Flavamed

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Flavamed

30 mg, tablets
Ambroxol hydrochloride

You should carefully read the contents of the leaflet before using 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 4 to 5 days there is no improvement or you feel worse, you should contact your 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 packaging 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 fluid and can be coughed up more easily.

2. Important information before taking Flavamed

When not to take Flavamed

Warnings and precautions

Before starting to take Flavamed, you should discuss it with your 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 on mucous membranes, such as the mouth, throat, nose, eyes, genitals), you should stop taking Flavamed and contact your doctor immediately.

Children

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

Flavamed and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ambroxol/antitussives
When taking Flavamed with medicines that suppress the cough reflex (antitussives), there may be a (dangerous) accumulation of bronchial secretions due to a weakened cough reflex in patients with concomitant respiratory diseases characterized by excessive mucus production, such as cystic fibrosis or bronchiectasis.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Flavamed can only be used if your doctor recommends it! 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 monohydrate (a sugar found in milk)

If you have been diagnosed with an intolerance to some sugars, you should contact your 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 the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The following information applies if your doctor has not recommended a different use of Flavamed.
You should follow the instructions for taking the medicine, as 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 use

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, you should contact your doctor immediately!
If you feel that the effect of Flavamed is too strong or too weak, you should consult your doctor or pharmacist.

Use of a higher than recommended dose of Flavamed

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 used in recommended doses, and symptomatic treatment may be necessary. You should contact your doctor.

Missing a dose of Flavamed

If you miss a dose of the medicine or take a smaller dose of the medicine, you should take the next prescribed dose of the medicine at the usual time.
You should not take a double dose to make up for the missed dose.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may occur in less than 1 in 10 people):

• Nausea

Uncommon (may occur in less than 1 in 100 people):

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

Rare(may occur in less than 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, you should stop taking Flavamed immediately.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help 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 packaging. 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 of the medicine are: lactose monohydrate, cornstarch, cellulose, powder, croscarmellose sodium, povidone K 30, magnesium stearate.

What Flavamed looks like and contents of the packaging

White, round tablets, flat on both sides, with beveled edges and a dividing line on one side.
Flavamed is available in packages containing: 10, 20, and 50 tablets.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Parallel importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:07-0280
Parallel import authorization number:329/22

Date of leaflet approval: 03.01.2024

This medicine is authorized for use 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
[Information about the trademark]