Active ingredients: Neomycin, Eucalyptol, Camphor
ABIOSTIL nasal ointment
Indications Why is Abiostil used? What is it for?
ABIOSTIL contains neomycin, an aminoglycoside antibiotic used against infections caused by certain bacteria, balsamic substances (eucalyptol, Scots pine essence, camphor, menthol also called terpenic derivatives) and chlorobutanol, which is a disinfectant. This medicine is used in the local treatment of bacterial infections of the nose and throat.
Talk to your doctor if you don't feel better or if you feel worse after 3 days.
Contraindications When Abiostil should not be used
Do not use ABIOSTIL
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- in children up to 30 months of age;
- in children suffering from epilepsy or predisposed to convulsions (violent and involuntary contractions of the muscles) related to fever;
- in children who have had episodes of throat muscle spasm or convulsions, even if older than 30 months.
Precautions for use What you need to know before taking Abiostil
Talk to your doctor or pharmacist before using Abiostil.
This product contains substances called terpene derivatives which, in excessive doses, can cause disorders such as violent and involuntary contractions of the muscles (convulsions) in infants and children.
Do not use this medicine for more than 3 days without your doctor's advice, to prevent some substances contained in this medicine, terpene derivatives, from accumulating in your body and brain.
Prolonged use of products for topical (local) use can give rise to sensitization phenomena (excessive reaction of the organism to foreign substances with which it has come into contact) and can cause the development of infections that are not sensitive to Neomycin.
In this case, stop the treatment and consult your doctor to start a suitable therapy.
Do not exceed the recommended dose (see section 3 "If you use more ABIOSTIL than you should" and section 4 "Undesirable effects"). The product is for external use only and therefore must NOT be ingested. Avoid contact with eyes. The product is potentially flammable, keep away from flames.
Children
This medicine should NOT be used in children under 30 months of age and in children with a history of epilepsy or predisposed to convulsions (violent and involuntary contractions of the muscles) related to fever. In children who have had episodes of throat muscle spasm or convulsions it should be used with caution, even if over 30 months of age (see section 2 "Do not use ABIOSTIL").
Interactions Which drugs or foods can modify the effect of Abiostil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Abiostil 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) regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).
- if you are taking antibiotics called 'aminoglycosides', as cross-hypersensitivity can occur. In this case, ask your doctor before using Abiostil.
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:
Abiostil is not recommended during pregnancy and in women of childbearing potential who do not use methods to avoid pregnancy. In pregnant women the medicine should only be used when clearly needed and under direct medical supervision.
Feeding time:
Abiostil is not recommended during lactation. There is insufficient information on the excretion of neomycin sulfate, eucalyptol, Scots pine essence, camphor, menthol, chlorobutanol in breast milk.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Dosage and method of use How to use Abiostil: Dosage
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended dose.
The recommended dose is the quantity sufficient to form a thin layer covering the nasal mucosa, to be applied three or four times a day or according to medical prescription.
Method of administration
Introduce the ointment into each nostril by tilting the head sideways, first on one side, then on the opposite side.
Duration of treatment
Treatment should not exceed 3 days (see also section 2 "Warnings and precautions") or according to medical prescription.
Overdose What to do if you have taken too much Abiostil
In case of accidental ingestion / intake of an excessive dose of ABIOSTIL in children, notify your doctor immediately or go to the nearest hospital.
There may be a risk of neurological disorders in children. These symptoms require the adoption of adequate emergency measures, therefore, please contact the nearest hospital and take this sheet with you.
Side Effects What are the side effects of Abiostil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of higher doses than those indicated, violent and involuntary contractions of the muscles (convulsions) may occur in children due to the presence of the balsamic substances of the product (see also section 2 "Warnings and precautions").
It is possible that there are signs of an excessive reaction of the organism to foreign substances contained in the product such as redness of the skin and itching. For prolonged treatments it is possible to produce toxic effects on hearing or kidneys connected with the use of the antibiotic contained in the product (neomycin).
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: www.agenziafarmaco.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 "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines into wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Abiostil contains
The active ingredients are neomycin sulfate, eucalyptol, Scots pine, camphor, menthol, chlorobutanol.
The other ingredients are precipitated silica, liquid paraffin, white petroleum jelly.
What Abiostil looks like and contents of the pack
Abiostil comes as a silkscreened tube with a nasal applicator.
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
ABIOSTIL NASAL OIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contains:
Active principles: Neomycin Sulphate equal to Neomycin Base g 0.50, Eucalyptol g 1.60, Scots pine essence g 0.025, Camphor g 0.20, Menthol g 0.20, Chlorobutanol g 0.50.
03.0 PHARMACEUTICAL FORM
Nasal ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
For the antibiotic treatment of nasopharyngeal diseases caused by germs sensitive to Neomycin.
04.2 Posology and method of administration
ABIOSTIL is contraindicated in children up to 30 months of age (see section 4.3).
The duration of the treatment should not exceed 3 days.
Apply the product in sufficient quantity to form a thin layer that covers the mucosa three or four times a day or according to medical prescription.
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
• In children with a predisposition to laryngospasm and convulsions, it should be used with caution even if they are older.
04.4 Special warnings and appropriate precautions for use
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, eucalyptol, menthol, Scots pine essence (due to their lipophilic properties, the rate of metabolism and disposal is not known. ) in tissues and the brain, in particular neuropsychological disorders.
In case of hypersensitivity reactions it is necessary to interrupt the treatment and notify the doctor in order, where necessary, to establish a suitable therapy. Prolonged or repeated use of products for topical use can give rise to sensitization phenomena or the development of bacterial or fungal infections not sensitive to neomycin. Cross-hypersensitivity to other antibiotics of the aminoglycoside group is possible.
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.
04.5 Interactions with other medicinal products and other forms of interaction
ABIOSTIL should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, skin, nasal or inhalation).
04.6 Pregnancy and breastfeeding
Pregnancy
There are no or limited data on the use of neomycin sulphate, eucalyptol, Scots pine essence, camphor, menthol, chlorine butanol in pregnant women.
ABIOSTIL is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. In pregnant women, use only if clearly needed and under direct medical supervision.
Feeding time
There is insufficient information on the excretion of neomycin sulfate, eucalyptol, Scots pine essence, camphor, menthol, chlorine butanol in breast milk.
ABIOSTIL should not be used during breastfeeding.
04.7 Effects on ability to drive and use machines
Abiostil does not affect driving ability or use of machines.
04.8 Undesirable effects
Due to the presence of camphor, eucalyptol, menthol, Scots pine essence and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants.
Locally signs of hypersensitivity such as hyperemia and itching. For prolonged treatments ototoxic and nephrotoxic effects associated with the use of neomycin can be produced.
04.9 Overdose
In the event of accidental oral intake or incorrect administration in infants or 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
Abiostil is a product based on neomycin and balsamic substances (eucalyptol, Scots pine essence, camphor, menthol and chlorobutanol). Neomycin is an amino-glycosidic antibiotic topically active against Staphylococcus Epidermis and numerous gram-negative germs such as Proteus and Serratia, it is scarcely active on streptococci while Pseudomonas Aeruginosa is generally resistant.
Terpene derivatives can lower the epileptogenic threshold.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Precipitated silica, liquid paraffin, white petroleum jelly.
06.2 Incompatibility
None.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
No particular precautions.
06.5 Nature of the immediate packaging and contents of the package
10 g aluminum tube, internally coated and nasal nozzle
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Chemical Laboratory Deca Dr. Capuani S.r.l., Via Balzaretti 17 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 010772022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
19/04/1989 - November 2009
10.0 DATE OF REVISION OF THE TEXT
June 2012
