Active ingredients: Paracetamol, Vitamin C (ascorbic acid), Phenylephrine (Phenylephrine hydrochloride)
KOFIDEC powder for oral solution
Why is Kofidec used? What is it for?
WHAT IS IT"
KOFIDEC is a drug with analgesic, antipyretic and nasal decongestant activity.
WHY IT IS USED
KOFIDEC is used for the symptomatic treatment of flu, colds and related feverish and painful states, with a decongestant action on the upper upper airways.
Contraindications When Kofidec should not be used
WHEN IT SHOULD NOT BE USED
- Hypersensitivity to the active substances or to any of the excipients.
- Children under the age of 12.
- In patients taking beta-blockers, monoamine oxidase inhibitors and tricyclic antidepressants.
- In patients suffering from renal insufficiency, diabetes, hyperthyroidism, hypertension and cardiovascular diseases.
Precautions for use What you need to know before taking Kofidec
During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions may occur, including severe liver disease and changes in the kidney and blood.
Paracetamol products should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that impair liver function, glucose deficiency. 6- phosphate dehydrogenase, haemolytic anemia.
Also, before combining any other medication, contact your doctor (see also "Which medicines or foods can change the" effect of the medicine ").
Do not administer for more than 3 consecutive days without consulting your doctor.
The use of the product is not recommended if the patient is being treated with anti-inflammatories.
Interactions Which drugs or foods can modify the effect of Kofidec
WHICH MEDICINES OR FOODS MAY CHANGE THE EFFECT OF THE MEDICINAL PRODUCT
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The hepatotoxic effect of paracetamol can be enhanced by the intake of other drugs active on the liver.
Patients being treated with rifampicin, cimetidine or antiepileptic drugs such as glutethimide, phenobarbital, carbamazepine, should use paracetamol with extreme caution and only under strict medical supervision.
Paracetamol increases the half-life of chloramphenicol.
Paracetamol taken in high doses can potentiate the effect of coumarin anticoagulants.
Phenylephrine may reduce the efficacy of beta-blocking and antihypertensive drugs and may enhance the action of monoamine oxidase inhibitors.
Warnings It is important to know that:
It is important to know that:
The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and with that of blood sugar (by the method of glucose-oxidasiperoxidase).
When it can be used only after consulting your doctor
During pregnancy and breastfeeding (see "What to do during pregnancy and" breastfeeding "). It is advisable to consult your doctor even in cases where these problems have occurred in the past.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
During pregnancy and breastfeeding, KOFIDEC should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
Driving and using machines
KOFIDEC does not affect the ability to drive and use machines.
Important information about some of the ingredients of KOFIDEC
KOFIDEC contains sucrose: patients with rare hereditary problems of hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.
Dosage and method of use How to use Kofidec: Dosage
HOW TO USE THIS MEDICINAL PRODUCT
How many
Adults and children over 12 years: 1 sachet every 4-6 hours and up to a maximum of 3 sachets in 24 hours.
Children under the age of 12: the drug cannot be taken by children under the age of 12. Warning: do not exceed the indicated doses without medical advice.
When and for how long
Warning: use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Dissolve one sachet in a glass of very hot water and, if desired, dilute with cold water to cool and sweeten as desired.
Overdose What to do if you have taken too much Kofidec
WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF MEDICINAL PRODUCT
At the recommended doses, or even in the hypothesis in which the entire pack is taken, no symptoms of paracetamol overdose should appear. However, in the case of ingestion of very high doses of paracetamol (greater than 15 g), the most commonly encountered complication is liver damage, which usually occurs 2-4 days after ingestion. Early symptoms are nausea, vomiting and abdominal pain: the appropriate therapy recommended is gastric lavage using specific antidotes such as acetylcysteine or methionine. More than 10 hours after ingestion, a haemoperfusion may be necessary.
Other symptoms of overdose are caused by phenylephrine and are manifested by irritability, headache and increased blood pressure.
In case of accidental ingestion / intake of an excessive dose of KOFIDEC, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of KOFIDEC, ask your doctor or pharmacist.
Side Effects What are the side effects of Kofidec
Like all medicines, KOFIDEC can cause side effects, although not everybody gets them.
Skin reactions of various types and severities have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens Johnson syndrome and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, laryngeal edema, anaphylactic shock have been reported. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness.
With sympathomimetics (phenylephrine) skin irritation, tachycardia, hypertension and much more rarely nausea, vomiting or anorexia may occur occasionally.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
Do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored. Store below 25 ° C.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment. Keep this medicine out of the reach and sight of children.
Contents of the pack and other information
COMPOSITION
Each sachet contains: active ingredients: paracetamol 600 mg, ascorbic acid 40 mg, phenylephrine hydrochloride 10 mg. Excipients: sucrose, anhydrous citric acid, sodium citrate, corn starch, anhydrous colloidal silica, sodium cyclamate, sodium saccharin, lemon flavoring, honey flavoring, caramel flavoring.
HOW IT LOOKS
KOFIDEC is presented as a powder for oral solution. Each pack contains 10 sachets.
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
KOFIDEC POWDER FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
active principles: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder for oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of flu, colds and related feverish and painful states, with a decongestant action on the upper upper airways.
04.2 Posology and method of administration
Adults and children over 12 years: 1 sachet every 4-6 hours and up to a maximum of 3 sachets in 24 hours. Dissolve 1 sachet in half a glass of very hot water and, if desired, dilute with cold water to cool and sweeten as desired.
04.3 Contraindications
• Children under the age of 12.
• Hypersensitivity to the active substances or to any of the excipients.
