FrobeFlu Acetylsalicylic Acid and Vitamin C 20 Effervescent Tablets

Effervescent tablets based on acetylsalicylic acid and ascorbic acid.

Therapeutic indications

Acetylsalicylic acid and Vitamin C is used in the symptomatic treatment of feverish and painful states (flu, colds, headaches, toothache, rheumatic and muscular pains, menstrual pains, neuralgia).

Dosage and Posology

The drug should be taken according to the following doses and methods in adults, the elderly and children over 16 years:

• As an antipyretic and analgesic for mild or moderate pain: 1 tablet every 4-6 hours, as needed.
• In case of rheumatic and muscular pains, neuralgia: 1-2 tablets, two-three times a 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 or for prolonged periods

Overdose

In the event of a suspected overdose, observe the patient for 24 hours, as symptoms and elevated blood levels of salicylates may appear after several hours. In case of acute overdose, empty the stomach with emetics or aspiration and gastric lavage. For milder intoxications, drink plenty of fluids. In case of severe intoxication (plasma concentrations of salicylates higher than 500 µg / ml in the adult and 300 µg / ml in the child) practice forced and continuous alkaline diuresis until reaching a plasma concentration of salicylates lower than 350 µg / ml in the adult . At this point the intravenous administration can be suspended and the patient invited to take liquids orally. Plasma electrolytes, especially potassium and acid / base balance should be checked regularly. Acidemia should be corrected by sodium bicarbonate infusion before starting forced diuresis

In the presence of cardiac or renal insufficiency or very severe intoxication, hemodialysis or endoperitoneal dialysis may be necessary. Acute allergic reactions following intake of acetylsalicylic acid can be treated, if necessary, with administration of adrenaline, corticosteroids and an antihistamine

Contraindications

• Hypersensitivity to the active substances or to any of the excipients
• Hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs.
• Active gastro-duodenal ulcer and other gastropathies.
• Hemorrhagic 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.
• Dose> 100 mg / day during the third trimester of pregnancy
• Children and adolescents with flu or chickenpox symptoms due to the risk of Reye's syndrome.
• Deficit of glucose-6-phosphate dehydrogenase.

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, laryngeal edema, bronchospasm.
• An acute asthma attack can 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 higher dosages than those recommended, ascorbic acid can cause headaches and gastrointestinal disorders, consisting mainly of laxative-type phenomena. In such cases, treatment should be discontinued.

Conditions of pregnancy, puerperium and perinatal: delay in childbirth.

Pregnancy and breastfeeding

Since acetylsalicylic acid can cause haemorrhagic phenomena in the fetus and mother, delivery delays and, in the unborn child, early closure of the Botallo duct, its use is contraindicated in the third trimester of pregnancy. doctor's advice During lactation, after a single dose the quantity taken by the infant is negligible, while the mother's intake of high doses should be avoided.

• 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 regarding the use of doses above 100 mg / day up to 500mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this dose range.
• Doses of 500 mg / day and above Inhibition of prostaglandin synthesis can adversely 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. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%.

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 increased pre- and post-implantation loss and embryo-fetal mortality. In addition, 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 attempting to conceive, or during the first and second trimester of pregnancy, the dose or 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 closure of the arterial duct and pulmonary hypertension);
• renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

- the mother and the newborn, at the end of pregnancy, to:

• possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, acetylsalicylic acid at doses> 100mg / day is contraindicated during the third trimester of pregnancy.

Special warnings

This medicinal product should not be used in children and young people under the age of 16 (see section 4.3). People over 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting their 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 should in any case be carried out only after consulting the doctor and under the direct control of the latter.

Caution is also needed in the following cases:

- Elderly subjects with reduced renal function or decreased plasma albumin levels, due to the risk of increased toxicity;

- Subjects affected by 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 (see section 4.5). Medicines containing acetylsalicylic acid are contraindicated (see section 4.3) in children and adolescents with viral infections, especially influenza A, influenza B and chickenpox, due to the risk of Reye's syndrome, a very rare but life-threatening disease. which requires immediate medical attention. 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 one effervescent tablet contains 485 mg of sodium (equal to 21 mEq).

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 25 ° C. Keep the container tightly closed.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

An effervescent tablet of Acetylsalicylic Acid and Vitamin C Mylan contains:

Active principle

Acetylsalicylic acid 330 mg, ascorbic acid 200 mg

Excipients

Sodium bicarbonate, anhydrous citric acid, glycine, sodium benzoate (E211)