Deflegmin effect

Patient Information Leaflet: Instructions for the User

Deflegmin EFFECT
30 mg/5 ml, syrup
Ambroxol hydrochloride
Please read the entire 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 patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 to 5 days, or if your condition worsens, contact your doctor.

Table of Contents:

1. What Deflegmin EFFECT syrup is and what it is 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. Contents of the package and other information

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

Deflegmin EFFECT syrup is a mucolytic medicine containing ambroxol hydrochloride. It increases mucus secretion in the respiratory tract and improves its transport, thereby facilitating expectoration and relieving cough.
Deflegmin EFFECT is used in acute and chronic lung and bronchial diseases associated with difficulty in expectorating thick mucus 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);
• immediately before going to sleep.

Warnings and precautions
Before starting treatment with Deflegmin EFFECT, consult a doctor or pharmacist:

• if the patient suffers from gastric or duodenal ulcer;
• if the patient has impaired liver or kidney function;
• if the cough reflex is weakened or if there are disorders in ciliary clearance of the bronchi (in such cases there is a risk of mucus accumulation in the airways);
• in case of bronchial asthma (Deflegmin EFFECT may initially worsen coughing).

Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, or genital organs), treatment with Deflegmin EFFECT must be discontinued immediately and medical advice should be sought without delay.

Deflegmin EFFECT syrup and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.

• Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Antitussive drugs (e.g. codeine) reduce the effectiveness of ambroxol by suppressing the cough reflex and impairing the expectoration of liquefied mucus.
• No interactions of ambroxol with other drugs have 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

The use of Deflegmin EFFECT is not recommended during pregnancy, especially during the first trimester.

Ambroxol passes into breast milk. The use of Deflegmin EFFECT is not recommended during breastfeeding.

The effect of this medicine on human fertility has not been studied. Animal studies have not shown any harmful effect of ambroxol on fertility.

Driving and operating machinery
There is no evidence of an effect of the medicine on the ability to drive or operate machinery. However, no studies have been conducted on the effect of Deflegmin EFFECT on the ability to drive or operate machinery.

Deflegmin EFFECT syrup contains sorbitol in the form of sorbitol solution
The medicine contains 625 mg of sorbitol in the form of sorbitol solution in 1.25 ml of syrup, corresponding to 1250 mg sorbitol/2.5 ml syrup or 2500 mg sorbitol/5 ml syrup.
Sorbitol is a source of fructose. If the patient (or the patient's child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a 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 in 1.25 ml of syrup, corresponding to 84.8 mg/5 ml syrup.

Deflegmin EFFECT syrup contains sodium benzoate
The medicine contains 2.5 mg of sodium benzoate in 1.25 ml of syrup, corresponding to 10 mg/5 ml syrup.

Deflegmin EFFECT syrup contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup; therefore, the medicine is considered "sodium-free".

Deflegmin EFFECT does not contain sugar.

3. How to use Deflegmin EFFECT syrup

This medicine should always be used exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Typical dosage of Deflegmin EFFECT syrup:
For adults and children over 12 years of age:
Initially, for 2 to 3 days, 5 ml of syrup three times daily; thereafter, reduce the dose to 5 ml of syrup twice daily.
For children aged 6 to 12 years:
2.5 ml of syrup two to three times daily.
For children aged 2 to 6 years:
1.25 ml of syrup three times daily.
For children aged 1 to 2 years:
1.25 ml of syrup twice daily.
If there is no improvement or if the patient feels worse after 4 to 5 days of treatment, consult a doctor.

Taking more Deflegmin EFFECT syrup than recommended
No cases of overdose have been reported. However, if symptoms such as nausea, excessive fatigue, or excessive mucus secretion occur, consult a doctor immediately.

If you miss a dose of Deflegmin EFFECT syrup
If you miss a dose at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

Stopping Deflegmin EFFECT syrup
Discontinuing treatment with Deflegmin EFFECT does not cause adverse effects, except for the possible worsening of symptoms of the condition for which the medicine is being used.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, stop using the medicine
and contact your doctor immediately:

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

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

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

Uncommon adverse reactions (may affect up to 1 in 100 people):

• vomiting, diarrhoea, indigestion, and abdominal pain,
• dryness of the oral mucosa.

Rare adverse reactions (may affect up to 1 in 1000 people):

• hypersensitivity reactions,
• rash, urticaria.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• itching, other allergic reactions not listed above,
• dry throat.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Deflegmin EFFECT syrup

Store below 25°C. Keep in the original packaging. Protect from light.
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 "Expiry date". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Deflegmin EFFECT syrup contains

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

What Deflegmin EFFECT syrup looks like and contents of the pack
An amber glass bottle containing 120 ml or 150 ml of syrup, closed with a PP screw cap with child-resistant closure and tamper-evident seal. A polypropylene measuring cup is supplied with the bottle. Outer packaging: cardboard box.
Marketing Authorisation 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.
Przemysłowa 2 Street
35-105 Rzeszów
Poland