Acetylcysteine 600mg capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Acetylcysteine
Available from:
Alliance Healthcare (Distribution) Ltd
ATC code:
R05CB01
INN (International Name):
Acetylcysteine
Dosage:
600mg
Pharmaceutical form:
Capsule
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF:

Read the complete document

Mucolight 600mg Capsules

(Acetylcysteine)

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you are allergic to histamine. If you are not

able to tolerate food and drinks that contain

large amounts of histamine such as wine,

tomatoes or processed food, then Mucolight

Capsules are not suitable for you because

acetylcysteine affects how histamine is broken

down in the body. The most common

symptoms of histamine intolerance are

migraine headaches, flushing, hives and rhinitis

(stuffy, runny nose) and itching.

If you have asthma

Warnings and precautions

Serious skin rashes (Steven-Johnson syndrome

and Lyell's syndrome) have rarely been reported

with the use of acetylcysteine. The rash can often

involve ulcers of the mouth, throat, nose, genitals

Talk to your doctor, pharmacist or nurse before

taking Mucolight Capsules:

If you have a history of stomach ulcers

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section

Are under 14 years of age

2. WHAT YOU NEED TO KNOW BEFORE YOU

TAKE MUCOLIGHT CAPSULES

4.

Possible side effects

Are allergic to acetylcysteine or any of the

other ingredients of this medicine (listed in

section 6)

Mucolight Capsules contain a medicine called

acetylcysteine. This belongs to a group of

medicines called mucolytics. It works by making

the mucus (phlegm) less sticky which makes the

mucus easier to cough up. Acetylcysteine is used

for problems with the breathing passages

(respiratory tract).

2.

What you need to know before you take

Mucolight Capsules

1. WHAT MUCOLIGHT CAPSULES ARE AND

WHAT THEY ARE USED FOR

1.

What Mucolight Capsules are and what they

are used for

If you have any further questions, ask your

doctor, pharmacist or nurse.

Read all of this leaflet carefully before

you start taking this medicine because

it contains important information for

you.

This medicine has been prescribed for you

only. Do not pass it on to others. It may harm

them, even if their signs of illness are the

same as yours.

What is in this leaflet:

3.

How to take Mucolight Capsules

6.

Contents of the pack and other information

5.

How to store Mucolight Capsules

Keep this leaflet. You may need to read it

again.

Do NOT take Mucolight Capsules if you:

If you are pregnant or breast-feeding, think you

may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before

taking this medicine.

Effects of Mucolight Capsules on laboratory

tests

Mucolight Capsules with food, drink and

alcohol

The rash may progress to widespread blistering

and peeling of the skin. If you develop a rash or

these skin symptoms you should stop taking

these capsules and contact your doctor

immediately.

Other medicines and Mucolight Capsules

Tell your doctor or pharmacist if you are taking,

have recently taken, or might take any other

medicines. In particular:

Acetylcysteine may affect a test for salicylate (such

as aspirin) in the blood. It may also affect the

results when testing for ketones in urine. Ketones

are produced by the breakdown of fat in the body,

for example in people with high levels of sugar in

the blood.

Glyceryl trinitrate used to treat chest pain

(angina). Simultaneous administration of

acetylcysteine and glyceryl trinitrate may

increase the normal effect of glyceryl trinitrate

which is used to help widen the blood vessels

in patients with chest pain. If you doctor

considers combined treatment with these

medicines to be necessary, you will be

monitored for possible lowering of blood

pressure (hypotension), which can be serious

and may be indicated by headaches.

and conjunctivitis (red and swollen eyes). These

serious skin rashes are frequently followed by flu-

like symptoms of fever, headache and body ache.

Cough relieving medicines (antitussives) used

in combination with acetylcysteine can cause a

dangerous build-up of secretions

Mucolight Capsules should not be taken during

pregnancy or breast-feeding.

If you are unsure you should talk to your doctor

before taking these capsules.

