Twinrix Adult, suspension for injection in prefilled syringeHepatitis A (inactivated) and hepatitis B(rDNA) (HAB) vaccine(adsorbed)

Twinrix Adult is a vaccine used in adults and adolescents 16 years of age and above to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people ill for about a month.
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.

Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.

Twinrix Adult should not be given:

• if you have previously had any allergic reaction to Twinrix Adult, or any ingredient contained in this vaccine. The active substances and other ingredients in Twinrix Adult 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 have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
• if you have a severe infection with a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.

Take special care with Twinrix Adult:

• if you have experienced any health problems after previous administration of a vaccine.
• if you have a poor immune system due to illness or drug treatment.
• if you have a bleeding problem or bruise easily.

A poor response to the vaccine, possibly without achieving protection against hepatitis A, has been observed in obese people. A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments. Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response. If not, your doctor will advise you on the possible need to have extra doses.

Using other medicines or vaccines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.

Pregnancy and breast-feeding

Take special care with Twinrix Adult if you are or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks and benefits of having Twinrix Adult during pregnancy.
It is not known if Twinrix Adult passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.

Important information about some of the ingredients of Twinrix Adult

Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).

You will receive a total of three injections over 6 months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.

• First dose: at an elected date
• Second dose: 1 month later
• Third dose: 6 months after the first dose

Twinrix Adult can also be given as a total of three doses over 1 month. This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers). The first dose will be given on an elected date. The remaining 2 doses will be given 7 days and 21 days after the first dose. A fourth dose is recommended at 12 months.

• First dose: at an elected date
• Second dose: 7 days later
• Third dose: 21 days after the first dose
• Fourth dose: 12 months after the first dose

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

As indicated in Section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments. Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response. If not, your doctor will advise you on the possible need to have extra doses.

If you miss a scheduled injection, talk to your doctor and arrange another visit.

Make sure you finish the complete vaccination course of three injections. If not, you may not be fully protected against the diseases.

The doctor will give Twinrix Adult as an injection into your upper arm muscle.

The vaccine should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less.

The vaccine should never be given into a vein.

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

Side effects that may occur are the following:

Very common (These may occur in 1 in 10 doses or more of the vaccine):

• Headache
• Pain and redness at the injection site
• Tiredness Common (These may occur in up to 1 in 10 doses of the vaccine):
• Diarrhoea, nausea
• Swelling, bruising or itching at the injection site
• Generally feeling unwell Uncommon (These may occur in up to 1 in 100 doses of the vaccine):
• Dizziness
• Vomiting, stomach pain
• Aching muscles
• Upper respiratory tract infection
• Fever equal to or greater than 37.5°C Rare (These may occur in up to 1 in 1,000 doses of the vaccine):
• Swollen glands in the neck armpit or groin (lymphadenopathy)
• Loss of skin sensitivity to pain or touch (hypoaesthesia)
• Feeling of pins and needles (paraesthesia)
• Rash, itching
• Joint pain
• Loss of appetite
• Low blood pressure
• Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills Very rare (These may occur in up to 1 in 10,000 doses of the vaccine): Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include:
• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Purple or red brown spots visible through the skin(thrombocytopenic purpura)
• Swelling or infection of the brain (encephalitis)
• Degenerative disease of the brain (encephalopathy)
• Inflammation of nerves (neuritis)
• Numbness or weakness of the arms and legs (neuropathy), paralysis
• Fits or seizures
• Swelling of the face, mouth or throat (angioneurotic oedema)
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives
• Joint swelling, muscular weakness
• Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis)
• Inflammation of some blood vessels (vasculitis)
• Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness). Signs of serious allergic reactions may be 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, if you get any of these symptoms you should contact a doctor urgently.
• Abnormal laboratory liver test results
• Multiple sclerosis, swelling of the spinal cord (myelitis)
• Drooping eyelid and sagging muscles on one side of the face (facial palsy)
• A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
• A disease of the nerves of the eye (optic neuritis)

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 Twinrix Adult 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 Twinrix Adult contains

• The active substances are: Hepatitis A virus (inactivated) 1,2720 ELISA Units Hepatitis B surface antigen 3,420 micrograms

31Produced on human diploid MRC-5 cells 2Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al3Produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.4 milligrams Al3

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

What Twinrix Adult looks like and contents of the pack

Suspension for injection in prefilled syringe.

Twinrix Adult is a white, slightly milky liquid presented in a glass prefilled syringe (1 ml).

Twinrix Adult is available in packs of 1, 10, and 25 with or 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

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

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 infoglaxosmithkline.dk 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

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

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 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

diam@gsk.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

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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.

The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.