Description
BENAGOL TABLETS
PHARMACOTHERAPEUTIC CATEGORY
Antiseptic.
ACTIVE INGREDIENTS
2,4-dichlorobenzyl alcohol; amylmetacresol.
EXCIPIENTS
Ginger and Spice flavoured lozenges: sucrose, liquid glucose, tartrate, anthocyanins (E163), plum flavour, cream flavour, spice flavour, ginger flavour, medium chain triglycerides.
Honey and Lemon flavoured lozenges: mint essence, lemon essence, tartaric acid, honey, liquid glucose, sucrose.
Menthol-Eucalyptol flavoured lozenges: indigo carmine (E 132), eucalyptol essence, tartaric acid, liquid sucrose, liquid glucose.
Orange flavoured Vitamin C tablets: sucrose, liquid glucose, tartaric acid, orange flavouring, menthol, propylene glycol.
Lemon Flavored Sugar Free Lozenges: lemon flavor, sodium saccharinate, tartaric acid, maltitol syrup, isomaltose.
Strawberry flavoured sugar-free lozenges: strawberry flavouring, anthocyanins (E163), sodium saccharinate, tartaric acid, maltitol syrup, isomaltose.
Cold Mint Flavored Lozenges: Xylitol, Menthol, Mint Flavoring, Eucalyptus Oil, Liquid Sucrose, Liquid Glucose.
DIRECTIONS
Oral antiseptic.
CONTRAINDICATIONS/SIDE EFFECTS
Hypersensitivity to the active substances or to any of the excipients listed; do not administer to children under 6 years of age.
The Menthol-Eucalyptus flavoured medicine is contraindicated in children with a history of epilepsy or febrile convulsions; do not administer the Cold Mint and Ginger and Spice flavoured medicine to children under 12 years of age.
DOSAGE
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Adults and children over 6 years of age: one tablet every 2 or 3 hours.
In children over 6 years of age, consult your doctor for an appropriate dosage.
Do not exceed the recommended doses and in particular, for the Orange and Cold Mint flavoured Vitamin C medicine, do not exceed the daily maximum of 8 tablets.
For all other flavours do not exceed the maximum daily dose of 12 tablets.
Administer the medicine gus to Menta Fredda e Ginger e Spezie to adults and children over 12 years of age.
The duration of treatment with the Menthol-E ucalyptol flavoured medicine should not exceed 3 days.
The Lemon Sugar Free and Strawberry Sugar Free flavoured medicines are suitable for those patients who need to control their sugar and calorie intake.
Elderly population: no data available.
Method of administration: oromucosal administration.
The tablet should be dissolved slowly in the mouth.
CONSERVATION
Do not store above 25 degrees C.
WARNINGS
Be careful with preschool children as tablets swallowed whole may cause choking.
If sensitization or irritation phenomena appear, administration must be discontinued and appropriate treatment instituted.
The Menthol-Eucalyptus flavoured medicine contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in newborns and children.
Treatment with the Menthol-Eucalyptus flavoured medicine should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineo, niaouli, wild thyme, terpineol, terpin, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties, the speed of metabolism and disposal is unknown) in the tissues and in the brain, in particular neuropsychological disorders.
A dose higher than the recommended one should not be used to avoid an increased risk of adverse reactions to the medicinal product and disorders associated with overdose.
The Menthol-Eucalyptus flavoured medicine is flammable, it should not be brought close to flames.
The Ginger and Spice, Honey and Lemon, Cold Mint, Menthol - Eucalyptol and Orange flavoured Vitamin C lozenges contain glucose.
The Ginger and Spice, Honey and Lemon, Cold Mint, Menthol-Eucalyptus and Orange flavoured Vitamin C lozenges contain sucrose.
The Sugar Free Lemon Flavor and Sugar Free Strawberry Flavor Lozenges contain maltitol.
The Ginger and Spice flavoured lozenges contain excipients that can induce a sensation of heat in the mouth and throat when sucking the lozenge.
INTERACTIONS
No interactions with other drugs are known.
The Menthol-Eucalyptus flavoured medicine should not be used in conjunction with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).
SIDE EFFECTS
Menthol - Eucalyptus flavour: due to the presence of menthol and in case of non-compliance with the recommended doses, there may be a risk of convulsions in children and infants.
Adverse reactions associated with the use of 2,4 dichlorobenzyl alcohol, amylmetacresol, levomenthol and ascorbic acid are listed below, divided by frequency and organ class.
Frequencies are defined as: very common (>=1/10); common (>=1/100 and <1/10); uncommon (>=1/1000 and <1/100); rare (>=1/10000 and <1/1000); very rare (<1/10000); not known.
Immune system disorders.
Rare: hypersensitivity.
Gastrointestinal disorders.
Rare: glossitis; not known: abdominal pain, nausea, gastrointestinal discomfort.
Skin and subcutaneous tissue disorders.
Not known: skin rash.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
PREGNANCY AND BREASTFEEDING
In pregnant and breastfeeding women, the product should be administered only if strictly necessary.
There are no or limited amount of data from the use of the active ingredients of the medicinal product in pregnant women.
The Menthol-Eucalyptus flavoured medicine is not recommended during pregnancy and in women of childbearing age who do not use contraceptive measures.
It is not known whether the active substances or their metabolites are excreted in human milk.
A risk to newborns and infants cannot be excluded.
Ascorbic acid or its metabolites are excreted in breast milk.
No data are available on the effect on fertility.
The Menthol-Eucalyptus flavoured medicine is not recommended in women of childbearing age who do not use contraceptive measures.
