Patient Information Leaflet

BROMEXINA PENSA 4 mg/5 ml syrup

Bromhexine hydrochloride
Equivalent medicine
Read this entire leaflet carefully before taking this medicine, as it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after a short time.

Contents of this leaflet:

What BROMEXINA PENSA is and what it is used for
What you need to know before taking BROMEXINA PENSA
How to take BROMEXINA PENSA
Possible side effects
How to store BROMEXINA PENSA
Contents of the pack and other information

1. What BROMEXINA PENSA is and what it is used for

BROMEXINA PENSA contains the active substance bromhexine, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
BROMEXINA PENSA is therefore indicated in the treatment of acute and chronic respiratory diseases (such as bronchitis) associated with cough and phlegm.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period.

2. What you need to know before taking BROMEXINA PENSA

Do not take BROMEXINA PENSA

if you are allergic to bromexine or to any of the other ingredients of this medicine (listed in section 6);
if you have a stomach or intestinal ulcer;
if you are breastfeeding (see section “Pregnancy and breastfeeding”);
if the person taking the medicine is a child under 2 years of age (see section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking BROMEXINA PENSA.
Avoid taking this medicine for prolonged periods. If after a short course of treatment there is no noticeable improvement, consult your doctor.
Severe skin reactions have been reported with the use of bromexine. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking BROMEXINA PENSA and contact your doctor immediately.
Treatment with BROMEXINA PENSA increases bronchial secretion, facilitating its elimination.

Children
BROMEXINA PENSA is contraindicated in children under 2 years of age, as it may cause bronchial obstruction.

Other medicines and BROMEXINA PENSA
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 BROMEXINA PENSA and other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, take this medicine only after consulting your doctor and only if clearly necessary. Exercise particular caution during the first trimester of pregnancy.
Breastfeeding
Do not take BROMEXINA PENSA while breastfeeding, as bromexine passes into breast milk.

Driving and using machines
BROMEXINA PENSA does not affect the ability to drive or operate machinery.

BROMEXINA PENSA contains sorbitol, ethanol (alcohol), benzoic acid and sodium
This medicine contains 571.4 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has diagnosed you with an intolerance to certain sugars, or if you have hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, contact your doctor before taking this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect. Calorific value: 2.6 kcal/g of sorbitol.
This medicine contains 30 mg of ethanol per ml, equivalent to 3.7% vol ethanol. A 10 ml dose may contain up to 0.3 g of ethanol per dose, equivalent to 7.4 ml of beer and 3 ml of wine per dose.
The amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not clearly evident. However, some effects may occur in very young children, for example drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.
This medicine contains 2 mg of benzoic acid per ml.
This medicine contains 0.46 mg of sodium per ml, less than 1 mmol (23 mg) of sodium per 10 ml dose, i.e. essentially ‘sodium-free’.

3. How to take BROMEXINA PENSA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 5–10 ml three times daily. Your doctor may decide to increase your dose up to 48 mg divided into three doses at the beginning of treatment.
Use in children over 2 years
The recommended dose for children over 2 years is 2.5–5 ml three times daily.
Avoid exceeding the recommended doses or taking this medicine for prolonged periods.
Take this medicine after meals.
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 contains no fructose or sucrose.
If you take more BROMEXINA PENSA 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 or overdose of BROMEXINA PENSA, inform a doctor immediately or go to the nearest hospital Emergency Department.
If you forget to take BROMEXINA PENSA
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported with the use of BROMEXINA PENSA are:
Rare (may affect up to 1 in 1,000 people)

hypersensitivity reactions;
rash, urticaria.

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 cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis). In addition, cases of diarrhoea, nausea, vomiting, other mild gastrointestinal disorders, bronchospasm, and bronchial obstruction have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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 BROMEXINA PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
After first opening the bottle, the medicine should be used within 9 months, provided it is stored at a temperature below 25°C; after this period, any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BROMEXINA PENSA 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 carmellose, glycerol, liquid sorbitol, ethanol (96%), tutti frutti flavour, sodium hydroxide, purified water.

Description of the appearance of BROMEXINA PENSA and contents of the pack
BROMEXINA PENSA is presented as a syrup. The pack contains one 250 ml bottle.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A. - Via Enrico Tazzoli, 6 - 20154 Milan – Italy
Manufacturer
ICE S.p.A., Cantone Moretti, 29 - 10015 Ivrea (TO) - Italy