the syringe upright with a closed hand.
2. Shake the syringe by turning it upside down and then back upright.
3. Repeat this action vigorously for at least 15 seconds.
4. Inspect the vaccine again:
   1. If the vaccine appears as a white, turbid and uniform suspension, it is ready to use (it should not have a translucent appearance).
   2. If the vaccine still does not appear as a white, turbid and uniform suspension, turn it upside down and then back upright again for at least another 15 seconds and then inspect again.

Before administration, the vaccine must be visually inspected to observe any foreign particles and/or abnormal physical appearance. If any of these circumstances are observed, do not administer the vaccine.

Instructions for the pre-filled syringe after resuspension

Disposal of residues

The disposal of unused medicinal product and any other materials that have been in contact with it must be in accordance with local regulations.