Engerix – B Paediatric Suspension

How ENGERIX - B works: ENGERIX - B is a vaccine used to prevent hepatitis B disease. This vaccine can also protect against hepatitis D, as hepatitis D does not occur in the absence of hepatitis B infection. ENGERIX B contains a small amount of the ‘outer coating’ of the hepatitis B virus. This ‘outer coating’ is not infectious and cannot make you ill.

• When you/your child are given the vaccine it will trigger the body’s immune system to prepare itself to protect against these viruses in the future.
• ENGERIX B will not protect you/your child if you have already caught the hepatitis B virus. ENGERIX B can only help to protect you or your child against infection with hepatitis B virus.

What hepatitis B is: Hepatitis B is an infectious illness of the liver caused by a virus. Some people have the hepatitis B virus in their body but cannot get rid of it. They can still infect other people and are known as carriers. The disease is spread by the virus entering the body following contact with body fluids, most often blood, from an infected person. If the mother is a carrier of the virus, she can pass the virus to her baby at birth. It is also possible to catch the virus from a carrier through, for example, unprotected sex, shared injection needles or treatment with medical equipment which has not been properly sterilised. The main signs of the illness include headache, fever, sickness and jaundice (yellowing of the skin and eyes) but in about three out of 10 patients there are no signs of illness.

Carriers of hepatitis B: In those infected with hepatitis B one out of 10 adults and up to nine out of 10 babies will become carriers of the virus and are likely to go on to develop serious liver damage and in some cases cancer of the liver.

You or your child should not be given ENGERIX - B if you:

• have previously had an allergic reaction to ENGERIX - B, or any ingredient contained in this vaccine. The active substance and other ingredients in ENGERIX - B are listed in section 6 of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• are suffering from a fever or infection. In these cases, the vaccination will be postponed until you or your child are feeling better. A minor infection such as a cold should not be a problem; your doctor will advise whether you or your child can still be vaccinated with ENGERIX - B.

Tell your doctor or healthcare professional before being given ENGERIX - B if you or your child:

• are on dialysis for kidney disease
• have an illness which may affect your immune system
• have a bleeding problem or bruise(s) easily. Fainting can occur following, or even before any needle injection, therefore, tell your doctor or nurse if you/your child fainted with a previous injection. If your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).

Not everyone who is vaccinated will be protected from getting the infection. Also, if you/your child have unknowingly been infected with hepatitis B virus before being vaccinated with ENGERIX - B, the vaccine may not be able to prevent you or your child getting the disease.

Pregnancy and Breastfeeding: If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice, before you are given ENGERIX - B.

ENGERIX B - PAEDIATRIC is used to vaccinate children from birth up to 15 years of age. The dose is 0,5 ml. ENGERIX - B is used to vaccinate people from 16 years of age and over. The dose is 1,0 ml. ENGERIX - B is usually injected into the upper arm muscle in adults and children or into the thigh muscle in babies and young children. However, this vaccine may be injected under the skin for patients with blood disorders. The vaccine must NOT be injected into the buttocks, into the skin, or into a vein.

ENGERIX - B is usually given as a total of three separate injections over 6 months as follows:

1. 1st injection Now
2. 2nd injection 1 month later
3. 3rd injection 6 months after first injection

ENGERIX - B can also be given as a total of three doses over 3 months as follows: (This accelerated schedule may be given to people needing rapid protection).

1. 1st injection Now
2. 2nd injection 1 month later
3. 3rd injection 2 months after first injection

A fourth dose (booster injection) is recommended 12 months after the first injection. In infants this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines. However these should be given at separate injection sites.

In children aged 11 to 15 years, ENGERIX - B may be given as a total of 2 doses as follows:

1. 1st injection Now
2. 2nd injection 6 months after first injection

However, in this case, protection against hepatitis B may not be obtained until after the second dose. Therefore, this schedule should be used only when there is a low risk of hepatitis B infection during the vaccination course and when it is certain that the two doses will be taken. If not, then the three-dose schedule or the accelerated schedule of ENGERIX - B PAEDIATRIC should be used.

In adults only, ENGERIX - B can also be given as a total of three doses over 1 month as follows: (This schedule may be given only to adults needing a rapid protection (e.g., if travelling to a high-risk area)).

1. 1st injection Now
2. 2nd injection 7 days later
3. 3rd injection 21 days after first injection

A fourth dose is recommended 12 months after the first dose. Depending on individual circumstances and particularly if you or your child suffers from kidney disease, your doctor may decide to do a blood test or give extra doses of vaccine to ensure protection. For maximum protection from getting infected by Hepatitis B virus, make sure you or your child completes the full course of injections.

If you miss a dose of ENGERIX - B: If you miss an injection arrange another appointment as soon as you can. Your doctor will advise on the possible need for extra doses, including future booster doses.

ENGERIX - B can have side effects. Not all side effects reported for ENGERIX - B are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using ENGERIX - B, please consult your doctor, pharmacist or other healthcare professional for advice.

Allergic reactions: Some people can have a serious allergic reaction to ENGERIX - B. Tell your doctor or nurse immediately if you/your child have any of the following side effects:

• itchy rash of the hands and feet
• swelling of the eyes and face
• difficulty in breathing or swallowing.

These reactions will usually occur before leaving the doctor's surgery. However, if any of the above happens, tell your doctor immediately or go to the nearest casualty department at your nearest hospital.

➔ These are all very serious side effects. If you or your child have them, you/your child may have had a very serious allergic reaction to ENGERIX - B.

Frequent side effects:

• Irritability, pain and redness at the injection site, tiredness
• loss of appetite; headache, drowsiness; nausea, vomiting, diarrhoea, abdominal pain; hard lump and swelling at the injection site; fever, generally feeling unwell.

Less frequent side effects:

• dizziness; aching muscles; flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills.

Other side effects which may occur:

• swollen glands in the neck, armpit or groin; abnormal sensation such as of burning, prickling, tickling or tingling; rash, itching, hives; joint pain
• Inflammation of the membrane around the brain (meningitis). The symptoms are fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light
• bleeding or bruising more easily than normal
• paralysis, convulsions, fits or seizures, loss of skin sensitivity to pain or touch; swelling or infection of the brain, numbness or weakness of the arms and legs, inflammation of nerves
• low blood pressure, narrowing or blockage of blood vessels
• purple or reddish-purple bumps on the skin, serious rashes
• joint pain and swelling, muscle weakness.

Store this vaccine out of sight and reach of children. Store at +2 °C to +8 °C (in a refrigerator). Do not freeze. Store in the original package in order to protect from light. Discard if vaccine has been frozen. Do not use after the expiry date stated on the label and packaging. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).