Flutoxil

Italy
Brand name Flutoxil
Form syrup
Active substance / Dosage
BROMHEXINE HYDROCHLORIDE
Prescription type Over-the-counter
ATC code
R05CB02
Registration number 037910
Manufacturer AESCULAPIUS FARMACEUTICI SRL
Flutoxil syrup

BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET
This is a self-medication product which you can use to treat mild and transient disorders that are easily recognizable and resolvable without medical intervention.
It may therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and minimize side effects.

  • For further information and advice, consult your pharmacist.
  • Consult a doctor if symptoms persist after a short course of treatment.

NAME OF THE MEDICINAL PRODUCT
FLUTOXIL 4 mg/5 ml syrup
bromhexine

WHAT IS IT?
FLUTOXIL syrup is a mucolytic agent: it liquefies thick mucus deposits in the respiratory tract and thus facilitates their elimination.

WHY IT IS USED
FLUTOXIL syrup is used in the treatment of secretory disorders (e.g. presence of cough and phlegm) in acute and chronic respiratory conditions.

WHEN IT MUST NOT BE USED
Hypersensitivity to the active substance or to any of the excipients.
The medicine is contraindicated in children under 2 years of age.
Breastfeeding (see section "What to do during pregnancy and breastfeeding").
In case of inherited conditions that may be incompatible with one of the excipients (see section "Important information about excipients").

PRECAUTIONS FOR USE
Treatment with FLUTOXIL syrup increases bronchial secretion (which facilitates expectoration).
Do not use for prolonged periods. Consult a doctor if there is no improvement after a short treatment period.
Severe skin reactions have been reported following administration of bromhexine. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Flutoxil and contact your doctor immediately.
These reactions may be symptoms of serious skin diseases such as Stevens-Johnson syndrome or Lyell’s syndrome. Most of these cases could be explained by the severity of underlying diseases or concomitant use of other medications.

WHICH MEDICINES OR FOODS MAY INTERACT WITH THIS MEDICINE
No interactions with other medicines have been reported.
If you are taking other medicines, consult your doctor or pharmacist.

IMPORTANT INFORMATION
Mucolytics may cause bronchial obstruction in children under 2 years of age.
This is due to limited mucus drainage capacity in this age group, related to the physiological characteristics of the respiratory tract.
Therefore, this medicine must not be used in children under 2 years of age.

When use should only occur after consulting a doctor
There are no absolute contraindications, but in patients with gastroduodenal ulcer, use is recommended only after consulting a doctor. Pregnancy (see section "What to do during pregnancy and breastfeeding").
It is also advisable to consult a doctor if such symptoms have occurred previously.

What to do during pregnancy and breastfeeding
During pregnancy, FLUTOXIL should be used only after consulting a doctor and evaluating the risk-benefit ratio in your specific case.
FLUTOXIL must not be used during breastfeeding.
Consult your doctor if you suspect you are pregnant or plan to become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Bromhexine hydrochloride does not affect the ability to drive or operate machinery.

Important information about certain excipients in FLUTOXIL
This medicine contains sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. The product may cause mild laxative effects. The caloric value of sorbitol is 2.6 kcal/g.
The product contains 3.7 vol% ethanol. A single dose may contain up to 0.3 g of ethanol per dose, equivalent to 7.4 ml of beer or 3 ml of wine per dose. It may be harmful for alcoholics. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.

HOW TO USE THIS MEDICINE

Dosage
The following doses are recommended unless otherwise prescribed by a doctor:
Adults: 1–2 teaspoonfuls (5–10 ml) three times daily.
At the beginning of treatment, the total daily dose may be increased up to 48 mg (60 ml), divided into three doses.
Children over 2 years of age: 1/2 – 1 teaspoon (2.5 – 5 ml) three times daily (= 12 mg/day).
The syrup can be administered to diabetics and children; it contains neither fructose nor sucrose.
Do not exceed the recommended doses.

When and for how long
It is recommended to take the medicine after meals. Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
Caution: use only for short-term treatment.

How to take
Administer orally.

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE
Cases of overdose have never been reported. In case of overdose, symptomatic treatment is required.
In the event of accidental ingestion of an excessive dose of FLUTOXIL, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about using FLUTOXIL, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, FLUTOXIL can cause side effects, although not everyone experiences them.

The following undesirable effects may occur after using Flutoxil:

Rare (may affect up to 1 in 1,000 people):

  • Hypersensitivity reactions;
  • Rash, urticaria.

Not known (frequency cannot be estimated from available data):

  • Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
  • Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized exanthematous pustulosis);
  • Bronchospasm.

Discontinue treatment immediately if any of these occur.
Cases of diarrhea, nausea, vomiting, and other mild gastrointestinal disturbances have also been reported.
Bronchial obstruction with unknown frequency.
These side effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you help provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
See expiry date on the packaging.
The expiry date refers to the product in unopened packaging and properly stored.
Caution: Do not use the medicine after the expiry date stated on the packaging.
After first opening the bottle, the product should be used within 9 months if stored at a temperature below 25°C; after this period, any remaining product should be discarded.
Keep both the outer box and the package leaflet, as they contain important information.
Keep the medicine out of the reach and sight of children.

COMPOSITION
5 ml of syrup contain:
Active substance: bromhexine hydrochloride 4 mg (equivalent to bromhexine 3.65 mg)
(1 teaspoon, equal to 5 ml, contains: bromhexine hydrochloride 4 mg).
Excipients: tartaric acid, benzoic acid, sodium carmellose, glycerol, sorbitol liquid, ethanol (96%), tutti-frutti flavor, sodium hydroxide, purified water.

PRESENTATION
FLUTOXIL is available as a syrup. The package contains 250 ml.

MARKETING AUTHORIZATION HOLDER
Aesculapius Farmaceutici S.r.l. – Via Cefalonia, 70 – 25124 Brescia

MANUFACTURER AND FINAL CONTROLLER
ICE S.P.A. – Cantone Moretti, 29 – 10015 Ivrea (TO)