Package leaflet: Information for the user

TUSSAL EXPECTORANS
30 mg, tablets
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 4 to 5 days, you should consult your doctor.

Table of contents:

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

1. What Tussal Expectorans is and what it is used for

Tussal Expectorans is a mucolytic agent that increases the amount of mucus in the respiratory tract, reduces its viscosity, and improves the function of respiratory epithelial cilia. As a result, it enhances mucus transport in the airways, facilitating expectoration and relieving cough.

Therapeutic indications
Tussal Expectorans is used as an adjunctive treatment in acute and chronic diseases of the lungs and bronchi associated with impaired mucus secretion and difficulty in mucus transport, for example:

acute or chronic bronchitis or pneumonia,
bronchial asthma,
pulmonary emphysema,
cystic fibrosis.

2. Important information before using Tussal Expectorans

When not to use Tussal Expectorans:

if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Tussal Expectorans, please consult your doctor or
pharmacist:

if the patient has impaired kidney function or severe liver disease. In such cases, the medicine should be used with special caution. The doctor may recommend longer intervals between doses or administration of lower doses,
if the patient has disorders in mucus transport in the bronchi, as in these patients bronchial secretions may accumulate,
if the patient has had a peptic ulcer of the stomach and/or duodenum in the past, because mucolytic agents may damage the gastric mucosa. Consult a doctor before using Tussal Expectorans.
if skin or mucous membrane changes occur, treatment with Tussal Expectorans must be stopped immediately and medical advice must be sought without delay. These may be symptoms of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome (see section 4).

Cases of severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash occurs (including lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Tussal Expectorans must be discontinued and immediate contact with a doctor must be established.
Tussal Expectorans and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Co-administration of ambroxol with certain antibiotics (amoxicillin, erythromycin, ampicillin, doxycycline and cefuroxime) increases the concentration of these antibiotics in lung tissue and consequently enhances their effect.
Ambroxol and theophylline mutually enhance each other's action.
Ambroxol should not be used simultaneously with antitussive medicines that suppress the cough reflex, as this may lead to accumulation of secretions in the bronchi.
Tussal Expectorans with food and drink
Tussal Expectorans should be taken after meals, with sufficient amount of water.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
This medicine should be used during pregnancy and breastfeeding only if so advised by a doctor.
Driving and operating machinery
Tussal Expectorans has no effect or negligible effect on the ability to drive and operate machinery.
Tussal Expectorans contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Tussal Expectorans

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Tussal Expectorans tablets are intended for oral use.
The medicine should be taken after meals, with an adequate amount of water. Do not take the medicine immediately before going to sleep.
If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.

Adults and children over 12 years of age:
Take one Tussal Expectorans tablet three times daily for the first 2 to 3 days (corresponding to 30 mg of ambroxol hydrochloride three times daily). Thereafter, take one Tussal Expectorans tablet twice daily (corresponding to 30 mg of ambroxol hydrochloride twice daily).

Children aged 6 to 12 years:
The recommended dose is ½ tablet of Tussal Expectorans 2 to 3 times daily (corresponding to 15 mg of ambroxol hydrochloride 2 to 3 times daily).
Tussal Expectorans should not be used in children under 6 years of age.

Use of Tussal Expectorans in patients with renal and/or hepatic impairment
Tussal Expectorans should be used with particular caution in patients with impaired renal and/or hepatic function; the recommended dose should be reduced.

Taking more Tussal Expectorans than recommended
No symptoms of severe poisoning have been observed. Transient restlessness and diarrhoea may occur.
In case of significant overdose, increased salivation, nausea, vomiting and hypotension may occur.
Contact a doctor. Usually, immediate interventions such as inducing vomiting and gastric lavage are not necessary; however, these may be considered in cases of significant overdose. Symptomatic treatment is recommended depending on the symptoms of overdose.
Do not take a higher dose than that recommended by the treating doctor.
If an overdose is taken, seek immediate advice from a doctor or pharmacist.

Missed dose of Tussal Expectorans
If a dose is missed, continue taking the medicine as recommended.
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects occurring commonly (occur in not more than 1 in 10 people):

diarrhoea.

Adverse effects occurring uncommonly (occur in not more than 1 in 100 people):

nausea, abdominal pain, vomiting,
fever.

Adverse effects occurring rarely (occur in not more than 1 in 1,000 people):

heartburn,
hypersensitivity reactions,
rash, urticaria.

Frequency not known: frequency cannot be estimated from the available data

anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), itching, breathing difficulties.
severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tussal Expectorans

Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Keep out of 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 the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tussal Expectorans contains

The active substance is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
Other components of the medicine are: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, magnesium stearate.

What Tussal Expectorans looks like and contents of the pack
Tussal Expectorans tablets are white, round, and biconvex.
Pack:
A cardboard box containing 10 tablets in a blister.
Marketing authorisation holder and manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań