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FLAVAMED (AMBROXOL) 30MG TBL N20

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
FLAVAMED-AMBROXOL-drug/medicine -tablets aproximate price on "FLAVAMED (AMBROXOL) 30MG TBL N20" in Riga city, Latvia is:
  • 2.50€  2.7$  2.14£  289Rub  28.8SEK  11PLN  9.9₪ 

FLAVAMED, 30 mg, tabletės, N20


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  FLAVAMED (AMBROXOL) 30MG TBL N20     Recheck

Reģ. Nr.: 07-0280

ATC codeR05CB06 

Active substances: Ambroxoli Hydrochloridum

 


Vendor, principal: Berlin-Chemie Ag
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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FLAVAMED 30 mg tabletes, 20 gab.

 .

FLAVAMED 30MG N20

Package leaflet: Information for the patient Flavamed 30 mg tablets
Ambroxol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 4 to 5 days.
What is in this leaflet
1.   What Flavamed 30 mg is and what it is used for
2.   What you need to know before you take Flavamed 30 mg
3.   How to take Flavamed 30 mg
4.   Possible side effects
5.   How to store Flavamed 30 mg
6.   Contents of the pack and other information

1.   What Flavamed 30 mg is and what it is used for

Flavamed 30 mg is a mucus-loosening medicine for respiratory tract diseases.
Flavamed 30 mg is indicated in adults, adolescents and children over 6 years.
Flavamed 30 mg is used in acute or chronic diseases of the lungs and bronchial tubes with formation of stubborn mucus. The stubborn mucus becomes more liquid through Flavamed 30 mg and can be coughed up more easily.

2.   What you need to know before you take Flavamed 30 mg

Do not take Flavamed 30 mg
-   If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (see section 6).
-   In children under 6 years.
Warnings and precautions
Talk to you doctor or pharmacist before taking Flavamed 30 mg
-   If you had very severe hypersensitivity reactions of the skin in the past (Stevens-Johnson syndrome, Lyell's syndrome).
•   Stevens-Johnson syndrome is a disease in which there is high fever and skin and mucous-membrane rash with blistering.
•   The life-threatening Lyell's syndrome is also known as scalded skin syndrome. Signs of this are severe blistering of the skin, similar to a burn.
There have been reports of severe skin reactions associated with the administration of ambroxol. If you develop a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals), stop using Flavamed 30 mg and contact your doctor immediately.
-   If you suffer from impaired kidney function or from a severe liver disease. You must then only take Flavamed 30 mg with particular caution (i.e. at greater dose intervals or at a reduced dose - ask your doctor about this). In severe kidney-function disturbance, there may be an accumulation of the breakdown products of the active substance of Flavamed 30 mg.
-   If you suffer from a rare disease of the bronchial tubes with increased mucus formation (e.g. immotile cilia syndrome). Here, the mucus is unable to be transported away from the lungs. In this case, only take Flavamed 30 mg under the supervision of a doctor.
-   If you have a history of peptic ulcer disease, you should take advice from your doctor how to take Flavamed 30 mg, since mucolytics may disrupt the gastric mucosal barrier. Ask your doctor before taking Flavamed 30 mg.
Children
Flavamed 30 mg may only be taken by children above the age of 6 years.
Other medicines and Flavamed 30 mg
No clinically relevant unfavourable interaction with other medications has been reported.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Only take Flavamed 30 mg during pregnancy and breast-feeding at the explicit direction of your doctor!
Especially during the first trimester, the use of Flavamed 30 mg is not recommended.
It has been observed that the sctive substance of Flavamed 30 mg crosses into breast milk. Flavamed 30 mg is not recommended during the breast-feeding period.
Animal studies did not indicate harmful sffects of ambroxol with respect to fertility.
Driving and using machines
There is no evidence for an effect on the ability to drive and use machines. Studies on the effects on the ability to drive and use machines have not been performed.
Flavamed 30 mg contain lactose (milk sugar)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Flavamed 30 mg

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The following details apply unless your doctor has prescribed Flavamed 30 mg to you otherwise. Please keep to the instructions for use, as Flavamed 30 mg is otherwise unable to work properly!
The recommended dose is:
Age
Single dose
Max. daily dose
Children 6 - 12 years
54 a tablet 2 to 3 times daily (equivalent to 15 mg ambroxol hydrochloride 2 - 3 times)
14 tablets
(equivalent to 45 mg ambroxol hydrochloride)
Adolescents above 12 years
During the first 2 to 3 days,
3 tablets
and adults
1 tablet each 3 times daily (equivalent to 30 mg ambroxol hydrochloride 3 times),
(equivalent 90 mg ambroxol hydrochloride)

then 1 tablet each twice daily (equivalent to 30 mg ambroxol


hydrochloride twice)

Note:
In adults, the daily dose may be increased to 2 tablets two times a day.

Method of use

For oral use Flavamed 30 mg is best swallowed whole after meals with sufficient liquid (e.g. water, tea or fruit juice).
The tablet can be divided into equal doses.

Duration of use

Flavamed 30 mg should not be taken for longer than 4 - 5 days without the advice of a doctor.
If your complaints still do not get better after 4 to 5 days or even get worse, you should go to a doctor at once!
Please speak to your doctor or pharmacist if you have the impression that the effect of Flavamed 30 mg is too strong or too weak.

If you take more Flavamed 30 mg than you should

No specific overdose symptoms have been reported in man to date. Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of ambroxol hydrochloride at recommended doses and may need symptomatic treatment. Contact a doctor.

If you forget to take Flavamed 30 mg

or have taken too little, simply take the medicine in the prescribed dosage at the next dose time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10people):
-   Nausea
Uncommon (may affect up to 1 in 100people):
-   Stomach-ache, vomiting, diarrhoea, abdominal pain and dyspepsia
Rare (may affect up to 1 in 1,000people):
-   Hypersensitivity reactions
-   Rash, urticaria
Not known (frequency cannot be estimated from the available data):
-   Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) and pruritus
-   Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Counter-measures

If you notice that you have one or more of the side effects set out above, discontinue treatment with Flavamed 30 mg at once.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee.
By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Flavamed 30 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and folding box after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information

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

What Flavamed 30 mg looks like and contents of the pack

White, round tablets flat on both sides with bevelled edges and a break-mark on one side. Flavamed 30 mg comes in packages with 10, 20 and 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder BERLIN-CHEMIE AG (MENARINI GROUP)
Gliencker Weg 125 12489 Berlin Germany

Manufacturer

Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
OÜ Berlin-Chemie Menarini Eesti
Paldiski mnt 27/29 10612 Tallinn Estonia
Phone: +372 667 5001

This leaflet was last approved in 03/2018.






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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