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ACCURETIC 10/12.5 TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / QUINAPRIL HYDROCHLORIDE

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Package leaflet: Information for the user

Accuretic® 10/12.5 Tablets
(quinapril/hydrochlorothiazide)
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. Most people do not have serious problems when taking Accuretic but side effects can occur. If you experience swelling of
the face, tongue or throat, see your doctor immediately.
 Accuretic is a treatment for high blood pressure.
 You should take Accuretic regularly to get the maximum benefit, even if you are feeling well.
 Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other
medicines.
 If you are pregnant, trying to become pregnant or are of child bearing potential and not using adequate contraception, do not take
Accuretic and tell your doctor.
The name of your medicine is Accuretic 10/12.5 Tablets but will be referred to as Accuretic throughout this leaflet.
What is in this leaflet
1. What Accuretic is and what it is used for
2. What you need to know before you take Accuretic
3. How to take Accuretic
4. Possible side effects
5. How to store Accuretic
6. Contents of the pack and other information

1. What Accuretic is and what it is
used for
Accuretic is used to treat high blood pressure.
Accuretic contains the active ingredients quinapril and
hydrochlorothiazide (HCTZ). Quinapril belongs to a group of
medicines called angiotensin converting enzyme (ACE)
inhibitors. ACE inhibitors work by widening blood vessels in the
body, which can help to reduce the pressure in the vessels.
HCTZ belongs to a group of medicines called diuretics. Diuretics
help the body to get rid of extra fluid and are used in patients
with high blood pressure. Because they get rid of fluid diuretics
are sometimes called ‘water tablets’.
You must talk to a doctor if you do not feel better or if you feel
worse.

2. What you need to know before you
take Accuretic
◆ Do not take Accuretic:
 If you are allergic to quinapril, hydrochlorothiazide, any of
the other ingredients of this medicine (listed in section 6),
similar drugs or to a group of antibiotics called
sulphonamides.
 If you are in your second or third trimester of pregnancy. It
is also better to avoid Accuretic in early pregnancy – see
Pregnancy, breast-feeding and fertility section.
 If you have kidney disease or are experiencing problems
passing water (anuria).
 If you have an obstruction in your heart that slows blood in
the heart.
 If you have hereditary (inherited)/idiopathic (unknown
cause) angioneurotic oedema (a swelling of the face,
tongue or throat which causes difficulty breathing).
 If you have a history of angioedema relating to previous
treatment with an ACE inhibitor.
 If you have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren.
 If you are taking sacubitril/valsartan, a medicine for heart
failure.
◆ Warnings and precautions
Talk to your doctor or pharmacist before taking Accuretic if:
 You have aortic stenosis (narrowing of the main blood
vessel from the heart).
 You have kidney disease, a transplanted kidney, or use a
haemodialysis machine (an artificial kidney).
 You have liver disease.
 You have heart disease or heart failure.
 You are elderly.
 You have low blood pressure (hypotension), likely to occur
if you are dehydrated (excessive loss of body water) or
have salt deficiency due to diuretic therapy (water tablets),
low-salt diet, diarrhoea, vomiting, or haemodialysis.
 You have a dry cough.
 You are of African-Caribbean ethnic origin.
 You have collagen vascular disease (deposits of collagen
in your blood vessels).
 You are having, or about to have, low density lipoprotein
apheresis treatment (removal of cholesterol from your
blood by machine).
 You have a history of severe allergic reactions, asthma or
angioedema (such as swelling of the eyes, face, lips,
tongue or throat).
 You are having, or about to have desensitisation treatment,
i.e. to reduce the effects of an allergy to a bee or wasp
sting.
 You are planning to become pregnant, or you just became
aware of being pregnant (see Pregnancy, breast-feeding
and fertility section).
 You are breast-feeding or about to start breast-feeding
(see Pregnancy, breast-feeding and fertility section).
 You are taking medicines containing lithium.
 You have diabetes or gout.
 You have systemic lupus erythematosus (SLE) an allergic
condition which causes joint pain, skin rashes and fever.
 You have a salt or electrolyte imbalance in your blood (e.g.
sodium or potassium), your doctor may want to monitor
you more closely.
 You experience visual disturbances and increased
pressure in the eye. Symptoms of increased pressure in
the eye are intense pain, redness of the eye, headaches,
tender eye area, misty vision and loss of vision. If this is
not treated, it can lead to permanent loss of vision.
 You are about to have surgery or receive anaesthetics
(even at the dentist), remember to tell any medical staff
that you are taking Accuretic.
 You have a fever, sore throat, mouth ulcers, tiredness,
unexplained bruising or bleeding, or a blood problem such
as low or lack of white blood cells (neutropenia or
agranulocytosis).



