Quinapril 10mg / Hydrochlorothiazide 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrochlorothiazide; Quinapril hydrochloride

Available from:

Milpharm Ltd

ATC code:

C09BA06

INN (International Name):

Hydrochlorothiazide; Quinapril hydrochloride

Dosage:

12.5mg ; 10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 8901175013258

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 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 Quinapril/Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Quinapril/Hydrochlorothiazide
3.
How to take Quinapril/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Quinapril/Hydrochlorothiazide
6.
Contents of the pack and other information
Quinapril/Hydrochlorothiazide film-coated tablets contain medicines
called (i) quinapril and
(ii) hydrochlorothiazide. Both of these medicines reduce blood
pressure.
(I) Quinapril belongs to a class of medicines known as “ACE
inhibitors”. Quinapril helps
blood vessels relax and so lowers blood pressure.
(ii) Hydrochlorothiazide belongs to a group of medicines called
thiazide diuretics (also known
as “water tablets”). Hydrochlorothiazide inhibits the ability of
the kidneys to retain fluid and
this leads to a reduction in blood pressure.
Quinapril/Hydrochlorothiazide is used to treat high blood pressure in
patients who are
already taking (i) quinapril and (ii) hydrochlorothiazide as separate
tablets and who may
benefit from taking one tablet containing both substances.
DO NOT TAKE QUINAPRIL/HYDROCHLOROTHIAZIDE
•
are allergic to
-
quinapril hydrochloride
-
any other ACE inhibitors
-
hydrochlorothiazide
-
medicines containing sulfonamides
-
any other ingredients of Quinapril/Hydrochlorothiazide(listed in
section 6).
•
have developed severe allergic reactions after previous treatment with
an ACE inhibitor.
Such reactions lead to swelling of the fac

Summary of Product characteristics

OBJECT 1
QUINAPRIL/HYDROCHLOROTHIAZIDE 10/12.5 MG FILM-
COATED TABLETS
Summary of Product Characteristics Updated 04-Jun-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Quinapril/Hydrochlorothiazide 10/12.5 mg film-coated tablets
2. Qualitative and quantitative composition
_10/12.5 mg: _
Each film-coated tablet contains 10 mg of quinapril equivalent to
10.83 mg of quinapril hydrochloride
and 12.5 mg hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 18.45 mg
of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
_10mg/12.5mg: _
Pink coloured, scored, oval shaped, biconvex, film-coated tablets
debossed with 'D' on scored side and
'18' on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Quinapril/Hydrochlorothiazide is indicated as substitution therapy
only in adult patients with essential
hypertension already adequately controlled with quinapril and
hydrochlorothiazide given concurrently.
4.2 Posology and method of administration
POSOLOGY
Patients receiving quinapril and hydrochlorothiazide from separate
tablets may be switched to
combination tablets of Quinapril/Hydrochlorothiazide containing the
same component doses.
_Adults:_
The recommended dose of Quinapril/Hydrochlorothiazide is one tablet
per day.
_Renal impairment_
Due to hydrochlorothiazide component, Quinapril/Hydrochlorothiazide is
contraindicated in patients with
severe renal impairment (creatinine clearance < 30 ml/min) (see
sections 4.3, 4.4 and 5.2).
_Elderly patients _(>65 years old)
The dose should be kept as low as possible commensurate with
achievement of adequate blood pressure
control.
Children and adolescents (less than 18 years of age)
Quinapril/Hydrochlorothiazide is not recommended for use in children
and adolescents due to lack of data
on safety and efficacy.
Method of administration
For ora