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TRANDOLAPRIL 4 MG CAPSULES

Active substance(s): TRANDOLAPRIL

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Trandolapril 0.5mg, 1mg, 2mg and 4mg Capsules
(Trandolapril)

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 or pharmacist.
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 or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Trandolapril Capsules are and what they are used for
2.
What you need to know before you take Trandolapril Capsules
3.
How to take Trandolapril Capsules
4.
Possible side effects
5.
How to store Trandolapril Capsules
6.
Contents of the pack and other information

1.

What trandolapril capsules are and what they are used for

Trandolapril belongs to a group of medicines called angiotensin-converting enzyme
inhibitors (sometimes called ACE inhibitors). These work by widening blood vessels which
makes it easier for the heart to pump blood around the body. This helps to lower blood
pressure.
Trandolapril Capsules are used to treat hypertension (high blood pressure). The capsules
may also be prescribed to protect your heart after a heart attack.

2.

What you need to know before you take Trandolapril Capsules

Do not take Trandolapril Capsules:








If you are allergic to trandolapril
If you are allergic to any of the other ingredients of this medicine (listed in section 6)
If you are allergic to other ACE inhibitors
If you are more than 3 months pregnant.(It is also better to avoid Trandolapril
Capsules in early pregnancy – see pregnancy section)
If you or someone in your family has had symptoms such as swelling of the face,
tongue or throat, intense itching, skin rashes, difficulty in swallowing and/or
breathing associated with previous ACE inhibitor treatment or have had these
symptoms in any other circumstances (this is a condition called ‘angioedema’).
If you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.

If you are unsure, talk to your doctor.
Warnings and precautions

Talk to your doctor or pharmacist before taking Trandolapril Capsules
















If you have heart problems or if you have any kidney or liver disease. Your doctor
may need to monitor you and change the dose of your medicine
If you suffer from a kidney disorder caused by the narrowing of the artery in the
kidney
If you have been taking diuretics (water tablets) for a long time, have a restricted
salt diet or are undergoing dialysis
If you have recently had severe or prolonged sickness (vomiting) or diarrhoea
If you are undergoing haemodialysis. Tell your doctor this so that a different
technique can be chosen to prevent allergic reactions
If you have a condition known as aortic stenosis (the narrowing of one of the valves
in the heart) or any other obstruction that slows the flow of blood in the heart
If you have a condition known as primary hyperaldosteronism
If you are undergoing desensitisation treatment for an insect’s sting (a bee or
wasp’s sting)
If you have diabetes
If you are undergoing blood/plasma exchange treatment for a high lipid problem
If you need an operation or an anaesthetic. Tell your doctor or dentist that you are
taking trandolapril
If you have a collagen vascular disease such as scleroderma or systemic lupus
erythematosus. Tell your doctor immediately if you develop any sort of infection
while taking trandolapril.
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 diabetes-related kidney
problems.
Aliskiren

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 Trandolapril Capsules”
You must tell your doctor if you think you are (or might become) pregnant. Trandolapril
Capsules are 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).
It is important that you tell your doctor everything about your condition and of any
problems that you may have had in the past. Tell him if you have ever reacted badly to
Trandolapril Capsules.

Trandolapril Capsules are not recommended for children.
Other medicines and Trandolapril Capsules
Tell your doctor if you are taking, have recently taken or might take any other medicines.


Diuretics (water tablets) including potassium sparing diuretics such as amiloride

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Allopurinol (a treatment for gout) or procainamide (used to correct irregular
heartbeats)
Immunosuppressants used for the treatment of auto-immune disease (e.g.
rheumatoid arthritis) or following transplant surgery
Lithium (an antidepressant)
Medicines for the treatment of high blood pressure including vasodilators
Medicines for the treatment of diabetes such as insulin and sulphonylurea tablets
Medicines or supplements containing potassium
Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin
Medicines for the treatment of depression or schizophrenia
Medicines used for the treatment of low blood pressure, shock, colds and asthma
(e.g. (pseudo)ephedrine and (nor)adrenaline).
Heparin (used to thin the blood)
Antacids (used to treat indigestion and/or heartburn)

