Fendrix suspension for injectionHepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

What Fendrix is

Fendrix is a vaccine which prevents hepatitis B.
It is used for patients with kidney problems:

• patients having ?haemo-dialysis?- where a ?dialysis? machine removes waste products from the blood
• patients who are going to have ?haemo-dialysis? in the future.

Fendrix is for adults and young people aged 15 years and above.

What is hepatitis B?

Hepatitis B is caused by a virus which makes the liver swollen.

• Signs may not be seen for 6 weeks to 6 months after infection.
• The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice). These or other signs may mean the person might need treatment in hospital. Most people fully recover from the illness.
• Some people with hepatitis B do not look or feel ill - they do not have any signs of illness.
• The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit).

Carriers of hepatitis B

• The hepatitis B virus stays in the body of some people all through their lives.
• This means they can still infect other people and are know as virus ?carriers?.
• Carriers of the virus are likely to get serious liver problems, such as ?cirrhosis? or liver cancer.

How Fendrix works

• Fendrix helps your body to produce its own protection against the virus (antibodies). These antibodies will protect you against the disease.
• Fendrix contains two things called ?MPL? (a non-toxic purified fat derivative from bacteria) and ?aluminium phosphate?. These make the vaccine work quicker, better and last for longer.
• As with all vaccines, a course of Fendrix cannot fully protect all people that are vaccinated.
• Fendrix may not protect you from being ill if you have already caught the hepatitis B virus.
• Fendrix can only help to protect you against infection with the hepatitis B virus. It cannot protect you against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis B virus.

Fendrix should not be given if:

• you are allergic (hypersensitive) to Fendrix or any of the ingredients in Fendrix (listed in Section 6).Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue
• you have ever had an allergic reaction to any vaccine against hepatitis B
• you have a severe infection with a high temperature. The vaccine can be given after you have recovered. A minor infection such as a cold should not be a problem, but talk to your doctor first.

Fendrix should not be given if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Fendrix.

Take special care with Fendrix

Check with your doctor or pharmacist before having Fendrix if:

• you have any known allergies
• you have had any health problems after having a vaccine in the past.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having Fendrix.

Using other medicines and vaccines

Please tell your doctor or pharmacist if you are taking, have recently taken, or are about to take any other medicines or vaccines.

• You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine.
• Fendrix may need to be given at the same time as an injection of hepatitis B ?immuno-globulins?. Your doctor will make sure that the vaccines are injected into different parts of the body.

Pregnancy and breast-feeding

Talk to your doctor before having this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

You may feel tired or get a headache after receiving Fendrix. If this happens, take special care while driving or using any tools or machines.

How your injection is given

• The doctor or nurse will give Fendrix as an injection into your muscle. This is usually in your upper arm.
• They will make sure that Fendrix is not given into a blood vessel or into the skin.

How much is given

• You will have a series of four injections.
• The injections will be given within 6 months:
• First injection - on a date agreed with your doctor.
• Second injection - 1 month after the first injection.
• Third injection - 2 months after the first injection.
• Fourth injection - 6 months after the first injection.
• The doctor or nurse will tell you when you should come back for the next injections.
• Once you have had the first injection of Fendrix, the next injections need also to be Fendrix (not another sort of hepatitis B vaccine).

Your doctor will tell you if you need any extra or ?booster? injections in the future. Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.

If you miss a dose

• If you miss an injection, talk to your doctor and arrange another visit.
• Make sure you finish the complete course of four injections. If not, you may not be fully protected against the disease.

Like all medicines, Fendrix can cause side effects, although not everybody gets them.

The following side effects may happen with this vaccine. Their frequency is defined using the conventions listed below:
Very common: these may occur with more than 1 in 10 doses of the vaccine
Common: these may occur with up to 1 in 10 doses of the vaccine
Uncommon: these may occur with up to 1 in 100 doses of the vaccine
Rare: these may occur with up to 1 in 1,000 doses of the vaccine
Very rare: these may occur with up to 1 in 10,000 doses of the vaccine

Very common

• headache
• feeling tired
• pain or discomfort where the injection was given.

Common

• redness or swelling where the injection was given
• fever
• stomach and digestion problems.

Uncommon

• chills
• red, raised skin rash
• other reactions where the injection was given.

Rare

• allergy
• hot flushes
• feeling dizzy
• feeling thirsty
• feeling nervous
• infection caused by a virus
• back pain, swelling of your tendons.

Additionally, the following side effects have also been reported with other hepatitis B vaccines:

Very rare

• fits
• fainting
• problems with the nerves of your eye (optic neuritis)
• multiple sclerosis
• loss of feeling or problems moving some parts of your body
• severe headache with a stiff neck
• numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy).
• allergic reactions, including anaphylactoid reactions. These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions may occur before leaving the doctor?s surgery. However, you should seek immediate treatment in any event.

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.

• Keep out of the reach and sight of children.
• Do not use Fendrix after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C).
• Store in the original package in order to protect from light.
• Do not freeze. Freezing destroys the vaccine.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Fendrix contains

• The active substance in 1 dose (0.5 ml) of Fendrix is:

Hepatitis B surface antigen 1, 2, 320 micrograms

1adjuvanted by AS04C containing - 3-O-desacyl-4- monophosphoryl lipid A MPL 250 micrograms

2adsorbed on aluminium phosphate 0.5 milligrams Al3 in total

3produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology.

• The other ingredients in Fendrix are: sodium chloride, water for injections.

What Fendrix looks like and contents of the pack

• Suspension for injection in a prefilled syringe.
• Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
• Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
• 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 any information about this medicine, please contact the local representative of the Marketing Authorisation holder.

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

Polska

GlaxoSmithKline A.E.B.E. T 30 210 68 82 100 GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

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The following information is intended for medical or healthcare professionals only

Upon storage, a fine white deposit with a clear colourless supernatant can be observed.

Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.

The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance. The vaccine must not be used if any change in the appearance of the vaccine has taken place.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.

Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.

Fendrix should not be given to subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation.

Fendrix should be injected intramuscularly in the deltoid region.

Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.

Fendrix should under no circumstances be administered intradermally or intravenously.

As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.

Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.