Influmed C 12 Effervescent Tablets

AIFA PACKAGE LEAFLET

PHARMACOTHERAPEUTIC CATEGORY:
Analgesics and antipyretics.

ACTIVE INGREDIENTS:
Film-coated tablets: paracetamol 500 mg, caffeine 25 mg, chlorphenamine maleate 8 mg, isopropamide iodide 0.2 mg.
Effervescent tablets with Vitamin C: paracetamol 500 mg, ascorbic acid 500 mg, caffeine 25 mg, chlorphenamine maleate 8 mg, isopropamide iodide 0.2 mg.

EXCIPIENTS:
Film-coated tablets: sodium starch glycolate, sodium saccharin, hypromellose, microcrystalline cellulose, lactose, colloidal silica, talc, magnesium stearate, macrogol 6000, macrogol 4000, titanium dioxide.
Effervescent tablets with Vitamin C: tartaric acid, glycine sodium carbonate, orange/lemon flavor, sodium saccharin, aspartame, sodium benzoate, sunset yellow (E110), sodium lauryl sulfate, sucrose.

INDICATIONS:
Symptomatic treatment of influenza, colds, and related febrile and painful conditions; treatment of acute and chronic inflammatory processes of the upper respiratory tract.

CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to the active ingredients, other closely related substances, or any of the excipients; hyperthyroidism; prostatic hypertrophy and glaucoma; the product is contraindicated in lower respiratory tract conditions, including asthma, in urinary retention syndromes, in stenosis of various segments of the gastrointestinal and urogenital tract, in stenosing gastric ulcer; paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and in those suffering from severe hemolytic anemia; severe hepatocellular insufficiency; contraindicated in patients undergoing concomitant treatment with monoamine oxidase inhibitors (MAOIs) and in the 2 weeks following such treatment, as the anticholinergic effects of chlorphenamine are potentiated by monoamine oxidase inhibitors; due to the presence of aspartame, a source of phenylalanine, effervescent tablets with vitamin C are contraindicated in patients with phenylketonuria; do not administer to children under 12 years of age; pregnancy and breastfeeding.

DOSAGE:
>>Adults and children 12 years and older.
Film-coated tablets: 1 tablet to be swallowed with half a glass of water, every 12 hours.
Effervescent tablets: 1 effervescent tablet to be dissolved in half a glass of plain water every 12 hours.
>>Elderly.
Film-coated tablets: 1 tablet to be swallowed with half a glass of water per day.
Effervescent tablets: 1 effervescent tablet to be dissolved in half a glass of plain water per day.
It is advisable to take the product on a full stomach.
Do not administer for more than 3 consecutive days without consulting a doctor.
Do not exceed the recommended doses.

STORAGE:
This medicine does not require any special storage conditions.

WARNINGS:
Patients with renal or hepatic impairment must consult a doctor before taking this medicine.
Administer with caution in patients with glutathione depletion states, such as sepsis, as the use of paracetamol may increase the risk of metabolic acidosis.
During treatment with paracetamol-based products, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur.
Advise the patient to contact the doctor before associating any other medicine.
High or prolonged doses of paracetamol can cause high-risk liver disease and even serious changes in the kidneys and blood.
Chlorphenamine, like other drugs with anticholinergic properties, should be administered with caution in case of epilepsy, severe hypertension, severe cardiovascular disorders, increased intraocular pressure (including glaucoma), prostatic hypertrophy, severe hepatic impairment, severe renal impairment, bronchitis, bronchiectasis, and bronchial asthma.
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision, and psychomotor impairment in some patients, which can seriously interfere with the ability to drive and use machinery.
Chlorphenamine can increase the effects of alcohol; therefore, concomitant use should be avoided.
The concomitant use of drugs that can cause sedation, such as anxiolytics and hypnotics, can lead to an increase in sedative effects; therefore, it is necessary to consult a doctor before taking chlorphenamine at the same time as these drugs.
Particular caution is required in determining the dose in the elderly and in pediatric subjects in consideration of the greater likelihood that they will experience anticholinergic neurological effects and paradoxical excitation (increased energy, agitation, nervousness).
The drug should not be used together with products containing antihistamines, including other cough and cold preparations containing antihistamines.
Excessive use of foods containing caffeine (e.g., coffee, tea, and some soft drinks) should be avoided while taking the drug.
Film-coated tablets contain lactose.
Effervescent tablets with vitamin C contain sucrose; this should be taken into account in case of diabetes or low-calorie diets.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase insufficiency must not take the drug with vitamin C.
The excipient sunset yellow E110, in effervescent tablets, can cause allergic reactions.
Each effervescent tablet with vitamin C contains 177.3 mg of sodium; this should be taken into account in patients on a low-sodium diet.
If symptoms persist, consult your doctor.

INTERACTIONS:
Use with extreme caution and under strict supervision during chronic treatment with drugs that may induce hepatic monooxygenases or in case of exposure to substances that may have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine).
The administration of paracetamol may interfere with the determination of uricemia (by the phosphotungstic acid method) and glycemia (by the glucose oxidase-peroxidase method).
The anticoagulant effect of warfarin and other coumarin derivatives may be enhanced by the regular and prolonged use of paracetamol, with an increased risk of bleeding; occasional intake has no significant effects.
The use of the product is not recommended if the patient is being treated with anti-inflammatories.
The concomitant use of chlorphenamine and hypnotic, anxiolytic, and sedative drugs may potentiate drowsiness.
The concomitant use of alcohol may have similar effects.
Chlorphenamine inhibits the metabolism of phenytoin with the consequent possible manifestation of toxic effects from phenytoin.
The anticholinergic effects of chlorphenamine are potentiated by monoamine oxidase inhibitors.

SIDE EFFECTS:
Blood and lymphatic system disorders: thrombocytopenia, leukopenia, anemia, agranulocytosis.
Immune system disorders: hypersensitivity reactions such as angioedema, laryngeal edema, anaphylactic shock.
Metabolism and nutrition disorders: anorexia.
Psychiatric disorders: nervousness, confusion, excitement, irritability, nightmares.
Nervous system disorders: sedation, drowsiness, insomnia, attention disorders, abnormal coordination, dizziness, headache.
Eye disorders: visual function disorders, blurred vision.
Cardiac disorders: palpitations, tachycardia, arrhythmias.
Vascular disorders: hypotension, hot flashes.
Respiratory, thoracic, and mediastinal disorders: bronchospasm in patients sensitive to aspirin and other non-steroidal anti-inflammatory drugs, thickening of bronchial secretions.
Gastrointestinal disorders: nausea, dry mouth, vomiting, abdominal pain, diarrhea, dyspepsia.
Hepatobiliary disorders: abnormal liver function and hepatitis.
Skin and subcutaneous tissue disorders: exfoliative dermatitis, skin rashes, urticaria, photosensitivity.
Very rare cases of serious skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported.
Musculoskeletal and connective tissue disorders: muscle contractions, muscle weakness.
Renal and urinary disorders: acute renal failure, interstitial nephritis, hematuria, anuria, urinary retention.
General disorders and administration site conditions: fatigue, chest tightness.
When the recommended dosage of the product is associated with caffeine intake in the diet, it is possible that there may be an increase in the potential side effects associated with caffeine, such as insomnia, agitation, anxiety, irritability, headache, gastrointestinal disturbances, and palpitations.
Reporting suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows for continuous monitoring of the benefit/risk ratio of the medicinal product.

PREGNANCY AND BREASTFEEDING:
The medicine must not be used during pregnancy and breastfeeding.