Regurin 20 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trospium chloride

Available from:

PCO Manufacturing Ltd.

ATC code:

G04BD09

INN (International Name):

Trospium chloride

Dosage:

20 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

trospium

Authorization status:

Authorised

Authorization date:

2011-09-09

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGURIN
® 20 MG COATED TABLETS
trospium chloride
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.
IN THIS LEAFLET:
1.
What Regurin is and what it is used for
2.
What you need to know before you take Regurin
3.
How to take Regurin
4.
Possible side effects
5.
How to store Regurin
6.
Contents of the pack and other information
1.
WHAT REGURIN IS AND WHAT IT IS USED FOR
Regurin is a medicine used for the relaxation of the urinary
bladder. It is used for the treatment of symptoms associated with
involuntary loss of urine (wetting) and/or increased frequency of
urination and imperative urge of urination in patients with
hyperactive urinary bladder (involuntary urge of urination and
voiding problems of unknown origin or due to nervous system
disorders)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REGURIN
DO NOT TAKE REGURIN

If you have ever had an allergic reaction to trospium
chloride or any of the other ingredients of this medicine
(listed in section 6) (An allergic reaction can be a rash,
itchiness, or shortness of breath).

If you suffer from any of the following:
-
urinary retention, i.e. blockage of the urinary tract,
-
the eye condition narrow-angle glaucoma,
-
abnormal/faster than normal heart beats,
-
myasthenia gravis (a disorder that causes muscle
fatigue),
-
a severe gastro-intestinal condition, such as toxic
megacolon.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING REGURIN
If you suffer from any of the following:

any type of stomach

Summary of Product characteristics

Health Products Regulatory Authority
04 April 2023
CRN00DHPM
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regurin 20 mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is trospium chloride.
Each coated tablet contains 20 mg trospium chloride.
Excipients with known effect:
Each coated tablet contains lactose monohydrate, sucrose and wheat
starch.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
_Product imported from France and Greece:_
Brownish-yellow, glossy coated, biconvex tablets
4 CLINICAL PARTICULARS
As per PA 23355/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 23355/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tabletcore:
Wheat starch
Microcrystalline cellulose
Lactose monohydrate
Povidone (K29-32)
Croscarmellose sodium
Stearic acid
Colloidal anhydrous silica
Talc
Tabletcoat:
Sucrose
Carmellose sodium
Talc
Silica colloidal anhydrous
Calcium carbonate E170
Macrogol 8000
Titanium dioxide E171
Iron oxide hydrate yellow E172
Beeswax white
Carnauba wax
Health Products Regulatory Authority
04 April 2023
CRN00DHPM
Page 2 of 2
Note for diabetics: one coated tablet corresponds to 0.06 g
carbohydrate (equivalent to 0.005 bread
units).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
container and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Product imported from France
PVC foiled aluminium blister packs of 60 tablets.
Product imported from Greece
Blisters of 60 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Mea