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Boehringer Ingelheim Limited

The Hyde Building, 4th Floor, The Park, Carrickmines, Dublin 18,
Telephone: +353 1 2959620
Fax: +353 1 2959624
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com


Summary of Product Characteristics last updated on medicines.ie: 20/12/2013
SPC Bisolvon Oral Solution



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1. NAME OF THE MEDICINAL PRODUCT

Bisolvon 4 mg/5 ml Oral Solution


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains bromhexine hydrochloride 4 mg.

Excipients: contains maltitol liquid

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Oral solution

A clear to almost clear, colourless to almost colourless solution with a fruity aromatic odour.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As a mucolytic in the management of viscid mucoid secretions associated with bronchitis, bronchiectasis, sinusitis.


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4.2 Posology and method of administration

Oral.

Adults and children over 12 years:

Children 5 - 12 years:

Children 2 - 5 years:

2 × 5 ml three times daily to 3 × 5 ml four times daily.

1 × 5 ml four times daily.

1 × 5 ml twice daily.

BISOLVON Oral Solution is sugar free and therefore suitable for diabetics.


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4.3 Contraindications

Bisolvon Oral Solution should not be used in patients known to be hypersensitive to bromhexine or other components of the formulation.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions”) the use of this product is contraindicated.


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4.4 Special warnings and precautions for use

Bromhexine should be used with caution in patients with a history of, or existing, peptic ulceration.

There have been very few reports of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants such as bromhexine. Mostly these could be explained by the patient's underlying disease and/or concomitant medication. In addition during the early phase of a Stevens-Johnson syndrome or TEN a patient can first experience non-specific influenza-like prodomes e.g. fever, aching body, rhinitis, cough and sore throat. Misled by these non-specific influenza-like prodomes it is possible that a symptomatic treatment is started with a cough and cold medication. Therefore, if skin or mucosal lesions occur, medical advice should be sought immediately and treatment with bromhexine discontinued as a precaution.

As the product contains maltitol liquid, patients with rare hereditary problems of fructose intolerance should not take this medicine.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant unfavourable interactions with other medications have been reported.


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4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of bromhexine in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of BISOLVON during pregnancy.

Lactation

It is unknown whether bromhexine/metabolites are excreted in human milk.

Available pharmacodynamic/toxicological data in animals have shown excretion of bromhexine/metabolites in breast milk. A risk to the breastfed infant cannot be excluded.

BISOLVON should not be used during breast-feeding.

Fertility

No studies on the effect on human fertility have been conducted with BISOLVON.

Based on available pre-clinical experience there are no indications for possible effects of the use of bromhexine on fertility.


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4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed with BISOLVON.


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4.8 Undesirable effects

The following side effects have been reported based on clinical trials involving 3,992 patients

Frequencies

Very common ≥1/10

Common ≥ 1/100 < 1/10

Uncommon ≥ 1/1,000 < 1/100

Rare ≥ 1/10,000 < 1/1,000

Very rare < 1/10,000

Not known cannot be estimated from the available data

Immune system disorders

Hypersensitivity

Anaphylactic reaction*

Anaphylactic shock*

Rare

Not known

Not known

Respiratory, thoracic and mediastinal disorders

Bronchospasm*

Not known

Gastro-intestinal disorders

Abdominal pain upper

Nausea

Vomiting

Diarrhoea

Uncommon

Uncommon

Uncommon

Uncommon

Skin and subcutaneous tissue disorders

Rash

Angioedema*

Urticaria*

Pruritus*

Rare

Not known

Not known

Not known

*This adverse reaction has been observed in post-marketing experience. With 95 % certainty, the frequency category is not greater than rare (3/3,992), but might be lower. A precise frequency estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of 3,992 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via 'freepost', in addition to the traditional post-paid 'yellow card' option.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie


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4.9 Overdose

No specific overdose symptoms have been reported in man to date. Based on accidental overdose and/or medication error reports the observed symptoms are consistent with the known side effects of Bisolvon at recommended doses and may need symptomatic treatment.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Bromhexine is a synthetic derivative of the herbal active ingredient vasicine. Preclinically, it has been shown to increase the proportion of serous bronchial secretion. Bromhexine enhances mucus transport by reducing mucus viscosity and by activating the ciliated epithelium (mucociliary clearance).

