Bronchenol Sedative And Fluidifying Pastilles Dry And Oily Cough 20 Pastilles

Mint flavored tablets for oral use based on dextromethorphan hydrobromide and guaifenesin .

Therapeutic indications

Bronchenolo Sedative and Fluidifying Tablets is used for the symptomatic treatment of cough, it is used to calm coughs and make the phlegm more fluid, therefore more easily eliminated. Talk to your doctor if you do not feel better or if you feel worse after 5-7 days of treatment.

Dosage and posology

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

• Adults and children over 12 years: 3-6 tablets per day, up to a maximum of 6 tablets per day.
• Children between 6 and 12 years of age: 2-3 tablets per day, up to a maximum of 3 tablets per day.

Method of administration

Take Bronchenolo Sedative and Fluidifying Tablets letting them dissolve in the mouth (orally). Wait at least 4-6 hours between one dose and the next. Do not exceed the indicated doses without your doctor's advice.

Overdose

Immediately notify your doctor or go to the emergency room of the nearest hospital, as appropriate measures may be necessary. In the event of an overdose, the risk of having side effects increases. You may also notice: arousal, mental confusion, agitation, nervousness and instability of character (irritability), stupor, loss of muscle coordination (ataxia), altered muscle tone (dystonia), hallucinations, loss of contact with reality (psychosis) ) and breathing problems (respiratory depression).

Contraindications

Do not take Bronchenolo Sedative and Fluidifying Tablets if:

• you are allergic to dextromethorphan hydrobromide, guaifenesin or any of the other ingredients of this medicine
• you are taking or have taken within the last two weeks medicines used for depression called monoamine oxidase inhibitors (MAOIs)
• have or are likely to have breathing problems (respiratory failure), for example you have chronic obstructive airway disease, pneumonia, an ongoing asthma attack or worsening of asthma.
• Do not use Bronchenolo Sedativo and Fluidificante in children under 6 years of age.

Side effects

Clinical trial data The adverse events reported below were observed in clinical trials and are considered uncommon adverse reactions (i.e. occurring in a percentage ranging from ≥1 / 1000 to <1/100 patients). Adverse reactions are listed according to the MedDRA classification.

Nervous system disorders: drowsiness.

Ear and labyrinth disorders: vertigo.

Gastrointestinal disorders: gastrointestinal disturbance; nausea; He retched; abdominal discomfort. Post marketing data Adverse reactions identified during post marketing use are listed below. As these reactions are reported voluntarily from a population of uncertain size, their frequency is unknown but is probably very rare (found in <1/10000 patients).

Nervous system disorders: serotonin syndrome. Serotonin syndrome (with altered mental status, agitation, myoclonus, hyperreflexia, diaphoresis, chills, tremors and hypertension) has been reported with concomitant use of dextromethorphan with antidepressants (monoamine oxidase inhibitors or serotonin reuptake inhibitors).

Immune system disorders: hypersensitivity (e.g. rash, hives, angioedema).

Pregnancy and breastfeeding

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 using this medicine. In pregnant and lactating women, the medicine should only be administered if clearly needed and under the direct supervision of the doctor.

Special warnings

Talk to your doctor or pharmacist before taking Bronchenolo Sedativo e Fluidificante if:

• have a long-term cough (chronic or persistent), asthma such as that occurs in asthma or emphysema;
• have severe liver or kidney problems;  are taking medicines used for depression called selective serotonin reuptake inhibitors or tricyclic antidepressants;
• are taking other cough or cold medicines.

If your cough does not improve or if you notice a high fever, skin lesions such as patchy or diffuse color changes (rashes) or persistent headache, contact your doctor as your treatment may need to be adjusted. Take care as this medicine can cause changes (false positives) in tests that measure the concentration of vanylmandelic acid in the urine. In this case, tell your doctor that you are taking Bronchenolo Sedativo e Fluidificante Tablets.

Bronchenolo Sedative and Fluidifying Tablets contains:

• sucrose; if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product;
• aspartame. This medicine contains a source of phenylalanine. It can be harmful to you if you have phenylketonuria.

Expiry and Retention

Keep this medicine out of the sight and reach of children. No special storage precautions are required. Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition

1 tablet of Bronchenolo Sedative and Fluidifying Mint Taste contains:

Active principles

7.5 mg dextromethorphan hydrobromide and 55 mg guaifenesin.

Excipients

Mountain pine essential oil; magnesium trisilicate; aspartame; magnesium stearate; sucrose; mint flavor.