Zerinolflu

Package leaflet: Information for the user

Zerinolflu effervescent tablets

Please read all of this leaflet carefully before taking 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 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 any improvement, or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What Zerinolflu is and what it is used for

Zerinolflu is an oral analgesic (relieves pain) and antipyretic (reduces fever) medicine containing the active substances paracetamol, chlorpheniramine maleate and sodium ascorbate (vitamin C).
Zerinolflu is used for the treatment of symptoms of influenza and the common cold in adults.
Consult your doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before taking Zerinolflu

Do not take Zerinolflu

• if you are allergic to paracetamol, chlorpheniramine maleate, or sodium ascorbate (vitamin C), or to any of the other ingredients of this medicine (listed in section 6), or to other antihistamines (substances similar to chlorpheniramine, i.e. medicines used in the treatment of allergies);
• during pregnancy and 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 lack of which may cause haemolytic anaemia);
• if you have severe hepatic insufficiency (a disease associated with impaired liver function);
• if you have glaucoma (an eye disease often associated with increased pressure of the fluid inside the eye);
• in case of prostatic hypertrophy (a condition characterized by an enlarged prostate);
• in case of bladder neck obstruction (obstruction of the urinary bladder);
• in case of pyloric, duodenal or other gastrointestinal tract stenosis (gastrointestinal diseases characterized by narrowing of specific parts of the digestive system);
• in case of urogenital stenosis (narrowing of urinary and reproductive organs);
• if you are currently or have been treated within the previous two weeks with monoamine oxidase inhibitors (MAOIs) (see section “Other medicines and Zerinolflu”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zerinolflu.

• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may lead to haemolytic anaemia): You must not take this medicine for more than 3 consecutive days without consulting your doctor. If there is no noticeable improvement after a short period of treatment, consult your doctor. If fever persists for more than three days, or if symptoms do not improve or new ones appear within three days, or if they are accompanied by high fever, exanthema (skin rashes with redness), excessive mucus production, or persistent cough, consult your doctor, who will establish the correct diagnosis.
  Paracetamol: During treatment with paracetamol, 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 (see also section “If you take more Zerinolflu than you should”). Additionally, before combining with any other medicine, contact your doctor (see also section “Other medicines and Zerinolflu”). High or prolonged doses of this product may cause hepatopathy (liver disease) that poses a serious risk to you (see also section “If you take more Zerinolflu than you should”) as well as serious kidney and blood disorders.
  Severe skin reactions: Potentially life-threatening skin reactions have been reported with paracetamol use, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug fixed eruption, and exfoliative dermatitis. If symptoms or signs of these severe skin reactions occur (e.g. progressive skin redness associated with blisters or mucosal lesions), stop treatment with Zerinolflu immediately and go to the nearest hospital.
  During treatment with Zerinolflu, inform your doctor immediately if:
  You suffer from serious illnesses, including severe renal impairment 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). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.
  Use Zerinolflu with caution 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 section “Possible side effects”), discontinue treatment and consult your doctor at the first sign of an allergic reaction following the use of Zerinolflu.
  Zerinolflu should be used with caution and only after medical evaluation in cases of chronic alcoholism, excessive alcohol consumption (3 or more alcoholic drinks per day), eating disorders (anorexia, bulimia, cachexia, chronic malnutrition), dehydration, reduced circulating blood volume (hypovolemia), liver diseases such as mild to moderate liver insufficiency and Gilbert's syndrome, or severe renal insufficiency.

Chlorpheniramine maleate
Zerinolflu contains an antihistamine (chlorpheniramine). At normally prescribed doses, antihistamines may cause variable adverse effects from person to person and from drug to drug, and should be used with caution in individuals with high blood pressure or heart or thyroid diseases.
The most common adverse effect is sedation (physical and mental relaxation), which may manifest as drowsiness (see also sections “Driving and use of machines” and “Side effects”). Children and elderly patients are more susceptible to these adverse effects.
Chlorpheniramine may induce photosensitivity (skin allergic reaction following exposure to light).

Sodium ascorbate
Sodium ascorbate (vitamin C) should be used with caution if you currently suffer or have previously suffered from nephrolithiasis (kidney stones), or if you have glucose-6-phosphate dehydrogenase deficiency (see “Do not take Zerinolflu”), or if you have blood disorders such as haemochromatosis, thalassemia, or sideroblastic anaemia, which involve iron accumulation in the body.

