Deflegmin effect

Package leaflet: Information for the user

Deflegmin EFFECT
30 mg, tablets
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 physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, 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 your condition worsens, you should contact your doctor.

Contents of the leaflet:

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

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

Deflegmin EFFECT tablets 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 is used in acute and chronic lung and bronchial diseases associated with difficulty in expectorating viscous 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);
• immediately before going to sleep.

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

• if the patient has gastric or duodenal ulcer disease;
• if the patient has liver or kidney function disorders;
• 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 cough).

Severe skin reactions associated with ambroxol hydrochloride have been reported.
If a rash occurs (including mucosal lesions, e.g. in the oral cavity, throat, nose, eyes, genital organs), discontinue use of Deflegmin EFFECT and contact a doctor immediately.

Deflegmin EFFECT and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.

• Ambroxol increases concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in lung tissue.
• Antitussive drugs (e.g. codeine) reduce the effect of ambroxol by suppressing the cough reflex and impairing expectoration of liquefied mucus.
• No interactions of ambroxol with other drugs have been demonstrated.

Deflegmin EFFECT with food and drink
Deflegmin EFFECT tablets 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 have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Deflegmin EFFECT during pregnancy, especially during the first trimester, is not recommended.
Ambroxol passes into breast milk. Use of Deflegmin EFFECT during breastfeeding is not recommended.
The effect of the medicine on human fertility has not been studied.
Animal studies have not shown harmful effects 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.
No studies have been conducted on the effect of Deflegmin EFFECT on the ability to drive or operate machinery.

Deflegmin EFFECT contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Deflegmin EFFECT

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Typical dosage of Deflegmin EFFECT tablets:
For adults and children over 12 years of age:
Initially, 1 tablet 3 times daily for 2 to 3 days; thereafter, the dose should be reduced to
1 tablet 2 times daily.
For children aged 6 to 12 years:
Half a tablet 2 to 3 times daily.
For children under 6 years of age:
The tablet form of this medicine should not be used in children under 6 years of age (Deflegmin oral drops, solution, or syrup may be used instead).
If there is no improvement after 4 to 5 days of treatment, or if the patient feels worse, medical advice should be sought.
Taking more Deflegmin EFFECT 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.
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. Do not take a double dose to make up for a missed one.
Stopping Deflegmin EFFECT treatment
Discontinuing treatment with Deflegmin EFFECT does not cause adverse effects, except for the possible worsening of symptoms of the condition for which the medicine was prescribed.
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 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-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

The frequency of occurrence of the above-mentioned adverse reactions is unknown (cannot be
determined from available data).
Additionally, the following adverse reactions of the medicine 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, dyspepsia, and abdominal pain.

Rare adverse reactions (may occur in 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.

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 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.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Deflegmin EFFECT

Store below 25°C. Keep in the original packaging to protect from light and moisture.
Keep the medicine out of 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 should 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 pack and other information

What Deflegmin EFFECT contains

• The active substance is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
• The other ingredients are: lactose, maize starch, colloidal silicon dioxide, magnesium stearate.

What Deflegmin EFFECT looks like and contents of the pack
White, round, biconvex tablets.
Deflegmin EFFECT tablets are packed in Al/PCW foil blisters. Each cardboard box contains one blister with 20 tablets.
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