TRANDOLAPRIL 0.5 MG CAPSULES

Active substance: TRANDOLAPRIL

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TRANDOLAPRIL
0.5 mg, 1 mg AND 2 mg CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:

1. What Trandolapril is and what it is used for
2. Before you take Trandolapril
3. How to take Trandolapril
4. Possible side effects
5. How to store Trandolapril
6. Further information

1

WHAT TRANDOLAPRIL IS AND WHAT IT IS USED
FOR

• Trandolapril belongs to a group of drugs called angiotensinconverting enzyme inhibitors (ACE inhibitors). It works by
relaxing the blood vessels making it easier for the heart to
pump blood around the body. This helps to reduce blood
pressure and relieve the strain on the heart muscle.
• Trandolapril is used:
• In the treatment of high blood pressure
• To protect the heart after a heart attack.

2

BEFORE YOU TAKE TRANDOLAPRIL

Do NOT take Trandolapril if you:
• are allergic (hypersensitive) to trandolapril or any of the
other ingredients of this medicine
• are allergic (hypersensitive) to any other ACE inhibitors
(e.g. lisinopril, ramipril)
• have suffered from angioedema or Quinke’s oedema (these
are severe allergic reactions, including swelling of the face,
lips, tongue or throat with difficulty in swallowing or
breathing)
• are more than 3 months pregnant. (It is also better to avoid
Trandolapril in early pregnancy-see pregnancy section.)
• are breast-feeding.
Trandolapril is not suitable for children.
Take special care with Trandolapril
Tell your doctor before you start to take this medicine if you:
• think you are (or might become) pregnant.
Trandolapril 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)
• have a condition known as aortic stenosis (the narrowing
of one of the valves of the heart) or any other obstruction
that slows the flow of blood in the heart
• have been taking diuretics (water tablets) for a long time or
have been on a low salt diet
• have recently had severe or prolonged sickness or diarrhoea
• have kidney problems
• are on dialysis (as some types of dialysis membrane
remove trandolapril from the blood)
• have liver problems
• have diabetes mellitus
• have suffered from a condition known as heart failure
• have a condition known as connective tissue disease
(lupus or scleroderma)
• need an operation or an anaesthetic. Tell your doctor or
dentist that you are taking Trandolapril.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription:
• Any other medication for high blood pressure (e.g.
captopril, enalapril, propranolol)
• Diuretics (water tablets, e.g. bendroflumethiazide,
amiloride, spironolactone) or potassium supplements
• Antacids (e.g. calcium carbonate)
• Antidiabetic medicines (e.g. glibenclamide, insulin,
metformin)
• Lithium or tricyclic antidepressants (e.g. dosulepin,
amitriptyline)
• Any of the group of medicines known as tranquilisers (e.g.
chlorpromazine, thioridazine, flupentixol)

• Anti-inflammatory pain killers (e.g. ibuprofen, diclofenac,
indometacin)
• Sympathomimetics which may be found in decongestants
or cough/cold remedies or asthma remedies (e.g.
ephedrine, pseudoephedrine, salbutamol)
• Allopurinol (for gout) or procainamide (for abnormal heart
rhythm)
• Immunosuppressants (e.g. ciclosporin), steroid medication
(e.g. prednisolone) or anticancer agents.
If you are due to have an operation, it is important that you
tell the surgeon, dentist or nursing staff that you are taking
Trandolapril. It may affect the anaesthetic or other
treatments used.
Using Trandolapril with food and drink
You may take Trandolapril with or after food and with drink.
Drinking alcohol increases the blood pressure lowering
effect of Trandolapril. Alcohol can also reduce your reactions,
see “Driving and using machines”
.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might
become) pregnant. Your doctor will normally advise you to
stop taking Trandolapril before you become pregnant or as
soon as you know you are pregnant and will advise you to
take another medicine instead of Trandolapril. Trandolapril is
not recommended in early 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. Trandolapril 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.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Trandolapril can make some people feel dizzy or faint,
especially when they first start to take the capsules. This can be
made worse by alcohol, even in small amounts. Do not drive,
operate machinery or do anything that requires you to be alert
for several hours after your first dose or any increase in the
dose of Trandolapril. Wait and see how the capsules affect you.
Important information about some of the ingredients of
Trandolapril
Patients who are intolerant to lactose should note that
Trandolapril capsules contain a small amount of lactose. If
you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
Trandolapril 1 mg Capsules also contain sunset yellow
(E110), which may cause allergic reactions.

3

HOW TO TAKE TRANDOLAPRIL

Always take Trandolapril exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure. The usual dose is as follows:
Hypertension:
The usual starting dose is one 0.5 mg capsule, once a day.
Your doctor will probably increase this dose to one 1 mg or
one 2 mg capsule, once a day. The maximum dose of
trandolapril is 4 mg a day.
Following a heart attack:
Treatment will normally be started quite as early as the third
day after a heart attack, usually at a low dose of 0.5 mg each
day. Your doctor will probably increase this dose gradually to
a maximum of 4 mg each day.
Dose for adults treated earlier with diuretics (water
tablets):
The diuretic treatment (water tablets) should be
discontinued at least 72 hours (3 days) before beginning
treatment with Trandolapril, and/or treatment may be started
with 0.5 mg once daily. Afterwards the dose will be adjusted
when your doctor sees the effect of the treatment.
Patients that are older than 70 years of age:
It is not necessary to reduce the dose if you have normal
kidney function. You must start with a low dose, and your
doctor will watch your blood pressure and measure your
kidney function during treatment.
However, caution is needed if at the same time you are
being treated with diuretics (water tablets) or you have
reduced heart, liver or kidney function.

