Captopril 5mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Captopril

Available from:

JensonR+ (Ireland) Limited

ATC code:

C09AA; C09AA01

INN (International Name):

Captopril

Dosage:

5/5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; captopril

Authorization status:

Not marketed

Authorization date:

2018-07-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Captopril 5 mg/5 ml Oral Solution
Captopril 25 mg/5 ml Oral Solution
Captopril
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Captopril Oral Solution is and what it is used for
2. What you need to know before you take Captopril Oral Solution
3. How to take Captopril Oral Solution
4. Possible side effects
5. How to store Captopril Oral Solution
6. Contents of the pack and other information
1.
WHAT CAPTOPRIL ORAL SOLUTION IS AND WHAT IT IS USED FOR
Captopril Oral Solution contains the active substance captopril which
belongs to the group of
medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE
inhibitors work by helping
to widen your blood vessels, which then make it easier for your heart
to pump blood through them.
Captopril is used to treat the following in adults, the elderly and
children:
• High blood pressure and certain heart conditions.
If high blood pressure is left uncontrolled it can increase the risk
of heart disease or stroke.
Captopril works by lowering your blood pressure which reduces this
risk.
• People whose heart no longer pumps blood as well as it once did.
This condition is known as heart
failure.
• People who have recently suffered a heart attack. A heart attack
happens once one of the major
blood vessels supplying blood to the heart muscle becomes blocked.
This means that the heart does
not receive the oxygen it needs and the heart muscle becomes damaged.
• Kidney disease in people with diabetes.
2. WHAT YOU NE

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2021
CRN00C76W
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Captopril 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Captopril 5 mg/5 ml Oral Solution contains 1 mg captopril.
Each 5 ml of Captopril 5 mg/5 ml Oral Solution contains 5 mg
captopril.
Excipient(s) with known effects:
This medicinal product contains 0.192 mmol (or 4.40 mg) sodium per 5
mL.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Captopril oral solution is indicated for:
_Hypertension: _the treatment of essential hypertension.
_Heart Failure: _for the treatment of chronic heart failure.
_Myocardial Infarction:_
- _short-term (4 weeks) treatment:_ Captopril Oral Solution is
indicated in any clinically stable patient within the first 24 hours
of
an infarction.
- _long-term prevention of symptomatic heart failure:_ indicated in
clinically stable patients with asymptomatic left ventricular
dysfunction.
_Type I Diabetic Nephropathy: _indicated for the treatment of
macroproteinuric diabetic nephropathy in patients with type I
diabetes. (See section 5.1).
Captopril oral solution can be used alone or in combination with other
antihypertensive agents (see sections 4.3, 4.4, 4.5 and
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dose should be individualised according to patient's profile (see
section 4.4) and blood pressure response. The recommended
maximum daily dose is 150 mg.
Captopril oral solution may be taken before, during and after meals.
_Hypertension:_ the recommended starting dose is 25-50 mg daily in two
divided doses. The dose may be increased
incrementally, with intervals of at least 2 weeks, to 100-150 mg/day
in two divided doses as needed to reach target blood
pressure. Captopril oral solution may be used alone or with other
antihypertensive agents, especially thiazide diuretics. A
once-daily dosing regime