Deflegmin Effect

Package Leaflet: Information for the User

Deflegmin EFFECT

30 mg/5 ml, syrup

Ambroxol hydrochloride

Read the package leaflet carefully before using the medicine, as it contains

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

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

Package Leaflet Contents:

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

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

Deflegmin EFFECT syrup is a mucolytic medicine containing ambroxol hydrochloride. It increases the production 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 viscous secretions from the respiratory tract.

2. Important information before using Deflegmin EFFECT syrup

When not to use Deflegmin EFFECT syrup

• 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 their doctor or
pharmacist:

• if the patient has stomach or duodenal ulcers;
• if the patient has liver or kidney function disorders;
• if the patient's 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).

There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. 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 patient should contact their doctor immediately.

Deflegmin EFFECT syrup and other medicines

The patient should inform their 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 thinned mucus.
• No interaction between ambroxol and other medicines has been demonstrated.

Deflegmin EFFECT syrup with food and drink

Deflegmin EFFECT syrup should be taken after meals.

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 their doctor or pharmacist before using this medicine.
Deflegmin EFFECT should not be used during pregnancy, especially during the first trimester.
Ambroxol passes into breast milk. Deflegmin EFFECT should not be used 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 that the medicine affects the ability to drive or use machines.
No studies have been conducted on the effect of Deflegmin EFFECT on the ability to drive or use machines.

Deflegmin EFFECT syrup contains sorbitol

The medicine contains 625 mg of sorbitol in the form of sorbitol solution per 1.25 ml of syrup, which corresponds to 1250 mg of sorbitol/2.5 ml of syrup or 2500 mg of sorbitol/5 ml of syrup.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Deflegmin EFFECT syrup contains propylene glycol

The medicine contains 21.2 mg of propylene glycol per 1.25 ml of syrup, which corresponds to 84.8 mg/5 ml of syrup.

Deflegmin EFFECT syrup contains sodium benzoate

The medicine contains 2.5 mg of sodium benzoate per 1.25 ml of syrup, which corresponds to 10 mg/5 ml of syrup.

Deflegmin EFFECT syrup contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, which means the medicine is considered "sodium-free".
Deflegmin EFFECT syrup does not contain sugar.

3. How to use Deflegmin EFFECT syrup

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by
a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.
The usual dose of Deflegmin EFFECT syrup:
for adults and children over 12 years of age:
initially, for 2 to 3 days, 5 ml of syrup 3 times a day, then the dose should be reduced to 5 ml of syrup 2 times a day;
for children from 6 to 12 years of age:
2.5 ml of syrup 2 to 3 times a day;
for children from 2 to 6 years of age:
1.25 ml of syrup 3 times a day;
for children from 1 to 2 years of age:
1.25 ml of syrup 2 times a day.
If there is no improvement or the patient feels worse after 4 to 5 days of using the medicine, they should contact their doctor.

Using a higher dose of Deflegmin EFFECT syrup than recommended

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

Missing a dose of Deflegmin EFFECT syrup

If a dose of the medicine 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 syrup

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 being used.
If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

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 patient should stop using the medicine and contact their doctor immediately:

• anaphylactic reactions, including anaphylactic shock, angioedema, 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 estimated from the available data).
In addition, the following side effects may occur:
Very common side effects(may affect up to 1 in 10 people):

• nausea,
• numbness in the mouth and throat,
• taste disorders (e.g. altered taste).

Common side effects(may affect up to 1 in 100 people):

• vomiting, diarrhea, indigestion, and abdominal pain,
• dryness of the mucous membranes in the mouth.

Uncommon side effects(may affect up to 1 in 1000 people):

• hypersensitivity reactions,
• rash, urticaria.

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

• itching, other allergic reactions not listed above,
• dryness in the throat.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the patient should inform their doctor or pharmacist. 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 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 syrup

Store in a temperature below 25°C. Store in the original package. Protect from light.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Deflegmin EFFECT syrup contains

• The active substance of the medicine is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
• The other ingredients of the medicine are: sorbitol solution, glycerol, propylene glycol (E 1520), sodium benzoate, purified water, masking flavor 11031-33 (containing, among others, propylene glycol (E 1520) and anise oil), hydrochloric acid 10% (for pH adjustment).

What Deflegmin EFFECT syrup looks like and what the package contains

A brown glass bottle containing 120 ml or 150 ml of syrup, closed with a child-resistant PP cap and a tamper-evident seal. A polypropylene measuring cup is attached to the bottle. The outer package is a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the package leaflet: