PNEUMOVAX 23 Injectable Solution in Prefilled Syringe

Introduction

Package Leaflet: Information for the User

PNEUMOVAX 23 injectable solution in pre-filled syringe

pneumococcal polysaccharide vaccine

For adults and children from 2 years of age.

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or 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 symptoms are the same as yours or your child's.
• If you or your child experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What PNEUMOVAX 23 is and what it is used for

1. What you or your child need to know before using PNEUMOVAX 23
2. How to use PNEUMOVAX 23
3. Possible side effects
4. Storage of PNEUMOVAX 23
5. Contents of the pack and other information

1. What PNEUMOVAX 23 is and what it is used for

PNEUMOVAX 23 is a pneumococcal vaccine. Vaccines are used to protect you or your child against infectious diseases. Your doctor has recommended the vaccine for you or your child (from 2 years of age) to help protect against serious infections caused by a bacterium called pneumococcus.

Pneumococcus can cause infections of the lungs (especially pneumonia) and of the membranes covering the brain and spinal cord (meningitis) and in the blood (bacteremia or septicemia). The vaccine will only protect you or your child against pneumococcal infections caused by the types of bacteria included in the vaccine. However, the 23 types of pneumococci in the vaccine include those that cause nearly all (about 9 out of 10) pneumococcal infections.

When the vaccine is given to you or your child, the body's natural defenses produce antibodies that help protect against infectious diseases.

Pneumococcal infections occur worldwide and can occur in anyone of any age, but are more likely in:

• the elderly.
• people who have had their spleen removed or have a spleen that does not work.
• people with low resistance to infections due to a long-standing illness or infection (such as heart disease, lung disease, diabetes mellitus, kidney disease, liver disease or HIV infection).
• people with low resistance to infections due to treatment for a disease (such as cancer).

Pneumococcal infections of the membranes covering the brain and spinal cord (meningitis) sometimes occur after a head injury or skull fracture and very rarely after certain medical procedures. This vaccine may not prevent all such infections.

Pneumococcal infections can also occur in the sinuses, ears, and other parts of the body. The vaccine is not intended to protect you or your child against these lesser types of infection.

2. What you or your child need to know before using PNEUMOVAX 23

PNEUMOVAX 23 can only be used in people who are at least 2 years of age. This is because young children do not respond reliably to the vaccine.

To make sure the vaccine is suitable for you or your child, it is important to tell your doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand or are not sure about, ask your doctor or nurse. As with any vaccine, vaccination with PNEUMOVAX 23 may not result in complete protection of all vaccinated individuals.

Do not usePNEUMOVAX 23if you or your child are allergic (hypersensitive) to pneumococcal polysaccharide vaccine or any of the components listed in section 6.

Warnings and precautions

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

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

You should also tell your doctor before vaccination if:

• you or your child have low resistance to infections due to treatment (such as medicines or radiation for cancer treatment).
• you or your child have a long-standing illness or infection that may reduce resistance to pneumococcal infections.

In these cases, vaccination may need to be delayed and may not protect as well as it protects healthy individuals.

It is possible that people 65 years of age or older may not tolerate medical procedures as well as younger people. Therefore, it cannot be ruled out that some older people may have a greater number and/or greater severity of reactions.

Using PNEUMOVAX 23 with other medicines

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 the flu vaccine, provided that different injection sites are used. Most people are able to respond to the two vaccines at the same time, and can therefore be protected against both infections.

For more information about the simultaneous administration of PNEUMOVAX 23 and ZOSTAVAX, consult your doctor or healthcare professional.

If you or your child are receiving antibiotic treatment to prevent pneumococcal disease, this treatment should not be stopped after vaccination. Also, even after vaccination, it is important that you see a doctor and take antibiotics promptly if you or your child think you may have any type of infection or you or your child are at high risk of getting pneumococcal disease (for example, if you do not have a spleen or your spleen does not work properly).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant or breastfeed, consult your doctor or pharmacist before using this vaccine.

Driving and using machines

No information is available to suggest that the vaccine may affect the ability to drive or use machines.

