Tusseval mucolytic

Patient Information Leaflet

TUSSEVAL MUCOLITIC 4 mg/5 ml syrup

Bromhexine hydrochloride
Please read this leaflet carefully before taking/giving this medicine to your child because it contains important information for you.
Always take/give 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 any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What TUSSEVAL MUCOLITIC is and what it is used for
2. What you need to know before taking/giving TUSSEVAL MUCOLITIC to your child
3. How to take/give TUSSEVAL MUCOLITIC to your child
4. Possible side effects
5. How to store TUSSEVAL MUCOLITIC
6. Contents of the pack and other information

1. What TUSSEVAL MUCOLITICO is and what it is used for

TUSSEVAL MUCOLITICO contains the active substance bromhexine hydrochloride, which belongs to the group of mucolytic medicines. It works by liquefying thick mucus deposits in the respiratory tract, thus facilitating their elimination.
TUSSEVAL MUCOLITICO is used to treat alterations in secretions (for example, presence of cough and phlegm) in acute and chronic respiratory diseases in adults, adolescents, and children from 2 years of age.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before taking/giving TUSSEVAL MUCOLYTIC to your child

Do not take/give TUSSEVAL MUCOLYTIC to your child

• if you/your child are allergic to bromhexine or to any of the other ingredients of this medicine (listed in section 6).
• during breastfeeding (see section 2 “Pregnancy and breastfeeding”).
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving TUSSEVAL MUCOLYTIC to your child:

• if you/your child suffer(s) from a respiratory tract 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/your child have/had stomach and/or intestinal lesions (gastroduodenal ulcer).

Serious skin reactions have been reported with administration of bromhexine hydrochloride. If a skin rash occurs (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking bromhexine hydrochloride and contact your doctor immediately.
Such reactions could be symptoms of severe skin diseases characterized by skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis).
Most of these cases might be due to pre-existing severe illnesses or concomitant use of other medicines. Moreover, in the initial phase of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN), non-specific symptoms similar to those of influenza may occur, such as fever, chills, runny nose (rhinitis), cough and sore throat. Because of these misleading symptoms, treatment with cough and cold remedies might be initiated.
Treatment with TUSSEVAL MUCOLYTIC syrup increases bronchial secretion (which facilitates expectoration). Do not use/give to the child for prolonged treatments. If no noticeable improvement occurs after a short period of treatment, consult your doctor.
In patients with gastroduodenal ulcer, use is recommended only after consulting a doctor.
You should also consult your doctor in cases where such disorders have occurred previously.

Children
Do not give this medicine to children under 2 years of age (see section “Do not use TUSSEVAL MUCOLYTIC”).
Mucolytics may cause bronchial obstruction in children under 2 years of age. Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.

Other medicines and TUSSEVAL MUCOLYTIC
No interactions with other medicines have been reported.
Inform your doctor or pharmacist if you/your child are taking, have recently taken or might take any other medicines.

TUSSEVAL MUCOLYTIC with food and drink
Take/give TUSSEVAL MUCOLYTIC to your child after meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
As a precautionary measure, it is preferable to avoid taking TUSSEVAL MUCOLYTIC if you are pregnant (see section 2 “Warnings and precautions”). TUSSEVAL MUCOLYTIC should be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.

Breastfeeding
TUSSEVAL MUCOLYTIC must not be used during breastfeeding (see section 2 “Do not take TUSSEVAL MUCOLYTIC”).

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

Driving and using machines
No studies have been conducted on the effects of bromhexine hydrochloride on the ability to drive vehicles or use machinery.

TUSSEVAL MUCOLYTIC contains sorbitol, alcohol, sodium and benzoic acid
TUSSEVAL MUCOLYTIC contains 4 g of sorbitol per 10 ml dose, equivalent to 400 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance 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.
TUSSEVAL MUCOLYTIC contains 290 mg of alcohol (ethanol) in 10 ml, equivalent to 29 mg/ml. The amount in 10 ml of this medicine is equivalent to less than 0.5 ml of beer or 1.25 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
TUSSEVAL MUCOLYTIC contains 20 mg of benzoic acid per dose equivalent to 2 mg/ml.
TUSSEVAL MUCOLYTIC contains less than 1 mmol (23 mg) of sodium per 10 ml, i.e., essentially “sodium-free”.

3. How to take/give TUSSEVAL MUCOLYTIC to your child

Take/give this medicine to your child exactly as described in this leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The package contains a dosing cup to help measure the correct dose, marked with graduations at 2.5 ml, 5 ml, and 10 ml.
The recommended dose is as follows:

Adults:
Unless otherwise prescribed by a doctor, the recommended dose is 5–10 ml three times daily.
In adults, at the beginning of treatment, the total daily dose may need to be increased up to 48 mg (60 ml), divided into three doses.

Children over 2 years of age:
Unless otherwise prescribed by a doctor, the recommended dose is 2.5–5 ml three times daily.
Do not exceed the recommended doses.
It is advisable to take the medicine after meals.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Use only for short-term treatment.
Administer orally.

If you take/give your child more TUSSEVAL MUCOLYTIC than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital, as symptomatic treatment may be required.

If you forget to take/give your child TUSSEVAL MUCOLYTIC
Do not take/give a double dose to make up for the missed dose.

If you stop treatment with TUSSEVAL MUCOLYTIC
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of TUSSEVAL MUCOLITICO:
Uncommon (may affect up to 1 in 100 people)

• nausea, vomiting, diarrhoea, 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 generalised exanthematous pustulosis).
• Bronchoconstriction causing breathing difficulties (bronchospasm).

In such cases, discontinue treatment. These side effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you or your child experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website: 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 TUSSEVAL MUCOLYTIC

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use/do not give this medicine to your child after the expiry date stated on the packaging
after Exp. The expiry date refers to the product kept in its original intact packaging and stored correctly.
After first opening the bottle, the medicine must be used within 9 months if stored at a temperature below 25°C; after this period, any remaining medicine must be discarded.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TUSSEVAL MUCOLITIC contains

• The active substance is bromhexine. 5 ml of syrup contain 4 mg of bromhexine hydrochloride (equivalent to 3.65 mg bromhexine). (5 ml contain 4 mg bromhexine hydrochloride).

The other components are: tartaric acid, benzoic acid, sodium carmellose, glycerol, liquid sorbitol,
ethanol (96%), tutti frutti flavour, sodium hydroxide, purified water. (see section 2. “TUSSEVAL
MUCOLITIC contains”)
Description of the appearance of TUSSEVAL MUCOLITIC and pack sizes
TUSSEVAL MUCOLITIC is a syrup.
It is available in a pack containing 1 dark glass bottle of 250 ml with a dosing cup.
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38
36100 Vicenza
Manufacturer
ICE S.P.A. – Canton Moretti, 29 – 10015 San Bernardo D’Ivrea (TO)