Your doctor may need to change your dose and/or to take other precautions:
If you are taking angiotensin II receptor blocker (ARB) or aliskiren (see also information
under the headings “Do not take Trandolapril Capsules” and “Warnings and precautions”)
Trandolapril Capsules with food, drink and alcohol
It is recommended that you do not drink alcohol whilst taking Trandolapril Capsules.
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 Capsules before you become pregnant or
as soon as you know you are pregnant and will advise you to take another medicine
instead of Trandolapril Capsules. Trandolapril Capsules are 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Trandolapril
Capsules are 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 Capsules 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 Capsules. Wait and
see how the capsules affect you.
If you are unsure about anything you should discuss it with your doctor or pharmacist.
Trandolapril Capsules contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
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Sunset yellow FCF (E-110) and allura red AC (E-129) may cause allergic reactions.
3.

How to take trandolapril capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow your capsules whole with a little water without chewing them. Trandolapril
Capsules can be taken before, during or after your meal but it is recommended that you
take your capsules at the same time each day.
The number of capsules that you will need to take will depend on what you are being
treated for. If you are already taking a diuretic medicine (“water tablets”) your doctor may
tell you to reduce the dose of the diuretic or even to stop taking it before you start to take
Trandolapril Capsules. Always follow your doctor’s advice carefully.
For hypertension (high blood pressure)
The recommended starting dose is one 0.5mg capsule once a day. The recommended
maintenance dose is one 1mg or 2mg capsule once a day. The maximum dose of
Trandolapril Capsules is 4mg a day.
Following a heart attack
The recommended starting dose is 0.5mg once a day which will be given 3-7 days after
the heart attack. The dose will then be increased to 1mg the next day and gradually
increased further up to a maximum of 4mg each day.
Patients with kidney problems
If you suffer from minor kidney problems, your doctor will normally prescribe the usual
dose. However if you suffer from more serious kidney problems the maximum dose of
Trandolapril Capsules is 0.5-1mg once a day depending on severity of problem.
Patients with liver problems
If you have liver problems, the maximum dose of Trandolapril Capsules is one 2mg
capsule once a day.
If you take more Trandolapril Capsules than you should, you may cough a lot and/or
feel dizzy, anxious or faint. Your heart may also flutter or beat faster or slower than normal
and you may experience heavy or rapid breathing. You should contact a doctor
immediately or go to the nearest hospital casualty department. Remember to take the pack
and any remaining capsules with you.
If you forget to take Trandolapril Capsules at the right time, take them as soon as you
remember. However if it is almost time for your next dose do not take the missed dose at
all. Do not take a double dose to make up for a forgotten dose.
If you stop taking Trandolapril Capsules, your original symptoms may return. It is
important that you keep taking these capsules until your doctor tells you to stop. Don’t stop
just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

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4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
If you notice a rash, blistering or other effects on the skin, eyes, mouth or genitals,
itching or high temperature, you should stop taking Trandolapril Capsules and
contact your doctor immediately.
Tell your doctor immediately if:
 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:
Common (may affect up to 1 in 10 people):
dizziness/ light-headedness
headache
diarrhoea
vomiting
cough
fainting when standing up
kidney problems
weakness or loss of strength (asthenia)
Uncommon (may affect up to 1 in 100 people):
mood changes
numb or tingling hands and feet
dizziness/spinning feeling
change in sense of taste
sleeping problems
heart problems such as chest pain, heart attack, angina, heart disorder, irregular or
fast heart beat
upper respiratory tract infection
runny or stuffy nose
shortness of breath
inflamed sinuses
sore throat, hoarseness
Raynaud’s phenomenon (fingers and toes appear white or bluish and cold or numb)
feeling sick (nausea)
indigestion and stomach pain
constipation
anorexia
rash, itching
impotence
fatigue
feeling of weakness (malaise)
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-

chest pain
swelling
feeling abnormal
increases in potassium, creatinine or urea in the blood
increases in liver enzymes
inflammation of the tongue and mouth
disturbed sleep patterns (insomnia)
reduced sex drive or erectile dysfunction
stroke
back pain, muscle spams, pain in hands and feet

