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Brontex 30mg tablets N20

Ratiopharm

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Note. This product is not distributed or sold, and information is provided for information purposes only.
For more detailed information, contact your nearest pharmacy, pharmacist or your family doctor.

Brontex. Facilitate an expectorant in patients with acute and chronic bronchial and lung diseases, which cause secretion of lumber.

Brontex 30 mg tablets

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 directed by your doctor or pharmacist.

- Keep this leaflet You may need to read it.

- If you want more information or advice, ask your pharmacist. See. Chapter 4.

- If you get side effects (even if it is not listed), ask your doctor or pharmacist.

- If you within 4-5 days for your well-being has not improved or even worse, see your doctor.

What is in this leaflet?

  1. What is Brontex is and what it is used for
  2. Before you Brontex
  3. How Brontex
  4. Possible side effects
  5. How to store Brontex
  6. Contents of the pack and other information

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

Brontex used to facilitate coughing in patients with acute and chronic bronchial and lung diseases, which cause secretion of lumber.

If within 4-5 days for your well-being has not improved or even worse, see your doctor.

  1. Before you Brontex

Brontex Do not

- If you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine;

- Brontex 30 mg tablets should not be less than 6 years of age.

Warnings and Precautions

Check with your doctor or pharmacist before taking Brontex.

Very rarely reports of severe Stevens-Johnson and Lyell type skin reactions occurring during the use of ambroxol. The emergence of the skin and mucous membrane changes, you should immediately seek medical attention and discontinue the use of ambroxol.

Impaired renal function

If poor kidney function, after consultation with the doctor, Brontex should be used very carefully (that is, a lower dose or by the medicine longer breaks).

Severe renal insufficiency

In severe kidney failure, liver ambroxol of the metabolites may accumulate in the body.

Impaired liver function

If you have severe liver disease, after consultation with the doctor, Brontex should only be used very carefully (it is a lower dose or by the medicine longer breaks).

Some are rare bronchial disease (eg., Malignant ciliary syndrome), which manifests itself in a rich accumulation of phlegm in the respiratory tract, Brontex should be used with extreme caution, under medical supervision, because of respiratory tract secretions can accumulate.

Kids

Brontex 30 mg tablets for they contain a high dose is not suitable for children under 6 years of age.In these patients the treatment is suitable for use in syrup, which is less active substance.

Since Ambroxol can irritate the lining of the digestive tract, the medicine should be used with caution in patients who have or have had a peptic ulcer.

Other medicines and Brontex

If you are taking or have recently taken any other medicines, or because you are not sure, talk to your doctor or pharmacist.

medicine from coughing

Ambroxol in combination with medicines for cough, cough reflex inhibition due to a hazardous secretion stasis, and therefore co-administration is possible only by a very well-identified indications.

antibiotics

It is observed that ambroxol is used in combination with amoxicillin, cefuroxime, erythromycin and doxycycline, improves the above-mentioned antibiotic penetration into bronchial secretions.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, you think you may be pregnant, or are planning to become pregnant before taking this medicine, talk to your doctor or pharmacist.

Ambroxol hydrochloride crosses the placental barrier. Animal studies indicate direct or indirect harmful effects on pregnancy, embryonic or fetal development, parturition or postnatal development. During the first three months of pregnancy is not recommended Brontex.

The active substance is excreted in breast milk. Brontex during lactation is not recommended, although the infant adverse effects are unlikely to occur.

Driving and using machines

Ability to drive and use machines Brontex broken.

Brontex contains lactose monohydrate

This product contains lactose monohydrate. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

  1. How Brontex

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use in children

6-12-year-olds

It usually takes for 2-3 times daily dosing of half a tablet (corresponding to 2-3 of 15 mg ambroxol hydrochloride per day).

Adults and children older than 12 years of age

It usually takes about 2-3 days to use 3 times daily one tablet (equivalent to 2 - 3 times 30 mg ambroxol hydrochloride per day), then - 2 times one tablet (equivalent to 2 x 30 mg ambroxol hydrochloride per day ).

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If you have impaired kidney function or have severe liver disease, the doctor acknowledged, the dose should be reduced or the administration to make a longer break.

If you think that Brontex is too strong or too weak, talk to your doctor or pharmacist.

Method and duration

The tablets should be swallowed whole after meals, take with abundant liquid (eg. A glass of water, juice or tea).

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By drinking enough fluids, increased secretion pour Brontex effect. Therefore, during treatment should drink enough fluids.

The period of administration, according to the seriousness of the disease, determined by the physician. If you are taking the medicine without the doctor's instructions, it Brontex do not take longer than 4-5 days.

If you take a large dose Brontex?

In case of overdose, call your doctor. Emergency medical treatment - the induction of vomiting and gastric lavage - usually not adequate; they can try to apply only in the event of overdose symptoms.It is appropriate to use the tools to treat those symptoms associated with overdose.

Reported short-term agitation and diarrhea. In case of accidental or deliberate very overdose may cause the following symptoms: profuse drooling, vomiting, low blood pressure.

If you forget to Brontex

If you forget to take Brontex 30 mg tablets or oral administration of too little, you can not take a double dose to make up for a missed dose. Continue to take the medicine the doctor follows.

If you stop taking Brontex

Talking to your doctor, do not stop taking your medicine as this may worsen disease.

  1. Possible side effects

This medicine, like all others, can cause side effects, although not everybody gets them.

Generally, ambroxol hydrochloride is well tolerated.

Frequencies are defined as:

Very common (≥1 / 10);

Common (≥1 / 100 to <1/10);

Uncommon (≥1 / 1 000 to <1/100);

Rare (≥1 / 10, 000 to <1/1, 000);

Very rare (<1/10 000).

Immune system disorders

Rarely. Skin rash, urticaria, angioneurotic edema.

Very rarely. Anaphylactic reactions including anaphylactic shock (facial swelling, shortness of breath, an increase in temperature, chills), and other allergic reactions.

Respiratory, thoracic and mediastinal disorders

Rarely. Runny nose.

Gastrointestinal disorders

Uncommon. Indigestion and other mild gastrointestinal symptoms, nausea, vomiting.

Rarely. Salivation, heartburn, diarrhea.

Renal and urinary disorders

Rarely. Urinary problems.

Notification of side effects

If you experience side effects, including not listed, please tell your doctor or pharmacist. The side effects can also report directly by filling out the web site www.vvkt.lt the form by mail to the State Medicines Control Agency under the Lithuanian Ministry of Health, Žirmūnų g. 139A, LT 09120 Vilnius Tel: 8 800 73 568, fax 8 800 20131 or e-mail. Email NepageidaujamaR@vvkt.lt. When reporting side effects you can help us to get more information about the safety of the medicine.

  1. How to store Brontex

Keep this medicine out of the sight and reach of children place.

On the blister and carton after EXP after the expiry date of this medicine. The expiry refers to the last day of the month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. How to dispose of unwanted medication, ask your pharmacist. These measures will help to protect the environment.

  1. Contents of the pack and other information

Brontex composition

- The active substance is: ambroxol hydrochloride. Each tablet contains 30 mg of ambroxol hydrochloride.

- The other ingredients are lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica.

Brontex 30mg tablets looks like and contents of the pack

The tablets are white, round with a score line. The tablet can be divided into two equal doses ..

PVC / Aliumunio blisters.

Each carton contains 20 tablets. Each blister pack contains 10 tablets.

Marketing Authorisation Holder and Manufacturer

MAH

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm, Germany

manufacturer

Merckle GmbH,

Ludwig-Merckle-Str. 3

89143 Blaubeuren, Germany