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.
 You are simultaneously receiving an mTOR (mammalian
target of Rapamycin) inhibitor (e.g. temsirolimus) or a
DPP-4 (dipeptidyl-peptidase-4) inhibitor (e.g. vildagliptin) or
a neutral endopeptidase inhibitor (e.g. racecadotril), may
have an increased risk for angioedema (swelling of the
face, eyes, tongue or throat). Special caution is advised if
treatment with an mTOR inhibitor or DPP-4 inhibitor or a
neutral endopeptidase inhibitor is initiated in patients who
are already receiving an ACE inhibitor.
Your doctor may check your kidney function, blood pressure and
the amount of electrolytes (e.g. potassium) in your blood at
regular intervals.
See also information under the heading ‘Do not take Accuretic’.
Children and adolescents
Accuretic should not be used in children and adolescents under
18 years of age.
Other medicines and Accuretic
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. There are some medicines that
may interact with Accuretic. Your doctor may need to change
your dose and/or to take other precautions:
 Angiotensin II receptor blocker (ARB) or aliskiren (see also
information under the headings ‘Do not take Accuretic’ and
‘Warnings and precautions’).
 Other blood pressure treatments and diuretics (including
aliskiren and water tablets).
 Medicines called tetracyclines used to treat infections.
 Cholestyramine and colestipol (medicines used to treat
high levels of fats in the blood).
 Medicines called ‘pressor amines’ such as norepinephrine
and epinephrine.
 Antibiotics like sulfamethoxazole and trimethoprim.
 Potassium supplements (this includes salt substitutes
which often contain potassium).
 Anaesthetics.
 Lithium (used to treat depression).
 Non-steroidal anti-inflammatory pain killers (including
aspirin or ibuprofen).
 Corticosteroids (including hydrocortisone, dexamethasone
or prednisolone) and ACTH (tetracosactide) or drugs
known to reduce the amount of potassium in the blood.
 Procainamide (used to correct irregular heartbeats),
cytostatic drugs (cancer therapy), immunosuppressants
(for the treatment of autoimmune diseases such as
Crohn’s disease and rheumatoid arthritis), allopurinol,
uricosurics and xanthine oxidase inhibitors (for the
treatment of chronic gout).
 Indigestion and heartburn medicines (antacids).
 Medicines that have a sedative effect. This includes
alcoholic drinks and sleeping pills.
 Digitalis glycosides (e.g. digoxin, for the treatment of heart
problems).
 mTOR inhibitors used to treat kidney cancer (including
temsirolimus), certain antidiabetic drugs (DPP-4 inhibitors
e.g. vildagliptin) or certain drugs against heart insuffici
ency and high blood pressure (neutral endopeptidase
inhibitor, e.g. racecadotril): the risk of an angioedema
(swelling of the face, eyes, tongue or throat) can be
elevated.
Laboratory Tests
Accuretic may affect the results of some laboratory tests. Tell
your doctor or hospital you are taking Accuretic if you need to
have any tests carried out by your doctor or in hospital.
◆ Accuretic with food and drink
See section 3 How to take Accuretic.
◆ Pregnancy, breast-feeding and fertility
Do not start taking Accuretic if you are pregnant or planning to
become pregnant.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine. Your doctor will normally advise you to stop
taking Accuretic before you become pregnant or as soon as you
know you are pregnant and will advise you to take another
medicine instead of Accuretic. Accuretic 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.
Tell your doctor if you are breast-feeding or about to start breastfeeding. Accuretic is not recommended for mothers who are
breast-feeding.
◆ Driving and using machines:
Your tablets may affect your ability to drive or operate machines
safely. They may make you feel dizzy or weary. If affected, do
not drive or operate machines and contact your doctor
immediately.
Accuretic contains lactose monohydrate
Lactose monohydrate is 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 Accuretic
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
Do not wait until your tablets are finished before seeing your
doctor.
Adults
The recommended dose is one tablet each day. Try to take the
tablet at about the same time every day. Accuretic can be taken
with or without food.
Accuretic is not recommended for use in patients who suffer with
