Active ingredients: Menthol (menthol ethylglycolate), Vitamin C (sodium ascorbate)
Coryfin 2.8 mg + 16.8 mg lozenges
Indications Why is Coryfin used? What is it for?
Coryfin is used to treat cough and voice changes (hoarseness) because it relieves throat irritation and reduces phlegm, even in smokers.
Talk to your doctor if you don't feel better or if you feel worse after three days.
Contraindications When Coryfin should not be used
Do not use Coryfin
- if you are allergic to the active substances or to any of the other ingredients of this medicine;
- in children under 30 months of age;
- in children suffering from epilepsy;
- in children who have had convulsions (violent and involuntary muscle contractions) related to fever (febrile convulsions).
Precautions for use What you need to know before taking Coryfin
Talk to your doctor or pharmacist before using Coryfin.
This product contains menthol, a balsamic substance (terpene derivative) which, in large quantities, can cause convulsions in infants and children.
Do not use this medicine for more than 3 days, to prevent some substances contained in this medicine, terpene derivatives, from accumulating in your body and brain.
Do not exceed the recommended dose (see section 3 "If you use more Coryfin than you should" and section 4 "Undesirable effects").
The product is flammable, keep away from flames.
Interactions Which drugs or foods can modify the effect of Coryfin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Coryfin should not be used together with other products (medicinal or cosmetic) that contain terpene derivatives (such as: camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine ).
Coryfin with food, drink and alcohol
There are no known interactions.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicine is not recommended during pregnancy and in women of childbearing potential who do not use methods to avoid pregnancy.
This medicine should not be used during breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Coryfin contains glucose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product contains 0.9 g of sucrose per tablet and 1.1 g of glucose per tablet. To be taken into consideration in people with diabetes mellitus.
Dose, Method and Time of Administration How to use Coryfin: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not exceed the indicated doses.
The recommended dose is one tablet every 1 - 2 hours, up to a maximum of 8 tablets per day.
Use in children
This medicine should not be used in children below 30 months of age.
In children over 30 months of age, the dose should be halved (up to a maximum of 4 tablets per day).
Duration of treatment: The duration of treatment should not exceed 3 days.
Overdose What to do if you have taken too much Coryfin
In case of mistakenly ingesting this medicine by infants, or taking doses higher than those indicated in children, there may be a risk of convulsions (violent and involuntary contractions of the muscles) due to the presence of menthol. In such cases, immediately go to the nearest emergency room or contact a doctor.
Side Effects What are the side effects of Coryfin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, sensitization phenomena (excessive reaction of the organism to foreign substances with which it has come into contact, which can lead to allergy) or irritation may occur.If this happens, stop the treatment and consult a doctor.
Additional side effects in children
If you take doses higher than those indicated, violent and involuntary contractions of the muscles (convulsions) may occur in children due to the presence of menthol (see also section 3 "If you use more Coryfin than you should").
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Coryfin contains In a Coryfin tablet
- The active ingredients are: menthol ethylglycolate 2.8 mg, sodium ascorbate 16.8 mg (equal to 15 mg of ascorbic acid or Vitamin C).
- The other ingredients are: menthol, citric acid, lemon essence, sucrose, glucose.
What Coryfin looks like and contents of the pack
Coryfin comes in a box containing 24 tablets in blisters.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CORYFIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Coryfin 6.5 mg + 18 mg lozenges
Active principles:
menthol ethylglycolate 6.5 mg;
sodium ascorbate 18.0 mg equal to 16 mg of ascorbic acid (Vitamin C).
Excipients with known effects: glucose 0.9 g, sucrose 1.1 g.
Coryfin 2.8 mg + 16.8 mg lozenges
Active principles:
menthol ethylglycolate 2.8 mg;
sodium ascorbate 16.8 mg equal to 15 mg of ascorbic acid (Vitamin C).
Excipients with known effects: glucose 0.9 g, sucrose 1.1 g.
Coryfin 6.5 mg + 112.5 mg lozenges
Active principles:
menthol ethylglycolate 6.5 mg;
sodium ascorbate 112.5 mg equal to 100 mg of ascorbic acid (Vitamin C).
Excipients with known effects: glucose 0.8 g, sucrose 1 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablet.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic in the treatment of cough and hoarseness.
Coryfin relieves local irritation and reduces phlegm, even in smokers.
