Bronquidiazina C.R.

  • International name (active ingredient): drug
  • Production company: FAES FARMA
  • Country of manufacture: Spain
  • Release form: 150 ml oral suspension vial #1
  • Dispensing mode: II group (dispensed with form N3 prescription)

Bronquidiazina C.R.

DOSAGE FORM: Suspension

 

COMPOSITION: 

                                      Per 7.5 ml  Per 2.5 ml
Trimethoprim 80 mg 26.7 mg
Sulphametoxazol 400 mg 133.3 mg
Bromhexine HCI            4 mg 1.3 mg
Sodium Benzoate 250 mg 83.3 mg
Tolu Balsam syrup 325 mg 108.3 mg

 

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.

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.

 

Antibiotics are used to treat bacterial infections. They are not effective in the treatment of viral infections, such as flu or colds.

Please follow carefully your doctor’s instructions with regard to dose, administration interval and duration of treatment.

Do not keep this medicine or use it to treat other conditions. If you have any antibiotic remaining at the end of your course of treatment, please return it to your pharmacist, who will dispose of it properly. Do not throw away any medicines via wastewater or household waste.

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.

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.

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.

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.

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.

Packaging form: 150 ml bottle.

Shake well before use.

Shelf life: 5 years

Dispensing conditions from the pharmacy:

It is issued with a doctor’s prescription.