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Mucoflux

BRONCHIAL CLEANSER

 

1. TRADENAME OF THE MEDICINAL PRODUCT MUCOFLUX

2. QUALI-QUANTITATIVE COMPOSITION
Each capsule contains:
Active ingredient
D,L-trans-1-methyl-4-(2-hydroxy-isopropyl)-cyclohex-1,2-en-6-ol or Cyclidrol (Sobrerol) 100 mg


Excipients
Starch, Talc, Magnesium stearate.
Hard-gelatine capsule: Gelatin, Titanium dioxide (E171), Yellow iron oxide (E172), Indigotin (E132)


100 ml of syrup contain:
Active ingredient
D,L-trans-1-methyl-4-(2-hydroxy-isopropyl)-cyclohex-1,2-en-6-ol or Cyclidrol (Sobrerol) 0.8 g


Excipients
Sucrose, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Monobasic sodium phospate, Glicerine, Caramel (E150), Cardamon aroma, Saccharin, Sodium hydroxide, Ethyl alcohol, Purified water.

3. PHARMACEUTICAL FORMS

Capsules, syrup.

4. DESCRIPTION
Capsules: hard-gelatine, snap-fit light green opaque/white opaque capsules (size n4), containing a white homogeneous, free-flowing powder.
Syrup: clear solution, free of solid matters, with a yellow-brown colour, characteristic smell and sweet taste.
 

5. SUMMARY OF PHARMACODINAMICS AND PHARMACOKINETICS

5.1 PHARMACODINAMIC PROPERTIES
The active substance of Mucoflux is cyclidrol (sobrerol), a synthetic compound chemically defined as: D,L-trans-1-methyl-4-(2-hydroxy-isopropyl)-cyclohex -1,2-en-6-ol.


Cyclidrol lowers the viscosity of mucus, favouring the expulsion of mucous clusters from the respiratory tract. It does not effect the alveolar surfactant or the ciliary movements of the bronchotracheal mucosa. It has no bronchoconstrictory effects.


Because of these properties and of the low toxicity and good tolerability, cyclidrol is an effective and safe agent in all those disorders where the respiratory tract is obstructed or overloaded by an excess of mucus, that hinders the normal flow of air. Mucoflux has therefore two main actions:
- cleansing since it allows and facilitates the removal of mucous and mucopurulent secretions
- eupneic, since it improves the respiratory parameters.

5.2 PHARMACOKINETIC PROPERTIES
Cyclidrol is rapidly absorbed by the first tract of the gastro-enteric apparatus. The maximum absorption has been observed at 60'.


Cylidrol is rapidly distributed. The rapid distribution is confirmed by the high levels of cyclidrol found in the bronchial mucus already one hour after the administration. In man, the plasmatic half-life of cyclidrol administered by i.v. route is 1.60 hours, while in the mucus is 10.82 hours. By oral administration the plasmatic half-life of cyclidrol is 2.39 hours and 2.98 hours in the bronchial mucus.


The biotransformation of cyclidrol in man consists of two reactions phases: a phase I reaction leading to carvone and a phase II reaction leading to the conjugation with glucuronic acid. A total of 9 metabolites have been found in man and animal.


In man cyclidrol is excreted nearly exclusively through the kidneys as free cyclidrol, glucurono-conjugates cyclidrol and carvone.

6. CLINICAL INFORMATION

6.1 INDICATIONS
Cyclidrol is a mucolytic agent which lowers the viscosity of mucus and is indicated in the acute and chronic disorders of the respiratory tract characterized by excessive, viscous mucus.
 

6.2 RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION
Capsules:
Adults: 2 capsules twice daily for 2 weeks or longer, according to medical prescription.

Syrup:
Adults: 1-2 measurefuls (10-20 ml) twice daily.
Children over 2 years: 1 measureful (10 ml) twice daily.


A measuring cup for the administration of the recommended volume (10 ml) of syrup is included in the package.

6.3 CONTRA-INDICATIONS
Known hypersensitivity to the ingredients of the product.
The drug is contraindicated in children younger than 2 years.

6.4 SIDE-EFFECTS
Nausea and gastrointestinal disorders.

6.5 PRECAUTIONS/WARNINGS
Patients with renal failure should be monitored while on treatment with Mucoflux.


KEEP OUT OF REACH OF CHILDREN.

6.6 DRUG INTERACTIONS
No drug interactions have so far been reported. Mucoflux may be combined with antibiotics, bronchodilators, anti-asthmatic and antitubercolous agents.

6.7 PREGNANCY AND LACTATION
Mucoflux is exempt from mutagenic and teratogenic potential, nevertheless it should be administered to pregnant women only if necessary and under medical monitoring.


No contra-indications during lactation are known.

6.8 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No effects on the ability to drive or use machines are known.

6.9 SYMPTOMS AND TREATMENT FOR OVERDOSAGE
In the case of overdose the usual rescue measures should be adopted.
No overdosage has so far been reported.
 

7. PHARMACEUTICAL PARTICULARS

7.1 INCOMPATIBILITIES
Not known.

7.2 SHELF-LIFE
Capsules: 30 months
Syrup: 30 months

7.3 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25C.

7.4 NATURE AND CONTENTS OF CONTAINER
Capsules: box of 4's (sample pack), 100's and 500's.
Syrup: bottle of 30 ml (sample pack) and 60 ml.

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