KAMIREN Prolonged-release tablet Ref.[49837] Active ingredients: Doxazosin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Kamiren 4 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablets.

Kamiren 4 mg prolonged-release tablets are white, round, biconvex tablets.

Qualitative and quantitative composition

Each tablet contains 4mg doxazosin (as mesilate).

Excipient(s) with known effect: Lactose Monohydrate 74.27mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Doxazosin

Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure.

List of Excipients

Tablet core:

Hypromellose
Calcium hydrogen phosphate
Lactose monohydrate
Magnesium stearate

Coating:

Opadry white Y-1-7000 consists of:

Hypromellose
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

Kamiren 4 mg prolonged-release tablets are available as pack of 28 tablets.

OPA/Alu/PVC film with Alu foil blister strips in a carton box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/038/001

Date of first authorisation: 3rd March 2006
Date of last renewal: 3rd March 2011

Drugs

Drug Countries
KAMIREN Estonia, Hong Kong, Croatia, Ireland, Lithuania, Poland, Romania

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