Driving and using machines

Mucolight Capsules should not affect your ability to

drive or use machinery.

Mucolight Capsules should be taken after food.

Pregnancy and Breast-feeding

Antibiotics (e.g. aminoglycosides, penicillins,

tetracycline) may not work as well when taken

at the same time as acetylcysteine. If you need

to take antibiotics and acetylcysteine you

should leave at least two hours between taking

these medicines. This does not apply to

antibiotics such as cefixime and loracarbef,

these medicines can be taken at the same time

as acetylcysteine

Always take this medicine exactly as you doctor

has told you. Check with your doctor or pharmacist

if you are not sure.

3. HOW TO TAKE MUCOLIGHT CAPSULES

Your doctor will decide how long you should take

this medicine for.

Children under the age of 14 years:

If you take more Mucolight Capsules than you

should

For oral administration only. Swallow the capsule

be taken after food.

If you forget to take Mucolight Capsules

Adults and children aged 14 years and over:

The usual dose is 1 capsule, once daily. Swallow

the capsule with a drink of water. The capsule

should be taken after food.

Mucolight Capsules are not suitable for children

under the age of 14.

If you take more Mucolight Capsules than you

should, talk to your doctor or contact your nearest

hospital casualty department immediately. Take

your capsule pack with you. You may have

diarrhoea, heartburn, stomach ache or feel sick.

If you stop taking Mucolight Capsules

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side

effects, although not everyone gets them.

If you have forgotten to take a dose, leave out that

dose completely. Take you next dose at the normal

time. Do not take a double dose to make up for a

forgotten dose. If you have trouble remembering to

take you capsules, tell your doctor or pharmacist.

If you have swelling of the lips, throat or

tongue, difficulty in swallowing or breathing.

This could be a sign of an allergic reaction

Any changes to the skin or mucus membranes

(such as your nose, mouth, lips and genitals)

including skin rashes, blistering or peeling of

the skin. These may be accompanied by flu-like

symptoms. These could be signs of serious

skin reaction such as Stevens-Johnson

Syndrome or Lyell's Syndrome.

Other side effects reported with this medicine

are shown below:

Stop taking Mucolight Capsules and see a

doctor or contact your nearest hospital

casualty department immediately:

You should talk to you doctor or pharmacist before

stopping taking these capsules.

If you have any further questions on the use of this

medicine, ask your doctor, pharmacist or nurse.

Stomach pains

Swelling in the mouth and swelling of the lips

Diarrhoea

Skin rashes and itching

Uncommon (may affect up to 1 in 100 people)

Fever

Feeling sick or being sick

Ringing in the ears (tinnitus)

Headache

Increased heart rate

Low blood pressure.

6. CONTENTS OF THE PACK AND OTHER

INFORMATION

The active substance is acetylcysteine. Each

capsule contains 600 mg acetylcysteine.

What Mucolight Capsules look like and

contents of the pack

Shortness of breath

Indigestion

Very rare (may affect up to 1 in 10,000

people)

Rare (may affect up to 1 in 1,000

people)

Do not use this medicine after the expiry date

which is stated on the blister and carton. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These

measures will help protect the environment.

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard or search

for MHRA Yellow Card in the Google Play or Apple

App Store.

Not known (frequency cannot be

estimated form the available data)

Swelling of the face.

Store below 25˚C.

What Mucolight Capsules contain:

Bleeding in the upper respiratory tract.

By reporting side effects you can help provide

more information on the safety of this medicine.

Reporting of side effects

5. HOW TO STORE MUCOLIGHT CAPSULES

Keep this medicine out of the sight and reach

of children.

The other ingredients are: Crospovidone C1-SF,

Stearic acid, Gelatine and Titanium dioxide.

Mucolight Capsules are white hard capsules with

an almost white crystalline powder filling.

