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ACCURETIC TABLETS 10/12.5 MG

Active substance(s): HYDROCHLOROTHIAZIDE / QUINAPRIL

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You suffer from allergies or asthma

PACKAGE LEAFLET: INFORMATION FOR THE USER



ACCURETIC TABLETS 10/12.5
(quinapril hydrochloride and hydrochlorothiazide)

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



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.



The active ingredient hydrochlorothiazide can cause an unusual
reaction resulting in 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.

461 LEAFLET Accuretic 20150227

Your medicine is known as Accuretic 10/12.5mg Tablets but will be
referred to as Accuretic throughout the following leaflet.
Important things that you SHOULD know about your medicine:


Accuretic is a treatment for high blood pressure.



Read all of this leaflet carefully before you start taking this
medicine.



Keep this leaflet. You may need to read it again.



This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



You should take Accuretic regularly to get the maximum benefit,
even if you are feeling well.



Most people do not have serious problems when taking
Accuretic but side effects can occur – see Section 4 for details.
If you experience swelling of the face, tongue or throat, see
your doctor immediately. If any of the side effects gets serious,
or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.





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.

Please read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that might
be especially important to you. If you have any further questions,
ask your doctor or pharmacist.
In this leaflet:

If this is not treated, it can lead to permanent loss of vision. If
you experience any such symptoms, you should seek
immediate medical attention.




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 also taking other medicines.

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. 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’).

3. How to take Accuretic



Other blood pressure treatments and diuretics (water tablets).

4. Possible side effects



Medicines to treat infections called tetracyclines.

5. How to store Accuretic



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



Anaesthetics.

1. WHAT ACCURETIC IS AND WHAT IT IS USED FOR



Lithium (used to treat depression).

Accuretic is used to treat high blood pressure.



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



Corticosteroids (for example hydrocortisone, dexamethasone or
prednisolone) and ACTH (tetracosactide).



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 (for the treatment of chronic
gout).



Indigestion and heartburn medicines (antacids).



Drugs that have a sedative effect. This includes alcoholic drinks
and sleeping pills.



Drugs to treat diabetes.



Digitalis glyocsides (for the treatment of heart problems).

1. What Accuretic is and what it is used for
2. Before you take Accuretic

6. Further information

Accuretic contains the active ingredients quinapril and
hydrochlorothiazide. 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. Hydrochlorothiazide
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’.
2. BEFORE YOU TAKE ACCURETIC




Do not take Accuretic
If you ever had a reaction to Accuretic, any of its ingredients,
similar drugs or to a group of antibiotics called sulphonamides.



If you are pregnant, trying to become pregnant, or are of child
bearing potential and are not using adequate contraception.



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).

You should always tell your doctor if you are taking or have recently
taken any other medicine, even those not prescribed, because they
might interact with Accuretic.
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.



If you have a history of angiooedema 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.

Accuretic can be taken with or without food.

Warnings and precautions

Do not take Accuretic if you are pregnant or trying to become
pregnant. Ask your doctor for advice before taking any medicine.



Talk to your doctor or pharmacist before taking Accuretic.
If any of the following statements applies to you, and you have not
already discussed the matter with your doctor, you must contact
your doctor before taking Accuretic, as this medicine may not be
suitable for you:


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



You are elderly



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).





Taking Accuretic with food and drink

Pregnancy

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breastfeeding. Your doctor will advise you on the benefits and risks of
taking Accuretic whilst breast-feeding and decide whether or not
you should continue taking Accuretic.



Driving and using machinery:

Your tablets may affect your ability to drive or operate machinery
safely. They may make you feel dizzy or weary. If affected, do not
drive or operate machinery and contact your doctor immediately.
Important information about some of the ingredients in
Accuretic
Accuretic contains 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 ACCURETIC
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 should not be used in children and adolescents under 18
years of age.



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

Swallow the tablets whole with water. Do not chew, divide or
crush the tablets.

 viral infection
Rare side effects

If you are still not sure, ask your doctor or pharmacist.

These can affect up to 1 in every 1000 people:

It is important to keep taking your tablets. They help to control your
blood pressure.



problems with balance



inflammation of the lungs which can cause breathlessness,
cough and raised temperature



constipation



inflammation of the tongue

Don‘t wait until your tablets are finished before seeing your doctor.
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 miss a dose of 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 missed dose.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Accuretic 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. Although they are
very rare, 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).



Heart attack (symptoms may include chest pain, tightness of
the chest, shortness of breath or trouble breathing), speeding
up of the heart rate



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).

 inflammation of blood vessels
Very Rare side effects
These can affect up to 1 in every 10,000 people:


obstruction of the digestive system (bowel)

 blurred vision
Other side effects (how often they happen is not known):


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).

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 any of these side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
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.

Tell your doctor immediately if you experience any of the following
symptoms after taking Accuretic. Although they are very rare, these
symptoms can be serious.

5. HOW TO STORE ACCURETIC


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





Do not store above 25°C.



Do not use the tablets after the expiry date on the package. For
example "Expiry 11-05" means you should not take your tablets
after Nov 2005. Return any out-of- date tablets to your
pharmacist.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.



Chest pain (angina), tightness of the chest, shortness of breath,
wheezing or trouble breathing, irregular or strong heartbeat
(palpitations).



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
These can affect up to 1 in every 10 people:

6. FURTHER INFORMATION
What Accuretic contains


Each film-coated tablet contains 10mg quinapril (as the
hydrochloride) and 12.5mg of hydrochlorothiazide.



Accuretic also contains the following inactive ingredients:
lactose monohydrate, heavy magnesium carbonate, povidone,
magnesium stearate, crospovidone. Film Coat: pink opadry OY6937, candelilla wax.

What Accuretic looks like and contents of the pack



diarrhoea, indigestion, mild stomach pain, feeling or being sick

Accuretic tablets are pink, elliptical film-coated tablet scored on both
sides.



dizziness, headache, tiredness, feeling weak, sleepiness or
sleeplessness

Accuretic Tablets are available as calendar blister packs of 28
tablets.



painful muscles, muscle weakness, back pain,

Product Licence holder



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



coughing, bronchitis

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex, HA0 1DX.



nose or throat infections, nasal stuffiness and/or runny nose
(rhinitis)

 widening of blood vessels
Uncommon side effects:
These can affect up to 1 in every 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)



fainting, low blood pressure

Manufacturer
This product is manufactured by Pfizer Manufacturing Deutschland
GmbH Betriebstatte Freiburg, Mooswaldallee 1, D-79090 Freiburg,
Germany.
POM

PL No: 08747/0461

Leaflet revision date: 27 February 2015
Accuretic is a registered trade mark of Parke, Davis & Company
LLC.
461 LEAFLET Accuretic 20150227

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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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