Flavamed

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Flavamed

30 mg, tablets

Ambroxol hydrochloride

It is necessary to 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 a doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 packaging and other information

1. What is Flavamed and what is it used for

Flavamed is a mucolytic medicine 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

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of the medicine (listed in section 6).
• 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

• if the patient has a history of severe skin hypersensitivity reactions (Stevens-Johnson syndrome, Lyell's syndrome).
• Stevens-Johnson syndrome is a disease characterized by high fever and rash with blisters on the skin and mucous membranes.
• Lyell's syndrome is a life-threatening condition also known as 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, such as in the mouth, throat, nose, eyes, genitals), the use of Flavamed should be discontinued and a doctor should be consulted immediately.

• if the patient has kidney function disorders or severe liver disease. In such cases, particular caution should be exercised when taking Flavamed (i.e., the intervals between doses of the medicine should be extended or a smaller dose of the medicine should be used - the patient should consult a doctor). In severe kidney function disorders, the breakdown products of the active substance of Flavamed may accumulate.
• if the patient has a rare bronchial disease characterized by increased mucus production (e.g., primary ciliary dyskinesia). In this case, the mucus is not removed from the lungs. Flavamed should only be used under medical supervision.
• if the patient has a history of stomach or duodenal ulcers, they should consult a doctor on how to take Flavamed, as mucolytic medicines may damage the stomach mucosa. The patient should consult a doctor before taking Flavamed.

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/antitussive medicines
When Flavamed is used concomitantly with medicines that suppress the cough reflex (antitussive medicines), there may be a (dangerous) accumulation of bronchial secretions due to the 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, Flavamed can only be used if the 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Flavamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that 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 a doctor or pharmacist.
The following information applies if the doctor has not recommended a different use of Flavamed.
The patient 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 an adequate 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, the patient should immediately consult a doctor!
If the patient feels that the effect of Flavamed is too strong or too weak, they should consult a 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. The patient should consult a doctor.

Missing a dose of Flavamed

If a dose of the medicine is missed or a smaller dose is taken, the patient should take the next prescribed dose at the usual time. A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Flavamed 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 erythema multiforme, 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 use of Flavamed should be discontinued immediately.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Flavamed

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store at a temperature below 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 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 are: lactose monohydrate, corn starch, cellulose, powder, croscarmellose sodium, povidone K 30, magnesium stearate.

What Flavamed looks like and what the packaging contains

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

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 07-0280

Parallel import authorization number: 349/24

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

Date of leaflet approval: 30.09.2024

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