Zerinofeb

Package leaflet: Information for the patient

ZERINOFEBB 300 mg + 150 mg tablets

Paracetamol, sobrerol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What ZERINOFEBB is and what it is used for
2. What you need to know before taking ZERINOFEBB
3. How to take ZERINOFEBB
4. Possible side effects
5. How to store ZERINOFEBB
6. Contents of the pack and other information

1. What ZERINOFEBB is and what it is used for

ZERINOFEBB contains the active substances paracetamol and sobrerol. This medicine acts against fever and pain, and as a liquefying agent for respiratory tract secretions.
ZERINOFEBB is used in adults for the treatment of symptoms of acute febrile respiratory disorders.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking ZERINOFEBB

Do not take ZERINOFEBB

• If you are allergic to paracetamol or sobrerol, or to any of the other ingredients of this medicine (listed in section 6);
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition leading to a decrease in red blood cell count);
• If you have any of the following conditions:
• reduced number of red blood cells (severe haemolytic anaemia);
• reduced liver function (severe hepatocellular insufficiency);
• severe kidney function impairment;
• severe blood cell disorders (haematopoietic system disorders).

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 not severe;
• if you are being treated with blood-thinning medicines (anticoagulants), as in this case ZERINOFEBB should be administered at a reduced dose (see "Other medicines and ZERINOFEBB");
• if you have previously experienced sensitivity reactions after taking acetylsalicylic acid (such as aspirin) and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use ZERINOFEBB outside the acute febrile phase and do not take the medicine for more than 3 consecutive days without consulting your doctor.
During treatment with ZERINOFEBB, before taking any other medicine, check that it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses.
In addition, before combining with any other medicine, contact your doctor (see also "Other medicines and ZERINOFEBB").
High or prolonged doses of this medicine may cause serious alterations of the kidneys, blood cells (haematopoietic system), and liver.
Liver damage (hepatotoxicity) may occur with paracetamol even when prescribed doses are taken, after short-term treatment, even in patients without prior liver disease (see section "Possible side effects").
Severe skin reactions: potentially life-threatening adverse effects such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. If you experience any of these symptoms or signs of such syndromes (e.g., progressive skin redness associated with blisters or mucosal lesions), stop treatment with ZERINOFEBB immediately and seek medical attention at the nearest hospital.

Other medicines and ZERINOFEBB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking ZERINOFEBB, inform your doctor if you are taking:

• cimetidine (used for gastritis and gastric ulcers) or similar medicines. Use ZERINOFEBB only under strict medical supervision;

• alcohol or medicines potentially harmful to the liver (hepatotoxic), such as rifampicin (an antibiotic) or medicines for epilepsy treatment (antiepileptics), for example phenobarbital, phenytoin, carbamazepine or topiramate, as this increases the risk of paracetamol-related adverse effects;

• medicines that slow gastric emptying (e.g., propantheline), as they may reduce the therapeutic effect of paracetamol;

• medicines that increase gastric emptying rate (e.g., metoclopramide, domperidone), as they may increase paracetamol absorption;

• blood-thinning medicines, such as warfarin and similar medicines (vitamin K antagonists), as paracetamol may increase the risk of bleeding; if taken together, inform your doctor if you notice any bleeding;

• non-steroidal anti-inflammatory drugs (NSAIDs) (used for pain, fever or inflammation) or opioid medicines (used for pain), as concomitant use may lead to excessive enhancement of analgesic effect;

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum daily doses of paracetamol are used;

• ethinylestradiol (commonly used as a contraceptive pill), as paracetamol increases its blood concentration;

• lamotrigine (used for epilepsy and certain psychiatric disorders), as paracetamol may reduce its blood concentration.

