Bronquidiazina CR 150ml susp.

Bronquidiazina C.R.

DOSAGE FORM: Suspension

COMPOSITION: 

Excipients: Glycerol (E422), sucrose, xanthan gum, sodium saccharine, methyl parahydroxybenzoate (E218), polysorbate 80, propyl parahydroxybenzoate (E216), dimethylpolysiloxane anti-foaming agents, aniseed essence, water, q.s.

PROPERTIES

The combination of a sulfamide, sulfamethoxazole and a diaminopyrimidine, trimethoprim, is an effective drug that acts on a wide variety of pathogens causing different diseases.

Bronquidiazina C.R. also achieves a fluidifying effect on respiratory secretions, through bromhexine, which is brought about by a reduction in the viscosity of the mucous. The result is a greater ability to expel these secretions.

Finally, thanks to its content in sodium benzoate and tolu balsam syrup, Bronquidiazina C.R. has a clear balsamic and expectorant effect.

INDICATIONS

Respiratory infections: Acute bronchitis and acute worsening of chronic bronchitis, pneumonia, middle ear infections and sinusitis.

Treatment and prevention of pneumonia caused by Pneumocystis Carinii

All the above infections must be diagnosed, and the treatment thereof established by a doctor, so this medicine must never be used without medical prescription.

POSOLOGY. INSTRUCTIONS FOR USE

The doses prescribed by the doctor must not be modified or discontinued. As a rule, the following guidelines may be established in using the drug In adults and adolescents over 12 years of age: 7.5 ml three times a day. In children between 2 and 12 years of age: 2.5 ml three times a day.

WARNINGS

There have been reports of serious skin reactions associated with the administration of bromhexine. If a skin rash appears (including mucosal lesions of, for example, the mouth, throat, nose, eyes and genitals), stop using Bronquidiazina C.R. suspension and see your doctor immediately.

Warning about the excipients: This medicine contains glycerol as an excipient which may be dangerous at high doses. It can cause headache, stomach disorders and diarrhoea.

CONTRAINDICATIONS

–  This medicine may be contraindicated in subjects who are sensitive to any of the ingredients it contains.

–  This medicine must not be used in children aged under two years.

–  This medicine must not be used without adequate monitoring in patients with serious blood disorders.

PRECAUTIONS

–  It must be used with caution in patients with kidney or liver failure, or in patients affected by malnutrition or alcoholism.

–  This medicine must be used with caution in patients with severe allergies or bronchial asthma.

–  Special care should be taken when treating elderly patients with this medicine.

–  Avoid excessive exposure to sun or the use of sunlamps.

Skin rashes that may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported when using BRONQUIDIAZINA C.R. These rashes initially appear as red spots or circular blotches, often with a blister in their centre.

Other signs that may appear include sores in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These rashes are often accompanied by flu-like symptoms. The rash may progress to form widespread blisters or flaking of the skin.

The highest risk period of the appearance of severe skin reactions is during the first few weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis when using BRONQUIDIAZINA C.R., you should never use BRONQUIDIAZINA C.R. again ever. 

If you develop a rash or any of these skin symptoms you should stop taking BRONQUIDIAZINA C.R., visit your doctor immediately and tell him/her that you are taking this medicine.

Pregnancy and nursing

The advisability of using this medicine during pregnancy and nursing must also be evaluated by the doctor.

SIDE EFFECTS

This medication is generally well tolerated by most patients.

However, in certain cases nausea, vomiting, diarrhoea or breathing difficulties may develop.

Rare side effects (may affect up to one out of every 1000 people)

- Hypersensitivity reactions

- Rash, hives

Less common problems in elderly patients are more serious skin rashes.

With unknown frequency (cannot be estimated from the available data)

- Anaphylactic reactions such as anaphylactic shock, angioedema (fast progression swelling of the skin, subcutaneous tissue and mucous membranes or submucosal tissue) and pruritus.

- Serious adverse skin reactions that can be life-threatening for the patient (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis). 

(See section PRECAUTIONS).

Consult the doctor immediately if any of the mentioned symptoms appear.

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 the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to provide further information on the safety of this medicine.

INCOMPATIBILITIES

This medicine can affect the actions of other drugs taken concomitantly; therefore, if you are under treatment for diabetes, epilepsy or treated with drugs that affect blood coagulation, ask your doctor.

INTOXICATION AND TREATMENT

Inform your doctor immediately of any accidental intake or overdose of this drug, indicating the amount taken. The most common symptoms of overdose are vomiting, nausea, dizziness and confusion.

In all cases:

In case of overdose or accidental intake, contact the Toxicology Information Service.Phone 91 562 04 20. 

PRESENTATION

Bottle containing 150 mL and graduated dispenser.

SHAKE WELL BEFORE USE

With medical prescription.

All medicines must be kept out of the reach of children.

Medicines should not be disposed of down drains or with household waste. Place the containers

and medicines you no longer use in the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unwanted medicines and containers. These measures will help to protect the environment.

More detailed and updated information on this medicinal product is available from the website of the Spanish Drug Agency (AEMPS) http://www.aemps.gob.es/

FAES FARMA, S.A.

Máximo Aguirre, 14 – 48940 Leioa