Ennogen Healthcare Limited

Riverside Way, Dartford, DA1 5BS, UK

Unit G4, Riverside Industrial Estate,

Mucolight Capsules are available in a carton

containing 30 capsules packed in PVC/PVDC

blister packs.

This leaflet was last revised in June 2019.

Marketing Authorisation Holder and

Manufacturer

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Mucolight 600mg Capsules

Acetylcysteine 600mg Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 600 mg acetylcysteine. For the full list of excipients, see

section 6.1.

3

PHARMACEUTICAL FORM

Almost white, crystalline powder, filled in white hard gelatin 00 Capsule size.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Mucolight 600mg Capsules are a mucolytic agent for the adjunctive therapy of

respiratory

tract

disorders

characterized

excessive,

viscous

mucus,

including

chronic obstructive airways disease.

4.2

Posology and method of administration

In general the usual recommended dosage is:

Adults including elderly and adolescents 14 years and older: 600 mg (1 capsule) once

daily.

Duration of therapy: the duration of therapy is dependent on the nature and severity of

the illness and should be decided by the doctor.

For oral use.

Swallow the capsule with a drink of water. The capsule should be taken after food.

Hepatic and Renal Impairment

In patients with impaired kidney or liver function there is insufficient data on whether

dosage adjustments are required. Hepatic and renal impairment can reduce clearance

which may result in an increase in adverse drug reactions due to drug accumulation.

4.3

Contraindications

Hypersensitivity to acetylcysteine or to any of the excipients listed in section 6.1.

This medicine should not be used in children under 14 years of age.

4.4

Special warnings and precautions for use

Serious skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have

been reported whilst taking acetylcysteine, but these occur rarely. For this reason,

medical advice should be sought immediately and the patient should stop taking

acetylcysteine in the event of new-onset changes to the skin and mucous membranes.

See also section 4.8.

There are no studies on the efficacy and safety of once daily acetylcysteine 600 mg

capsule in the adolescent population. However, mild, moderate or severe adverse

reactions have been reported with the use of IV acetylcysteine in the adolescent

population.

This product should be used with caution by patients with bronchial asthma and

patients with a history of peptic ulcer disease.

This product should be used with caution by patients with histamine intolerance.

They should avoid long-term therapy because Acetylcysteine 600mg Capsules affect

the metabolism of histamine and can lead to symptoms of intolerance (e.g. headaches,

rhinitis, itching).

Acetylcysteine can, especially at the start of treatment, cause thinning and increased

volume

bronchial

secretions.

patient

able

expectorate

this

adequately, appropriate supportive measures should be implemented (such as postural

drainage and suction removal).

No specific studies have been performed in patients with renal or hepatic impairment.

Hepatic and renal impairment can reduce clearance and increase acetylcysteine

plasma levels which may result in an increase in adverse drug reactions due to drug

accumulation.

4.5

Interaction with other medicinal products and other forms of interaction

Analysis of interactions with other medicines has been performed only in adults.

Antitussives

If this product is used in combination with cough-relieving medicines (antitussives)

the suppressed cough reflex may cause a dangerous build-up of secretions, which

means

that the indication

this combination

treatment

should

established

particularly carfully.

Activated charcoal

Co-administration

with

activated

charcoal

reduce

effectiveness

acetylcysteine.

Antibiotics

Reports of inactivation of antibiotics (aminoglycosides, penicillins, tetracycline) by

acetylcysteine indicate that this inactivation occurs only when these substances are

mixed

directly

together

vitro.

Nevertheless,

administration

oral

doses

antibiotics and acetylcysteine capsules should be separated by minimum period of

two hours. This does not apply to the antibiotics cefixime or loracarbef.

Acetylcysteine and glyceryl trinitrate

Simultaneous administration of these drugs may increase the vasodilatory and platelet

aggregation-inhibiting effect of glyceryl trinitrate. If such combined treatment is

considered necessary, the patient should be monitored for possible hypotension,

which can be serious and may be indicated by headaches.

