TACHIPIRINA "100 MG/ML ORAL DROPS, SOLUTION" 30 ML BOTTLE"

Name
TACHIPIRINA 100 mg/ml oral drops, solution
Paracetamol


What is it and what is it for?
Tachipirina is a solution in drops for oral use containing the active ingredient paracetamol.
Paracetamol works by reducing fever (antipyretic) and relieving pain (analgesic).

Tachipirina oral drops are used in children weighing less than 12 kg for:
- the treatment of febrile conditions such as influenza, exanthematous diseases (infectious diseases typical of children and adolescents), acute respiratory tract diseases, etc.;
- pain of various origins and natures (headaches, neuralgia, muscle pain and other moderately severe painful symptoms).

Contact your doctor if your child does not feel better or if he or she feels worse after 3 days of treatment.


What you need to know before taking the medicine
Do not use Tylenol
- if the person taking the medicine is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if the person taking the medicine suffers from severe haemolytic anaemia (a disease caused by the destruction of some blood cells, the red blood cells);
- if the person taking the medicine suffers from severe liver disease (severe hepatocellular insufficiency).


Warnings and precautions
Talk to your doctor or pharmacist before using Tachipirina.

In the following cases use with caution:
- if the person taking the medicine suffers from bulimia (an eating disorder in which a person eats excessive amounts of food and then resorts to various methods to eliminate it);
- if the person taking the medicine suffers from cachexia (a condition characterized by extreme thinness, reduced muscle mass and thinning of the skin due to chronic diseases);
- if the person taking the medicine has been following an incorrect diet for a long time (chronic malnutrition);
- if the person taking the medicine suffers from dehydration (severe loss of water/fluid from the body);
- if the person taking the medicine suffers from hypovolemia (reduced blood volume in circulation);
- if the person taking the medicine has liver diseases that reduce its functionality (liver failure, hepatitis, Gilbert's syndrome);
- if the person taking the medicine is undergoing concomitant treatment with drugs that alter liver function (see "Other medicines and Tachipirina");
- if the person taking the medicine suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
- if the person taking the medicine suffers from haemolytic anaemia (a disease caused by the destruction of some blood cells, the red blood cells).

During treatment with TACHIPIRINA, inform your doctor immediately if:
- if you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Use of high doses and/or for prolonged periods
The use of high and/or prolonged doses of this medicine can cause liver problems (hepatopathy) and potentially serious changes in the kidneys and blood. In these cases, the doctor will monitor liver and kidney function and blood composition over time through appropriate tests. Before giving this medicine to your child, inform the doctor if the child receiving this medicine has kidney or liver disease.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects STOP taking this medicine and contact your doctor immediately :
• allergic reactions with :
- redness of the skin accompanied by itching (hives);
- swelling of the throat (laryngeal edema);
- swelling of the hands, feet, ankles, face, lips, tongue and/or throat (angioedema);
- severe allergic reaction (anaphylactic shock).

Furthermore, those taking the medicine may experience the following side effects, for which there are not enough data to establish the frequency.

Effects affecting the blood
• reduction in the number of platelets in the blood (thrombocytopenia);
• reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis);
• reduction of hemoglobin in the blood, the substance that carries oxygen in the blood (anemia).

Effects on the nervous system
• dizziness.

Effects on the stomach and intestines
• stomach and intestinal disorders.

Effects affecting the liver
• abnormal liver function;
• inflammation of the liver (hepatitis).

Effects on the skin and subcutaneous tissue
• red spots, bullous lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Very rare cases of serious skin reactions have been reported.

Effects on the kidneys and urinary tract
• reduction in kidney function (acute renal failure);
• inflammation of the kidneys (interstitial nephritis);
• blood in the urine (hematuria);
• cessation or reduction in urine production (anuria).

Frequency not known (cannot be estimated from the available data): serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.