The blood levels of acetylsalicylic acid (aspirin) and chloramphenicol (an antibiotic) are increased when these medicines are taken with paracetamol.
Interference with laboratory tests
Paracetamol may interfere with blood tests for the measurement of uric acid levels (uricemia) and blood sugar levels (glycemia).
ZERINOFEBB and alcohol
Avoid consuming alcoholic beverages, as alcohol increases the risk of liver damage (see also "Other medicines and ZERINOFEBB").
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of ZERINOFEBB, as with any similar medicine, is not recommended if you are planning to become pregnant.
During pregnancy or breastfeeding, use ZERINOFEBB only if clearly necessary and under direct medical supervision.
Discontinue taking the medicine if you have fertility problems or are undergoing fertility investigations.
Driving and using machines
Due to the possible occurrence of dizziness, ZERINOFEBB may impair your ability to drive vehicles or operate machinery.
ZERINOFEBB contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take ZERINOFEBB

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: 2 - 4 tablets per day
Do not exceed the maximum daily dose.
Do not administer for more than 3 consecutive days without consulting your doctor.
If you take more ZERINOFEBB than you should
In case of accidental ingestion/overdose of ZERINOFEBB, consult your doctor immediately or go to the nearest hospital.
Symptoms of paracetamol overdose include pallor, nausea, vomiting, loss of appetite (anorexia), and abdominal pain; these symptoms generally occur within the first 24 hours after paracetamol overdose.
A paracetamol overdose may cause destruction of liver cells (hepatic cytolysis), which can lead to impaired liver function (hepatic insufficiency), gastrointestinal bleeding, accumulation of acids in the body (metabolic acidosis), encephalopathy (brain disorders), coma, and death.
Increased blood test values related to the liver (hepatic transaminases, lactate dehydrogenase, bilirubin), along with decreased prothrombin, may appear between 12 and 48 hours after acute overdose.
Overdose may also lead to inflammation of the pancreas (pancreatitis), reduced kidney function (acute renal failure), and reduction in all blood cells (pancytopenia).
In severe cases, impaired liver function due to destruction of liver cells (hepatic failure from cellular necrosis) may occur.
If you forget to take ZERINOFEBB
Do not take a double dose to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following side effects occur, stop using ZERINOFEBB and contact your doctor immediately:

• rare, very severe 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, or larynx (angioedema), anaphylactic shock;
• skin irritations (erythema, urticaria, fixed drug eruption);
• decreased platelet count (thrombocytopenia) and white blood cell count (neutropenia, leucopenia);
• decreased white blood cell count (agranulocytosis) and red blood cell count (haemolytic anaemia) in patients with a disease caused by deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
• excess acid in the blood due to accumulation of pyroglutamic acid resulting from low glutathione levels;
• liver function abnormalities and inflammation of the liver (hepatitis);
• destruction of liver cells (cytolytic hepatitis) which may lead to reduced liver function (acute liver failure);
• reduced kidney function (acute renal failure), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria), failure to produce urine (anuria);
• gastrointestinal disorders;
• dizziness;
• allergic-type heart artery disorders (Kounis syndrome);
• narrowing of the bronchi with breathing difficulty (bronchospasm).

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

5. How to store ZERINOFEBB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZERINOFEBB contains
ZERINOFEBB 300 mg + 150 mg tablets

• The active substances are paracetamol and sobrerol. One tablet contains 300 mg of paracetamol and 150 mg of sobrerol.
• The other components are: calcium hydrogen phosphate dihydrate, maize starch, talc, magnesium stearate, povidone, microcrystalline cellulose, sodium starch glycolate (Type A).

Description of the appearance of ZERINOFEBB and the pack contents
ZERINOFEBB is presented as tablets.
The pack contains 15 tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7 – 20121 Milano
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de’ Stampi/Rozzano, IT - 20089 Rozzano (MI)

Patient information leaflet

ZERINOFEBB 12.8 mg/ml + 8 mg/ml syrup

Paracetamol, sobrerol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What ZERINOFEBB is and what it is used for
2. What you need to know before taking ZERINOFEBB
3. How to take ZERINOFEBB
4. Possible side effects
5. How to store ZERINOFEBB
6. Contents of the pack and other information

1. What ZERINOFEBB is and what it is used for

ZERINOFEBB contains the active substances paracetamol and sobrerol. This medicine acts against fever and pain, and as a fluidifier of respiratory tract secretions.
ZERINOFEBB is used for the treatment of symptoms of acute febrile respiratory disorders.
Consult a doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking ZERINOFEBB

Do not take ZERINOFEBB

• If you are allergic to paracetamol or sobrerol, or to any of the other ingredients of this medicine (listed in section 6);
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited disorder leading to a decrease in red blood cell count);
• If you have any of the following conditions:
  • reduced number of red blood cells (severe haemolytic anaemia);
  • reduced liver function (severe hepatocellular insufficiency);
  • severe kidney function impairment;
  • severe blood cell disorders (haematopoietic system disorders);
• if the person taking this medicine is a child under 2 years of age (see section “Children”).

