Package leaflet: Information for the patient

Ambroxol Aflofarm
30 mg/5 mL, syrup
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before taking this 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
the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
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 4-5 days, or if your condition worsens, consult your doctor.

Table of contents

What Ambroxol Aflofarm is and what it is used for
Important information 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, reducing the viscosity of respiratory tract secretions, thereby facilitating airway clearance and relieving cough. The medicine is in the form of an oral syrup.
Therapeutic indications
Adjunctive treatment in acute and chronic bronchial disorders associated with impaired expectoration of viscous bronchial secretions.
If there is no improvement after 4 to 5 days, or if the patient feels worse, medical advice should be sought.

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);
if the patient has a rare inherited fructose intolerance.

Warnings and precautions
Before starting treatment with Ambroxol Aflofarm, discuss with your doctor or
pharmacist:

if the patient has peptic ulcer disease of the stomach and/or duodenum;
if the patient has impaired kidney and/or liver function;
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 mucus from the respiratory tract may appear.
In such cases, coughing should be encouraged to facilitate expectoration. Suctioning of mucus 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 occurs (including lesions of mucous membranes, e.g. in the mouth, throat, nose, eyes, or genital organs), discontinue use of Ambroxol Aflofarm and contact a doctor immediately.
Children
This medicine must not be given to children under 12 years of age.
Ambroxol Aflofarm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking:

antibiotics (medicines used to treat infections, e.g.: amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime), because ambroxol increases their penetration into the lungs and enhances their effect;
theophylline (a medicine used to treat bronchial asthma), because it enhances the effect of ambroxol;
antitussives (medicines used to treat dry, exhausting cough), because they may suppress the cough reflex and lead to mucus accumulation in the airways.

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 is not recommended during pregnancy, especially during the first three months of pregnancy.
Use of this medicine is not recommended in breastfeeding women, because ambroxol hydrochloride passes into breast milk.
Driving and operating machinery
Ambroxol Aflofarm has no effect or negligible effect on the ability to drive
vehicles and operate machinery.
Ambroxol Aflofarm contains sorbitol, non-crystallizing liquid (E 420), propylene glycol, benzoic acid (E 210), sodium, ethanol, and linalool
Sorbitol, non-crystallizing liquid (E 420)
The medicine contains 2500 mg of non-crystallizing liquid sorbitol in 5 mL of syrup.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or a rare inherited fructose intolerance, a genetic disorder in which the patient's body cannot metabolize fructose, the patient should contact a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Propylene glycol
The medicine contains 152 mg of propylene glycol in 5 mL of syrup, equivalent to 30.4 mg/mL.
Benzoic acid (E 210)
The medicine contains 10 mg of benzoic acid in 5 mL of syrup, equivalent to 2 mg/mL.
Sodium
The medicine contains 0.19 mg of sodium in 5 mL of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium per 5 mL of syrup, meaning the medicine is considered "sodium-free".
Ethanol
This medicine contains 0.02 micrograms of alcohol (ethanol) in each 5 mL of syrup. The amount of alcohol in 5 mL of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take Ambroxol Aflofarm

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
The recommended doses apply in the treatment of acute respiratory diseases and at the beginning of treatment for chronic conditions.
If there is no improvement after 4 to 5 days, or if symptoms worsen, consult a doctor.
For long-term treatment (beyond 5 days), this medicine should only be used after consultation with a doctor.
For long-term treatment (beyond 14 days), after consultation with a doctor, the dose may be reduced by half.
A measuring device is provided with the package to facilitate accurate dosing. Use it to measure the medicine.
Adults and adolescents over 12 years of age:
5 mL of syrup 3 times daily during the first 2 to 3 days of treatment, then 5 mL of syrup 2 times daily.
Method of administration
The medicine should be taken orally.
Do not take the medicine immediately before going to sleep.
Taking more Ambroxol Aflofarm than recommended
If more medicine than recommended has been taken, contact a doctor immediately.
Symptoms of overdose may include nausea, fatigue, and excessive bronchial mucus secretion.
If you miss a dose of Ambroxol Aflofarm
Take the missed dose as soon as possible, then take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
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.
You must immediately stop taking this medicine and contact your doctor or go to
the emergency department of the nearest hospital if any of the following occur:

anaphylactic shock (skin rash, itching of hands and feet spreading over the whole body, facial, lip or throat swelling making breathing difficult, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, cold extremities, loss of consciousness, cardiac arrest) – frequency unknown;
rash (including lesions on mucous membranes, e.g. in the oral cavity, throat, nose, eyes, genital organs) – frequency unknown;
severe skin-related adverse reactions with unknown frequency such as:
erythema multiforme (bluish-red skin spots, sometimes with blisters);
Stevens-Johnson syndrome (characterized by blisters on the skin and/or mucous membranes which, when ruptured, form painful sores; fever, muscle and joint pain often occur simultaneously);
toxic epidermal necrolysis (a condition involving blister formation and shedding of the outer layer of the skin);
acute generalized exanthematous pustulosis (red, scaly rash with subcutaneous nodules and blisters, usually located in skin folds, trunk, and upper limbs, accompanied by fever occurring at the beginning of treatment (also known as acute generalized exanthematous pustulosis)).

Other adverse reactions may occur
Common (occur in 1 to 10 people out of 100):

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

Uncommon (occur in 1 to 10 people out of 1,000):

dryness of the oral mucosa due to lack of saliva production (xerostomia);
vomiting;
diarrhoea, constipation, heartburn, indigestion, abdominal pain.

Rare (occur in 1 to 10 people out of 10,000):

hypersensitivity reactions;
rash, urticaria – bright pink, itchy wheals on the skin;
pain and burning during urination (dysuria).

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

anaphylactic reactions, including angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissue) and itching;
dryness of the throat mucosa.

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 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 the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and the carton.
The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 2 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Ambroxol Aflofarm contains

The active substance is ambroxol hydrochloride. 5 mL of syrup contains 30 mg of ambroxol hydrochloride (Ambroxoli hydrochloridum).
Other ingredients are: hydroxyethylcellulose, sorbitol, non-crystallizing liquid (E 420), glycerol, propylene glycol, sodium saccharin (E 954), benzoic acid (E 210), Tutti-Frutti AR 1459 flavour (containing, among others, propylene glycol, linalool, ethanol), purified water.

What Ambroxol Aflofarm looks like and contents of the pack
Ambroxol Aflofarm is a syrup. The syrup is colourless to yellow, with a candy-like odour and a bitter-sweet taste.
Brown glass bottle type III closed with a white aluminium cap.
Pack sizes: 100 mL, 120 mL.
A measuring cup is included in the package.
Outer packaging: 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