MHRA Informacion

PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5
PER CENT ORAL SOLUTION
PECTODRILL FOR CHESTY COUGHS 5 PER CENT

ORAL SOLUTION
PL 05630/0031-2
UKPAR
TABLE OF CONTENTS
Lay summary
Page 2
Scientific discussion
Page 3
Steps taken for assessment
Page 13
Summary of product characteristics
Page 14
Patient information leaflet
Page 21
Labelling
Page 30
MHRA PAR; PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION
AND PECTODRILL FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION, PL 05630/0031-2
PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL

SOLUTION
PECTODRILL FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION
PL 05630/0031-2
LAY SUMMARY
The Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing
Authorisations (licences) for the medicinal products PectoDrill sugar-free for chesty coughs 5
per cent oral solution and PectoDrill for chesty coughs 5 per cent oral solution (Product
Licence numbers: 05630/0031-2).
These medicines belong to a group known as the mucolytics or expectorants, which are used
for the treatment of chesty coughs. These types of medicines work by modifying secretions
(mucus or phlegm) in your lungs making them easier to remove by coughing or spitting.
PectoDrill sugar-free for chesty coughs 5 per cent oral solution and PectoDrill for chesty
coughs 5 per cent oral solution raised no clinically significant safety concerns and it was,
therefore, judged that the benefits of using these products outweigh the risks; hence
Marketing Authorisations have been granted.

SOLUTION
PL 05630/0031-2
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 4
Pharmaceutical assessment
Page 5
Preclinical assessment
Page 7
Clinical assessment
Page 10
Overall conclusions and risk benefit assessment
Page 12
INTRODUCTION
Based on the review of the data on quality, safety and efficacy, the UK granted marketing
authorisations for the medicinal products PectoDrill sugar-free for chesty coughs 5 per cent
oral solution and PectoDrill for chesty coughs 5 per cent oral solution to Pierre Fabre
Medicament on 17 September 2009. These medicines are only available on prescription.
These are bibliographic applications submitted under article 10a of Directive 2001/83/EC.
Carbocisteine, also known as S-carboxymethylcarbocisteine, is a well-established active
ingredient with documented efficacy and acceptable safety in clinical use. It is a
mucoregulator that affects the secretory functions of the bronchial mucosa by increasing
sialomucins over fucomicins and sulphomucins, thereby normalising and increasing the
elasticity of the secretions, and increasing mucociliary transport. It also has an antiinflammatory effect.
These products are indicated for the treatment of bronchial secretion disorders, particularly
during acute bronchial impairments such as acute bronchitis and acute episode of chronic
bronchopneumopathies. One 15 ml measure should be given three times daily initially; after
a satisfactory response this may be reduced to three 10 ml measures daily.
PHARMACEUTICAL ASSESSMENT
DRUG SUBSTANCE
Carbocisteine
C5H9NO4S
Mr 179.2
Physical form: a white, crystalline powder, practically insoluble in water, in alcohol and in
ether. It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides.
An appropriate specification has been provided.
Analytical methods have been appropriately validated and are satisfactory for ensuring
compliance with the relevant specifications.
Active carbocisteine is stored in appropriate packaging. The specifications and typical
analytical test reports are provided and are satisfactory.
Batch analysis data are provided and comply with the proposed specification.
Satisfactory certificates of analysis have been provided for working standards used by the
active substance manufacturer and finished product manufacturer during validation studies.
Appropriate stability data have been generated supporting an acceptable retest period.
DRUG PRODUCT
Description and Composition of the Drug Product
PectoDrill sugar-free for chesty coughs 5 per cent oral solution contains the following
excipients: sodium saccharin, methyl parahydroxybenzoate (E218), hydroxyethylcellulose,
aromatic flavour, sodium hydroxide and purified water. PectoDrill for chesty coughs 5 per
cent oral solution contains essentially the same excipients, but sucrose solution is used
instead of sodium saccharin and caramel flavour is used instead of aromatic flavour.
Appropriate justification for the inclusion of each excipient has been provided.
The excipients in PectoDrill are all Ph. Eur. grade, with the exception of the sucrose solution,
which is controlled by the French monograph and the flavourings (in the absence of relevant
Ph Eur monographs, this is acceptable). Certificate of analysis for all excipients are provided
in support of the proposed specifications. The flavours used in these products comply with
EC 88/388. No excipient used contains material of animal or human origin.
Manufacture
The methods of manufacture of the sugar free and sugar containing solutions are basically
similar. Descriptions and flow-charts of the manufacturing methods have been provided.
In-process controls are appropriate considering the nature of the products and the method of
manufacture. Process validation has been carried out on product batches. The results are
satisfactory.
Finished product specification
The finished product specification is satisfactory. Acceptance limits have been justified with
respect to conventional pharmaceutical requirements and, where appropriate, safety. Test
methods have been described and have been adequately validated, as appropriate. Batch data
have been provided and comply with the release specification. Certificates of analysis have
been provided for any working standards used.
Container Closure System
The finished product is packaged in 150 ml or 200 ml glass bottles, with or without a
measuring cup (15 ml).
Specifications are given for packaging materials and these are supported by certificates of
analysis. The glass used to make the bottles complies with the requirements of the Eur. Ph.
The measuring cup is CE marked and a suitable certificate is given.
Stability
Finished product stability studies have been conducted in accordance with current guidelines.
Based on the results, a shelf-life of 30 months with the storage precaution Do not store
above 30C has been set, which is satisfactory.
Bioequivalence / Bioavailability
As the product is in solution no study is reported.
Product literature
All product literature (SPCs, PILs and labelling) are satisfactory. The package leaflets were
been submitted to the MHRA along with results of consultations with target patient groups
("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results
indicate that the package leaflets are well-structured and organised, easy to understand and
written in a comprehensive manner. The test shows that the patients/users are able to act upon
the information that they contains.
Assessors overall conclusions on quality
These products are satisfactory and Marketing Authorisations may be granted.
PRECLINICAL ASSESSMENT
GOOD LABORATORY PRACTICE (GLP) ASPECTS