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 not severe;
• if you are being treated with blood-thinning medicines (anticoagulants), as in this case ZERINOFEBB should be administered at a reduced dose (see “Other medicines and ZERINOFEBB”);
• if in the past you have experienced sensitivity reactions after taking acetylsalicylic acid (such as aspirin) and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use ZERINOFEBB outside the acute febrile phase and do not take the medicine for more than 3 consecutive days without consulting your doctor.
During treatment with ZERINOFEBB, before taking any other medicine, check that it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses.
Moreover, before combining with any other medicine, contact your doctor (also see “Other medicines and ZERINOFEBB”).
High or prolonged doses of this medicine may cause serious adverse effects on the kidneys, blood cells (haematopoietic system), and liver.
Liver damage (hepatotoxicity) may occur with paracetamol even at recommended doses, after short-term treatment, even in patients without prior liver disease (see section "Possible side effects").
Serious skin reactions: potentially life-threatening adverse effects such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis have been reported with paracetamol use. If you experience symptoms or any signs of these syndromes (e.g. progressive skin redness associated with blisters or mucosal lesions), stop treatment with ZERINOFEBB immediately and go to the nearest hospital.

Children
ZERINOFEBB must not be administered to children under 2 years of age due to their reduced ability to excrete bronchial mucus.

Other medicines and ZERINOFEBB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking ZERINOFEBB, inform your doctor if you are taking:

• cimetidine (used for gastritis and gastric ulcers) or similar medicines. Use ZERINOFEBB only under strict medical supervision;
• alcohol or medicines potentially harmful to the liver (hepatotoxic), such as rifampicin (an antibiotic) or medicines for epilepsy treatment (antiepileptics), e.g. phenobarbital, phenytoin, carbamazepine or topiramate, as this increases the risk of paracetamol-related adverse effects;
• medicines that slow gastric emptying (e.g. propantheline), as they may reduce the therapeutic effect of paracetamol;
• medicines that increase gastric emptying rate (e.g. metoclopramide, domperidone), as they may increase paracetamol absorption;
• blood-thinning medicines, e.g. warfarin and similar medicines (vitamin K antagonists), as paracetamol may increase the risk of bleeding; if taken together, inform your doctor if you notice any bleeding;
• non-steroidal anti-inflammatory drugs (NSAIDs) (used for pain, fever or inflammation) or opioid medicines (used for pain), as concomitant use may lead to excessive enhancement of analgesic effect;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap) requiring urgent treatment, particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used;
• ethinylestradiol (commonly used in oral contraceptives), as paracetamol increases its blood concentration;
• lamotrigine (used for epilepsy and certain psychiatric disorders), as paracetamol may reduce its blood concentration.

The blood levels of acetylsalicylic acid (aspirin) and chloramphenicol (an antibiotic) may be increased if these medicines are taken with paracetamol.
Interference with laboratory tests
Paracetamol may interfere with blood tests for measuring uric acid levels (uricaemia) and blood sugar levels (glycaemia).

ZERINOFEBB and alcohol
Avoid alcoholic beverages, as alcohol increases the risk of liver damage (see also “Other medicines and ZERINOFEBB”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of ZERINOFEBB, as with any similar medicine, is not recommended if you are planning to become pregnant.
During pregnancy or breastfeeding, use ZERINOFEBB only if clearly needed and under direct medical supervision.
Stop taking the medicine if you have fertility problems or are undergoing fertility investigations.

Driving and using machines
Due to the possible occurrence of dizziness, ZERINOFEBB may impair your ability to drive or operate machinery.

