Carbocisteine 375mg Hard Capsules

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Carbocisteine

Fáanlegur frá:

Chanelle Medical Unlimited Company

ATC númer:

R05CB; R05CB03

INN (Alþjóðlegt nafn):

Carbocisteine

Skammtar:

375 milligram(s)

Lyfjaform:

Capsule, hard

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Mucolytics; carbocisteine

Leyfisstaða:

Not marketed

Leyfisdagur:

2016-12-09

Upplýsingar fylgiseðill

ID: PL 185M DCP Harmonised
VERSION: 00
REVIEW DATE: 20/10/2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOCISTEINE 375 MG HARD CAPSULES
Carbocisteine
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 signs of illness 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 375mg
capsules are and what they are used for
2. What you need to know before you take Carbocisteine 375mg capsules
3. How to take Carbocisteine 375mg capsules
4. Possible side effects
5. How to store Carbocisteine 375mg capsules
6. Contents of the pack and other information
1.
WHAT CARBOCISTEINE 375MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Carbocisteine 375mg 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 375mg 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.
ID: PL 185M DCP Harmonised
VERSION: 00
REVIEW DATE: 20/10/2016
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE 375MG CAPSULES
DO NOT TAKE CARBOCISTEINE 375MG CAPSULES:

If you are allergic to carbocisteine or to 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.

If 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 t

Vara einkenni

Health Products Regulatory Authority
01 September 2022
CRN00D143
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbocisteine 375mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 375 mg of carbocisteine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Yellow, size 0 capsule, hard, containing a white to off- white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbocisteine 375mg capsulesis 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 including the elderly:
Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine
(6 capsules) in divided doses, reducing to 1500 (4
capsules) mg daily in divided doses when a satisfactory response is
obtained. For example, two capsules three times a day
reducing to one capsule four times a day.
Paediatric population:
This formulation is not recommended for children.
Method of administration:
Carbocisteine 375mg capsules are for oral use.
4.3 CONTRAINDICATIONS
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
medication known to cause gastrointestinal bleeding. If bleeding
occurs, patients should discontinue medication.
Because of the possible effect on the mucous glands of the stomach,
this product should be used with caution in patients with
a history of peptic ulceration.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interaction studies have been performed.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
01 September 2022
CRN00D143
Page 2 of 4
Pregnancy
Although tests in mamma