Prospect: information for the user

PNEUMOVAX 23 injectable solution in pre-filled syringe

Polysaccharide pneumococcal vaccine

For adults and children two years of age and older.

1. What you or your child need to know before starting to use PNEUMOVAX 23
2. How to use PNEUMOVAX 23
3. Possible adverse effects
4. Storage of PNEUMOVAX 23
5. Contents of the package and additional information

PNEUMOVAX23 is a pneumococcal vaccine. Vaccines are used to protect you or your child from infectious diseases. Your doctor has recommended the vaccine to you or your child (from 2years of age) to help protect against severe infections caused by a bacterium called pneumococcus.

Pneumococcus can cause lung infections (especially pneumonia) and infections of the membranes that cover 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 almost all (approximately 9 out of 10) infections caused by pneumococci.

When you or your child receive the vaccine, 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 to occur in:

• the elderly.
• people who have lost their spleen or whose spleen does not function.
• people with weakened immunity due to a long illness or infections (such as heart disease, lung disease, diabetes mellitus, kidney disease, liver disease or HIV infection).
• people with weakened immunity due to treatment for some disease (such as cancer).

Pneumococcal meningitis sometimes occurs after a head injury or fracture and very rarely after certain medical interventions. This vaccine may not prevent against all those infections.

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

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

To ensure that the vaccine is suitable for you or your child, it is essential to inform your doctor or nurse if any of the following points apply to you or your child. If you do not understand something or are unsure, ask your doctor or nurse. As with any other vaccine, vaccination with PNEUMOVAX 23 may not result in complete protection for all vaccinated individuals.

Do not usePNEUMOVAX 23if you or your child are allergic (hypersensitive) to the pneumococcal polysaccharide vaccine or to any of the componentsincluded in section6.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before vaccination if:

• You or your child have a fever infection, as it may be necessary to delay vaccination until you or your child have recovered.

You must also inform your doctor before vaccination if:

• You or your child have reduced resistance to infections due to treatment (such as medications 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, it may be necessary to delay vaccination and it may not protect you as it protects healthy individuals.

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

Use of PNEUMOVAX 23 with other medications

Inform your doctor or pharmacist if you or your child are using, have used recently, or may need to use any other medication.

PNEUMOVAX 23 can be administered at the same time as the flu vaccine, as long as different injection sites are used. Most people are prepared to respond to both vaccines at the same time, thereby protecting 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 discontinued after vaccination. Additionally, even after vaccination, it is essential to see a doctor and take antibiotics promptly if you think you or your child may have any type of infection or if you or your child are at high risk of contracting pneumococcal disease (for example, if you do not have a spleen or if it does not function properly).

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

No information is available to indicate that the vaccine may affect the ability to drive or operate machinery.

PNEUMOVAX 23contains sodium

This medicationcontains less than 23mg of sodium (1mmol) per dose; this is, essentially “sodium-free”.

The vaccine must be administered by a trained doctor or nurse. The vaccine must be administered in a consultation or clinic where the necessary equipment is available to treat any severe allergic reaction after the injection.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.This medicationshould be consulted again with your doctor or pharmacist if in doubt.

The vaccinemust be injected into the muscle or by deep subcutaneous injection. Your doctor or nurse must avoid administering the vaccine to you or your child both within the skin and into a blood vessel.

The vaccine is sometimes administered before (usually 2 weeks before) the planned date for removing the spleen or the start of special cancer treatments. If you or your child have already started or completed these special treatments, vaccination should be delayed for around 3 months.

Individuals with Human Immunodeficiency Virus infection should be vaccinated as soon as possible after confirmation of their diagnosis.

You or your child will receive a dose of the vaccine. A second dose of the vaccine is usually not administered until at least 3years after the first dose. Healthy individuals usually do not need a second dose. However, in individuals with an increased risk of severe pneumococcal infection (such as patients with asplenia or those with a non-functioning spleen), additional vaccine doses are recommended, usually between 3 and 5years after the first dose. Normally, a repeated dose is not recommended within the first 3 years after the first dose due to the high risk of adverse effects.

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

If you are administered more PNEUMOVAX23 than you should

No cases of overdose withthe vaccinehave been reported. An overdose is highly unlikely due to the vaccine being provided in a single pre-filled syringe dose and administered by a doctor or nurse.

Like all medicines,PNEUMOVAX23 may cause side effects, although not everyone will experience them.

Allergic reactions

You must seek immediate medical help 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 accompanied by discomfort, pain, and inflammation and swelling of the joints and muscles,
• swelling of the face, lips, tongue, and/or throat and neck,
• swelling of the hands, feet, or ankles,
• urticaria (inflamed patches on the skin) and rashes.

Any allergic reaction usually appears very shortly after the injection while still at the clinic.

Side effects

The most frequently reported (can affect more than 1 in 10 individuals) areinflammation,pain, redness, heat, swelling, and hardness at the injection site and fever. These reactionstend to bemore common after the second dose of vaccine than after the first dose.

Other side effects include:

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

• extensive inflammation inthe vaccinated limb.

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

• reduced mobility of the injected limb,
• sensation of fatigue,
• usually unwell,
• uncontrollable chills,
• sensation or state of illness,
• enlarged and/or inflamed glands,
• pain, inflammation, and swelling of the joints and muscles,
• decrease in the number of certain types of blood cells 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 petechiae,
• headache, sensation of skin alterationsor 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,
• an episode of fever-associated seizures.

Reporting of side effects

If you or your child experienceany type of side effect, consult your doctoror pharmacist, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Vaccines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and unused medications. This will help protect the environment.

Composition ofPNEUMOVAX23

A dose of 0.5milliliters contains:

• The active principles are 25micrograms (a small amount) of each of the 23serotypes of purified polysaccharide of the bacterium known as pneumococcus. The 23serotypes 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, 33F.

• The other components are phenol, sodium chloride, and water for injection preparations.

This medication contains less than 23mgof sodium(1mmol) per dose; this is,essentially "free of sodium".

Appearance of the product and contents of the package

It is presented asa pre-filled syringe (0.5ml).

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

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

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

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 42

28027Madrid

Tel.: 91 3210600

Responsible manufacturer:

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

This medication is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)