Read all of this leaflet carefully before you start receiving this vaccine.
– 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. Do not pass it on to others.
– 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.
BEFORE YOU RECEIVE CERVARIX
Cervarix should not be given if the person to be vaccinated:
Is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Cervarix.
The active substances and other ingredients of Cervarix are listed at the end of the leaflet (see section 6).
Signs of an allergic reaction may include
itchy skin rash,
shortness of breath and
swelling of the face or tongue.
Has 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 the doctor first.
Take special care with Cervarix
You should tell the doctor if the person to be vaccinated:
has a bleeding problem or bruises easily.
has any disease which reduces her resistance to infection such as HIV infection.
POSSIBLE SIDE EFFECTS
Like all medicines, Cervarix can cause side effects, although not everybody gets them.
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):
pain or discomfort at the injection site
redness or swelling at the injection site
headache
aching muscles,
muscle tenderness or weakness (not caused by exercise)
tiredness
Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
gastrointestinal symptoms including nausea, vomiting, diarrhoea and
abdominal pain
itching, red skin rash, hives (urticaria)
joint pain
fever (=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 (infection of the nose, throat or trachea)
dizziness
other injection site reactions such as hard lump, tingling or numbness.
Side effects that have been reported during marketed use of Cervarix include:
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
These reactions will usually occur before leaving the doctors surgery. However, if your child gets any of these symptoms you should contact a doctor urgently.
swollen glands in the neck, armpit or groin
fainting sometimes accompanied by shaking or stiffness.
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.
