CARACE 20 PLUS

Active substance: LISINOPRIL DIHYDRATE

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Patient Information Leaflet

Carace® 20 PlusLisinopril 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® 20 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. 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.
8247

• 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.
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, potassiumcontaining salt substitutes or are on a low-salt diet.
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.
XXXXX/XXXXXX-X



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),
overproduction of a hormone causing fluid retention, resulting in
weakness, tiredness or confusion, 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 25°C.
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® 20 Plus tablet contains lisinopril 20mg, as the dihydrate and
12.5mg hydrochlorothiazide as the active ingredients. In addition Carace®
20 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 tablets are available in calendar packs of 28 tablets.

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,
Hertfordshire
EN11 9BU, United Kingdom
Date of preparation: December 2011
© Merck Sharp & Dohme Limited 2011. All rights reserved.
PIL.CAR-PLUS.11.UK.3558(0000)
XXXXX/XXXXXX-X

For Position Only

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.
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’.

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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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