VAQTA Adult, suspension for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vaqta Adult is and what it is used for
2. What you need to know before Vaqta Adult is given
3. How Vaqta Adult is given
4. Possible side effects
5. How to store Vaqta Adult
6. Contents of the pack and other information

• if you are allergic to the active substance or any of the other ingredients of Vaqta Adult (listed in section 6) or to neomycin or formaldehyde (see section "Warnings and precautions").
• if you are ill with a high temperature. The vaccination should be delayed until you have recovered.

Talk to your doctor, pharmacist or nurse before Vaqta Adult is given:

• if you have ever had an allergic reaction to a previous dose of Vaqta Adult. This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, both of which are used during vaccine production and may be present in the vaccine in trace amounts.
• if you have a poor or reduced immune system, due to:
  • corticosteroids, cytotoxic drugs or radiotherapy. Your doctor or nurse may wait until the treatment has finished.
  • HIV (human immunodeficiency virus infection) or any disease that affects the immune system. The vaccine may not protect as well as it protects people whose immune system is healthy.
• if you have any problems with the blood that causes easy bruising or bleeding for a long time after minor cuts. Your doctor or nurse may still advise that you should have Vaqta Adult but extra care is needed because of the risk of bleeding at the injection site. Your doctor or nurse may give Vaqta Adult as an injection under the skin instead of into muscle (see section 3) to try to reduce the risk of deep bleeding.

The container of this medicinal product contains latex rubber. May cause severe allergic reactions.

As with other vaccines, Vaqta Adult may not completely protect all persons who are vaccinated.

Please tell your doctor if you have a history of jaundice or have lived in an area where hepatitis A is common. Your doctor will determine whether you should be tested for hepatitis A antibodies prior to vaccination.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (or other vaccines).

This vaccine can be given at the same time as any of the following provided that they are given in different parts of the body (for example another arm) and are not mixed in the same syringe.

• Vi polysaccharide typhoid vaccine,
• Yellow fever vaccine,
• Immunoglobulins (antibodies obtained from blood donors)

Studies with a paediatric formulation have shown that the vaccine may be given at the same time as measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis or Haemophilus influenzae type b vaccines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice whether you should receive the vaccine.

There are no data to suggest that Vaqta Adult affects the ability to drive or operate machinery.

This medicine contains less than 1mmol (23mg) per dose, that is to say, essentially ‘sodium-free’.

The doctor or nurse will shake the syringe immediately before use and check that the liquid is white and cloudy and that there are no large particles.

The vaccine is given as an injection into a muscle in the upper outer part of the arm. Your doctor or nurse will avoid giving you the injection either into the skin or into a blood vessel. People who are at risk of bleeding a lot after an injection (see section 2) may sometimes be given Vaqta Adult as an injection under the skin but not into muscle to try to reduce the risk of bleeding.

Vaqta Adult is not recommended for individuals less than 18 years of age.

Side effects

Very common: may affect more than 1 in 10 people

injection-site tenderness, pain, warmth, swelling, redness

Common: may affect up to 1 in 10 people

• headache
• arm pain (in the injected arm)
• weakness/tiredness, fever (38.3°C or over), bleeding under the skin at the injection site (ecchymosis), pain and soreness

Uncommon: may affect up to 1 in 100 people

• sore throat, upper respiratory infections
• swelling of the lymph nodes
• dizziness, abnormal skin sensations such as tingling
• ear ache
• hot flushes
• runny or blocked nose and airways, cough
• feeling sick (nausea), diarrhoea, excessive gas in the stomach and intestines, vomiting
• hives, itching, redness
• muscle pain, stiffness, shoulder pain, musculoskeletal pain (pain that affects the muscles, ligaments and tendons, along with the bones) back pain, joint pain, leg pain, neck pain, muscle weakness
• itching at the injection-site, stiffness/tightness, pain, bruising at the injection-site, chills, stomach ache, feeling generally unwell, hardness (induration) and numbness at the injection-site, cold sensation, flu-like illness

Rare: may affect up to 1 in 1,000 people

• bronchitis, inflammation of the stomach and intestines (gastroenteritis)
• loss of appetite
• lacking energy, trouble sleeping
• sleepiness, migraine, tremor
• itching eyes, sensitivity to light, increased flow of tears
• vertigo
• swelling of the throat, problems with the sinuses
• dryness of the mouth, mouth ulcers
• night sweats, rash, skin disorders
• muscle cramp, elbow pain, hip pain, jaw pain, spasm
• problems with periods
• injection-site burning, lump (≤2.5 centimetres), muscle twitching, rash, swelling of the stomach, chest pain, pain in the side; irritability

Not known: frequency cannot be estimated from the available data

• Guillain-Barré syndrome (muscle weakness, abnormal sensations, tingling in the arms, legs and upper body)
• thrombocytopenia (reduction in blood platelets which increases risks of bleeding and bruising)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is: Inactivated hepatitis A virus (produced on MRC-5 human diploid cells, adsorbed on amorphous aluminium hydroxyphosphate sulfate).

One dose (1 mL) contains 50U hepatitis A virus (inactivated) adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.45 milligram as aluminium).

The other ingredients are:

• sodium borate
• sodium chloride
• water for injections

A pre-filled syringe or vial containing 1 millilitre (one dose) of the vaccine.

The vaccine is available in single packs of the vial or pre-filled syringe with or without a needle.

Not all presentations may be marketed.

After thorough agitation Vaqta Adult is an opaque white suspension.

The Marketing Authorisation Holder in the UK is:

The manufacturer responsible for batch release at the following manufacturing sites is: