FLUIBRON FLU AND COLD*10SA

FLUIBRON INFLUENZA E RAFFREDDORE 600 mg/10 mg granules in sachet
Paracetamol/phenylephrine hydrochloride

What it is and what it is used for
FLUIBRON INFLUENZA E RAFFREDDORE is a medicine containing the active ingredients paracetamol and phenylephrine hydrochloride, which is 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/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.

What you need to know before taking the medicine
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 in the last two weeks;
- if you suffer from bronchial asthma;
- if you suffer from pheochromocytoma (a tumour of the adrenal glands);
- if you suffer from 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 suffer from severe liver failure;
- 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 (a hereditary disease that leads 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 (arterial obstruction, e.g. Raynaud's syndrome);
• if you have reduced kidney function (FLUIBRON INFLUENZA E RAFFREDDORE contains sodium).

Do not use FLUIBRON INFLUENZA E RAFFREDDORE for more than 3 consecutive days without consulting your doctor.
Do not drink alcohol during treatment with FLUIBRON INFLUENZA E RAFFREDDORE.
If you are taking anti-inflammatory drugs, 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, severe adverse reactions may occur, including severe liver disease and kidney and blood disorders.
Paracetamol can interfere with tests for blood sugar levels (in people with diabetes) and uric acid levels (in people with gout).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following list includes the side effects of paracetamol and phenylephrine.
Side effects are presented in descending order of 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 consult your doctor or go to the nearest hospital if you notice any of the following side effects:
- allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty breathing or dizziness);
- very rare cases of severe skin reactions have been reported: severe rash or exfoliation or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphic);
- respiratory problems (bronchospasm).
If you experience any of the following side effects, talk to 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 that may appear as unexplained bruising, paleness or poor resistance to infection; decrease in specific blood cells (agranulocytosis, leucopenia, thrombocytopenia);
- tachycardia (increased heart rate), palpitations (sensation of heart beating in the chest);
- abnormal liver function (increased 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 falling asleep), nervousness, anxiety, agitation, confusion, irritability;
- tremor (shaking), dizziness, headache;
- prolonged use of high doses of paracetamol may lead to interstitial nephrosis (kidney inflammation) and kidney side effects.
Not known (frequency cannot be estimated from the available data): - anaemia (decrease in haemoglobin levels in the blood);
- mydriasis (pupil dilation), acute angle-closure glaucoma (an eye disease often associated with increased fluid pressure in the eye);
- laryngeal oedema (swelling of the throat);
- diarrhoea, gastrointestinal discomfort;
- liver disease, hepatitis (yellowing of the skin and/or eyes);
- kidney disorders (aggravated kidney failure), blood in the urine (haematuria),
- difficulty urinating (anuria, urinary retention);
- increased blood pressure (hypertension).

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