Varilrix powder and solvent for solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Varilrix powder and solvent for solution for injection in pre-filled syringe

Varicella vaccine (live virus)

Read all of this leaflet carefully before you or your child is given this medicine because it contains important information for you/your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child, and you should not give it to other people.
• If you or your child experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Varilrix is and what it is used for
2. What you need to know before you or your child is given Varilrix
3. How Varilrix is administered
4. Possible side effects
5. How to store Varilrix
6. Contents of the pack and other information

1. What Varilrix is and what it is used for

Varilrix is a vaccine used in individuals from 12 months of age onwards to protect them against varicella (chickenpox). In certain circumstances, Varilrix may also be administered to infants from 9 months of age.

Vaccination within 3 days after exposure to a case of varicella may help prevent chickenpox or reduce the severity of the disease.

How Varilrix works

When a person is vaccinated with Varilrix, the immune system (the body's natural defence system) will produce antibodies to protect the person against infection by the varicella virus. Varilrix contains weakened virus, so it is very unlikely to cause varicella in healthy individuals.

As with any vaccine, Varilrix may not fully protect all vaccinated individuals.

2. What you need to know before you or your child receives Varilrix

Do not use Varilrix

• If you or your child has any illness (such as blood disorders, cancer, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)) or has recently received or is still taking any medicine that weakens the immune system (except low-dose corticosteroid treatment for asthma or replacement therapy). Whether you or your child should receive the vaccine will depend on the level of your immune defenses. See section 2 “Warnings and precautions”.
• If you or your child is allergic to any of the components of this vaccine (listed in section 6). Signs of an allergic reaction may include: itchy skin rash, difficulty breathing, and swelling of the face or tongue.
• If you or your child is allergic to neomycin (an antibiotic). A history of contact dermatitis (skin rash caused when the skin comes into direct contact with allergens such as neomycin) should not be a reason to avoid vaccination. However, consult your doctor first.
• If you or your child has previously had an allergic reaction to any varicella vaccine.
• If you or your daughter is pregnant. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you or your child receives Varilrix:

• If you or your child has a serious infection with high fever. Vaccination may need to be postponed until recovery. A minor infection, such as a cold, does not require postponing vaccination. However, consult your doctor first.
• If you or your child has a weakened immune system due to illness (e.g., HIV infection) and/or treatments, or is going to take a medicine that weakens the immune system. You or your child should be closely monitored, as the response to vaccination may not be sufficient to ensure protection against the disease (see section 2 “Do not use Varilrix”).
• If you have bleeding problems or bruise easily.

Fainting (syncope) may occur before or after any injection (especially in adolescents), so inform your doctor or nurse if you or your child has previously fainted after receiving an injection.

Like other vaccines, Varilrix may not fully protect you or your child against varicella. However, people who have been vaccinated and still develop varicella usually experience a very mild form of the disease compared to unvaccinated individuals.

Rarely, the weakened virus may be transmitted from a vaccinated person to others. This usually occurs when the vaccinated person has skin rashes or blisters. Healthy individuals who become infected in this way typically develop only a mild skin rash that is not harmful.

After vaccination, you or your child should, as far as possible, avoid close contact with the following individuals for 6 weeks after vaccination:

• People with weakened immune systems,
• Pregnant women who have not had varicella or have not been vaccinated against varicella,
• Newborn infants whose mothers have not had varicella or have not been vaccinated against varicella.

Other medicines and Varilrix

Tell your doctor or pharmacist if you or your child is taking, has recently taken, or might need to take any other vaccine and/or medicine.

Inform your doctor if you or your child needs to undergo a skin test to detect possible tuberculosis. If this test is performed within 6 weeks after administration of Varilrix, the result may not be reliable.

Vaccination should be delayed for at least 3 months if you or your child has received a blood transfusion or human antibodies (immunoglobulins).

