Package leaflet: Information for the user

DIFTETALL injectable suspension

Diphtheria and tetanus vaccine, adsorbed (reduced antigen content)
Please read all of this leaflet carefully before you or your child receive this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine can only be prescribed and administered by a doctor and has been prescribed solely for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

What DIFTETALL is and what it is used for
What you need to know before receiving DIFTETALL
How to use DIFTETALL
Possible side effects
How to store DIFTETALL
Contents of the pack and other information

1. What DIFTETALL is and what it is used for

DIFTETALL is a vaccine used in individuals aged 7 years and older to prevent diphtheria and tetanus.
Diphtheria is a contagious disease that mainly affects the respiratory system, causing inflammation of the nose, throat, and airways, which may eventually lead to suffocation. The bacterium causing diphtheria also releases a toxin that can enter the bloodstream and affect the heart and kidneys. Without treatment, diphtheria can be fatal.
Tetanus is a disease caused by a bacterium that enters the body through a skin wound, such as a cut or a burn. The bacterium responsible for tetanus releases a toxin that affects the nervous system, causing stiffness and muscular spasms of the jaw, back, chest, and abdominal muscles. Without treatment, tetanus can be fatal.
DIFTETALL works by stimulating the immune system (the body's natural defense system) to produce protection (antibodies) against these diseases. None of the components of this vaccine can cause tetanus or diphtheria.

2. What you need to know before using DIFTETALL

To ensure that DIFTETALL is suitable for you or your child, it is important to inform your
doctor or pharmacist if any of the following apply to you or your child. If there is
anything you do not understand, ask your doctor or pharmacist for clarification.
Do not use DIFTETALL if you or your child:

are allergic (hypersensitive) to diphtheria and tetanus toxoids, to any of the ingredients of DIFTETALL, or to formaldehyde (see section 6 “Other information”).
have a disease with high fever or an acute infection. In this case, vaccination should be postponed until you or your child have recovered.
have previously experienced an allergic reaction (hypersensitivity) or a neurological reaction (brain or nervous system) after a prior vaccination.

Warnings and precautions

As with all vaccines, DIFTETALL may not fully protect every vaccinated individual.
Inform your doctor if you or your child are undergoing medical treatment that weakens the immune system; such treatments may reduce your immune response. Your doctor may decide to postpone vaccination until the treatment is completed.
Fainting, feeling faint, or other stress-related reactions (particularly in adolescents) may occur following, or even before, any injection with a needle. Therefore, inform the doctor or nurse if you or your child have previously fainted during an injection.
Individuals sensitive to latex:
Pre-filled syringe with fixed needle: the needle cap contains latex. It may cause severe allergic reactions. If you are allergic to latex, speak with your doctor before receiving DIFTETALL.
Pre-filled syringe without fixed needle: although natural rubber latex has not been detected in the syringe tip cap, the safety of using DIFTETALL in individuals sensitive to latex has not been established. Inform your doctor if you have ever had an allergic reaction to latex.

Other medicines, vaccines, and DIFTETALL
Inform your doctor or pharmacist if you or your child are taking or have recently
taken any other vaccines or medicines, including those obtained without a prescription.
If you or your child have a weakened immune system or are undergoing medical treatment
that weakens the immune system (such as corticosteroids, cytotoxic drugs, or
radiotherapy), you may not develop an adequate immune response.
Pregnancy, breastfeeding, and fertility
Inform your doctor if you are pregnant or if your child is breastfeeding.
Your doctor will decide whether vaccination with DIFTETALL can be administered during
pregnancy or breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery; therefore,
exercise caution if you need to drive or operate machinery after vaccination.
DIFTETALL contains
1 dose of DIFTETALL (0.5 ml) contains less than 4.25 mg of sodium chloride. This means that
DIFTETALL is essentially sodium-free.
Formaldehyde is used in the manufacturing process and may be present in the vaccine in
very small amounts (see section 6 “Other information”).

3. How to use DIFTETALL

Vaccination schedule
The vaccination schedule consists of 3 separate doses administered at different times,
and additional booster doses.
Your doctor will evaluate the most appropriate schedule for you or your child, based on
previous medical history, current health status, and prior vaccinations.
It is important to follow the instructions provided by your doctor or nurse regarding the administration of
DIFTETALL.

