ABIOSTIL 10 Г Мазь

Содержание инструкции

1. ABIOSTIL nasal ointment
   1. What ABIOSTIL is and what it is used for
   2. What you need to know before using ABIOSTIL
   3. How to use ABIOSTIL
   4. Possible side effects
   5. How to store Abiostil
   6. Contents of the pack and other information

ABIOSTIL nasal ointment

Neomycin Sulfate equivalent to Neomycin Base 0.50 g, Eucalyptus oil 1.60 g, Pine essence 0.025 g, Camphor 0.20 g, Menthol 0.20 g, Chlorobutanol 0.50 g.

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ABIOSTIL is and what it is used for
• 2. What you need to know before you use ABIOSTIL
• 3. How to use ABIOSTIL
• 4. Possible side effects
• 5. How to store ABIOSTIL
• 6. 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, pine essence, camphor, menthol also
known as terpene derivatives) and chlorobutanol, which is a disinfectant.
This medicine is used in the local treatment of bacterial infections of the nose and throat.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using ABIOSTIL

Do not use ABIOSTIL

• if you are allergic to the active ingredients or 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 predisposed to convulsions (violent and involuntary muscle contractions) related to fever;
• in children who have had episodes of spasm of the throat muscles or convulsions, even if over 30 months of age.

Warnings and precautions
Consult 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 muscle contractions (convulsions) in newborns and
children.
Do not use this medicine for more than 3 days without consulting your doctor, to avoid the accumulation of some
substances contained in this medicine, the terpene derivatives, in your body
and your brain.
Prolonged use of topical (local) products can lead to sensitization (excessive reaction of the body to foreign substances with which it has come in
contact) and can cause the development of infections that are not sensitive to Neomycin.
In this case, stop 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 “Possible side effects”).
The product is for external use only and therefore MUST NOT be ingested.
Avoid contact with eyes. If accidental contact occurs, it is recommended to
wash your eyes thoroughly with water, until any residue of nasal ointment is removed. Wash your hands after use
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 muscle contractions)
related to fever.
In children who have had episodes of spasm of the throat muscles or convulsions, it should be
used with caution, even if over 30 months of age (see section 2 “Do not use
ABIOSTIL”).

Other medicines and 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 (medicines or cosmetics) that contain 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), because you may also be allergic to ABIOSTIL

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, 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 are not using contraception. In pregnant women, the medicine should only be used in case of
actual need and under direct medical supervision.

Breastfeeding:
Abiostil is not recommended during breastfeeding. There is insufficient information
on the excretion of neomycin sulfate, eucalyptus oil, pine essence, camphor, menthol,
chlorobutanol in breast milk.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use ABIOSTIL

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 that covers the nasal
mucosa, to be applied three or four times a day or as prescribed by your doctor.
Method of administration
Introduce the ointment into each nostril tilting your head to the side 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 as prescribed by your doctor.

If you use more ABIOSTIL than you should
In case of ingestion/accidental intake of an excessive dose of ABIOSTIL in children immediately
notify your doctor or go to the nearest hospital.
In children, there may be a risk of neurological disorders. These symptoms require the adoption
of appropriate emergency measures, therefore, go to the nearest hospitalbringing this
leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with ABIOSTIL:
With the use of doses higher than those indicated, children may experience violent and
involuntary muscle contractions (convulsions) due to the presence of the balsamic substances in the
product (see also section 2 “Warnings and precautions”).
Effects on the immune system are possible, such as hypersensitivity reactions, skin sensitization.
It is possible that signs of an excessive reaction of the body to the substances
contained in the product may manifest, such as skin rashes, burning and itching. With prolonged
treatments, toxic effects on hearing or kidneys connected with the use of the antibiotic
contained in the product (neomycin) may occur.
Bacterial or fungal infections not sensitive to neomycin.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.By reporting
side effects 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 particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abiostil contains
The active ingredients are neomycin sulfate, eucalyptus oil, pine oil, camphor, menthol,
chlorobutanol
The other ingredients are Precipitated silica, Liquid paraffin, white petrolatum

Description of the appearance of Abiostil and contents of the pack
Abiostil is presented as a screen-printed tube with a nasal applicator.

Marketing authorisation holder and manufacturer
Laboratorio Chimico Deca Dr. Capuani S.r.l., Via G. Balzaretti 17 – 20133 Milano

Manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A., Via Licinio 11 - 22036 ERBA (CO)