Cervarix

Package leaflet: Information for the user

Cervarix injectable suspension in vial

Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Please read all of this leaflet carefully before you start using this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cervarix is and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by Human Papillomavirus (HPV) infection in individuals from the age of 9 years.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous cervical, vulvar, vaginal and anal lesions (changes in the genital or anal cells that carry a risk of developing into cancer).

The types of Human Papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancer cases, 90% of anal cancer cases, and 70% of HPV-related precancerous vulvar and vaginal lesions. Other types of HPV may also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defence system) produces antibodies against HPV types 16 and 18.
Cervarix is non-infectious and therefore cannot cause HPV-related diseases.
Cervarix does not treat existing HPV-related diseases present at the time of vaccination.
Cervarix should be used in accordance with official recommendations.

2. What you should know before using Cervarix

Do not use Cervarix:

• if you are allergic to any of the active substances or to any of the components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath, or swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding disorder or bruise easily;
• if you have any illness that reduces your resistance to infections, such as HIV infection;
• if you have a serious infection with high fever. Vaccination may need to be postponed until after recovery. A mild infection such as a cold should not be a problem, but discuss this with your doctor first.

Fainting (especially in adolescents) may occur during or even before any needle injection. Therefore, inform your doctor or nurse if you or your child have previously fainted after an injection.
Like all vaccines, Cervarix may not fully protect all individuals who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 if individuals are already infected with human papillomavirus types 16 or 18 at the time of vaccination.
Although vaccination may protect against cervical cancer, it does not replace regular cervical screening. The vaccinated person should continue to follow the doctor's advice regarding Pap smears/Pap tests (tests to check for changes in cervical cells caused by HPV infection) and preventive measures.
Since Cervarix does not protect against all types of human papillomavirus, vaccinated individuals should continue to take appropriate precautions to avoid exposure to HPV and sexually transmitted diseases.
Cervarix does not protect against diseases not caused by human papillomavirus.

Other medicines and Cervarix
Cervarix can be administered at the same visit as a combined booster vaccine against diphtheria (d), tetanus (T), and pertussis [acellular] (pa) with or without inactivated poliovirus (IPV), (vaccines dTpa, dTpa-IPV), a combined vaccine against hepatitis A and hepatitis B (Twinrix), a hepatitis B vaccine (Engerix B), or a meningococcal serogroup A, C, W-135, Y conjugate vaccine adsorbed (MenACWY-TT), provided that each vaccine is given at a separate injection site (a different part of the body, e.g., the other arm).
Cervarix may not achieve optimal effect when used together with other medicines that suppress the immune system.
In clinical studies, oral contraceptives (e.g., the pill) did not reduce the protection provided by Cervarix.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, or if you have recently been vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination schedule, or if you are planning a pregnancy, vaccination should be postponed or discontinued until after pregnancy is completed.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this vaccine.

Driving and using machines
Cervarix has no influence on the ability to drive or use machinery. However, do not drive or operate machinery if you do not feel well.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to use Cervarix

How the vaccine is administered
Your doctor or nurse will administer Cervarix as an intramuscular injection into the upper arm.
Number of doses
Cervarix is indicated for use 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 of age
you will receive two injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection
If you are 15 years of age or older
you will receive three injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection
If necessary, the vaccination schedule may be more flexible. Speak with your doctor for further information.
When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another HPV vaccine) be used for the complete vaccination course.
Cervarix is not recommended for use in children under 9 years of age.
The vaccine must never be administered intravenously.
If you miss a dose
It is important that you follow the instructions provided by your doctor or nurse regarding appointments for subsequent doses. If you forget to return for a scheduled dose, consult your doctor for advice.
If you do not complete the full vaccination course (two or three doses depending on your age at vaccination), you may not achieve optimal immune response and protection.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them.
The side effects observed during clinical studies with Cervarix were as follows:

♦ Very common (occurring 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 pain or weakness (not caused by physical exercise)
♦ fatigue

♦ Common (occurring in less than 1 in 10 doses but more than 1 in 100 doses of vaccine):
♦ gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
♦ itching, skin redness, urticaria
♦ joint pain
♦ fever (temperature equal to or higher than 38°C)

♦ Uncommon (occurring in less than 1 in 100 doses but more than 1 in 1,000 doses of vaccine):
♦ upper respiratory tract infections (infection of the nose, throat or trachea)
♦ dizziness
♦ other reactions at the injection site such as hardening, tingling or numbness

