CERVARIX INJECTABLE SUSPENSION IN VIAL

Introduction

Package Leaflet:Information for the User

Cervarix injectable suspension in a vial

Vaccine against Human Papillomavirus [Types 16, 18]

(Recombinant, adjuvanted, adsorbed)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Cervarix and what is it used for
2. What you need to know before you receive Cervarix
3. How Cervarix is administered
4. Possible side effects
5. Storage of Cervarix
6. Contents of the pack and other information

1. What is Cervarix and what is it used for

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

These diseases include:

• cervical cancer (i.e. cancer of the neck of the womb or uterus) and anal cancer,
• pre-cancerous lesions of the cervix, vulva, vagina, and anus (changes in the genital or anal cells that have the risk of turning into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related vulvar and vaginal pre-cancerous lesions, and 78% of HPV-related anal pre-cancerous lesions. Other types of HPV can also cause anogenital cancers. Cervarix does not protect against all types of HPV.

When a person is vaccinated with Cervarix, the immune system (the body's natural defense system) generates antibodies against HPV types 16 and 18.

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

Cervarix is not used to treat HPV-related diseases that are already present at the time of vaccination.

Cervarix should be used in accordance with official recommendations.

2. What you need to know before you receive Cervarix

Cervarix must not be administered:

• if you are allergic to any of the active substances or 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 problem or bruise easily
• if you have any disease that reduces your resistance to infection, such as an HIV infection
• if you have a severe infection with high fever. It may be necessary to postpone vaccination until you recover. A minor infection, such as a cold, should not be a problem for vaccination, but consult your doctor before vaccination.

Before or after any injection, fainting (especially in adolescents) may occur, so you should inform your doctor or nurse if you or your child have fainted after a previous injection.

Like all vaccines, Cervarix may not fully protect all people who are vaccinated.

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

Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening. You should continue to follow your doctor's advice about having cervical smear tests/Pap tests (a test to detect changes in the cells of the cervix caused by HPV infection) and using protective measures.

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

Cervarix does not protect against diseases that are not caused by Human Papillomavirus.

Other medicines and Cervarix

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

Cervarix may not have an optimal effect if you are using medicines that suppress the immune system.

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

Tell your doctor if you are using, have recently used, or might use any other medicines or if you have recently received any other vaccine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, have become pregnant during the vaccination period, or are planning to become pregnant, it is recommended that you postpone or interrupt vaccination until the end of pregnancy.

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

Driving and using machines

Cervarix is unlikely to affect your ability to drive or use machines. However, do not drive or use machines if you do not feel well.

Cervarix contains sodium

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

3. How Cervarix is administered

How the vaccine is administered

Your doctor or nurse will administer Cervarix by injection into the muscle of the upper arm.

How much is administered

Cervarix is indicated for individuals from the age of 9 years.

The total number of injections you will receive depends 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 old or more

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 can 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 in individuals under 9 years of age.

The vaccine should never be injected into a vein.

If you miss a dose

It is important that you follow the instructions given by your doctor or nurse regarding follow-up visits. If you miss your doctor's appointment, ask your doctor for advice.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

The side effects that occurred during clinical trials with Cervarix were:

• Very common (side effects that occur in more than 1 in 10 doses of vaccine):

• pain or discomfort at the injection site
• redness or swelling at the injection site
• headache

• muscle pain, muscle tenderness, or muscle weakness (not caused by physical exercise)
• fatigue.

• Common (side effects that occur in less than 1 in 10 but more than 1 in 100 doses of vaccine):

• gastrointestinal symptoms including nausea, vomiting, diarrhea, and abdominal pain
• itching, skin redness, and rash, urticaria (hives)
• joint pain
• fever (?38°C).

• Uncommon (side effects that occur in less than 1 in 100 but more than 1 in 1,000 doses of vaccine):

• upper respiratory tract infection (infection of the nose, throat, or trachea)
• dizziness
• other injection site reactions such as induration, tingling, or numbness of the area.

The side effects observed during the marketing 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, you should contact a doctor urgently.

• swelling of the neck, armpit, or groin lymph nodes
• fainting, sometimes accompanied by tremors or stiffness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cervarix

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

Do not use this vaccine after the expiry date which is stated on the carton. The expiry date is the last day of the month stated.

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

Do not freeze.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition ofCervarix

• The active substances are:

Human Papillomavirus type 16 L1 protein 20 micrograms

Human Papillomavirus type 18 L1 protein 20 micrograms

1 Human Papillomavirus = HPV

2 adjuvanted with AS04 which contains:

3-O-desacil-4’-monophosphoryl lipid A (MPL) 50 micrograms

3 adsorbed on hydrated aluminum hydroxide (Al(OH)3) 0.5 milligrams of Al3+ in total

4 L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system that uses cells derived from the insect Trichoplusia ni.

• The other ingredients are: sodium chloride (NaCl), disodium phosphate dihydrate (Na2HPO4.2 H2O), and water for injections.

Appearance of the product and pack contents

Injectable suspension.

Cervarix is a white, turbid suspension.

Cervarix is available in 1-dose vials (0.5 ml) in packs of 1, 10, and 100.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

B-1330 Rixensart, Belgium

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

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

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

The contents of the vial should be inspected visually both before and after agitation for any foreign particles and/or variation in physical appearance before administration.

If any of these conditions are observed, the vaccine should be discarded.

The vaccine should be shaken well before use.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.