CARACE 10 PLUS

Active substance: LISINOPRIL DIHYDRATE

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Patient Information Leaflet

Carace 10 Plus
Lisinopril and Hydrochlorothiazide
Please read this leaflet carefully before you start taking your medicine.
This leaflet provides a summary of the information available on your medicine.
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. If you want to know
more or are not sure ask your Doctor or Pharmacist.
In this leaflet:
1.
What Carace® Plus is and what it is used for
2.
Before taking your medicine
3.
Taking your medicine
4.
Possible Side Effects
5.
How to Store your Medicine
6.
Further Information

1.

What Carace Plus is and what it is used for




The name of your Medicine is Carace 10 Plus (called Carace Plus in this leaflet).
Each Carace Plus tablet contains lisinopril and hydrochlorothiazide.
Lisinopril belongs to the group of drugs called angiotensin converting enzyme
inhibitors (ACE inhibitors). These medicines work by helping to widen your blood
vessels to make it easier for your heart to pump blood through them to all parts of
your body.
Hydrochlorothiazide belongs to the group of drugs called diuretics (water tablets).
These medicines increase the amount of water you lose in your urine and therefore
reduce the amount of fluid in your blood vessels.


Carace Plus is used to treat high blood pressure. If high blood pressure is left

uncontrolled it can increase the risk of heart disease or a stroke. Carace Plus works
by lowering your blood pressure which reduces this risk.

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2.

Before taking your medicine


Do not take Carace Plus tablets if:











If you are more than 3 months pregnant. (It is also better to avoid Carace Plus
in early pregnancy – see pregnancy section.)
You have ever had an allergic reaction to this medicine or to any of its
ingredients.
You have previously been treated with a medication in the same group of

medicines as Carace (ACE inhibitors) and have had allergic reactions with
symptoms such as swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing.
You suffer from hereditary or idiopathic angioedema (very bad swelling of
your skin especially around the eyes, lips, nose, tongue, voicebox (larynx) or
hands). This means you were either born with this illness or your doctor does
not know what causes it.
You have a specific type of heart disease called aortic stenosis.
You have high levels of potassium in the blood.
You are allergic to any sulphonamide-derived drugs. (Ask your doctor if you
are not sure what sulphonamide-derived drugs are).
You suffer from an inability to pass water (anuria).


Carace Plus is not for use in children
If any of the above affects you, or you are unsure if they do, tell your doctor who will
be able to advise you.
You must tell your doctor if:











You have or have had any medical problems or any allergies.
You suffer from liver, kidney or heart disease.
You are undergoing dialysis.
You have recently suffered from excessive vomiting or diarrhoea.
You have been told you have abnormal levels of the following natural body
chemicals: potassium, calcium, urea, creatinine, uric acid, cholesterol or
triglycerides.
You have gout.
You have a condition which causes joint pain, skin rashes and fever (called
systemic lupus erythematous).
You think you are (or might become) pregnant. Carace Plus 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).

If you are about to have desensitisation treatment, that is treatment to reduce the
effects of an allergy to bee or wasp stings, you should tell the doctor who is treating

you that you are taking Carace Plus.
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If you are about to have a treatment for the removal of cholesterol from your blood by
a machine, (called LDL apheresis), you should tell the doctor who is treating you that

you are taking Carace Plus.
If you are due to have surgery
Before surgery and anaesthesia (even at the dentists) you should tell the doctor or

dentist that you are taking Carace Plus as there may be a sudden fall in blood
pressure.


Taking Carace Plus with other medicines
Always tell your doctor about other medicines you may be taking or have recently
taken including those obtained without a prescription. Some medicines can have an
effect on each other's actions. It is especially important that you tell your doctor if you
are taking medicines for:










Diabetes such as insulin or tablets to lower blood sugar.
Mental disorders, such as lithium or antipsychotics.
Gout (such allopurinol).
The treatment of cancer.
Abnormal heart rhythms (e.g. procainamide).
Indigestion (e.g. antacids).
Hypertension, shock, heart failure, asthma or allergies (e.g. ephedrine,
noradrenaline or epinephrine (adrenaline)).
Helping you to sleep or reduce anxiety (sedatives).
High blood cholesterol (medicines called colestyramine or colestipol).

Or if you are taking:









Any diuretics (water tablets). If you are already taking a diuretic your doctor
may tell you to reduce the dose of the diuretic, or even tell you to stop taking

them, before you start taking Carace Plus.
Steroids to treat various conditions including rheumatism, arthritis, allergic
conditions, certain skin disease, asthma or a blood disorder.
Non-steroidal anti-inflammatory drugs (NSAID) (a type of pain killer e.g.
indomethacin).
A narcotic pain killer (e.g. codeine, dextropopoxyphene, diamorphine,
morphine, pentazocine, pethidine).
Medicines that suppress your immune system following surgery (e.g.
ciclosporin) or some autoimmune disorder such as rheumatoid arthiritis
ACTH to test whether your adrenal glands are working properly.
potassium supplements, potassium-sparing agents, potassium-containing salt
substitutes or are on a low-salt diet.

