PUMILFLU 500 mg/250 mg /2 Mg Effervescent Tablet

Зміст інструкції

1. PUMILFLU Influenza e Raffreddore 500 mg/250 mg/2 mg effervescent tablets
   1. What is PUMILFLU Influenza e Raffreddore and what is it used for
   2. What you need to know before taking PUMILFLU Influenza e Raffreddore
   3. How to take PUMILFLU Influenza e Raffreddore
   4. Possible side effects
   5. How to store PUMILFLU Influenza e Raffreddore
   6. Contents of the pack and other information

PUMILFLU Influenza e Raffreddore 500 mg/250 mg/2 mg effervescent tablets

paracetamol, ascorbic acid, chlorphenamine maleate

Read 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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days

Contents of this leaflet

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

1. What is PUMILFLU Influenza e Raffreddore and what is it used for

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

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

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

2. What you need to know before taking PUMILFLU Influenza e Raffreddore

Do not take PUMILFLU Influenza e Raffreddore

• if you are allergic to the active ingredients (paracetamol, chlorphenamine maleate 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 (for example, antihistamines - medicines used in the treatment of allergies);
• during pregnancy and breastfeeding (see section Pregnancy, breastfeeding and fertility)
• if you suffer from glaucoma (increased pressure inside the eye)
• if you suffer from prostatic hypertrophy (enlargement of the prostate), in case of obstruction

(narrowing) of the bladder neck, in case of stenosis of the pylorus or duodenum (narrowing
of the stomach or duodenum), or any other narrowing of the digestive or urogenital system;

• if you are or have been in treatment with monoamine oxidase inhibitors (see section “Other medicines and PUMILFLU Influenza e Raffreddore”) in the two weeks prior;

Do not administer PUMILFLU Influenza e Raffreddore to children under 15 years of age.

Warnings and precautions
Consult your doctor before taking PUMILFLU Influenza e Raffreddore if you have:

• mild to moderate liver dysfunction (including Gilbert's syndrome, a condition characterized by excessive production of bilirubin, a substance that causes a yellowish tinge to the skin and eyes)
• severe liver disorders
• acute hepatitis (acute inflammation of the liver)
• concomitant treatment with medicines that alter liver function
• glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the lack of which can cause hemolytic anemia);
• hemolytic anemia (a disease caused by the destruction of some blood cells, red blood cells)
• renal insufficiency (kidney disease).

After a short period of treatment without appreciable results, consult your doctor. If the fever or pain
persists for more than 3 days, or if symptoms do not improve within 3 days, or if other symptoms appear,
or are accompanied by high fever, rash (skin redness accompanied by skin flushing),
excessive respiratory secretions and persistent cough, consult your doctor who will determine
the correct diagnosis.

Paracetamol
During treatment with paracetamol, before taking any other medicine, check that
it does not contain paracetamol, as if paracetamol is taken in high doses, serious
side effects can occur (see also section “If you take more PUMILFLU Influenza e
Raffreddore than you should”).
Also, before combining any other medicine, contact your doctor (see also sections “Other
medicines and PUMILFLU Influenza e Raffreddore”).
High or prolonged doses of the product can cause liver damage (hepatopathy) at
high risk for you (see also section “If you take more PUMILFLU Influenza e Raffreddore than
you should”) and severe kidney and blood disorders.
Stop treatment and consult your doctor at the first signs of an allergic reaction following the use of
PUMILFLU Influenza e Raffreddore, as severe allergic reactions to paracetamol
have been observed (e.g. anaphylactic shock, see also section “Possible side effects”)

Chlorphenamine maleate
PUMILFLU Influenza e Raffreddore contains an antihistamine (chlorphenamine). At normally
taken doses, antihistamines have highly variable side effects from subject to subject and from
drug to drug. The most common side effect is sedation (physical and mental relaxation) which can
manifest as drowsiness (see also sections “Driving and using machinery” and
“Side effects”).

Ascorbic acid
Ascorbic acid (vitamin C) should be used with caution if you suffer from, or have suffered in the past, from
nephrolithiasis (kidney stones) and if you have a glucose-6-phosphate dehydrogenase deficiency or if you suffer from diseases
such as hemochromatosis (excessive iron deposition in the liver and other organs), thalassemia, sideroblastic anemia (a disorder in the production of blood cells).