kidney disease with a creatinine clearance of less than
40mL/min.
Your doctor may increase the dose to two tablets which may be
taken together once a day or may be taken separately, one tablet
in the morning and one in the evening.
Swallow the tablets whole with water. Do not chew, divide or
crush the tablets.
If you take more Accuretic than you should
Taking too many tablets at once may make you unwell. If you
take too many Accuretic tablets, tell your doctor or go to your
nearest hospital casualty department immediately.
If you forget to take Accuretic
Do not worry. If you forget to take a dose, miss out the forgotten
dose completely and take the next dose at the normal time. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Accuretic
Do not stop taking your tablets or alter the dose you are currently
taking without seeing your doctor first. It is important to keep
taking your tablets. They help to control your blood pressure.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
STOP taking Accuretic and seek immediate medical
attention if you experience any of the following symptoms as
they can be serious:
Common: may affect up to 1 in 10 people
 Severe chest pain, tightness of the chest, shortness of
breath, wheezing or trouble breathing, irregular or strong
heartbeat (palpitations). These symptoms may be due to
heart attack or angina.
Uncommon: may affect up to 1 in 100 people
 Ringing or noise in the ears.
Very rare: may affect up to 1 in 10,000 people
 Severe abdominal pain causing you to be sick (intestinal
angioedema).
Not known: frequency cannot be estimated from the
available data
 Severe allergic (anaphylactoid) reaction to this medicine
such as swelling of the face, tongue and throat which
cause great difficulty breathing (angioedema).
 Weakness of arms, legs or problems speaking which may
be symptoms of a possible stroke.
 Fever, cough, and other nonspecific symptoms, followed
by redness and sloughing of the skin and mucous
membranes (Toxic epidermal necrolysis). A skin rash with
irregular red spots or ‘target’ lesions (erythema
multiforme). Intense skin rash including hives, severe
itching, blistering, peeling and swelling of the skin,
inflammation of mucous membranes (Stevens Johnson
Syndrome).
 Feeling faint, particularly when standing; this may mean
your blood pressure is too low (hypotension). This is more
likely to occur if you have been taking diuretics (water
tablets), other blood pressure medication in addition to
Accuretic, alcohol, or if you are dehydrated or are on
dialysis. If you feel light headed or faint, lie down until this
feeling passes.
 Severe sore throat or severe mouth ulcers, particularly if
you suffer from kidney problems or collagen vascular
disease.
 Neutropenia/agranulocytosis resulting in decreased
numbers of white blood cells or decrease in blood platelets
which may result in bruising or easy bleeding.
 Severe abdominal and back pain accompanied with feeling
very unwell (pancreatitis).
 Liver inflammation (hepatitis), abdominal pain, nausea,
dark brown urine, yellowing of the skin or the eyes
(jaundice).
 Inflammation of the kidneys (tubulointerstitial nephritis)
symptoms include fever and a rash but occasionally
patients might notice blood in urine as well.
The following side effects have also been reported in patients
with high blood pressure being treated with Accuretic. If any of
these side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.
Common: may affect up to 1 in 10 people
 diarrhoea, indigestion, mild stomach pain, feeling or being
sick
 dizziness, headache, tiredness, feeling weak, sleepiness
or sleeplessness
 painful muscles, muscle weakness, back pain
 high levels of uric acid in your blood causing swollen,
painful joints (gout)
 coughing, bronchitis
 nose or throat infections, nasal stuffiness and/or runny
nose (rhinitis)
 widening of blood vessels
 increased levels of creatinine in the blood
 increased levels of blood urea
 chest pain
 increased levels of Potassium in serum
 rapid heart rate
Uncommon: may affect up to 1 in 100 people
 kidney and urinary problems, urinary tract infection
 numbness or tingling sensation in your limbs, aching joints
 depression, nervousness, confusion
 wind
 lazy eye
 feeling of spinning or rotation of surroundings (vertigo)
 fainting, low blood pressure
 dry mouth, or throat, taste disturbances