Side effects reported during the post-marketing use of Cervarix include:
♦ allergic reactions. These may be recognized by: itchy red rash on the 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 occur before leaving the medical office. However, if your child experiences any of these symptoms, contact a doctor immediately.
♦ swelling of the glands in the neck, armpits or groin
♦ fainting, sometimes accompanied by tremors or stiffness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cervarix contains

• The active substances are:

Human Papillomavirus type 16 L1 protein 20 micrograms
Human Papillomavirus type 18 L1 protein 20 micrograms
Human Papillomavirus = HPV
adjuvanted with AS04 containing:
3-O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms
adsorbed on aluminium hydroxide, hydrated (Al(OH)<sub>3) 0.5 milligrams Al in total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system employing Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

• The other components are sodium chloride (NaCl), sodium monophosphate dihydrate (NaH\2PO\4.2H\2O) and water for injections.

Description of the appearance of Cervarix and contents of the pack
Injectable suspension.
Cervarix is a white, cloudy suspension.
Cervarix is available in single-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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA./NV GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals Tel. +359 GlaxoSmithKline Pharmaceuticals SA./NV
80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA Tel: +356
Tlf: + 45 36 35 91 00 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA Tel: +372 GlaxoSmithKline AS
8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH.
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tél: + 33 (0) 1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA Tel: +40
Tel.: +385 800787089 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA Tel: +386
Tel: + 353 (0)1 495 5000 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA Tel: +421
Sími: +354 535 7000 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA Tel: +357 GlaxoSmithKline AB
80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA Tel: +371 GlaxoSmithKline Biologicals SA
80205045 Tel: +44(0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at
temperatures between 8°C and 25°C, or up to 1 day at temperatures between 25°C and 37°C. If not
used within this time period, the vaccine must be discarded.
During storage, a fine white deposit with a clear, colourless supernatant may be observed in the vial.
This does not indicate deterioration.
The vial contents should be inspected visually both before and after shaking for the presence of any
foreign particles and/or abnormal physical appearance prior to administration.
If any such conditions are observed, the vaccine must be discarded.
The vaccine must be shaken well before use.
Any unused medicinal product and waste materials derived from this medicinal product should be
disposed of in accordance with local requirements.

Package leaflet: information for the user

Cervarix injectable suspension, multidose vial

Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Please read this leaflet carefully before using this vaccine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Cervarix is and what it is used for
2. What you need to know before using Cervarix
3. How to use Cervarix
4. Possible side effects
5. How to store Cervarix
6. Package contents and other information

1. What Cervarix is and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by human papillomavirus (HPV) infection in individuals from the age of 9 years.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous cervical, vulvar, vaginal and anal lesions (changes in the genital or anal cells that carry a risk of developing into cancer).

The types of human papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancer cases, 90% of anal cancer cases, and 70% of HPV-related precancerous vulvar and vaginal lesions. Other types of HPV may also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defence system) produces antibodies against HPV types 16 and 18.
Cervarix is non-infectious and therefore cannot cause HPV-related diseases.
Cervarix does not treat existing HPV-related diseases present at the time of vaccination.
Cervarix should be used in accordance with official recommendations.

2. What you should know before using Cervarix

Do not use Cervarix:

• if you are allergic to any of the active substances or to any of the components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath, and swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding disorder or bruise easily;
• if you have any illness that reduces your resistance to infections, such as HIV infection;
• if you have a severe infection with high fever. Vaccination may need to be postponed until you recover. A mild infection such as a cold should not be a problem, but discuss it with your doctor first.

Fainting (especially in adolescents) may occur during or even before any needle injection. Therefore, inform your doctor or nurse if you or your child have previously fainted after an injection.
Like all vaccines, Cervarix may not fully protect all individuals who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 if individuals are already infected with human papillomavirus type 16 or 18 at the time of vaccination.
Even though vaccination can protect against cervical cancer, it does not replace regular cervical screening. Vaccinated individuals should continue to follow their doctor's advice regarding Pap smears/Pap tests (tests to monitor HPV-related cellular changes in the cervix) and preventive measures.
Since Cervarix does not protect against all types of human papillomavirus, vaccinated individuals should continue to take appropriate precautions against exposure to HPV and sexually transmitted diseases.
Cervarix does not protect against diseases not caused by human papillomavirus.

