Ambroxol aflofarm

Package leaflet: Information for the patient

Ambroxol Aflofarm
15 mg/5 mL, syrup
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
your doctor or pharmacist.

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

Table of contents

1. What Ambroxol Aflofarm is and what it is used for
2. Important information before taking Ambroxol Aflofarm
3. How to take Ambroxol Aflofarm
4. Possible side effects
5. How to store Ambroxol Aflofarm
6. 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 secretions and thereby facilitating airway clearance and alleviating cough. The medicine is available as an oral syrup.
Indications
For adjunctive treatment of 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 the rare inherited fructose intolerance;
• in children under 2 years of age.

Warnings and precautions
Before starting to take 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 may appear from the respiratory tract.
In such cases, coughing should be encouraged to expel the mucus. 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 mucosal lesions, e.g. in the mouth, throat, nose, eyes, genital organs), discontinue use of Ambroxol Aflofarm immediately and contact a doctor without delay.
Children
This medicine must not be given to children under 2 years of age.
Ambroxol Aflofarm with other medicines
Tell 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 enhances their penetration into the lungs and potentiates their effect;
• theophylline (a medicine used in the treatment of bronchial asthma), because it enhances the effect of ambroxol;
• antitussives (used to treat dry, exhausting cough), because they may suppress the cough reflex and cause mucus retention in the airways.

Pregnancy and breastfeeding
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 this medicine during pregnancy, especially during the first three months of pregnancy, is not recommended.
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
and operate machinery.
Ambroxol Aflofarm contains sorbitol, liquid non-crystallizing (E 420), propylene glycol, benzoic acid (E 210), sodium, ethanol, and linalool
Sorbitol, liquid non-crystallizing (E 420)
The medicine contains 2500 mg of liquid non-crystallizing sorbitol in 5 mL of syrup.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if the patient has previously been diagnosed with inherited fructose intolerance, a rare genetic disorder in which the patient's body cannot break down 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 0.045 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 to the treatment of acute respiratory tract diseases and to the initial phase of treatment of chronic conditions.
If there is no improvement after 4 to 5 days, or if the patient feels worse, a doctor should be consulted.
For long-term treatment (beyond 5 days), the medicine may be used only after consultation with a doctor.
For prolonged treatment (beyond 14 days), after consultation with a doctor, the doses may be reduced by half.
A measuring device is provided with the packaging to facilitate dosing, and the medicine should be measured using this device.

Method of administration
The medicine should be taken orally.
The medicine should not be taken immediately before going to sleep.

Overdose of Ambroxol Aflofarm
If more medicine has been taken than recommended, contact a doctor immediately.
Symptoms of overdose may include: nausea, fatigue, excessive mucus secretion from the bronchi.

Missed dose of Ambroxol Aflofarm
Take the syrup as soon as possible, and 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 regarding 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 this medicine immediately and contact your doctor or go to
the nearest hospital emergency department if any of the following occur:

• anaphylactic shock (skin rash, itching of hands and feet spreading over the whole body, swelling of the face, lips or throat causing difficulty in breathing, 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. oral cavity, throat, nose, eyes, genital organs) – frequency unknown;
• severe skin 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 skin);
• acute generalized exanthematous pustulosis (red, scaly rash with subcutaneous nodules and pustules, usually located in skin folds, on the trunk and upper limbs, accompanied by fever occurring at the beginning of treatment (also known as acute generalized pustular eruption)).

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

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

Uncommon (affects 1 to 10 people in 1,000):

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

Rare (affects 1 to 10 people in 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 estimated from available data):

• anaphylactic reactions, including angioedema (rapidly progressing swelling of skin, subcutaneous tissue, mucous membrane 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,
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 this medicine.

5. How to store Ambroxol Aflofarm

Keep the medicine out of 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 on the carton.
The expiry date refers to the last day of the stated month.
Usable period after first opening of 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 practices will 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 15 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 raspberry-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