Patient Information Leaflet

Ambroxol Aflofarm
30 mg, tablets
Ambroxoli hydrochloridum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor 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 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, consult your doctor.

Table of Contents

What Ambroxol Aflofarm is and what it is used for
What you need to know before taking Ambroxol Aflofarm
How to take Ambroxol Aflofarm
Possible side effects
How to store Ambroxol Aflofarm
Contents of the pack and other information

1. What Ambroxol Aflofarm is and what it is used for

Ambroxol Aflofarm contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic properties, helping to loosen and thin mucus in the respiratory tract, thereby facilitating expectoration and relieving cough. The medicine is available in tablet form.
Indications
For adjunctive treatment of acute and chronic respiratory diseases associated with difficulty in expectorating viscous bronchial secretions, e.g. bronchial asthma, cystic fibrosis, bronchitis, pneumonia.
If there is no improvement after 4 to 5 days, or if your condition worsens, consult your doctor.

2. Important information before taking Ambroxol Aflofarm

When not to take Ambroxol Aflofarm

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

Warnings and precautions
Before starting treatment with Ambroxol Aflofarm, consult a doctor or pharmacist:

if the patient has gastric and/or duodenal ulcer disease;
if the patient has renal function disorders and/or severe liver insufficiency;
if the patient has a weakened cough reflex (difficulty expectorating) or impaired ciliary clearance of the bronchi, due to the risk of mucus accumulation;
if the patient has bronchial asthma, because ambroxol may initially worsen cough and cause excessive expectoration of mucus.

At the beginning of treatment, increased amounts of liquid secretion from the respiratory tract may occur.
In such a case, coughing should be encouraged to facilitate expectoration. Suctioning of secretions may be necessary; in this case, the patient should contact a doctor.
Severe skin reactions associated with ambroxol hydrochloride have been reported.
If a rash appears (including lesions of mucous membranes, e.g. oral cavity, throat, nose, eyes, genital organs), discontinue use of Ambroxol Aflofarm immediately and contact a doctor without delay.

Ambroxol Aflofarm and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Ambroxol Aflofarm increases the concentration of antibiotics (medicines used to treat infections, e.g.: amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime) in bronchopulmonary secretions and sputum.
Ambroxol Aflofarm and theophylline (a medicine used in the treatment of bronchial asthma) mutually enhance each other's effects.
Ambroxol Aflofarm should not be taken simultaneously with antitussive medicines (used to treat dry, exhausting cough, e.g. codeine), because they may suppress the cough reflex and lead to mucus retention in the airways.

If the patient is unsure whether they are taking any of the medicines listed above, they should contact a doctor or pharmacist.

Food and drink with Ambroxol Aflofarm
This medicine can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy, especially during the first three months of pregnancy, is not recommended.
Use of this medicine in breastfeeding women is not recommended, as ambroxol hydrochloride passes into breast milk.

Driving and operating machinery
No studies have been conducted on the effects of ambroxol on the ability to drive vehicles or operate machinery.

Ambroxol Aflofarm contains lactose monohydrate
One tablet contains 186 mg of lactose monohydrate. 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 take Ambroxol Aflofarm

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
The recommended doses apply to the treatment of acute respiratory tract diseases and the initial phase of treatment of chronic conditions.
In long-term treatment (beyond 14 days), the dose may be reduced by half following consultation with a doctor.
Adults
1 tablet 3 times daily for the first 2 to 3 days of treatment, then reduce the dose to 1 tablet 2 times daily.
Method of administration
The medicine should be taken orally.
Ambroxol Aflofarm may be taken with or without food.
This medicine should not be taken immediately before going to bed.
If there is no improvement after 4 to 5 days, or if symptoms worsen, consult your doctor.
Accidental overdose of Ambroxol Aflofarm
In case of taking more than the recommended dose, contact your doctor immediately.
Symptoms of overdose may include nausea, fatigue, and excessive bronchial mucus secretion.
Missed dose of Ambroxol Aflofarm
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, and then take the next dose at the usual time.
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.
You must stop taking Ambroxol Aflofarm and contact your doctor immediately if you experience:

anaphylactic shock (skin rash, itching of hands and feet spreading over the entire body, swelling of the face, lips or throat causing breathing difficulties, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, cold extremities, loss of consciousness, cardiac arrest).

The following adverse reactions may occur
Common (may affect up to 1 in 10 people):

nausea;
taste disturbances (e.g. altered taste);
sensation of numbness in the oral cavity and throat.

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

diarrhoea;
vomiting;
dyspepsia;
abdominal pain;
heartburn;
constipation.

Rare (may affect up to 1 in 1,000 people):

hypersensitivity reactions;
rash, urticaria;
pain and burning during urination (dysuria).

Frequency not known (frequency cannot be estimated from the available data):

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);
skin changes, fever, shortness of breath, chills, facial swelling, pain and dizziness;
dryness of the oral mucosa due to lack of saliva production (xerostomia).

If any of the above symptoms occur, the medicine should be discontinued and a doctor should be consulted immediately.

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 181C, 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 Ambroxol Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date (EXP) stated on the blister and carton.
The expiry date refers to the last day of the stated month.
Lot: batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ambroxol Aflofarm contains

The active substance is ambroxol hydrochloride. One tablet contains 30 mg of ambroxol hydrochloride.
The other ingredients are: Ludipress (povidone K 30, crospovidone Type A, monohydrate lactose), magnesium stearate.

What Ambroxol Aflofarm looks like and contents of the pack
Ambroxol Aflofarm is a white, round, biconvex tablet with a single-score line on one side. The score line is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee equal dose division.

Pack sizes: 20, 25 and 50 tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100