In clinical studies, bromhexine showed a secretolytic and secretomotor effect in the bronchial tract area, which facilitates expectoration and eases cough.

Following the administration of bromhexine antibiotic concentrations (amoxycillin, erythromycin, oxytetracycline) in the sputum and bronchopulmonary secretions are increased.


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5.2 Pharmacokinetic properties

Absorption

Bromhexine is rapidly and completely absorbed from the gastrointestinal tract.

After oral administration solid and liquid formulations show similar bioavailability. The absolute bioavailability of bromhexine hydrochloride was about 22.2 ± 8.5 % and 26.8 ± 13.1 % for BISOLVON® tablets and solution, respectively. The first pass metabolism amounts to about 75-80%. Concomitant food leads to an increase of bromhexine plasma concentrations.

Distribution

After intravenous administration bromhexine was rapidly and widely distributed throughout the body with a mean volume of distribution (Vss) of up to 1209 ± 206 L (19 L/kg). The distribution into lung tissue (bronchial and parenchymal) was investigated after oral administration of 32 mg and 64 mg bromhexine. Lung tissue concentrations two hours post dose 1.5 -4.5 times higher in bronchiolo-bronchial tissues and between 2.4 and 5.9 times higher in pulmonary parenchyma compared to plasma concentrations. Unchanged bromhexine is bound to plasma proteins by 95 % (non-restrictive binding).

Metabolism

Bromhexine is almost completely metabolised to a variety of hydroxylated metabolites and to dibromanthranilic acid. All metabolites and bromhexine itself are conjugated most probably in form of N-glucuronides and O-glucuronides. There are no substantial hints for a change of the metabolic pattern by a sulphonamide or oxytetracyclin. There is insufficient pharmacokinetic data to evaluate a possible drug-drug interaction between bromhexine and erythromycin.

Elimination

Bromhexine is a high extraction ratio drug after i.v. administration in the range of the hepatic blood flow, 843-1073 mL/min resulting in high inter- and intraindividual variability (CV > 30 %) After administration of radiolabelled bromhexine about 97.4 ± 1.9 % of the dose were recovered as radioactivity in urine, with less than 1% as parent compound.

Bromhexine plasma concentrations showed a multiexponential decline. After administration of single oral doses between 8 and 32 mg, the terminal elimination half-life ranged between 6.6 and 31.4 hours. The relevant half-life to predict the multiple dose pharmacokinetics is about 1 hour, thus no accumulation was seen after multiple dosing (accumulation factor 1.1).

General

Bromhexine shows dose proportional pharmacokinetics in the range of 8-32 mg following oral administration. There are no data for bromhexine pharmacokinetics in the elderly or in patients with renal or liver insufficiency.

Bromhexine pharmacokinetics are not relevantly affected by co-administration of ampicillin or oxytetracycline.

Interaction studies with oral anticoagulants or digoxin were not performed.


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5.3 Preclinical safety data

No details on schedule.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Maltitol liquid (E965)

Sucralose (E955)

Benzoic acid (E210)

Cherry aroma 96323-33

Chocolate aroma 96534-33

Levomenthol

Water, purified


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

Unopened: 3 years.

In-use: Use within 12 months of opening bottle.


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6.4 Special precautions for storage

Store in the original container.


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6.5 Nature and contents of container

Bisolvon Oral Solution is available in amber type III glass bottles with tamper-evident polyethylene caps with low density polyethylene liners. The registered pack sizes are 100 ml, 200 ml and 250 ml.

Not all pack sizes may be marketed.

A polypropylene measuring dish is provided.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire, RG12 8YS

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PA 7/25/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:14 November 1984

Date of last renewal: 01 April 2008


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10. DATE OF REVISION OF THE TEXT

December 2013



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Active Ingredients

 
   Bromhexine hydrochloride