Patients with renal or hepatic (liver) insufficiency:if you have renal or liver insufficiency,
use this medicine with caution.

Elderly:due to their greater sensitivity to the drug, the elderly should adhere to the dosages
indicated. 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).

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

• rifampicin (an antibiotic drug)
• isoniazid (a drug used in the treatment of tuberculosis);
• cimetidine (a drug used in the treatment of gastric ulcer);
• antiepileptic drugs (drugs used for the treatment of epilepsy such as glutethimide, phenobarbital, carbamazepine).

Normally harmless doses of paracetamol can cause liver damage if taken together with
these drugs. The same applies to substances potentially hepatotoxic and in case of alcohol abuse

• probenecid (drug used for the treatment of gout);
• oral anticoagulants (drugs used to reduce or block blood clot formation);
• chloramphenicol (an antibiotic);
• zidovudine (a drug used for the treatment of patients with HIV);
• other substances with anticholinergic action (drugs that block the effects of acetylcholine, a substance involved in the transmission of nerve impulses);
• phenytoin (drug used in the treatment of seizures).

The effectiveness of PUMILFLU Influenza e Raffreddore may decrease in case of habitual use of:

• anticonvulsant drugs (drugs used in the treatment of seizures, such as for example in epilepsy);
• oral contraceptives (the pill);
• cholestyramine (a medicine used to treat high cholesterol);
• medicines that slow down gastric emptying, such as propantheline, as they reduce the rate of absorption of paracetamol and delay the onset of its effect.

Do not take PUMILFLU Influenza e Raffreddore if you are being treated with:

• tricyclic antidepressants (drugs used in the treatment of depression);
• monoamine oxidase inhibitors (another class of antidepressant drugs such as isocarboxazide, phenelzine and tranylcypromine) or within two weeks of such treatment;
• neuroleptics (drugs used in the treatment of mental disorders such as psychoses);
• other drugs with a depressive effect on the central nervous system (drugs that have a sedative effect on the central nervous system such as barbiturates, sedatives, tranquilizers, hypnotics);
• metoclopramide (a drug that blocks vomiting).

The use of the medicine is not recommended if you are being treated with anti-inflammatory drugs.
Like all preparations containing antihistamines, PUMILFLU Influenza e Raffreddore can mask the
early signs of ototoxicity (harmful effects on the ear) of certain antibiotics.

Interference with laboratory tests:
If you are going to have blood tests, keep in mind that the administration of paracetamol may interfere
with the determination of the amount of uric acid (uricemia) and the amount of sugar (glycemia) in
the blood.

PUMILFLU Influenza e Raffreddore with food, drinks and alcohol
Take PUMILFLU Influenza e Raffreddore after meals. Do not consumealcoholic beverages during
treatment with PUMILFLU Influenza e Raffreddore effervescent tablets.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, do not
use PUMILFLU Influenza e Raffreddore.

Driving and using machinery
PUMILFLU Influenza e Raffreddore can cause fatigue, drowsiness and dizziness. If you experience
these symptoms, do not drive or use machinery.

PUMILFLU Influenza e Raffreddore contains aspartame.
This medicine contains 40 mg of aspartame in each effervescent tablet.
Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare
genetic disease that causes the accumulation of phenylalanine because the body is unable to dispose of it properly.

PUMILFLU Influenza e Raffreddore contains sorbitol.
This medicine contains 212 mg of sorbitol in each effervescent tablet.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to
some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease for
which patients cannot transform fructose, talk to your doctor before you (or your child)
take this medicine.

PUMILFLU Influenza e Raffreddore contains sodium.
This medicine contains 314 mg of sodium (the main component of table salt) per effervescent
tablet. This is equivalent to 16% of the recommended maximum daily intake with the diet of an
adult.

3. How to take PUMILFLU Influenza e Raffreddore

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Follow the recommended dosage. Do not take more than the recommended dose without consulting your doctor.

Adults and adolescents over 15 years of age
Take 1 effervescent tablet every 4 – 6 hours if necessary. Do not take more than 6 effervescent tablets in 24 hours.

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

Use in children
PUMILFLU Influenza e Raffreddore should not be administered to children under 15 years of age.

