Package leaflet: what is it for?

foglietto illustrativo
foglietto illustrativo

Package leaflet or also called “leaflet”. Why call it your own leaflet? Maybe to make it clear that the things written on it don’t have to be taken so literally? What can be interpreted?

No, I don’t think so. It is an extremely important act to declare how a drug is made, what it is used for and if there are any side effects. The population, the patient, us, the people (as Fred Vargas calls us in his book “Humanity in danger”), must know what he is going to take and what are the risks he can face if that medicine is ingested or injected.

Fundamental for us doctors is first of all: “Don’t harm”. That is, I can try to cure a person but surely I MUST NOT cause them damage with my work or with the prescription of any therapy.

Well. Let’s read.

Package leaflet.

Excerpts taken from the leaflet of the diphtheria-tetanus-pertussis vaccine, which you can search for on the internet by yourself … it’s very easy.

Package Leaflet: Information for the user

X ……, suspension for injection in a pre-filled syringe

Diphtheria, tetanus and pertussis vaccine (adsorbed, with reduced antigen content) (acellular component)

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.

• – Keep this leaflet. You may need to read it again.
• – If you have any further questions, ask your doctor or pharmacist.
• – This vaccine has only been prescribed for you or your baby. Never give it to others.
• – If you or your child experiences any side effects, including those not listed in
• this leaflet, ask your doctor or pharmacist. See paragraph 4.

“Let’s start reading this leaflet very carefully. Then everyone will draw their own conclusions. Mine is just a sharing of different thoughts to try to help us understand more.”

Contents of this leaflet:

  1. What is X …… and what is it for
  2. What you need to know before you or your child receive X ….
  3. How to use X ……
  4. Possible side effects
  5. How to store X ….
  6. Contents of the pack and other information
  1. What is X ….. and what is it for

X ….. is a vaccine used as a booster dose in children from 4 years of age, adolescents and adults for the prevention of three diseases: diphtheria, tetanus, whooping cough (whooping cough). The vaccine works by stimulating the body to produce protection (antibodies) against these diseases.

“Clearly in the leaflet it is first of all clarified which are the pathologies for which this vaccine has been produced. It is therefore rightly explained what are diphtheria, tetanus and whooping cough ….”

• Diphtheria: diphtheria leads mainly to the respiratory tract and sometimes to the skin. Generally the respiratory tract becomes inflamed (swollen) causing serious breathing problems and sometimes leading to suffocation. Diphtheria bacteria also release a toxin (poison) which can cause damage to the nervous system, heart problems and even death.

• Tetanus: tetanus bacteria enter the body following cuts, scratches or skin wounds. The wounds most at risk of infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood chips. The bacteria release a toxin (poison) which can cause muscle stiffness, painful muscle spasms, seizures and even death. Muscle spasms can be so violent that they cause fractures in the bones of the spine.

• Pertussis (whooping cough): whooping cough is a very contagious disease. The disease affects the respiratory tract causing severe repeated coughing that can interfere with normal breathing. Cough is often accompanied by a convulsive inspiration for which the common name of “convulsive cough”. The cough can last for 1-2 months or longer. Whooping cough can also cause ear infections, bronchitis that can last for a long time, pneumonia, convulsions, brain damage and even death.

None of the ingredients in the vaccine can cause diphtheria, tetanus or whooping cough.

Let’s take a moment to relax and oxygenate the mind

2. What you need to know before you or your child receive X ….

Package Leaflet …… must not be administered:

• if you or your child have previously had an allergic reaction to X …… or to any of the other components contained in this vaccine (listed in section 6).

“I wonder how I know if the fetus in the belly may have previously had an allergic reaction to this drug … maybe in a previous life?”

The signs of an allergic reaction may include itchy skin rash, shortness of breath, swelling of the face or tongue.
if you or your child have previously had an allergic reaction to any other diphtheria, tetanus or whooping cough vaccine (whooping cough).

if you or your child have experienced nervous system problems (encephalopathy) within 7 days of your previous vaccination with a pertussis vaccine (whooping cough).

A little thought

“This leaflet leaves me a little perplexed about the fetus and the vaccinations that I should suggest during pregnancy to give birth to an already vaccinated fetus …… compared to what I just read I tell myself … I still don’t know if the fetus may have had encephalopathy in its previous life! “


if you or your child have a severe infection with a high fever (over 38 ° C). A mild infection does not cause problems, but you must tell your doctor first.

if you or your baby have experienced a temporary decrease in blood platelets (which increases the risk of bleeding or bruising) or brain or nerve problems after a previous vaccination with a diptera and / or tetanus vaccine.

Package Leaflet: Warnings and Precautions

Talk to your doctor or pharmacist before you or your child receive X ……:

if you or your child have experienced health problems after the previous administration of X ……. or other pertussis (whooping cough) vaccines, especially:

High fever (over 40 ° C) within 48 hours of vaccination;
Collapse or shock within 48 hours of vaccination
Persistent crying, lasting 3 hours or more, occurring within 48 hours of vaccination;

continue …

Epileptic seizures / seizures with or without high fever that occur within 3 days of vaccination
from vaccination
if your child has progressive or undiagnosed brain disease or
uncontrolled epilepsy. The vaccine should be administered after reaching control of the disease.
if you or your baby have bleeding problems or bruising easily
“continue …” if you or your child have a tendency to seizures / fever convulsions or there is a family history of similar events
“and more ….”


if you or your child have long-lasting immune problems of any nature (including HIV infection). In this case, you or your child can receive X ……, but protection against infections after receiving the vaccine may not be comparable to that in children or adults with normal immune response to infections.

Fainting (especially in adolescents) may occur following, or even before, any needle injection. Therefore, tell your doctor or nurse if you or your child passed out with a previous injection.
Like all vaccines, X …….. may not fully protect the people who are vaccinated.
Pregnancy and breastfeeding
Your doctor will inform you of the possible risks and benefits of receiving X …… during pregnancy.
It is not known whether X …… passes into breast milk. Your doctor will inform you of the possible risks and benefits of receiving X …….. during breastfeeding.
If you are pregnant, breastfeeding or planning to become pregnant, or breast-feeding, ask your doctor or pharmacist for advice before receiving this vaccine.


Per favore inserisci il tuo commento!
Per favore inserisci il tuo nome qui