CORYFINORO 600 mg/10 mg Granulki W Saszetkach

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

CORYFINORO Influenza e Raffreddore

600 mg/10 mg granules for oral solution
Paracetamol/phenylephrine hydrochloride

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 a short period of treatment.

Contents of this leaflet:

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

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

CORYFINORO 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.
CORYFINORO 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.
CORYFINORO Influenza e Raffreddore is indicated for adults and children over 12
years.
See a doctor if you do not feel better or if you feel worse after 3 days.

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

Do not take CORYFINORO 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 disease);
• 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 tumor 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 psychostimulants similar to amphetamines);
• if you suffer from severe hepatic insufficiency;
• if you have liver or kidney problems; 1 of 5
• 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 disease that leads to a decrease in red blood cell count);
• if you suffer from severe hemolytic anemia (abnormal breakdown of blood cells). Do not use the medicine in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking CORYFINORO Influenza e Raffreddore:

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

During treatment with CORYFINORO Influenza e Raffreddore, immediately inform your
doctor if:

• you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

Do not use CORYFINORO Influenza e Raffreddore for more than 3 consecutive days without consulting your
doctor.
Do not drink alcohol during treatment with CORYFINORO Influenza e Raffreddore.
If you are taking anti-inflammatory drugs, the use of CORYFINORO Influenza e Raffreddore is
not recommended (see section 2 “Other medicines and CORYFINORO Influenza e Raffreddore”).
Do not take the medicine in combination with other medicines containing paracetamol. If
paracetamol is taken in high doses, serious adverse reactions may occur, including severe
liver damage and alterations in the kidneys and blood.
Paracetamol may interfere with tests to determine blood sugar levels (in
people with diabetes) and uric acid levels (in people with gout).

Other medicines and CORYFINORO Influenza e Raffreddore
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular it is important to inform your doctor or pharmacist if you are taking any of the following
medicines:

• medicines that can alter liver function, such as zidovudine or isoniazid, which may increase the harmful effect of paracetamol on the liver;
• medicines that can alter the urinary excretion of paracetamol, such as probenecid;
• medicines that contain rifampicin (used in the treatment of tuberculosis), cimetidine (used in the treatment of stomach ulcers) or medicines such as glutethimide, phenobarbital, carbamazepine (used in the treatment of epilepsy); when taken together with paracetamol these medicines must be used with extreme caution and under strict medical supervision;
• medicines used in the treatment of eye infections such as chloramphenicol;
• medicines used to delay blood clotting or prevent coagulation, e.g. warfarin, as paracetamol taken at high doses may lead to an increased risk of bleeding;

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• medicines that can accelerate (e.g. metoclopramide, domperidone) or reduce/delay (e.g. colestyramine, anticholinergics) the absorption of paracetamol;
• medicines used in the treatment of high blood pressure that contain beta-blockers;
• medicines that contain monoamine oxidase inhibitors (see also the section “Do not take CORYFINORO Influenza e Raffreddore);
• medicines that contain tricyclic antidepressants or sympathetic amine mimetics;
• medicines prescribed for heart failure (digoxin);
• medicines used in the treatment of migraine such as ergotamine and methysergide;
• anti-inflammatory medicines;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs urgent treatment (see paragraph 2).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of CORYFINORO Influenza e Raffreddore is not recommended during pregnancy and breastfeeding;
use CORYFINORO Influenza e Raffreddore only after consulting your doctor.

Driving and operating machinery
CORYFINORO Influenza e Raffreddore does not impair your ability to drive or operate machinery.
However, if you experience dizziness, you should not drive or operate machinery.

CORYFINORO 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 disease that causes a build-up of phenylalanine because the body cannot dispose of it properly Sodium contentThis medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take CORYFINORO 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.

Dosage
Adults and children over 12 years: 1 sachet every 4-6 hours up to a maximum of 3 sachets in 24 hours.
Use in children
Use is contraindicated in children under 12 years of age.
Do not take more than the recommended dose without consulting your doctor.

