Deflegmin Effect Long

Package Leaflet: Information for the User

Deflegmin EFFECT LONG

75 mg, prolonged-release capsules

Ambroxol hydrochloride

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the 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.

Table of Contents of the Leaflet:

• 1. What is Deflegmin EFFECT LONG in the form of prolonged-release capsules and what is it used for
• 2. Important information before taking Deflegmin EFFECT LONG in the form of prolonged-release capsules
• 3. How to take Deflegmin EFFECT LONG in the form of prolonged-release capsules
• 4. Possible side effects
• 5. How to store Deflegmin EFFECT LONG in the form of prolonged-release capsules
• 6. Contents of the pack and other information

1. What is Deflegmin EFFECT LONG in the form of prolonged-release capsules and

what is it used for
Deflegmin EFFECT LONG in the form of prolonged-release capsules is a mucolytic medicine containing ambroxol hydrochloride. It increases the production of mucus in the airways and improves its transport, making it easier to cough up and relieving cough. Deflegmin EFFECT LONG is used in acute and chronic lung and bronchial diseases with difficulty in coughing up viscous secretions from the airways. If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

2. Important information before taking Deflegmin EFFECT LONG in the form of

prolonged-release capsules

When not to take Deflegmin EFFECT LONG in the form of prolonged-release capsules

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

The medicine should not be taken immediately before bedtime.

Warnings and precautions

Before starting to take Deflegmin EFFECT LONG, 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 has a weakened cough reflex or respiratory ciliary function disorders (there is a risk of secretions accumulating in the airways);
• if the patient has bronchial asthma (Deflegmin EFFECT LONG may initially worsen cough).

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

Children and adolescents

The medicine in the form of prolonged-release capsules should not be used in children and adolescents.

Deflegmin EFFECT LONG in the form of prolonged-release capsules 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) suppress the cough reflex and make it difficult to cough up liquefied mucus, so ambroxol should not be taken at the same time as cough suppressants.
• No significant interaction between ambroxol and other medicines has been found.

Deflegmin EFFECT LONG in the form of prolonged-release capsules with food and drink

Deflegmin EFFECT LONG in the form of prolonged-release capsules 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 their doctor or pharmacist before taking this medicine. The use of Deflegmin EFFECT LONG is not recommended during pregnancy, especially during the first trimester. Ambroxol passes into breast milk. The use of Deflegmin EFFECT LONG 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 that the medicine affects the ability to drive or use machines. No studies have been conducted on the effect of Deflegmin EFFECT LONG on the ability to drive or use machines.

Deflegmin EFFECT LONG contains sucrose.

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

Deflegmin EFFECT LONG contains indigo carmine.

The medicine may cause allergic reactions.

3. How to take Deflegmin EFFECT LONG in the form of prolonged-release

capsules
This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The usual dose of Deflegmin EFFECT LONG in the form of prolonged-release capsules:
for adults:
orally, 1 capsule per day, in the morning or evening, after meals, washed down with a small amount of liquid. The medicine should not be taken immediately before bedtime.

If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Use in children and adolescents

The medicine in the form of prolonged-release capsules should not be used in children and adolescents.

Taking a higher dose of Deflegmin EFFECT LONG in the form of prolonged-release capsules than recommended

No specific symptoms of overdose have been reported in humans.
After taking a higher dose of Deflegmin EFFECT LONG than recommended, the side effects listed in section 4 "Possible side effects" may occur. If these symptoms occur, the patient should contact their doctor.

Missing a dose of Deflegmin EFFECT LONG in the form of prolonged-release capsules

If a dose is missed, the patient should take it as soon as possible. However, if the time for the next dose is near, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Deflegmin EFFECT LONG in the form of prolonged-release capsules

Stopping treatment with Deflegmin EFFECT LONG does not cause any adverse effects, except for the possibility of worsening symptoms of the disease for which it is being taken.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Deflegmin EFFECT LONG can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking Deflegmin EFFECT LONG and contact their doctor immediately:

• anaphylactic reactions, including anaphylactic shock, angioedema, and itching,
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

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

• nausea.

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

• vomiting, diarrhea, indigestion, and abdominal pain.

Rare side effects(may affect up to 1 in 1,000 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 airways, runny nose,
• heartburn, dry mouth, salivation,
• urination disorders.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Deflegmin EFFECT LONG in the form of prolonged-release

capsules
Store in a temperature below 25°C. Store in the original package. The medicine should be kept out of sight and reach of children. Do not use this medicine after the expiry date stated on the package after EXP. 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Deflegmin EFFECT LONG in the form of prolonged-release capsules contains

• The active substance of the medicine is ambroxol hydrochloride. One prolonged-release capsule contains 75 mg of ambroxol hydrochloride.
• The other ingredients of the medicine are: sucrose spheres, corn starch, shellac, povidone, talc; the ingredients of the gelatin capsule are: erythrosine (E 127), titanium dioxide (E 171), indigo carmine (E 132), gelatin.

What Deflegmin EFFECT LONG in the form of prolonged-release capsules looks like and what the pack contains

PVC/PVDC/Aluminum blister pack in a cardboard box.
The pack contains: 10 or 20 prolonged-release capsules.

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
Date of last revision of the leaflet:April 2025