PATIENT INFORMATION LEAFLET

Meningitec Suspension for Injection in Pre-filled Syringe

Conjugate Vaccine for Meningococcal Oligosaccharide Serogroup C (adsorbed)

Read this leaflet carefully before you start using this vaccine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only and must not be given to others.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

Prescription-only medicine.

Meningitec is a meningococcal vaccine of serogroup C.

Meningitec helps protect you or your child from diseases such as meningitis and septicemia (blood poisoning).

Meningitec is a vaccine used in children from 2 months of age, adolescents, and adults to prevent infections caused by the bacteriumNeisseria meningitidisserogroup C. It will not protect against other serogroups ofNeisseria meningitidisor other bacteria or viruses that may sometimes cause meningitis and septicemia (blood infection). This vaccine works by stimulating the production of protective antibodies against the bacterium of serogroup CNeisseria meningitidisserogroup C can cause serious and sometimes life-threatening infections, such as meningitis and septicemia (blood infection). Meningitec does not contain live organisms, and it cannot cause meningitis C (meningococcal disease C).

Remember that no vaccine can provide complete and lifelong protection for all vaccinated individuals.

Do not administer Meningitec:

• If you or your child are allergic (hypersensitive) to the meningococcal oligosaccharide or any of the components of Meningitec.
• If you or your child have shown signs of allergy to any other vaccine that contains diphtheria toxoid or the CRM197 diphtheria protein.
• If you or your child have shown signs of allergy after a previous dose of Meningitec.
• If you or your child have any illness with high fever. Vaccination is usually postponed, although it may be carried out if the fever and illness are moderate, after consulting with your doctor or nurse beforehand.

Warnings and precautions:

Consult your doctor, pharmacist, or nursing staff before vaccination:

• If you or your child have hemophilia or any other bleeding disorder, or are taking any medication that affects blood clotting. If so, your doctor will take special precautions.
• If you or your child have a weakened immune system, or have received or are currently receiving radiation treatment, corticosteroids, or any other medication that may reduce your immunity to infections. Meningitec may be administered, but the protective effect may be lower than in other people.
• If you or your child have a kidney disease in which large amounts of protein appear in the urine (called nephrotic syndrome). There have been cases of relapse of this disease after vaccination. Your doctor will advise you whether you/your child, despite this, can use Meningitec depending on the kidney problem you have.

Although Meningitec contains a protein (called CRM197), which comes from the bacteria that cause diphtheria, it does not protect against diphtheria, so it is essential that your child receives vaccines that protect against diphtheria when the time comes. Your doctor or nurse may advise you.

Meningitec has been administered mainly to babies from 2 months, children, and adolescents. There is currently no information available about the administration of Meningitec in people over 65 years or in babies under 2 months.

Use of Meningitec with other medications/vaccines

Inform your doctor or pharmacist if you/the child is using or has recently used or may need to use any other medication, including those obtained without a prescription or if you have recently received any other vaccine.

You should continue taking the medications that have been prescribed to you in the same way before and after vaccination unless your doctor or nurse advises you otherwise.

Meningitec may be administered at the same time as other vaccines such as:

Polio (both oral and injectable)

Diphtheria

Tetanus

Pertussis (whooping cough)

Haemophilus influenzaetype b (known as Hib vaccines)

Hepatitis B

Measles, mumps, and rubella

Pneumococcal disease (conjugate 7-valent pneumococcal polysaccharide vaccine and conjugate 13-valent pneumococcal polysaccharide vaccine)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before vaccinating.

Normally, Meningitec should not be administered to pregnant women or breastfeeding women unless it is considered essential to vaccinate as soon as possible.

Driving and operating machinery

After receiving the vaccine, you may experience drowsiness, dizziness, and other adverse effects that may interfere with driving or operating machinery (see possible adverse effects).

Do not drive or operate machinery until you know how Meningitec affects you.

Meningitec contains sodium chloride

One of the ingredients of Meningitec is sodium chloride. This vaccine contains less than 1 mmol of sodium (23 mg) per dose of 0.5 ml and is therefore considered essentially "sodium-free".

Meningitec should be administered by a doctor or a nurse.

Your doctor or nurse will ensure that the vaccine is injected correctly into a muscle (not into a nerve or near it or blood vessels or too superficially under the skin) and that Meningitec is not mixed with other vaccines in the same syringe. The vaccine is a 0.5 ml injection and is usually applied in the thigh muscle in young children and in the deltoid muscle in older children, adolescents, and adults. It should not be administered in the buttocks.

For children aged 2 to 12 months, two doses of Meningitec should be given with a gap of at least two months.

To maintain protection, a booster dose should be given when the two-dose treatment of the child has been completed. Your doctor will advise you when to administer it to your child.

For adults, adolescents, and children over 12 months who have not been previously immunized with Meningitec, a single dose of the vaccine (0.5 ml) is recommended.

When administered at the same time as another injectable vaccine, Meningitec should be administered via a separate injection in a different site on the body.

If more Meningitec is administered than it should:

Overdose is very unlikely since the vaccine is presented in pre-filled syringes and is administered by a doctor or nurse.

There have been some cases of excessive doses, administration of a dose greater than recommended, or consecutive doses administered before the recommended time. In most cases, there were no adverse effects, while in some cases, adverse effects similar to those observed after normal and correct use of Meningitec occurred.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forget to go to the doctor

If you forgot to go to the doctor or nurse at the scheduled time, seek advice from your doctor or nurse.