Rare (may affect up to 1 in 1,000 people):
dry mouth
difficulty in breathing or wheezing
serious allergic reactions causing swelling of the face, fingers/toes, tongue or throat
lumpy rash with itching
hives (urticarial)
loss of appetite
hair loss
psoriasis, eczema, acne, dry skin, skin rash (erythema multiforme)
problems with balance
blurred vision
muscle twitching
nervousness
kidney failure
toxic substances in the blood due to kidney problems
urinary tract infection
increase in the frequency and amount of urination
hot flushes
blushing
ringing in the ears
abnormal enlargement of breasts in men
changes in blood: low blood cell count, low haemoglobin, low sodium, high bilirubin
increase in protein levels in urine
anaemia (pale skin, weakness or breathlessness due to low red blood cell count)
loosening of the nails
sensitivity to light
increased risk of bleeding or bruising due to low blood platelets
increased risk of infection due to low white blood cell count
bone marrow depression leading to low blood cells production
increased numbers of white blood cells
excessive sweating
hypersensitivity
increased levels of glucose, lipids, cholesterol and uric acid in your blood
gout
increased appetite
enzyme abnormality
seeing and hearing things which are not there (hallucinations), anxiety, agitation,
apathy, mental confusion, depression
sleepiness (somnolence)
migraine with or without aura
swelling of the eyelids and eyes, blurred vision, eye disorder
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extremely sore throat (pharyngitis)
high blood pressure
disease of the blood vessels (angiopathy), narrowing of the blood vessels, varicose
veins
nosebleed
vomiting blood (hematemesis)
inflammation of the stomach lining (gastritis), wind (flatulence)
pain in the bones and joints (including osteoarthritis)
congenital arterial malformation
ichthyosis (hereditary dry skin)
injury
Very rare (may affect up to 1 in 10,000 people):
low blood sugar levels
inflammation in the lungs
inflamed pancreas
jaundice
hepatitis (inflamed liver)
abdominal pain with or without nausea and vomiting
autoimmune disease such as pemphigus (in which the body is attacked by its own
immune system)
swollen glands
low or no urine production
serious illnesses with blistering of the skin (toxic epidermal necrosis) or skin, mouth,
eyes and genitals (Stevens-Johnson syndrome))
bacterial infection in the kidneys
Not known (frequency cannot be estimated from the available data):
decrease in the number of all blood cells (pancytopenia)
fever
heart rhythm disorder (atrioventricular block), loss of heart function (cardiac arrest),
abnormal heart rhythm, disruption in the electrical signals of the heart
muscle pain
abnormal results of blood tests or other medical examinations
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.
5.

How to store Trandolapril Capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister
after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
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6.

Contents of the pack and other information

What Trandolapril Capsules contain



The active substance is trandolapril (each capsule contains 0.5mg, 1mg, 2mg or
4mg of trandolapril)
The other ingredients are povidone, lactose monohydrate, maize starch,
croscarmellose sodium and sodium stearyl fumurate. The constituents of the
capsule shell are gelatin and titanium dioxide (E-171).

In addition the 1mg and 2mg capsules also contain the following colourants in the capsule
shell:



1mg capsules: brilliant blue (E-133), erythrosine (E-127), allura red AC (E-129) and
sunset yellow FCF (E-110)
2mg capsules: brilliant blue (E-133), erythrosine (E-127) and allura red AC (E-129).

The black printing ink contains shellac, propylene glycol, purified water, potassium
hydroxide and black iron oxide (E-172).
What Trandolapril Capsules look like and contents of the pack
Your medicine is in the form of hard gelatin capsules.
The 0.5mg capsules have a white body and cap and are printed with ‘TN’ and ‘5’ in black.
The 1mg capsules have a scarlet body and peach cap and are printed with ‘TN’ and ‘1’ in
black.
The 2mg capsules have a scarlet body and cap and are printed with ‘TN’ and ‘2’ in black.
The 4mg capsules have a white body and cap and are printed with ‘TN’ and ‘4’ in black.
The capsules are available in blister packs containing 14, 20, 28, 50, 56, 84 (0.5, 2 & 4mg
only), 98 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.
Manufacturer
Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate,
Clonshaugh, Dublin 17, Republic of Ireland
or
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia, BBG06, Malta
or
Akmon Pharmaceutical Industries LLC, Industrijska cesta 1J, 1290 Grosuplje, Slovenia
or
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Actavis Ltd., BLB 016, Bulebel Industrial estate, Zejtun, ZTN 3000, Malta
This leaflet was last revised in September 2014 .

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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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