CAPVAXIVE solution for injection in pre-filled syringe

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

• if you are allergic to the active substances, including diphtheria toxoid, or to any of the ingredients of this vaccine (listed in section 6).

Talk to your doctor, pharmacist, or nurse before you receive CAPVAXIVE if:

• you have a high fever or severe infection. In these cases, the vaccination may have to be postponed until you have recovered. However, a mild fever or infection (for example having a cold) itself is not a reason to delay vaccination.
• you have any bleeding problems, bruise easily, or are taking medicines to prevent blood clots.
• you have anxiety related to injections or have ever fainted after any injection.
• your immune system is weakened (which means your body is less able to fight off infections) or if you are taking certain medicines that may weaken your immune system.

As with any vaccine, CAPVAXIVE may not fully protect all those who get the vaccine.

CAPVAXIVE has not been studied in children and adolescents younger than 18 years of age.

CAPVAXIVE can be given at the same time as the flu vaccine (inactivated influenza).

Tell your doctor, pharmacist, or nurse if:

• you are taking, have recently taken, or might take any other medicines.
• you have recently received or plan to receive any other vaccine.

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

CAPVAXIVE has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

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

This medicine contains 0.5 mg of polysorbate 20 in each 0.5 mL dose of solution for injection.

Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

You will receive 1 injection (1 dose of 0.5 mL).

Your doctor or nurse will give the vaccine into your upper arm muscle.

Rare (may affect up to 1 in 1 000 people):

CAPVAXIVE may cause allergic (hypersensitivity) reactions including excessive contraction of the airway muscles causing breathing difficulty (bronchospasm). Get medical care right away if you have symptoms of an allergic reaction, which may include:

• Wheezing or trouble breathing
• Swelling of the face, lips, or tongue
• Hives
• Rash

The following side effects have been seen after the use of CAPVAXIVE:

Very common (may affect more than 1 in 10 people):

• Headaches
• Pain at the injection site
• Feeling tired

Common (may affect up to 1 in 10 people):

• Muscle aches (very common in people 18 to 49 years of age)
• Redness or swelling at the injection site (very common in people 18 to 49 years of age)
• Fever

Uncommon (may affect up to 1 in 100 people):

• Swelling of lymph nodes
• Dizziness
• Feeling sick (nausea)
• Diarrhoea
• Vomiting
• Joint pain
• Itching at injection site
• Chills
• Bruising at injection site

These side effects are generally mild or moderate and last a short time.

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 substances are:

• Polysaccharides from pneumococcus types 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, de-O-acetylated type 15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B (4 micrograms of each type);

Each polysaccharide is linked to a carrier protein (CRM197). The polysaccharides and the carrier protein are not alive and do not cause disease.

One dose (0.5 mL) contains approximately 65 micrograms carrier protein.

The other ingredients are sodium chloride (NaCl), histidine, polysorbate 20 (E432), hydrochloric acid (HCl; for pH adjustment) and water for injections. For more information on polysorbate 20 (E432), see Section 2.

CAPVAXIVE is a colourless, clear to opalescent solution for injection (injection), provided in a single-dose, pre-filled syringe (0.5 mL). CAPVAXIVE is available in pack sizes of 1 or 10 pre-filled syringes, either without needles, with 1 separate needle or with 2 separate needles per pre-filled syringe.

Not all pack sizes may be marketed.

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