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QUINAPRIL/HYDROCHLOROTHIAZIDE 20/12.5 MG FILM-COATED TABLETS

Active substance: QUINAPRIL HYDROCHLORIDE

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Package leaflet: Information for the user

Quinapril/Hydrochlorothiazide 10/12.5 mg film-coated tablets
Quinapril/Hydrochlorothiazide 20/12.5 mg film-coated tablets
Quinapril/Hydrochlorothiazide 20/25 mg film-coated tablets
Quinapril/Hydrochlorothiazide
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.













P150

P150

Quinapril/Hydrochlorothiazide
film-coated tablets

Quinapril/Hydrochlorothiazide
film-coated tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Drugs that have a sedative effect. This includes alcoholic drinks and sleeping pills
Anti-inflammatory medicines such as hydrocortisone, prednisolone, ACTH
Non-steroidal anti-inflammatory drugs (for example, aspirin or ibuprofen).
Insulin or tablets taken for diabetes to control the blood sugar
Antacids (medicines used for indigestion)
Medicines used during surgical operations to relax muscles (e.g. tubocurarine)
Procainide and digoxin, used to treat heart problems.
Allopurinol, used to treat gout
Ciclosporin and other medicines used to suppress the body’s immune response
Drugs used in cancer therapy
Tetracycline, an antibiotic

Surgery

Remember to tell any medical staff that you are taking Quinapril/Hydrochlorothiazide.
This is important if you go into hospital for an operation as your anaesthetist will want
to know.

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

Your doctor may need to change your dose and/or to take other precautions:

1.

Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

What Quinapril/Hydrochlorothiazide is and what it is used for

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.
2.

What you need to know before you take Quinapril/Hydrochlorothiazide

DO NOT take Quinapril/Hydrochlorothiazide if you

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 face, hands or feet, lips, tongue or
throat – which can cause shortness of breathe or difficulty in swallowing
(angioedema).

suffer from hereditary or unexplained swelling of the skin (angioedema)

have severe kidney or liver problems.

have aortic stenosis (narrowing of the main blood vessel from the heart).

If you are more than 3 months pregnant. (It is also better to avoid
Quinapril/Hydrochlorothiazide in early pregnancy – see pregnancy section.)

if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quinapril/Hydrochlorothiazide
if you:

have heart, liver or kidney problems

have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea,
sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for
a long time or having had dialysis

have allergies or asthma

are going to have treatment to reduce your allergy to bee or wasp stings
(desensitization)

are known to have an obstructed outflow from the heart

have collagen vascular disease such as scleroderma or systemic lupus
erythematosus

are about to have a treatment called LDL apheresis for removal of cholesterol

have diabetes or gout.

are of child bearing potential, talk to your doctor about adequate contraception.

are breast-feeding or about to start breast-feeding

if you are taking any of the following medicines used to treat high blood pressure:
- an “angiotensin II receptor blocker” (ARBs) (also known as sartans - for example
valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney
problems.
- aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information
under the headings “Do not take Quinapril/Hydrochlorothiazide” and “Warnings and
precautions”)
Taking Quinapril/Hydrochlorothiazide with food and drink and alcohol
Quinapril/Hydrochlorothiazide can be taken with or without a meal.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Quinapril/Hydrochlorothiazide before you become
pregnant or as soon as you know you are pregnant and will advise you to take another
medicine instead of Quinapril/Hydrochlorothiazide . Quinapril/Hydrochlorothiazide is not
recommended during pregnancy, and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Quinapril/Hydrochlorothiazide is not recommended for mothers who are breast-feeding.
Driving and using machines
The tablets may make you feel dizzy. Therefore, you should be careful when driving or using
machines.
Quinapril/Hydrochlorothiazide contains
Quinapril/Hydrochlorothiazide film-coated tablets contain lactose (a type of sugar). If you
have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product
3.