The use of aspirin or other salicylates (a substance present in some medicines used to reduce fever and relieve pain) should be avoided for 6 weeks after vaccination with Varilrix, as this may cause a serious illness called Reye's syndrome, which can affect all organs of the body.

Varilrix can be administered at the same time as other vaccines. A separate injection site will be used for each vaccine.

Pregnancy and breastfeeding

Varilrix must not be given to pregnant women.

If you or your daughter is pregnant or breastfeeding, thinks she might be pregnant, or plans to become pregnant, consult your doctor or pharmacist before receiving the vaccine. It is also important that you or your daughter avoid becoming pregnant for one month after vaccination. During this time, an effective contraceptive method should be used to prevent pregnancy.

Inform your doctor if you or your daughter is breastfeeding or intends to breastfeed. Your doctor will decide whether you or your daughter should receive Varilrix.

Driving and using machines

Varilrix has no or negligible influence on the ability to drive and use machines. However, some of the side effects mentioned in section 4 "Possible side effects" may temporarily affect the ability to drive or use machines.

Varilrix contains sorbitol, phenylalanine, and proline

This vaccine contains 6 mg of sorbitol per dose.

This vaccine contains 331 micrograms of phenylalanine per dose. Phenylalanine may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This vaccine contains 402 micrograms of proline per dose. Proline may be harmful in patients with hyperprolinemia, a rare genetic disorder in which proline accumulates in the body. If you have hyperprolinemia, do not use this medicine unless your doctor recommends it.

3. How Varilrix is given

Varilrix is injected under the skin or into a muscle, either in the upper arm or the outer part of the thigh.

Individuals from 12 months of age should receive 2 doses of Varilrix, with at least 6 weeks between them. The interval between the first and second dose must not be less than 4 weeks.

In certain circumstances, the first dose of Varilrix may be given to infants aged 9 to 11 months. In these cases, two doses are required, administered at least 3 months apart.

Individuals at risk of severe chickenpox, such as those receiving cancer treatment, may receive additional doses. The interval between doses must not be less than 4 weeks.

Your doctor will determine the appropriate timing and number of doses based on official recommendations.

If you or your child has been given more Varilrix than you should have

Overdose is very unlikely because the vaccine is supplied in a single-dose vial and is administered by a doctor or nurse. However, if you or your child receives more Varilrix than intended, contact your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service at 91 562 04 20.

A few cases of accidental administration have been reported, and only in some of these cases were abnormal drowsiness and seizures (convulsions) reported.

If you think you or your child has missed a dose of Varilrix

Contact your doctor, who will decide whether a dose is needed and when it should be administered.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with this vaccine:

Very common (may affect more than 1 in 10 people): pain and redness at the injection site

Common (may affect up to 1 in 10 people): skin rash (spots and/or blisters); swelling at the injection site*; fever equal to or above 38°C (rectal)*

Uncommon (may affect up to 1 in 100 people): upper respiratory tract infection; sore throat and discomfort when swallowing (pharyngitis); swollen lymph nodes; irritability; headache; drowsiness; cough; itching, runny or stuffy nose, sneezing (rhinitis); nausea; vomiting; chickenpox-like rash; itching; joint pain; muscle pain; fever above 39.5°C (rectal); lack of energy (tiredness); general malaise

Rare (may affect up to 1 in 1,000 people): eye inflammation (conjunctivitis); stomach pain; diarrhoea; raised, itchy rash (urticaria)

*Swelling at the injection site and fever may occur very commonly in adolescents and adults. Swelling may also occur very commonly after the second dose in children under 13 years of age.

