ZERINOLFLU*20EFF TABS

Zerinolflu effervescent tablets

What it is and what it is used for
Zerinolflu is an analgesic (pain reliever) and antipyretic (fever reducer) for oral use that contains the active ingredients paracetamol, chlorphenamine maleate and sodium ascorbate (vitamin C).
Zerinolflu is used for the treatment of flu and cold symptoms in adults.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not take Zerinolflu
- if you are allergic to paracetamol or chlorphenamine maleate or sodium ascorbate (vitamin C) or any of the other ingredients of this medicine (listed in paragraph 6) or to other antihistamines (substances similar to chlorphenamine, i.e. medicines used in the treatment of allergies);
- if you are pregnant or breastfeeding;
- if you suffer from severe haemolytic anaemia (a disease caused by the destruction of red blood cells);
- if you have a deficiency of a specific enzyme called glucose-6-phosphate dehydrogenase (the absence of which can cause haemolytic anaemia);
- if you suffer from severe hepatocellular insufficiency (a disease associated with impaired liver function);
- if you suffer from glaucoma (an eye disease often associated with increased pressure of the fluid inside the eye);
- in case of prostatic hypertrophy (a disease characterized by an increase in prostate volume);
- in case of bladder neck obstruction (obstruction of the urinary bladder);
- in case of pyloric, duodenal and other gastrointestinal tract stenoses (gastrointestinal diseases characterized by narrowing of specific parts of the digestive system);
- in case of urogenital stenosis (narrowing of the urinary and reproductive organs);
- if you are or have been treated in the previous two weeks with monoamine oxidase inhibitors (MAOIs) (see section Other medicines and Zerinolflu).

Warnings and precautions
You should not take this medicine for more than 3 consecutive days without consulting your doctor.
After a short period of treatment without appreciable results, consult your doctor. If the fever persists for more than three days, or if symptoms do not improve or others appear within three days, or are accompanied by high fever, rash (skin eruptions accompanied by skin redness), excessive mucus and persistent cough, consult your doctor who will establish the correct diagnosis.

Paracetamol
During treatment with paracetamol, before taking any other medicine, you should check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious undesirable effects may occur (see also the section If you take more Zerinolflu than you should). In addition, before combining any other medicine, contact your doctor (see also the sections Other medicines and Zerinolflu).

High or prolonged doses of the product can cause liver disease (liver disease) with a high risk for you (see also the section If you take more Zerinolflu than you should) and even severe kidney and blood alterations.

Serious skin reactions: potentially fatal skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), fixed drug eruption and exfoliative dermatitis have been reported with the use of paracetamol. If symptoms or signs of these serious skin reactions occur (e.g. progressive skin redness associated with blisters or mucosal lesions), immediately stop treatment with Zerinolflu and go to the nearest hospital.

Use Zerinolflu with caution if you are allergic to aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Since serious allergic reactions to paracetamol have been observed (e.g. anaphylactic shock, see also the section Possible undesirable effects), at the first signs of an allergic reaction following the use of Zerinolflu, stop treatment and consult your doctor.

Zerinolflu should be used with caution and after medical evaluation in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic beverages per day), eating disorders (anorexia, bulimia, cachexia, chronic malnutrition), dehydration, decreased circulating blood volume (hypovolaemia), liver diseases such as mild to moderate insufficiency and Gilbert's syndrome, severe renal insufficiency.

Chlorphenamine maleate
Zerinolflu contains an antihistamine (chlorphenamine). At normally taken doses, antihistamines have highly variable side effects from person to person and from drug to drug and should be used with caution in people who suffer from high blood pressure, heart or thyroid diseases. The most frequent side effect is sedation (physical and mental relaxation) which can manifest as drowsiness (see also the sections Driving and using machines and Side effects). Children and the elderly are more exposed to this type of side effects.
Chlorphenamine can induce photosensitivity (allergic skin reaction following light exposure).

Sodium ascorbate
Sodium ascorbate (vitamin C) should be used with caution if you suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and if you have a glucose-6-phosphate-dehydrogenase deficiency (see Do not take Zerinolflu), or if you suffer from blood diseases such as hemochromatosis, thalassemia or sideroblastic anaemia which involve an accumulation of iron in the body.

Patients with renal or hepatic (liver) insufficiency: if you have renal insufficiency or mild-moderate liver insufficiency, use this medicine with caution.

Elderly: due to their greater sensitivity to the drug, the elderly must adhere to the indicated dosages. In elderly patients treated with antihistamines, effects such as dizziness, sedation, confusion and hypotension are more likely to occur. Elderly patients are particularly sensitive to the anticholinergic secondary effects of antihistamines such as dry mouth and urinary retention (especially in men).
Elderly patients with mental disorders (such as confused state, delirium, dementia, impaired cognitive abilities such as memory and reasoning) should avoid the use of Zerinolflu due to adverse effects on the central nervous system.

Possible undesirable effects
Like all medicines, this medicine can cause undesirable effects, although not everyone experiences them.
For the following undesirable effects, the frequency cannot be established based on available data.

If you experience any of the following symptoms, IMMEDIATELY STOP using Zerinolflu and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
- severe skin reactions that manifest as skin rash, some of which are fatal (including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis);
- allergic reactions such as:
     - angioedema (sudden swelling of the skin or mucous membranes);
     - laryngeal oedema (swelling of the larynx);
     - anaphylactic shock (severe allergic reaction).

Undesirable effects affecting the blood:
- thrombocytopenia (reduction in the number of platelets in the blood);
- neutropenia (reduction in the number of neutrophils in the blood);
- leucopenia (reduction in the number of white blood cells in the blood);
- haemolytic anaemia (decrease in the amount of haemoglobin and red blood cells);
- agranulocytosis (reduction in the number of granulocytes in the blood);
- pancytopenia (reduction in the number of all cells present in the blood);
- excess acid in the blood due to the presence of too much pyroglutamic acid resulting from low glutathione levels.

Nervous system disorders such as:
- sedation;
- drowsiness;
- asthenia (weakness);
- vertigo (dizziness);
- headache;
- inability to concentrate;
- abnormal coordination.

With the use of paracetamol, skin reactions of various types and severity have been reported, including cases of:
- rash (skin eruption);
- urticaria (appearance of red spots on the skin);
- severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), fixed drug eruption and exfoliative dermatitis;
- photosensitization (allergic skin reaction following light exposure).

Other undesirable effects may be:
- blurred vision;
- thickening of bronchial secretions (thicker mucus), bronchospasm (temporary narrowing of the airways);
- dry mouth, nausea, gastrointestinal disorders;
- alterations in liver function and hepatitis (liver inflammation);
- kidney disorders: acute renal failure (reduction of kidney function), interstitial nephritis (inflammation of the kidneys), haematuria (presence of blood in the urine), anuria (absence of urine), urinary retention (difficulty in urinating);
- psychiatric disorders: confusion, nightmares, depression;
- heart alterations: tachycardia (increased heart rate), palpitations (perception of heart beat);
- hypotension (reduction of blood pressure);
- ear disorder: tinnitus.

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