Method of administration
Oral use.
PUMILFLU Influenza e Raffreddore is available in the form of effervescent tablets.
Dissolve one effervescent tablet in a glass of water (15 – 25 °C). The appearance of the reconstituted solution should be slightly opalescent, colourless. Drink the solution without letting it rest.
Take PUMILFLU Influenza e Raffreddore after meals.

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

Renal impairment
In case of renal impairment ( kidney disease), consult your doctor who will adjust the doses and intervals between administrations.

Hepatic impairment
In case of hepatic impairment ( liver disease), consult your doctor who will adjust the doses and intervals between administrations.

If you take more PUMILFLU Influenza e Raffreddore than you should
In case of taking an excessive dose of PUMILFLU Influenza e Raffreddore effervescent tablets, contact your doctor immediately or go to the nearest hospital, due to the risk of serious and delayed liver damage..
Within the first 24 hours, the main symptoms of intoxication are: 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 (reduction of respiratory activity).
N-acetylcysteine (a substance that purifies the liver), administered in the hours immediately following the intake of an excessive dose of paracetamol, is effective in limiting liver damage. It is recommended to induce vomiting or possibly undergo gastric lavage (to be performed in hospital by specialized personnel); furthermore, you should be kept under observation and given supportive therapy, as established by the doctor.

If you forget to take PUMILFLU Influenza e Raffreddore
If you have forgotten to take PUMILFLU Influenza e Raffreddore, if the fever and pain persist, take the next dose. The administration interval should not be less than 4 – 6 hours. Do not take a double dose to compensate for the missed tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. 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 on the basis of the available data.

STOP using PUMILFLU Influenza e Raffreddore immediately and contact your
doctor or the nearest hospital where you will be given appropriate and specific treatment if
you experience any of the following symptoms:

• severe skin reactions manifesting with 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);
• leukopenia (reduction in the number of white blood cells in the blood);
• anemia (decrease in the amount of hemoglobin and red blood cells);
• agranulocytosis (reduction in the number of granulocytes in the blood);
• pancytopenia (reduction in the number of all cells present in the blood).

Nervous system disorders such as:

• somnolence;
• asthenia (weakness);
• vertigo (dizziness);
• headache;
• attention impairment.
• With the use of paracetamol, skin reactionsof varying types and severity have been reported, including cases of:
• urticaria (appearance of red spots on the skin);
• erythema multiforme (skin inflammation);
• photosensitization (allergic skin reaction following exposure to light).

Other side effects may be:

• blurred vision;
• increased viscosity of bronchial secretions (thicker mucus);
• gastrointestinal disorders such as dry mouth and nausea;
• alterations in liver function and hepatitis (liver inflammation);
• kidney disorders: acute renal failure (reduction in kidney function), interstitial nephritis (kidney inflammation), hematuria (presence of blood in the urine), anuria (absence of urine), urinary retention (presence of urine in the bladder).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 PUMILFLU Influenza e Raffreddore

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C. Keep the tube tightly closed to protect the medicine from
light and humidity.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to
the last day of that month. Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment. Do not use the medicine after 3 months from the date of first opening.

6. Contents of the pack and other information

What PUMILFLU Influenza e Raffreddore contains

• The active ingredients 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 chlorphenamine maleate.
• The other ingredients are: citric acid, sodium hydrogen carbonate, sorbitol (E420); sodium carbonate, aspartame (E951), orange flavour, lemon flavour, povidone K30, simethicone (as a 30% simethicone emulsion).

Description of the appearance of PUMILFLU Influenza e Raffreddore and contents of the pack
PUMILFLU Influenza e Raffreddoreis presented in the form of effervescent tablets of colour from
white to almost white, flat, round with a nominal diameter of 25 mm, a nominal thickness of 4.4
mm and a nominal weight of 3,000 grams, packaged in a tube.
The medicinal product is available in a pack containing 12 tablets in a tube.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AESCULAPIUS FARMACEUTICI S.r.l. - Via Cefalonia, 70 - 25124 BRESCIA
Manufacturer: E-Pharma Trento S.p.A., via Provina 2, 38123 Trento (TN) – Italy.

This medicinal product is authorised in the Member States of the EEA under the following denominations:
Lithuania: LEVIOFLU 500 mg/250 mg/2 mg effervescent tablets
Italy: PUMILFLU Influenza e Raffreddore