How to take Quinapril/Hydrochlorothiazide

Always take this medicine exactly as your doctor has told you. Take the tablet with plenty of
water. The tablets can be taken irrespective of the food intake in the morning. You should
check with your doctor or pharmacist if you are not sure. The usual dose is:
Adults:
The starting dose is one tablet in the morning. Your doctor may increase the dose if he feels
that the dose is not sufficient.
Renal impairment
Use of Quinapril/Hydrochlorothiazide should be avoided if you have severely impaired
kidney function.
In patients with renal impairment, your doctor may prescribe you a lower dose.
Elderly:
If you are elderly you should use Quinapril/Hydrochlorothiazide with caution. Your doctor will
prescribe the lowest effective dose.
Children and adolescents (less than 18 years of age):
Quinapril/Hydrochlorothiazide is not recommended for use in children and adolescents.
Take this tablet as follows:
1.
Do not push the tablet
Do not push against the tablet pocket.

2.
Tear off one tablet pocket
Bend and tear off one tablet pocket along the dotted lines.

See also information under the heading “Do not take Quinapril/Hydrochlorothiazide”
Contact your doctor immediately if you experience symptoms such as a sudden decreased
vision or eye pain. Symptoms usually occur within hours to weeks after starting treatment
with Quinapril/Hydrochlorothiazide and may be signs of acute transient myopia and a form of
acute glaucoma (angle-closure glaucoma).

3.
Peel off the lid
Lift, hold and peel off the lidding foil, starting from the side indicated by the arrow.

You must tell your doctor if you think you are (or might become) pregnant.
Quinapril/Hydrochlorothiazide is not recommended in early pregnancy, and must not be
taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if
used at that stage (see pregnancy section).
At the start of treatment, more frequent medical check-ups may be necessary.Your doctor
will decide how often you need to be checked. You should not skip these visits even if you
feel well.

4.

Remove the Tablet with dry hands and take as directed above.

If your blood pressure falls too much and you feel faint then you should lie down. You may
need medical help.
Other medicines and Quinapril/Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
The effect of Quinapril/Hydrochlorothiazide can be affected by or can affect the following
medicines:






Other medicines used to lower blood pressure
diuretic medicines (water tablets)
Medicines which lead to increases in the level of potassium in the blood:
blood thinning medicines (e.g. heparin)
potassium supplements or salt substitutes containing potassium
Lithium, used for mental health

Black

If you take more Quinapril/Hydrochlorothiazide than you should
Contact your doctor or nearest casualty department immediately. Take the container and
any remaining tablets with you. Signs and symptoms of Quinapril/Hydrochlorothiazide
overdose include: giddiness and fainting which causes low blood pressure.
If you forget to take Quinapril/Hydrochlorothiazide
If you miss a dose take it as soon as you remember unless it is nearly time for your next
dose. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Quinapril/Hydrochlorothiazide.
Do not stop taking Quinapril/Hydrochlorothiazide without first asking your doctor, even
though you feel better.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you suffer from any of the following symptoms, stop taking
Quinapril/Hydrochlorothiazide and contact your doctor or go to your nearest
emergency department immediately:

symptoms of an allergic (hypersensitivity) reaction (angioedema) such as:
swelling of the skin, of the face and lips or voice box
swelling of the tongue and throat causing difficulty breathing or swallowing
If you are black you are more likely to suffer angiooedema.

severe abdominal pain causing you to be sick (intestinal angiooedema)

heart attack (myocardial infarction), symptoms may include chest pain, tightness of
the chest, shortness of breath or trouble breathing

weakness of arms, legs or problems speaking which may be symptoms of a possible
stroke (cerebrovascular accident)

intense skin rash including hives, severe itching, blistering, peeling and swelling of the
skin, inflammation of mucous membranes (Stevens- Johnson syndrome)
Common (may affect up to 1 in 10 people):

tiredness (fatigue), difficulty in sleeping (insomnia), sleepiness (somnolence)

feeling of weakness (asthenia)

dizziness

cough, bronchitis

nose or throat infections (upper respiratory tract infections, pharyngitis), runny, itchy
nose (rhinitis)

feeling sick (nausea), being sick (vomiting), diarrhoea, indigestion (dyspepsia)

headache

abdominal pain, back pain, muscle pain (myalgia)

chest pain, feeling of tightness and pain in the chest (angina pectoris)

abnormally high concentration of uric acid in the blood (hyperuricaemia)

abnormally high concentration of potassium in the blood (hyperkalaemia)

increases of creatinine and urea in the blood (these are indicators of kidney function)

high levels of uric acid in the blood causing swollen, painful joints (gout)

faster heart beat (tachycardia), feeling the heart beating in the chest (palpitations)

relaxation of the blood vessels (vasodilatation)
Uncommon (may affect up to 1 in 100 people):

impaired glucose tolerance

low blood pressure (hypotension)

nervousness

abnormal feelings in the skin, like pins and needles, itching or tingling (pruritus,
paraesthesia), rash, sensitivity to sunlight (photosensitivity)

fainting (syncope), a feeling of dizziness or “spinning” (vertigo)

mini stroke (transient ischaemic attack or TIA), a brief attack (from a few minutes to an
hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit

excessive wind (flatulence), altered taste (dysgeusia)

dryness of the mouth

excessive sweating (hyperhidrosis)

hair loss (alopecia)

erectile dysfunction

viral infection, urinary tract infection

inflammation of your sinuses (sinusitis)

fever (pyrexia)

confusion

depression

lazy eye (amblyopia)

ringing in the ears (tinnitus)

shortness of breath (dyspnoea)

dry throat

fluid retention in the body (generalised oedema), swelling of the ankles, feet or fingers
(peripheral oedema)

pain in joints (arthralgia)

impaired kidney function

presence of an excess of serum proteins in the urine (proteinuria)
Rare (may affect up to 1 in 1,000 people):

swelling of the skin, of the face and lips or voice box, swelling of the tongue and throat
causing difficulty breathing or swallowing (upper airways obstruction by angiooedema)

inflammation of the lungs which can cause breathlessness, cough and raised
temperature (eosinophilic pneumonia)

disturbances of balance

skin disorders may be associated with: fever, inflamed blood vessels (vasculitis),
muscle pain (myalgia), joint pain, inflammation (arthralgia/arthritis), variety of
inflammatory skin disorders (dermatitis psoriasiforms) and change in several
laboratory values

constipation

inflammation of the tongue (glossitis)
Very rare (may affect up to 1 in 10,000 people):

hives (urticaria)

temporary blurring of vision

decreased movements of the bowel (ileus)
Frequency not known (frequency cannot be estimated from the available data):

purple or red pinpoint spots in the skin or mucous membranes caused by minor
haemorrhage (purpura)

red blotchy skin rash (erythema multiforme)

inflamed and scaling skin (dermatitis exfoliative)

blistering of the skin (pemphigus), severe, even life-threatening skin reaction (toxic
epidermal necrolysis)

allergic condition which causes joint pain, skin rashes and fever (systemic lupus
erythematosus)

inflamed body tissues (serositis)

abnormal increase in eosinophils (a certain type of white blood cells)

slight reduction in the number of red cells in the blood (haematocrit decreased)

increased amounts of liver enzymes in the blood

increased amounts of bilirubin in the blood

increased amounts of antinuclear antibody (ANA) in the blood

increases in cholesterol and triglycerides (types of fats) in the blood

inflammation of the kidneys (interstitial nephritis)

inflamed liver (hepatitis)

yellowing of the skin and of the whites of the eyes (jaundice, caused by blockage of
the flow of bile)

inflamed pancreas (pancreatitis)

tightening (constriction) of the lower airways (bronchospasm)










a fall in blood pressure on standing up which causes dizziness, lightheadedness or
fainting (orthostatic hypotension)
irregular heart beat (arrhythmia)
allergic (anaphylactic) reactions
reduced number of white cells in the blood (neutropenia)
severe low number of white blood cells which makes infections more likely
(agranulocytosis)
reduction in red blood cells which can make the skin pale yellow and cause weakness
or breathlessness (haemolytic anaemia)
reduction in blood platelets, which increases risk of bleeding or bruising
(thrombocytopenia)
red blood cell sedimentation rate increased (non-specific measure of inflammation)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help
provide more information on the safety of this medicine.
5.

