Flavamed

Leaflet attached to the packaging: patient information

Flavamed, 30 mg, tablets

Ambroxol hydrochloride

Read the 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, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the 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 Flavamed and what is it used for
• 2. Important information before taking Flavamed
• 3. How to take Flavamed
• 4. Possible side effects
• 5. How to store Flavamed
• 6. Contents of the pack and other information

1. What is Flavamed and what is it used for

Flavamed is a mucolytic agent used in respiratory tract diseases. Flavamed is indicated for use in adults, adolescents, and children over 6 years of age. Flavamed is used in acute and chronic lung and bronchial diseases, characterized by the production of thick mucus. Thanks to the use of Flavamed, thick mucus becomes more watery and can be coughed up more easily.

2. Important information before taking Flavamed

When not to take Flavamed

• in children under 6 years of age.

Warnings and precautions

Before starting to take Flavamed, the patient should discuss it with their doctor or pharmacist,

• Stevens-Johnson syndrome is a disease characterized by high fever and rash with blisters on the skin and mucous membranes.
• Life-threatening Lyell's syndrome is also called toxic epidermal necrolysis. The symptoms of this syndrome are severe skin changes in the form of blisters, similar to those that occur in burns.

There have been reports of severe skin reactions associated with the use of ambroxol. If a rash occurs (including changes in the mucous membranes, e.g. in the mouth, throat, nose, eyes, genitals), the patient should stop taking Flavamed and contact their doctor immediately.

Children

Flavamed can only be used in children over 6 years of age.

Flavamed and 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/cough suppressants
When taking Flavamed with medicines that suppress the cough reflex (cough suppressants), there may be a (dangerous) accumulation of bronchial secretions due to a weakened cough reflex in patients with underlying respiratory diseases characterized by excessive mucus production, such as cystic fibrosis or bronchiectasis.

Pregnancy, breastfeeding, and fertility

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.
During pregnancy and breastfeeding, Flavamed can only be used if clearly prescribed by a doctor! The use of Flavamed is not recommended, especially during the first trimester of pregnancy.
It has been observed that the active substance contained in Flavamed passes into breast milk. Flavamed is not recommended during breastfeeding.
Animal studies have not shown any harmful effects of ambroxol on fertility.

Driving and using machines

There is no evidence of an effect on the ability to drive and use machines. No studies have been conducted on the effect on the ability to drive and use machines.

Flavamed contains lactose (a sugar found in milk)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Flavamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Flavamed

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The following information applies if the doctor has not prescribed a different dosage of Flavamed.
The patient should follow the instructions for taking the medicine, otherwise Flavamed will not work properly!

Recommended dose:

Note:
In adults, the daily dose can be increased to 2 tablets twice a day.

Method of administration

For oral use. Flavamed is best taken whole after a meal, with a sufficient amount of liquid (e.g. water, tea, or fruit juice).
The tablet can be divided into equal doses.

Duration of treatment

Without consulting a doctor, Flavamed should not be taken for more than 4-5 days.
If after 4-5 days the symptoms do not decrease or even worsen, the patient should contact their doctor immediately!
If the patient feels that the effect of Flavamed is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Flavamed than recommended

So far, no specific symptoms of overdose have been reported in humans. Based on reports of accidental overdose and/or incorrect dosing, the observed symptoms are consistent with the known side effects of ambroxol hydrochloride at recommended doses, and symptomatic treatment may be necessary. The patient should contact their doctor.

Missing a dose of Flavamed

In case of a missed dose or taking a smaller dose of the medicine, the patient should take the next prescribed 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 the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Flavamed can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• Nausea

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

• Stomach pain, vomiting, diarrhea, abdominal pain, and indigestion

Rare(may affect up to 1 in 1000 people) :

• Hypersensitivity reactions
• Rash, urticaria

Unknown (frequency cannot be estimated from the available data):

• Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue edema) and itching
• Severe skin reactions (including polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Action to be taken

If one or more of the above side effects occur, the patient should stop taking Flavamed immediately.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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, it is possible to gather more information on the safety of the medicine.

5. How to store Flavamed

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
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 Flavamed contains

The active substance of Flavamed is ambroxol hydrochloride.
One tablet contains 30 mg of ambroxol hydrochloride.
The other ingredients are: lactose monohydrate, corn starch, cellulose (powder), croscarmellose sodium, povidone K 30, magnesium stearate.

What Flavamed looks like and contents of the pack

White, round tablets, flat on both sides, with beveled edges and a dividing line on one side.
Flavamed is available in packs containing: 10, 20, and 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria:
Flavamed Cough Tablets
Estonia:
Flavamed 30 mg
Finland:
Flavamed 30 mg Tablets
Germany: Flavamed Hustentabletten
Latvia:
Flavamed Cough Tablets
Lithuania:
Flavamed Cough Tablets
Poland:
Flavamed
Slovak Republic:
Flavamed Cough Tablets
Slovenia:
Flavamed 30 mg Tablets

Date of last revision of the leaflet: 04/2023