FLAVAMED SYR 15MG/5ML 100ML (BĒRNIEM)

ATC code: R05CB06 

Active substances: Ambroxolum

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

FLAVAMED VAARIKAS 3MG/1ML 100ML

Package leaflet: Information for the patient

Flavamed vaarikas 3 mg/ml oral solution For children from two years, adolescents and adults 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 possible 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 4-5 days.

What is in this leaflet

1.   What Flavamed vaarikas is and what it is used for
2.   What you need to know before you take Flavamed vaarikas
3.   How to take Flavamed vaarikas
4.   Possible side effects
5.   How to store Flavamed vaarikas
6.   Contents of the pack and other information

1.   What Flavamed vaarikas is and what it is used for

Flavamed vaarikas contains 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. Flavamed vaarikas is indicated in children from two years, adolescents and adults.
Mucus becomes more liquid through Flavamed vaarikas and can be coughed up more easily.
You must talk to a doctor if you do not feel better or if you feel worse after 4-5 days.

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

- if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Flavamed vaarikas must not be used in children under two years.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flavamed vaarikas
-   If you have had very severe hypersensitivity reactions of the skin in the past (StevensJohnson 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 vaarikas and contact your doctor immediately.
-   If you suffer from impaired kidney function or from a severe liver disease. You must then only take Flavamed vaarikas 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 vaarikas.
-   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 vaarikas under the supervision of a doctor.
-   If you suffer from histamine intolerance. You should then avoid long-term therapy, as the active substance of Flavamed vaarikas influences the histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
-   If you have a history of peptic ulcer disease, you should take advice from your doctor how to take Flavamed vaarikas, since mucolytics may disrupt the gastric mucosal barrier. Ask your doctor before taking Flavamed vaarikas.

Children

Persistent or recurrent cough in children between 2-4 years requires medical diagnosis before treatment.

Other medicines and Flavamed vaarikas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Cough-suppressant agents (antitussives)
While taking Flavamed vaarikas, 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, breast-feeding and fertility

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 vaarikas during pregnancy and breast-feeding at the explicit direction of your doctor! Especially during the first trimester, the use of Flavamed Hustensaft is not recommended.
It has been observed that the active substance of Flavamed vaarikas crosses into breast milk.
Flavamed Hustensaft 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

There is no evidence for an effect on the ability to drive and use machines.
Studies on the effects on the ability to drive and use machines have not been performed.

Flavamed vaarikas 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.
Each measuring spoon with 5 ml of oral solution contains sorbitol 1.75 g (= 0.15 bread units). Sorbitol may have a mild laxative effect. The calorific value is 2.6 kcal/g sorbitol.

3. How to take Flavamed vaarikas

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 vaarikas to you otherwise. Please keep to the instructions for use, as Flavamed vaarikas is otherwise unable to work properly!

The recommended dose is:

Children from 2 - 5 years:
54 a measuring spoon each with 2.5 ml of oral solution 3 times daily (equivalent to 3 times 7.5 mg ambroxol hydrochloride = 22.5 mg ambroxol hydrochloride/day)
Children from 6 - 12 years:
1   measuring spoon each with 5 ml of oral solution 2 - 3 times daily (equivalent to 2 - 3 times 15 mg ambroxol hydrochloride = 30 - 45 mg ambroxol hydrochloride/day)
Adolescents from 12 years and adults:
2   measuring spoons each with 5 ml of oral solution 3 times daily
(equivalent to 3 times 30 mg ambroxol hydrochloride = 90 mg ambroxol hydrochloride/day) during the first 2 to 3 day, then
2 measuring spoons each with 5 ml of oral solution 2 times daily
(equivalent to 2 times 30 mg ambroxol hydrochloride = 60 mg ambroxol hydrochloride/day) Note:
The dose in adults can be increased to 4 measuring spoons each with 5 ml of oral solution 2 times daily
(equivalent to 2 times 60 mg ambroxol hydrochloride = 120 mg ambroxol hydrochloride/day).

Method of use

For oral use. Take Flavamed vaarikas after meals with the aid of the enclosed measuring spoon.

Duration of use

Flavamed vaarikas should not be taken for longer than 4 to 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 vaarikas is too strong or too weak.

If you take more Flavamed vaarikas than you should

Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the possible side effects of Flavamed Hustensaft 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 vaarikas

or have taken too little, simply take the medicine in the prescribed 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 10people):
-   Nausea
-   Changed taste
-   Numbness of the mouth and throat (hypoaesthesia)
Uncommon (may affect up to 1 in 100people):
-   Vomiting
-   Dry mouth
-   Diarrhoea
-   Digestive Complaints (dyspepsia)
-   Abdominal pain
-   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, pharmacist or nurse. 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 vaarikas

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 label and folding box 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 of the bottle: 6 months.
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 vaarikas contains

The active substance is ambroxol hydrochloride. 1 ml of oral solution contains 3 mg ambroxol hydrochloride.
One measuring spoon with 5 ml of oral solution contains 15 mg ambroxol hydrochloride.
The other ingredients are:
Sorbitol,liquid non-crystallising (E420); benzoic acid; glycerol 85 per cent; hydroxyethylcellulose; raspberry flavouring; purified water.

What Flavamed vaarikas looks like and contents of the pack

Clear, colourless to slightly brownish liquid with a fruity odour of raspberry Flavamed vaarikas comes in packs with 60 ml and 100 ml of oral solution.
Not all pack sizes may be marketed.
The measuring spoon is made from polypropylene and has graduation lines for 1.25 ml, 2.5 ml and 5 ml (rim of the spoon)

Marketing Authorisation Holder

BERLIN-CHEMIE AG (Menarini Group)
Glienicker Weg 125 12489 Berlin Germany

Manufacturer

Berlin-Chemie AG Glienicker Weg 125
12489 Berlin Germany
This leaflet was last revised in 08/2017.