ZERINOL*20FC 300MG+2MG

Zerinol 300 mg + 2 mg coated tablets
Paracetamol + chlorphenamine maleate

What it is and what it is used for
Zerinol is an analgesic (pain reliever) and antipyretic (fever reducer) that contains the active ingredients paracetamol and chlorphenamine maleate.
Zerinol 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 Zerinol
- if you are allergic to paracetamol or chlorphenamine maleate or any of the other ingredients of this medicine (listed in section 6) or to other antihistamines (substances similar to chlorphenamine, i.e. medicines used in the treatment of allergies);
- during pregnancy and breastfeeding;
- if you suffer from severe hemolytic anemia (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 lack of which can cause hemolytic anemia;
- 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 Zerinol).

Warnings and precautions
Consult your doctor or pharmacist before taking Zerinol.
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 you have a fever 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 must check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur (see also the section If you take more Zerinol than you should).
Furthermore, before combining any other medicine, contact your doctor (see also the section Other medicines and Zerinol).
Before starting therapy with Zerinol, do not take medicines whose combined use is not recommended (see section Other medicines and Zerinol).

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

Severe 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 severe skin reactions occur (e.g., progressive skin redness associated with blisters or mucosal lesions), immediately stop treatment with Zerinol and go to the nearest hospital.

Be cautious with Zerinol if you are allergic to aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs).

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

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

Chlorphenamine maleate
Zerinol contains an antihistamine (chlorphenamine). At normally assumed doses, antihistamines have highly variable side effects from person to person and from drug to drug and should be used with caution in people suffering 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 effect.
Chlorphenamine can induce photosensitivity (allergic skin reaction following light exposure).

Patients with renal or hepatic (liver) insufficiency: if you have mild to moderate renal or hepatic 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, constipation, and urinary retention (especially in men).
Elderly patients with mental disorders (such as confusion, delirium, dementia, cognitive impairment such as memory and reasoning) should avoid the use of Zerinol due to adverse effects on the central nervous system.

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

If you experience any of the following symptoms, IMMEDIATELY STOP using Zerinol and contact your doctor or the nearest hospital where you will be subjected to appropriate and specific treatment:
- severe skin reactions manifesting 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 edema (swelling of the larynx);
     - anaphylactic shock (severe allergic reaction).

Side effects affecting the blood:
- thrombocytopenia (reduction in the number of platelets in the blood);
- neutropenia (reduction in the number of neutrophils in the blood);
- leukopenia (reduction in the number of white blood cells in the blood);
- hemolytic anemia (decrease in the amount of hemoglobin and red blood cells), especially in patients suffering from glucose-6-phosphate dehydrogenase deficiency;
- agranulocytosis (reduction in the number of granulocytes in the blood);
- pancytopenia (reduction in the number of all blood cells);
- 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);
- dizziness;
- headache;
- inability to concentrate;
- abnormal coordination;
- confusion.

Various types and severities of skin reactions have been reported with the use of paracetamol, including cases of:
- rash (skin eruption);
- urticaria (appearance of red spots on the skin);
- erythema multiforme (skin inflammation);
- 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 side effects may include:
- blurred vision;
- mydriasis (pupil dilation);
- 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 alterations: acute renal failure (reduction in kidney function), interstitial nephritis (kidney inflammation), hematuria (presence of blood in the urine), anuria (absence of urine), urinary retention (difficulty urinating);
- psychiatric disorders: confusion, nightmares, depression;
- heart alterations: tachycardia (increased heart rate), palpitations;
- orthostatic hypotension (excessive drop in blood pressure when standing up);
- ear disorder: tinnitus.

Reporting of side effects
If you get 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.