ZERINOFEBB syrup contains ethanol (alcohol)
This medicine contains 1.25% vol ethanol, for example up to 300 mg per dose, equivalent to 7.5 ml of beer or 3.1 ml of wine per dose. The small amount of alcohol in this medicine is unlikely to have significant effects in adults and adolescents. Its effects in children are not well established, but some effects may occur in young children, for example drowsiness. In children, the alcohol contained in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist before administering this medicine to a child.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor before taking this medicine.

ZERINOFEBB syrup contains sucrose
This medicine contains 9 g of sucrose (sugar) per dose. This should be considered in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

ZERINOFEBB syrup contains para-hydroxybenzoates (parabens)
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

ZERINOFEBB syrup contains sodium
This medicine contains 36.5 mg of sodium (the main component of table salt) per maximum daily dose. This corresponds to 1.8% of the maximum daily intake recommended in an adult diet. This should be considered in patients with reduced kidney function or those on a low-sodium diet.

ZERINOFEBB syrup contains propylene glycol (E1520)
This medicine contains 3 g of propylene glycol per maximum daily dose.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take ZERINOFEBB

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Syrup: 4 - 6 teaspoonfuls per day.
Do not exceed the maximum daily dose.
Do not administer for more than 3 consecutive days without consulting a doctor.

If you take more ZERINOFEBB than you should
In case of accidental ingestion or intake of an excessive dose of ZERINOFEBB, consult your doctor immediately or go to the nearest hospital.
Symptoms of paracetamol overdose include pallor, nausea, vomiting, loss of appetite (anorexia), and abdominal pain; these symptoms usually appear within the first 24 hours after paracetamol overdose.
A paracetamol overdose may cause destruction of liver cells (hepatic cytolysis), which can lead to impaired liver function (hepatocellular insufficiency), gastrointestinal bleeding, accumulation of acids in the body (metabolic acidosis), encephalopathy (brain disorders), coma, and death.
Increased levels of certain liver blood tests (liver transaminases, lactate dehydrogenase, bilirubin), along with decreased prothrombin, may appear between 12 and 48 hours after acute overdose.
Overdose may also lead to inflammation of the pancreas (pancreatitis), reduced kidney function (acute renal failure), and reduction in all blood cells (pancytopenia).
In severe cases, impaired liver function due to destruction of liver cells (hepatic failure from cellular necrosis) may develop.

If you forget to take ZERINOFEBB
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following side effects occur, stop using ZERINOFEBB and contact your doctor immediately:

• rare, very severe skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and generalized acute exanthematous pustulosis (see section “Warnings and precautions”);
• allergic reactions (hypersensitivity) such as swelling of the skin, mucous membranes, or larynx (angioedema), anaphylactic shock;
• skin irritations (erythema, urticaria, drug-induced fixed eruption);
• decreased number of platelets (thrombocytopenia) and white blood cells (neutropenia, leucopenia);
• decreased number of white blood cells (agranulocytosis) and red blood cells (haemolytic anaemia) in patients with a disease caused by deficiency of a substance called glucose-6-phosphate dehydrogenase;
• excess acid in the blood due to elevated pyroglutamic acid resulting from low glutathione levels;
• liver function abnormalities and inflammation of the liver (hepatitis);
• destruction of liver cells (cytolytic hepatitis) which may lead to reduced liver function (acute liver failure);
• reduced kidney function (acute renal failure), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria), failure to produce urine (anuria);
• gastrointestinal disorders;
• dizziness;
• allergic-type heart artery disorders (Kounis syndrome);
• narrowing of the bronchi causing breathing difficulty (bronchospasm).

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

5. How to store ZERINOFEBB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZERINOFEBB contains
ZERINOFEBB 12.8 mg/ml + 8 mg/ml syrup

• The active substances are paracetamol and sobrerol. 100 ml of syrup contain 1.28 g of paracetamol and 0.8 g of sobrerol.
• The other components are: propylene glycol, glycerol, carmellose sodium, sucrose, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, ethanol 96 percent, saccharin, E 150, ethylvanillin, cardamom flavour, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water.

