Indoramin 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indoramin hydrochloride

Available from:

DE Pharmaceuticals

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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6 pt
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Non-Print
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Date:
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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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(1)
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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
printing - United Kingdom
* Will be printed only after serialisation go live
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Variable Dat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indoramin 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ’22 mg’ of Indoramin hydrochloride equivalent
to 20mg of
Indoramin.
Excipient(s) with known effect:
Each film-coated tablet contains ‘172.2mg’ of lactose (as lactose
monohydrate). For
the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
Pale yellow, triangular, biconvex, film coated tablets embossed with a
key on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indoramin is indicated in adults for conditions in which alpha
blockade is indicated
and the management of urinary outflow obstruction due to benign
prostatic
hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
_Elderly: _
20 mg at night may be adequate.
_ _
Paediatric population
_ _
Not recommended. There is no relevant use of indoramin in the
paediatric population
Route of administration
Oral
4.3
CONTRAINDICATIONS
Patients with established heart failure.
Patients already under treatment with a monoamine oxidase inhibitor.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
Incipient cardiac failure should be controlled before treatment with
indoramin.
Caution should be observed in prescribing indoramin for patients with
hepatic or
renal insufficiency.
A few cases of extrapyramidal disorders have been reported in patients
treated with
indoramin. Caution should be observed in prescribing indoramin 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 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
previously