Active ingredients: Eucalyptus, Menthol, Thyme, Balsam of Peru, Benzoin
FOMENTIL Tablets for fumigations.
Why is Fomentil used? What is it for?
Fomentil contains a combination of substances belonging to the class of preparations for colds.
This medicine is used in inflammation of the nose (rhinitis) and throat (pharyngitis and laryngitis) for:
- reduce phlegm;
- decrease the swelling of the mucous membranes by improving breathing (decongestant);
- calm symptoms and fight germs (antiseptic action).
Talk to your doctor if you don't feel better or if you feel worse after three days.
Contraindications When Fomentil should not be used
Do not use Fomentil
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- in children under 30 months of age;
- in children who suffer or have suffered from epilepsy;
- in children who have had convulsions (violent and involuntary muscle contractions) related to fever (febrile convulsions).
Precautions for use What you need to know before taking Fomentil
This medicine is for inhalation use only, it should not be ingested.
Do not use this medicine for more than 3 days, to prevent some substances contained in this medicine, terpene derivatives, from accumulating in your body and brain.
Do not exceed the recommended dose (see section 3 "If you use more Fomentil than you should" and section 4 "Undesirable effects"). The product is potentially flammable, keep away from flames.
Children
Fomentil is contraindicated in children under 30 months.
This medicine should be used with caution in children between the ages of 30 months and 6 years because it can cause severe difficulty in breathing (glottal spasm).
This medicine contains balsamic substances (terpene derivatives) which, in large quantities, can cause brain disorders and convulsions in infants and children.
Interactions Which drugs or foods can modify the effect of Fomentil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Fomentil should not be used together with other products (medicinal or cosmetic) that contain terpene derivatives (such as: camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine ).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
This medicine is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive methods.
Feeding time
This medicine must not be used during breastfeeding. If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Fomentil contains:
- balsam of Peru. It can cause local skin reactions.
- benzoin. Slightly irritating to the skin, eyes and mucous membranes.
Dose, Method and Time of Administration How to use Fomentil: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults: The recommended dose is 1 - 2 tablets to be dissolved in about half a liter of boiling water. Breathe the vapors for about 3 - 4 minutes by collecting them either by means of a cardboard funnel or with your hands. Repeat 3 - 4 times a day. day.
Use in children: The recommended dose in children over 30 months of age is 3 - 4 tablets once a day to be dissolved one at a time in a bowl of boiling water. Place the basin next to the child's bed.
How to use
The water must be boiling for the tablet to dissolve completely releasing the essences. Break the tablets. Do not cover your head with cloths while inhaling. When doing the inhalation, keep your face at a distance of about 40 cm to prevent the hot steam from irritating the skin.
This medicine is for inhalation use only: do not swallow the tablets.
The duration of treatment should not exceed 3 days. Do not exceed the recommended doses.
Contact your doctor if you do not notice any improvement or if you notice your symptoms worsening after three days.
Overdose What to do if you have taken too much Fomentil
In case of mistakenly ingesting this medicine, or using higher doses than those indicated in infants and children, there may be a risk of convulsions (violent and involuntary contractions of the muscles). In such cases, go to the nearest emergency room or contact a doctor immediately, taking this leaflet with you.
Side Effects What are the side effects of Fomentil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects in children
Violent and involuntary contractions of the muscles (convulsions) may occur in children if higher than indicated doses are used (see also section 3 "If you use more Fomentil than you should").
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine. .
Expiry and Retention
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Fomentil contains
- The active ingredients are Eucalyptus essence 40 mg; Menthol 10 mg; Thyme essence 12 mg; Balsam of Peru 30 mg; Benzoin 50 mg.
- The other ingredients are lavender essence, tartaric acid, sodium bicarbonate, bentonite, talc, magnesium stearate, polyethylene glycol 400, glycerol palmito-stearate, precipitated silica, microgranular cellulose, povidone.
What Fomentil looks like and contents of the pack
Fomentil is presented as a silkscreened tube closed by a cap containing 10 tablets for fumigations.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
FOMENTIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One tablet contains:
• Eucalyptus essence FU g 0.040
• Menthol FU 0.010 g
• Thyme essence (titrant not less than 50% of thymol) g 0.012
• Balsam of Peru (titrant not less than 50% cinnamein) 0.030 g
• Benzoin (titrant not less than 20% cinnamic acid) 0.050 g.