Interface with the measurement of laboratory parameters

Acetylcysteine can influence the colourimetric assay of salicylates.

Acetylcysteine can influence results when measuring ketones in urine.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are no data on the use of acetylcysteine in pregnant women. Animal studies do

indicate

direct

indirect

adverse

effects

pregnancy,

embryonic

fetal

development, birth or postnatal development (see also section 5.3).

Lactation

There is insufficient information on the excretion of acetylcysteine or its metabolites

in human milk. Use during pregnancy and while breast-feeding should be subject to

careful consideration of the risk/benefit balance.

Fertility

No human data on the effect of acetylcysteine are available.

4.7

Effects on ability to drive and use machines

Acetylcysteine has no influence on the ability to drive and use machines.

4.8

Undesirable effects

In the evaluation of side effects, the following frequencies are defined as:

Very common (> 1/10), Common (> 1 /100 to < 1/10), Uncommon (> 1/1,000 to <1/

100), Rare (> 1/10,000 to < 1/1,000), Very rare (< 1/10,000),

Not known (frequency cannot be estimated from the available data).

Adverse Reactions

System/organ classes

Uncommon

Rare

Very rare

Not known

Immune system

disorders

Hypersensitivity

reactions

Anaphylactic

shock,

anaphylactic/

anaphylactoid

reactions

Nervous system

disorders

Headache

Ear and labyrinth

disorders

Tinnitus

Cardiac disorders

Tachycardia

Vascular disorders

Haemorrhage

Respiratory , thoracic

and mediastinal disorders

Bronchospasm,

dyspnoea

Gastrointestinal

disorders

Vomiting, diarrhoea,

stomatitis , abdominal

pain, nausea

Dyspepsia

Skin

and subcutaneous tissue

disorders

Urticaria, rash,

angioedema , pruritus,

Exanthema

General disorders

Fever

Facial

oedema

Investigations

Hypotension

Serious skin reactions, such as Stevens-Johnson syndrome and Lyell‘s syndrome,

have been reported whilst taking acetylcysteine, but these occur rarely. In most

reported cases at least one further medicine was being taken simultaneously, so the

described muco-cutaneous effects could be exacerbated. For this reason, in the event

of new-onset changes of the skin and mucous membranes medical advice should be

sought immediately and the patient should stop taking acetylcysteine.

A reduction of blood platelet aggregation in the presence of acetylcysteine has been

confirmed by various studies. The clinical relevance is not yet understood.

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

via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

4.9

Overdose

There

have

been

cases

toxic

overdose

observed

with

orally-dosed

acetylcysteine. No serious undesirable effects were observed in volunteer test subjects

dosed over a 3-month period with 11.6g acetylcysteine per day. Oral doses of up to

500mg/kg of acetylcysteine were tolerated without toxic effects.

a) Symptoms of intoxication

Overdoses

cause

gastrointestinal

symptoms

such

nausea,

vomiting

diarrhoea. In infants, there is a risk of hypersecretion.

b ) Treatments for overdose

Treat symptomatically if applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Mucolytic agent

ATC code: R05CB01

Acetylcysteine belongs to the group of amino acid cysteine derivate.

Mechanism of action

Acetylcysteine is believed to break the disulfide bonds in mucoproteins and it

depolymerizes DNA strands in purulent mucus.

Pharmacodynamic effects

The effect of this activity is a reduction in the viscosity of mucous secretions.

Another possible effect is detoxification of free radicals by interaction with the active

sulfhydryl group of acetylcysteine.

In addition acetylcysteine increases synthesis of glutathione. Due to this mechanism

of action, acetylcysteine is also indicated as a specific antidote in paracetamol

poisoning.

There are no studies on the efficacy and safety of once daily acetylcysteine 600mg

Capsules in the adolescent population. However mild, moderate or severe adverse

reactions

have

been

reported

with

acetylcysteine

including

adolescent population.

