BRONTEX-AMBROXOL RATIOPHARM SAFT 100ML N20

ATC code: R05CB06 

Active substances: Ambroxoli Hydrochloridum

Vendor, principal: Ratiopharm. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

BRONTEX SIIRUP 3MG/1ML 100ML

Package leaflet: Information for the user Brontex Syrup 3 mg/mL

Ambroxol hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use 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.
-   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 Brontex Syrup is and what it is used for
2.   What you need to know before you use Brontex Syrup
3.   How to use Brontex Syrup
4.   Possible side effects
5.   How to store Brontex Syrup
6.   Contents of the pack and other information

1. What Brontex Syrup is and what it is used for

Brontex Syrup is used for loosening phlegm in the case of acute and chronic bronchopulmonary diseases accompanied by productive coughing.

2. What you need to know before you use Brontex Syrup

Do not use Brontex Syrup:

-   if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

-   if you have a renal function disorder or a severe liver disease. In such cases, caution must be exercised when using ambroxol (administer with longer intervals or in a lower dose).
-   if you have rare bronchial disease, which is accompanied by large amounts of secretion (i.e. malignant ciliary syndrome). Due to the risk of mucous obstruction, talk to a doctor before using amborxol if this is the case.
-   severe skin reactions have been reported in connection with the administration of ambroxol. If you develop a skin rash (incl. lesions on mucous membranes, such as in the mouth, throat, nose, eyes, or on the genitals), stop using Brontex Syrup and talk to your doctor immediately.
-   in very rare cases, severe skin disorders, such as Stevens-Johnson and Lyell’s syndrome have been reported in connection with the temporary use of ambroxol.
•   Stevens-Johnson syndrome is a disease characterised by high fever and blistering rash on the skin and mucous membranes.
•   The life-threatening Lyell’s syndrome is also known as the “scalded skin syndrome”. It is characterised by extensive blistering rash similar to burns.
In most cases, these have occurred in connection to a severe concomitant illness or other concomitantly used medicines. If you get lesions on your skin or mucous membrane, immediately talk to your doctor and stop using ambroxol.
-   caution should be exercised when using ambroxol in patients with a predilection for ulcerous gastrointestinal disease, as the use of this substance can exacerbate the clinical presentation.

Children

-   Ambroxol syrup should not be administered to children under the age of 2.

Other medicines and Brontex Syrup

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of medicines containing ambroxol with antitussives can lead to a dangerous bronchial mucus obstruction due to the inhibition of the coughing reflex.
Increased absorption of the antibiotics amoxicillin, cefuroxime, doxycycline, and erythromycin into bronchial secretion has been reported in connection with the concomitant administration of ambroxol.

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.
Insufficient data are available about the use of ambroxol in pregnant subjects, especially in the first 28 weeks of pregnancy. Ambroxol can only be used during pregnancy, especially during the first three months of pregnancy, after thorough consideration of the expected benefits and potential risk.
Ambroxol is excreted in milk in animals. As insufficient data are currently available about its use in humans, the medicine can only be used during breast-feeding under a doctor’s recommendation.

Driving and using machines

Ambroxol has no influence on the ability to drive and use machines.

Brontex Syrup contains sorbitol

Brontex Syrup contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before using Brontex Syrup.
The energy value of sorbitol is 2.6 kcal/g. Sorbitol can have a mild laxative effect. 5 mL of Brontex Syrup contains 2.1 g of sorbitol (equal to 0.18 CEU).

3. How to use Brontex Syrup

Always use 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.
Unless prescribed otherwise by your doctor, the standard administration regimen is as follows:
Children aged 2-5 years:
2.5 mL of syrup 3 times per day (22.5 mg of ambroxol per day).
Children aged 6-12 years
5 mL of syrup 2-3 times per day (30-45 mg of ambroxol per day).
Children over the age of 12 and adults:
10 mL of syrup* 3 times per day over 2-3 days (90 mg of ambroxol per day), followed by 10 mL of syrup* 2 times per day (60 mg of ambroxol per day).
* For the ease of dosage, the package contains a measuring cup with the correct markings.
Brontex Syrup is taken after a meal.
Attention: in the case of a severe renal function disorder, reduce the dose or extend the administration intervals.
Duration of treatment
It is not recommended to use Brontex for longer than 4-5 days, unless prescribed otherwise by your doctor. If your symptoms do not disappear in 4-5 days or are exacerbated, talk to your doctor.
The phlegm-loosening effect of ambroxol hydrochloride is facilitated by the copious consumption of liquids.
If you feel that the effect of Brontex is too strong or too weak, talk to your doctor or pharmacist.

If you use more Brontex Syrup than you should

In the event of a possible overdose you should talk to your doctor immediately.
No severe symptoms of poisoning have been reported in connection with an ambroxol overdose.
There have been reports of temporary agitation and diarrhoea. Accidental or intentional overdose can cause increased saliva production, vomiting, and reduced blood pressure.
Talk to your doctor if you have taken more Brontex Syrup than you should. Immediate measures, such as the induction of emesis or gastric lavage, are generally not recommended and can only be used in the case of a very large overdose. The treatment is symptomatic.
Dialysis or forced diuresis does not significantly increase the elimination of ambroxol.

If you forget to use Brontex Syrup

Do not take a double dose.
If you have skipped a dose or taken too little, do not take a bigger dose the next time; continue as prescribed in the instructions.
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.

Side effects are cl	assified by their frequency (probability) as follows:
Very common	more than 1 user in 10
Common	1 to 10 users in 100
Uncommon	1 to 10 users in 1,000
Rare	1 to 10 users in 10,000
Very rare	less than 1 user in 10,000
Unknown	cannot be estimated from available data

Immune system disorders
Rare:   Hypersensitivity reactions
Unknown:   anaphylactic reactions, incl. anaphylactic shock, angioedema (sudden swelling
of skin, subcutaneous, mucosal or submucosal tissues) and itching
Gastrointestinal disorders Common:    diarrhoea
Uncommon:   nausea, vomiting
Rare:   heartburn
Very rare:   dyspepsia
Skin and subcutaneous tissue disorders Rare:    rash, urticaria
Unknown:   severe skin reactions (incl. erythema multiforme, Stevens-Johnson syndrome/toxic
epidermal necrolysis and acute generalised exanthematous pustulosis)
If you get hypersensitivity reactions, stop using the medicine immediately. Talk to your doctor about the necessity of other measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Brontex Syrup

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 carton after “Use by:”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The syrup can be used for up to 12 months after the first opening of the bottle. Store at a temperature of up to 25 °C after first opening the bottle.
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 Brontex Syrup contains

-   The active substance is ambroxol hydrochloride
-   The other ingredients are sorbitol, propylene glycol, raspberry aroma, saccharine, purified water.

What Brontex Syrup looks like and contents of the pack

Clear, slightly yellowish solution.
Brontex Syrup 5 mL (= 1 measuring cap) contains 15 mg (3 mg/mL) of ambroxol hydrochloride.
100 mL of syrup in an amber glass bottle (type III) with a yellow nozzle, white screw cap, and a 5 mL measuring cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany
Manufacturer Merckle GmbH,
Ludwig-Merckle-Straße 3,
89143 Blaubeuren,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 661 0801

This leaflet was last revised in May 2016