Pumilflu for influenza and cold

Italy
Brand name Pumilflu for influenza and cold
Form tablets, effervescent
Active substance / Dosage
ACID ASCORBIC
Chlorpheniramine Maleate
PARACETAMOL
Prescription type Over-the-counter
ATC code
N02BE51
Registration number 049484
Manufacturer AESCULAPIUS FARMACEUTICI SRL

Table of Contents

Patient Information Leaflet: Information for the Patient

PUMILFLU Influenza and Cold 500 mg/250 mg/2 mg effervescent tablets

paracetamol, ascorbic acid, chlorpheniramine maleate
Please read this leaflet carefully before taking 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.

  • 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, consult your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What PUMILFLU Influenza and Cold is and what it is used for

PUMILFLU Influenza and Cold is used in adults and adolescents over 15 years of age for the treatment of symptoms of influenza and the common cold.
PUMILFLU Influenza and Cold contains 3 active substances that have different effects:

  • paracetamol, which relieves pain and reduces fever,
  • chlorpheniramine, which reduces nasal congestion and relieves runny nose and watery eyes,
  • ascorbic acid (vitamin C), which compensates for the increased need of this vitamin during acute viral infections.

Consult your doctor if fever or pain persist for more than 3 days, or if symptoms do not improve after 3 days of treatment.

2. What you should know before taking PUMILFLU Influenza and Cold

Do not take PUMILFLU Influenza and Cold

  • if you are allergic to the active substances (paracetamol, maleate chlorpheniramine or ascorbic acid) or to any of the other ingredients of this medicine (listed in section 6),

  • if you are allergic to other similar medicines (e.g. antihistamines – medicines used to treat allergies);

  • during pregnancy and breastfeeding (see section Pregnancy, breastfeeding and fertility)

  • if you have glaucoma (increased pressure inside the eye)

  • if you have prostate enlargement (prostatic hypertrophy), bladder neck obstruction, pyloric or duodenal stenosis (narrowing
    of the stomach or duodenum), or any other narrowing of the digestive or urogenital system;

  • if you are currently being treated or have been treated in the previous two weeks with monoamine oxidase inhibitors (see section “Other medicines and PUMILFLU Influenza and Cold”).

Do not administer PUMILFLU Influenza and Cold to children under 15 years of age.
Warnings and precautions
Consult your doctor before taking PUMILFLU Influenza and Cold if you have:

  • mild to moderate liver function impairment (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance causing yellowish skin and eyes);
  • severe liver disorders;
  • acute hepatitis (acute inflammation of the liver);
  • concomitant treatment with medicines affecting liver function;
  • 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);
  • glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose absence may cause hemolytic anemia);
  • hemolytic anemia (a disease caused by destruction of red blood cells);
  • kidney failure (kidney disease).

During treatment with PUMILFLU Influenza and Cold, inform your doctor immediately if:
If you suffer from serious illnesses, including severe kidney 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 for prolonged periods 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.
Do not take this medicine for more than 3 consecutive days without consulting your doctor.
If you do not experience noticeable improvement after a short period of treatment, consult your doctor. If fever or pain persist for more than 3 days, or if symptoms do not improve within 3 days, or if new symptoms appear, or if symptoms are accompanied by high fever, skin rash (erythema with redness of the skin), excessive respiratory secretions, or persistent cough, consult your doctor for proper diagnosis.
Paracetamol
During treatment with paracetamol, before taking any other medicine, check whether it contains paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses (also see section “If you take more PUMILFLU Influenza and Cold than you should”).
Additionally, before combining with any other medicine, contact your doctor (also see sections “Other
medicines and PUMILFLU Influenza and Cold”).
High or prolonged doses of this product may cause liver disease (hepatopathy), which may be life-threatening (also see section “If you take more PUMILFLU Influenza and Cold than you should”), as well as serious kidney, blood and liver disorders.
Severe skin reactions: potentially fatal skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug-induced fixed eruption and exfoliative dermatitis have been reported with paracetamol use. If symptoms or signs of these severe skin reactions occur (e.g. progressive skin redness associated with blisters or mucosal lesions), stop treatment with PUMILFLU Influenza and Cold immediately and seek medical attention at the nearest hospital.
Exercise caution with PUMILFLU Influenza and Cold if you are allergic to aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs).
Discontinue treatment and consult your doctor at the first sign of an allergic reaction following the use of PUMILFLU Influenza and Cold, as severe allergic reactions to paracetamol have been observed (e.g. anaphylactic shock, also see section “Possible side effects”).
Maleate chlorpheniramine
PUMILFLU Influenza and Cold contains an antihistamine (chlorpheniramine). At normal doses, antihistamines may cause variable side effects from person to person and from drug to drug, and should be used with caution in individuals with high blood pressure, heart disease or thyroid disorders. The most common side effect is sedation (physical and mental relaxation), which may manifest as drowsiness (also see sections “Driving and use of machinery” and “Side effects”). Chlorpheniramine may cause photosensitivity (skin allergic reaction following exposure to light).
Ascorbic acid
Ascorbic acid (vitamin C) should be used with caution if you have or have previously had nephrolithiasis (kidney stones), glucose-6-phosphate dehydrogenase deficiency, or conditions such as haemochromatosis (excessive iron deposition in the liver and other organs), thalassemia, or sideroblastic anemia (a disorder in blood cell production).
Patients with kidney or liver impairment: if you have kidney or liver impairment, use this medicine with caution.
Elderly patients: due to their increased sensitivity to the drug, elderly patients should strictly follow the recommended dosages. In elderly patients treated with antihistamines, side 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).
Other medicines and PUMILFLU Influenza and Cold
Inform 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 medicine)
  • isoniazid (a medicine used to treat tuberculosis);
  • cimetidine (a medicine used to treat gastric ulcers);
  • antiepileptic medicines (medicines used to treat epilepsy such as glutethimide, phenobarbital, carbamazepine, topiramate);
  • flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

