Neo Borocillina cough fluidifier
Italy
Table of Contents
PACKAGE LEAFLET
Package leaflet: Information for the user
Neo Borocillina Fluidificante Cough 30 mg/10 ml syrup
ambroxol hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, consult your pharmacist.
- If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What Neo Borocillina Fluidificante Tosse is and what it is used for
- What you need to know before taking Neo Borocillina Fluidificante Tosse
- How to take Neo Borocillina Fluidificante Tosse
- Possible side effects
- How to store Neo Borocillina Fluidificante Tosse
- Contents of the pack and other information
1. What Neo Borocillina Fluidificante Tosse is and what it is used for
Neo Borocillina Fluidificante Tosse contains the active substance ambroxol hydrochloride; this
medicine belongs to the class of mucolytics and acts as a liquefying agent for respiratory tract secretions (phlegm).
Neo Borocillina Fluidificante Tosse is used for the treatment of cough associated with phlegm (for
example, in the presence of acute and chronic respiratory tract diseases).
2. What you need to know before taking Neo Borocillina Fluidificante Tosse
Do not take Neo Borocillina Fluidificante Tosse
- if you are allergic to the active substance (ambroxol hydrochloride) or to any of the other ingredients of this medicine (listed in section 6);
- if you have severe liver and/or kidney impairment;
- if you have rare hereditary conditions that may be incompatible with one of the excipients (see section Neo Borocillina Fluidificante Tosse contains Sorbitol). Do not administer this medicine to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Neo Borocillina Fluidificante Tosse.
- Take Neo Borocillina Fluidificante Tosse with caution if you have a lesion on the inner surface of the stomach (peptic ulcer).
- Consult your doctor before taking Neo Borocillina Fluidificante Tosse if you have mild or moderate kidney problems.
- Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Neo Borocillina Fluidificante Tosse and contact your doctor immediately. Particularly in the early stages, you may also experience non-specific symptoms similar to those of influenza, such as fever, malaise, rhinitis, cough, and sore throat.
- Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.
Children
Do not administer this medicine to children under 2 years of age.
Other medicines and Neo Borocillina Fluidificante Tosse
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially antibiotics (amoxicillin, cefuroxime, erythromycin).
Ambroxol increases antibiotic concentrations in respiratory tract secretions and in saliva. No interactions with other medicines have been reported.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ambroxol crosses the placental barrier; therefore, Neo Borocillina Fluidificante Tosse should only be taken after consulting your doctor and evaluating with him the benefit-risk ratio in your individual case.
As a precautionary measure, especially during the first trimester of pregnancy, the use of Neo Borocillina Fluidificante Tosse is not recommended.
There are no clinical data available on ambroxol use during pregnancy.
Normal precautions regarding medicine use during pregnancy should nevertheless be observed.
Breastfeeding
Ambroxol hydrochloride passes into breast milk. Although adverse effects in breastfed infants are not expected, the use of Neo Borocillina Fluidificante Tosse is not recommended during breastfeeding.
Fertility
Animal studies do not indicate direct or indirect harmful effects on male and female fertility.
Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery; therefore, there is no evidence demonstrating any effect of Neo Borocillina Fluidificante Tosse on the ability to drive or operate machinery.
Neo Borocillina Fluidificante Tosse contains Sorbitol, Propylene glycol, Benzoic acid, and Glycerol
Sorbitol
This medicine contains 5 g of sorbitol per 10 mL of syrup.
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.
Propylene glycol
This medicine contains 300 mg of propylene glycol per 10 mL of syrup.
Benzoic acid
This medicine contains 20 mg of benzoic acid per 10 mL of syrup.
Glycerol
This medicine contains 1.5 g of glycerol per 10 mL of syrup.
3. How to take Neo Borocillina Fluidificante Tosse
Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
- Adults: 10 ml (30 mg) three times daily.
- Children over 5 years: 5 ml (15 mg) three times daily.
- Children from 2 to 5 years: 2.5 ml (7.5 mg) three times daily.
Use the dosing cup provided in the package to measure the correct dose.
Do not exceed the stated doses without medical advice.
It is recommended to take Neo Borocillina Fluidificante Tosse after meals.
Use Neo Borocillina Fluidificante Tosse only for short periods of time.
If you take more Neo Borocillina Fluidificante Tosse than you should
Contact your doctor immediately or go to the nearest hospital if you have accidentally taken an excessive dose of Neo Borocillina Fluidificante Tosse. Symptoms observed in cases of accidental overdose and/or administration errors may be the same as the expected undesirable effects of Neo Borocillina Fluidificante Tosse at the recommended doses (see section Possible side effects) and may require symptomatic treatment.
If you have any doubts about the use of Neo Borocillina Fluidificante Tosse, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Common side effects (may affect less than 1 in 10 people)
- Taste disturbances (dysgeusia)
- Loss of sensitivity in the oral cavity and pharynx (hypoesthesia)
- Nausea
Uncommon side effects (may affect less than 1 in 100 people)
- Vomiting, diarrhoea, stomach discomfort (dyspepsia), abdominal pain, dry mouth
Rare side effects (may affect less than 1 in 1,000 people)
- Headache (cephalaea)
- Increased nasal secretion (rhinorrhoea)
- Heartburn (pyrosis), constipation
- Hypersensitivity reactions
- Rash, urticaria, contact dermatitis
- Difficulty urinating (dysuria)
- Fatigue
Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus
- Serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)
- Bronchial obstruction
- Dry throat
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Neo Borocillina Fluidificante Tosse
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle.
The expiry date refers to the last day of that month.
After the first opening of the bottle, the syrup is valid for one year.
Do not use this medicine if the packaging is open or damaged.
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.
It is important to always keep the medicine information available; therefore, retain both the
carton and the package leaflet.
6. Package contents and other information
What Neo Borocillina Fluidificante Tosse contains
- The active substance is ambroxol hydrochloride. 100 ml of syrup contain 300 mg of ambroxol hydrochloride.
- The other components are hydroxyethylcellulose, sorbitol 70%, glycerol, benzoic acid, propylene glycol, tartaric acid, purified water, and black cherry flavor.
Description of the appearance of Neo Borocillina Fluidificante Tosse and the contents of the package
Neo Borocillina Fluidificante Tosse is an oral syrup.
The package contains a 200 ml glass bottle with an attached dosing spoon, in a printed cardboard carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)