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ACCURETIC 10/12.5MG

Active substance(s): HYDROCHLOROTHIAZIDE / QUINAPRIL HYDROCHLORIDE

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Package leaflet: Information for the user

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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.

◆ 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.

UNITED KINGDOM

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◆ 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
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.

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YOU WILL FIND MORE
ABOUT ACCURETIC ON THE
BACK OF THIS LEAFLET

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Reviewed by Pharma-Print-Design

Creator: SK

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PPD

Code Nr.: XXXX
Color: Black, Blue (PMS 541 U), Blue (PMS 277 U)
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Betriebsstätte Freiburg

Product: PP ACCURETIC 10/12,5mg GB

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.

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1. What Accuretic is
and what it is used for

• 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.
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.
• Medicines to treat diabetes (including vildagliptin).
• Digitalis glycosides (e.g. digoxin, for the treatment of
heart problems).
• mTOR inhibitors used to treat kidney cancer (including
temsirolimus).
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.

Documentation

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

Pfizer Manufacturing Deutschland GmbH

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.

Druckreif:

quinapril hydrochloride and hydrochlorothiazide (HCTZ)

Ersetzt-Mat.-Nr.:

Accuretic 10/12.5 mg Tablets

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5. Draft
29.06.2016

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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

5. How to store Accuretic
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 carton and blister after EXP. The expiry date refers to
the last day of that month.
Do not store above 25°C. Store in the original package.
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 Accuretic contains
The active substances in Accuretic are quinapril and HCTZ.
Each tablet contains 10 mg of quinapril (present as 10.85 mg
quinapril hydrochloride) and 12.5 mg of HCTZ.
The other ingredients are magnesium carbonate, lactose
monohydrate (see section 2. Accuretic contains lactose
monohydrate), povidone, crospovidone and magnesium stearate.
The coating of the tablets contains candelilla wax and Opadry
pink OY-S-6937 which contains iron oxide (E172), titanium
dioxide (E171), hydroxypropyl methyl cellulose, hydroxypropyl
cellulose and polyethylene glycol.
What Accuretic looks like and contents of the pack
Accuretic tablets are oval pink, film coated tablets scored on
both sides.
The tablets are available in cartons of 7, 28, 30, 100 and
156 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ,
United Kingdom.
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
Company Contact address
For further information on this medicine, please contact
Medical Information at Pfizer Limited, Walton Oaks, Tadworth,
Surrey, UK, Tel: +44 1304 616161.
This leaflet was last revised in 05/2016
Ref: AH 23_3

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Pfizer Limited
Sandwich, England

mock up 3334.indd 2

29.06.16 08:11

Reviewed by Pharma-Print-Design

Creator: SK

Smallest Font Size 8,5 pt
Comments:

Size: 180 x 420 mm

PPD

Color: Black, Blue (PMS 541 U), Blue (PMS 277 U)
Techn. Kontrolle:

Code Nr.: XXXX

Product: PP ACCURETIC 10/12,5mg GB

XXXXXX

Page 2

Documentation

Betriebsstätte Freiburg

5. Draft
29.06.2016

Ersetzt-Mat.-Nr.:

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
40 mL/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.

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Pfizer Manufacturing Deutschland GmbH

3. How to take Accuretic

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, pharmacist or
nurse. 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. By reporting
side effects you can help provide more information on the
safety of this medicine.

Druckreif:

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.

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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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