Coryfinoro for influenza and cold

Package leaflet: Information for the user

CORYFINORO Influenza and Cold

600 mg/10 mg granules in sachet
Paracetamol/phenylephrine hydrochloride
Please read all of 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, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

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

CORYFINORO Influenza e Raffreddore is a medicine containing the active substances paracetamol and
phenylephrine hydrochloride, used for the treatment of pain, fever, and nasal congestion.
CORYFINORO 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.
CORYFINORO Influenza e Raffreddore is indicated for adults and children over 12 years of age.
Consult a doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before taking CORYFINORO Cold and Flu

Do not take CORYFINORO Cold and Flu

• if you are allergic to paracetamol, hydrochloride phenylephrine, 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 have bronchial asthma;
• if you have phaeochromocytoma (a tumor 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, or amphetamine-like psychostimulants);
• if you have severe liver failure;
• if you have liver or kidney problems; 1 of 5
• if you have 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 condition 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 CORYFINORO Cold and Flu:

• if you are taking other medicines (see also “Other medicines and CORYFINORO Cold and Flu”);
• 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 (CORYFINORO Cold and Flu contains sodium).

During treatment with CORYFINORO Cold and Flu, inform your doctor immediately 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 use CORYFINORO Cold and Flu for more than 3 consecutive days without consulting your doctor.
Do not drink alcohol while taking CORYFINORO Cold and Flu.
If you are taking anti-inflammatory medicines, the use of CORYFINORO Cold and Flu is not recommended (see section 2 “Other medicines and CORYFINORO Cold and Flu”).
Do not take this 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 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 CORYFINORO Cold and Flu
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly 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 alter 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 strict 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;

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• medicines that may speed up (e.g. metoclopramide, domperidone) or reduce/delay (e.g. colestyramine, anticholinergics) the absorption of paracetamol;
• medicines used to treat high blood pressure that contain beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take CORYFINORO Cold and Flu”);
• 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 abnormalities (called metabolic acidosis) that requires urgent treatment (see section 2).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of CORYFINORO Cold and Flu is not recommended during pregnancy or breastfeeding; use CORYFINORO Cold and Flu only after consulting your doctor.
Driving and using machines
CORYFINORO Cold and Flu does not affect your ability to drive or operate machinery.
However, if you experience dizziness, you should not drive or operate machinery.
CORYFINORO Cold and Flu 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 CORYFINORO 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.
Dosage
Adults and children over 12 years: 1 sachet every 4–6 hours, up to a maximum of 3 sachets within 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. CORYFINORO Influenza and Cold dissolves with saliva, allowing 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 dilute it further with cold water to cool and sweeten the solution. Once prepared, drink the solution within a few minutes.
Warning: This product is intended for short-term use only.
Do not take this medicine 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 CORYFINORO Influenza and Cold than you should
If you or someone else takes more CORYFINORO Influenza and Cold than recommended, or if you suspect a child has swallowed the contents of a sachet, go immediately to the nearest hospital or see a doctor, even if you feel well. Bring this leaflet, any remaining sachets, and the pack with you. In case of accidental ingestion of high doses of this medicine, symptoms such as pallor, nausea, vomiting, loss of appetite (anorexia), abdominal pain, disturbances in blood sugar levels (glucose metabolism abnormalities), and accumulation of acids in the body (metabolic acidosis) may occur.
In severe poisoning, liver failure may progress to brain damage (encephalopathy, cerebral edema), bleeding (haemorrhage), low blood sugar (hypoglycaemia), and death. Even in the absence of severe liver damage, reduced kidney function (acute renal failure) may occur, manifesting as kidney injury (acute tubular necrosis), blood in the urine (haematuria), and protein in the urine (proteinuria).
Changes in heart rhythm (cardiac arrhythmias) and inflammation of the pancreas (pancreatitis) may also occur.
Other possible symptoms include irritability, headache (cephalalgia), and increased blood pressure. In more severe cases, confusion, hallucinations, and seizures may develop. High doses of the medicine may cause a brief episode of watery diarrhoea (transient osmotic diarrhoea).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 CORYFINORO Influenza and Cold immediately and contact your doctor or go to hospital immediately 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 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, 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 that may appear as unexplained bruising, paleness, or reduced resistance to infection; decrease 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 falling asleep), nervousness, anxiety, restlessness, confusion, irritability;
• Tremor (trembling), dizziness, headache;
• Following prolonged use of high doses of paracetamol, interstitial nephrosis (kidney inflammation) and adverse effects on the kidneys may occur.

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

• Anaemia (decrease in haemoglobin levels in the blood);
• Mydriasis (dilation of the pupil), 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 disorders, hepatitis (yellowing of the skin and/or eyes);
• Kidney disorders (worsening of renal failure), blood in the urine (haematuria);
• Difficulty urinating (anuria, urinary retention);
• Increased blood pressure (hypertension);
• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness using paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 CORYFINORO Influenza and Cold

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 package. The expiry date refers to the last day of that month.
It is important to always keep the product information available. Keep the outer carton and the leaflet.
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.
Keep this medicine out of the sight and reach of children.

6. Package contents and other information

What CORYFINORO Cold and Flu 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, sodium carboxymethylcellulose),
lemon flavour, sorbitol (E 420), ascorbic acid, citric acid, colloidal hydrated silica, aspartame (E 951), sodium saccharin.
Description of the appearance of CORYFINORO Cold and Flu and pack contents
CORYFINORO Cold and Flu comes in sachets containing a granulate ranging in colour from white to ivory.
CORYFINORO Cold and Flu is available in cardboard boxes containing 10 or 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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