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FLAVAMED (AMBROXOL) PUT.TBL 60MG N10

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-29
FLAVAMED-AMBROXOL-drug/medicine -tablets aproximate price on "FLAVAMED (AMBROXOL) PUT.TBL 60MG N10" in Riga city, Latvia is:
  • 5.90€  6.38$  5.05£  681Rub  68SEK  25PLN  23.48₪ 

FLAVAMED (AMBROXOL) PUT.TBL 60MG N10


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  FLAVAMED (AMBROXOL) PUT.TBL 60MG N10     Recheck

ATC codeR05CB06 

Active substances: Ambroxolum

 


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

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FLAVAMED 60 mg putojošās tabletes, 10 gab.

 .

FLAVAMED 60MG N10

Package leaflet: Information for the patient

Flavamed 60 mg effervescent tablets

For adults and adolescents above 12 years 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 60 mg is and what it is used for
2.   What you need to know before you take Flavamed 60 mg
3.   How to take Flavamed 60 mg
4.   Possible side effects
5.   How to store Flavamed 60 mg
6.   Contents of the pack and other information

1.   What Flavamed 60 mg is and what it is used for

Flavamed 60 mg contain the active substance ambroxol hydrochloride and belongs to the therapeutic group cough and cold preparations, mucolytics. Ambroxol hydrochloride is used to treat productive cough associated with acute or chronic diseases of the lungs and bronchial tubes.
Mucus becomes more liquid through Flavamed 60 mg and can be coughed up more easily.

2.   What you need to know before you take Flavamed 60 mg Do not take Flavamed 60 mg

-   If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (see section 6).
-   In children under 12 years.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flavamed 60 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 forte 60 mg effervescent tablets and contact your doctor immediately.
-   If you suffer from histamine intolerance. You should then avoid long-term therapy, as the active substance of Flavamed 60 mg influences the histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
-   If you suffer from impaired kidney function or from a severe liver disease. You must then only take Flavamed 60 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 60 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 60 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 60 mg, since mucolytics may disrupt the gastric mucosal barrier. Ask your doctor before taking Flavamed 60 mg.

Children and adolescents

Flavamed 60 mg may only be taken by adolescents above the age of 12 years.
Other medicines and Flavamed 60 mg
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Cough-suppressant agents (antitussives)
While taking Flavamed 60 mg, you should not use any medicines that suppress the cough reflex (so-called antitussives). The cough reflex is important in order to cough up the liquefied mucus and thus remove it from the lungs.
Pregnancy and breast-feeding
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 60 mg during pregnancy and breast-feeding at the explicit direction of your doctor! Especially during the first trimester, the use of 60 mg Effervescent Tablets is not recommended.
It has been observed that the active substance of Flavamed 60 mg crosses into breast milk. Flavamed 60 mg is not recommended for use during the breast-feeding period.
Animal studies did not indicate harmful effects of ambroxol with respect to fertility.
Driving and using machines
Flavamed 60 mg has no, or negligible, influence on the ability to drive and use machines.
Flavamed 60 mg contain lactose (milk sugar), sorbitol (sweetener) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains 5.5 mmol (126.5 mg) sodium per effervescent tablet. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Flavamed 60 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 60 mg to you otherwise. Please keep to the instructions for use, as Flavamed 60 mg is otherwise unable to work properly!
The recommended dose is:
Age
Single dose
Max. daily dose
Adolescents above 12 years and adults
During the first 2 to 3 days, 54 effervescent tablet each 3 times daily (equivalent to 30 mg ambroxol hydrochloride 3 times),
then 54 effervescent tablet each twice daily (equivalent to 30 mg ambroxol hydrochloride twice)
154 effervescent tablets (equivalent 90 mg ambroxol hydrochloride)
Note:
In adults, the daily dose may be increased to 1 tablet twice daily.
The safety and efficacy of Flavamed 60 mg in children under 12 years have not yet been established.

Method of use

For oral use. The effervescent tablets are dissolved after meals in a glass of water, and the solution drunk.
The effervescent tablet can be divided into equal doses.

Duration of use

Flavamed 60 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 60 mg is too strong or too weak.

If you take more Flavamed 60 mg than you should

Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the possible side effects of Flavamed 60 mg at recommended doses.
In case of overdose contact a doctor, who then will initiate treatment according to the occurring signs of the overdose.

If you forget to take Flavamed 60 mg

or have taken too little, simply take the medicine in the directed 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Undesirable effects

Common (may affect up to 1 in 10 people):
Dysgeusia (e.g. changed taste)
Nausea, oral and pharyngeal hypoaesthesia
Uncommon (may affect up to 1 in 100_people):
-   vomiting, diarrhoea, dyspepsia, stomach-ache and dry mounth
-   fever
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).
-   dry throat

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 the national reporting system listed in www.ravimiamet.ee.
By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Flavamed 60 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 multidose container label and folding box after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep the multidose container tightly closed in order to protect from light and moisture.
Do not throw away any 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 60 mg contains
The active substance is ambroxol hydrochloride. One effervescent tablet contains 60 mg ambroxol hydrochloride.
The other ingredients are:
Citric acid, anhydrous Sodium hydrogen carbonate Sodium carbonate, anhydrous Saccharin sodium Sodium cyclamate Sodium chloride Sodium citrate Lactose, anhydrous
Mannitol (E 421)
Sorbitol (E 420)
Flavour cherry “ALH”; Code 801 consisting of: natural / nature identical liquid cherry flavour (code 5443), natural / nature identical liquid black cherry flavour (code 5410), Natural / nature identical powder flavour cherry (code 5862P), maltodextrin, mannitol, gluconolactone, sorbitol, acacia and colloidal anhydrous silica Simeticone

What Flavamed 60 mg looks like and contents of the pack

Round, white tablets with diameter of 18 mm and a score line on one side.
The effervescent tablet can be divided into equal doses.
Flavamed 60 mg comes in packages with 10 or 20 effervescent tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

BERLIN-CHEMIE AG (MENARINI GROUP)
Glienicker Weg 125 12489 Berlin, Germany

This leaflet was last revised in 11/2016.






  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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