Carbocisteine 375 mg Capsules, Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbocisteine

Available from:

Key Pharmaceuticals Ltd

ATC code:

R05CB; R05CB03

INN (International Name):

Carbocisteine

Dosage:

375 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Mucolytics; carbocisteine

Authorization status:

Not marketed

Authorization date:

2020-03-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION
FOR THE USER
CARBOCISTEINE 375 MG CAPSULES, HARD
Carbocisteine
Your medicine is called carbocisteine 375 mg capsules, hard, but it
will be
referred to as carbocisteine capsules throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT CARBOCISTEINE CAPSULES ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE CAPSULES
3. HOW TO TAKE CARBOCISTEINE CAPSULES
4. POSSIBLE SIDE-EFFECTS
5. HOW TO STORE CARBOCISTEINE CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CARBOCISTEINE CAPSULES ARE AND WHAT THEY ARE USED FOR
Carbocisteine capsules contain a medicine called carbocisteine. This
belongs
to a group of medicines called ‘mucolytics’. It works by making
mucus
(phlegm) less sticky. This makes the mucus easier to cough up.
Carbocisteine capsules are used for problems with the breathing
passages
(respiratory tract). These problems happen when too much mucus is
made, or
the mucus is too sticky.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE CAPSULES.
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
you are allergic (hypersensitive) to carbocisteine or any of the other
ingredients of this medicine (listed in section 6). Signs of an
allergic
reaction include: a rash, swallowing or breathing problems, swelling
of the
lips, face, throat or tongue.
•
you have an ulcer in your stomach or gut
Do not take this medicine if any of the above apply to you. If you are
not sure,
talk to your doctor or pharmacist bef

Summary of Product characteristics

Health Products Regulatory Authority
06 March 2020
CRN008K59
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375 mg carbocisteine
Excipient(s) with known effect
Each Carbocisteine 375 mg Hard Capsule contains 22.5 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Yellow cap and yellow body, size '0' hard gelatine capsule, filled
with white to off white
granular powder imprinted with C on cap and 375 on body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine is a mucolytic agent for the adjunctive therapy of
respiratory tract disorders characterised by excessive, viscous
mucus, including chronic obstructive airways disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
Dosage is based upon an initial daily dosage of 2250 mg carbocisteine
in divided doses, reducing to 1500 mg daily in divided
doses when a satisfactory response is obtained e.g. two capsules three
times a day reducing to one capsule four times a day.
_ _
_Paediatric population_
Carbocisteine 375 mg Capsules, hard are not recommended for children.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
This medicine is contraindicated in case of:
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Use in patients with active peptic ulceration.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is recommended in the elderly, in those with a history of
gastroduodenal ulcers, or those taking concomitant
medications known to cause gastrointestinal bleeding. If
gastrointestinal bleeding occurs, patients should discontinue
medication.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.
Health Products Regulatory Authority
06 March 2020
CRN008K59
Page 2 of 4
4.5 INTERACTION