03.0 PHARMACEUTICAL FORM -
Compresses for fumigations.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Anticatarral, decongestant, calming and antiseptic in rhinitis, pharyngitis and laryngitis.
04.2 Posology and method of administration -
External use.
1-2 tablets in about half a liter of boiling water and breathe in the vapors by collecting them either by means of a cardboard funnel, or with your hands, for 3-4 minutes, 3-4 times a day. For children over 30 months, place a basin with boiling water near the patient's bed and dissolve 3-4 tablets, one at a time. Do not exceed the recommended doses and carry out short courses of treatment or consult your doctor.
FOMENTIL is contraindicated in children up to 30 months of age (see section 4.3).
The duration of the treatment should not exceed 3 days.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients.
Children up to 30 months of age.
Children with a history of epilepsy or febrile seizures.
04.4 Special warnings and appropriate precautions for use -
The product should not be used for children up to 30 months of age. Up to 6 years of age, the product can induce glottal spasm.
The product is for external use only.
This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.
The treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders.
A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9).
The product is flammable, it must not be approached to flames.
The water must be boiling for the tablet to dissolve completely, releasing the essences. Break the tablets. Do not cover your head with cloths while inhaling. When doing the inhalation, take care to keep the face at a distance of about cm. 40 to prevent hot water vapor from irritating the skin.
04.5 Interactions with other medicinal products and other forms of interaction -
FOMENTIL should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).
04.6 Pregnancy and breastfeeding -
Pregnancy
There are no or limited data on the use of eucalyptus essence, menthol and thyme essence in pregnant women.
FOMENTIL is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
Feeding time
There is insufficient information on the excretion of eucalyptus essence, menthol and thyme essence in breast milk.
FOMENTIL should not be used while breastfeeding.
04.7 Effects on ability to drive and use machines -
They are not known.
04.8 Undesirable effects -
Due to the presence of eucalyptus essence, menthol, thyme essence and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants.
04.9 Overdose -
There are no known symptoms of overdosing.
In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders.
If necessary, administer appropriate symptomatic treatment in specialized treatment centers.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Cough suppressants, excluding combinations with expectorants. Other combinations of preparations for colds.
ATC code: R05X
Pharmacological tests conducted with FOMENTIL were:
1) the study of the protective action against SO2 mucosal hypersecretion in the rat
2) the effects on ciliary motility of the respiratory epithelium (trachea) in mice.
In the first case, in animals treated with FOMENTIL, a lower incidence of bronchial obstructions was detected, also appreciating a clear improvement in the peripheral picture, in the second even prolonged treatments of FOMENTIL were found to be compatible with the integrity of the ciliary function of the respiratory mucous membranes in the rat. .
Terpene derivatives can lower the epileptogenic threshold.
05.2 "Pharmacokinetic properties -
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05.3 Preclinical safety data -
Studies of general toxicity and respiratory tolerability conducted on mice and dogs exposed repeatedly to FOMENTIL vapors did not show statistically significant differences between treated and controls and in any case referable to the treatment; in fact, there were no respiratory tract lesions or symptoms of general toxicity.
A test of embryo-fetal toxicity and teratogenesis conducted on mice and rabbits repeatedly exposed to exposure to FOMENTIL vapors during pregnancy, allowed to exclude any embryo-fetotoxic and teratogenic effects of the preparation.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Lavender essence
Tartaric acid
Sodium bicarbonate
Bentonite
Talc
Magnesium stearate
Polyethylene glycol 400
Glycerol palmito-stearate
Precipitated silica
Microgranular cellulose
Polyvinylpyrrolidone.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
24 months when properly stored intact packaging.
06.4 Special precautions for storage -
None.
06.5 Nature of the immediate packaging and contents of the package -
Screen-printed tube of 10 polypropylene tablets with addition of titanium dioxide and closing cap in PELD with addition of titanium dioxide.
06.6 Instructions for use and handling -
None.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Pharmaceutical Laboratory SIT Specialità Igienico Terapeutiche S.r.l. - Via Cavour, 70 - Mede (PV).
08.0 MARKETING AUTHORIZATION NUMBER -
Fomentil 10 tablets for fumigations - AIC n. 006239026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
June 1, 2010
10.0 DATE OF REVISION OF THE TEXT -
July 2012
