Captopril Thame Sugar Free Oral Solution 5mg/5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAPTOPRIL

Available from:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC code:

C09AA01

INN (International Name):

CAPTOPRIL 5 mg/5ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

CAPTOPRIL 5 mg/5ml

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2019-03-14

Patient Information leaflet

MRP/Renewal
Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPTOPRIL THAME 5MG/5ML SUGAR FREE ORAL SOLUTION
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.
The name of your medicine is Captopril Thame 5mg/5ml Sugar Free Oral
Solution but it will
be referred to as 'Captopril' throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Captopril is and what it is used for
2. What you need to know before you take Captopril
3. How to take Captopril
4. Possible side effects
5. How to store Captopril
6. Contents of the pack and other information
1. WHAT CAPTOPRIL IS AND WHAT IT IS USED FOR
This medicine contains the active substance Captopril. Captopril
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 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.
Captopril can also help people whose heart no longer pumps blood as
well as it once did. This
condition is known as heart failure.
Captopril may also be used to treat patients who 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

Summary of Product characteristics

Page
1
of
15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Captopril Thame 5mg/5ml Sugar Free Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 5mg captopril
Each ml of oral solution contains 1mg captopril
_Excipients with known effect:_
Each 5ml of oral solution contains 1.25mg sodium benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution
A clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypertension:_
Captopril is indicated for the treatment of essential hypertension.
_Heart Failure:_
Captopril is indicated for the treatment of chronic heart failure.
_Myocardial Infarction:_
•
_Short-term (4 weeks) treatment: _
Captopril is indicated in any clinically stable patient
within the first 24 hours of an infraction.
•
_Long-term prevention of symptomatic heart failure: _
Captopril is indicated in clinically
stable patients with asymptomatic left ventricular dysfunction.
_Type I Diabetic Nephropathy:_
Captopril is indicated for the treatment of macroproteinuric
diabetic nephropathy in patients with type I diabetes.
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 150mg.
Captopril may be taken before, during and after meals.
HYPERTENSION:
The recommended starting dose is 25-50mg daily in two divided doses.
The dose may be
increased incrementally, with intervals of at least 2 weeks, to
100-150mg/day in two divided
doses as needed to reach target blood pressure. Captopril may be used
alone or with other
antihypertensive agents, especially thiazide diuretics (see sections
4.3, 4.4, 4.5 and 5.1). A
Page
2
of
15
once-daily dosing regimen may be appropriate when concomitant
antihypertensive medication
such as thiazide diuretics is added.
In patients with a strongly active renin-angiotensin-aldosterone
system (hypovolaemia,
renovascular hype