ZERINOFEBB "300 MG + 150 MG TABLETS" 15 TABLETS"

Name
ZERINOFEBB 300 mg + 150 mg tablets
Paracetamol, sobrerol


What is it and what is it used for?
ZERINOFEBB contains the active ingredients paracetamol and sobrerol. This medicine acts against fever and pain and thins respiratory secretions.

ZERINOFEBB is used in adults to treat the symptoms of acute febrile respiratory disorders.

Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment.


What you need to know before taking the medicine
Do not take ZERINOFEBB
• if you are allergic to paracetamol or sobrerol or any of the other ingredients of this medicine (listed in section 6);
• if you have glucose-6-phosphate dehydrogenase deficiency (an inherited disease that leads to a lowering of the red blood cell count);
• if you have one of the following diseases:
- decrease in the number of red blood cells (severe hemolytic anemia);
- reduction in liver function (severe hepatocellular insufficiency);
- serious alterations in kidney function;
- serious alterations in blood cells (blood coagulation).


Warnings and precautions
Talk to your doctor or pharmacist before taking ZERINOFEBB:
- if you have liver or kidney problems (hepatic or renal insufficiency), even if they are not serious;
- if you are being treated with medicines that thin the blood (anticoagulants), since in this case ZERINOFEBB must be administered at a reduced dose (see "Other medicines and ZERINOFEBB");
- if you have had sensitivity problems in the past after taking acetylsalicylic acid (such as aspirin) and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use ZERINOFEBB outside the acute phase of fever and do not take the medicine for more than 3 consecutive days without consulting your doctor.

During treatment with ZERINOFEBB, tell 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.

During treatment with ZERINOFEBB, before taking any other medicine, check that it does not contain paracetamol, since if paracetamol is taken in high doses, serious side effects can occur.

Also, before taking any other medicine, contact your doctor (see also "Other medicines and ZERINOFEBB").

High or prolonged doses of this medicine can cause alterations, even serious ones, of the kidneys, blood cells (blood coagulation) and liver.

Liver damage (hepatotoxicity) can occur with paracetamol even when taking the prescribed doses, after short-term treatment, even in patients without previous liver disease (see section "Possible side effects").

Serious skin reactions: Life-threatening side effects such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported with paracetamol use. If you experience any symptoms or signs of one of these syndromes (e.g., progressive skin redness associated with blisters or mucosal lesions), stop treatment with ZERINOFEBB immediately and contact the nearest hospital.


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

If any of the following side effects occur, stop using ZERINOFEBB and contact your doctor immediately:
- rare, very serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalized exanthematous pustulosis (see section "Warnings and precautions");
- allergic reactions (hypersensitivity) such as swelling of the skin, mucous membranes, larynx (angioedema), anaphylactic shock;
- skin irritations (erythema, urticaria, fixed drug eruption);
- decrease in the number of platelets (thrombocytopenia) and white blood cells (neutropenia, leukopenia);
- decrease in the number of white blood cells (agranulocytosis) and red blood cells (haemolytic anaemia) in patients with a disease due to the lack of a substance called glucose 6-phosphate dehydrogenase;
- excess acid in the blood due to the presence of too much pyroglutamic acid resulting from low glutathione levels;
- alterations in liver function and inflammation of the liver (hepatitis);
- destruction of liver cells (cytolytic hepatitis) which can lead to reduced liver function (acute liver failure);
- reduced kidney function (acute renal failure), inflammation of the kidneys (interstitial nephritis), presence of blood in the urine (hematuria), lack of urine production (anuria);
- gastrointestinal disorders;
- dizziness;
- allergic heart artery disorders (Kounis syndrome);
- narrowing of the bronchi with difficulty breathing (bronchospasm).

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.