Other medicines and Cervarix
Cervarix may be administered together with a combined booster vaccine against diphtheria (d), tetanus (T), and pertussis [acellular] (pa), with or without inactivated poliovirus (IPV) (vaccines dTpa, dTpa-IPV), with a combined hepatitis A and hepatitis B vaccine (Twinrix), with a hepatitis B vaccine (Engerix B), or with a meningococcal serogroup A, C, W-135, Y conjugate vaccine adsorbed with tetanus toxoid (MenACWY-TT), at a separate injection site (another part of the body, e.g. the other arm) during the same visit.
Cervarix may not achieve optimal effect when used together with other medicinal products that suppress the immune system.
In clinical studies, oral contraceptives (e.g. the pill) did not reduce the protection provided by Cervarix.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, or if you have recently been vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination course, or if you are planning a pregnancy, it is recommended to postpone or interrupt vaccination until after completion of pregnancy.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this vaccine.

Driving and using machines
Cervarix has no influence on the ability to drive or use machinery. However, do not drive or operate machinery if you do not feel well.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to use Cervarix

How the vaccine is administered
Your doctor or nurse will administer Cervarix by intramuscular injection into the upper arm.

How many doses are given
Cervarix is indicated for use 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 of age
you will receive 2 injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection

If you are 15 years of age or older
you will receive 3 injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection

If necessary, the vaccination schedule may be more flexible. Speak with your doctor for further information.

When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another HPV vaccine) be used for the complete vaccination course.

Cervarix is not recommended for use in children under 9 years of age.
The vaccine must never be administered intravenously.

If you miss a dose
It is important that you follow the instructions provided by your doctor or nurse regarding appointments for subsequent doses. If you forget to return for a scheduled vaccination, consult your doctor.

If you do not complete the full vaccination course (two or three injections depending on age at the time of vaccination), you may not achieve optimal immune response and protection.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody experiences them.
The side effects observed during clinical studies with Cervarix are listed below:

♦ Very common (occurring 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 pain or weakness (not caused by physical exercise)
♦ fatigue

♦ Common (occurring in less than 1 in 10 doses but more than 1 in 100):
♦ gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
♦ itching, skin redness, urticaria
♦ joint pain
♦ fever (temperature equal to or higher than 38°C)

♦ Uncommon (occurring in less than 1 in 100 doses but more than 1 in 1,000):
♦ upper respiratory tract infections (infection of the nose, throat or trachea)
♦ dizziness
♦ other injection site reactions such as hardening, tingling or numbness

Side effects reported during the post-marketing use of Cervarix include:

♦ allergic reactions. These may present as itchy red rash on the 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 occur before leaving the medical office. However, if your child experiences any of these symptoms, contact a doctor immediately.
♦ swelling of the glands in the neck, armpits or groin
♦ fainting, sometimes accompanied by trembling or stiffness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep in the original packaging to protect the medicine from light.
Immediate use is recommended after first opening. If not used immediately, the vaccine must be stored in a refrigerator (2°C–8°C). If not used within 6 hours, it must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cervarix contains

• The active substances are:

Human Papillomavirus type 16 L1 protein 20 micrograms
Human Papillomavirus type 18 L1 protein 20 micrograms
Human Papillomavirus = HPV
adjuvanted with AS04 containing:
3-O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms
adsorbed on aluminium hydroxide hydrate (Al(OH)₃), 0.5 milligrams Al in total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system employing Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

• The other components are sodium chloride (NaCl), monobasic sodium phosphate dihydrate (NaH₂PO₄·2H₂O), and water for injections.

Description of the appearance of Cervarix and contents of the pack
Injectable suspension.
Cervarix is a white, cloudy suspension.
Cervarix is available in 2-dose vials (1 ml) in packs of 1, 10 and 100 pieces.
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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA./NV GlaxoSmithKline Biologicals SATel: +370 80000334
Tél/Tel: +32 10 85 52 00

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA Tel. +359 80018205 GlaxoSmithKline Pharmaceuticals SA./NV
Tél/Tel: +32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SATel.: +36 80088309
Tel: +420 2 22 00 11 11
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SATel: +356 80065004
Tlf: +45 36 35 91 00
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: +49 (0)89 360448701 Tel: +31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA Tel: +372 8002640 GlaxoSmithKline AS
Tlf: +47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH.
Tηλ: +30 210 68 82 100 Tel: +43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: +34 900 202 700 Tel.: +48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tél: +33 (0)1 39 17 84 44 Tel: +351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Biologicals SATel.: +385 800787089 GlaxoSmithKline Biologicals SATel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SATel: +386 80688869
Tel: +353 (0)1 495 5000

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SATel: +421 800500589
Sími: +354 535 7000

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: +39 (0)45 7741 111 Puh/Tel: +358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA Τηλ: +357 80070017 GlaxoSmithKline AB
Tel: +46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA Tel: +371 80205045 GlaxoSmithKline Biologicals SA
Tel: +44 (0)800 221 441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at
temperatures between 8°C and 25°C, or up to 1 day at temperatures between 25°C and 37°C. If not
used within this time period, the vaccine must be discarded.
During storage, a fine white deposit with a clear, colourless supernatant may be observed in the vial.
This does not indicate deterioration.
The vial contents should be inspected visually both before and after agitation to ensure the absence of
any foreign particulate matter and/or abnormal physical appearance prior to administration.
If any such conditions are observed, the vaccine should be discarded.
The vaccine must be shaken well before use.
When using the multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe;
precautions must be taken to avoid contamination of the contents.
Any unused medicinal product and waste material derived from this medicinal product should be
disposed of in accordance with local requirements.

Package leaflet: information for the user

Cervarix, injectable suspension in a pre-filled syringe

Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Please read this leaflet carefully before using this vaccine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cervarix is and what it is used for

Cervarix is a vaccine developed to protect against diseases caused by human papillomavirus (HPV) infection in individuals from the age of 9 years.
These diseases include:

• cervical cancer (cancer of the cervix, i.e. the lower part of the uterus) and anal cancer,
• precancerous lesions of the cervix, vulva, vagina, and anal lesions (changes in genital or anal cells that carry a risk of developing into cancer).

The types of human papillomavirus (HPV) contained in the vaccine (HPV types 16 and 18) are responsible for
approximately 70% of cervical cancer cases, 90% of anal cancer cases, and 70% of HPV-related precancerous lesions of the vulva and vagina. Other types of HPV may also cause anogenital cancer. Cervarix does not protect against all types of HPV.
When a woman or a man is vaccinated with Cervarix, the immune system (the body's natural defense system)
produces antibodies against HPV types 16 and 18.
Cervarix is not infectious and therefore cannot cause diseases related to HPV infection.
Cervarix does not cure existing HPV-related diseases present at the time of vaccination.
Cervarix should be used in accordance with official recommendations.

2. What you need to know before using Cervarix

Do not use Cervarix:

• if you are allergic to any of the active substances or to any of the components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath, or swelling of the face or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Cervarix:

• if you have a bleeding disorder or bruise easily;
• if you have any illness that reduces your resistance to infections, such as HIV infection;
• if you have a severe infection with high fever. Vaccination may need to be postponed until after recovery. A mild infection such as a cold should not be a problem, but discuss it with your doctor first.

Fainting (especially in adolescents) may occur following, or even before, any
needle injection. Therefore, inform your doctor or nurse if you or your child has fainted after a previous
injection.
Like all vaccines, Cervarix may not fully protect all individuals who are vaccinated.
Cervarix does not protect against diseases caused by HPV types 16 or 18 if individuals are
already infected with human papillomavirus type 16 or 18 at the time of vaccination.
Although vaccination may protect against cervical cancer, it does not replace regular cervical screening. The vaccinated person should continue to follow the doctor’s advice regarding Pap smears/Pap tests (tests to monitor changes in cervical cells caused by HPV infection) and preventive measures.
Since Cervarix does not protect against all types of human papillomavirus, the vaccinated person should
continue to take appropriate precautions to avoid exposure to HPV and sexually transmitted diseases.
Cervarix does not protect against diseases not caused by human papillomavirus.

Other medicines and Cervarix
Cervarix may be administered at the same visit together with a booster combination vaccine against diphtheria (d), tetanus (T), and pertussis [acellular] (pa), with or without inactivated poliovirus (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 meningococcal serogroup A, C, W-135, Y conjugate vaccine using tetanus toxoid as carrier protein (MenACWY-TT), at a separate injection site (a different part of the body, e.g. the other arm).
Cervarix may not achieve an optimal effect when used together with other medicines that suppress the immune system.
In clinical studies, oral contraceptives (e.g. the pill) did not reduce the protection provided by Cervarix.
Inform your doctor if you are taking, have recently taken, or might take any other medicines, or if you have recently been vaccinated with any other vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant, if pregnancy occurs during the vaccination course, or if you are planning a pregnancy, vaccination is recommended to be postponed or interrupted until after completion of pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before using this vaccine.

Driving and using machines
Cervarix has no influence on the ability to drive or use machinery. However, do not drive or operate machinery if you do not feel well.