Elderly patients: In elderly patients treated with antihistamines, effects such as dizziness, sedation, confusion, and hypotension may occur more frequently. Elderly patients are particularly sensitive to the anticholinergic side effects of antihistamines, such as dry mouth and urinary retention (especially in men).
Elderly patients with mental disorders (such as confusion, delirium, dementia, or impaired cognitive functions such as memory and reasoning) should avoid using Zerinolflu due to adverse effects on the central nervous system.

Other medicines and Zerinolflu
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are being treated with:

• rifampicin (an antibiotic);
• cimetidine (a medicine used to treat gastric ulcers);
• antiepileptic drugs (medicines used to treat epilepsy such as glutethimide, phenobarbital, phenytoin, carbamazepine, topiramate);
• probenecid (a medicine used to treat gout). The risk of paracetamol toxicity may be increased. Normally harmless doses of paracetamol may cause liver damage when taken together with these medicines. The same applies to potentially hepatotoxic substances and in cases of alcohol abuse;
• oral anticoagulants (medicines used to reduce or block blood clot formation) such as warfarin and similar medicines (vitamin K antagonists), as paracetamol may increase the risk of bleeding; inform your doctor if you notice any bleeding;
• chloramphenicol (an antibiotic);
• zidovudine (a medicine used to treat HIV patients);
• other substances with anticholinergic action (medicines that block the effects of acetylcholine, a substance involved in nerve impulse transmission);
• phenytoin (a medicine used to treat seizures);
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).
  The effectiveness of Zerinolflu may be reduced with habitual use of:
• anticonvulsant medicines (used to treat seizures, such as in epilepsy);
• oral contraceptives (the pill);
• colestyramine (a medicine used to treat high cholesterol);
• medicines that slow gastric emptying, such as propantheline, as they reduce the absorption rate of paracetamol and delay the onset of its effect.
  Do not take Zerinolflu if you are being treated with:
• tricyclic antidepressants (medicines used to treat depression);
• monoamine oxidase inhibitors (another class of antidepressants such as isocarboxazid, phenelzine, and tranylcypromine) or within two weeks after such treatment;
• neuroleptics (medicines used to treat mental disorders such as psychoses);
• other medicines with central nervous system depressant effects (medicines that have a sedative effect on the central nervous system, such as barbiturates, sedatives, tranquillisers, hypnotics);
• metoclopramide (a medicine that prevents vomiting).
  The use of this product is not recommended if you are being treated with anti-inflammatory drugs. Like all preparations containing antihistamines, Zerinolflu may mask the early signs of ototoxicity (harmful effects on the ear) caused by certain antibiotics.

Interference with laboratory tests
If you need to undergo blood tests, keep in mind that paracetamol administration may interfere with the measurement of blood uric acid levels (uricemia) and blood glucose levels (glycemia).

Zerinolflu with food, drinks, and alcohol
This product may interact with alcoholic beverages; therefore, you must not take Zerinolflu at the same time as consuming alcohol.

Pregnancy, breastfeeding, and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, you must not use Zerinolflu.

Fertility
No studies have been conducted with Zerinolflu to evaluate its effects on fertility in humans.

Driving and use of machines
No studies have been conducted with Zerinolflu to evaluate its effects on the ability to drive or operate machinery. Zerinolflu may cause drowsiness; you should be aware of this if you are driving or performing tasks requiring attention and vigilance.

Zerinolflu effervescent tablets contain aspartame, sorbitol, and sodium
This medicine contains:

• 40 mg of aspartame (E 951) per dose (1 effervescent tablet). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation, because your body cannot properly eliminate it;
• 212 mg of sorbitol (E 420) per dose (1 effervescent tablet). Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine;
• 341 mg (14.83 mmol) of sodium (the main component of table salt) per dose (1 effervescent tablet). This corresponds to 17% of the maximum recommended daily dietary intake for an adult. Talk to your doctor or pharmacist if you have been advised to follow a low-sodium diet.

3. How to take Zerinolflu

Take 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.
Adults:
The recommended dose is 1–2 tablets three times a day, with an interval of at least 4 hours between doses. The maximum daily dose is 6 tablets. Do not exceed the recommended doses.
Dissolve the effervescent tablet in about half a glass of water.
Zerinolflu should be taken after meals.

Caution:

• Use this medicine only for short-term treatment. If fever persists or symptoms do not improve within 3 days of treatment, consult your doctor.
• Consult your doctor if the condition occurs repeatedly or if you have noticed any recent changes in its characteristics.

Elderly and patients with renal or hepatic impairment (kidney or liver problems):
A dose reduction may be necessary.

Children and adolescents:
The safety and efficacy of Zerinolflu have not been established.

If you take more Zerinolflu than you should:

• due to paracetamol: overdose may also lead to: coagulation disorders (blood clotting and bleeding). Elderly people, young children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients receiving concomitant treatment with enzyme-inducing drugs, are at increased risk of poisoning, including fatal outcomes. In case of excessive intake, the following symptoms may occur: drowsiness, lethargy (a state of deep sleep with reduced response to normal stimuli), respiratory depression (reduced breathing activity), agitation, confusion, hallucinations, dizziness, uncontrolled movements, dry mouth, changes in heartbeat, nausea, vomiting, anorexia, pallor, abdominal pain, hepatic cytolysis (destruction of liver cells), which could lead to gastrointestinal bleeding, metabolic acidosis, massive necrosis (death of liver cells). In case of accidental ingestion of an excessive dose of Zerinolflu, contact your doctor immediately or go to the nearest hospital.

If you forget to take Zerinolflu:
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 experiences them.
For the following side effects, frequency cannot be determined from the available data (frequency not known).

Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).
If you experience any of the following symptoms, STOP using Zerinolflu IMMEDIATELY and contact your doctor or go to the nearest hospital, where you will be given appropriate and specific treatment:

• Severe skin reactions presenting as skin rash, some of which have been fatal (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and 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 (reduced number of platelets in the blood);
• Neutropenia (reduced number of neutrophils in the blood);
• Leukopenia (reduced number of white blood cells in the blood);
• Hemolytic anemia (decrease in hemoglobin and red blood cells);
• Agranulocytosis (reduced number of granulocytes in the blood);
• Pancytopenia (reduced number of all blood cells);
• Excess acid in the blood due to elevated levels of pyroglutamic acid resulting from low glutathione levels.

Disorders of the nervous system such as:

• Sedation;
• Drowsiness;
• Asthenia (weakness);
• Dizziness;
• Headache;
• Inability to concentrate;
• Abnormal coordination.

Skin reactions of varying type and severity have been reported with the use of paracetamol, including cases of:

• Rash (skin eruption);
• Urticaria (appearance of red patches on the skin);
• Severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug-induced fixed eruption, and exfoliative dermatitis;
• Photosensitization (allergic skin reaction following exposure to light).

Other possible side effects include:

• Blurred vision;
• Thickening of bronchial secretions (thicker mucus), bronchospasm (temporary narrowing of the airways);
• Dry mouth, nausea, gastrointestinal disturbances;
• Changes in liver function and hepatitis (inflammation of the liver);
• Changes affecting the kidney: acute renal failure (reduced kidney function), interstitial nephritis (kidney inflammation), hematuria (presence of blood in urine), anuria (absence of urine), urinary retention (difficulty passing urine);
• Psychiatric disorders: confusion, nightmares, depression;
• Effects on the heart: tachycardia (increased heart rate), palpitations (awareness of heartbeat), hypotension (low blood pressure);
• Ear disorder: tinnitus.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at 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 Zerinolflu

Store below 25°C.
Period of validity after first opening: 6 months.
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 Zerinolflu effervescent tablets contain

• The active substances are: paracetamol 300 mg, chlorphenamine maleate 2 mg equivalent to chlorphenamine 1.41 mg, sodium ascorbate 280 mg corresponding to vitamin C 250 mg;
• The other components are: sodium bicarbonate, sodium carbonate, anhydrous citric acid, sorbitol (E 420) , povidone, dimethicone, aspartame (E 951) , orange flavour, lemon flavour.

Description of the appearance of Zerinolflu and package contents
Zerinolflu is available as effervescent tablets, packed in a bottle with a cap.
The pack contains 10 effervescent tablets.
The pack contains 12 effervescent tablets.
The pack contains 20 effervescent tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa, 7 – 20121 Milan, Italy

Manufacturer
E-Pharma Trento S.p.A. – Frazione Ravina – Trento (TN)