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Package leaflet: Information for the user

Carace 10 Plus
Lisinopril and 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, pharmacist or nurse.

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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:

What Carace Plus is and what it is used for
What you need to know before you take Carace Plus
How to take Carace Plus
Possible Side Effects
How to Store Carace Plus
Contents of the pack and other 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.
2. What you need to know before you take Carace Plus
Do not take Carace Plus tablets if:


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 have ever had an allergic reaction to this medicine or to any
sulphonamide-derived drugs. (Ask your doctor if you are not sure what
sulphonamide-derived drugs are).
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.
If you are more than 3 months pregnant. (It is also better to avoid Carace Plus
in early pregnancy – see pregnancy section.)
You have severe liver disease
You suffer from an inability to pass water (anuria).
You have a specific type of heart disease called aortic stenosis.
You have high levels of potassium in the blood.
You have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren.

If any of the above affects you, or you are unsure if they do, tell your doctor who will
be able to advise you.
Warnings and precautions
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 had a kidney transplant
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
You have gout.
You have a condition which causes joint pain, skin rashes and fever (called
systemic lupus erythematous).
You develop jaundice (yellowing of the skin and/or the whites of the eyes).
You are diabetic (your doctor may want to monitor you for the first month of
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).

Tell your doctor if 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 diabetesrelated kidney problems

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 Carace Plus tablets if”
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.
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.
Children and adolescents
Carace Plus is not for use in children
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.
Your doctor may need to change your dose and/or to take other precautions:
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see
also information under the headings “Do not take Carace Plus tablets if:” and
“Warnings and Precautions”).
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 (e.g. aliskiren).
Mental disorders, such as lithium or antipsychotics.
Gout (such as allopurinol).
The treatment of cancer.
Abnormal heart rhythms (e.g. procainamide or sotalol).
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.
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.
Antidepressants and/or antipsychotics.
Gold therapy which is used to treat arthritis.
Muscle relaxant used during surgery (e.g. tubocurarine chloride).
Trimethoprim (used to treat urinary infections).

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
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.
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 may have a mild effect your ability to drive or operate machinery,
especially when treatment is first started or when the dose is changed and if used with
alcohol. When driving or operating machinery it should be taken into account that
occasionally dizziness or tiredness may occur.
3. How to take Carace Plus
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.
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

4. Possible Side Effects
Like all medicines, Carace Plus can cause side effects, although not everybody gets
The following terms are used to describe how often side effects have been reported:
• Very common (occurring in 1 or more of 10 patients treated)


Common (occurring in 1 or more of 100 and less than 1 of 10 patients
Uncommon (occurring in 1 or more of 1000 and less than 1 of 100
patients treated)
Rare (occurring in 1 or more of 10000 and less than 1 of 1000 patients
Very rare (occurring in less than 1 of 10000 patients treated including
isolated reports).

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 following side effects have been reported:
Common: dizziness, headache, feeling of light headedness when standing up quickly,
due to a drop in blood pressure (orthostatic hypotension) which may result in fainting,
cough, diarrhoea, vomiting, kidney problems.
Uncommon: abnormal sensations such as ‘pins and needles’, spinning sensation, taste
disturbance, changes in mood, sleep disturbances, heart attacks or stroke in some
patients (which may be due to a drop in blood pressure), fast or irregular heartbeat,
Raynaud’s syndrome (symptoms include cold fingers and toes), sneezing, nausea,
abdominal pain, indigestion, rash, itchiness, impotence, weakness and tiredness,
alterations in some laboratory blood tests.
Rare: mental confusion, dry mouth, hives and itching, hair loss, redness of the skin,
high levels of urea in the blood, kidney problems or failure, breast enlargement in
men, low levels of sodium in the blood, which may cause weakness, tiredness,
headache, feeling sick, being sick (vomiting) and cramps.
Very rare: There have been very rare reports of blood disorders which may cause
fever or chills, sore throats, ulcers in your mouth or throat, unusual bleeding or
unexplained bruises. Swollen lymph nodes, low blood sugar, bronchitis, painful
sinuses, difficulty breathing, inflammation of the pancreas, hepatitis (causing nausea,
fever and dark urine), jaundice ( yellowing of the skin and/or whites of eyes), liver
failure, profuse sweating, blisters, skin problems including redness and shedding of
skin and painful areas, change in urine volume.
Very rarely, it has been reported that in some patients the undesirable development of
hepatitis has progressed to hepatic failure. If you develop jaundice, you should tell
your doctor straight away.
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.
Other side effects (frequency unknown): depression, pain and swelling of the salivary
glands, loss of appetite (anorexia), presence of sugar in the urine, increased
cholesterol, gout, restlessness, transient blurred vision, vertigo (spinning sensation),

fluid on the lungs, constipation, sensitivity to light, unusual bleeding or bruising under
the skin.
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.
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:
By reporting side effects you can help provide more information on the safety of this
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
6.Contents of the pack and other 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.

Marketing Authorisation Holder and Manufacturer
Manufactured by:
Merck, Sharp & Dohme Limited,
Shotton Lane, Cramlington,
Northumberland NE23 3JU, United Kingdom
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited,


Hertford Road, Hoddesdon,
EN11 9BU, United Kingdom
This leaflet was last revised in October2014
© Merck Sharp & Dohme Limited 2014. All rights reserved.

PIL.CAR10PLUS.14.UK.4199-RAS Blockade


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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.