Flavamed

Leaflet attached to the packaging: information for the user

Flavamed, 60 mg, effervescent tablets

For adults and adolescents over 12 years old
ambroxol hydrochloride

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet 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 not mentioned in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 4 to 5 days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

• 1. What is Flavamed and what is it used for
• 2. Important information before using Flavamed
• 3. How to use 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 contains the active substance ambroxol hydrochloride and belongs to the therapeutic group of cough and cold products, mucolytics. Ambroxol hydrochloride is used to treat wet cough associated with acute or chronic lung and bronchial diseases.
Thanks to the use of Flavamed, mucus becomes more watery and can be coughed up more easily.
Flavamed is indicated for use in adults and adolescents over 12 years old.

2. Important information before using Flavamed

When not to use Flavamed

• if the patient is allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• in children under 12 years of age.

Warnings and precautions

Before starting to use Flavamed, the doctor or pharmacist should be consulted.

• 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.
• 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.

Severe skin reactions associated with the use of ambroxol have been reported. If a rash occurs (including changes on the mucous membranes, e.g. in the mouth, throat, nose, eyes, genitals), the use of Flavamed should be discontinued and the doctor should be contacted immediately.

• if the patient has histamine intolerance. In such a case, long-term treatment should be avoided, as the active substance of Flavamed affects histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
• if the patient has kidney or liver function disorders. In such a case, particular caution should be exercised when using Flavamed (i.e. the intervals between doses of the medicine should be extended or the dose of the medicine should be reduced - the doctor should be consulted). In severe kidney function disorders, the breakdown products of the active substance of Flavamed may accumulate.
• if the patient has a rare disease of the bronchi, characterized by increased mucus production (e.g. primary ciliary dyskinesia). Then the mucus is not removed from the lungs. In such a case, Flavamed should be used only under medical supervision.
• if the patient has a history of stomach or duodenal ulcer, the doctor should be consulted on how to use Flavamed, as mucolytics may damage the stomach mucosa. The doctor should be consulted before using Flavamed.

Children and adolescents

Flavamed may be used only in adolescents over 12 years old.

Flavamed and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, including those available without a prescription.
Cough suppressants (antitussives)
During the use of Flavamed, medicines that suppress the cough reflex (so-called antitussives) should not be used. The cough reflex is important as it allows the coughing up of liquefied mucus and its removal from the lungs.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have a child, she should consult a doctor or pharmacist.
During pregnancy and breastfeeding, Flavamed can be used only if the doctor recommends it! The use of Flavamed is not recommended during pregnancy, especially in the first trimester.
It has been observed that the active substance contained in Flavamed passes into breast milk. The use of Flavamed is not recommended during breastfeeding.
Animal studies have not shown any adverse effects of ambroxol on fertility.

Driving and using machines

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

Flavamed contains lactose, sorbitol, sodium, and benzyl alcohol

Lactose
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
Sorbitol
The medicine contains 29.29 mg of sorbitol in each effervescent tablet.
Sodium
The medicine contains 126.5 mg of sodium (the main component of common salt) in each effervescent tablet.
This corresponds to 6.33% of the maximum recommended daily intake of sodium in the diet for adults.
Benzyl alcohol
The medicine contains 0.78 mg of benzyl alcohol in each effervescent tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse reactions (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse reactions (so-called metabolic acidosis).

3. How to use Flavamed

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The following information applies if the doctor has not recommended a different use of Flavamed.
The instructions for use of the medicine should be followed, as otherwise Flavamed will not work properly.

Recommended dose:

Note:
In adults, the daily dose can be increased to 1 tablet of the medicine 2 times a day.
The safety and efficacy of Flavamed in children under 12 years of age have not been established.

Method of administration

For oral use. Effervescent tablets should be dissolved after a meal, in a glass of water, and then the resulting solution should be drunk.
An effervescent tablet can be divided into equal doses.

Duration of use

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

Use of a higher than recommended dose of Flavamed

Based on cases of unintentional overdose and/or reports of improper use, symptoms corresponding to the known adverse reactions of the medicinal product Flavamed used in recommended doses have been observed.
In case of overdose, the doctor should be contacted, who will start treatment depending on the symptoms of the overdose.

Missed use of Flavamed

In case of a missed dose or use of a lower dose of the medicine, the next prescribed dose of the medicine should be taken at the usual time.
A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

Side effects

Common (may affect up to 1 in 10 people):

• Taste disorders (e.g. changed taste)
• Nausea, numbness of the mouth and throat

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

• Vomiting, diarrhea, indigestion, abdominal pain, and dryness of the mouth mucosa
• Fever

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

• Hypersensitivity reactions
• Rash, urticaria

Not known (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)
• Dryness in the throat

Reporting side effects

If any side effects occur, including those not mentioned in the leaflet, the doctor or pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. 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, more information can be collected on the safety of the medicine.

5. How to store Flavamed

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging and carton after: EXP. The expiry date stated is the last day of the specified month.
The medicine should not be stored at temperatures above 30°C.
The container should be kept tightly closed to protect the contents from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 is ambroxol hydrochloride.
One effervescent tablet contains 60 mg of ambroxol hydrochloride.
Other ingredients of the medicine are:
anhydrous citric acid
sodium bicarbonate
anhydrous sodium carbonate
sodium saccharin
sodium cyclamate
sodium chloride
sodium citrate
anhydrous lactose
mannitol (E 421)
sorbitol (E 420)
cherry flavor "ALH" with the composition: sorbitol, sodium, propylene glycol, and benzyl alcohol
simethicone.

What Flavamed looks like and contents of the pack

Round, white tablets with a diameter of 18 mm, with a dividing line on one side.
An effervescent tablet can be divided into equal doses.
Flavamed is available in packs of 10 or 20 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany
For more information, please contact the 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria:
Flavamed Effervescent Tablets
Estonia:
Flavamed 60 mg
Finland:
Flavamed Effervescent Tablets
Germany:
Flavamed 60 mg Brausetabletten
Latvia:
Flavamed 60 mg putojošās tabletes
Lithuania:
Flavamed 60 mg snypsciosios tabletes
Poland:
Flavamed
Slovak Republic:
Flavamed šumivé tablety
Slovenia:
Flavamed 60 mg šumeče tablete
Date of last revision of the leaflet:12/2020