Patients with kidney problems:
If you have kidney problems, the maximum dose of
trandolapril should not exceed 2 mg a day.
Patients with liver problems:
The initial dose is 0.5 mg daily. Afterwards your doctor may
adjust your dose as needed.
Children:
This medicinal product is not recommended for children.
If you take more Trandolapril than you should
If you (or someone else) swallow a lot of the capsules all
together, or if you think a child has swallowed any of the
capsules, contact your nearest hospital casualty department
or your doctor immediately. An overdose is likely to cause
very low blood pressure (dizziness and fainting), shock,
unconsciousness, slow heart rate or kidney failure. Treatment
should include emptying the stomach contents and if the
blood pressure should fall too low, volume expansion should
be considered. Please take this leaflet, any remaining
capsules and the container with you to the hospital or doctor
so that they know which capsules were consumed.
If you forget to take Trandolapril
If you forget to take a capsule, take one as soon as you
remember, unless it is nearly time to take the next one. Never
take two doses together. Take the remaining doses at the
correct time.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Trandolapril can cause side effects,
although not everybody gets them.
If you develop any of the following symptoms, contact a
doctor immediately:
• you get a swollen face, tongue and/or throat, severe
reddening of the skin (hives) and/or have difficulty in
swallowing and/or breathing (angioedema)
• you feel ill after your first dose (a few people react to their
first dose and feel very dizzy, weak, faint and are sick)
• you get a lot of infections with sore throats or mouth ulcers
or if you bruise more easily while you are on this medicine.
The following side effects have been reported at the
approximate frequencies shown:
Common (affecting fewer than one person in 10 but more
than one person in 100):
• Cough
• Headaches
• Weakness
• Dizziness.
Uncommon (affecting fewer than one person in 100 but more
than one person in 1,000):
• Low blood pressure
• Irregular heartbeat (palpitations)
• Itching
• Feeling sick (nausea)
• General feeling of being unwell (malaise)
• The condition known as heart failure
• Chest pain
• Increases in creatinine (used to test your kidney function).
Rare (affecting fewer than one person in 1,000 but more than
one person in 10,000):
• Inflamed sinuses
• Runny and itchy nose
• Inflammation of the tongue
• Difficulty in breathing
• Wheezing
• Shortness of breath.
Very rare (affecting fewer than one person in 10,000):
• serious allergic reactions causing swelling of the face,
fingers/toes, tongue or throat (angioneurotic oedema).
Side effects with unknown frequency:
• Transient ischaemic attack (mini-stroke)
• faster heart beat
• irregular heart beat
• chest pain (angina)
• heart attack
• cerebral haemorrhage (bleeding in the brain)
• vomiting
• abdominal pain
• diarrhoea
• constipation
• dry mouth
• indigestion
• ileus (blockage of the intestine)












pancreatitis (inflammation of the pancreas)
hepatitis (inflammation of the liver)
jaundice (yellowing of the skin and whites of the eyes)
deterioration of kidney function
kidney failure
hair loss
sweating
bronchitis
allergic reactions with an itchy rash
serious illnesses with blistering of the skin (toxic
epidermal necrosis) or skin, mouth, eyes and genitals
(Stevens-Johnson syndrome) which may include fever and
muscle pain
• psoriasis (thickened and sore skin patches)
• abnormal liver function tests
• blood disorders may occur, which may be characterised by
pallor, fever or chills, sore throat, ulcers in your mouth or
throat
• unusual bleeding or unexplained bruising due to low
blood platelets.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5

HOW TO STORE TRANDOLAPRIL

Keep out of the reach and sight of children. Do not store
above 25°C. Store in the original package. Do not use
Trandolapril after the expiry date that is stated on the outer
packaging.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

What Trandolapril contains:
• The active ingredient is trandolapril
• Each capsule contains 0.5 mg, 1 mg or 2 mg of trandolapril
• The other ingredients are:
• 0.5 mg capsules: povidone, lactose, pregelatinised
starch, sodium stearyl fumarate. The capsule shell
contains erythrosine (E127), titanium dioxide (E171),
yellow iron oxide (E172), gelatin and quinoline yellow
(E104). The printing ink contains shellac, iron oxide black
(E172), propylene glycol
• 1 mg capsules: povidone, lactose, pregelatinised starch,
sodium stearyl fumarate. The capsule shell contains
erythrosine (E127), titanium dioxide (E171), yellow iron
oxide (E172), gelatin and sunset yellow (E110). The
printing ink contains shellac, iron oxide black (E172),
propylene glycol
• 2 mg capsules: povidone, lactose, pregelatinised starch,
sodium stearyl fumarate. The capsule shell contains
erythrosine (E127), titanium dioxide (E171), yellow iron
oxide (E172), gelatin. The printing ink contains shellac,
iron oxide black (E172), propylene glycol.
What Trandolapril looks like and contents of the pack:
• Trandolapril 0.5 mg Capsules are rich yellow and medium
orange coloured, hard capsules. The capsules are
imprinted with TD0.5
• Trandolapril 1 mg Capsules are light orange and medium
orange coloured, hard capsules. The capsules are
imprinted with TD1
• Trandolapril 2 mg Capsules are medium orange coloured,
hard capsules. The capsules are imprinted with TD2
• The product is available in the following pack sizes:
0.5 mg and 1 mg capsules: 14, 20, 28, 30, 40, 50, 60, 98,
100 and 200 capsules.
2 mg capsules: 7, 14, 20, 28, 30, 50, 56, 60, 98 and 280
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible
for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
PL 00289/0800
PL 00289/0801
PL 00289/0802
This leaflet was last revised: January 2009.

88342-A

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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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