 fluid retention in the body
 inflammation of your sinuses (sinusitis)
 increased sweating, feeling hot (fever)
 hair loss, itching, sensitivity of skin to light
 failure/inability to achieve penile erection
 viral infection
 heart attack (myocardial infarction)
 increased glucose levels in blood
 painful joints
 shortness of breath
 swelling under the skin
 protein in urine
Rare: may affect up to 1 in 1,000 people
 problems with balance
 inflammation of the lungs which can cause breathlessness,
cough and raised temperature
 constipation
 inflammation of the tongue
 inflammation of blood vessels
 psoriasis
 swelling of the hands, face and tongue (angioedema)
 skin disorders
Very rare: may affect up to 1 in 10,000 people
 obstruction of the digestive system (bowel)
 blurred vision
 hives
Not known: frequency cannot be estimated from the
available data
 allergic condition which causes joint pain, skin rashes and
fever (systemic lupus erythematosus)
 inflammation of the lining of the lungs, heart or abdomen
(serositis)
 erythema and scaling of the skin (dermatitis exfoliative)
 bruising or a purple or red rash (purpura)
 small fluid-filled blisters on the skin (pemphigus)
 skin discolouration
 low numbers of red blood cells (anaemia)
 bleeding from blood vessels in the brain
 narrowing of the airways in the lungs (bronchospasm)
 short-sightedness
 acute closure glaucoma (increased pressure in the eyes)
Accuretic may cause certain changes in your blood and your
doctor may do blood tests to monitor this. If you notice bruising,
feeling very tired or if you are diabetic and notice your sugar
levels rising let your doctor know so blood tests can be arranged
if necessary.
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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Accuretic
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original pack.
Do not take the medicine after the expiry date which is stated on
the carton and blister labels after ‘Exp’. The expiry date refers to
the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Accuretic contains
The active ingredient in Accuretic is quinapril (as the
hydrochloride) and hydrochlorothiazide.
Each film-coated tablet contains 10mg quinapril (as the
hydrochloride) and 12.5mg hydrochlorothiazide
The other ingredients are lactose monohydrate, magnesium
carbonate, povidone K25, magnesium stearate, crospovidone.
Table coating: pink opadry OY-S-6937 (hypromellose,
hydroxypropylcellulose, titanium dioxide (E171), iron oxide red
and yellow (E172), macrogol 400) and candelilla wax.
What Accuretic looks like and contents of the pack
Accuretic is pink, oval, film-coated tablet marked with a breakline
on each side.
Each calendar blister pack contains 28 tablets.
Manufactured by: Pfizer Manufacturing Deutschland GmbH,
Betriebstatte Freiburg, Mooswaldallee 1, 79090 Freiburg,
Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
®
Accuretic 10/12.5 Tablets; PL 18799/2769
Leaflet date: 15.12.2017
POM

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