Fluental Children 250mg + 100mg Paracetamol 10 Suppositories

NAME
FLUENTAL

PHARMACOTHERAPEUTIC CATEGORY
Paracetamol, combinations except psycholeptics.

ACTIVE PRINCIPLES
Tablets: paracetamol 300 mg, sobrerol 150 mg. Children 250mg + 100mg suppositories: paracetamol 250mg, sobrerol 100mg. Adults 500 mg + 200 mg suppositories: paracetamol 500 mg, sobrerol 200 mg. Syrup: 100 ml of syrup contain 1.28 g paracetamol, 0.8 g sobrerol.

EXCIPIENTS
Tablets: calcium hydrogen phosphate dihydrate, corn starch, talc, magnesium stearate, povidone, microcrystalline cellulose, sodium starch glycolate (Type A). Suppositories: triglycerides, s medium chain. Syrup: propylene glycol, glycerol, carmellose sodium, sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 96 percent ethanol, saccharin, E150, ethylvanillin, cardamom flavoring, disodium phosphate dodecahydrate, sodium phosphate dihydrogen dihydrate, purified water.

INDICATIONS
Symptomatic treatment of acute febrile processes of the respiratory system.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients; patients with manifest insufficiency of glucose-6-phosphate dehydrogenase; patients with severe haemolytic anemia; severe hepatocellular insufficiency; severe alterations in renal function; severe changes in the blood count.

DOSAGE
Adult suppositories: 2 suppositories pro / day. Suppositories for children: 2 suppositories pro / day. Adult tablets: 2 - 4 tablets pro / day. Syrup: 4 - 6 teaspoons per / day. The product is contraindicated in patients with severe hepatocellular insufficiency and in patients with severe renal impairment. Administer with caution in subjects with renal or hepatic insufficiency. Do not exceed the maximum total daily dosage.

STORAGE
Suppositories: do not store above 30 degrees C. Tablets, syrup: this medicine does not require any special storage conditions.

WARNINGS
High or prolonged doses of the product can cause even serious alterations to the kidney and blood crase and a high-risk liver disease. Not to be used outside the acute febrile phase. Do not administer for more than 3 consecutive days without consulting your doctor. For administration to children younger 'less than 3 years consult your doctor. In patients treated with anticoagulants, the product should be administered in 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 may occur with paracetamol even at therapeutic doses, after short-term treatment and in patients without pre-existing hepatic dysfunction. Caution is advised in patients with a history of sensitivity to aspirin and / or non-steroidal anti-inflammatory drugs (NSAIDs). Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (NET) and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. Patients should be informed of the signs and symptoms and monitored carefully 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 blistering or mucosal lesions) occur, the patient should immediately discontinue paracetamol treatment and consult a doctor. The use is not recommended in women who intend to become pregnant. Administration should be discontinued in women who have fertility problems' or who are undergoing fertility investigations. Instruct the patient to contact the physician before associating any other medication. The syrup contains 1.25 vol% ethanol (alcohol), e.g. up to 300 mg per serving, equivalent to 7.5 ml of beer, 3.1 ml of wine per serving. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy. The syrup contains up to 9 g of sucrose per serving. To be taken into consideration in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. The syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: they can cause allergic reactions (even delayed). The syrup can contain up to 2 mmol of sodium per dose. To be taken into consideration in people with impaired renal function or who follow a low sodium diet.

INTERACTIONS
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 cimetidine). The risk of daparacetamol toxicity may be increased in patients taking other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as some antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol. 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-oxidase-peroxidase). Drugs that slow down gastric emptying (eg propantheline) can reduce the absorption rate of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase gastric emptying speed (eg 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 acetaminophen and vitamin K antagonists should be monitored for appropriate clotting and for bleeding. The presence of paracetamol in the product increases the plasma rates of aspirin and chloramphenicol. The simultaneous use of NSAIDs or opioids can 'determine a reciprocal enhancement of the analgesic effect. Co-administration of flucloxacillin with paracetamol may lead to metabolic acid in patients with risk factors for glutathione depletion. Paracetamol increases the AUC of ethinylestradiol by 22%. Paracetamol can 'reduce the plasma concentration of lamotrigine.

SIDE EFFECTS
Skin and subcutaneous tissue disorders: erythema, urticaria, rash, fixed drug eruption. Very rare cases of severe skin reactions such as toxic epidermal necrolysis (NET), Stevens-Johnson syndrome (SSJ) and acute generalized exanthematous pustulosis have been reported. Immune system disorders: hypersensitivity reactions' such as angioedema, edema of the larynx, anaphylactic shock. Blood and lymphatic system disorders: thrombocytopenia, neutropenia, leukopenia. Agranulocytosis, haemolytic anemia in patients with glucose 6-phosphate dehydrogenase deficiency. Hepatobiliary disorders: impaired liver function and hepatitis. Cytolytic hepatitis which can lead to acute liver failure. Eurinary renal disorders: acute renal failure, interstitial nephritis, haematuria, anuria. Gastrointestinal disorders: gastrointestinal reactions. Ear and labyrinth disorders: dizziness. Cardiac disorders: Kounis syndrome. Respiratory, thoracic and mediastinal disorders: bronchospasm. The reported side effects require the interruption of treatment and the institution of an appropriate therapy. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
In case of pregnancy or breastfeeding use only in case of real need under the direct supervision of the doctor.