Tussicom 200

Leaflet attached to the packaging: information for the user

TUSSICOM 200, 200 mg/5 g, powder for solution

Acetylcysteine

TUSSICOM 400, 400 mg/5 g, powder for solution

Acetylcysteine

TUSSICOM 600, 600 mg/5 g, powder for solution

Acetylcysteine
{logo of the responsible entity}

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tussicom and what is it used for
• 2. Important information before using Tussicom
• 3. How to use Tussicom
• 4. Possible side effects
• 5. How to store Tussicom
• 6. Package contents and other information

1. What is Tussicom and what is it used for

Tussicom contains acetylcysteine, which is a derivative of the natural amino acid L-cysteine. The medicine reduces the viscosity of respiratory tract secretions, making it easier to cough them up and improving breathing and relieving cough.
The medicine is used to treat respiratory diseases with thick bronchial secretions that require thinning, as well as in cystic fibrosis.

2. Important information before using Tussicom

When not to use Tussicom

• if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age.

Warnings and precautions

Using acetylcysteine may cause an increase in the volume of bronchial secretions.
Particular caution should be exercised when using the medicine:

• in patients with asthma; if bronchospasm occurs and persists, the medicine should be discontinued;
• in patients with gastric and duodenal ulcer disease, especially when other medicines that irritate the mucous membrane of the gastrointestinal tract are used at the same time;
• in elderly patients;
• in patients with severe respiratory failure.

Acetylcysteine should not be given to patients with reduced ability to cough, unless the patient is provided with respiratory physiotherapy during treatment.
If any new skin or mucous membrane changes occur during treatment with acetylcysteine (symptoms of a severe skin reaction such as Stevens-Johnson syndrome or toxic epidermal necrolysis), the doctor should be consulted immediately and treatment with acetylcysteine should be discontinued (see section 4).

Tussicom and other medicines

The doctor should be informed about all medicines currently being taken by the patient or recently taken, as well as medicines that are available without a prescription.
Acetylcysteine should not be used at the same time as antibiotics (erythromycin, tetracyclines, amoxicillin); a 2-hour interval should be maintained between taking the medicines.
Medicines that reduce the cough reflex should not be given at the same time as acetylcysteine.
Acetylcysteine may enhance the vasodilating effect of nitroglycerin. Caution should be exercised when these medicines are used together.
Activated charcoal may reduce the effect of acetylcysteine due to reduced absorption.
Acetylcysteine may affect the results of laboratory tests, such as salicylate analysis by colorimetry. The doctor and medical staff should be informed about the use of this medicine.

Pregnancy and breastfeeding

Before using any medicine, a doctor should be consulted.
The medicine should not be used during pregnancy and breastfeeding, unless it is necessary.

Driving and operating machinery

There is no available data on the effect of acetylcysteine on the ability to drive vehicles.

Tussicom contains sugar (sucrose)

1 sachet of Tussicom 200 contains 4.759 g of sucrose – approximately 0.4 bread units in one sachet.
1 sachet of Tussicom 400 contains 4.575 g of sucrose – approximately 0.4 bread units in one sachet.
1 sachet of Tussicom 600 contains 4.370 g of sucrose – approximately 0.4 bread units in one sachet.
This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before using this medicine.

Tussicom 400 contains tartrazine

The medicine may cause allergic reactions.

Tussicom 600 contains cochineal red

The medicine may cause allergic reactions.

3. How to use Tussicom

This medicine should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Dosage

The usual dose of Tussicom:

• in adults and children over 14 years of age - up to 600 mg of acetylcysteine per day;
• in children between 6 and 14 years of age - up to 400 mg of acetylcysteine per day;
• in children between 2 and 6 years of age - up to 300 mg of acetylcysteine per day.

Recommended dosage in cystic fibrosis:

• in children over 6 years of age - up to 600 mg of acetylcysteine per day;
• in children between 2 and 6 years of age - up to 400 mg of acetylcysteine per day.

Method of administration

The contents of the sachet should be dissolved in a glass of water and taken immediately after dissolution. The contents of the sachets should not be divided.
Warning:
Contact between the solution and metals or rubber should be avoided.

Using a higher dose of Tussicom than recommended

Overdose of the medicine may cause excessive liquefaction of mucopurulent secretions, especially in patients with inadequate cough reflex, in whom mechanical methods of suctioning secretions from the bronchi may be necessary. Additionally, overdose of the medicine may also lead to gastrointestinal symptoms such as nausea, vomiting, and diarrhea.
In case of suspected overdose, a doctor should be consulted immediately.

Missing a dose of Tussicom

If a dose is missed, a double dose should not be taken, but the next dose should be taken at the recommended time.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)

• hypersensitivity, which may manifest as bronchospasm, dyspnea, itching, urticaria, skin rash; severe allergic reaction known as "angioedema" with symptoms including: swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing and swallowing, tachycardia,
• headache,
• tinnitus,
• stomatitis, abdominal pain, nausea, vomiting, diarrhea,
• fever,
• hypotension.

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

• indigestion.

Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions (anaphylactic shock, anaphylactic and/or pseudoanaphylactic reactions). Anaphylactic shock is a severe systemic allergic reaction, its symptoms include: dyspnea, swelling of the larynx and throat, itching and redness of the skin, headache, feeling of "pressure", dizziness, significant weakness up to loss of consciousness. Anaphylactic shock can be life-threatening in severe cases.
• bleeding,
• in the initial period of treatment: bronchospasm, excessive mucus production, irritating cough,
• Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, mainly in the mouth, eyes, nose, and genital areas), toxic epidermal necrolysis.

Frequency not known (frequency cannot be estimated from the available data)

• vasodilation and sudden flushing of the face after administration of high doses,
• facial edema.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible entity.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tussicom

There are no special recommendations for storage.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tussicom 200 contains

• The active substance of the medicine is acetylcysteine. Each sachet contains 200 mg of acetylcysteine.
• The other ingredients are: sucrose, beta-carotene 2.5%, flavor and aroma enhancer, orange.

What Tussicom 400 contains

• The active substance of the medicine is acetylcysteine. Each sachet contains 400 mg of acetylcysteine.
• The other ingredients are: sucrose, flavor and aroma enhancer, lemon, tartrazine.

What Tussicom 600 contains

• The active substance of the medicine is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
• The other ingredients are: sucrose, colloidal silica, flavor and aroma enhancer, raspberry, flavor and aroma enhancer, orange, and cochineal red.

What Tussicom looks like and what the package contains

Tussicom 200 is a light orange powder with an orange flavor and aroma, in sachets. Each sachet contains 5 g of powder. The cardboard box contains 20 sachets.
Tussicom 400 is a light yellow powder with a lemon flavor and aroma, in sachets. Each sachet contains 5 g of powder. The cardboard box contains 20 sachets.
Tussicom 600 is a light pink powder with a fruity flavor and aroma, in sachets. Each sachet contains 5 g of powder. The cardboard box contains 20 sachets.

Responsible entity and manufacturer

Responsible entity:
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information, please contact:
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: (22) 280 00 00
Date of last update of the leaflet:March 2022