DORALESE Film-coated tablets Ref.[9312] Active ingredients: Indoramin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Chemidex Pharma Ltd., T/A Essential Generics, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Product name and form

Doralese Tiltab Tablets 20 mg.

Indoramin 20 mg Tablets.

Pharmaceutical Form

Film-coated tablets (tablets).

Pale yellow, triangular film-coated tablet, bearing a raised kite shape on each face.

Qualitative and quantitative composition

Each film-coated tablet contains indoramin hydrochloride equivalent to 20 mg of indoramin base.

Excipient with known effect: Each film-coated tablet contains 152 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Indoramin

Indoramin is an alpha adrenoceptor blocking agent. It acts selectively and competitively on post-synaptic alpha-1 receptors, causing a decrease in peripheral resistance. It also produces relaxation of hyperplastic muscle in the prostate.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose
Amberlite IRP-88
Magnesium stearate

Film-coating:

Opadry OY-3736
Purified water
Carnauba wax

Pack sizes and marketing

Blister packs – packs of 60.

Marketing authorization holder

Chemidex Pharma Ltd., T/A Essential Generics, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Marketing authorization dates and numbers

PL 17736/0089

25th February 1998

Drugs

Drug Countries
DORALESE United Kingdom

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