Package Insert: Information for the User

Varilrix Powder and Diluent for Injectable Solution in Pre-filled Syringe

Varicella Vaccine (Live Virus)

Read this package insert carefully before you or your child receives this medication, as it contains important information for you/your child.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccinehas been prescribed only for you or your child, and should not be given to others.
• If you or your child experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Varilrix and how is it used

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

3. How to administer Varilrix

4. Possible adverse effects

5. Storage of Varilrix

6. Contents of the package and additional information

Varilrix is a vaccine for use in individuals aged 12 months and above to protect them against chickenpox. In some circumstances, Varilrix may also be administered to infants aged 9 months and above.

Vaccination within 3 days after contact with a chickenpox case 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 defense system) will produce antibodies to protect the person from infection by the chickenpox virus. Varilrix contains weakened viruses, making it highly unlikely to cause chickenpox in healthy individuals.

Like any vaccine, Varilrix may not protect all vaccinated individuals completely.

Do not useVarilrix

• If you or your child has any disease (such as blood disorders, cancer, Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)) or is taking any medication (including high doses of corticosteroids) that may weaken the immune system..Whether you or your child receives the vaccine will depend on the level of your defenses..See section 2 “Contraindications and precautions”.
• If you or your child is allergic to any of the components of this vaccine (including those listed in section 6). The signs of an allergic reaction may include: skin rash with itching, 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 produced when the skin comes into direct contact with allergens such as neomycin) should not be a reason not to vaccinate. However, consult your doctor first.
• If you or your child has had a previous allergic reaction to any varicella vaccine.
• If you or your daughter is pregnant. Additionally, pregnancy should be avoided for 1 month after vaccination.

Contraindications and precautions

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

• If you or your child has a severe infection with high fever. It may be necessary to postpone the vaccination until recovery. A minor infection, such as a cold, does not require postponing the vaccination. However, consult your doctor first.
• If you or your child has a weakened immune system due to diseases (e.g., HIV infection) and/or treatments. You or your child should be closely monitored since the response to the vaccine 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.

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

Like other vaccines, Varilrix may not completely protect you or your child against chickenpox. However, people who have been vaccinated and develop chickenpox usually have a very mild disease compared to those who have not been vaccinated.

In rare cases, the weakened virus may be transmitted from a vaccinated person to others. Normally, this occurs when the vaccinated person has some skin lesions or blisters. Healthy people who become infected in this way usually only develop a mild skin rash that is not harmful.

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

• people with weakened immune systems,
• pregnant women who have not had chickenpox or have not been vaccinated against chickenpox,
• newborn babies of mothers who have not had chickenpox or have not been vaccinated against chickenpox.

Other medicines and Varilrix

Inform your doctor or pharmacist if you or your child is taking, has taken recently or may 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.

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

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

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

Pregnancy and breastfeeding

Varilrix should not be administered to pregnant women.

If you or your daughter is pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before receiving the vaccine. It is also important that you or your daughter do not become pregnant for 1 month after vaccination. During this time, an effective contraceptive method should be used to avoid pregnancy.

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

Driving and operating machinery

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

Varilrix contains sorbitol and phenylalanine

This vaccine contains 6 mg of sorbitol in each dose.

This vaccine contains 331 micrograms of phenylalanine in each dose. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

People aged 12 months and older should receive 2 doses of Varilrix with at least 6 weeks between them. The time between the first and second dosesmust notbe less than 4 weeks.

In some cases, the first dose of Varilrix can be administered to babies aged 9 to 11 months. In these cases, 2 doses are needed and should be administered with at least 3 months between them.

People at risk of severe chickenpox, such as those receiving cancer treatment, may receive additional doses. The interval between dosesmust notbe less than 4 weeks.

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

If you or your child receive more Varilrix than you should

Overdose is very unlikely because the vaccine is provided in a single-dose vial and is administered by a doctor or nurse. However, if you or your child receive more Varilrix than you should, consult your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone 91 562 04 20.

A few cases of accidental administration have been reported, and in some of them, abnormal somnolence and seizures (convulsions) were noted.