Most of the preclinical data have been taken from the published literature. Hence,
compliance with GLP regulations cannot be verified. Reports of single-dose toxicity studies
conducted by the applicant do not contain a GLP statement but the studies appear to have
been performed to a suitable standard.
PHARMACODYNAMICS
The non-clinical overview contains a selective review of publications on the effects of
carbocisteine in rheological, biochemical and mucociliary clearance studies relevant to the
proposed indication. Appropriate animal and in vitro models showed that carbocisteine was
effective in:
normalisation of bronchial mucus secretion

reduction of mucosal goblet cell hyperplasia
reduction of purulent mucous obstructions in the tracheobronchial tree
increasing mucociliary transport
increasing respiratory compliance
reduction of inflammation (indirectly)
There are three major classes of glycoproteins in bronchial mucus: the acid sialomucins and
sulphomucins, and the neutral fucomucins. Normally, the sialomucins predominate but, in
chronic bronchitis, there is an increase in fucomucins and, as the disease progresses, in
sulphomucins. Carbocisteine increases sialomucins over fucomucins by stimulating
sialyltransferase activity. The reduction in viscosity of the bronchial mucus by carbocisteine
is related to the splitting of disulphide bonds in the long-chain glycoproteins of the mucus
layer.
General pharmacological effects include antioxidant and possible immunostimulant effects,
while, with cimetidine, metabolic interaction and increased levels of amoxicillin in the lung
have been reported. None of these would interfere adversely with the intended therapeutic
effect.
The non-clinical overview provides an adequate summary of the pharmacodynamics relevant
to the clinical indication.
PHARMACO/TOXICOKINETICS
No pharmacokinetic studies have been conducted by the applicant and none are needed.
Absorption, Distribution, Metabolism and Excretion (ADME)
No ADME studies have been conducted by the applicant. The literature has been reviewed
and summarised.
In rodents, primates and humans, carbocisteine is rapidly and well absorbed by the oral route,
with a maximum plasma concentration (Cmax) approximately two hours after administration
and the subsequent kinetics fit a one-compartment open model. Distribution in the mouse is
primarily to the lungs and respiratory mucus. Most of the drug is excreted unchanged in the
urine with the main metabolite in rodents and humans being the sulphoxide and minor
pathways being acetylation and decaroboxylation.
The review of ADME of carbocisteine is adequate, given its long-established clinical use.
TOXICOLOGY
Single-dose toxicity studies in rats and mice were conducted to compare the toxicity of a
tablet formulation with that of the active ingredient. The results were compared with those
available in the literature, which date generally from the 1970s and 1980s.
SINGLE-DOSE TOXICITY
Single-dose toxicity studies in mice and rats by various routes showed carbocisteine to be
lethal at doses considerably higher than those used clinically.
REPEAT-DOSE TOXICITY
Repeat-dose toxicity studies using carbocisteine by oral gavage in rats of one months
duration at doses up to 1500 mg/kg and of six months duration at doses up to 700 mg/kg
were conducted. With doses of 750 and 1500 mg/kg, some treatment-related but not doserelated changes were noted in the blood chemistry. Some dose-related changes in organ
weights were found but there were no histopathological changes. In females dosed for three
months of the six-month study, some dose-dependent changes in blood chemistry were found
but they were not present at six months. At 350 and 700 mg/kg in females at six months,
ketone bodies in the urine were noted but there were no effects on organ weights or any
histopathological changes.
REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

