Cervarix® (Human Papillomavirus Vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted))

Consumer Medicine Information

• CMI Cervarix

Product Information (Intended for Healthcare Professional)

• PI Cervarix

CERVARIX®

Do not take if:

You must not take CERVARIX if:

• if you have previously had any allergic reaction to human papillomavirus vaccines, or any ingredient contained in CERVARIX. The active substances and other ingredients in CERVARIX are listed at the end of the leaflet.
  
• Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
  
• If you are already pregnant. If you become pregnant after commencing the course of vaccination then further doses should be postponed until after completion of the pregnancy.
  
• if you have a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
  
• the expiry date (EXP) printed on the pack has passed.
  
• the packaging is torn or shows signs of tampering.
  
• Take special care with CERVARIX if you have a bleeding problem or bruise easily.
  

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you have fainted with a previous injection.

Tell your doctor if:

You must tell your doctor if:

• you are allergic to foods, dyes, preservatives or any other medicines.
  
• you are taking any other medicines, including medicines you buy without a prescription.
  
• you are breastfeeding, pregnant or trying to become pregnant.
  

Back to Top

Check with your doctor as soon as possible if you think you or your child are experiencing any side effects or allergic reactions due to taking CERVARIX, even if the problem is not listed below.

Like other medicines, CERVARIX can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

You or your child may feel:

• pain or discomfort at the injection site

or you or your child may see some:

• redness or swelling at the injection site.

However, these effects usually clear up within a few days.

Other side effects that occurred during clinical trials with CERVARIX were as follows:

• Very common (side effects which may occur in more than 1 per 10 doses of vaccine):
  • headache
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • fatigue
    
• Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
  • gastrointestinal including nausea, vomiting, diarrhoea and abdominal pain
  • itching, red skin rash, hives
  • joint pain
  • fever (less than or equal to 37.5°C - more than or equal to 38°C)
    
• Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine):
  • upper respiratory tract infection
  • swollen glands in the neck, armpit or groin
  • dizziness
  • other injection site reactions including hard lump, loss of feeling, especially pain, during a medical procedure, itching
  • flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
    
• Rare (side effects which may occur in less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine):
  • spinning sensation
  • muscular weakness
  • generally feeling unwell

Following rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) have been reported

• allergic reactions. These can be recognised by:
  • itchy rash of the hands and feet
  • swelling of the eyes and face
  • difficulty in breathing or swallowing
  • sudden drop in blood pressure and loss of consciousness
    
    
  • fainting sometimes accompanied by shaking or stiffness.

These reactions will usually occur before leaving the doctor’s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently.

• fainting sometimes accompanied by shaking or stiffness.

If you or your child gets any of these symptoms you should contact a doctor urgently.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.

Do not be alarmed by this list of possible side-effects. You may not experience any of them.

Select Vaccine Select Boostrix® Synflorix® INFANRIX® hexa Boostrix® IPV Engerix®-B Fluarix® Hiberix® Infanrix® IPV Infanrix® Penta Priorix® Havrix® Twinrix® Typherix® Varilrix® Rotarix® Cervarix® Mencevax® ACWY

• Boostrix®
• Boostrix® IPV
• Fluarix®
• Mencevax® ACWY