Fluibrón influenza and cold

Package leaflet: Information for the user

FLUIBRON INFLUENZA E RAFFREDDORE 600 mg/10 mg granules in sachet

paracetamol/phenylephrine hydrochloride
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 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What FLUIBRON INFLUENZA E RAFFREDDORE is and what it is used for

FLUIBRON INFLUENZA E RAFFREDDORE is a medicine containing the active substances
paracetamol and phenylephrine hydrochloride, used for the treatment of pain, fever, and
congestion.
FLUIBRON INFLUENZA E RAFFREDDORE is used for the short-term treatment of
cold and flu symptoms, including mild to moderate pain and fever, when associated with nasal
congestion.
FLUIBRON INFLUENZA E RAFFREDDORE is indicated for adults and children over 12 years of age.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking FLUIBRON INFLUENZA E RAFFREDDORE

Do not take FLUIBRON INFLUENZA E RAFFREDDORE

• if you are allergic to paracetamol, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you are taking beta-blockers (used to treat high blood pressure or heart conditions);
• if you are taking tricyclic antidepressants (medicines used to treat depression);
• if you are taking monoamine oxidase inhibitors (medicines used to treat depression) or have taken them within the last two weeks;
• if you suffer from bronchial asthma;
• if you have phaeochromocytoma (a tumour of the adrenal glands);
• if you have glaucoma (an eye condition often associated with increased intraocular pressure);
• if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and amphetamine-like psychostimulants);
• if you have severe hepatic insufficiency;
• if you have liver or kidney problems;
• if you suffer from diabetes;
• if you have an overactive thyroid (hyperthyroidism);
• if you have high blood pressure or heart or circulatory problems;
• if you have glucose-6-phosphate dehydrogenase deficiency (an inherited disorder leading to a decrease in red blood cell count);
• if you suffer from severe haemolytic anaemia (abnormal breakdown of blood cells). Do not use this medicine in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIBRON INFLUENZA E RAFFREDDORE:

• if you are taking other medicines (see also “Other medicines and FLUIBRON INFLUENZA E RAFFREDDORE”);
• if you have an enlarged prostate gland;
• if you have occlusive vascular disease (blockage of arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (FLUIBRON INFLUENZA E RAFFREDDORE contains sodium).

During treatment with FLUIBRON INFLUENZA E RAFFREDDORE, 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 and rapid breathing, drowsiness, nausea, and vomiting.

Do not use FLUIBRON INFLUENZA E RAFFREDDORE for more than 3 consecutive days without consulting your doctor.
Do not drink alcohol while taking FLUIBRON INFLUENZA E RAFFREDDORE.
If you are taking anti-inflammatory medicines, the use of FLUIBRON INFLUENZA E RAFFREDDORE is not recommended (see section 2 “Other medicines and FLUIBRON INFLUENZA E RAFFREDDORE”).
Do not take in combination with other medicines containing paracetamol. If paracetamol is taken in high doses, serious adverse reactions may occur, including severe liver damage and effects on the kidneys and blood.
Paracetamol may interfere with tests measuring blood sugar levels (in people with diabetes) and uric acid levels (in people with gout).

Other medicines and FLUIBRON INFLUENZA E RAFFREDDORE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines that may affect liver function, such as zidovudine or isoniazid, which may increase the harmful effects of paracetamol on the liver;
• medicines that may affect the urinary excretion of paracetamol, such as probenecid;
• medicines containing rifampicin (used in the treatment of tuberculosis), cimetidine (used to treat stomach ulcers), or medicines such as glutethimide, phenobarbital, carbamazepine (used to treat epilepsy); when taken together with paracetamol, these medicines should be used with extreme caution and under close medical supervision;
• medicines used to treat eye infections such as chloramphenicol;
• medicines used to delay or prevent blood clotting, e.g. warfarin, since high-dose paracetamol may increase the risk of bleeding;
• medicines that may speed up (e.g. metoclopramide, domperidone) or slow down/reduce (e.g. cholestyramine, anticholinergics) the absorption of paracetamol;
• medicines used to treat high blood pressure containing beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take FLUIBRON INFLUENZA E RAFFREDDORE”);
• medicines containing tricyclic antidepressants or sympathomimetic amines;
• medicines prescribed for heart failure (digoxin);
• medicines used to treat migraine such as ergotamine and methysergide;
• anti-inflammatory medicines;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (known as high anion gap metabolic acidosis), which require urgent treatment.

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 FLUIBRON INFLUENZA E RAFFREDDORE is not recommended during pregnancy and breastfeeding; use FLUIBRON INFLUENZA E RAFFREDDORE only after consulting your doctor.

Driving and using machines
FLUIBRON INFLUENZA E RAFFREDDORE does not affect your ability to drive or operate machinery. However, if you experience dizziness, you should not drive or operate machinery.