The following adverse effects have been reported in some cases during routine use of Varilrix:

• Brain infection or inflammation (encephalitis) has been observed after vaccination with live attenuated varicella virus vaccines. In some cases, this condition has been fatal, particularly in individuals with weakened immune systems (as noted in section 2, Varilrix must not be used in patients with weakened immune systems). Seek immediate medical attention if you or your child experience loss or reduction in consciousness level, seizures, or loss of control over body movements, accompanied by fever and headache, as these may be signs of brain infection or inflammation. Inform your doctor or pharmacist that you or your child have received a live attenuated varicella virus vaccine.
• Infection or inflammation of the spinal cord and peripheral nerves, causing temporary difficulty walking (instability) and/or temporary loss of control over body movements
• Stroke (brain damage caused by interruption of blood flow)
• Seizures or convulsions
• Herpes zoster
• Small bleeding spots or increased tendency to bruise due to a decrease in a type of blood cell called platelets
• Allergic reactions. Rashes that may cause itching or blisters, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. These reactions may occur before leaving the doctor's office. However, if you or your child develop any of these symptoms, contact a doctor urgently.
• Inflammation, narrowing, or blockage of blood vessels. This may involve unusual bleeding or bruising under the skin (Henoch-Schönlein purpura), or fever lasting more than five days associated with a rash on the trunk, sometimes followed by skin peeling on the hands and fingers, redness of the eyes, lips, throat, and tongue (Kawasaki disease)
• Erythema multiforme (symptoms include red spots, often itchy, resembling measles rash, starting on the limbs and sometimes on the face and rest of the body).

Reporting of adverse effects

If you or your child experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Varilrix

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

Do not use this vaccine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

After reconstitution, use the vaccine promptly. If this is not possible, it must be stored at room temperature (25 °C) and used within 90 minutes after reconstitution, or stored in the refrigerator (between 2 °C and 8 °C) and used within 8 hours after reconstitution.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Varilrix

The active substance is: live attenuated varicella virus (Oka strain, produced in human diploid MRC-5 cells). Each 0.5 ml dose of reconstituted vaccine contains no less than 103.3 PFU (plaque-forming units) of varicella virus.

The other components are:

Powder: amino acids (containing phenylalanine and proline), anhydrous lactose, sorbitol (E-420), mannitol (E-421).

Solvent: water for injections.

See section 2 “Varilrix contains sorbitol, phenylalanine and proline”.

Appearance of the product and contents of the pack

Powder and solvent for injectable solution in a pre-filled syringe. The powder is pale cream to yellowish or pinkish in colour. The solvent is a clear, colourless liquid.

Varilrix consists of:

• Powder for 1 dose in a glass vial.
• Solvent for 1 dose in a pre-filled syringe.

Pack sizes of 1 or 10, with 1 or 2 separate needles or without needles. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals

Rue de l'Institut 89

1330 Rixensart (Belgium)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 04/2026

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

As with all injectable vaccines, appropriate medical supervision and availability of emergency medical treatment must be ensured in case an uncommon anaphylactic reaction occurs following vaccine administration.

Allow alcohol and other antiseptic agents to evaporate from the skin before injecting the vaccine, as they may inactivate the attenuated viruses in the vaccine.

Varilrix must not be administered intravascularly or intradermally.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Before reconstitution or administration, the solvent and the reconstituted vaccine should be inspected visually. The color of the reconstituted vaccine may range from light orange to pink due to minor pH variations. It may contain translucent particles related to the product. This is normal and does not affect the vaccine's efficacy.

Do not administer if the vaccine has a different color or contains other particles.

The vaccine should be reconstituted by adding the entire contents of the pre-filled syringe containing the solvent to the vial containing the powder, using an appropriate needle (21G to 25G).

For instructions on how to insert the needle into the syringe, read the instructions carefully.

1. Add the solvent to the powder. Shake well until the powder is completely dissolved in the solvent.

2. Withdraw all the contents from the vial.

3. Use a new needle to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle, repeating the previous steps.

After reconstitution, use the vaccine promptly. If this is not possible, it must be stored at room temperature (25 °C) and used within 90 minutes after reconstitution, or it must be stored in the refrigerator (between 2 °C and 8 °C) and used within 8 hours after reconstitution.

Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.