Pneumovax 23 solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This vaccine has been prescribed for you or your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child's.
• If you or your child 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 PNEUMOVAX 23 is and what it is used for
2. What you need to know before you or your child use PNEUMOVAX 23
3. How to use PNEUMOVAX 23
4. Possible side effects
5. How to store PNEUMOVAX 23
6. Contents of the pack and other information

Talk to your doctor, pharmacist or nurse before vaccination if:

• you or your child has an infection with a high temperature, as vaccination may need to be delayed until you or your child has recovered.

You should also tell your doctor before vaccination if:

• you or your child has a low resistance to infections because of a course of treatment (such as drugs or radiation treatment for cancer).
• you or your child has a longstanding illness or an infection that may have lowered resistance to pneumococcal infections.

In these cases vaccination may need to be delayed and even then it may not protect you as well as it protects healthy people.

Individuals aged 65 years and older may not tolerate medical interventions as well as younger individuals. Therefore a higher number and/or greater severity of reactions in some older individuals cannot be ruled out.

Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other medicines.

PNEUMOVAX 23 can be given at the same time as influenza vaccine as long as different injection sites are used. Most people are able to respond to both vaccines at the same time so that they can be protected against both infections.

For information about the administration of PNEUMOVAX 23 and ZOSTAVAX at the same time, talk to your doctor or health care provider.

If you or your child are already taking antibiotics to prevent pneumococcal infection, these should not be stopped after vaccination. Also, even after having the vaccine, it is still important that you see a doctor and get antibiotic treatment quickly if you think that you or your child may have any type of infection and you or your child have been told that you have a high risk of getting a pneumococcal infection (for example, if you have no spleen or it is not working properly).

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

There is no information to suggest that the vaccine will affect your ability to drive or use machines.

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

There have been no reports of overdose with the vaccine. Overdose is very unlikely because the vaccine is provided in single dose, pre-filled syringe and is given by a doctor or nurse.

You must seek urgent medical help if you or your child experience any of the symptoms, listed below, or other serious symptoms after vaccination:

• difficulty in breathing, blue discolouration of the tongue or lips,
• low blood pressure (causing dizziness) and collapse,
• fever, generally feeling unwell with pains or even inflammation and swelling in the joints and muscle pain,
• swelling of the face, lips, tongue and/or throat and neck,
• swelling of the hands, feet or ankles,
• hives (inflamed wheals on the skin) and rashes.

If serious allergic reactions occur, they often do so very soon after the injection, while still in the clinic.

The most common reactions (may affect more than 1 in 10 people) reported are soreness, pain, redness, warmth, swelling and hardening at the injection site, and fever. These reactions tend to be more common after the second dose of the vaccine than after the first dose.

Other side effects include:

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

• extensive swelling of the vaccinated limb.

Not known (frequency cannot be estimated from the available data):

• decreased mobility of the injected limb,
• feeling tired,
• feeling generally unwell,
• uncontrollable shivering,
• feeling sick or being sick,
• enlarged and/or inflamed glands,
• pain, inflammation and swelling of the joints and muscle pains,
• a drop in the number of certain types of particles in the blood called platelets in people who already have low numbers of these due to another illness called ITP that causes a higher risk of bleeding and bruising,
• headache, altered skin sensation or pins and needles, decreased limb mobility, numbness and weakness of the legs and arms (including an illness called Guillain-Barré syndrome),
• an increase in the value of a blood test that is a measure of inflammation in the body (C-reactive protein (CRP)),
• patients who have had blood disorders may develop destruction of red blood cells leading to an inadequate number of red blood cells (haemolytic anaemia),
• an increase in the number of certain types of white blood cells,
• a fit (convulsion) associated with a high temperature.

If you or your child 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.

0.5 millilitre dose contains the following:

• Active ingredients - 25 micrograms (a very small amount) of each of 23 types of polysaccharide from bacteria known as pneumococci. The 23 types of pneumococcal polysaccharide in the vaccine are types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F.
• Other ingredients - phenol, sodium chloride and water for injections.

The vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

It is provided as a solution for injection in pre-filled syringe (0.5 mL).

It is available in pack containing 1 or 10 pre-filled syringes without needle.

It is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.

It is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

This medicine is authorised in the Member States of the European Economic Area, in the United Kingdom (Northern Ireland) and Great Britain under the following names:

Austria; Belgium; Bulgaria; Croatia; Cyprus; Czech Republic; Germany; Greece; Ireland; Luxemburg; Malta; Netherlands; Portugal; Romania; Slovakia; Slovenia; Spain; United Kingdom (Northern Ireland); Great Britain PNEUMOVAX 23

Denmark; Finland; France; Italy; Iceland; Lithuania; Norway; Sweden PNEUMOVAX