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.

  • probenecid (a medicine used to treat gout);
  • oral anticoagulants (medicines used to reduce or prevent blood clotting) such as warfarin and similar medicines (vitamin K antagonists), as paracetamol may increase the risk of bleeding; inform your doctor if you notice 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);

The effectiveness of PUMILFLU Influenza and Cold may decrease with habitual use of:

  • anticonvulsant medicines (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 its onset of action.

Do not take PUMILFLU Influenza and Cold 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 psychosis);
  • 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 medicine is not recommended if you are being treated with anti-inflammatory medicines.
Like all preparations containing antihistamines, PUMILFLU Influenza and Cold may mask the early signs of ototoxicity (harmful effects on the ear) of certain antibiotics.
Interference with laboratory tests:
If you need to undergo blood tests, be aware that paracetamol administration may interfere with the measurement of blood uric acid levels (uricemia) and blood sugar levels (glycemia).
PUMILFLU Influenza and Cold with food, drinks and alcohol
Take PUMILFLU Influenza and Cold after meals. Do not consume alcoholic beverages during treatment with PUMILFLU Influenza and Cold effervescent tablets.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant or are planning to become pregnant, you must not
use PUMILFLU Influenza and Cold.
Fertility
No studies have been conducted with PUMILFLU Influenza and Cold to evaluate effects on fertility in humans.
Driving and use of machinery
No studies have been conducted with PUMILFLU Influenza and Cold to evaluate effects on the ability to drive or operate machinery. PUMILFLU Influenza and Cold may cause drowsiness; you should be aware of this if you drive or perform tasks requiring attention and vigilance.
PUMILFLU Influenza and Cold contains aspartame.
This medicine contains 40 mg of aspartame per effervescent tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
PUMILFLU Influenza and Cold contains sorbitol.
This medicine contains 212 mg of sorbitol per effervescent tablet.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before you (or your child) take this medicine.
PUMILFLU Influenza and Cold contains sodium.
This medicine contains 314 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 16% of the maximum daily intake recommended in an adult diet.

3. How to take PUMILFLU Influenza and Cold

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Stick to the recommended dosage.
Do not take more than the recommended dose without consulting your doctor.

Adults and adolescents aged over 15 years
Take 1 effervescent tablet every 4–6 hours as needed. Do not take more than 6 effervescent tablets in 24 hours.

Elderly
Elderly patients should particularly adhere to the recommended dosage due to increased sensitivity to this type of medication.

Use in children
PUMILFLU Influenza and Cold must not be administered to children under 15 years of age.

Method of administration
For oral use.
PUMILFLU Influenza and Cold is available as an effervescent tablet.
Dissolve one effervescent tablet in a glass of water (15–25 °C). The reconstituted solution should appear slightly opalescent and colourless. Drink the solution immediately without allowing it to stand.
Take PUMILFLU Influenza and Cold after meals.

Duration of treatment
Take the medicine for a short period only. Do not continue taking this medicine without consulting your doctor if fever or pain persists for more than 3 days. If symptoms worsen or do not improve after 3 days of treatment, consult your doctor for further management.

Renal impairment
If you have renal impairment (kidney disease), consult your doctor, who will adjust the dosage and dosing intervals accordingly.

Hepatic impairment
If you have hepatic impairment (liver disease), consult your doctor, who will adjust the dosage and dosing intervals accordingly.