How to store Quinapril/Hydrochlorothiazide

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
EXP. The expiry date refers to the last day of that month.
Store below 25ºC.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment
6.

Contents of the pack and other information

What Quinapril/Hydrochlorothiazide contains
-

The active substances are quinapril (as quinapril hydrochloride ) and
hydrochlorothiazide.

Quinapril/Hydrochlorothiazide 10/12.5mg film-coated tablet contains 10 mg of quinapril
equivalent to 10.83 mg of quinapril hydrochloride and 12.5 mg hydrochlorothiazide.
Quinapril/Hydrochlorothiazide 20/12.5mg film-coated tablet contains 20 mg of quinapril
equivalent to 21.66 mg of quinapril hydrochloride and 12.5 mg hydrochlorothiazide.
Quinapril/Hydrochlorothiazide 20/25mg film-coated tablet contains 20 mg of quinapril
equivalent to 21.66 mg of quinapril hydrochloride and 25 mg hydrochlorothiazide.
The other ingredients are:
Tablet core: Lactose monohydrate, magnesium carbonate heavy, crospovidone (type A),
povidone (K 30), magnesium stearate.
Tablet coat (Opadry pink): Hypromellose, titanium dioxide (E171), hydroxypropyl cellulose,
Macrogol 400, iron oxide red (E172), iron oxide yellow (E172).
What Quinapril/Hydrochlorothiazide looks like and contents of the pack
Film-coated tablet.
10mg/12.5mg:
Pink colored, 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.
20mg/12.5mg:
Pink colored, triangular, biconvex, film-coated tablets debossed with ‘D’ and ‘19’ on either
sides of a scoreline on one side and plain on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
20mg/25mg:
Pink colored, round shaped, biconvex, film-coated tablets debossed with ‘D’ on one side and
‘20’ on other side.
Quinapril/Hydrochlorothiazide film-coated tablets are available in blister packs of 7, 10, 14,
20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, 156, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
Manufacturer:
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the
following names:
Bulgaria

Quinapril/Hydrochlorothiazide Aurobindo 10/12.5 mg, 20/12.5 mg,
20/25 mg филмирани таблетки
Czech Republic Quinapril/Hydrochlorothiazid Aurobindo 10/12,5 mg, 20/12,5 mg
potahované tablety
France
Quinapril/Hydrochlorothiazide Arrow Lab 20/12,5 mg, comprimés pelliculés
Germany
Quinapril/Hydrochlorothiazid Aurobindo 10/12,5 mg, 20/12,5 mg,
20/25 mg Filmtabletten
Italy
Quinapril/idroclorotiazide Aurobindo 10/12,5 mg, 20/12,5 mg, 20/25 mg
compresse rivestite con film
Latvia
Quinapril/Hydrochlorothiazid Aurobindo 10/12,5 mg, 20/12,5 mg, 20/25 mg
apvalkotās tablets
Lithuania
Quinapril/Hidrochlorotiazide Aurobindo 10/12,5 mg, 20/12,5 mg, 20/25 mg
plėvele dengtos tabletės
Slovak Republic Quinapril/Hydrochlorotiazid Aurobindo 10/12,5 mg, 20/12,5 mg, 20/25 mg
filmom obalené tablety
Spain
Quinapril/Hidroclorotiazida Aurobindo 20/12,5 mg comprimidos
recubiertos con película
United Kingdom Quinapril/Hydrochlorothiazide 10/12.5 mg, 20/12.5 mg, 20/25 mg filmcoated tablets
This leaflet was last revised in 01/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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