04.2 Posology and method of administration
Dosage
Coryfin 6.5 mg + 18 mg and Coryfin 2.8 mg + 16.8 mg:
One tablet every 1-2 hours, up to a maximum of 8 tablets per day.
Coryfin 6.5 mg + 112.5 mg:
One tablet every 2-3 hours, up to a maximum of 6 tablets per day.
Pediatric population
In children over 30 months, halve the doses.
Do not exceed the indicated doses.
The duration of the treatment should not exceed 3 days.
04.3 Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Children up to 30 months of age.
- Children with a history of epilepsy or febrile seizures.
04.4 Special warnings and appropriate precautions for use
This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.
The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders.
A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9).
The product is flammable, it must not be approached to flames.
Coryfin contains glucose. Patients with rare glucose-galactose malabsorption problems should not take this medicine.
Coryfin contains sucrose. Patients with rare problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
To be taken into consideration in people with diabetes mellitus.
04.5 Interactions with other medicinal products and other forms of interaction
Coryfin should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).
04.6 Pregnancy and breastfeeding
Pregnancy
There are no or limited amount of data on the use of menthol in pregnant women.
Coryfin is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
Feeding time
There is insufficient information on the excretion of menthol in breast milk. Coryfin should not be used during breastfeeding.
04.7 Effects on ability to drive and use machines
This medicine does not affect the ability to drive or use machines.
04.8 Undesirable effects
In rare cases of sensitizing or irritating effects, discontinue use and institute appropriate therapy.
Pediatric population
Due to the presence of menthol and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
There are no known effects of overdose.
Pediatric population
In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders.
If necessary, administer appropriate symptomatic treatment in specialized treatment centers.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: preparations for cough and colds. Expectorants.
ATC code: R05CA10.
Mechanism of action
Menthol ethylglycolate is a particularly active derivative of menthol, with balsamic-emollient properties.
Ascorbic acid, or vitamin C, actively intervenes in cellular redox processes: therefore there is no body tissue that is not affected by this water-soluble vitamin.
Clinical efficacy and safety
Terpene derivatives can lower the epileptogenic threshold.
05.2 Pharmacokinetic properties
Absorption
Ascorbic acid, or vitamin C, is a water-soluble vitamin, which is absorbed from the gastro-enteric tract.
Distribution
Ascorbic acid is widely distributed in tissues. Its concentration is higher in leukocytes and platelets than in erythrocytes or plasma.
Elimination
Excess ascorbic acid is rapidly eliminated in the urine, generally resulting in a slight diuresis. There is therefore no danger of accumulation.
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
One tablet of Coryfin 6.5 mg + 18 mg contains: menthol-eucalyptol flavor, citric acid, sucrose, glucose.
One tablet of Coryfin 2.8 mg + 16.8 mg contains: menthol, citric acid, lemon essence, sucrose, glucose.
One tablet of Coryfin 6.5 mg + 112.5 mg contains: menthol, mandarin aroma, citric acid, sucrose, glucose.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Coryfin 6.5 mg + 18 mg comes in a box containing 24 tablets in PVC-PVDC-Al blisters.
Coryfin 2.8 mg + 16.8 mg comes in a box containing 24 tablets in PVC-PVDC-Al blisters.
Coryfin 6.5 mg + 112.5 mg comes in a box containing 24 tablets in PVC-PVDC-Al blisters.
06.6 Instructions for use and handling
No special instructions for disposal.
07.0 MARKETING AUTHORIZATION HOLDER
Pharmaceutical Laboratory SIT S.r.l. - Via Cavour 70 - 27035 Mede (PV).
08.0 MARKETING AUTHORIZATION NUMBER
Coryfin 6,5 mg + 18 mg - 24 A.I.C. n. 012377026
Coryfin 2.8 mg + 16.8 mg - 24 A.I.C. n. 012377089
Coryfin 6.5 mg + 112.5 mg - 24 A.I.C. n. 012377053
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Coryfin 6.5 mg + 18 mg - 24 tablets:
Date of first authorization: 25/06/1981
Date of most recent renewal: 01/06/2010
Coryfin 2.8 mg + 16.8 mg - 24 tablets:
Date of first authorization: 25/06/1981
Date of most recent renewal: 01/06/2010
Coryfin 6.5 mg + 112.5 mg - 24 tablets:
Date of first authorization: 25/06/1981
Date of most recent renewal: 01/06/2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of 24/06/2014
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