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BRONTEX (AMBROXOL) 30MG TABL N20

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
BRONTEX-AMBROXOL-drug/medicine -tablets aproximate price on "BRONTEX (AMBROXOL) 30MG TABL N20" in Riga city, Latvia is:
  • 2.50€  2.7$  2.14£  289Rub  28.8SEK  11PLN  9.95₪ 

BRONTEX, 30 mg, tabletės, N20


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  BRONTEX (AMBROXOL) 30MG TABL N20     Recheck

Reģ. Nr.: 99-0111

ATC codeR05CB06 

Active substances: Ambroxoli Hydrochloridum

 


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

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BRONTEX 30 mg tabletes, 20 gab.

 .

BRONTEX TABLETID 30MG N20

Package leaflet: Information for the user Brontex Tablets 30 mg

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

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

Brontex Tablets are 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 Tablets

Do not use Brontex Tablets:
if you are allergic to ambroxol or any of the other ingredients of this medicine (listed in section 6);
-   due to large content of the active substance, the tablets are not suitable for children under the age of 6.
-   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).

Warnings and precautions

-   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 ambroxol 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 Tablets 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.

Other medicines and Brontex Tablets

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, cefuroxim, 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.

3. How to use Brontex Tablets

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. Follow the administration instructions for Brontex Tablets for a sufficient effect.
Unless prescribed otherwise by your doctor, the standard administration regimen is as follows:
Children aged 6-12 years
Vi tablets 2-3 times per day (30-45 mg of ambroxol per day)
Adults and children above the age of 12
For the first 2-3 days, take 1 tablet 3 times per day (90 mg per day); after that, 1 tablet twice per day (60 mg per day).
You can take up to 60 mg of ambroxol hydrochloride 2 times per day (120 mg per day) if necessary -this can potentially increase the effect of the medicine.
The tablets must be taken after a meal.
The phlegm-loosening effect of ambroxol hydrochloride is facilitated by the copious consumption of liquids.
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.

If you use more Brontex Tablets 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 Tablets 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 focred diuresis do not significantly increase the elimination of ambroxol.

If you forget to use Brontex Tablets

Do not take a double dose.
If you have skipped a dose or taken too little, do not take an increased 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 Tablets

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.
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 Tablets contain

-   The active substance is ambroxol hydrochloride
-   The other ingredients are lactose, corn starch, magnesium stearate, anhydrous colloidal silica.

What Brontex Tablets looks like and contents of the pack

White, round convex tablets with a score on one side. The tablet can be divided into equal doses. Brontex Tablets contains 30 mg of ambroxol hydrochloride.
The blister package contains 20 tablets.

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






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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