FLAVAMED 20 tablets
Flavamed is mucolytic drug (liquefy the thick bronchial secretions) for respiratory diseases.
Flavamed be used in diseases of the lungs and bronchi, accompanied by the formation of thick bronchial secretions (mucus). Flavamed liquefy the thick bronchial secretions and allows easy detachment by coughing.
2. Before you take Flavamed
Do not take Flavamed
if you are hypersensitive (allergic) to the active substance of Flavamed (ambroxol hydrochloride) or any of the other ingredients of Flavamed (see section 6, "What Flavamed");
children under 6 years.
Take special care with Flavamed
If you had a very severe skin hypersensitivity reactions (Stevens-Johnson syndrome, Lyell);
Stevens-Johnson disease with fever and rashes on the skin and mucosal blistering.
Lyell's syndrome is a life-threatening condition known as scalded skin syndrome. Sign is the appearance of large blisters like burns.
Therefore, if you notice changes in skin and mucous membranes should immediately stop taking Flavamed. Visit a doctor immediately!
If you suffer from renal impairment or severe hepatic disease. In this case Flavamed can only be used with caution (eg. In longer intervals or at a reduced dose - talk to your doctor about this). In severe renal impairment may occur accumulation of breakdown products of the active substance of Flavamed;
If you suffer from a rare disease with increased bronchial mucus production (eg. Of fixed cilia syndrome). Then the mucus can not be separated from the lung. In this case Flavamed can only be used under medical supervision;
If you had peptic ulcer disease, you should consult with your doctor how to take Flavamed because mucolytics can irritate the stomach lining. Consult your doctor before taking Flavamed.
Flavamed can only be used by children over 6 years.
Taking other medicines
There were no reported clinically significant adverse interactions with other medications.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
During pregnancy or lactation can take Flavamed only according to precise instructions of your doctor!
So far there is not enough experience in humans during pregnancy and lactation. Nevertheless must be respected usual warnings for use of drugs during pregnancy. Especially during the first trimester is not recommended for use ambroxol hydrochloride.
The active substance of Flavamed passes into breast milk. Although not expected side effects in breast-fed infants is not recommended for use Flavamed of nursing mothers.
Driving and using machines
No evidence of an effect on driving and operating machinery. No studies on the effects on driving and operating machinery.
Important information about some of the ingredients of Flavamed
This medicinal product contains lactose (milk sugar). If your doctor has told you that you suffer from an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Flavamed
Always take Flavamed exactly as directed in this leaflet. If you're not sure, ask your doctor or pharmacist.
Unless your doctor has prescribed otherwise, they should consider the following guidelines Flavamed. Please follow the instructions for use, otherwise Flavamed may not have the expected effect.
Unless your doctor advises otherwise, the usual dose is
Age Single dose Maximum daily dose
Children 6-12 years 1/2 tablet 2-3 times a day (equivalent to 2-3 times of 15 mg ambroxol hydrochloride)
1 and 1/2 tablet (equivalent to 45 mg of ambroxol hydrochloride)
Adolescents over 12 years and adults
1 tablet 3 times daily (equivalent to 3 x 30 mg ambroxol hydrochloride) during the first 2 to 3 days, and then continues with 1 tablet 2 times daily (equivalent to 2 times 30 mg of ambroxol hydrochloride). 3 tablets (equivalent to 90 mg ambroxol hydrochloride)
For adult patients a daily dosage may be increased to 2 tablets 2 times daily.
Method of administration
Best Flavamed be taken after meals, without chewing and with plenty of liquid (eg. Water, tea or fruit juice).
The tablet can be divided into two equal halves.
Duration of treatment
Flavamed should not be applied more than 4-5 days without consulting a doctor.
If your symptoms do not respond after 4-5 days of treatment or even worsen, visit a doctor immediately!
Please tell your doctor or pharmacist if you feel that the effect of Flavamed is too strong or too weak.
If you take more dose Flavamed
So far not reported specific symptoms of overdose in humans. Based on accidental overdose and / or reports of medical errors, symptoms observed are consistent with the known side effects of ambroxol hydrochloride at recommended doses and may require symptomatic treatment.
Consult your doctor!
If you forget to take Flavamed
or you take a very small dose, take the medicine prescribed dose in the next intake. Do not take a double dose to make up for forgotten tablet.
If you have further questions on the use of this medicine, ask your doctor or pharmacist!
4. Possible side effects
Like all medicines, Flavamed can cause side effects, although not everybody gets them.
Assessment of adverse reactions is considered the following frequencies:
Very common: More than 1 in 10 treated patients;
Common: Less than 1 in 10 but more than 1 in 100 patients treated;
Uncommon: less than 1 in 100 but more than 1 in 1000 patients treated;
Rare: Less than 1 in 1,000, but more than 1 in 10,000 patients treated;
Very rare: Less than 1 in 10,000 patients treated, not known (can not be estimated from available data)
Uncommon: abdominal pain, vomiting, diarrhea, abdominal pain, and dyspepsia.
Skin and subcutaneous tissue disorders
Very rare: severe skin reactions, such as Lyell's syndrome and Stevens-Johnson (see. Ie. 2 "Take special care with Flavamed").
General disorders and administration site conditions
Rare: rash, urticaria;
Not known: severe allergic (anaphylactic) reactions to shock, angioedema, pruritus and other hypersensitivity reactions.
If you notice that you have one or more of the above side effects, discontinue treatment with Flavamed immediately.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Flavamed
Keep out of reach of children!
Do not use Flavamed after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C!
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
The active substance is ambroxol hydrochloride (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.
How does Flavamed and contents of the pack
White, round, flat tablets with bevelled edges and scored on one side.
Flavamed in packs of 10, 20 and 50 tablets.