Frobengolmed - sore throat medicament 15 ml spray

Product Description

Spray medicine for the treatment of sore throat.

Indications

Frobengolmed is indicated for the short-term symptomatic treatment of acute sore throat in adults.

Composition

Active ingredients

One spray contains 2.92 mg of flurbiprofen and three sprays are equivalent to one dose, which contains 8.75 mg and corresponds to 17.16 mg/ml of flurbiprofen.

Excipients

Sodium saccharin, Citric acid, Sodium hydroxide, Disodium phosphate dodecahydrate, Betadex (E459), Hydroxypropylbetadex, Purified water. Cherry flavour: Ethyl alcohol, Glyceryl triacetate (E1518), Propylene glycol (E1520), Ascorbic acid (E300), D-alpha tocopherol (E307).

Directions for use and Dosage

• Adults aged 18 years and over: One dose (3 actuations) directed to the back of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period. Do not inhale during actuation. It is recommended not to use this product for more than three days. Before first use, activate the pump by pointing the actuator away from your body and spray at least four times until a uniform and constant mist is released. The pump is then activated and ready for use. Between doses, point the dispenser away from your body and spray at least once until a uniform and constant mist is released. Always ensure that the mist is uniform and constant before using the product.
• Paediatric population: The safety and efficacy of frobengolmed in children or adolescents under 18 years of age have not been established.
• Elderly patients: A general dose recommendation cannot be made as current clinical experience is limited. Elderly patients are at greater risk of serious consequences of adverse reactions. The lowest effective dose for the lowest effective dose should be used. short duration necessary to control symptoms.

Method of administration: For short-term administration on the oral mucosa only.

Warnings

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed.
• Patients who have previously shown hypersensitivity reactions (e.g., asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs.
• Current or previous recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulcer.
• History of gastrointestinal bleeding or perforation, severe colitis, bleeding or haematopoietic disorders related to previous NSAID therapy.
• Last trimester of pregnancy
• Severe cardiac insufficiency, severe renal insufficiency, or severe hepatic insufficiency
• Children and adolescents under 18 years of age.

Overdose

The majority of patients who have ingested clinically important quantities of NSAIDs will develop nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, central nervous system toxicity is observed, manifested by drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally, patients develop convulsions. In cases of severe NSAID intoxication, metabolic acidosis may occur, and the prothrombin time/INR may decrease. be prolonged, probably due to interference with the action of circulating clotting factors.

Acute renal failure and liver damage may occur. Asthma exacerbation is possible in asthmatics. Management Management should be symptomatic and supportive and should include maintaining a clear airway and monitoring cardiac function and vital signs until stable. Oral administration of activated charcoal or gastric lavage and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer asthma bronchodilators. There is no specific antidote for flurbiprofen.

Pregnancy and breastfeeding

• Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryonic/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations, and gastroschisis following use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations was increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period. Flurbiprofen should not be administered during the first and second trimesters of pregnancy.
  • During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
    • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
    • Renal dysfunction which may progress to renal failure with oligohydramnios.
  • The mother and the neonate, at the end of pregnancy, to:
    • Possible prolongation of bleeding time, an antiaggregant effect which may increase the risk of developing hepatitis C. occur even at very low doses;
    • Inhibition of uterine contractions resulting in a delay or prolongation of labor. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.
• Breastfeeding: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant. However, due to the possible adverse effects of NSAIDs on breast-fed infants, the use of flurbiprofen spray by breast-feeding mothers is not recommended.
• Fertility: There is evidence that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Interactions

No studies have yet detected any interaction between flurbiprofen and tolbutamide or antacids.

Paediatric population: No additional information available.

Format

15 ml