NOYADA Oral solution Ref.[27955] Active ingredients: Captopril

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Martindale Pharmaceuticals Limited (T/S Martindale Pharma), Bampton Road, Harold Hill, Essex, RM3 8UG

Product name and form

Noyada 5mg/5ml Oral Solution.

Pharmaceutical Form

Oral solution.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml of 5mg/5ml oral solution contains 1mg captopril.

Excipient(s) with known effects: Each mL of Noyada oral solution contains 0.017 mmol (or 0.391 mg) sodium including 0.5 mg sodium benzoate (E211).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Captopril

Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors). Inhibition of ACE results in decreased plasma angiotensin-II, which leads to decreased vasopressor activity and to reduced aldosterone secretion. In patients with hypertension, captopril causes a reduction in supine and erect blood pressure, without inducing any compensatory increase in heart rate, nor water and sodium retention.

List of Excipients

Disodium EDTA
Sodium Benzoate E211
Citric Acid E330
Sodium Citrate E331
Sodium Hydroxide (pH adjuster)
Purified water

Pack sizes and marketing

mber glass bottle with child resistant and tamper evident caps. Each bottle is packed in a cardboard carton containing 1ml and 5ml syringes with an adaptor along with a patient leaflet.

5 mg/5 ml oral solution.

1 ml syringe- each numbered increment is 0.1 ml equivalent to 0.1 mg of captopril. The intermediate increments are 0.05 ml equivalent to 0.05 mg of captopril.

5 ml syringe- each numbered increment is 1 ml equivalent to 1 mg of captopril. The intermediate increments are 0.2 ml equivalent to 0.2 mg of captopril.

Pack size: 100ml

Marketing authorization holder

Martindale Pharmaceuticals Limited (T/S Martindale Pharma), Bampton Road, Harold Hill, Essex, RM3 8UG

Marketing authorization dates and numbers

PL 00156/0361

Date of first authorisation: 29/05/2013
Date of latest renewal: 24/04/2018

Drugs

Drug Countries
NOYADA France, United Kingdom

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