Cervarix contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Cervarix

How the vaccine is administered
Your doctor or nurse will administer Cervarix as an intramuscular injection into the upper arm.

How many doses are given
Cervarix is indicated for use 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 of age
you will receive 2 injections:
First injection: on the scheduled date
Second injection: between 5 and 13 months after the first injection

If you are 15 years of age or older
you will receive 3 injections:
First injection: on the scheduled date
Second injection: 1 month after the first injection
Third injection: 6 months after the first injection

If necessary, the vaccination schedule may be more flexible. Speak with your doctor for further information.

When Cervarix is administered as the first dose, it is recommended that Cervarix (and not another HPV vaccine) be used for the complete vaccination course.

Cervarix is not recommended for use in children under 9 years of age.
The vaccine must never be administered intravenously.

If you miss a dose
It is important that you follow the instructions provided by your doctor or nurse regarding appointments for subsequent doses. If you forget to return for your scheduled dose, consult your doctor for advice.

If you do not complete the full vaccination course (two or three doses depending on age at vaccination), you may not achieve optimal immune response and protection.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone experiences them.
The side effects observed during clinical studies with Cervarix are as follows:
♦ Very common (occurring in more than 1 in 10 vaccine doses): pain or discomfort at the injection site, redness or swelling at the injection site, headache, muscle pain, muscle pain or weakness (not caused by physical exercise), fatigue.
♦ Common (occurring in less than 1 in 10 but more than 1 in 100 vaccine doses): gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain, itching, skin redness, urticaria, joint pain, fever (temperature equal to or greater than 38°C).

• Uncommon (occurring in less than 1 in 100 but more than 1 in 1,000 vaccine doses): upper respiratory tract infections (infection of the nose, throat or trachea), dizziness, other injection site reactions such as hardening, tingling or numbness.

Side effects reported during the post-marketing use of Cervarix include:

• Allergic reactions. These may be recognized by: itchy red rash on the 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 occur before leaving the doctor's office. However, if your child experiences any of these symptoms, contact a doctor immediately.
• Swelling of the glands in the neck, armpits or groin
• Fainting, sometimes accompanied by trembling or stiffness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly through the national reporting system indicated in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cervarix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cervarix contains

• The active substances are:

Human Papillomavirus type 16 L1 protein 20 micrograms
Human Papillomavirus type 18 L1 protein 20 micrograms
Human Papillomavirus = HPV
adjuvanted with AS04 containing:
3-O-desacyl-4’-monophosphoryl lipid A (MPL) 50 micrograms
adsorbed on aluminium hydroxide, hydrated (Al(OH)_3) 0.5 milligrams Al in
total
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by
recombinant DNA technology using a Baculovirus expression system employing Hi-5 Rix 4446 cells derived from the insect Trichoplusia ni.

• The other components are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH_2PO_4.2H_2O) and water for injections.

Description of the appearance of Cervarix and contents of the pack
Injectable suspension in a pre-filled syringe.
Cervarix is a white, cloudy suspension.
Cervarix is available in pre-filled syringes containing 1 dose, with or without separate needles, in packs of 1 and 10.
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 medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA./NV
GlaxoSmithKline Pharmaceuticals SA./NV Tél/Tel: + 32 10 85 52 00
Tél/Tel: + 32 10 85 52 00

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals SA./NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH.
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tél: + 33 (0) 1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel.: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel:+ 39 (0)45 7741 111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel: +371 80205045 Tel: +44 (0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

Cervarix should be administered as soon as possible after removal from the refrigerator.
However, stability has been demonstrated when stored outside the refrigerator for up to 3 days
between 8°C and 25°C, or up to 1 day between 25°C and 37°C. If not used within this time, the
vaccine must be discarded.
During storage, a fine white deposit with a clear, colorless supernatant may be observed in the syringe.
This is not an indication of deterioration.
The syringe contents should be inspected visually both before and after shaking to ensure the absence
of foreign particles and/or any abnormal physical appearance before administration.
If any such conditions are observed, the vaccine must be discarded.
The vaccine must be shaken well before use.
Instructions for the pre-filled syringe

Luer Lock adapter
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning counterclockwise.
Plunger
Barrel
Cap
Needle hub
To attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate a quarter turn clockwise until firmly secured.
Do not remove the syringe plunger from the barrel.
If this occurs, do not administer the vaccine.
Any unused medicinal product and waste material derived from such medicinal product must be disposed of in accordance with local regulations.