FLUIBRON INFLUENZA E RAFFREDDORE contains sorbitol and aspartame:
This medicine contains:

• 42 mg of sorbitol per sachet;
• 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. HOW TO TAKE FLUIBRON INFLUENZA E RAFFREDDORE

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and children over 12 years of age: 1 sachet every 4–6 hours, up to a maximum of 3 sachets in 24 hours.
Use in children
This medicine is contraindicated in children under 12 years of age.
Do not exceed the recommended dose without consulting your doctor.
Instructions for use
Place the granules directly on the tongue and swallow. FLUIBRON INFLUENZA E RAFFREDDORE dissolves with saliva: this allows it to be taken without water.
Alternatively, you may dissolve the contents of one sachet in a glass of warm water (not boiling), stirring with a teaspoon. If desired, you can further dilute it with cold water to cool and sweeten it.
Once prepared, drink the solution within a few minutes.
Warning: This product is intended for short-term use only.
Do not take for more than 3 consecutive days without consulting your doctor.
Consult your doctor if symptoms persist or if you notice any new changes in their characteristics.
If you take more FLUIBRON INFLUENZA E RAFFREDDORE than you should
If you or someone else takes more FLUIBRON INFLUENZA E RAFFREDDORE than recommended, or if you suspect that a child has ingested the contents of a sachet, go immediately to the nearest hospital or see a doctor, even if you feel well, and take this leaflet, any remaining sachets, and the pack with you.
In case of accidental ingestion of high doses of this medicine, symptoms may include pallor, nausea, vomiting, loss of appetite (anorexia), abdominal pain, disturbances in blood sugar levels (abnormalities in glucose metabolism), and accumulation of acids in the body (metabolic acidosis).
In severe poisoning, liver failure may progress to brain damage (encephalopathy, cerebral edema), bleeding (hemorrhage), low blood sugar (hypoglycemia), and death. Even in the absence of severe liver damage, acute kidney dysfunction (acute renal failure) may occur, manifesting as kidney injury (acute tubular necrosis), blood in the urine (hematuria), and protein in the urine (proteinuria).
Other possible effects include changes in heart rhythm (cardiac arrhythmias) and inflammation of the pancreas (pancreatitis).
Additional symptoms may include irritability, headache (cephalalgia), and increased blood pressure. In more severe cases, confusion, hallucinations, and seizures may occur. High doses of the medicine may cause a brief episode of watery diarrhea (transient osmotic diarrhea).
If you have any questions 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.
The following list includes the side effects of paracetamol and phenylephrine.
Side effects are listed in order of decreasing frequency:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: frequency cannot be estimated from the available data.

Stop taking FLUIBRON INFLUENZA E RAFFREDDORE immediately and contact your doctor or go to hospital straight away if you experience any of the following side effects:

• Allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty in breathing or dizziness);
• Very rare cases of serious skin reactions have been reported: severe rash, skin peeling, or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphous erythema);
• Breathing problems (bronchospasm).

If you experience any of the following side effects, contact your doctor or pharmacist.

Common (may affect up to 1 in 10 people):

• Loss of appetite;
• Nausea and vomiting.

Rare (may affect up to 1 in 1,000 people):

• Blood disorders which may present as unexplained bruising, paleness, or reduced resistance to infection; reduction in specific blood cells (agranulocytosis, leucopenia, thrombocytopenia);
• Tachycardia (increased heart rate), palpitations (awareness of heartbeat in the chest);
• Abnormal liver function (elevated liver transaminases);
• Hypersensitivity, including skin rashes, angioedema (sudden swelling of the skin and mucous membranes).

Very rare (may affect up to 1 in 10,000 people):

• Insomnia (difficulty sleeping), nervousness, anxiety, agitation, confusion, irritability;
• Tremor (shaking), dizziness, headache;
• After prolonged use of high doses of paracetamol, interstitial nephrosis (kidney inflammation) and other adverse kidney effects may occur.

Not known (frequency cannot be estimated from the available data):

• Anaemia (decrease in blood haemoglobin levels);
• Mydriasis (pupil dilation), acute angle-closure glaucoma (an eye condition often associated with increased fluid pressure in the eye);
• Laryngeal oedema (swelling of the throat);
• Diarrhoea, gastrointestinal discomfort;
• Liver disorders, hepatitis (yellowing of the skin and/or eyes);
• Kidney disorders (worsening of kidney failure), blood in urine (haematuria);
• Difficulty urinating (anuria, urinary retention);
• Increased blood pressure (hypertension);
• Severe condition leading to increased acidity of the blood (called metabolic acidosis), in patients with serious underlying illness using paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can 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 FLUIBRON INFLUENZA E RAFFREDDORE

This medicine does not require any special storage temperature.
Store in the original container to protect the medicine from moisture and light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
It is important to always keep product information available. Keep the carton and the leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.

6. Package contents and other information

What FLUIBRON INFLUENZA E RAFFREDDORE contains
The active substances are: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg of phenylephrine).
The other components are: mannitol (E 421), Xylitab 200 (xylitol, carboxymethylcellulose), lemon flavour, sorbitol (E 420), ascorbic acid, citric acid, hydrated colloidal silica, aspartame (E 951), sodium saccharin.
Description of the appearance of FLUIBRON INFLUENZA E RAFFREDDORE and contents of the
pack
FLUIBRON INFLUENZA E RAFFREDDORE comes in sachets containing a granulate ranging in colour from white to ivory.
FLUIBRON INFLUENZA E RAFFREDDORE is available in cardboard boxes containing 10 or 16 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Chiesi Italia S.p.A. – Via Giacomo Chiesi 1 – 43122 Parma
Manufacturer: E-Pharma Trento S.p.A. - Via Provina 2 - 38123 Trento.