If you take more PUMILFLU Influenza and Cold than you should
Elderly patients, young children, patients with liver disorders, chronic alcohol consumption, chronic malnutrition, and patients concurrently treated with enzyme-inducing drugs are at higher risk of poisoning, which may even be fatal.
In case of overdose with PUMILFLU Influenza and Cold effervescent tablets, seek immediate medical attention or contact the nearest hospital due to the risk of severe and delayed liver damage.
Within the first 24 hours, the main symptoms of overdose may include: vomiting, abdominal pain, and pallor.
You may experience the following symptoms: 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 heart rate, 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).
N-acetylcysteine (a substance that detoxifies the liver), administered within hours after an overdose of paracetamol, is effective in limiting liver damage. Inducing vomiting or undergoing gastric lavage (performed in hospital by trained personnel) is recommended. Furthermore, you must be kept under medical observation and receive supportive therapy as directed by the doctor.

If you forget to take PUMILFLU Influenza and Cold
If you forget to take PUMILFLU Influenza and Cold and fever or pain persists, take the next dose as scheduled. The dosing interval must not be less than 4–6 hours. Do not take a double dose to make up for the missed tablet.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
For the following adverse effects, frequency cannot be established based on available data.
STOP using PUMILFLU Influenza and Cold immediately and consult your
doctor or go to the nearest hospital where you will be given appropriate and specific treatment if you
experience any of the following symptoms:

  • severe skin reactions presenting as skin rash, some of which have been fatal (including Stevens-Johnson syndrome, 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).

Blood-related adverse effects:

  • thrombocytopenia (reduced number of platelets in the blood);
  • neutropenia (reduced number of neutrophils in the blood);
  • leucopenia (reduced number of white blood cells in the blood);
  • haemolytic anaemia (decreased haemoglobin and red blood cells);
  • agranulocytosis (reduced number of granulocytes in the blood);
  • pancytopenia (reduced number of all blood cells);

Nervous system disorders such as:

  • sedation;
  • drowsiness;
  • asthenia (weakness);
  • dizziness;
  • headache;
  • attention disturbance;
  • abnormal coordination.

Skin reactions of various types 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 eruption with fixed eruption, and exfoliative dermatitis;
  • erythema (skin inflammation);
  • photosensitization (allergic skin reaction following exposure to light).

Other possible adverse effects include:

  • blurred vision;
  • increased viscosity of bronchial secretions (thicker mucus), bronchospasm (temporary narrowing of the airways);
  • gastrointestinal disorders such as dry mouth and nausea;
  • liver function abnormalities and hepatitis (liver inflammation);
  • kidney-related disorders: acute renal failure (reduced kidney function), interstitial nephritis (kidney inflammation), haematuria (presence of blood in urine), anuria (absence of urine), urinary retention (difficulty passing urine);
  • psychiatric disorders: confusion, nightmares, depression;
  • heart-related disorders: tachycardia (increased heart rate), palpitations (awareness of heartbeat);
  • hypotension (low blood pressure);
  • ear disorders: tinnitus.
  • severe condition that may increase blood acidity (called metabolic acidosis) in patients with serious illness using paracetamol (see section 2).

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

5. How to store PUMILFLU Influenza and Cold

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep the tube tightly closed to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. 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. Do not use the medicine more than 3 months after first opening.

6. Package contents and other information

What PUMILFLU Influenza and Cold contains

  • The active substances are paracetamol, chlorphenamine and ascorbic acid. Each effervescent tablet contains 500 mg of paracetamol, 250 mg of ascorbic acid (as sodium ascorbate) and 2 mg of maleate chlorphenamine.
  • The other components are: citric acid, sodium hydrogen carbonate, sorbitol (E420); sodium carbonate, aspartame (E951), orange flavour, lemon flavour, povidone K30, simeticone (as simeticone emulsion 30%).

Description of the appearance of PUMILFLU Influenza and Cold and contents of the pack
PUMILFLU Influenza and Cold is presented as effervescent tablets, white to almost white in colour, flat, round, with a nominal diameter of 25 mm, a nominal thickness of 4.4 mm and a nominal weight of 3.000 grams, packed in a bottle.
The medicine is available in a pack containing 12 tablets in a bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AESCULAPIUS FARMACEUTICI S.r.l. - Via Cefalonia, 70 - 25124 BRESCIA
Marketing Authorisation Holder for sale: MONTEFARMACO OTC S.p.A.
Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer: E-Pharma Trento S.p.A., via Provina 2, 38123 Trento (TN) – Italy.
This medicinal product is authorised in the EEA Member States under the following names:
Lithuania: LEVIOFLU 500 mg/250 mg/2 mg šnypščiosios tabletės
Italy: PUMILFLU Influenza e Raffreddore