Tussal Expectorans

Package Leaflet: Information for the User

TUSSAL EXPECTORANS

30 mg, tablets

Ambroxol hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet:

• 1. What is Tussal Expectorans and what is it used for
• 2. Important information before taking Tussal Expectorans
• 3. How to take Tussal Expectorans
• 4. Possible side effects
• 5. How to store Tussal Expectorans
• 6. Contents of the pack and other information

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

Tussal Expectorans is a mucolytic agent, it increases the amount of mucus in the respiratory tract, reduces its viscosity, and improves the function of the respiratory epithelium. As a result, it improves mucus transport in the respiratory tract, making it easier to cough up and relieving cough.

Indications for Use

Tussal Expectorans is used as an adjunct in acute and chronic lung and bronchial diseases with impaired mucus secretion and its transport, such as:

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

2. Important Information Before Taking Tussal Expectorans

When Not to Take 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 taking Tussal Expectorans, discuss it with your doctor or pharmacist:

• if the patient has kidney function disorders or severe liver disease. In such cases, the medicine should be taken with special caution. The doctor may recommend longer intervals between doses or the use of smaller doses of the medicine,
• if the patient has disorders of mucus transport in the bronchi, in these patients, there may be a risk of accumulation of bronchial secretions,
• if the patient has a history of gastric or duodenal ulcer disease, as mucolytic agents may damage the gastric mucosa. Consult a doctor before taking Tussal Expectorans.
• if skin or mucous membrane changes occur, discontinue taking Tussal Expectorans and consult a doctor immediately. These may be symptoms of severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome (see section 4).

There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If a rash occurs (including changes in the mucous membranes, such as the mouth, throat, nose, eyes, genitals), discontinue taking Tussal Expectorans and consult a doctor immediately.

Tussal Expectorans and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The 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 potentiate each other's effects.
Ambroxol should not be taken simultaneously with antitussive medicines that suppress the cough reflex. This may lead to accumulation of secretions in the bronchi.

Tussal Expectorans with Food and Drink

Tussal Expectorans should be taken after meals, with an adequate amount of water.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a doctor before taking this medicine.
The medicine can be used during pregnancy and breastfeeding only if recommended by a doctor.

Driving and Using Machines

The medicine has no or negligible influence on the ability to drive and use machines.

Tussal Expectorans Contains Lactose

If you have been diagnosed with an intolerance to some sugars, consult a doctor before taking the medicine.

3. How to Take Tussal Expectorans

This medicine should always be taken exactly as described in the package 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 directly before bedtime.
If after 4 to 5 days there is no improvement or you feel worse, consult a doctor.
Adults and children over 12 years:
Take one Tussal Expectorans tablet three times a day for the first 2 to 3 days (which corresponds to 30 mg of ambroxol hydrochloride three times a day), then take one Tussal Expectorans tablet twice a day (which corresponds to 30 mg of ambroxol hydrochloride twice a day).
Children from 6 to 12 years:
It is recommended to take ½ Tussal Expectorans tablet 2 to 3 times a day (which corresponds to 15 mg of ambroxol hydrochloride 2 to 3 times a day).
Tussal Expectorans should not be taken in children under 6 years of age.

Taking Tussal Expectorans in Patients with Kidney or Liver Function Disorders

In patients with kidney or liver function disorders, Tussal Expectorans should be taken with special caution; the recommended dose of the medicine should be reduced.

Taking a Higher Than Recommended Dose of Tussal Expectorans

No symptoms of severe poisoning have been observed. Transient anxiety and diarrhea may occur.
In case of significant overdose, increased salivation, nausea, vomiting, and decreased blood pressure may occur.
Consult a doctor. Usually, immediate action, such as inducing vomiting and rinsing the stomach, is not necessary; such action may be considered in case of significant overdose. Treatment should be carried out according to the symptoms of overdose that occur.
Do not take a dose higher than recommended by your doctor.
In case of taking a higher dose than recommended, consult a doctor or pharmacist immediately.

Missing a Dose of Tussal Expectorans

In case of missing a dose, continue taking the medicine according to the recommended dosage.
Do not take a double dose to make up for the missed dose.
In case of any doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Tussal Expectorans can cause side effects, although not everybody gets them.
Frequent side effects (occurring in no more than 1 in 10 people):

• diarrhea.

Uncommon side effects (occurring in no more than 1 in 100 people):

• nausea, abdominal pain, vomiting,
• fever.

Rare side effects (occurring in no more than 1 in 1,000 people):

• heartburn,
• allergic reactions,
• rash, urticaria.

Unknown frequency: frequency cannot be estimated from the available data

• anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissue), itching, difficulty breathing.
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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] Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Tussal Expectorans

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

6. Contents of the Pack and Other Information

What Tussal Expectorans Contains

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

What Tussal Expectorans Looks Like and Contents of the Pack

Tussal Expectorans tablets are white, round, and biconvex.
Packaging:
A cardboard box containing 10 tablets in a blister pack.

Marketing Authorization Holder and Manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Date of Last Revision of the Leaflet: