Indoramin 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indoramin hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

C02CA02

INN (International Name):

Indoramin hydrochloride

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040100

Patient Information leaflet

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07 Aug 2019
20:20
Indoramin 20 mg 60
Label Leaflet
1925285
1473329
1925285
PL 04569/0473
NA
LL0437AG
259
NA
384695
1
United Kingdom
NA
5016695000251
NA
4
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52 x 101 mm
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TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v3/July 2017
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
07 Aug 2019
20:20
Indoramin 20 mg 60
Label Leaflet
1925285
1473329
1925285
PL 04569/0473
NA
LL0437AG
259
NA
384695
1
United Kingdom
NA
5016695000251
NA
4
Myriad Pro
52 x 101 mm
9 pt
6 pt
Braille
Keyline
Varnish
Free
INDORA-
MIN
#20 mg
Tablets
INDORA-
MIN
#20 mg
Tablets
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Keep this section as part of the artwork in keyline colour.
Keep this flap blank and varnish free for online printing.
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*PC: 00000000000000
*SN: 00000000000000
Lot: 0000000000
EXP: MM/YYYY
Variable Data Information box for online
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* Will be printed only after serialisation go live
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Variable Dat

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Indoramin 20 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg indoramin (as hydrochloride).
Excipient of known effect: Each film-coated tablet contains 186.53 mg
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
9mm x 9mm shield shaped, normal convex, white film coated tablet
debossed ‘G’ on one side
and ‘IR’ on the other.
20
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Conditions for which alpha blockade is indicated.
Management of urinary outflow obstruction due to benign prostatic
hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hyperplasia
_ _
_Adults: _
20 mg twice daily
Dosage may be increased in 20 mg increments at two-weekly intervals up
to max. 100 mg
per day if required.
_Older People: _
20 mg at night may be adequate.
_Children: _
Not recommended.
Method of administration
Oral.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with established heart failure.
Patients already under treatment with a monoamine oxidase inhibitor.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Incipient cardiac failure should be controlled before treatment with
Indoramin 20 mg tablets.
Caution should be observed in prescribing Indoramin 20 mg tablets for
patients with hepatic
or renal insufficiency.
A few cases of extrapyramidal disorders have been reported in patients
treated with Indoramin
20 mg tablets. Caution should be observed in prescribing Indoramin 20
mg tablets in patients
with Parkinson's disease.
In animals and in the one reported case of overdose in humans,
convulsions have occurred.
Due consideration should be given and great caution exercised in the
use of Indoramin 20 mg
tablets in patients with epilepsy.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small
pupil syndrome) has been
observed during cataract surgery in some patients on or