Ambroxol Aflofarm

Package Leaflet: Information for the Patient

Ambroxol Aflofarm

30 mg, tablets

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.

• -Keep this leaflet, so you can read it again if you need to.
• -If you need advice or additional information, consult a pharmacist.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 to 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 in the respiratory tract, making it easier to cough up mucus and relieving cough. The medicine is in the form of tablets.

Indications for Use

As an adjunct in acute and chronic respiratory diseases with difficulty in coughing up viscous bronchial secretions, e.g., bronchial asthma, cystic fibrosis, bronchitis, pneumonia.
If after 4 to 5 days there is no improvement or the patient feels worse, they should consult their 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 to take Ambroxol Aflofarm, the patient should discuss it with their doctor or pharmacist:

• if the patient has gastric or duodenal ulcer disease;
• if the patient has kidney or severe liver function disorders;
• if the patient has a weakened cough reflex (difficulty coughing up) or disorders of mucociliary clearance of the bronchi, due to the possibility 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, there may be an increased amount of fluid secretions from the respiratory tract.
In such cases, the patient should induce coughing to expel the secretions. It may be necessary to aspirate the secretions, in which case the patient should consult their doctor.
Severe skin reactions associated with the use of ambroxol hydrochloride have been reported.
If a rash appears (including changes in mucous membranes, e.g., mouth, throat, nose, eyes, genitals), the patient should stop taking Ambroxol Aflofarm and immediately consult their doctor.

Ambroxol Aflofarm with Other Medicines

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

• Ambroxol Aflofarm increases the concentration of antibiotics(medicines used to treat infections, such as amoxicillin, erythromycin, ampicillin, doxycycline, and cefuroxime) in bronchopulmonary secretions and sputum.
• Ambroxol Aflofarm and theophylline(a medicine used to treat bronchial asthma) potentiate each other's effects.
• -Ambroxol Aflofarm should not be used simultaneously with cough suppressants(used to treat dry, irritating cough, e.g., codeine), as they may suppress the cough reflex and cause secretions to accumulate in the respiratory tract.

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should consult their doctor or pharmacist.

Ambroxol Aflofarm with Food and Drink

The medicine can be taken with or without food.

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.
Ambroxol Aflofarm is not recommended during pregnancy, especially during the first three months of pregnancy.
Ambroxol Aflofarm is not recommended for breastfeeding women, as ambroxol hydrochloride passes into breast milk.

Driving and Using Machines

No studies have been conducted on the effects of ambroxol on the ability to drive and use machines.

Ambroxol Aflofarm Contains Lactose

One tablet contains 186 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

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. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended Dose

Recommended doses are used to treat acute respiratory diseases and in the initial period of chronic conditions.
In long-term treatment (more than 14 days), after consulting a doctor, the dose can be reduced to half.

Adults

1 tablet 3 times a day for the first 2 to 3 days of treatment, then the dose should be reduced to 1 tablet 2 times a day.

Method of Administration

The medicine should be taken orally.
The medicine can be taken with or without food.
The medicine should not be taken before bedtime.
If after 4 to 5 days there is no improvement or the patient feels worse, they should consult their doctor.

Taking More Than the Recommended Dose of Ambroxol Aflofarm

In case of taking more than the recommended dose, the patient should consult their doctor.
Overdose symptoms may occur: nausea, fatigue, excessive secretion of mucus from the bronchi.

Missing a Dose of Ambroxol Aflofarm

The patient should not take a double dose to make up for a missed dose.
The patient should take the medicine as soon as possible and take the next dose at the usual time.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Ambroxol Aflofarm can cause side effects, although not everybody gets them.

The Patient Should Stop Taking Ambroxol Aflofarm and Immediately Consult Their Doctor If:

• anaphylactic shock (rash on the skin, itching of 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).

The Following Side Effects May Occur

Frequent(may occur in up to 1 in 10 people):

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

Infrequent(may occur in up to 1 in 100 people):

• diarrhea;
• vomiting;
• indigestion;
• abdominal pain;
• heartburn;
• constipation. Rare(may occur in up to 1 in 1,000 people):
• allergic 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 (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membrane, or submucosal tissue) and itching;
• severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• skin changes, fever, shortness of breath, chills, swelling of the face, pain, and dizziness;
• dryness of the mucous membrane of the mouth due to lack of saliva production (xerostomia). If any of the above symptoms occur, the patient should stop taking the medicine and consult their doctor.

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 use this medicine after the expiry date (EXP) stated on the blister and carton.
The expiry date refers to the last day of the month.
Batch: means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. 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, lactose monohydrate), 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. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Pack sizes: 20, 25, and 50 tablets in 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: