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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.
Accuretic is a treatment for high blood pressure.
You should take Accuretic regularly to get the maximum benefit, even if you are feeling well.
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.
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.
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.
The name of your medicine is Accuretic 10/12.5 Tablets but
will be referred to as Accuretic throughout this leaflet.

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 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.

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
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

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’.
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’).

◆ Do not take Accuretic:

Other blood pressure treatments and diuretics
(including aliskiren and water tablets).

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.

Medicines to treat infections called tetracyclines.
Antibiotics like Sulfamethoxazole and Trimethoprim.

If you are more than 3 months pregnant. It is also better
to avoid Accuretic in early pregnancy – see ‘Pregnancy,
breast-feeding and fertility’ section.

Potassium supplements (this includes salt substitutes
which often contain potassium).

If you have kidney disease or are experiencing
problems passing water (anuria).

Anaesthetics.

If you have an obstruction in your heart that slows
blood in the heart.

Non-steroidal anti-inflammatory pain killers (including
aspirin or ibuprofen).

If you have hereditary (inherited)/idiopathic (unknown
cause) angioneurotic oedema (a swelling of the face,
tongue or throat which causes difficulty breathing).

Corticosteroids (including hydrocortisone,
dexamethasone or prednisolone) and ACTH
(tetracosactide) or drugs known to reduce the amount
of potassium in the blood.

Lithium (used to treat depression).

If you have a history of angioedema relating to previous
treatment with an ACE inhibitor.

◆ Warnings and precautions

Procainamide (used to correct irregular heart beats),
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).

Talk to your doctor or pharmacist before taking Accuretic if:

Indigestion and heartburn medicines (antacids).

If you have diabetes or impaired kidney function and
you are treated with a blood pressure lowering
medicine containing aliskiren.

You have aortic stenosis (narrowing of the main blood
vessel from the heart).
You have kidney disease or use a haemodialysis
machine (an artificial kidney).
You have liver disease.
You have heart disease or heart failure.
You are elderly.
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 suffer from allergies or asthma.
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 must tell your doctor if you think you are (or might
become) pregnant. Accuretic 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,
breast-feeding and fertility’ section).
You are breast-feeding or about to start breast-feeding.
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.

Medicines that have a sedative effect. This includes
alcoholic drinks and sleeping pills.
Medicines to treat diabetes (including vildagliptin).
Digitalis glycosides (for example digoxin, for the
treatment of heart problems).
mTOR inhibitors used to treat kidney cancer (including
temsirolimus).
Surgery
Remember to tell any medical staff that you are taking
Accuretic. This is important if you go into hospital for an
operation as your anaesthetist will want to know.
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
You must tell your doctor if you think you are (or might
become) pregnant. 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
breast-feeding. 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 usual dose of Accuretic is one tablet each day. 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. Accuretic can
be taken with or without food.

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
Rare side effects: 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)
Very rare side effects: may affect up to 1 in 10,000
people
obstruction of the digestive system (bowel)
blurred vision

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.

Not known: frequency cannot be estimated from the
available data
skin discolouration
decreased numbers of white blood cells or decrease in
blood platelets which may result in bruising or easy
bleeding, low numbers of red blood cells (anaemia)
bleeding from blood vessels in the brain
narrowing of the airways in the lungs (bronchospasm)
liver inflammation (hepatitis)
short-sightedness
acute closure glaucoma (increased pressure in the
eyes)

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.

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.

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.

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

Swallow the tablets whole with water. Do not chew, divide
or crush the tablets.
Use in children and adolescents
Accuretic should not be used in children and adolescents
under 18 years of age.

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.
Severe allergic (anaphylactoid) reaction to this
medicine such as swelling of the face, tongue and
throat which cause great difficulty breathing
(angioedema).
Severe abdominal pain causing you to be sick
(intestinal angioedema).
Severe chest pain, tightness of the chest, shortness of
breath, wheezing or trouble breathing, irregular or
strong heart beat (palpitations). These symptoms may
be due to heart attack or angina.
Weakness of arms, legs or problems speaking which
may be symptoms of a possible stroke.
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. You may not have enough of certain white
blood cells (neutropenia/agranulocytosis) which may
lead to increased risk of infection or fever.
Severe abdominal and back pain accompanied with
feeling very unwell (pancreatitis).
Yellowing of the skin or the eyes (jaundice).
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 side effects: 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
Uncommon side effects: 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
ringing or noise in the ears
wind
lazy eye
feeling of spinning or rotation of surroundings (vertigo)

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 label or blister strip 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 tablets 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 Magnesium carbonate, lactose
monohydrate, crospovidone, povidone, magnesium
stearate, Opadry Pink OY-S-6937 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: Godecke GmbH, 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: 26.04.2016
ACCURETIC is a registered trademark of PARKE, DAVIS
& COMPANY LLC

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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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