Tussicom 400

Package Leaflet: 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 marketing authorization holder}

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Tussicom and what is it used for
• 2. Important information before taking Tussicom
• 3. How to take 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 a nagging cough.
The medicine is used to treat respiratory diseases with thick bronchial secretions that require thinning and in cystic fibrosis.

2. Important information before taking Tussicom

When not to take Tussicom

• if you are 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

Taking acetylcysteine may cause an increase in the volume of bronchial secretions.
Particular caution should be exercised when taking 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 digestive 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 respiratory physiotherapy is provided during treatment.
If any new skin or mucous membrane changes occur during acetylcysteine treatment (symptoms of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis), you should consult a doctor immediately and discontinue acetylcysteine treatment (see section 4).

Tussicom and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as those that are available without a prescription.
Acetylcysteine should not be taken at the same time as antibiotics (erythromycin, tetracyclines, amoxicillin); a 2-hour interval should be maintained between taking the medicines.
Do not give cough suppressants at the same time as acetylcysteine.
Acetylcysteine may enhance the vasodilating effect of nitroglycerin. Caution should be exercised when taking these medicines 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. You should inform your doctor and medical staff that you are taking this medicine.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor.
Do not take the medicine during pregnancy and breastfeeding, unless necessary.

Driving and using machines

There is no available data on the effect of acetylcysteine on the ability to drive and use machines.

Tussicom contains sugar

1 sachet of Tussicom 200 contains 4.759 g of sugar – approximately 0.4 bread units per sachet.
1 sachet of Tussicom 400 contains 4.575 g of sugar – approximately 0.4 bread units per sachet.
1 sachet of Tussicom 600 contains 4.370 g of sugar – approximately 0.4 bread units per sachet.
This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Tussicom 400 contains quinoline yellow

The medicine may cause allergic reactions.

Tussicom 600 contains cochineal red

The medicine may cause allergic reactions.

3. How to take Tussicom

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The usual dose of Tussicom:

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

Recommended dosage in cystic fibrosis:

• in children over 6 years - up to 600 mg of acetylcysteine per day;
• in children from 2 to 6 years - 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.
Caution:
Avoid contact between the solution and metals and rubber.

Taking 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 aspiration of secretions from the bronchi may be necessary. Additionally, overdose of the medicine may also lead to gastrointestinal symptoms such as nausea, vomiting, and diarrhea.
If you suspect an overdose, seek medical attention immediately.

Missing a dose of Tussicom

If you miss a dose, do not take a double dose, just take the next dose at the recommended time.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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 occur in the form of bronchospasm, dyspnea, itching, urticaria, skin rash; severe allergic reaction called "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,
• low blood pressure.

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, life-threatening allergic reaction, with symptoms including: 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. In severe cases, anaphylactic shock can be life-threatening.
• 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 taking high doses,
• facial edema.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje 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 marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tussicom

There are no special precautions for storage.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Tussicom 200 contains

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

What Tussicom 400 contains

• The active substance is acetylcysteine. Each sachet contains 400 mg of acetylcysteine.
• The other ingredients are: sugar, flavor and aroma enhancer, lemon, quinoline yellow.

What Tussicom 600 contains

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

What Tussicom looks like and contents of the pack

Tussicom 200 is a light orange powder with an orange flavor and aroma, in sachets. Each sachet contains 5 g of powder. The carton 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 carton 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 carton box contains 20 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi-Aventis Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Rzeszów Branch
Lubelska 52 Street
35-233 Rzeszów
To obtain more detailed information, please contact:
Sanofi-Aventis Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: (22) 280 00 00
Date of last revision of the package leaflet:March 2022