Flavamed

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Flavamed
30 mg, tablets
Ambroxoli hydrochloridum
Please read carefully the entire 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
the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 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 diseases.
Flavamed is indicated for use in adults, adolescents and children above 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 the use of Flavamed, thick mucus becomes more fluid and can be coughed up more easily.

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 6 years of age.

Warnings and precautions
Before taking Flavamed, consult your doctor or pharmacist:

• if the patient has previously experienced 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, also known as toxic epidermal necrolysis, causes severe skin lesions with blistering similar to those seen in burns.

Severe skin reactions have been reported with ambroxol use. If a rash occurs (including lesions on mucous membranes such as the mouth, throat, nose, eyes, or genital organs), discontinue Flavamed immediately and contact your doctor without delay.

• if the patient has impaired kidney function or severe liver disease. In such cases, special caution is required when using Flavamed (i.e., extend the intervals between doses or use a lower dose – consult your doctor). In severe renal impairment, accumulation of metabolites of the active substance in Flavamed may occur.
• if the patient has a rare bronchial disorder associated with excessive mucus production (e.g., primary ciliary dyskinesia). In such cases, mucus is not effectively cleared from the lungs, and Flavamed should be used only under medical supervision.
• if the patient has a history of gastric or duodenal ulcer disease, consult your doctor on how to use Flavamed, as mucolytic agents may damage the gastric mucosa. Consult your doctor before using Flavamed.

Children
Flavamed may be used only in children above 6 years of age.
Flavamed and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Ambroxol/antitussives
Concomitant use of Flavamed with cough suppressants (antitussives) may lead to (potentially dangerous) accumulation of bronchial secretions due to suppressed cough reflex in patients with underlying 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 might 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 or breastfeeding only if clearly indicated and explicitly 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 any 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. However, no studies have been conducted specifically assessing the impact on driving or operating machinery.
Flavamed contains monohydrate lactose (a sugar found in milk)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Flavamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Flavamed

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The following information applies unless your doctor has advised a different way of taking Flavamed.
Always follow the instructions for using this medicine, because if not, Flavamed may not work properly!
Recommended dose is:

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 a meal, with an adequate amount of liquid (e.g. water, tea or fruit juice).
The tablet may be divided into equal doses.
Duration of use
Flavamed should not be used for longer than 4–5 days without consulting a doctor.
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 of the medicine is missed or an insufficient dose is taken, take the next prescribed dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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 everyone 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 1,000 people):

• Hypersensitivity reactions
• Rash, urticaria

Unknown frequency (cannot be estimated from available data):

• Anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissue, mucous membranes or submucosal tissues), and pruritus
• Severe skin-related adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Action to take
If one or more of the adverse reactions listed above occur, treatment with Flavamed should be discontinued immediately.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flavamed

Keep this medicine 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 stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Flavamed contains
The active substance is ambroxol hydrochloride.
Each tablet contains 30 mg of ambroxol hydrochloride.
Other components 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, biconvex tablets 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 marketing authorisation holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Latvia, country of export: 07-0280
Parallel import authorisation number: 329/22

This medicine is authorised for marketing in the European Economic Area member states 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