FLAVAMED eff tabl x 10
Flavamed Effervescent Tablets
60 mg effervescent tablets
For adults and adolescents over 12 years of age
ambroxol hydrochloride (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 has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 4-5 days or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What Flavamed effervescent tablets are and what they are used for
2. What you need to know before you take Flavamed effervescent tablets
3. How to take Flavamed effervescent tablets
4. Possible side effects
5. How to store Flavamed effervescent tablets
1. What Flavamed effervescent tablets are and what they are used for
Flavamed effervescent tablets contain the active substance ambroxol hydrochloride, which belongs to the therapeutic group of cough and cold products, mucolytics. Ambroxol hydrochloride is used to treat wet cough in acute or chronic diseases of the lungs and bronchi.
Flavamed effervescent tablets liquefy bronchial secretions (mucus) and allow for easier coughing.
Flavamed effervescent tablets are indicated for adults and adolescents over 12 years of age.
2. What you need to know before you take Flavamed effervescent 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);
in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flavamed effervescent tablets.
if you have had very severe skin hypersensitivity reactions (Stevens-Johnson syndrome, Lyell's syndrome).
Stevens-Johnson syndrome is a disease with high fever and rashes on the skin and mucous membranes with blistering.
Lyell's syndrome is a life-threatening condition, also known as scalded skin syndrome. It is characterized by the appearance of large blisters, similar to a burn.
There have been reports of severe skin reactions associated with the use of ambroxol. If you get a skin rash (including lesions of the mucous membranes, e.g. mouth, throat, nose, eyes, genitals), stop using Flavamed effervescent tablets and call your doctor immediately.
If you suffer from histamine intolerance, you should avoid long-term treatment, as the active substance of Flavamed effervescent tablets affects the metabolism of histamine and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
if you suffer from impaired kidney function or severe liver disease. In this case, Flavamed effervescent tablets can only be used with special care (e.g. at longer intervals or in a reduced dose - consult your doctor about this). In severely impaired kidney function, an accumulation of breakdown products of the active substance of Flavamed effervescent tablets may occur.
if you suffer from a rare disease of the bronchi with increased mucus production (e.g. immobile cilia syndrome). Then the mucus cannot be separated from the lungs. In this case Flavamed effervescent tablets can only be used under medical supervision.
If you have had peptic ulcer disease, you should consult your doctor about how to take Flavamed effervescent tablets, because mucolytics can irritate the stomach lining. Consult your doctor before taking Flavamed effervescent tablets.
Children and adolescents
Flavamed effervescent tablets can only be taken by adolescents over the age of 12 years.
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 suppressants (antitussives)
While taking Flavamed effervescent tablets, you should not take medicines that suppress the cough reflex (so-called antitussives). The cough reflex is important so that the liquefied bronchial secretion (mucus) can be coughed up and thus removed 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 using this medicine.
During pregnancy or breastfeeding, take Flavamed effervescent tablets only according to the exact 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 breastfeeding.
Animal studies have not shown harmful effects of ambroxol on fertility.
Driving and using machines
Flavamed effervescent tablets have no or negligible influence on the ability to drive and use machines.
Flavamed effervescent tablets contain lactose, sorbitol, sodium and benzyl alcohol.
Lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking Flavamed effervescent tablets.
This medicinal product contains 5.5 mmol (126.6 mg) sodium per effervescent tablet. To be taken into consideration by patients on a controlled sodium diet.
Sorbitol
This medicinal product contains 29>29 mg sorbitol in each effervescent tablet. Sodium
This medicine contains 126 mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 6.33% of the recommended maximum daily dietary intake of sodium for an adult.
Benzyl alcohol
This medicine contains 0.78 mg of benzyl alcohol in each effervescent tablet. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called “metabolic acidosis”).
Talk to your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and may cause side effects (called "metabolic acidosis").
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 a doctor, the following instructions for Flavamed effervescent tablets should be taken into account. Please follow the instructions for use, otherwise Flavamed effervescent tablets may not have the expected effect.
The recommended dose is:
Age
Single dose
Maximum daily dose
Adolescents over 12 years of age and adults ½ effervescent tablet 3 times daily (equivalent to 3 times 30 mg ambroxol hydrochloride) during the first 2 to 3 days, then continue with ½ effervescent tablet twice daily (equivalent to 2 times 30 mg ambroxol hydrochloride). 1 ½ effervescent tablets (equivalent to 90 mg ambroxol hydrochloride)
Note:
In adult patients, the daily dose may be increased to one tablet 2 times a day.
The safety and efficacy of Flavamed effervescent tablets in children under 12 years of age have not yet been established.
Method of administration