Flavamed 60mg. 10 tablets


Flavamed effervescent tablets contain the active substance ambroxol hydrocloride, which belongs to a therapeutic group of products for the treatment of cough and cold, mucolytics.


Flavamed 60mg. 10 tablets

What Flavamed tablets is and what it is used for

Flavamed effervescent tablets contain the active substance ambroxol hydrocloride, which belongs to a therapeutic group of products for the treatment of cough and cold, mucolytics. Ambroxol hydrochloride is used to treat wet cough in acute or chronic diseases of the lung and bronchi.
Flavamed effervescent tablets fluidize the bronchial secretion (mucus) and make it easier to cough.

2. What you need to know before taking Flavamed tablets

Do not use Flavamed effervescent tablets
- if you are allergic to the active substance or any of the other ingredients of this medicine (see section 6);
- children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flavamed tablets - if you have had severe skin reactions of hypersensitivity (Stevens-Johnson syndrome, Lyell syndrome).

• Stansons-Johnson syndrome is a high fever and rash on the skin and mucous membranes with blistering.

• Lyell's syndrome is a life-threatening condition, also known as smoothed skin syndrome. Significant is the appearance of large bubbles, similar to burning.

Severe skin reactions associated with ambroxol have been reported. If you get a skin rash (including mucosal lesions such as mouth, throat, nose, eyes, genitals), stop using Flavamed tablets and contact your doctor immediately.

- If you suffer from intolerance to histamine, you should avoid continued treatment because the active substance of Flavamed tablets influences the metabolism of histamine and may lead to intolerance symptoms (eg headache, runny nose, pruritus).

- If you suffer from impaired kidney function or severe liver disease. In this case, Flavamed effervescent tablets may only be given with extreme caution (eg at longer intervals or at a reduced dose - consult your doctor for this). In case of severely impaired renal function, degradation of the active substance of Flavamed effervescent tablets may occur.

- If you suffer from a rare bronchitis with increased mucus (eg, fixed cilia syndrome). Then the mucus can not be detached from the lung. In this case, Flavamed effervescent tablets may only be administered under medical supervision.

- If you have a peptic ulcer disease, you should consult your doctor about taking Flavamed tablets because mucolytics can irritate the stomach lining. Talk to your doctor before taking Flavamed effervescent tablets.

Children and adolescents
Flavamed tablets may only be taken by adolescents over 12 years of age.
Other medicines and Flavamed effervescent tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Cough suppressing drugs (antitussives)
You should not take medicines that suppress cough reflex (so-called antitussives) during the use of Flavamedo effervescent tablets. Cough reflex is important in order for the liquefied bronchial secretion (mucus) to crumble and thus to be detached from the lungs.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

During pregnancy or lactation, take Flavamed tablets only according to the instructions of your doctor! Especially during the first trimester, the use of Flavamed effervescent tablets is not recommended.

It has been observed that the active substance of Flavamed effervescent tablets passes into breast milk. Flavamed effervescent tablets are not recommended for use during breast-feeding.

Animal studies do not indicate harmful effects of ambroxol on fertility.

Driving and using machines
Flavamed tablets have no or negligible influence on the ability to drive or use machines.

Flavamed effervescent tablets 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 Flavamed tablets.
This medicinal product contains 5.5 mmol (126.6 mg) of sodium per effervescent tablet. Take into account in patients on a low-sodium diet.

3. How to take Flavamed effervescent tablets

Always take this medicine exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist.

Unless otherwise prescribed by the physician, the following guidelines for Flavamed effervescent tablets should be considered. Please follow the instructions
The recommended dose is:

Age Single dose Maximum daily dose
Adults over 12 years old and adults ½ effervescence tablet 3 times a day (equivalent to 3 times 30 mg of ambroxol hydrochloride) during the first 2 to 3 days, followed by ½ effervescent tablet twice daily (equivalent to 2 times the 30 mg of ambroxol hydrochloride). 1 ½ effervescent tablets (equivalent to 90 mg of ambroxol hydrochloride)

In adults, the daily dose may be increased to one tablet twice a day.

The safety and efficacy of Flavamed effervescent tablets in children under 12 years of age has not yet been established.

Application method
For oral use. The effervescent tablets are dissolved in a glass of water and the solution is taken after a meal.

The effervescent tablets can be divided into two equal doses.

Duration of application
Flavamed tablets should not be administered more than 4-5 days without consulting a doctor.

If your complaints do not respond after 4-5 days of treatment or even get worse, go to a doctor immediately!

Please talk to your doctor or pharmacist if you feel that the effect of Flavamed tablets is too strong or too weak.

If you take more Flavamed effervescent tablets than you should
Based on accidental overdoses and / or drug-related error messages, the observed symptoms are consistent with the possible side effects of Flavamed effervescent tablets at recommended doses.

In case of overdosage, contact your doctor who will start treatment depending on the signs of overdose.

If you forget to take Flavamed effervescent tablets
or take a very small dose, take the medicine at the prescribed dose at the next intake. Do not take a double dose to make up for the missed dose.

If you have any further questions on the use of this medicine, talk to your doctor or pharmacist.

4. Possible side effects

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

Unwanted reactions

Common (may affect up to 1 in 10 people):
- dysgeusia (changes in taste)
- nausea, hearing loss (reduced sensitivity) in the mouth and pharynx

Uncommon (may affect up to 1 in 100 people):
- vomiting, diarrhea, dyspepsia (indigestion), stomach pain and dry mouth
- fever

Rare (may affect up to 1 in 1,000 people):
- hypersensitivity reactions
- rash, urticaria

Not known (can not be estimated from available data):
- anaphylactic reactions, including anaphylactic shock, angioedema (fast developing swelling of the skin, subcutaneous tissue, mucous membranes or sublingual layer) and pruritus
- severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthema)
- dry throat
How to store Flavamed effervescent tablets

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label of the multidose container and the carton after EXP. The expiry date refers to the last day of that month.

Store below 30 ° C.

Keep the multi-dose container tightly closed to protect the tablets from light and moisture.

Do not dispose of medicines in the sewer or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Flavamed tablets contain
The active substance is ambroxol hydrochloride.

One effervescent tablet contains 60 mg of ambroxol hydrochloride.

The other ingredients are:
Citric acid, anhydrous
Sodium hydrogencarbonate
Sodium carbonate, anhydrous
Saccharin sodium
Sodium cyclamate
Sodium chloride
Sodium citrate
Lactose, anhydrous
Mannitol (E 421)
Sorbitol (E 420)
Aroma cherry "ALH"; (code 5443), natural / natural identical liquid aroma black cherry (code 5410), natural / natural identical cherry flavor (code 5862P), maltodextrin, mannitol, gluconolactone, sorbitol, gum arabic and colloidal anhydrous silica Simethicon

What Flavamed tablets looks like and contents of the pack
Round, white tablets with a diameter of 18 mm and a score line on one side.
The effervescent tablet can be divided into two equal doses.
Flavamed effervescent tablets are in packs of 10 and 20 effervescent tablets.
Not all pack sizes may be marketed.



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