5.2

Pharmacokinetic properties

Absorption and metabolism

Acetylcysteine is absorbed rapidly and almost completely after oral administration. It

is metabolized in the liver into a pharmaceutically active metabolite cysteine, inactive

diacetylcystine and cystine and into the other disulfides. Due to the high first pass

effect,

bioavailability

orally

administered

acetylcysteine

very

(approximately 10%). In humans peak plasma levels of acetylcysteine are reached in

approximately 1-3 hours after an oral dose. Plasma concentration of the active

metabolite cysteine is about 2

mol/l and binding with proteins is about 50%.

Elimination

Acetylcysteine is excreted almost entirely as inactive metabolites (inorganic sulfates,

diacetylcystine)

through

renal

route.

elimination

half-life

acetylcysteine

about

which

primarily

determined

rapid

biotransformation in the liver. In patients with liver dysfunction the elimination half-

life of acetylcysteine increases to 8 h.

Distribution

In a pharmacokinetic study, intravenously administrated acetylcysteine in humans

showed a distribution volume of 0.47 l/kg; the plasma clearance is 0.11 l/h/kg.

The elimination half-life after oral administration is 6.25 hours.

In a study with rats it was shown that acetylcysteine crosses the placenta.

There is no information on whether acetylcysteine crosses the blood-brain barrier in

humans. There are no data on whether acetylcysteine is excreted in breast milk.

Hepatic and Renal impairment

There is evidence that clearance of acetylcysteine can be significantly reduced up to

90% in the subjects with end-stage renal disease. This could result in a marked

increase in systematic exposure to acetylcysteine in extreme cases of patients with

end-stage renal disease. It is not known to what extent the results can be extrapolated

to the less severe forms of renal impairment that are more likely to be encountered

during routine use of the proposed product (see section 4.2 and 4.4).

The elimination half-life of acetylcysteine was found to increase to eight hours in one

study of patients with chronic liver disease. The total clearance of acetylcysteine was

found to be significantly reduced following an intravenous dose of 600 mg over three

minutes in nine subjects with hepatic cirrhosis.

5.3

Preclinical safety data

Repeated dose toxicity

Studies

various

animals

(rats

dogs)

lasting

year

showed

pathological changes.

Carcinogenesis and Mutagenicity

There are no studies on the tumorigenic effects of acetylcysteine. Bacteriological test

did not show mutagenic effect.

Reproductive toxicity

Embryotoxicity studies on pregnant rabbits and rats during organogenesis were

undertaken with orally administered acetylcysteine. The rabbits were dosed with 250,

500 and 750 mg/kg and the rats were dosed with 500, 1000 and 2000 mg/kg. Both

tests did not show any developmental effects.

In fertility studies, peri- and postnatal study with rats no adverse effects on delivery

and lactation or on physical development and maturation of the offspring were noted.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Crospovidone Cl-SF

Stearic acid

Capsule shell contains:

Gelatine

Titanium dioxide

6.2

Incompatibilities

This medicinal product must not be mixed with antibiotics (see section 4.5).

In the absence of compatibility studies, this medicinal product must not be mixed

with other medicinal products.

6.3

Shelf life

2 years.

6.4

Special precautions for storage

Store below 25°C.

6.5

Nature and contents of container

Pack size of 30.

Capsules are packed in PVC/PVDC blister packs. Blisters are place in carton boxes

together with a patient leaflet.

6.6

Special precautions for disposal

No special requirements.

7

MARKETING AUTHORISATION HOLDER

Ennogen Healthcare Limited

Unit G4 Riverside Industrial Estate, Riverside Way,

Dartford, Kent, DA1 5BS

United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 40739/0181

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

13/09/2019

10

DATE OF REVISION OF THE TEXT

13/09/2019

Read the complete document

Public Assessment Report

National Procedure

Mucolight 600mg Capsules

Acetylcysteine 600mg Capsules

(acetylcysteine)

PL 40739/0181

Ennogen Healthcare Limited

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

2

LAY SUMMARY

Mucolight 600mg Capsules

Acetylcysteine 600mg Capsules

(acetylcysteine)

This is a summary of the Public Assessment Report (PAR) for Mucolight 600mg

Capsules/Acetylcysteine 600mg Capsules. It explains how this product was assessed and its

authorisation recommended, as well as its conditions of use. It is not intended to provide practical

advice on how to use this product.

