gentamicin sulphate (antibiotic) or sodium Patient Information deoxycholate. Signs of an allergic reaction may Leaflet include itchy skin rash, shortness of breath and swelling of the face or tongue.

However, in a pandemic situation, it may be Pandemrix suspension appropriate for you to have the vaccine provided that appropriate medical treatment is immediately and emulsion for available in case of an allergic reaction. emulsion for injection If you are not sure, talk to your doctor or nurse Pandemic influenza vaccine (H1N1) before having this vaccine. (split virion, inactivated, adjuvanted) Talk to your doctor • if you have had any allergic reaction other than For the most up-to-date information a sudden lifethreatening allergic reaction to any please consult the website of the UK ingredient contained in the vaccine, to thiomersal, Medicines and Healthcare products to egg and chicken protein, ovalbumin, Regulatory Agency at: formaldehyde, gentamicin sulphate (antibiotic) or www.mhra.gov.uk/swineflu to sodiumdeoxycholate. (see section 6. Further information). Read all of this leaflet carefully before you receive this vaccine. • if you have a severe infection with a high - Keep this leaflet. You may need to read it again. temperature (over 38°C). If this applies to you - If you have any further questions, ask your then your vaccination will usually be postponed doctor or nurse. until you are feeling better. A minor infection such - If any of the side effects gets serious, or if you as a cold should not be a problem, but your notice any side effects doctor or nurse will advise whether you could still not listed in this leaflet, please tell your doctor. be vaccinated with Pandemrix,

In this leaflet: • if you are having a blood test to look for 1. What Pandemrix is and what it is used for evidence of infection with certain viruses. In the first few weeks after vaccination with Pandemrix 2. Before you receive Pandemrix the results of these tests may not be correct. Tell 3. How Pandemrix is given the doctor requesting these tests that you have 4. Possible side effects recently been given Pandemrix. In any of these 5. How to store Pandemrix cases, TELL YOUR DOCTOR OR NURSE, as 6. Further information vaccination may not be recommended, or may what it is used for need to be delayed. 1. What is Pandemrix Please inform your doctor or nurse if you have a Pandemrix is a vaccine to prevent pandemic bleeding problem or bruise easily. influenza (flu). Pandemic flu is a type of influenza that occurs every few decades and which Taking other medicines spreads rapidly around the world. The symptoms Please tell your doctor or nurse if you are taking of pandemic flu are similar to those of ordinary flu or have recently taken any other medicines, but may be more severe. When a person is including medicines obtained without a given the vaccine, the immune system (the prescription or have recently been given any body’s natural defence system) will produce its other vaccine. own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause There is no information on administration of the flu. vaccine Pandemrix with other vaccines. However, if this cannot be avoided, the vaccines 2. Before you receive Pandemrix should be injected into separate limbs. In such Before you receive Pa cases, you should be aware that the side effects You should not receive Pandemrix: may be more intense. • if you have previously had a sudden life- threatening allergic reaction to any ingredient of Pregnancy and breast-feeding Pandemrix (these are listed at the end of the Tell your doctor if you are pregnant, think you leaflet) or to any of the substances that may be may be pregnant, plan to become pregnant. You present in trace amounts as follows: egg and should discuss with your doctor whether you chicken protein, ovalbumin, formaldehyde, should receive Pandemrix. The vaccine may be used during breast-feeding. When Pandemrix is given and you need a second dose, you should be offered Pandemrix Driving and using machines again at your second clinic appointment. Some effects mentioned under section 4. “Possible side effects” may affect your ability to 4. Possible side effects drive or use machines. Please check before you Like all medicines, Pandemrix can cause side drive. effects, although not everybody gets them.

Important information about some of the Allergic reactions may occur following ingredients of Pandemrix vaccination, in rare cases leading to shock. This vaccine contains thiomersal as a Doctors are aware of this possibility and have preservative and it is possible that you may emergency treatment available for use in such experience an allergic reaction. Tell your doctor if cases. you have any known allergies. This medicinal product contains less than 1 mmol In the clinical studies with a similar vaccine, most sodium (23 mg) and less than 1 mmol of side effects were mild in nature and short term. potassium (39 mg) per dose, i.e. essentially The side-effects are generally similar to those sodium- and potassium-free. related to the seasonal flu vaccine.

3. How Pandemrix will be given The frequency of possible side effects listed Your doctor or nurse will give you the vaccine by below is defined using the following convention: injection into a muscle. Usually this will be in the upper arm. Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Following advice from the Joint Committee on Uncommon (affects 1 to 10 users in 1,000) Vaccination and Immunisation, the following Rare (affects 1 to 10 users in 10,000) vaccination schedule is recommended in the UK Very rare (affects less than 1 user in 10,000)

Adults and children - aged 10 years to 60 The side effects listed below have occurred with years Pandemrix in clinical studies in adults, including You will be given a single (0.5ml) dose of the the elderly and in children aged from 3-9 years: vaccine Very common: Adults over 60 years • Headache You will be given a single (0.5ml) dose of the • Tiredness vaccine. • Pain, redness, swelling or a hard lump at the The recommendation for now is a single dose but injection site you may be asked to return for a second dose • Fever more than three weeks after the first dose - this • Aching muscles, joint pain will be reviewed as more information becomes available Common: • Warmth, itching or bruising at the injection site • Increased sweating, shivering, flu-like Adults and children aged 10 years and symptoms over who have an impaired • Swollen glands in the neck, armpit or groin Immune system You will be given two (0.5ml) doses of the Uncommon: vaccine. The doses will be given at least three • Tingling or numbness of the hands or feet weeks apart. • Sleepiness • Dizziness Children aged 6 months and up to 10 • Diarrhoea, vomiting, stomach pain, feeling sick years of age (including those who have • Itching, rash an impaired immune system) • Generally feeling unwell You will be given two half (0.25ml) doses of the • Sleeplessness vaccine. The doses will be given at least three weeks apart. In children aged 3-9 years fever occurred more often when the adult dose (0.5 ml of vaccine) was The vaccine is not recommended in babies under given compared to administration of half the adult 6 months old. dose (0.25 ml of vaccine). Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years.

These side effects usually disappear within 1-2 Ask your pharmacist how to dispose of medicines days without treatment. If they persist, CONSULT no longer required. YOUR DOCTOR. These measures will help to protect the environment. The side effects listed below have occurred in the days or weeks after vaccination with vaccines 6. Further information given routinely every year to prevent flu. These 6. Further Information side effects may occur with Pandemrix. What Pandemrix contains Some of these side effects are serious. If any of • Active substance: these occur, please tell your doctor or nurse Split influenza virus, inactivated, containing immediately. antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) Uncommon 3.75 micrograms** per 0.5 ml dose • Generalised skin reactions including urticaria * propagated in eggs (hives) ** expressed in microgram haemagglutinin This vaccine complies with the WHO Rare recommendation and EU decision for the • Allergic reactions leading to a dangerous pandemic. decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this • Adjuvant: possibility and have emergency treatment The vaccine contains an ‘adjuvant’ AS03 to available for use in such cases. stimulate a better response. • Fits This adjuvant contains squalene (10.69 • Severe stabbing or throbbing pain along one or milligrams), DL-α-tocopherol (11.86 milligrams) more nerves and polysorbate 80 (4.86 milligrams). • Low blood platelet count which can result in bleeding or bruising • Other ingredients: The other ingredients are: polysorbate 80, Very rare octoxynol 10, thiomersal, sodium chloride, • Vasculitis (inflammation of the blood vessels disodium hydrogen phosphate, potassium which can cause skin rashes, joint pain and dihydrogen phosphate, potassium chloride, kidney problems) magnesium chloride, water for injections • Neurological disorders such as encephalomyelitis (inflammation of the central What Pandemrix looks like and contents nervous system), neuritis (inflammation of of the pack nerves) and a type of paralysis known a Guillain- Suspension and emulsion for emulsion for injection. Barré Syndrome The suspension is a colourless light opalescent liquid. If any of the side effects become serious, or if The emulsion is a whitish homogeneous liquid. you notice any side effects not listed in this Prior to administration, the two components leaflet, please tell your doctor. should be mixed. The mixed vaccine is a whitish emulsion. 5. How to store the vaccine One pack of Pandemrix consists of: Keep out of the reach and sight of children. • one pack containing 50 vials of 2.5 ml suspension (antigen) for 10 doses Before the vaccine is mixed: • two packs containing 25 vials of 2.5 ml emulsion Do not use the suspension and the emulsion (adjuvant) for 10 doses after the expiry date which is stated on the carton. The expiry date refers to the last day of Marketing Authorisation Holder and that month. Manufacturer Store in a refrigerator (2°C - 8°C). GlaxoSmithKline Biologicals s.a. Store in the original package in order to protect Rue de l’Institut 89 from light. B-1330 Rixensart Do not freeze. Belgium

After the vaccine is mixed: This leaflet was last approved in September After mixing, use the vaccine within 24 hours and 2009. do not store above 25°C. Medicines should not be disposed of via wastewater or household waste.