ILMODEC Farmitalia 8 Effervescent Tablets

ILMODEC Farmitalia - Medical Device

Febrile states, especially of flu origin, accompanied by colds or nasal congestion.

One tablet contains

Active ingredients: paracetamol 500 mg, pseudoephedrine hydrochloride 60 mg.

Excipients : sorbitol, aspartame, sodium. For the full list of excipients, see section 6.1

Contraindications

The drug is contraindicated in children younger than 12 years. Pregnancy and breastfeeding. Hypersensitivity to the active substances or to any of the excipients Severe cardiovascular disease, hypertension, hyperthyroidism, glaucoma and prostatic hypertrophy. Do not use in patients treated with MAO inhibitor drugs or tricyclic antidepressants or if such treatment has not been stopped for at least two weeks. The product is contraindicated in patients being treated with anti-inflammatories. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose 6-phosphate dehydrogenase and in those suffering from severe haemolytic anemia. Severe hepatocellular insufficiency. Due to the presence of aspartame, the product is contraindicated in patients with phenylketonuria.

Dosage

Adults and children over 12 years: 1 effervescent tablet (equal to 500 mg of Paracetamol and 60 mg of Pseudoephedrine hydrochloride). These doses can be repeated up to three times a day. The drug should be taken on a full stomach. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. Dissolve the tablet or half tablet in a glass of water and immediately drink the solution obtained.

Warnings and Precautions

Administer with caution in subjects with renal and hepatic insufficiency and in elderly patients since in the latter it may occasionally cause spasm of the bladder sphincter with urinary retention. Do not administer for more than three consecutive days without consulting your doctor. High or prolonged doses of the product can cause high-risk liver disease and even serious changes in the kidney and blood. The drug should be taken on a full stomach. The use of the product is not recommended if the patient is being treated with anti-inflammatories. During therapy with oral anticoagulants it is recommended to reduce the doses. In cases of allergic reactions, administration must be suspended. Avoid alcohol intake during therapy. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses. Instruct the patient to contact the physician before associating any other medication. See also section "Interactions". This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Keep this medicine out of the reach and sight of children.

Interactions

The use of Saniduo fever and stuffy nose at the same time as sympathomimetic agents (such as decongestants, anorectics and amphetamine-like) or MAO inhibitors should be avoided as it may occasionally cause increases in blood pressure. Furazolidone causes a progressive inhibition of monoamine oxidase and therefore should not be taken at the same time as Saniduo fever and stuffy nose. The effect of antihypertensives that interfere with sympathetic activity (eg methyldopa, beta-blockers, debrisoquine, guanethidine, betanidine and bretylium tosylate), can be partially canceled by Saniduo fever and stuffy nose. 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) . The administration of paracetamol can interfere with the determination of uricaemia (by the phospho-tungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method).

Side effects

Excitation and, more rarely, arrhythmias, palpitations, tachycardia, muscle tremors have been reported in sensitive subjects and with high doses, which normally disappear with dose adjustment. Nausea, vomiting, headache, dry nose and throat may sometimes occur; sleep disturbances and hallucinations have rarely been reported. 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.

Pregnancy and breastfeeding

In pregnant and lactating women the product is contraindicated.

Format

Pack of 8 effervescent tablets.