Like all medicines, Meningitec can cause side effects, although not everyone will experience them.

Severe allergic reactions are always a very rare possibility after being vaccinated. These reactions may include:

• inflammation of the face, tongue, or pharynx
• difficulty swallowing
• inflammation of the skin (urticaria) and difficulty breathing
• hypotension that can cause collapse and shock.

When these signs or symptoms occur, they develop very rapidly after the injection and usually while the affected person is still at the clinic or consultation. If any of these symptoms appear after leaving the place where the injection was administered, you should consult a doctor IMMEDIATELY.

Very rarely, severe rashes may appear that cover a large part of the body and lead to blisters and peeling. The interior of the mouth and eyes may also be affected. Other less severe adverse reactions include rashes that may be red and swollen, causing itching and a late general discomfort that may cause symptoms such as fever and joint inflammation.

This vaccine cannot cause meningitis C (meningococcal disease C). If you or your child experience neck pain and/or stiffness or intolerance to light (photophobia), drowsiness or confusion, or red or purple spots similar to hematomas that do not disappear when pressed on them, you should contact your doctor immediately to rule out other causes.

If your doctor has previously informed you that you have nephrotic syndrome (a kidney disease that can cause inflammation, particularly around the face and eyes and proteins in the urine that make it look foamy and heavy), there is a greater risk that this disease will recur a few months after vaccination. You should inform your doctor if you observe similar symptoms after vaccination.

The frequencies of the effects described in this section are:

- Very frequent: can affect more than 1 in 10 people who have received the vaccine

- Frequent: can affect up to 1 in 10 people who have received the vaccine

- Very rare: can affect up to 1 in 10,000 people who have received the vaccine

The very frequent adverse reactions include:

In all age groups - inflammation and sensitivity or pain at the injection site.

In children between 0 and 2 years - loss of appetite, irritability, drowsiness or alterations in sleep patterns, dizziness, diarrhea.

In adults - headaches.

In preschool children - fever.

The frequent adverse reactions include:

In all age groups - fever (very common in preschool children), but rarely severe.

In children between 0 and 2 years - crying.

In children between 3 and 6 years - drowsiness, headache, irritability.

In adults - muscle pain, drowsiness.

The very rare adverse reactions include (in all age groups except those mentioned earlier:

Lymph node inflammation, dizziness, fainting, partial or total loss of sensation in a part of the body, tingling or pins and needles sensation, nausea or vomiting, hematomas or skin bleeding, recurrences in certain kidney disorders in which large amounts of protein are present in the urine.

In very rare cases, a decrease in muscle tone (laxity) has been observed, which in some cases is accompanied by a decrease in alertness or response in the child and pale or bluish skin.

Seizures have been reported very rarely after vaccination with Meningitec, including seizures in people who had previously experienced them. In adolescents and adults, some of the reports of seizures may have been actual fainting spells. In children under one year and small children, the seizures were usually related to fever and were considered febrile seizures. Most people recovered quickly after the seizure. In children born very prematurely (in or before 28 weeks of gestation) may produce longer than normal intervals between breaths for 2-3 days after vaccination.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep this vaccine out of sight and reach of children.

Do not use Meningitec after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Meningitec

The active principle in each 0.5 ml dose is:

10 micrograms of group C meningococcal oligosaccharide*

* conjugated with the CRM 197 transport protein adsorbed on aluminium phosphate (0.125 mg)

The other components are sodium chloride and water for injection.

Appearance of the product and contents of the package

Meningitec is a suspension for injection that is presented in pre-filled syringes of 0.5 ml in packs of 1 and 10 (with or without needle) and in a multiple pack of 2 packs of 10 pre-filled syringes (without needles).After shaking, the vaccine is a white and homogeneous suspension.Not all pack sizes may be marketed.

Marketing Authorization Holder

NURON BIOTECH B.V.

Wtc Amsterdam, C-11, Strawinskylaan 1143

1077 XX - Amsterdam

Netherlands

Responsible for manufacturing

HALSA PHARMA GMBH

Nikolaus Dorkopp Str. 4

33602 Bielefeld, Germany

This leaflet was approved in June 2013

The following information is directed exclusively to healthcare professionals:

Instructions for use, handling and disposal

During storage, a white precipitate and clear supernatant may be observed.

The vaccine must be shaken well to obtain a white homogeneous suspension and, before administration, it must be visually inspected for the presence of particles and/or physical appearance variations. If this is observed, discard the vaccine. The disposal of unused medication and all materials that have been in contact with it, will be carried out in accordance with local regulations.

Meningitec MUST NOT BE ADMINISTERED BY INTRAVENOUS ROUTE UNDER ANY CIRCUMSTANCES.

Meningitec must be administered by intramuscular injection, preferably in the anterolateral aspect of the thigh in young children, and in the deltoid region in older children, adolescents and adults. Meningitec must not be injected in the gluteal area.

Avoid injection in or near nerves and blood vessels.

The vaccine must not be administered by intradermal, subcutaneous or intravenous route.

If more than one vaccine is to be administered, they must be injected in different locations. This vaccine must not be mixed with other vaccines in the same syringe.

As with all injectable vaccines, adequate medical supervision and treatment must be available for the unlikely event of an anaphylactic/anaphylactoid reaction following administration of the vaccine.

In the event of petechiae or purpura after vaccination, the etiology must be investigated. Non-infectious causes must be considered.

No data are available on the applicability of the vaccine for the control of outbreaks.

The 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/