Cilazapril 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cilazapril monohydrate

Available from:

DE Pharmaceuticals

ATC code:

C09AA08

INN (International Name):

Cilazapril monohydrate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CILAZAPRIL 0.5 MG FILM-COATED TABLETS
CILAZAPRIL 1 MG FILM-COATED TABLETS
CILAZAPRIL 2.5 MG FILM-COATED TABLETS
CILAZAPRIL 5 MG FILM-COATED TABLETS
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 Cilazapril is and what it is used for
2. What you need to know before you take Cilazapril
3. How to take Cilazapril
4. Possible side effects
5. How to store Cilazapril
6. Contents of the pack and other information
1. WHAT CILAZAPRIL IS AND WHAT IT IS USED FOR
Cilazapril belongs to the group of medicines called angiotensin
converting enzyme inhibitors (ACE-inhibitors).
Cilazapril is used in adults to treat the following:
● High blood pressure (hypertension).
● Chronic (long-term) heart failure.
It works by making your blood vessels relax and widen. This
helps to lower your blood pressure. It also makes it easier for
your heart to pump blood around your body if you have chronic
heart failure.
Your doctor may give you other medicines as well as Cilazapril
to help treat your condition.
2. WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
CILAZAPRIL
DO NOT TAKE CILAZAPRIL:
● If you are allergic to cilazapril or any other ingredients of this
medicine (listed in section 6).
● If you are allergic to other ACE inhibitor medicines. These
include enalapril, lisinopril and ramipril.
● If you have had a serious side effect called angioedema after
taking other ACE inhibitor medicines, hereditary angioedema
or angioedema of unknown cause. The signs include swelling
of the face,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cilazapril 5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg film-coated tablet contains 5 mg of Cilazapril (as
Cilazapril monohydrate).
Excipient(s) with known effect:
Each 5 mg film-coated tablet contains 117.824 mg of lactose
monohydrate
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oblong presenting a one sided score, weighing approximately 100
mg, film
coated tablets.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cilazapril is indicated for the treatment of hypertension.
Cilazapril is indicated for the t
reatment of chronic heart failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Cilazapril should be administered once daily.
As food intake has no clinically significant influence on absorption,
Cilazapril can be
administered before or after a meal. The dose should always be taken
at about the
same time of day.
Hypertension
The initial dose is 1 mg/day. Blood pressure should be assessed, and
dosage adjusted
individually in accordance with the blood pressure response. The usual
dose range of
Cilazapril is 2.5 to 5.0 mg once daily.
Patients with a strongly activated renin- angiotensin-aldosterone
system (in particular,
salt and/or volume depletion, cardiac decompensation, or severe
hypertension) may
experience an excessive blood pressure fall following the initial
dose. A lower
starting dose of 0.5 mg once daily is recommended in such patients and
the initiation
of treatment should take place under medical supervision.
Hypertensive patients receiving diuretics
If possible, the diuretic should be discontinued 2 – 3 days before
beginning therapy
with Cilazapril to reduce the likelihood of symptomatic hypotension.
It may be
resumed later if required. The recommended starting dose in these
patients is 0.5 mg
once daily.
Chronic heart failure
Therapy with Cilazapril should be initiated at a recommended starting
dose