DEFLEGMIN EFFECT LONG

Package leaflet: Information for the user

Deflegmin EFFECT LONG
75 mg, prolonged-release capsules
Ambroxoli hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If advice or further information is needed, please consult your pharmacist.
• If any adverse reactions occur, including any possible 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 the patient feels worse, consult a doctor.

Leaflet contents:

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

1. What Deflegmin EFFECT LONG prolonged-release capsules are and

what they are used for

Deflegmin EFFECT LONG prolonged-release capsules are 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 LONG is used in acute and chronic lung and bronchial diseases associated with difficulty in expectorating viscous respiratory secretions.
If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.

2. Information before using Deflegmin EFFECT LONG

Prolonged-release capsules

When not to use Deflegmin EFFECT LONG prolonged-release capsules

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

Do not take this medicine immediately before going to sleep.

Warnings and precautions

Before starting treatment with Deflegmin EFFECT LONG, consult your doctor or pharmacist:

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

Severe skin reactions associated with ambroxol hydrochloride have been reported. If a rash occurs (including mucosal lesions, e.g. in the mouth, throat, nose, eyes, or genital organs), discontinue use of Deflegmin EFFECT LONG immediately and contact your doctor without delay.

Children and adolescents

Deflegmin EFFECT LONG prolonged-release capsules must not be used in children and adolescents.

Deflegmin EFFECT LONG prolonged-release capsules and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.

• Ambroxol increases concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Antitussive medicines (e.g. codeine) suppress the cough reflex and may hinder the expectoration of liquefied mucus; therefore, ambroxol should not be used concomitantly with antitussive agents.
• No significant interactions of ambroxol with other medicines have been demonstrated.

Deflegmin EFFECT LONG prolonged-release capsules with food and drink

Deflegmin EFFECT LONG prolonged-release capsules should be taken after meals and swallowed with a small amount of liquid.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Use of Deflegmin EFFECT LONG is not recommended during pregnancy, especially during the first trimester.

Ambroxol passes into breast milk. Use of Deflegmin EFFECT LONG is not recommended during breastfeeding.

The effect of this medicine on human fertility has not been studied.

Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and operating machinery

There is no evidence of an effect of this medicine on the ability to drive or operate machinery.

No studies have been conducted on the effect of Deflegmin EFFECT LONG on the ability to drive or operate machinery.

Deflegmin EFFECT LONG contains sucrose.

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

Deflegmin EFFECT LONG contains indigo carmine.

This medicine may cause allergic reactions.

3. How to use Deflegmin EFFECT LONG capsules with prolonged release

This medicine should always be taken exactly as described in this patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Typical dosage of Deflegmin EFFECT LONG prolonged-release capsules:

For adults:
Orally, 1 capsule once daily, in the morning or evening, after food, taken with a small amount of liquid.
Do not take the medicine immediately before bedtime.

If there is no improvement after 4 to 5 days, or if the patient feels worse, consult a doctor.

Use in children and adolescents
Deflegmin EFFECT LONG prolonged-release capsules must not be used in children and adolescents.

Taking more than the recommended dose of Deflegmin EFFECT LONG prolonged-release capsules
Specific symptoms of overdose have not been reported in humans.
After taking more than the recommended dose, symptoms listed in section 4 "Possible side effects" may occur. If such symptoms occur, contact your doctor.

Missed dose of Deflegmin EFFECT LONG prolonged-release capsules
If a dose is missed, 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 treatment with Deflegmin EFFECT LONG prolonged-release capsules
Discontinuing treatment with Deflegmin EFFECT LONG 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 will experience them.
If the patient experiences any of the following adverse reactions, stop taking
Deflegmin EFFECT LONG immediately and contact a doctor without delay:

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and itching,
• severe skin-related 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 estimated from the available data).
Additionally, the following adverse reactions may occur:
Common adverse reactions (may occur in up to 1 in 10 people):

• nausea.

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

• vomiting, diarrhoea, indigestion, and abdominal pain.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• hypersensitivity reactions,
• rash, urticaria.

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

• itching, other allergic reactions not listed above,
• feeling of dryness in the respiratory tract, watery nasal discharge,
• heartburn, feeling of dryness in the mouth, hypersalivation,
• urinary disorders.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
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 LONG capsules with prolonged release

Store below 25°C. Keep in the original packaging.
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 EXP.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Deflegmin EFFECT LONG prolonged-release capsules contain

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

What Deflegmin EFFECT LONG prolonged-release capsules look like and contents of the pack
PVC/PVDC/Aluminum blister in a cardboard box.
Pack contains: 10 or 20 prolonged-release capsules.
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland