Froben productive cough

Patient Information Leaflet

Froben Tosse Grassa 4 mg/5 ml syrup

bromhexine hydrochloride
Generic Medicine
Please read all of 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 told you to.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What Froben Tosse Grassa is and what it is used for
2. What you need to know before taking Froben Tosse Grassa
3. How to take Froben Tosse Grassa
4. Possible side effects
5. How to store Froben Tosse Grassa
6. Contents of the pack and other information

1. What Froben Tosse Grassa is and what it is used for

Froben Tosse Grassa contains the active substance bromhexine. Bromhexine is a substance capable of
liquefying mucus that accumulates in the respiratory tract. This facilitates the expulsion of mucus from the
airways and consequently makes breathing easier.
Froben Tosse Grassa is therefore indicated for the symptomatic treatment of productive cough and disturbances of mucus secretion during acute and chronic respiratory diseases (such as bronchitis).

2. What you need to know before taking Froben Cough Expectorant

Do not take/administer Froben Cough Expectorant

• if you are allergic to bromhexine or to any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding (see section 2 “Pregnancy, breastfeeding and fertility”)
• if the person taking the medicine is a child under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Froben Cough Expectorant:

• if you suffer from a respiratory disease that develops and worsens over a relatively short period (acute respiratory conditions). Consult your doctor if symptoms do not improve or worsen during treatment;
• if you are pregnant (see section 2 “Pregnancy, breastfeeding and fertility”);
• if you have stomach or intestinal lesions (ulcer).

Cases of severe skin reactions have been reported with bromhexine administration. If you develop
a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking
Froben Cough Expectorant and consult your doctor immediately.
These reactions could be symptoms of serious skin diseases characterized by skin peeling and severe skin toxic reaction (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Most of these may be due to pre-existing serious illnesses or to concomitant use of other medicines.
Furthermore, in the initial phase of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN),
you may experience non-specific symptoms resembling those of influenza, such as fever, chills,
runny nose (rhinitis), cough and sore throat. Due to these misleading symptoms, you might start a
symptomatic treatment with a cough and cold remedy.
Treatment with Froben Cough Expectorant increases bronchial secretion (which facilitates expectoration).
Take/administer this medicine only for short periods.

Children
Do not give this medicine to children under 2 years of age. Mucolytics such as Froben Cough Expectorant
may cause bronchial obstruction due to the physiological characteristics of children in this age group.

Other medicines and Froben Cough Expectorant
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
There is no information available on interactions between Froben Cough Expectorant and other medicines.

Froben Cough Expectorant with food
Take/administer Froben Cough Expectorant after meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

Pregnancy
As a precautionary measure, it is preferable to avoid taking this medicine during pregnancy. Take
this medicine only after consulting your doctor.

Breastfeeding
Do not take Froben Cough Expectorant while breastfeeding, as bromhexine passes into breast milk.

Fertility
Based on preclinical experience, there are no indications of possible effects of bromhexine on fertility.

Driving and using machines
Froben Cough Expectorant does not affect the ability to drive or operate machinery.

Froben Cough Expectorant contains in each maximum dose (20 ml):

• 40 mg of benzoic acid, equivalent to 0.73 mg/kg;

• less than 23 mg of sodium, i.e. essentially “sodium-free”;

• 11.43 g of sorbitol, equivalent to 207.8 mg/kg. 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 problems and has a mild laxative effect;

• 576 mg of alcohol (ethanol), equivalent to 10.47 mg/kg. The volume amount of this medicine is equivalent to less than 15 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Froben Tosse Grassa

Take/administer 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.
Adults
The recommended dose is 1–2 teaspoons (5–10 ml) three times daily. Your doctor may decide to increase your dose at the beginning of treatment.
Children over 2 years
The recommended dose in children over 2 years of age is half a teaspoon to one teaspoon (2.5–5 ml) three times daily.
Method of administration
For oral use.
Take/administer the medicine after meals.
Avoid exceeding the recommended doses or taking this medicine for prolonged periods.
If you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment, consult your doctor.
This medicine can be taken by children over 2 years of age and by diabetic patients, as it does not contain fructose or sucrose.
If you take more Froben Tosse Grassa than you should
If you (or someone else) have ingested an excessive amount of the syrup, or if you think a child has taken the medicine, contact a doctor immediately.
In case of accidental ingestion/overdose of Froben Tosse Grassa, immediately contact a doctor or go to the nearest hospital emergency department.
Take this leaflet, the bottle and its packaging with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Froben Tosse Grassa
If you forget to take/administer a dose, take/administer it as soon as you remember, unless it is almost time for the next dose. Do not take/administer a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur with the use of Froben Tosse Grassa:

Uncommon (may affect up to 1 in 100 people)

• Diarrhea, nausea, vomiting, and upper abdominal pain

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

• Hypersensitivity reactions
• Skin rash, urticaria (appearance of red patches on the skin)

Not known (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)
• Bronchoconstriction causing breathing difficulty (obstruction)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may 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 Froben Tosse Grassa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after "Exp.". The expiry date refers to the last day of that month.
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 must be discarded.
Remember to record the date of first opening on the packaging.
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 Froben Tosse Grassa contains

• The active substance is bromhexine hydrochloride. 5 ml of syrup contain 4 mg of bromhexine hydrochloride (equivalent to 3.65 mg of bromhexine).
• The other components are: tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, liquid sorbitol, ethanol (96%), tutti-frutti flavour, sodium hydroxide, purified water.

Description of the appearance of Froben Tosse Grassa and contents of the pack
Froben Tosse Grassa is presented as a syrup. The pack contains one 250 ml bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10015 Ivrea (TO)