Abiostil: detailed information

Neomycin Sulfate equivalent to Neomycin Base 0.50 g, Eucalyptol 1.60 g, Pine sylvestris essence 0.025 g, Camphor 0.20 g, Menthol 0.20 g, Chlorobutanol 0.50 g.
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ABIOSTIL is and what it is used for
What you need to know before using ABIOSTIL
How to use ABIOSTIL
Possible side effects
How to store ABIOSTIL
Contents of the pack and other information

1. What ABIOSTIL is and what it is used for

ABIOSTIL contains neomycin, an aminoglycoside antibiotic used against infections caused by certain bacteria, balsamic substances (eucalyptol, essence of Pinus sylvestris, camphor, menthol, also known as terpene derivatives), and chlorobutanol, which is a disinfectant.
This medicinal product is used for the local treatment of bacterial infections of the nose and throat.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before using ABIOSTIL

Do not use ABIOSTIL

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
in children under 30 months of age;
in children who suffer from epilepsy or are prone to febrile convulsions (violent and involuntary muscle contractions);
in children who have experienced episodes of throat muscle spasms or convulsions, even if older than 30 months.

Warnings and precautions
Talk to your doctor or pharmacist before using Abiostil.
This product contains substances called terpene derivatives which, in excessive doses, may cause adverse effects such as violent and involuntary muscle contractions (convulsions) in newborns and children.
Do not use this medicine for more than 3 days without consulting your doctor, to avoid accumulation in your body and brain of certain substances contained in this medicine, namely terpene derivatives.
Prolonged use of topical (local) products may lead to sensitization (excessive reaction of the body to foreign substances it has come into contact with) and may cause development of infections resistant to Neomycin.
If this occurs, discontinue treatment and consult your doctor to start appropriate therapy.
Do not exceed the recommended dose (see section 3 “If you use more ABIOSTIL than you should” and section 4 “Side effects”).
This product is for external use only and must NOT be ingested.
Avoid contact with the eyes. In case of accidental contact, rinse eyes thoroughly with water until any traces of nasal ointment are removed. Wash hands after use.
The product is potentially flammable; keep away from flames.

Children
This medicine must NOT be used in children under 30 months of age or in children with a history of epilepsy or predisposition to febrile convulsions (violent and involuntary muscle contractions).
In children who have experienced episodes of throat muscle spasms or convulsions, use with caution, even if older than 30 months (see section 2 “Do not use ABIOSTIL”).

Other medicines and ABIOSTIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Abiostil must not be used:

together with other products (medicinal or cosmetic) containing terpene derivatives (such as, for example: camphor, cineole, niaouli, wild thyme, terpineol, terpin, 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 allergic to other antibiotics belonging to the aminoglycoside class (such as, for example, kanamycin, gentamicin, framycetin), as you may also be allergic to ABIOSTIL.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy:
ABIOSTIL is not recommended during pregnancy and in women of childbearing age who do not use contraception. In pregnant women, this medicine should be used only if clearly needed and under direct medical supervision.
Breastfeeding:
ABIOSTIL is not recommended during breastfeeding. There is insufficient information on the excretion of neomycin sulfate, eucalyptol, pinus sylvestris essence, camphor, menthol, and chlorobutanol into breast milk.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ABIOSTIL

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended dose.
The recommended dose is the amount sufficient to form a thin layer covering the nasal
mucosa, to be applied three or four times daily, or as prescribed by your doctor.
Method of administration
Introduce the ointment into each nostril by tilting the head laterally first to one side, then to the
other side.
Duration of treatment
Treatment should not exceed 3 days (see also section 2 "Warnings and precautions")
or as prescribed by your doctor.
If you use more ABIOSTIL than you should
In case of accidental ingestion/overdose of ABIOSTIL in children, inform the doctor immediately or go
to the nearest hospital.
In children, there may be a risk of neurological disturbances. These symptoms require appropriate
emergency measures; therefore, go to the nearest hospital, taking this leaflet with you.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been observed with ABIOSTIL:
When doses higher than those indicated are used, children may experience severe and involuntary muscle contractions (convulsions) due to the balsamic substances present in the product (see also section 2 “Warnings and precautions”).
Immune system-related reactions such as hypersensitivity reactions and skin sensitization are possible.
Signs of an excessive body reaction to the substances contained in the product, such as skin rashes, burning, and itching, may occur. With prolonged treatment, toxic effects on hearing or kidneys related to the antibiotic contained in the product (neomycin) may arise.
Bacterial or fungal infections not sensitive to neomycin.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Abiostil

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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiostil contains
The active substances are Neomycin sulfate, Eucalyptol, Pine sylvestre, Camphor, Menthol,
Chlorobutanol
The other components are Precipitated silica, Liquid paraffin, White soft paraffin
Description of the appearance of Abiostil and package contents
Abiostil is presented as a printed tube with a nasal applicator.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Deca Dr. Capuani S.r.l., Via G. Balzaretti 17 – 20133 Milan
Manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A., Via Licinio 11 - 22036 ERBA (CO)