Zerinofebb 300mg + 150mg 15 tablets

Zerinofebb 300mg + 150mg 15 tablets is a drug formulated for the symptomatic treatment of acute febrile processes of the respiratory system in adults . Each tablet contains two active ingredients: paracetamol 300 mg and sobrerol 150 mg , which act synergistically to relieve the symptoms associated with feverish states and respiratory congestion. Paracetamol is known for its analgesic and antipyretic properties, while sobrerol has a mucolytic action, facilitating the fluidification of mucus in the respiratory tract. This product is particularly suitable for those seeking rapid and effective relief from flu and cold symptoms. Packaged in practical tablets, Zerinofebb offers a convenient and easy-to-take solution to manage feverish and respiratory symptoms.

ACTIVE INGREDIENTS

Active ingredients contained in Zerinofebb 300mg + 150mg 15 tablets - What is the active ingredient of Zerinofebb 300mg + 150mg 15 tablets?

One tablet contains: active ingredients: paracetamol 300 mg, sobrerol 150 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Zerinofebb 300mg + 150mg 15 tablets - What does Zerinofebb 300mg + 150mg 15 tablets contain?

Calcium hydrogen phosphate dihydrate, maize starch, talc, magnesium stearate, povidone, microcrystalline cellulose, sodium starch glycolate (Type A).

DIRECTIONS

Therapeutic indications Zerinofebb 300mg + 150mg 15 tablets - Why is Zerinofebb 300mg + 150mg 15 tablets used? What is it used for?

Symptomatic treatment of acute febrile processes of the respiratory system in adults.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Zerinofebb 300mg + 150mg 15 tablets - When should Zerinofebb 300mg + 150mg 15 tablets not be used?

• Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1; • Patients with manifest glucose-6-phosphate dehydrogenase deficiency; • Patients with severe haemolytic anaemia; • Severe hepatocellular insufficiency; • Severe alterations in renal function; • Severe alterations in blood count.

DOSAGE

Quantity and method of taking Zerinofebb 300mg + 150mg 15 tablets - How to take Zerinofebb 300mg + 150mg 15 tablets?

Adults: 2 - 4 tablets per day The product is contraindicated in patients with severe hepatocellular insufficiency and in patients with severe alterations of renal function (see section 4.3). Administer with caution in subjects with renal or hepatic insufficiency (see section 4.4). Do not exceed the maximum total daily dosage.

CONSERVATION

Storage Zerinofebb 300mg + 150mg 15 tablets - How to store Zerinofebb 300mg + 150mg 15 tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Zerinofebb 300mg + 150mg 15 tablets - About Zerinofebb 300mg + 150mg 15 tablets it is important to know that:

High or prolonged doses of the product may cause even serious alterations to the kidney and blood count and high-risk liver disease. Do not use outside the acute febrile phase. Do not administer for more than 3 consecutive days without consulting your doctor. In patients being treated with anticoagulants, the product should be administered at a reduced dosage. Administer with caution in subjects with renal or hepatic insufficiency. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Hepatotoxicity with paracetamol may occur even at therapeutic doses, after short-term treatment and in patients without pre-existing liver dysfunction (see section “Undesirable effects”). Caution is recommended in patients with a history of sensitivity to aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs). Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. Patients should be informed of the signs and symptoms and monitored closely for skin reactions. If symptoms or signs of Stevens-Johnson syndrome, toxic epidermal necrolysis or acute generalized exanthematous pustulosis (e.g. progressive skin rash associated with blisters or mucosal lesions) occur, the patient should immediately stop treatment with paracetamol and consult a doctor. The use of ZERINOFEBB, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. The administration of ZERINOFEBB must be suspended in women who have fertility problems or who are undergoing investigations of fertility. Instruct the patient to contact the doctor before combining any other drug. See also the entry “Interactions with other medicinal products and other forms of interaction”.

INTERACTIONS

Interactions Zerinofebb 300mg + 150mg 15 tablets - Which medicines or foods can modify the effect of Zerinofebb 300mg + 150mg 15 tablets?

Use with extreme caution and under close monitoring 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 cimetidine). The risk of paracetamol toxicity may be increased in patients taking other potentially hepatotoxic drugs or drugs that induce hepatic microsomal enzymes, such as some antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol. The administration of paracetamol may interfere with the determination of uric acid (by the phosphotungstic acid method) and with that of glycaemia (by the glucose-oxidase-peroxidase method). Drugs that slow gastric emptying (e.g. propantheline) may reduce the rate of absorption of paracetamol, delaying its therapeutic effect; Conversely, drugs that increase the rate of gastric emptying (e.g. metoclopramide, domperidone) lead to an increase in the rate of absorption. Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking paracetamol and vitamin K antagonists should be monitored for appropriate coagulation and the occurrence of bleeding. The presence of paracetamol in the product increases the plasma levels of aspirin and chloramphenicol. Concomitant use of NSAIDs or opioids may result in mutual potentiation of the analgesic effect. Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, in patients with risk factors for glutathione depletion. Paracetamol increases the AUC of ethinyl estradiol by 22%. Paracetamol may reduce the plasma concentration of lamotrigine.

SIDE EFFECTS

Like all medicines, Zerinofebb 300mg + 150mg 15 tablets can cause side effects - What are the side effects of Zerinofebb 300mg + 150mg 15 tablets?

Skin and subcutaneous tissue disorders : Erythema, urticaria, rash, fixed drug eruption. Very rare cases of severe skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS) and acute generalised exanthematous pustulosis have been reported (see section 4.4 Special warnings and precautions for use ). Immune system disorders : Hypersensitivity reactions such as angioedema, laryngeal oedema, anaphylactic shock. Blood and lymphatic system disorders : Thrombocytopenia, neutropenia, leukopenia. Agranulocytosis, haemolytic anaemia in patients with basic glucose-6-phosphate dehydrogenase deficiency. Hepatobiliary disorders : Abnormal liver function and hepatitis. Cytolytic hepatitis which may lead to acute liver failure. Renal and urinary disorders : Acute renal failure, interstitial nephritis, haematuria, anuria. Gastrointestinal disorders : Gastrointestinal reactions. Ear and labyrinth disorders : Vertigo. Cardiac disorders : Kounis syndrome. Respiratory, thoracic and mediastinal disorders : Bronchospasm. The reported adverse reactions require the interruption of treatment and the institution of appropriate therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued 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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Zerinofebb 300mg + 150mg 15 tablets - What are the risks of Zerinofebb 300mg + 150mg 15 tablets in case of overdose?

Symptoms of paracetamol overdose are pallor, nausea, vomiting, anorexia and abdominal pain and generally appear during the first 24 hours after paracetamol overdose. Paracetamol overdose may cause hepatic cytolysis which can lead to hepatocellular failure, gastrointestinal bleeding, metabolic acidosis, encephalopathy, coma and death. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with a reduction in prothrombin levels may occur 12 to 48 hours after acute overdose. Overdose may also lead to pancreatitis, acute renal failure and pancytopenia. In severe cases, hepatic failure due to cellular necrosis may occur. Regarding sobrerol, there are no data in the literature regarding symptoms of overdose.

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 for advice before taking Zerinofebb 300mg + 150mg 15 tablets.

Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, in case of pregnancy or breastfeeding use only in case of real need under the direct supervision of a doctor.

DRIVING AND USE OF MACHINERY

Taking Zerinofebb 300mg + 150mg 15 tablets before driving or using machines - Does Zerinofebb 300mg + 150mg 15 tablets affect driving or using machines?

Due to the possible onset of dizziness, the product may alter the ability to drive vehicles or use machinery.