Cervarix suspension inyectable en jeringa precargada

Prospecto:information for the user

Cervarix pre-filled syringe suspension

Human Papillomavirus vaccine[Types 16, 18]

(Recombinant, adjuvanted, adsorbed)

Read this prospectus carefully before starting to receive this vaccine,because it contains important information for you.

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

• This medicine has been prescribed only for you, and you must not give it to other people.

-If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this prospectus.See section 4.

1.What is Cervarix and how it is used

2.What you need to know before receiving Cervarix

3.How to administer Cervarix

4.Possible adverse effects

5.Storage of Cervarix

6.Contents of the package and additional information

Cervarix is a vaccine indicated to protect individuals 9 years of age and older against diseases caused by Human Papillomavirus (HPV) infection.

These diseases include:

• cervical cancer (i.e., of the cervix or uterus) and anal cancer,
• precancerous lesions of the cervix, vulva, vagina, and anus (cell changes in the genital or anal area that have a risk of becoming cancer).

The HPV types contained in the vaccine (types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of precancerous lesions of the vulva and vagina related to HPV, and 78% of precancerous lesions of the anus related to HPV. Other HPV types can also cause ano-genital cancers. Cervarix does not protect against all HPV types.

When a person is vaccinated with Cervarix, the immune system generates antibodies against HPV types 16 and 18.

Cervarix is not infectious and therefore cannot cause diseases related to HPV.

Cervarix is not used to cure existing diseases related to HPV at the time of vaccination.

Cervarix should be used in accordance with official recommendations.

Cervarix should not be administered

• if you are allergic to any of the active ingredients or to any of the other components of this vaccine (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.

Warnings and precautions

Consult your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding disorder or if you bruise easily
• if you have any disease that reduces your resistance to infection, such as HIV infection
• if you have a severe infection with high fever. You may need to postpone vaccination until you recover. A minor infection, such as a cold, should not be a problem for vaccination, but inform your doctor before vaccinating.

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

Like all vaccines, Cervarix may not protect all people who receive it.

Cervarix does not protect against diseases caused by infection with types 16 or 18 of HPV if you are already infected with types 16 or 18 of Human Papillomavirus at the time of vaccination.

Although vaccination may protect you against cervical cancer, it is not a substitute for routine gynecological examination of the cervix.You should follow your doctor's advice regarding the performance of Pap smear / Papanicolau test (test to detect changes in cervical cells caused by HPV infection) and the use of preventive and protective measures.

Since Cervarix does not protect against all types of Human Papillomavirus, you should continue to take appropriate precautions to avoid transmission of HPV and sexually transmitted diseases.

Cervarix does not protect against other diseases not caused by Human Papillomavirus.

Other medicines and Cervarix

Cervarix can be administered with a combined booster vaccine containing diphtheria (d), tetanus (T), and pertussis [acellular] (pa), with or without inactivated poliomyelitis (IPV) (dTpa, dTpa-IPV), with a combined hepatitis A and B vaccine (Twinrix), with a hepatitis B vaccine (Engerix B), or with a conjugate vaccine with tetanus toxoid against meningococcal serogroups A, C, W-135, and Y (MenACWY-TT),in a different injection site (another part of your body, for example, another arm) on the same visit.

Cervarix may not have optimal effect if you use immunosuppressive medications.

In clinical studies, the use of oral contraceptives (e.g., the pill) did not reduce the protection obtained by Cervarix.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant,you have become pregnantduring the vaccination periodor are trying to become pregnant,it is recommended that you postponeor interruptthe vaccination until the end of pregnancy.

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

Driving and operating machinery

It is unlikely that Cervarix will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you do not feel well.

Cervarix contains sodium

This vaccine contains less than1 mmolof sodium (23 mg) per dose; this is essentially “sodium-free”.

How the Vaccine is Administered

The doctor or nurse will administerCervarixby injection into the muscle of the upper arm.

How Much is Administered

Cervarix is indicated for individuals aged 9 years or older.

The total number of injections you will receive will depend on your age at the time of the first injection.

If you are between 9 and 14 years old

You will receive 2 injections:

First injection: on the chosen date.

Second injection: between 5 and 13 months after the first injection.