Two abstracts from 1977 on reproductive and developmental toxicity are cited. In rats,
carbocisteine by the oral route at doses up to 500 mg/kg did not affect reproduction when
given to males before mating and females before mating and during pregnancy, and there was
no indication of teratogenicity. There were no effects on the offspring in rabbits dosed orally
with carbocisteine at doses up to 250 mg/kg during gestation.
GENOTOXICITY AND CARCINOGENICITY

No genotoxicity or carcinogenicity studies have been carried out on carbocisteine. This has
been addressed in accordance with NfG CPMP/SWP/799/95 and is satisfactory.
EXCIPIENTS
All the excipients are of EP or suitable grade and are present in acceptable quantities.
NON-CLINICAL OVERVIEW
The non-clinical overview was written by an expert who has experience in pharmaceutical
development and is a pharmacologist and toxicologist recognised by the appropriate French
ministry.
PRODUCT LITERATURE
The product literature is acceptable from a preclinical point of view.
CONCLUSION
Marketing Authorisations may be granted for these products.
CLINICAL ASSESSMENT
THERAPEUTIC CLASS
Carbocisteine is a mucolytic agent. It exerts its action on the gel phase of the mucus by
breaking the disulfide bonds of glycoproteins, thereby rendering the mucous less viscous and
aiding expectoration.
Carbocisteine has effects on bronchial secretion by normalisation of mucus hyperviscosity.
INDICATIONS
The Applicant has submitted the following:
Treatment of bronchial secretion disorders, particularly during acute bronchial impairments:
acute bronchitis and acute episode of chronic bronchopneumopathies.

This therapeutic indication is essentially the same as that for other UK products containing
carbocisteine as a single active substance. Therefore, the requested therapeutic indication
would be acceptable for use in the UK.
DOSE AND DOSE REGIMEN

The following has been submitted:
For oral use.
For use in adults and children over 12 years of age only.

One 15 ml measure three times daily initially; after a satisfactory response, this may be
reduced to three 10 ml measures daily.
One 15 ml measure contains 750 mg of carbocisteine.
The maximum total daily dose is 2250 mg of carbocisteine (45 ml of oral solution).
Not recommended for use in children 12 years of age and younger.
Shake the bottle prior to use.
This posology is essentially in line with the posology for other products containing
carbocisteine authorised in the UK and is, therefore, satisfactory.
CONSIDERATION FOR PAEDIATRIC USE

The Applicant is not seeking authorisation in children and, therefore, a clinical programme or
bibliographic review is not presented in support of use in this age group.
PHARMACODYNAMICS
Carbocisteine is a cysteine derivative and act as a mucolytic agent. It exerts its action on the
gel phase of the mucus by breaking the disulfide bonds of glycoproteins, thereby rendering
the mucous less viscous and aiding expectoration.
Carbocisteine has effects on bronchial secretion by normalisation of mucus hyperviscosity.
.
MHRA PAR; PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION 10
The pharmacological properties of carbocisteine have been well documented in the

