Prospect: information for the user

MENJUGATE 10 micrograms injectable suspension preloaded syringe

Conjugate vaccine against group C meningococcus

Read this prospect carefully before you or your child starts using this medicine, because it contains important information for you or your child.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This vaccine has been prescribed only for you or your child and should not be given to other people.
• If you or your child experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

1.What Menjugate is and for what it is used

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

3.How to use Menjugate

4.Possible adverse effects

5.Storage of Menjugate

6.Contents of the package and additional information

Menjugate is a vaccine used to prevent diseases caused by the bacteriaNeisseria meningitidisgroup C (also known as group C meningococcal bacteria). The vaccine works by stimulating the production of protective antibodies against group C meningococcus.

The bacteriaNeisseria meningitidisgroup C can cause severe, sometimes fatal, infections such as meningitis and septicemia (blood infection).

This vaccineis used for active immunization of children from 2 months of age, adolescents, and adults, andonly protects against group C meningococcal bacteria. It does not protect against other groups of meningococcal bacteriaor other causes of meningitis or septicemia (blood infection).

If you or your child experience neck pain/stiffness or have aversion to light (photophobia), drowsiness or confusion, red or purple spots like a bruise that do not fade under pressure, you should contact your doctor or Emergency immediately.

This vaccine cannot cause group C meningitis (group C meningococcal disease).

This vaccine contains the diphtheria protein CRM197.Menjugate does not protect against diphtheria.

This means that you (or yourchild) must receive other vaccines to protect against diphtheria when necessary or as indicated by your doctor.

No useMenjugate if you or your child:

• has ever had anallergic reaction to the active ingredientsor to any of the other components of Menjugate (listed in section 6)
• has ever had anallergic reaction todiphtheria toxoid(a substance used in numerous other vaccines)

Warnings and precautions

You may experience dizziness, lightheadedness, and other stress-related reactions in response to an injection with a needle. Inform your doctor or nurse if you (or your child) have experienced this type of reaction in the past.

Consult your doctor or nurse before Menjugate is administered to you or your child, or if you or your child:

• hashemophiliaor any other condition that may affect blood clotting (e.g. a low platelet count called thrombocytopenia) or is taking any medication that affects blood clotting
• has aweakened immune systemfor any reason (e.g. you (or your child) do not produce antibodies efficiently, or you (or your child) are taking medications that reduce immune defenses against infections such as cancer medications or high doses of corticosteroids)
• is receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with Menjugate, you still have a higher risk of invasive disease caused by theNeisseria meningitidisgroup C bacteria
• has had theirspleen removedor has been told that their spleen does not function properly
• has aninfectious disease or high fever. In this case, vaccination with Menjugate may need to be postponed. However, a mild infection (e.g. a cold) is not a sufficient reason to postpone vaccination
• is over 65 years old
• has akidney diseasecharacterized by large amounts of protein in the urine (called nephrotic syndrome). Recurrences have been reported after vaccination.

This vaccine only protects against group C meningococcal bacteria. It does not protect against other groups of meningococcal bacteria.

People sensitive to latex (for the syringe presentation):

Although natural rubber latex is not detected in the syringe cap, it has not been established that the use of Menjugate is safe in people sensitive to latex.

Use of Menjugate with other medications

Inform your doctor or nurse if you (or your child) are using, have used recently, or may need to useany other medication.

Menjugate can be administered at the same time as other vaccines, but any other injectable vaccine must be administered in a different injection site, preferably in a different arm or leg from the Menjugate injection site.

This includes:

• Oral or injectable polio vaccines.
• Diphtheria and tetanus vaccines alone or in combination with the pertussis vaccine.
• Haemophilus influenzae type B (Hib) vaccine.
• Hepatitis B vaccine administered alone or as combined vaccines against diphtheria, tetanus, Hib, polio, and pertussis.
• Combined measles, mumps, and rubella (MMR) vaccines.
• Pneumococcal combined vaccine.

These other vaccines should be administered at the recommended ages in the usual manner.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or nurse before Menjugate is administered to you. However, if you are at high risk of contracting a group C meningococcal infection, your doctor or nurse may advise that you receive Menjugate.

Driving and operating machinery

You may feel dizzy or experience other adverse effects after the injection. This may affect your ability to drive or operate machinery. Do not drive or operate machinery until you know how Menjugate affects you.

Menjugate contains:

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

Menjugate will be administered by a doctor or a nurse.

The vaccine is usually administered in the thigh muscle in infants and in the deltoid muscle in older children, adolescents, and adults. Your doctor or nurse will take care to ensure that the vaccine is not administered into a blood vessel and will make sure it is injected into the muscle and not into the skin.

In children 12 months of age and older, adolescents, and adults:a single dose (0.5 ml) of vaccine is recommended.

In infants from 2 months to 12 months:two doses of Menjugate should be administered at least two months apart.

To maintain protection, a booster dose should be administered after the two-dose vaccination schedule for the child has been completed.Your doctor will inform you when to administer this booster dose to your child.

See the section for the doctor or healthcare professional at the end of this leaflet for information on handling the vaccine.