• Patients taking beta-blockers, monoamine oxidase inhibitors and tricyclic antidepressants.
• Patients suffering from renal insufficiency, diabetes, hyperthyroidism, hypertension and cardiovascular diseases.
04.4 Special warnings and appropriate precautions for use
During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur.
Paracetamol products should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency, acute hepatitis, concomitant treatment with drugs that impair liver function, glucose-6 deficiency -phosphate dehydrogenase, haemolytic anemia.
Instruct the patient to contact the physician before combining any other medication (see also section 4.5).
The use of the product is not recommended if the patient is being treated with anti-inflammatories.
Do not administer for more than 3 consecutive days without consulting your doctor.
KOFIDEC contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
The hepatotoxic effect of paracetamol can be enhanced by the intake of other drugs active on the liver.
Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine) .
Paracetamol increases the half-life of chloramphenicol.
The product taken in high doses can enhance the effect of coumarin anticoagulants.
Phenylephrine can antagonize the effect of beta-blocking and antihypertensive drugs and can enhance the action of monoamine oxidase inhibitors.
Interference with some laboratory tests
The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and with that of blood glucose (by the method of glucose-oxidase-peroxidase).
04.6 Pregnancy and breastfeeding
The use during pregnancy is not contraindicated but requires caution; the administration of the preparation during pregnancy and lactation must take place under the direct supervision of the doctor and in case of real need.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive and use machines.
04.8 Undesirable effects
Skin reactions of various types and severities have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens Johnson syndrome and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, laryngeal edema, anaphylactic shock have been reported. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness.
With sympathomimetics (phenylephrine) skin irritation, tachycardia, hypertension and much more rarely nausea, vomiting or anorexia may occur occasionally.
04.9 Overdose
At the recommended doses, or even in the hypothesis in which the entire pack is taken, no symptoms of paracetamol overdose should appear. However, in the case of ingestion of very high doses of paracetamol (greater than 15 g), the most commonly encountered complication is liver damage, which usually occurs 2-4 days after ingestion. Early symptoms are nausea, vomiting and abdominal pain: the appropriate therapy recommended is gastric lavage using specific antidotes such as acetylcysteine or methionine. More than 10 hours after ingestion, a haemoperfusion may be necessary.
Other symptoms of overdose are caused by phenylephrine and are manifested by irritability, headache and increased blood pressure.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other analgesics / Paracetamol, combinations.
ATC code: N02BE51
KOFIDEC powder for oral solution contains paracetamol, vitamin C and phenylephrine hydrochloride and is indicated for the symptomatic treatment of flu and colds.
Paracetamol is a substance with analgesic and antipyretic properties ascribable to the inhibition of the cyclooxygenase of arachidonic acid with consequent inhibition of the biosynthesis of prostaglandins and thromboxanes responsible for the onset of the symptoms of inflammation, pain and fever present in the common cold.
Vitamin C exerts a protective effect on the vascular system and activates the body's defensive and immune powers. It is often introduced into cold combinations to compensate for the loss of vitamin C that occurs in the early stages of an acute viral infection including the common cold.
Phenylephrine hydrochloride is an aminosympathomimetic which is absorbed in the gastrointestinal tract and reaches the nasal mucosa. Phenylephrine hydrochloride induces vasoconstriction of congested microvessels of the nasal mucosa and consequently reduces secretion and promotes clearing of the airways.
05.2 Pharmacokinetic properties
Paracetamol is readily absorbed in the gastrointestinal tract and is distributed almost uniformly in most body fluids, is metabolized in the liver and excreted in the urine mainly in conjugated form as glucuronate and sulfate.
Vitamin C is a water-soluble vitamin; it is absorbed in the gastrointestinal tract and is widely distributed in the various tissues. 25% of absorbed vitamin C binds to plasma proteins. The amount in excess of the body's needs is metabolized and eliminated in the urine.
Phenylephrine hydrochloride is an aminosympathomimetic which is absorbed in the gastrointestinal tract and reaches the nasal mucosa.Absorbed phenylephrine is partially metabolised by intestinal and hepatic monooxidases and is completely eliminated in the urine as sulphate.
05.3 Preclinical safety data
Paracetamol:
Acute and chronic toxicity studies did not reveal any adverse effects. The LD50 for paracetamol administered orally varies from 850 to over 3000 mg / kg depending on the animal species used.
The hepatic toxicity of paracetamol in humans in case of overdose (10 g) is due to the formation, through the intervention of cytochrome P 450, of a small quantity (4%) of a reactive intermediate metabolite, which, in the absence of a adequate reserve of glutathione, it binds covalently to cellular macromolecules.
Ascorbic acid:
Its acute toxicity is practically nil.
Phenylephrine hydrochloride:
It has a LD50 equal to 350 mg / kg per os in rats, a dose significantly higher than that used in the clinic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sucrose, anhydrous citric acid, sodium citrate, corn starch, anhydrous colloidal silica, sodium cyclamate, sodium saccharin, lemon flavor, honey flavor, caramel flavor.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years
06.4 Special precautions for storage
Store below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Box of 10 paper / aluminum / polythene sachets.
06.6 Instructions for use and handling
Unused medicine and waste resulting from this medicine must be disposed of in accordance with current legislation.
07.0 MARKETING AUTHORIZATION HOLDER
Pool Pharma S.r.l. - Via Basilicata, 9 - 20098 San Giuliano Milanese (MI)
08.0 MARKETING AUTHORIZATION NUMBER
KOFIDEC powder for oral solution, 10 lemon and honey flavored sachets: AIC n. 041837016
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
19/12/2012
10.0 DATE OF REVISION OF THE TEXT
19/12/2012
