FrobeFlu 330mg + 200mg Mylan 20 Effervescent Tablets

FrobeFlu 330mg + 200mg Mylan Acetylsalicylic Acid + Vitamin C

ACTIVE PRINCIPLES

Acetylsalicylic acid, ascorbic acid.

EXCIPIENTS

Sodium bicarbonate, anhydrous citric acid, glycine, sodium benzoate.

INDICATIONS

Symptomatic treatment of feverish and painful states (flu, colds, headache, toothache, rheumatic and muscular pain, menstrual pain, neuralgia).

CONTRAINDICATIONS / SECONDARY EFFECT

Hypersensitivity to the active ingredients or to any of the excipient listed; hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs; active gastro-duodenal ulcer and other gastrop atie; haemorrhagic diathesis (in particular haemophilia, hypoprothrombinemia and vitamin K deficiency); severe hepatic or renal insufficiency; patients with bronchial asthma, particularly if it is associated with nasal polyposis and angioedema; the use of this medicine is contraindicated in children and young people under the age of 16; doses> 100 mg / day and during the third trimester of pregnancy; children and adolescents with flu or chickenpox symptoms due to the risk of Re ye syndrome; glucose-6-phosphate dehydrogenase deficiency.

DOSAGE

Adults, the elderly and children over 16 years The recommended doses are as follows.
As an antipyretic and analgesic for mild to moderate pain: 1 tablet every 4-6 hours, as needed.
Rheumatic and muscle pains, neuralgia: 1-2 tablets, two-three volts and per day.
It is recommended to dissolve the tablets in a glass of water.
Do not exceed the recommended doses without the advice of the doctor; in particular elderly patients should follow the minimum dosages indicated above.
The product should be taken on a full stomach, particularly when it is necessary to administer it in high doses and for prolonged periods.

STORAGE

Do not store above 25 degrees C; keep container tightly closed.

WARNINGS

This medicine should not be used in children and young people under the age of 16 years.
People over 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting your doctor.
After three days of use at the maximum dose or after 5-7 days of use without appreciable results, consult your doctor.
Any use of high doses and / or for a long time must in any case be carried out only after consulting the doctor and under the direct control of the latter.
Caution is also required in the following cases: elderly subjects with reduced renal function or decreased plasma albumin levels, due to the risk of greater toxicity; subjects with G-6-PD (Glucose-6-phosphate dehydrogenase) deficiency, due to the possible onset of hemolysis; subjects undergoing simultaneous treatment with anticoagulants, due to an increased risk of bleeding; subjects receiving concomitant treatment with corticosteroids, due to an increased risk of gastrointestinal bleeding.
Ascorbic acid (vitamin C) should be used with caution by people who suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and by those with G6PD (glucose-6-phosphate dehydrogenase) deficiency, hemochromatosis , thalassemia or sideroblastic anemia.
The activity of substances such as spironolactone, furosemide and antigout preparations is decreased by acetylsalicylic acid.
Therefore, avoid the simultaneous use of the latter with the aforementioned drugs, unless otherwise advised by the doctor.
Medicines containing acetylsalicylic acid are contraindicated in children and adolescents with viral infections, especially influenza A, influenza B and chicken pox, due to the risk of Reye's syndrome, a very rare but life-threatening disease requiring a immediate medical intervention.
Pre-operative use as it can hinder intra-operative haemostasis.
If prolonged vomiting and profound drowsiness occur during treatment, discontinue administration.
In the case of a low sodium regimen, it should be borne in mind that an effervescent tablet contains 485 mg of sodium (equal to 21 mEq).

INTERACTIONS

The administration of acetylsalicylic acid, particularly in the case of prolonged therapy, can enhance the activity of anticoagulant drugs (for example coumarin derivatives and heparin), the undesirable effects of methotrexate, the risk of gastrointestinal haemorrhage in case of simultaneous treatment with corticosteroids, the effects and secondary manifestations of all NSAIDs, the effect of oral hypoglycemic agents (sulfonylureas).
Acetylsalicylic acid, on the other hand, reduces the activity of substances such as spironolactone, furosemide and antigout preparations.
Ascorbic acid can interfere, at high doses, with the results of some diagnostic tests, in particular the search for glucose in the urine by non-specific means.
It is therefore advisable to stop taking vitamin C a few days before proceeding with this test.

SIDE EFFECTS

Gastric disturbances (heartburn, epigastralgia), constipation, nausea.
In sporadic cases and in predisposed patients, bleeding episodes and ulcers may occur.
Allergic reactions, such as rash, and haemalaryngeal, bronchospasm.
An acute asthma attack may occur in sensitive patients.
The clinical picture, in patients sensitive to acetylsalicylic acid, may present asthma, nasal polyps, rhinorrhea, angioedema.
Tinnitus and decreased hearing can occur at high doses.
Treatment should be temporarily suspended or the dosage reduced.
In patients with impaired renal function, acetylsalicylic acid can decrease renal blood flow and induce acute renal failure.
In extremely rare cases, thrombocytopenia is possible.
Reye's syndrome.
At doses already higher than those recommended, ascorbic acid can give headaches and gastrointestinal disorders, consisting mainly of laxative-type phenomena.
In such cases it is advisable to interrupt the treatment.
Conditions of pregnancy, puerperium and perinatal Delay in childbirth.
The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the physician.

PREGNANCY AND BREASTFEEDING

Since acetylsalicylic acid can cause haemorrhagic phenomena in the fetus and mother, delays in childbirth and, in the unborn child, early closure of the Botallo duct, its use is contraindicated in the third trimester of pregnancy.
Low doses (up to 100 mg / day) Clinical studies indicate that doses up to 100 mg / day can be considered safe for use in obstetrics, which requires specialist monitoring.
Doses of 100-500 mg / day: there are insufficient clinical data relating to the use of doses above 100 mg / day to or 500 mg / day.
Therefore, the recommendations below for doses of 500 mg / day also apply to this dose range.
Dosage of 500 mg / day and over Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
It has been estimated that the risk increases with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases.
If acetylsalicylic acid is used by a woman expecting conception, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
The mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, acetylsalicylic acid at doses> 100 mg / day is contraindicated during the third trimester of pregnancy.
During lactation, after a single dose the quantity taken by the infant is negligible, while the assumption of high doses by the mother should be avoided.

FORMAT

Pack of 20 effervescent tablets.