This product will be referred to as Mucolight Capsules in this lay summary for ease of reading. For

practical information about using Mucolight Capsules, patients should read the package leaflet or contact

their doctor or pharmacist.

What are Mucolight Capsules and what are they used for?

This application is for a generic medicine. This means that this medicine is the same as, and

considered interchangeable with, a reference medicine already authorised in the European Union (EU)

called Lysomucil 600 mg tablets.

Mucolight Capsules are used in the treatment of patients who have problems with the breathing passages

(respiratory tract).

How do Mucolight Capsules work?

Mucolight Capsules contain a medicine called acetylcysteine. This belongs to a group of medicines

called mucolytics. It works by making the mucus (phlegm) less sticky which makes the mucus easier to

cough up.

How are Mucolight Capsules used?

The pharmaceutical form of this medicine is hard capsule and the route of administration is oral (taken

by mouth). Mucolight Capsules should be swallowed with a drink of water and taken after food.

The patient’s doctor will decide how long the patient should take this medicine.

Adults and children aged 14 years and over:

The usual dose is 1 capsule, once daily.

Children under the age of 14

Mucolight Capsules are not suitable for children under the age of 14.

For further information on how Mucolight Capsules are used, refer to the package leaflet and Summary

of Product Characteristics available on the Medicines and Healthcare products Regulatory Agency

(MHRA) website.

This medicine can only be obtained with a prescription.

The patient should always take this medicine exactly as their doctor/pharmacist has told them. The

patient should check with their doctor or pharmacist if they are not sure.

What benefits of Mucolight Capsules have been shown in studies?

Mucolight Capsules are a generic medicine that fulfils criteria meaning that no additional studies are

required. Mucolight Capsules has been considered a generic medicine of the reference medicine based

on a comparison of their physical and chemical characteristics.

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

3

What are the possible side effects of Mucolight Capsules?

Because Mucolight Capsules are a generic medicine and are bioequivalent to the reference medicine,

their benefits and possible side effects are considered to be the same as the reference medicine.

For the full list of all side effects reported with this medicine, see Section 4 of the package leaflet or the

Summary of Product Characteristics (SmPC) available on the MHRA website.

Why Mucolight Capsules were approved?

It was concluded that, in accordance with EU requirements, Mucolight Capsules has been shown to be

comparable to the reference medicine. Therefore, the MHRA decided that, as for the reference

medicine, the benefits are greater than the risks and recommended that it can be approved for use.

What measures are being taken to ensure the safe and effective use of Mucolight Capsules?

A Risk Management Plan (RMP) has been developed to ensure that Mucolight Capsules are used as

safely as possible. Based on this plan, safety information has been included in the SmPC and the

package leaflet, including the appropriate precautions to be followed by healthcare professionals and

patients.

Known side effects are continuously monitored. Furthermore, new safety signals reported by

patients/healthcare professionals will be monitored and reviewed continuously.

Other information about Mucolight Capsules

A marketing authorisation for Mucolight Capsules was granted in the UK on 11 September 2019.

The full PAR for Mucolight Capsules follows this summary.

This summary was last updated in November 2019.

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

4

TABLE OF CONTENTS

Contents

INTRODUCTION ............................................................................................. 5

QUALITY ASPECTS ........................................................................................ 5

NON-CLINICAL ASPECTS .............................................................................. 7

CLINICAL ASPECTS ....................................................................................... 7

USER CONSULTATION .................................................................................. 7

Overall Conclusion, Benefit/Risk Assessment And Recommendation ............. 8

TABLE OF CONTENT OF THE PAR UPDATE ........................................................ 13

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

5

I

INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products

Regulatory Agency (MHRA) considered that the application for Mucolight 600mg

Capsules/Acetylcysteine 600mg Capsules (PL 40739/0181) could be approved.