Description of the appearance of ZERINOFEBB and contents of the pack
ZERINOFEBB is a syrup.
Pack contents: one 150 ml bottle.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7 – 20121 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - IT - 29016 Cortemaggiore (PC)

Patient Information Leaflet: Information for the patient

ZERINOFEBB Adults 500 mg + 200 mg suppositories, Children 250 mg + 100 mg suppositories

Paracetamol, thymoquinone
Please read this entire leaflet carefully before using this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

1. What ZERINOFEBB is and what it is used for
2. What you need to know before taking ZERINOFEBB
3. How to take ZERINOFEBB
4. Possible side effects
5. How to store ZERINOFEBB
6. Package contents and other information

1. What ZERINOFEBB is and what it is used for

ZERINOFEBB contains the active substances paracetamol and sobrerol. This medicine acts against fever and pain, and as a fluidifier of respiratory tract secretions.
ZERINOFEBB is used for the treatment of symptoms of acute febrile respiratory disorders.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you should know before taking ZERINOFEBB

Do not take ZERINOFEBB

• If you are allergic to paracetamol or sobrerol, or to any of the other ingredients of this medicine (listed in section 6);
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition leading to a decrease in red blood cell count);
• If you have any of the following conditions:
  • Decreased number of red blood cells (severe haemolytic anaemia);
  • Reduced liver function (severe hepatocellular insufficiency);
  • Severe impairment of kidney function;
  • Severe blood cell disorders (haematopoietic system disorders).
• If the person taking this medicine is a child under 2 years of age (see section “Children”).

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 not severe;
• If you are being treated with medicines that thin the blood (anticoagulants), as in this case ZERINOFEBB should be administered at a reduced dose (see “Other medicines and ZERINOFEBB”);
• If you have previously experienced sensitivity reactions after taking acetylsalicylic acid (such as aspirin) and/or non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use ZERINOFEBB outside the acute febrile phase and do not take the medicine for more than 3 consecutive days without consulting your doctor.
During treatment with ZERINOFEBB, before taking any other medicine, check that it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses.
Additionally, before combining with any other medicine, contact your doctor (see also “Other medicines and ZERINOFEBB”).
High or prolonged doses of this medicine may cause serious adverse effects on the kidneys, blood cells (haematopoietic system), and liver.
Liver damage (hepatotoxicity) may occur with paracetamol even when taken at recommended doses, after short-term treatment, and even in patients without prior liver disease (see section "Possible side effects").
Severe skin reactions: potentially life-threatening adverse effects have been reported with paracetamol use, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. If you experience any of these symptoms or signs of such syndromes (e.g., progressive skin redness associated with blisters or mucosal lesions), stop treatment with ZERINOFEBB immediately and seek medical attention at the nearest hospital.

Children
ZERINOFEBB suppositories for children must not be administered to children under 2 years of age due to their reduced ability to excrete bronchial mucus.

Other medicines and ZERINOFEBB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking ZERINOFEBB, inform your doctor if you are taking:

• Cimetidine (used for gastritis and gastric ulcers) or similar medicines. Use ZERINOFEBB only under strict medical supervision;
• Alcohol or medicines that may be harmful to the liver (hepatotoxic), such as rifampicin (an antibiotic) or antiepileptic medicines, e.g., phenobarbital, phenytoin, carbamazepine, or topiramate, as this increases the risk of paracetamol-related adverse effects;
• Medicines that slow gastric emptying (e.g., propantheline), as they may reduce the therapeutic effect of paracetamol;
• Medicines that increase the rate of gastric emptying (e.g., metoclopramide, domperidone), as they may increase the absorption of paracetamol;
• Medicines that thin the blood, such as warfarin and similar medicines (vitamin K antagonists), because paracetamol may increase the risk of bleeding; if taken together, inform your doctor if you notice any bleeding;
• Non-steroidal anti-inflammatory drugs (NSAIDs) (used for pain, fever, or inflammation) or opioid medicines (used for pain), as concomitant use may lead to excessive enhancement of analgesic effect;
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used;
• Ethinylestradiol (commonly used as a contraceptive pill), as paracetamol increases its blood concentration;
• Lamotrigine (used for epilepsy and certain psychiatric disorders), as paracetamol may reduce its blood concentration.

The blood levels of acetylsalicylic acid (aspirin) and chloramphenicol (an antibiotic) may be increased when these medicines are taken with paracetamol.