If you are 15 years or older

You will receive 3 injections:

First injection: on the chosen date.

Second injection: 1 month after the first injection.

Third injection: 6 months after the first injection.

In case of need, the vaccination schedule may be more flexible.Consult your doctor for more information.

Once the first dose of Cervarix has been administered, it is recommended that Cervarix (and not another HPV vaccine) be used to complete the vaccination schedule.

Cervarix is not recommended for use inindividualsunder 9 years of age.

The vaccine should never be injected into a vein.

What to Do if a Dose is Missed

It is essential to follow the instructions provided by your doctor or nurse regarding follow-up visits. If you forget to return to your doctor on the scheduled appointment, consultyour doctor.

If you do not complete the full vaccination cycle (two or three injections, depending on your age at the time of vaccination), you may not achieve the best effect and protection from the vaccination.

Like all medications, this vaccine may produce adverse effects, although not all people will experience them.

The adverse effects that occurredduring clinical trials with Cervarix were:

• Very common (adverse effects that occur in more than 1 in 10 vaccine doses): pain or discomfort at the injection site, redness or inflammation at the injection site, headache, muscle aches, muscle sensitivity or weakness (not caused by physical exercise), fatigue.

• Common (adverse effects that occur in less than 1 in 10 but more than 1 in 100 vaccine doses): gastrointestinal symptoms including nausea, vomiting, diarrhea, and abdominal pain, itching, skin redness and skin rash, urticaria (hives), joint pain, fever (?38°C).

• Uncommon (adverse effects that occur in less than 1 in 100 but more than 1 in 1,000 vaccine doses): upper respiratory tract infection (infection of the nose, throat, or trachea), dizziness, other reactions at the injection site such as induration, tingling, or numbness in the area.

The adverse effects observed during the commercialization of Cervarix include:

• allergic reactions. These can be recognized by:

• skin rash with itching on hands and feet,
• swelling of the eyes and face,
• difficulty breathing or swallowing,
• sudden drop in blood pressure and loss of consciousness.

These reactions usually appear before leaving the doctor's office. However, if your child experiences any of these symptoms, contact a doctor urgently.

• swelling of the lymph nodes in the neck, armpits, or groin
• lightheadedness, sometimes accompanied by tremors or stiffness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use,https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

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

Store in a refrigerator (between2°Cand8°C).

Do not freeze..

Store in the original packaging to protect it from light.

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

Composition ofCervarix

• Active principles are:

Human Papillomavirus Protein L1 1 type 16 2,3,4 20 micrograms

Human Papillomavirus Protein L1 1 type 18 2,3,4 20 micrograms

1 Human Papillomavirus = HPV

2 Adjuvanted with AS04 containing:

3- O -desacetyl-4'- monophosphoryl lipid A (MPL) 3 50 micrograms

3 Adsorbed on aluminum hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams of Al 3+

in total

4 Human Papillomavirus Protein L1 in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system in Hi-5 Rix4446 cells derived from the insect Trichoplusia ni .

• Other components are: sodium chloride (NaCl), dihydrogen phosphate sodium dihydrate (NaH 2 PO 4 .2 H 2 O) and water for injectable preparations.

Appearance of the product and contents of the package

Injectable suspension in pre-filled syringe.

Cervarix is a white turbid suspension.

Cervarix is available in pre-filled syringe of 1 dose, with or without separate needles; package sizes of 1 and 10.

Only some package 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 authorization holder in your country.

Date of the last revision of this leaflet: 04/2023

Other sources of information

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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This information is intended for healthcare professionals only:

Once out of the refrigerator, Cervarix should be administered as soon as possible. However, its stability has been demonstrated when stored out of the refrigerator for up to 3 days at a temperature between 8°C and 25°C or for up to 1 day at a temperature between 25°C and 37°C. If it has not been used within this period, discard the vaccine.

During storage of the syringe, a white deposit and a transparent supernatant may be observed. This is not a sign of deterioration.

The syringe should be visually inspected both before and after agitation to check for any foreign particles or variation in physical appearance before administration.

In the event of observing any of these circumstances, the vaccine should be discarded.

The vaccine should be shaken well before use.

Instructions for the pre-filled syringe

Disposal of residues

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