This product is a mucolytic agent approved for the adjunctive therapy of respiratory tract disorders

characterised by excessive, viscous mucus, including chronic obstructive airways disease.

The active substance, acetylcysteine, is a mucolytic agent. Acetylcysteine reduces the viscosity of

secretions probably by splitting disulfide bonds in mucoproteins, thereby altering their structure and

disrupting their ligand bonding to form smaller protein units.

This application was submitted under Article 10(1) of Directive 2001/83/EC, as amended, as a generic

medicine of a suitable originator medicinal product, Lysomucil 600 mg tablets that has been licensed

within the EU for a suitable time, in line with the legal requirements.

No new non-clinical studies were conducted, which is acceptable given that the application is based on

being a generic medicinal product of a reference product that has been licensed for over 10 years.

A biowaiver was submitted with this application, which was accepted. No bioequivalence study was

required, and no new clinical studies were provided with this application.

The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in

place for this product at all sites responsible for the manufacture, assembly and batch release of this

product

A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided

with this application and are satisfactory.

A marketing authorisation was granted for this product on 11 September 2019.

II

QUALITY ASPECTS

II.1

Introduction

This product consists of 600 mg of the active substance, acetylcysteine, in each capsule. In addition to

acetylcysteine, this product also contains the excipients Crospovidone Cl-SF, stearic acid, gelatin and

titanium dioxide.

The finished product is packaged in polyvinylchloride/polyvinylidene chloride blisters, along with the

patient information leaflet into cartons, in a pack size of 30 capsules.

Satisfactory specifications and Certificates of Analysis have been provided for all packaging

components. All primary packaging complies with the current European regulations concerning

materials in contact with food.

II.2

ACTIVE SUBSTANCE

rINN:

acetylcysteine

Chemical Name:

(2R)-2-(Acetylamino)-3-sulfanylpropanoic acid

Molecular Formula:

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

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Chemical Structure:

Molecular Weight:

163.2g/mol

Appearance:

White or almost white, crystalline powder or colourless crystals

Solubility:

Freely soluble in water and alcohol (ethanol); practically insoluble in methylene

chloride

Acetylcysteine is the subject of a European Pharmacopoeia monograph.

All aspects of the manufacture and control of the active substance are covered by a European

Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability.

II.3

DRUG PRODUCT

Pharmaceutical development

A satisfactory account of the pharmaceutical development has been provided.

Comparative in vitro dissolution profiles have been provided for the proposed and reference products.

All excipients comply with either their respective European/national monographs, or a suitable in-house

specification. Satisfactory Certificates of Analysis have been provided for all excipients.

With the exception of gelatin, no excipients of animal or human origin are used in the final product.

The suppliers of gelatin have provided Certificates of Suitability from the European Directorate for the

Quality of Medicines and Healthcare (EDQM) to show that it is manufactured in line with current

European guidelines concerning the minimising of risk of transmission of Bovine Spongiform

Encephalopathy/Transmissible Spongiform Encephalopathies (BSE/TSE).

This product does not contain or consist of genetically modified organisms (GMO).

Manufacture of the product

A description and flow-chart of the manufacturing method has been provided.

A satisfactory batch formula has been provided for the manufacture of the product, along with an

appropriate account of the manufacturing process. The manufacturing process has been validated and

has shown satisfactory results.

Finished Product Specification

The finished product specification is satisfactory. The test methods have been described and

adequately validated. Batch data have been provided that comply with the release specification.

Certificates of Analysis have been provided for any working standards used.

