Ambroxol Aflofarm

Package Leaflet: Information for the Patient

Ambroxol Aflofarm

30 mg/5 mL, syrup

Ambroxol hydrochloride

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4-5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

Ambroxol Aflofarm contains the active substance ambroxol hydrochloride, which has expectorant and mucolytic properties, making it easier to clear the airways and relieve cough. The medicine is in the form of a syrup for oral use.

Indications

As an adjunct in acute and chronic bronchial diseases with difficulty in expectorating viscous bronchial secretions. If after 4 to 5 days there is no improvement or the patient feels worse, they should consult a 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);
• if the patient has a rare hereditary fructose intolerance.

Warnings and precautions

Before starting to take Ambroxol Aflofarm, the patient should discuss it with their doctor or pharmacist:

• if the patient has stomach or duodenal ulcers;
• if the patient has kidney or liver function disorders;
• if the patient has a weakened cough reflex (difficulty in expectorating) or disorders of mucociliary clearance of the bronchi, due to the risk of secretions accumulating;
• if the patient has bronchial asthma, as ambroxol may initially exacerbate cough and cause excessive expectoration of secretions.

At the beginning of treatment, an excessive amount of fluid secretions from the airways may occur. In such cases, the patient should induce coughing to expectorate it. It may be necessary to aspirate the secretions, in which case the patient should consult a doctor. There have been reports of severe skin reactions associated with the use of ambroxol hydrochloride. If a rash occurs (including changes in the mucous membranes, e.g. in the mouth, throat, nose, eyes, genitals), the patient should stop taking Ambroxol Aflofarm and immediately consult a doctor.

Children

This medicine should not be given to children under 12 years of age.

Ambroxol Aflofarm and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor if they are taking:

• antibiotics(medicines used to treat infections, such as amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime), as ambroxol increases their penetration into the lungs and enhances their effect;
• theophylline(a medicine used to treat bronchial asthma), as it enhances the effect of ambroxol;
• cough suppressants(used to treat dry, irritating cough), as they may inhibit the cough reflex and cause secretions to accumulate in the airways.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The use of this medicine is not recommended during pregnancy, especially during the first three months. The use of this medicine is not recommended in breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and using machines

Ambroxol Aflofarm has no influence or negligible influence on the ability to drive and use machines.

Ambroxol Aflofarm contains sorbitol, liquid non-crystallizing (E 420), propylene glycol, benzoic acid (E 210), sodium, ethanol, and linalol

Sorbitol, liquid non-crystallizing (E 420)

The medicine contains 2500 mg of sorbitol, liquid non-crystallizing, in 5 mL of syrup. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare hereditary fructose intolerance, a genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their 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, which corresponds to 30.4 mg/mL.

Benzoic acid (E 210)

The medicine contains 10 mg of benzoic acid in 5 mL of syrup, which corresponds 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 in 5 mL of syrup, which means 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 have noticeable effects.

3. How to take Ambroxol Aflofarm

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Recommended doses are used in the treatment of acute respiratory diseases and in the initial period of treatment of chronic conditions. If after 4 to 5 days there is no improvement or the patient feels worse, they should consult their doctor. In long-term treatment (more than 5 days), the medicine may only be used after consulting a doctor. In long-term treatment (more than 14 days), after consulting a doctor, the dose may be reduced to half. A measuring cup is attached to the packaging to facilitate dosing, with which the medicine should be measured.

Adults and adolescents over 12 years of age:

5 mL of syrup 3 times a day for the first 2 to 3 days of treatment, then 5 mL of syrup 2 times a day.

Method of administration

The medicine should be taken orally. The medicine should not be taken before bedtime.

Taking a higher dose of Ambroxol Aflofarm than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor. Symptoms of overdose may occur: nausea, fatigue, excessive secretion from the bronchi.

Missing a dose of Ambroxol Aflofarm

The patient should take the syrup as soon as possible and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and consult their doctor or go to the emergency department of the nearest hospital immediately if they experience:

• anaphylactic shock (rash on the skin, itching of the hands and feet covering the whole body, swelling of the face, lips, or throat making breathing difficult, wheezing, shortness of breath, unpalpable pulse, significantly lowered blood pressure, sweating, cold limbs, loss of consciousness, cardiac arrest) - frequency not known;
• rash (including changes in the mucous membranes, e.g. in the mouth, throat, nose, eyes, genitals) - frequency not known;
• severe skin reactions of unknown frequency, such as:
• erythema multiforme (red-purple spots on the skin, sometimes with blisters);
• Stevens-Johnson syndrome (which manifests with blisters on the skin and/or mucous membranes that form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• toxic epidermal necrolysis (a disease with blistering and peeling of the outer layer of the skin);
• acute generalized exanthematous pustulosis (red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment, also known as acute generalized pustular eruption).

Other side effects may occur

Common (occurring in 1 to 10 people in 100):

• taste disorders (e.g. altered taste);
• nausea;
• numbness in the mouth and throat.

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

• dryness of the mucous membrane of the mouth due to lack of saliva production (xerostomia);
• vomiting;
• diarrhea, constipation, heartburn, indigestion, abdominal pain.

Rare (occurring in 1 to 10 people in 10,000):

• hypersensitivity reactions;
• rash, urticaria - light red, itchy blisters on the skin;
• pain and burning during urination (dysuria).

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

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ambroxol Aflofarm

The medicine should be stored out of sight and reach of children. Store in a temperature 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 carton. The expiry date refers to the last day of the month. Shelf life after first opening the bottle: 2 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ambroxol Aflofarm contains

• The active substance of the medicine is ambroxol hydrochloride. 5 mL of syrup contains 30 mg of ambroxol hydrochloride (Ambroxol hydrochloride).
• The other ingredients are: hydroxyethylcellulose, sorbitol, liquid non-crystallizing (E 420), glycerol, propylene glycol, sodium saccharin (E 954), benzoic acid (E 210), Tutti-Frutti AR 1459 flavor (contains, among others, propylene glycol, linalol, ethanol), purified water.

What Ambroxol Aflofarm looks like and what the pack contains

Ambroxol Aflofarm is a syrup. The syrup is colorless to yellow with a cherry-like odor and a bitter-sweet taste. The bottle is made of brown glass type III, closed with a white aluminum cap. Pack size: 100 mL, 120 mL. A measuring cup is attached to the packaging. The outer packaging is a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100

Date of last revision of the leaflet: