Regurin 20mg coated Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Trospium chloride

Dostopno od:

Imbat Limited

Koda artikla:

A03DA; A03DA06

INN (mednarodno ime):

Trospium chloride

Odmerek:

20 milligram(s)

Farmacevtska oblika:

Coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Synthetic anticholinergic agents in combination with analgesics; trospium and analgesics

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-11-23

Navodilo za uporabo

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGURIN
® 20MG COATED TABLETS
(trospium chloride)
Your medicine is available using the name Regurin 20mg coated
Tablets but will be referred to as Regurin 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. 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 further information
1.
WHAT REGURIN IS AND WHAT IT IS USED FOR
Regurin is a medicine used for the relaxation of the 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 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). For the list of ingredients
in Regurin, please see section 6.

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-inte

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regurin 20mg coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is trospium chloride.
Each coated tablet contains 20 mg trospium chloride.
Excipients: includes lactose monohydrate, sucrose and wheat starch per
coated tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet
_Product imported from France and UK:_
Brownish-yellow, glossy coated, biconvex tablets with no markings
4 CLINICAL PARTICULARS
As per PA1288/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1288/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Wheat starch
Microcrystalline cellulose
Lactose monohydrate
Povidone
Croscarmellose sodium
Stearic acid
Colloidal anhydrous silica
Talc
Tablet coat:
Sucrose
Carmellose sodium
Talc
Colloidal anhydrous silica
Calcium carbonate (E170)
Macrogol 8000
Titanium dioxide (E171)
Iron oxide hydrate yellow (E172)
Beeswax white
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_1_
_/_
_0_
_9_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_7_
_4_
_6_
_9_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
Carnauba wax
Note for diabetics: 1 coated tablet corresponds to 0.06g carbohydrate
(equivalent to 0.005 bread units).
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer carton of the product on the
market in the country of origin.
6.4