Deflegmin Effect

Leaflet attached to the packaging: information for the user

Deflegmin EFFECT

30 mg, tablets

Ambroxol hydrochloride

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, they should contact the doctor.

Table of contents of the leaflet:

• 1. What is Deflegmin EFFECT and what is it used for
• 2. Important information before using Deflegmin EFFECT
• 3. How to use Deflegmin EFFECT
• 4. Possible side effects
• 5. How to store Deflegmin EFFECT
• 6. Contents of the packaging and other information

1. What is Deflegmin EFFECT and what is it used for

Deflegmin EFFECT in the form of tablets is a mucolytic medicine containing ambroxol hydrochloride.
It increases the secretion of mucus in the respiratory tract and improves its transport, making it easier to cough up and relieving cough.
Deflegmin EFFECT is used in acute and chronic lung and bronchial diseases with difficulty in coughing up sticky secretions from the respiratory tract.

2. Important information before using Deflegmin EFFECT

When not to use Deflegmin EFFECT

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• directly before bedtime.

Warnings and precautions

Before starting to use Deflegmin EFFECT, the patient should discuss it with the doctor or
pharmacist:

• if the patient has stomach or duodenal ulcer disease;
• if the patient has liver or kidney function disorders;
• if the cough reflex is weakened or there are disorders of ciliary clearance of the bronchi (there is a risk of secretions accumulating in the respiratory tract);
• if the patient has bronchial asthma (Deflegmin EFFECT may initially worsen cough).

Severe skin reactions associated with the use of ambroxol hydrochloride have been reported.
If a rash occurs (including changes in mucous membranes, e.g. mouth, throat, nose, eyes, genitals), the use of Deflegmin EFFECT should be discontinued and the doctor should be contacted immediately.

Deflegmin EFFECT and other medicines

The patient should inform the doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Cough suppressants (e.g. codeine) weaken the effect of ambroxol by inhibiting the cough reflex and making it difficult to cough up liquefied mucus.
• No interaction between ambroxol and other medicines has been found.

Deflegmin EFFECT with food and drink

Deflegmin EFFECT in the form of tablets should be taken after meals and washed down with a small
amount of liquid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult the doctor or pharmacist before using this medicine.
The use of Deflegmin EFFECT is not recommended during pregnancy, especially in the first
trimester of pregnancy.
Ambroxol passes into breast milk. The use of Deflegmin EFFECT is not recommended during breastfeeding.
The effect of the medicine on human fertility has not been studied.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and using machines

There is no evidence of the medicine's effect on the ability to drive and use machines.
No studies have been conducted on the effect of Deflegmin EFFECT on the ability to drive and use machines.

Deflegmin EFFECT contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult the doctor before taking the medicine.

3. How to use Deflegmin EFFECT

This medicine should always be used exactly as described in the patient leaflet or as directed by
the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The usual dose of Deflegmin EFFECT in the form of tablets:
for adults and children over 12 years of age:
initially, for 2 to 3 days, 1 tablet 3 times a day, then the dose should be reduced to
1 tablet 2 times a day;
for children between 6 and 12 years of age:
half a tablet 2 to 3 times a day;
for children under 6 years of age:
the medicine in the form of tablets should not be used in children under 6 years of age (Deflegmin in the form of oral drops, solution, or syrup can be used).
If after 4 to 5 days of using the medicine there is no improvement or the patient feels worse, they should contact the doctor.

Using a higher dose of Deflegmin EFFECT than recommended

No cases of overdose have been reported. However, if symptoms such as nausea, excessive fatigue, or excessive mucus production occur, the doctor should be contacted immediately.

Missing a dose of Deflegmin EFFECT

If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for a missed dose.

Stopping the use of Deflegmin EFFECT

Stopping the use of Deflegmin EFFECT does not cause any adverse effects, except for the possibility of worsening symptoms of the disease for which it is used.
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, Deflegmin EFFECT can cause side effects, although not everybody gets them.

If any of the following side effects occur, the use of the medicine should be discontinued and the doctor should be contacted immediately:

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

The frequency of the above side effects is unknown (cannot be determined from available data).
In addition, the following side effects may occur:
Common side effects(may occur in up to 1 in 10 people):

• nausea.

Uncommon side effects(may occur in up to 1 in 100 people):

• vomiting, diarrhea, indigestion, and abdominal pain.

Rare side effects(may occur in up to 1 in 1000 people):

• hypersensitivity reactions;
• rash, urticaria.

Side effects with unknown frequency(frequency cannot be determined from available data):

• itching, other allergic reactions not listed above.

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 181 C, 02-222 Warsaw
tel.: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Deflegmin EFFECT

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
The medicine should be kept out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after "Expiry date". 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. Contents of the packaging and other information

What Deflegmin EFFECT contains

• The active substance of the medicine is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients of the medicine are: lactose, corn starch, colloidal silica, magnesium stearate.

What Deflegmin EFFECT looks like and what the packaging contains

White, round, biconvex tablets.
Deflegmin EFFECT in the form of tablets is packaged in Al/PCW film blisters. The carton contains one blister with 20 tablets.

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów, Poland
Date of last update of the leaflet:April 2025