Interference with laboratory tests
Paracetamol may interfere with blood tests for measuring uric acid levels (uricemia) and blood sugar levels (glycemia).

ZERINOFEBB and alcohol
Avoid consuming alcoholic beverages, as alcohol increases the risk of liver damage (see also “Other medicines and ZERINOFEBB”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of ZERINOFEBB, as with any similar medicine, is not recommended if you are planning to become pregnant.
During pregnancy or breastfeeding, use ZERINOFEBB only if clearly needed and under direct medical supervision.
Discontinue use of the medicine if you have fertility problems or are undergoing fertility investigations.

Driving and using machines
Due to the possible occurrence of dizziness, ZERINOFEBB may impair your ability to drive vehicles or operate machinery.

3. How to take ZERINOFEBB

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adult suppositories: 2 suppositories per day
Children's suppositories: 2 suppositories per day
Do not exceed the maximum daily dose.
Do not administer for more than 3 consecutive days without consulting your doctor.

If you take more ZERINOFEBB than you should
In case of accidental ingestion/overdose of ZERINOFEBB, consult your doctor immediately or go to the nearest hospital.
Symptoms of paracetamol overdose include pallor, nausea, vomiting, loss of appetite (anorexia), and abdominal pain; these symptoms generally occur within the first 24 hours after paracetamol overdose.
Paracetamol overdose may cause destruction of liver cells (hepatic cytolysis), which can lead to impaired liver function (hepatocellular insufficiency), gastrointestinal bleeding, accumulation of acids in the body (metabolic acidosis), encephalopathy (brain disorders), coma, and death.
Increased blood test values related to the liver (hepatic transaminases, lactate dehydrogenase, bilirubin) along with decreased prothrombin levels may appear between 12 and 48 hours after acute overdose.
Overdose may also lead to inflammation of the pancreas (pancreatitis), reduced kidney function (acute renal failure), and reduction in all blood cells (pancytopenia).
In severe cases, impaired liver function caused by destruction of liver cells (hepatic failure due to cellular necrosis) may develop.

If you forget to take ZERINOFEBB
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following side effects, stop using ZERINOFEBB and contact your doctor
immediately:

• rare, very serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and generalized acute exanthematous pustulosis (see section "Warnings and precautions");
• allergic reactions (hypersensitivity) such as swelling of the skin, mucous membranes, or larynx (angioedema), anaphylactic shock;
• skin irritations (erythema, urticaria, fixed drug eruption);
• decrease in platelet count (thrombocytopenia) and white blood cells (neutropenia, leucopenia);
• decrease in white blood cells (agranulocytosis) and red blood cells (haemolytic anaemia) in patients with a disease caused by deficiency of a substance called glucose-6-phosphate dehydrogenase;
• excess acid in the blood due to increased pyroglutamic acid resulting from low glutathione levels;
• changes in liver function and inflammation of the liver (hepatitis);
• destruction of liver cells (cytolytic hepatitis) which may 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 (haematuria), failure to produce urine (anuria);
• gastrointestinal disorders;
• dizziness;
• allergic-type heart artery disorders (Kounis syndrome);
• narrowing of the bronchi causing breathing difficulties (bronchospasm).

Reporting of side effects
If you get any side effects, including ones 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ZERINOFEBB

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ZERINOFEBB contains
ZERINOFEBB Adults 500 mg + 200 mg suppositories

• The active substances are paracetamol and sobrerol. Each suppository contains 500 mg of paracetamol and 200 mg of sobrerol.
• Other components: medium-chain triglycerides.

ZERINOFEBB Children 250 mg + 100 mg suppositories

• The active substances are paracetamol and sobrerol. Each suppository contains 250 mg of paracetamol and 100 mg of sobrerol.
• Other components: medium-chain triglycerides.

Description of the appearance of ZERINOFEBB and contents of the pack
ZERINOFEBB is available as suppositories.
Pack sizes:

• Adult suppositories: boxes of 6 and 10 suppositories
• Children's suppositories: boxes of 6 and 10 suppositories

Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7 – 20121 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - IT - 29016 Cortemaggiore (PC)