Pneumovax 23 solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PNEUMOVAX 23 solution for injection in a pre-filled syringe

pneumococcal polysaccharide vaccine

For adults and children from two years of age.

Read the entire leaflet carefully before you or your child are vaccinated, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed only for you or your child and must not be given to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before you or your child are given 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

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

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

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

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

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

• elderly individuals.
• people who have lost their spleen or whose spleen does not function properly.
• people with reduced resistance to infections due to chronic illness or infections (such as heart disease, lung disease, diabetes mellitus, kidney disease, liver disease, or HIV infection).
• people with reduced resistance to infections due to medical treatments for certain diseases (such as cancer).

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

Pneumococcal infections may 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 milder types of infection.

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

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

To ensure that 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 unsure about, 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 use PNEUMOVAX 23 if you or your child are allergic (hypersensitive) to the pneumococcal polysaccharide vaccine or to 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 fever, as vaccination may need to be postponed until you or your child have recovered.

You should also inform your doctor before vaccination if:

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

In these cases, vaccination may need to be postponed and may even provide less protection than in healthy individuals.

Individuals aged 65 years or older may not tolerate medical interventions as well as younger people. Therefore, it cannot be ruled out that some older individuals may experience a greater number and/or more severe reactions.

Use of PNEUMOVAX 23 with other medicines

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

PNEUMOVAX 23 can be administered at the same time as the influenza vaccine, provided different injection sites are used. Most people are able to respond to both vaccines simultaneously, thus providing protection 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 to see a doctor and to take antibiotics promptly if you suspect that you or your child may have any kind of infection or if you or your child are at high risk of developing pneumococcal disease (for example, if you do not have a spleen or it is not functioning properly).

Pregnancy, breastfeeding, and fertility

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

Driving and use of machines

There is no information indicating that the vaccine may affect the ability to drive or operate machinery.

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 must be administered by a doctor or nurse trained in vaccine administration. The vaccine should be given in a doctor's office or clinic where appropriate equipment is available to treat any serious allergic reaction following the injection.

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If you have any doubt, consult your doctor or pharmacist again.

The vaccine should be injected into the muscle or as a deep subcutaneous injection. Your doctor or nurse must avoid administering the vaccine either into the skin or into a blood vessel.

The vaccine is sometimes given before (usually 2 weeks before) the planned date for spleen removal 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 about 3 months.

Individuals with Human Immunodeficiency Virus (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 generally do not require a second dose. However, in individuals at increased risk of serious pneumococcal infection (such as patients without a spleen or in whom the spleen does not function properly), additional doses are recommended, usually between 3 and 5 years after the first dose. Repeated dosing within the first 3 years after the initial dose is generally not recommended due to the increased risk of adverse effects.

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

If you were given more PNEUMOVAX 23 than you should have received

Cases of overdose with the vaccine have not been reported. Overdose is highly unlikely because the vaccine is supplied in single-dose pre-filled syringes and is administered by a doctor or nurse.

4. Possible adverse effects

Like all medicines, PNEUMOVAX 23 can cause adverse effects, although not everyone experiences them.

Allergic reactions

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 breathing, bluish discoloration of the tongue or lips,
• low blood pressure (causing dizziness) and collapse,
• fever, general malaise with pain and even joint swelling and inflammation, and muscle pain,
• swelling of the face, lips, tongue and/or throat and neck,
• swelling of the hands, feet or ankles,
• hives (swollen, inflamed areas on the skin) and rashes.

If any allergic reaction occurs, it usually appears very shortly after the injection, while still at the clinic.

Adverse effects

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

Other adverse effects include:

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

• extensive swelling in the vaccinated limb.

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

• decreased mobility of the injected limb,
• feeling tired,
• generally unwell,
• uncontrollable shivering,
• feeling or state of illness,
• enlarged and/or inflamed glands,
• joint pain, inflammation and swelling, and muscle pain,
• decrease in the number of certain types of blood particles called platelets in individuals who already have a low platelet count due to another condition called ITP (idiopathic thrombocytopenic purpura), which increases the risk of bleeding and bruising,
• headache, skin sensation disturbances or tingling, decreased limb mobility, numbness and weakness in arms and legs (including a condition called Guillain-Barré syndrome),
• an increase in a blood test value measuring 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 febrile seizure episode.

Reporting of adverse effects

If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to 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 clear and colourless and that there are no particles in it before administering it to you or your child.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of PNEUMOVAX23

One dose of 0.5 millilitres contains:

• The active substances are 25 micrograms (a small amount) of each of the 23 purified polysaccharide serotypes from the bacterium known as Streptococcus pneumoniae. The 23 pneumococcal polysaccharide serotypes 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 injections.

This medicine contains less than 23 mg of sodium (1 mmol) per dose, which means it is essentially "sodium-free".

Appearance of the product and contents of the pack

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 needles.

It is available in packs of 1 or 10 pre-filled syringes with one 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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 42

28027 Madrid

Tel.: 91 3210600

Manufacturer:

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

This medicinal product is authorised in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

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

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