literature and the Applicant has reviewed a number of studies The Applicant has presented
no new data and none are required.
PHARMACOKINETCS
The Applicant presents no new data; the Applicant has provided a review of the literature.
Carbocisteine is rapidly adsorbed following oral administration; the plasma peak is reached
in two hours. The bioavailability is low less than 10% of the dose administered, probably
due to intraluminal metabolism and a marked liver first-pass effect. The elimination halflife is approximately 2 hours. Both it and its metabolites are mainly eliminated via the
kidneys
The Applicant has provided a comprehensive summary of the pharmacokinetics and it is
considered that no further work is required.
CLINICAL EFFICACY
The Applicant presents no new data. The literature has been reviewed and is presented in a
summarised format in both the Expert Report on the Clinical Documentation and in Part IV
of the dossier in a document entitled Clinical Documentation Literature Review Synthesis.
The applicant presents a literature review of four double-blind, placebo-controlled studies,
and two double-blind studies versus an active comparator within the same therapeutic
indication. In addition the results of a meta-analysis conducted on studies carried out in
Germany are presented. The review demonstrates adequate efficacy for the product.
CLINICAL SAFETY
No formal data are presented and none are required, a review of the literature is presented.
PRODUCT LITERATURE
All product literature is medically satisfactory.
CONCLUSIONS
This Application has been submitted as a so-called bibliographical application; the Applicant has
submitted no new data. The pharmacodynamics and pharmacokinetics of carbocisteine are well
documented in the literature and it is considered that no further work is required. In respect of
clinical efficacy the Applicant presents a literature review and highlights four placebo-controlled
studies, and two of studies that incorporated an active control. Carbocisteine has been used in man
for some years and would appear to be well tolerated when used within the recommended dose
range. In view of the long history of carbocisteine use and the relatively few adverse events it is
possible to conclude that the risk/benefit ratio is favourable. Therefore Marketing Authorisations
may be granted for these products.
OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT
QUALITY
The important quality characteristics of PectoDrill sugar-free for chesty coughs 5 per cent
oral solution and PectoDrill for chesty coughs 5 per cent oral solution are well defined and
controlled. The specifications and batch analytical results indicate consistency from batch to
batch. There are no outstanding quality issues that would have a negative impact on the
benefit/risk balance.
PRECLINICAL
No new preclinical data were submitted and none are required for applications of this type.
EFFICACY
The efficacy of carbocisteine is well documented.
No new or unexpected safety concerns arise from these applications.
The SPCs, PIL and labelling are satisfactory and consistent with those for other
carbocisteine-containing products.
RISK BENEFIT ASSESSMENT

The quality of these products is acceptable and no new preclinical or clinical safety concerns
have been identified. The risk benefit ratio is, therefore, considered to be acceptable.
.

SOLUTION
PL 05630/0031-2
STEPS TAKEN FOR ASSESSMENT

1
2
The MHRA received the marketing authorisation application on 16 June 2003

Following standard checks and communication with the applicant the MHRA
considered the application valid on 29 November 2005
3 Following assessment of the application the MHRA requested further
information relating to the quality dossier on 5 November 2003 and the clinical
dossier on 5 July 2004
4 The applicant responded to the MHRAs requests, providing further information
on the quality and clinical dossiers on 21 September 2005
5 Following assessment of the response the MHRA requested further information
relating to the quality dossier on 1 September 2006
on the quality dossier on 21 August 2007
relating to the quality dossier on 9 October 2007
on the quality dossier on 28 October 2008
relating to the quality dossier on 4 August 2009
on the quality dossier on 5 August 2009
11 The application was determined on 17 September 2009
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT

PectoDrill sugar-free for chesty coughs 5 per cent oral solution.
QUALITATIVE AND QUANTITATIVE COMPOSITION