Method and route(s) of administration
Dosage
DIFTETALL is administered as single doses of 0.5 ml.

Method of administration
Your doctor will administer DIFTETALL by injection into the muscle of the upper arm (deltoid muscle).
The vaccine must never be administered into a blood vessel.
If you need any clarification regarding the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DIFTETALL can cause side effects, although not everyone experiences them.
Side effects observed in clinical studies
The following side effects have been observed in clinical studies:
Very common (occurring in more than 1 in 10 people):

Redness at the injection site (erythema), pain at the injection site, swelling at the injection site, hardening of the skin at the injection site (induration).
General malaise
Fever
Muscle pain (myalgia)
Joint pain (arthralgia)
Headache

Common (occurring in fewer than 1 in 10 people):

Itching and inflammation at the injection site
Swelling of the glands in the neck, armpits, or groin (lymphadenopathy)
Nausea
Influenza-like symptoms

Uncommon (occurring in fewer than 1 in 100 people):

Bruising at the injection site (hematoma)
Skin rash (urticaria)
Inflammation of the stomach and intestine (gastroenteritis)
Ear pain (otitis media)
Sore throat (pharyngitis)

Other side effects
Additionally, the following side effects have been reported after the marketing of DIFTETALL. Due to the nature of the reports, it is not possible to estimate the frequency of these side effects.

Decrease in the number of blood clotting cells (thrombocytopenia)
Diarrhea, vomiting
Swollen glands near the injection site (injection site lymphadenopathy)
Formation of a lump under the skin at the injection site (abscess at the vaccination site)
Allergic reaction
Loss of appetite
Inflammation of nerves that may lead to weakness and numbness in the arms (neuralgic amyotrophy)
Inflammation of nerves that may lead to muscle weakness or temporary loss of movement (Guillain-Barré syndrome)
Drowsiness
Irritability
Hypersensitivity reactions, anaphylactic reactions Administration of any type of vaccine may cause hypersensitivity reactions, including anaphylactic reaction (which occurs in fewer than 1 in 10,000 people). Characteristic symptoms of anaphylactic reaction are: sudden and severe drop in blood pressure, increased or decreased heart rate, unusual fatigue or weakness, anxiety, restlessness, loss of consciousness, difficulty breathing or swallowing, itching (especially on the soles of the feet or palms of the hands), urticaria with or without angioedema (swollen and itchy skin areas, commonly affecting extremities, external genitalia, and face, particularly around the eyes and lips), skin redness (especially around the ears), nausea, vomiting, cramping abdominal pain, diarrhea.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
You can also report side effects directly through the national reporting system:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DIFTETALL

Keep DIFTETALL out of the reach and sight of children.
Store in the refrigerator (2°C – 8°C). Do not freeze.
Do not use DIFTETALL after the expiry date stated on the carton after the abbreviation
"EXP". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original packaging, stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What DIFTETALL contains:
The active substances are:
Tetanus toxoid not less than 20 IU
Diphtheria toxoid not less than 2 IU
Aluminium hydroxide (adsorbent) 1.5 milligrams
IU are International Units used to measure vaccine potency
added to enhance, improve and/or prolong the protective effect of the vaccine.
The other components are:
Sodium chloride
Water for injections

Residuals from the manufacturing process are:
Formaldehyde (not more than 0.001 mg)

Description of the appearance of DIFTETALL and contents of the pack
The vaccine is a milky, opalescent suspension for injection, supplied in:

Pre-filled syringe of 0.5 ml with or without needle, pack size of 1 syringe

Marketing Authorisation Holder
Astro-Pharma GmbH
Allerheiligenplatz 4
1200 Vienna, Austria

Manufacturers
GSK Vaccines S.r.l.
Bellaria-Rosia, 53018 Sovicille (SI), Italy

Release responsible
GSK Vaccines S.r.l.
Bellaria-Rosia, 53018 Sovicille, Italy

The following information is intended for healthcare professionals only:
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of an anaphylactic reaction following administration of the vaccine.
The vaccine must never be administered intravascularly.
Shake well before use. Visually inspect for presence of particles or discoloration. If present, do not use the vaccine.
The vaccine is presented as an opalescent suspension.