If you think you or your child forgot to receive a dose of Varilrix

Contact your doctor, who will decide if a dose is needed and when to administer it.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side 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 greater than 38°C (rectal)*

• Uncommon (may affect up to 1 in 100 people):
• • upper respiratory tract infection
  • sore throat and swallowing difficulties (pharyngitis)
  • swelling of the lymph nodes
  • irritability
  • headache
  • drowsiness
  • cough
  • itching, discharge or congestion, sneezing (rhinitis)
  • nausea
  • vomiting
  • skin rash similar to chickenpox
  • pruritus
  • joint pain
  • muscle pain
  • fever greater than 39.5°C (rectal)
  • fatigue
  • general malaise

• Rare (may affect up to 1 in 1000 people):
• • conjunctivitis (inflammation of the eye)
  • stomach pain
  • diarrhea
  • urticaria (hives with itching)

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

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

Reporting of side effects

If you or your child experiences any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish 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.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

After reconstitution, the vaccine must be administered immediately.

If this is not possible, the reconstituted vaccine can be stored for up to 90 minutes at room temperature (25°C) or up to 8 hours in a refrigerator (between 2°C and 8°C). If it is not used within the recommended storage and usage periods, the reconstituted vaccine must be discarded.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE collection pointat your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines.This will help protect the environment.

Varilrix Composition

• The active ingredient is: live attenuated varicella virus (Oka strain, produced in

Celulas diploides humanas MRC-5). Each dose of 0.5 ml of the reconstituted vaccine contains no less than 10 3.3 UFP (plaque-forming units) of the varicella virus.

• The other components are:

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

Disolvente: water for injection.

Appearance of the product and contents of the package

Varilrix is presented as a powder and solvent for injection (powder in a vial for 1 dose and solvent in a pre-loaded syringe (0.5 ml), with or without separate needles in the following package sizes:

• with 1 separate needle: package sizes of 1 or 10.
• with 2 separate needles: package sizes of 1 or 10.
• without needles: package sizes of 1 or 10.

Varilrix is supplied as a cream-colored to yellowish or pinkish powder and a colorless transparent solvent (water for injection) to reconstitute the vaccine.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

GlaxoSmithKline, S.A.

PTM C/ Severo Ochoa 2

28760 - Tres Cantos

Madrid

Phone: 900 202 700

Fax: 91 807 03 10

Email: [email protected]

Manufacturer responsible

GlaxoSmithKline Biologicals

Rue de l´Institut 89

1330 Rixensart (Belgium)

Last review date of this leaflet: 10/2021

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

As with all injectable vaccines, adequate medical supervision and availability of medical treatment should be ensured in case of an infrequent anaphylactic reaction following administration of the vaccine.

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

Varilrix should not be administered by intravascular or intradermal route.

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

Visually inspect the solvent and the reconstituted vaccine for any foreign particles and/or abnormal physical appearance before administration. If any are observed, do not administer the vaccine.

The vaccine should be reconstituted by adding the entire contents of the pre-loaded syringe of solvent to the vial containing the powder.

To know how to insert the needle into the syringe, read the instructions provided with images 1 and 2 carefully. However, the syringe provided with Varilrix may be slightly different (without a screw thread) from the syringe in the image. In this case, the needle should be inserted without screwing.

Always hold the syringe by the body, not by the plunger or the Luer lock adapter (ABL), and keep the needle in the syringe axis (as shown in image 2). Otherwise, the ABL may be deformed and cause leaks.

If the ABL is detached during the syringe assembly, use a new dose of the vaccine (new syringe and vial).

1. Remove the syringe cap by turning it counterclockwise (as shown in image 1).

Please follow the next steps, regardless of whether the ABL turns or not:

1. Insert the needle into the syringe by gently engaging the needle cone with the ABL and turning it a quarter of a turn clockwise until it locks (as shown in image 2).

1. Remove the needle cap (it may be difficult).

1. Add the solvent to the powder. The mixture should be shaken well until the powder is completely dissolved.

Due to small pH variations, the color of the reconstituted vaccine may vary from light orange to pink. This is normal and does not affect the vaccine's performance. Do not administer the vaccine if you observe any other variation.

1. Remove the entire contents of the vial

1. A new needle should be used to administer the vaccine. Remove the needle from the syringe and insert the injection needle, repeating step 2 above.

After reconstitution, it is recommended to administer the vaccine as soon as possible. However, it has been demonstrated that the reconstituted vaccine can be stored for up to 90 minutes at room temperature (25°C) and up to 8 hours in the refrigerator (between 2°C and 8°C). If it is not used within the recommended storage and use conditions, the reconstituted vaccine should be discarded.

The disposal of unused vaccine and all materials that have come into contact with it should be carried out in accordance with local regulations.