CARBOCISTEINE
5.0 g per 100 ml
Excipients: Methyl parahydroxybenzoate and Sodium
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Oral solution
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of bronchial secretion disorders, particularly during acute bronchial
impairments: acute bronchitis and acute episode of chronic bronchopneumopathies.
4.2
Posology and method of administration
For oral use.
One 15 ml measure three times daily initially; after a satisfactory response, this may
be reduced to three 10 ml measures daily.
4.3
Contraindications
- Known hypersensitivity to carbocisteine or any of the other constituents.
- Active peptic ulcer disease.
4.4
Special warnings and precautions for use
Special warnings
Productive coughs are a fundamental component of the bronchopulmonary defences
and should not be suppressed.
Precautions for use
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg
per 15 ml dose (ethanol content: 0.8 % v/v).
In the event of low sodium diet, the content of 0.1g of sodium per 15 ml measure
should be taken into account.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.5
Interaction with other medicinal products and other forms of
interaction
An expectorant or mucolytic medicinal product should not be combined with an
antitussive medicinal product or a medicinal product indicated for use to dry
secretions (such as anticholinergics).
4.6
Pregnancy and lactation
Pregnancy
Studies in animals have not revealed any teratogenic effect. In the absence of
available clinical data, the administration of this drug should be avoided during
pregnancy as a precautionary measure.
Lactation
The use of this drug is not recommended while breast-feeding.
4.7
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed.
4.8
Undesirable effects
Frequency is defined as: rare (1/10,000 to 1/1,000), according to the MedDRA
frequency convention and system organ classification.
Gastrointestinal disorders:
Rare: Gastric pain, nausea, diarrhoea.
Skin and subcutaneous tissue disorders:
Rare: rashes as well as allergic reactions caused by parahydroxybenzoate (possibly
delayed)
4.9
Overdose
Symptoms and signs:
Most likely gastrointestinal disturbance.
Treatment:
The treatment should be symptomatic and supportive. Gastric lavage may be
beneficial.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
MUCOLYTIC
ATC code: R05CB03
(R: respiratory system)
Carbocisteine is a mucolytic-type mucomodifier. It exerts its action on the gel phase
of the mucus, probably by breaking the disulphide bonds of the glycoproteins and thus
aids expectoration.
Moreover, carbocisteine has effects on bronchial secretion by normalization of mucus
hyperviscosity.
5.2
Pharmacokinetic properties
Carbocisteine is rapidly absorbed following oral administration; the plasma peak is
reached in two hours.
The bioavailability is low, less than 10% of the dose administered which is probably
due to intraluminal metabolism and a marked liver first-pass effect.
The elimination half-life is approximately 2 hours.
Both it and its metabolites are mainly eliminated via the kidneys.
5.3
Preclinical safety data
Preclinical safety data in literature have not revealed any relevant findings that have
not been mentioned elsewhere in this SPC.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Sodium Saccharin
Methyl parahydroxybenzoate (E218)
Hydroxyethylcellulose
Aromatic flavour*
Sodium hydroxide
Purified water
* Aromatic flavour : Rum, honey, cocoa tincture, orange tincture, cherry tincture,
harts tongue leaves, tonka bean, liquorice, vanillin, ethyl vanillin, maltol,
acetylmethylcarbinol, ethylacetate, caramel colouring, glycol propylene
6.2
Incompatibilities
Not applicable
6.3
Shelf life
30 months
6.4
Special precautions for storage
Do not store above 30C
6.5
Nature and contents of container
- 150 ml glass bottle
- 150 ml glass bottle with a measuring cup (15 ml)
Not all pack sizes may be marketed
6.6
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER

PIERRE FABRE MEDICAMENT
45, Place Abel Gance
92100 Boulogne
France
MARKETING AUTHORISATION NUMBER

PL 05630/0031
DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
17/09/2009
10
DATE OF REVISION OF THE TEXT

17/09/2009
NAME OF THE MEDICINAL PRODUCT

PectoDrill for chesty coughs 5 per cent oral solution.
QUALITATIVE AND QUANTITATIVE COMPOSITION

CARBOCISTEINE5.00 g per 100 ml
Excipients: Sucrose, Methyl parahydroxybenzoate and Sodium
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Oral solution
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of bronchial secretion disorders, particularly during acute bronchial
impairments: acute bronchitis and acute episode of chronic bronchopneumopathies.
4.2
Posology and method of administration
For oral use.
One 15 ml measure three times daily initially; after a satisfactory response, this may
be reduced to three 10 ml measures daily.
4.3
Contraindications
- Known hypersensitivity to carbocisteine or any of the other constituents.
- Active peptic ulcer disease.
4.4
Special warnings and precautions for use
Special warnings
Productive coughs are a fundamental component of the bronchopulmonary defences

