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TRANDOLAPRIL 4 MG CAPSULES

Active substance(s): TRANDOLAPRIL

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Trandolapril 0.5 mg, 1 mg, 2 mg and 4 mg 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 capsules contains the active substance trandolapril which 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 or 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

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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 recently had a kidney transplant
If you have been taking diuretics (water tablets) for a long time, have a restricted salt diet or are
undergoing dialysis
If you are over 70 years of age
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
If you are taking any of the following medicines, the risk of angioedema (rapid swelling under
the skin in area such as the throat) is increased:
sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors
(used to avoid rejection of transplanted organs)

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).
If you are of black origin you may have a higher risk of angioedema and this medicine may be less
effective in lowering your blood pressure than in non-black patients.
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.
Children and adolescents
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.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in
particular those so called potassium sparing such as amiloride, spironolactone and triamterene)
other drugs which can increase potassium in your body
heparin (used to thin the blood)
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co-trimoxazole also known as trimethoprim/sulfamethoxazole
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, steroid medication (e.g. prednisolone, hydrocortisone) or
anticancer medication
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
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).
Antacids (used to treat indigestion and/or heartburn)
Medicines which are most often used to avoid rejection of transplanted organs (sirolimus,
everolimus and other medicines belonging to the class of mTOR inhibitors). See section
“Warnings and precautions”.

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 Trandolapril Capsules” and “Warnings and precautions”)
Trandolapril Capsules with 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.
Sunset yellow FCF (E-110) and allura red AC (E-129) may cause allergic reactions.
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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 0.5 mg capsule once a day. The recommended maintenance
dose is one 1 mg or 2 mg capsule once a day. The maximum dose of Trandolapril Capsules is 4 mg a
day.
Following a heart attack
The recommended starting dose is 0.5 mg once a day which will be given 3-7 days after the heart
attack. The dose will then be increased to 1 mg the next day and gradually increased further up to a
maximum of 4 mg 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 0.5-1 mg 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 2 mg 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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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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.
Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin
disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic
epidermal necrolysis or erythema multiforme).
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)
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
stroke
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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 (urticaria)
loss of appetite
hair loss
psoriasis, eczema, acne, dry skin
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
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
fainting
accumulation of fluid or pus in the lungs
serious blistering skin disease (pemphigus), an autoimmune disease (in which the body is
attacked by its own immune system)
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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
swollen glands
low or no urine production
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 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:
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.

6.

Contents of the pack and other information

What Trandolapril Capsules contain
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The active substance is trandolapril (each capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg 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 1 mg and 2 mg capsules also contain the following colourants in the capsule shell:
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1 mg capsules: brilliant blue (E-133), erythrosine (E-127), allura red AC (E-129) and sunset
yellow FCF (E-110)
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2 mg 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 looks like and contents of the pack
Your medicine is in the form of hard gelatin capsules.
The 0.5 mg capsules have a white body and cap and are printed with ‘TN’ and ‘5’ in black.
The 1 mg capsules have a scarlet body and peach cap and are printed with ‘TN’ and ‘1’ in black.
The 2 mg capsules have a scarlet body and cap and are printed with ‘TN’ and ‘2’ in black.
The 4 mg 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 mg, 2 mg and 4 mg
only), 98 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
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
Actavis Ltd., BLB 016, Bulebel Industrial estate, Zejtun, ZTN 3000, Malta

This leaflet was last revised June 2017

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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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