If you use more Menjugate than you should

Since Menjugate is administered by a doctor or nurse, and each injection is a single dose of 0.5milliliters, it is very difficult for you (or your child) to receive too much vaccine. If you have any doubts about the amount of vaccine that has been given (or to your child), speak with your doctor or nurse.

If you have any other questions about the use of Menjugate, ask your doctor or nurse.

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

If a severe allergic reaction (usually in less than 1 in 10,000 people) occurs, inform your doctor immediately / take your child to the Emergency Department as urgent medical help may be needed.

The symptoms of severe allergic reactions can be:

• Swelling of the lips, mouth, and throat (which could cause difficulty swallowing).
• Difficulty breathing with wheezing or coughing.
• Rash and swelling of the hands, feet, and ankles.
• Loss of consciousness.
• Very low blood pressure.

These very rare adverse reactions can occur immediately or shortly after the injection and usually recover quickly after appropriate treatment is given.

Other allergic reactionscould start several days after the vaccine is administered.

They could be:

• Rash, sometimes with itching, purple or red skin spots.
• Blistering rashes that could also cause ulcers in the mouth and around the genital organs.

The most commonly reported side effects during clinical trials usually lasted only one to two days and were not usually severe. The side effects were:

Very common(can affect more than 1 in 10 people)

• In all age groups: redness, swelling, and sensitivity/pain at the injection site, which did not usually require medical attention. Rarely, redness or swelling of at least3 cmand sensitivity that causes discomfort when moving for more than 48 hours in duration.
• Infants: dizziness (vomiting).
• Infants and young children (between 12 and 36 months): irritability, drowsiness, difficulty sleeping, loss of appetite, and diarrhea.
• Secondary school students: headache.
• Older children and adults: muscle and joint pain, general discomfort.
• Adults: general discomfort (with nausea).

Common(can affect 1 in 10 people)

• In all age groups: fever (but rarely severe).
• Infants and young children (between 12 and 36 months): crying.
• Young children (between 12 and 36 months): dizziness (vomiting).
• Primary school students: headache.

Other side effectsnotified during routine vaccination programs:

Very rare(can affect 1 in 10,000 people)

Groups of different ages:

• Swollen lymph nodes
• Dizziness
• Loss of consciousness
• Numbness
• Tickling or cramps
• Temporary reduction in muscle tone
• Visual disturbances and light sensitivity. Usually accompanied by headache and dizziness
• Extensive swelling of the vaccinated limb.

Although convulsions have been very rarely reported after vaccination with Menjugate, some of these notifications in adolescents and adults may be considered as fainting. In infants and young children, convulsions were usually associated with high fever. Most affected people have recovered quickly.

There have been very infrequent reports of relapse of a kidney disorder called nephrotic syndrome after vaccination with this type of vaccine.

After vaccination, in very premature babies (born before 28 weeks of gestation) may produce longer than normal intervals between breaths for 2-3 days.

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use atwww.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 Menjugate after the expiration date that appears on the packaging. This vaccine contains a vial or syringe.

Store in refrigerator (2?°C – 8?°C). Do not freeze. Store the vial or syringe in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your doctor or nurse how to dispose ofthepackaging andthemedicines that you no longer need.

Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Menjugate

Each dose of 0.5 ml of vaccine contains the following amount of active principle:active principle: 10 micrograms of oligosaccharide fromNeisseria meningitidisgroup C (strain C11) chemically linked to 12.5-25.0 micrograms of the CRM197 protein fromCorynebacterium diphtheriae.

The active principle is adsorbed on aluminium hydroxide (0.3 to0.4 mg Al3+) in 0.5 ml (1 dose) of vaccine.

Theothercomponents are: sodium chloride, histidine and water for injection (see also the end of section 2).

Appearance of Menjugate and contents of the package

Menjugate isan injectable suspension.

Each dose of Menjugate is presented as:

• A vial with a white opalescent suspension

or

• A syringe with a white opalescent suspension

Containers: 1, 5 or 10 doses. Not all container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GSK Vaccines S.R.L.

Via Fiorentina 1

53100 Siena, Italy

Local representative:

GlaxoSmithKline, S.A.

P.T.M C/Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GSK Vaccines S.R.L.

Bellaria-Rosia

53018 Sovicille (Siena), Italy

Last review date of this leaflet:

January 2020

This information is intended solely for healthcare professionals:

Syringe:

Agitate the syringe with the vaccine gently before administration. Remove the syringe cap and attach an appropriate needle. The vaccine must be visually inspected to check that it does not contain particles or changes in color before administration. Check that the syringe does not contain air bubbles before injecting the vaccine.If any strange particles or changes in appearance are observed, the vaccine should be discarded.

Vial:

Agitate the vial with the vaccine gently. With a syringe and an appropriate needle (21G, 1½ inches [40 mm] in length), withdraw the entire contents of the vial. Before injection, change the needle to another suitable for administration. The vaccine must be visually inspected to check that it does not contain particles or changes in color before administration. Check that the syringe does not contain air bubbles before injecting the vaccine.If any strange particles or changes in appearance are observed, the vaccine should be discarded.

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