and should not be suppressed.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase isomaltase insufficiency should not take this medicine.
This product may be harmful for teeth.
Precautions for use
In the event of either diabetes mellitus or low-sugar diet, the content of 6 g of sucrose
per 15 ml measure should be taken into account.
In the event of low sodium diet, the content of 0.1g of sodium per 15 ml measure
should be taken into account.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.5
Interaction with other medicinal products and other forms of
interaction
An expectorant or mucolytic medicinal product should not be combined with an
antitussive medicinal product or a medicinal product indicated for use to dry
secretions (such as anticholinergics).
4.6
Pregnancy and lactation
Studies in animals have not revealed any teratogenic effect. In the absence of
available clinical data, the administration of this drug should be avoided during
pregnancy as a precautionary measure.
Lactation
The use of this drug is not recommended while breast-feeding.
4.7
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been
performed.
4.8
Undesirable effects
Frequency is defined as: rare (1/10,000 to 1/1,000), according to the MedDRA
frequency convention and system organ classification.
Gastrointestinal disorders:
Rare: Gastric pain, nausea, diarrhoea.
Skin and subcutaneous tissue disorders:
Rare: rashes as well as allergic reactions caused by parahydroxybenzoate (possibly
delayed)
4.9
Overdose
Symptoms and signs:
Most likely gastrointestinal disturbance.
Treatment:
The treatment should be symptomatic and supportive. Gastric lavage may be
beneficial.
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
MUCOLYTIC
ATC code: R05CB03
(R: respiratory system)
Carbocisteine is a mucolytic-type mucomodifier. It exerts its action on the gel phase
of the mucus, probably by breaking the disulphide bonds of the glycoproteins and thus
aids expectoration.
Moreover, carbocisteine has effects on bronchial secretion by normalization of mucus
hyperviscosity.
5.2
Pharmacokinetic properties
Carbocisteine is rapidly absorbed following oral administration; the plasma peak is
reached in two hours.
The bioavailability is low, less than 10% of the dose administered which is probably
due to intraluminal metabolism and a marked liver first-pass effect.
The elimination half-life is approximately 2 hours.
Both it and its metabolites are mainly eliminated via the kidneys.
5.3
Preclinical safety data
Preclinical safety data in literature have not revealed any relevant findings that have
not been mentioned elsewhere in this SPC.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Sucrose solution
Methyl parahydroxybenzoate (E218)
Hydroxyethylcellulose
Caramel flavour*
Sodium hydroxide
Purified water
* Caramel flavour : aromatic caramel, coffee extract, vanillin.
6.2
Incompatibilities
Not applicable
6.3
Shelf life
30 months
6.4
Special precautions for storage
Do not store above 30C
6.5
Nature and contents of container
Not all pack sizes may be marketed
6.6
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER

PIERRE FABRE MEDICAMENT
45, Place Abel Gance
92100 Boulogne
France
MARKETING AUTHORISATION NUMBER(S)

PL 05630/0032
DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION
17/09/2009
10
DATE OF REVISION OF THE TEXT

17/09/2009
PATIENT INFORMATION LEAFLET
PectoDrill sugar-free for chesty coughs 5 per cent oral solution:
PectoDrill for chesty coughs 5 per cent oral solution:
LABELLING
MHRA PAR; PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION AND PECTODRILL FOR CHESTY COUGHS 5 PER
CENT ORAL SOLUTION, PL 05630/0031-2
31
MHRA PAR; PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION AND PECTODRILL FOR CHESTY COUGHS 5 PER
CENT ORAL SOLUTION, PL 05630/0031-2
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PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5

PER CENT ORAL SOLUTION

PECTODRILL FOR CHESTY COUGHS 5 PER CENT

Steps taken for assessment

Summary of product characteristics

Patient information leaflet

PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL

PECTODRILL FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION

PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL

PECTODRILL FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION

Overall conclusions and risk benefit assessment

GOOD LABORATORY PRACTICE (GLP) ASPECTS

normalisation of bronchial mucus secretion

REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

GENOTOXICITY AND CARCINOGENICITY

acute bronchitis and acute episode of chronic bronchopneumopathies.

DOSE AND DOSE REGIMEN

For use in adults and children over 12 years of age only.

CONSIDERATION FOR PAEDIATRIC USE

The pharmacological properties of carbocisteine have been well documented in the

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

RISK BENEFIT ASSESSMENT

PECTODRILL SUGAR-FREE FOR CHESTY COUGHS 5 PER CENT ORAL

PECTODRILL FOR CHESTY COUGHS 5 PER CENT ORAL SOLUTION

STEPS TAKEN FOR ASSESSMENT

The MHRA received the marketing authorisation application on 16 June 2003

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

QUALITATIVE AND QUANTITATIVE COMPOSITION

MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION NUMBER

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

DATE OF REVISION OF THE TEXT

NAME OF THE MEDICINAL PRODUCT

QUALITATIVE AND QUANTITATIVE COMPOSITION

Productive coughs are a fundamental component of the bronchopulmonary defences

MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION NUMBER(S)

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

DATE OF REVISION OF THE TEXT

PATIENT INFORMATION LEAFLET

PectoDrill sugar-free for chesty coughs 5 per cent oral solution:

PectoDrill for chesty coughs 5 per cent oral solution:

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