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ENGERIX®-B Consumer Medicine Information

For adults, ENGERIX-B can also be given as a total of three doses over 3 weeks (a 0, 7, 21 day schedule). However, the body’s immune response to this rapid schedule may be reduced compared to the above two schedules. Therefore, this rapid schedule should only be used under special circumstances (e.g. travellers wanting to be vaccinated within one month of departure). A booster dose is recommended at 12 months.

For adolescents aged from 11 to 15 years, ENGERIX-B can also be given as a total of two adult (1 mL) doses 6 months apart. However, as protection against hepatitis B is only achieved after the second dose is given, this schedule should only be used when there is a relatively low risk of hepatitis B infection during the vaccination course and when it can be anticipated that the complete course is given.

Your doctor will advise on the possible need for extra doses, and future booster dosing.

protecting you or your child against hepatitis B.

THINGS TO BE CAREFUL OF: Be careful driving or operating machinery until you know how ENGERIX-B affects you. ENGERIX-B should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or lightheadedness. Make sure you know how you react to ENGERIX- B before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or lightheaded.

SIDE EFFECTS

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well during or after having had a dose of ENGERIX-B.

ENGERIX-B helps protect most people from hepatitis B, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.

IF YOU MISS A DOSE If you miss a scheduled dose, talk to your doctor and arrange another visit as soon as possible.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

WHILE YOU ARE USING ENGERIX-B

THINGS YOU MUST DO: Keep your follow up visits with the doctor or clinic. It is important the 2 follow-up doses of ENGERIX-B are given at the correct times. This will ensure the best effect of the vaccine in

Most unwanted effects with ENGERIX-B are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Events reported following ENGERIX-B which may have been related to the vaccine are listed below.

MILD EVENTS Tell your doctor if you notice any of the following

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that are troublesome or ongoing:

  • pain, redness, swelling, a

hard lump, bruising or itching around the injection site

  • headache, unusual

tiredness, dizziness or feeling generally unwell

  • vomiting or feeling sick,

stomach pains, loss of appetite or diarrhoea

  • muscle aches and pains,

back pain or neck stiffness

  • coughing, sore throat,

runny nose, mild fever, swollen glands in armpit or neck, fainting, sweating, flushing or chills

  • disturbed sleep.

MORE SERIOUS EVENTS Tell your doctor immediately if you notice any of the following:

  • difficulty in walking,

numbness, weakness and/or fatigue in limbs, tingling in fingers or toes, pain, blurred vision or other visual changes

  • drooping eyelid or sagging

muscles on one side of the face, also called Bell’s palsy

  • aches or pains in joints,

mild skin rash

  • swelling with fluid in

tissues

  • difficulty in passing urine

  • fever

  • reddening of the skin, red

swellings over the skin or in the mouth and on the lips, or other skin problems.

As with all vaccines given by injection there is a very small risk of serious allergic reaction. Contact your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the following:

  • swelling of limbs, face,

eyes, inside of nose, mouth or throat

  • shortness of breath,

breathing or swallowing difficulties

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