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Please note that when you are taking Carace Plus it may affect any tests your doctor
may perform on blood or urine samples. Please remind your doctor you are taking

Carace Plus if they ever want to carry out such a test.
Pregnancy and Breastfeeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your
doctor will normally advise you to stop taking Carace Plus before you become
pregnant or as soon as you know you are pregnant and will advise you to take another
medicine instead of Carace Plus. Carace Plus 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Carace Plus
is not recommended for mothers who are breast-feeding, and your doctor may choose
another treatment for you if you wish to breast-feed, especially if your baby is
newborn, or was born prematurely.
Taking with Food and Drink
You can drink alcohol while taking this medicine, however, medicines used to reduce
blood pressure taken together with alcohol may cause dizziness or light-headedness.
If you are concerned about how much alcohol you can drink while you are taking

Carace Plus you should discuss this with your doctor.
Driving or operating machinery
Carace® Plus should not affect your ability to drive or operate machinery, however, if
you feel tired or dizzy you should not do so until you have discussed it with your
doctor.

3.

Taking your Medicine


Take Carace Plus as your doctor has instructed. Your pharmacist may also help if
you are not sure.
The usual dosage is one tablet taken once a day, taken at the same time each day.


Carace Plus can be taken at any time of the day before, during, or after a meal.
Choose a time that is convenient for you and take your tablet at this time every day.
Be especially careful when you take your first dose or if your dose is increased. Let
your doctor know as soon as possible if you feel any dizziness or light-headedness.

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The effect of Carace Plus tablets lasts 24 hours so you only need to take the tablets
once a day.
Take the tablet for the day marked on the calendar pack. This will help you to
remember whether you have taken your tablet for that day.
Keep taking your tablets until your doctor tells you to stop.


If you take more Carace Plus than you should
If you take too many tablets seek medical attention immediately. The most likely
symptoms of overdose would be a feeling of lightheadedness or dizziness due to a
drop in blood pressure.


If you forget to take Carace Plus
If you forget to take a tablet, DO NOT WORRY – just take the next day’s tablet when
it is due. DO NOT take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your Doctor or
Pharmacist

4.

Possible Side Effects.


Most people find that Carace Plus tablets are suitable for them. However, as with all

medicines, Carace Plus can cause unwanted effects, although not everybody gets
them.
Stop taking the tablets and tell your doctor immediately if you get any of the
following symptoms: swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing. These may be signs of an allergic reaction.


The most common side effect experienced with Carace Plus is dizziness. Other less
frequent side effects are headache, tiredness, dry cough and a feeling of
lightheadedness when standing up quickly, due to a drop in blood pressure
(orthostatic hypotension). This may result in fainting.
Other less common side effects are diarrhoea, nausea, vomiting, dry mouth, rash, gout,
fast or irregular heartbeat, inflammation of the pancreas, chest discomfort, impotence,
muscle cramps and weakness and abnormal sensations such as ‘pins and needles’.
Other side effects include heart attacks or stroke in some patients (which may be due
to a drop in blood pressure), chest pain, difficulty breathing, bronchitis, severe
abdominal pain, hepatitis (causing nausea, fever, dark urine), jaundice (yellowing of
the skin and/or whites of eyes), constipation, indigestion, high levels of urea in the
blood, change in urine amount, kidney problems or failure, skin problems including
itchiness, rah or painful areas (cutaneous pseudolymphoma), , low levels of sodium in

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the blood, which may cause weakness, tiredness, headache, feeling sick, being sick
(vomiting) and cramps,, pain and swelling of the salivary glands, anaemia (low
number of red blood cells), muscle pain/spasm, fever, fluid on the lungs and serious
allergic (anaphylactic) reactions.
Changes in mood, mental confusion, vertigo, restlessness, loss of appetite (anorexia),
hives and itching, sensitivity to light, hair loss, redness of the skin, blisters and
blurred vision have also been reported.
There have been rare reports of blood disorders which may cause fever or chills, sore
throats, ulcers in your mouth or throat, unusual bleeding or unexplained bruises.
A condition with a group of symptoms including fever, muscle and joint pain and
inflammation of the blood vessels has been reported. The skin may also be sensitive
to light and a rash may occur.
If any of the side effects become serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist immediately. It will help if you
make a note of what you experienced, when it started and how long it lasted.

5. How to Store your Medicine
Do not store your tablets above 25oC.
Store in the original packaging.
Please check the expiry date of the product, shown on the carton and on the blister
pack. Do not use after the month stated.
Keep your medicines out of the reach of children.
If you are told to stop taking this medicine, return any unused tablets to your
pharmacist.

6. Further Information


What Carace Plus contains


Each Carace 10 Plus tablet contains lisinopril 10mg, as the dihydrate and 12.5mg

hydrochlorothiazide as the active ingredients. In addition Carace 10 Plus tablets
contain the following inactive ingredients: mannitol, calcium phosphate dibasic
dihydrate, yellow ferric oxide (E 172), pregelatinised starch, magnesium stearate.


What Carace Plus looks like and the contents of the pack
Carace 10 Plus tables are blue hexagonal biconvex tablets with product code ‘145’ on
one side.

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Carace tablets are available in calendar packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Manufactured by:
Merck, Sharpe & Dohme Limited,
Shotton Lane, Cramlington,
Northumberland NE23 3JU, United Kingdom
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire
EN11 9BU, United Kingdom
Date of preparation: February 2013
© Merck Sharp & Dohme Limited 2013. All rights reserved.
PIL.CAR10-PLUS.13.UK.3809

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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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