Instructions for use
Place the granules directly on the tongue and swallow. CORYFINORO Influenza e Raffreddore dissolves with saliva: this allows its use without water.
You can also dissolve the contents of one sachet in a glass of warm (not boiling) water, mixing with a teaspoon. If desired, you can dilute with cold water to cool and sweeten.
Once prepared, drink the solution within a few minutes.

Warning:This product should be used for a short period of treatment.
Do not take this medicine for more than 3 consecutive days without consulting your doctor.
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Consult your doctor if symptoms persist or if you notice any new change in their characteristics.

If you take more CORYFINORO Influenza e Raffreddore than you should
If you or someone else takes more CORYFINORO Influenza e Raffreddore than you should, or if you think a child has swallowed the contents of the sachet, go immediately to the nearest hospital or doctor, even if you feel well, and bring this leaflet, the remaining sachets and the box with you. In case of accidental intake of high doses of this medicine, paleness, nausea, vomiting, loss of appetite (anorexia), abdominal pain, alteration of blood sugar levels (glucose metabolism anomalies) and accumulation of acids in the body (metabolic acidosis) may occur.
In severe poisoning, liver failure may be complicated by brain damage (encephalopathy, cerebral edema), blood loss (hemorrhage), reduction of blood glucose (hypoglycemia), and death. Even in the absence of severe liver damage, a reduction in kidney function (acute renal failure) may occur, which manifests with kidney damage (acute tubular necrosis), blood loss in the urine (hematuria) and protein loss in the urine (proteinuria).
Alterations of the heartbeat (cardiac arrhythmias) and inflammation of the pancreas (pancreatitis) may also occur.
Irritability, headache, and increased blood pressure may also occur. In the most severe cases, confusion, hallucinations and convulsions may occur. High doses of the medicine can cause a short-lived liquid diarrhea (transient osmotic diarrhea).
If you have any doubts about 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.
The following list includes the side effects of paracetamol and phenylephrine.
The side effects are presented 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 1000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: the frequency cannot be estimated from the available data.

Immediately stop taking CORYFINORO Influenza e Raffreddore and
consult a doctor or go to hospital immediately 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 polymorphous);
• breathing problems (bronchospasm). If you experience any of the following side effects, consult 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 1000 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 (feeling of heartbeats 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):

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• insomnia (difficulty sleeping), nervousness, anxiety, agitation, confusion, irritability;
• tremor (shaking), dizziness, headache;
• with prolonged use of high doses of paracetamol, interstitial nephrosis (kidney inflammation) and kidney-related side effects may occur. Not known (the frequency cannot be estimated from the available data):
• anemia (decreased hemoglobin levels in the blood);
• mydriasis (pupil dilation), acute closed-angle glaucoma (an eye disease often associated with increased fluid pressure in the eye);
• laryngeal edema (swelling of the throat);
• diarrhea, gastrointestinal discomfort;
• liver diseases, hepatitis (yellowing of the skin and/or eyes);
• kidney disorders (worsening of renal failure), blood in the urine (hematuria);
• difficulty urinating (anuria, urinary retention);
• increased blood pressure (hypertension);
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

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

This medicine does not require any particular storage temperature.
Store in the original container to protect the medicine from humidity and light.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers to the
last day of that month.
It is important to always have the product information with you. Keep the package and the leaflet.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.

6. Contents of the pack and other information

What CORYFINORO Influenza e Raffreddore contains
The active ingredients are: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg).
The other ingredients are: mannitol (E 421), Xylitab 200 (xylitol, sodium carboxymethylcellulose),
lemon flavour, sorbitol (E 420), ascorbic acid, citric acid, hydrated colloidal silica, aspartame
(E 951), sodium saccharin.

Description of the appearance of CORYFINORO Influenza e Raffreddore and contents of the pack
CORYFINORO Influenza e Raffreddore is presented in sachets containing a granular powder of colour
from white to ivory.
CORYFINORO Influenza e Raffreddore is available in packs containing 10 and 16 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Laboratorio Farmaceutico S.I.T. S.r.l., via Cavour 70, 27035 Mede (PV)
Manufacturer: E-Pharma Trento S.p.A., via Provina 2, 38123 Trento (TN)
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