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Flavamed Forte syrup 30 mg. / 5 ml. 100 ml.

Product Code: Flavamed Forte syrup 30 mg. / 5 ml. 100 ml.
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What is Flavamed forte and what it is used for

Flavamedo contains the active substance ambroxol hydrochloride and belongs to the therapeutic group of cough and cold medicines, mucolytics. Ambroxol hydrochloride is used to treat wet cough in lung and bronchial diseases.
Flavamedo is indicated for children over 2 years of age, adolescents and adults.

Flavamed® forte liquefies the bronchial secretion (mucus) and makes it easier to cough. You should consult a doctor if you do not feel better or your condition gets worse after 4-5 days.

2. What you need to know before taking Flavamed Forte

Do not take Flavamed Forte
- if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (described in section 6).
Flavamedo should not be used in children under two years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flavamedo

- if you have had very severe skin reactions of hypersensitivity (Stevens Johnson Syndrome, Lyell syndrome);
• Stevens-Johnson syndrome is a high temperature disease and mucous membranes.
• Lyell syndrome is a life-threatening condition, also known as smoothed skin syndrome. Symptoms are the appearance of large blisters, 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 Flavamedo and contact your doctor immediately.
- If you suffer from impaired kidney function or severe liver disease. In this case, Flavamedo may only be used with extreme caution (eg at longer intervals or at a reduced dose - consult your doctor for this). In severely impaired renal function, degradation of the active substance of Flavamed Forte may occur.
- If you suffer from a rare bronchitis with increased mucus (eg primary ciliary dyskinesia). Then the mucus can not be detached from the lung. In this case, Flavamedo may only be administered under medical supervision.
- If you have a peptic ulcer disease, you should consult your doctor about taking Flavamedo forte because mucolytics can irritate the stomach lining. Check with your doctor before taking Flavamedo.

Other medicines and Flavamed Forte
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Cough suppressing drugs (antitussive)
You should not take medicines that suppress coughing reflex (so-called antitussives) while taking Flavamedo Forte. Cough reflex is important in order for the liquefied bronchial secretion (mucus) to crumble and thus to be detached from the lungs.

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy or breast-feeding, you may take Flavamedo forte only according to the instructions of your doctor! Especially during the first trimester, Flavamedo use is not recommended.
It has been observed that the active substance of Flamamed forte passes into breast milk. Flavamedo is not recommended for use during the lactation period.

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

Driving and using machines
There is no evidence of the effect on the ability to drive or use machines.
No studies on the effect on the ability to drive and use machines have been performed.

Flavamed forte contains sorbitol
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 Flavamedo Forte

Always take this medicine exactly as directed in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the following guidelines for Flavamedethe should be considered. Please follow the instructions for use, otherwise Flavamed Forte will not have the expected effect!

The recommended dose is:

Children between 2-5 years old
1/4 measuring spoon with 1.25 ml oral solution 3 times a day (equivalent to 3 times 7.5 mg ambroxol hydrochloride = 22.5 mg ambroxol hydrochloride / day).

Children between 6-12 years old
1/2 measuring spoon with 2.5 ml oral solution 2-3 times daily (equivalent to 2-3 times 15 mg ambroxol hydrochloride = 30-45 mg ambroxol hydrochloride / day).

Adolescents over 12 years old and adults
During the first 2-3 days, one scoop of 5 ml oral solution 3 times a day during the first 2 to 3 days (equivalent to 3 times 30 mg of ambroxol hydrochloride
Application method
For oral use. Take Flavamedo Forte after a meal with the measuring spoon.

Duration of application
Flavamed forte 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 Forte is too strong or too weak.

If you take more Flavamed Forte than you should
Based on reports of accidental overdosage and / or misuse, the observed symptoms are consistent with known side effects of Flavamedo forte at recommended doses. In the event of an overdose, contact a doctor who will start treatment according to the symptoms of overdose.

If you forget to take Flavamed Forte
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):
- nausea
- change in taste
- numbness of the mouth and throat (hypoaesthesia)

Uncommon (may affect up to 1 in 100 people):
- vomiting
- dry mouth
- diarrhea
- problems with digestion (dyspepsia)
- stomach ache
- fever

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

Not known (can not be estimated from the 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 reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthema pustulosis).
- dry throat

How to Store Flavamed Forte

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

Shelf life after first opening
Stability after opening the bottle: 6 months.

Do not dispose of medicines in the sewers 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 Forte contains
The active substance is ambroxol hydrochloride. 1 ml oral solution contains 6 mg of ambroxol hydrochloride.
Each measuring spoon of 5 ml oral solution contains 30 mg of ambroxol hydrochloride.
The other ingredients are:
Sorbitol (E 420), liquid (non-crystallising), benzoic acid (E 210), glycerol (E422) 85 percent, hydroxyethyl cellulose, raspberry raspberry (containing valerian oil, ethyl acetate, ethylbutyrate, p-hydroxyphenyl butanone, isoamyl butyrate, rose oil and 1,2-propylene glycol [E1520]), purified water.

What Flavamed Forte looks like and what the package contains
Clear, colorless to pale yellow solution.
Flavamedo is in a pack of 100 ml oral solution.
A measuring spoon is applied to the pack. The measuring spoon is made of polypropylene and has measuring lines of 1.25 ml, 2.5 ml and 5 ml (the tip of the spoon).






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