Stability

Finished product stability studies have been conducted in accordance with current guidelines, using

batches of the finished product stored in the packaging proposed for marketing. Based on the results, a

shelf-life of 2 years, with the storage conditions ‘Store below 25°C.’, is acceptable.

Suitable post approval stability commitments have been provided to continue stability testing on

batches of finished product.

II.4

Discussion on chemical, pharmaceutical and biological aspects

The grant of a marketing authorisation is recommended.

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

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III

NON-CLINICAL ASPECTS

III.1

Introduction

As the pharmacodynamic, pharmacokinetic and toxicological properties of acetylcysteine are

well-known, no new non-clinical studies are required, and none have been provided. An overview

based on the literature review is, thus, appropriate.

III.2

Pharmacology

No new pharmacology data were provided and none were required for this application.

III.3

Pharmacokinetics

No new pharmacokinetic data were provided and none were required for this application.

III.4

Toxicology

No new toxicology data were provided and none were required for this application.

III.5

Ecotoxicity/Environmental Risk Assessment

Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As

the application is for a generic version of an already authorised product, an increase in environmental

exposure is not anticipated following approval of the marketing authorisation for the proposed product.

III.6

Discussion on the non-clinical aspects

The grant of a marketing authorisation is recommended.

IV

CLINICAL ASPECTS

IV.1

Introduction

The clinical pharmacology, efficacy and safety of acetylcysteine are well-known. According to the

regulatory requirements, the applicant has provided a suitable biowaiver and a bioequivalence study is

not required for this product. An overview based on a literature review is, thus, satisfactory.

IV. 2

Pharmacokinetics

No new pharmacokinetic data have been submitted for this application and none were required.

IV.3

Pharmacodynamics

No new pharmacodynamic data have been submitted for this application and none were required.

IV.4

Clinical efficacy

No new efficacy data were submitted with this application and none were required.

IV.5

Clinical safety

No new safety data were submitted with this application and none were required. The safety profile for

this product is considered to be the same as that for Lysomucil 600 mg tablets.

IV.6

Risk Management Plan (RMP)

The applicant has submitted an RMP, in accordance with the requirements of Directive 2001/83/EC, as

amended. The applicant proposes only routine pharmacovigilance and routine risk minimisation

measures for all safety concerns. This is acceptable.

IV.7

Discussion on the clinical aspects

The grant of a marketing authorisation is recommended for this application.

V

USER CONSULTATION

A user consultation with target patient groups on the Patient Information Leaflet (PIL) has been

performed on the basis of a bridging report making reference to Acetylcysteine 600mg Effervescent

Tablets (PL 40739/0031; Ennogen Healthcare Limited). The bridging report submitted by the applicant

is acceptable.

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

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VI

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION

The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been

identified. Extensive clinical experience with acetylcysteine is considered to have demonstrated the

therapeutic value of the compound. The benefit/risk is, therefore, considered to be positive.

The Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling are

satisfactory, in line with current guidelines and consistent with the reference product.

In accordance with Directive 2012/84/EU, the current approved UK version of the SmPC and PIL for

this product is available on the MHRA website.

Representative copies of the labels at the time of UK licensing are provided below.

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

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Mucolight 600mg Capsules

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

10

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

11

Acetylcysteine 600mg Capsules

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

12

PAR Mucolight 600mg Capsules/Acetylcysteine 600mg Capsules

PL 40739/0181

Generic, Article 10(1) (V2.0)

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TABLE OF CONTENT OF THE PAR UPDATE

Steps taken after the initial procedure with an influence on the Public Assessment Report (non-

safety variations of clinical significance).

Please note that only non-safety variations of clinical significance are recorded below and in

the annexes to this PAR. The assessment of safety variations where significant changes are

made are recorded on the MHRA website or European Medicines Agency (EMA) website.

Minor changes to the marketing authorisation are recorded in the current SmPC and/or PIL

available on the MHRA website.

Application

type

Scope

Product

information

affected

Date of grant

Outcome

Assessment

report

attached

Y/N

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