PNEUMOVAX 23 contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

3. How to use PNEUMOVAX 23

The vaccine should be administered by a doctor or nurse trained in the administration of vaccines. The vaccine should be administered in a clinic or surgery where equipment is available to deal with any serious allergic reaction that may occur after the injection.

Follow the instructions for administration of this medicine exactly as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The vaccine should be injected into the muscle or by deep subcutaneous injection. Your doctor or nurse should avoid administering the vaccine to you or your child either into the skin or into a blood vessel.

The vaccine is sometimes given before (usually 2 weeks before) the scheduled date for spleen removal or the start of special cancer treatments. If you or your child have already started or finished these special treatments, vaccination should be delayed for about 3 months.

People with HIV infection should be vaccinated as soon as possible after diagnosis is confirmed.

You or your child will receive one dose of the vaccine. A second dose of the vaccine is not usually given until at least 3 years after the first dose. Healthy individuals usually do not need a second dose. However, in people with an increased risk of serious pneumococcal infection (such as patients without a spleen or with a spleen that does not work properly), more doses of vaccine are recommended, usually between 3 and 5 years after the first dose. Normally, a repeat dose is not recommended within the first 3 years after the first dose due to the increased risk of side effects.

Your doctor or nurse will decide if you or your child need another dose of the vaccine.

If you or your child are given more PNEUMOVAX 23 than you/they should

No cases of overdose with the vaccine have been reported. Overdose is very unlikely because the vaccine is provided in a single dose pre-filled syringe and is administered by a doctor or nurse.

4. Possible side effects

Like all medicines, PNEUMOVAX 23 can cause side effects, although not everybody gets them.

Allergic reactions

You must seek medical attention immediately if you or your child experience any of the following symptoms or other severe symptoms after vaccination:

• difficulty breathing, blue discoloration of the tongue or lips,
• low blood pressure (causing dizziness) and collapse,
• fever, usually feeling unwell with pain and even inflammation and swelling of 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 skin rash) and skin rashes.

If an allergic reaction occurs, it usually appears very soon after the injection while still in the clinic.

Side effects

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

Other side effects include:

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

• extensive swelling of the vaccinated limb.

Frequency not known (cannot be estimated from the available data):

• reduced mobility of the injected limb,
• feeling of tiredness,
• usually feeling unwell,
• shivering,
• feeling of being ill,
• enlarged and/or inflamed glands,
• pain, inflammation, and swelling of the joints and muscle pain,
• reduced number of certain types of blood particles called platelets in people who have a low number of platelets due to another disease called ITP (idiopathic thrombocytopenic purpura) that causes a higher risk of bleeding and bruising,
• headache, feeling of skin disturbances or tingling, reduced mobility of the limbs, numbness, and weakness of the legs and arms (including a condition called Guillain-Barré syndrome),
• an increase in a blood test value that measures inflammation in the body (C-reactive protein),
• patients who have had blood disorders may develop destruction of red blood cells leading to an inadequate number of red blood cells (hemolytic anemia),
• an increase in the number of certain types of white blood cells,
• a seizure episode associated with fever.

Reporting of side effects

If you or your child experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PNEUMOVAX 23

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Your doctor or nurse will check that the liquid is clear and colorless and that there are no particles in it before administering it to you or your child.

Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What PNEUMOVAX 23 contains

One dose of 0.5 milliliters contains:

• The active substances are 25 micrograms (a small amount) of each of the 23 serotypes of purified polysaccharide from the bacterium known as pneumococcus. The 23 serotypes of pneumococcal polysaccharide in the vaccine are serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F.

• The other ingredients are phenol, sodium chloride, and water for injections.

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

Appearance and packaging

It is presented as an injectable solution in a pre-filled syringe (0.5 ml).

It is available in packs of 1 or 10 pre-filled syringes without a needle.

It is available in packs of 1 or 10 pre-filled syringes with a separate needle.

It is available in packs of 1 or 10 pre-filled syringes with two separate needles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Merck Sharp & Dohme of Spain, S.A.

Josefa Valcárcel, 42

28027 Madrid

Tel.: 91 3210600

Manufacturer:

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands.

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

Date of last revision of this leaflet:12/2022.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)