Flavamed

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Flavamed
30 mg, tablets
Ambroxoli hydrochloridum
Please read the entire leaflet carefully before using this 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse after 4 to 5 days, consult a doctor.

Table of contents

1. What Flavamed is and what it is 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 Flavamed is and what it is 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 diseases of the lungs and bronchi associated with the production of thick mucus. With Flavamed treatment, thick mucus becomes more fluid and easier to cough up.

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 the medicine (listed in section 6).
• in children under 6 years of age.

Warnings and precautions
Before starting to take Flavamed, discuss this with your doctor or pharmacist:

• if the patient has previously experienced very severe skin hypersensitivity reactions (Stevens-Johnson syndrome, Lyell's syndrome).
• Stevens-Johnson syndrome is a disease characterized by high fever and blistering rash on the skin and mucous membranes.
• Life-threatening Lyell's syndrome is also known as toxic epidermal necrolysis. Symptoms of this syndrome include severe skin lesions in the form of blisters, similar to those seen in burns.

Cases of serious skin reactions associated with ambroxol use have been reported. If a rash occurs (including lesions on mucous membranes, e.g. in the mouth, throat, nose, eyes, genital organs), treatment with Flavamed must be discontinued and medical advice sought immediately.

• if the patient has kidney function disorders or severe liver disease. In such cases, special caution should be exercised when using Flavamed (i.e. extend the intervals between doses or use a lower dose – consult your doctor). In severe kidney function disorders, accumulation of metabolites of the active substance of Flavamed may occur.
• if the patient has a rare bronchial disease associated with increased mucus production (e.g. immotile cilia syndrome). In such cases mucus is not cleared from the lungs. Flavamed should then be used only under medical supervision.
• if the patient has previously suffered from gastric or duodenal ulcer disease, consult a doctor on how to use Flavamed, as mucolytic drugs may damage the gastric mucosa. Consult a doctor before using Flavamed.

Children
Flavamed may be used only in children over 6 years of age.
Flavamed and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ambroxol/cough suppressants
Concomitant use of Flavamed with medicines that suppress the cough reflex (cough suppressants) may lead to (dangerous) accumulation of bronchial secretions due to suppressed cough reflex in patients with coexisting respiratory diseases associated with excessive mucus production, such as cystic fibrosis or bronchiectasis.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Flavamed should be used during pregnancy and breastfeeding only if clearly recommended by a doctor! Use of Flavamed is not recommended, particularly during the first trimester of pregnancy.
It has been observed that the active substance in Flavamed passes into breast milk. Flavamed is not recommended during breastfeeding.
Animal studies have not shown harmful effects of ambroxol on fertility.
Driving and operating machinery
There is no evidence of an effect on the ability to drive or operate machinery. No studies have been conducted on the effect on the ability to drive or operate machinery.
Flavamed contains lactose monohydrate (a sugar found in milk)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Flavamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Flavamed

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The following information applies unless the doctor has advised otherwise.
Always follow the instructions for using this medicine, as it may not work properly otherwise!
Recommended dose:

Warning:
In adults, the daily dose may be increased to 2 tablets twice daily.
Method of administration
For oral use. Flavamed tablets should preferably be swallowed whole after meals, with an adequate amount of liquid (e.g. water, tea or fruit juice).
The tablet may be divided into equal doses.
Duration of use
Without consultation with a doctor, Flavamed should not be used for longer than 4–5 days.
If symptoms do not improve or even worsen after 4–5 days, consult a doctor immediately!
If you feel that the effect of Flavamed is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Flavamed
To date, no specific symptoms of overdose have been reported in humans. Based on reports of accidental overdose and/or incorrect dosing, observed symptoms are consistent with the known adverse effects of ambroxol hydrochloride administered at recommended doses, and symptomatic treatment may be necessary. Contact a doctor.
Missed dose of Flavamed
If a dose is missed or if an insufficient dose was taken, take the next prescribed dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common (may affect fewer than 1 in 10 people):

• Nausea

Uncommon (may affect fewer than 1 in 100 people):

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

Rare (may affect fewer 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 developing swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissue) and itching
• Severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Action required
If one or more of the adverse reactions listed above occur, discontinue use of Flavamed immediately.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Flavamed

Keep the medicine out of the 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 stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What Flavamed looks like and contents of the pack
White, round tablets, flat on both sides, with bevelled edges and a division line on one side.
Flavamed is available in packs containing: 10, 20 and 50 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Latvia, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Authorisation number in Latvia, country of export: 07-0280
Parallel import authorisation number: 349/24

This medicinal product is authorised in the European Economic Area countries 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