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TRANDOLAPRIL 2 MG CAPSULES

Active substance(s): TRANDOLAPRIL / TRANDOLAPRIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANDOLAPRIL 0.5, 1 AND 2 MG CAPSULES
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.
2.
3.
4.
5.
6.

What Trandolapril is and what it is used for
What you need to know before you take Trandolapril
How to take Trandolapril
Possible side effects
How to store Trandolapril
Contents of the pack and other information

1. What Trandolapril is and what it is used for




Trandolapril belongs to a group of drugs called angiotensin-converting 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. What you need to know before you take Trandolapril
Do not take Trandolapril:
 if you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this
medicine (listed in section 6)
 if you are allergic (hypersensitive) to any other ACE inhibitors (e.g. lisinopril, ramipril)
 if you 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)
 if you are more than 3 months pregnant. (It is also better to avoid Trandolapril in early
pregnancy - see pregnancy section.)
 if you are breast-feeding

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if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.

Trandolapril is not suitable for children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trandolapril
 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)
 if you 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
 if you have been taking diuretics (water tablets) for a long time or have been on a low
salt diet
 if you have recently had severe or prolonged sickness or diarrhoea
 if you have kidney problems
 if you are on dialysis (as some types of dialysis membrane remove trandolapril from the
blood)
 if you have liver problems
 if you have diabetes mellitus
 if you have suffered from a condition known as heart failure
 if you have a condition known as connective tissue disease (lupus or scleroderma).
 if you need an operation or an anaesthetic. Tell your doctor or dentist that you are 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”.
Other medicines and Trandolapril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
 Any other medication for high blood pressure (e.g. captopril, enalapril, propranolol)
 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”.
 Diuretics (water tablets, e.g. bendroflumethiazide, amiloride, spironolactone) or
potassium supplements, other drugs which can increase potassium in your body (such as
heparin and co-trimoxazole also known as trimethoprim/ sulfamethoxazole).
 Antacids (e.g. calcium carbonate)
 Antidiabetic medicines (e.g. glibenclamide, insulin, metformin)

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Lithium or tricyclic antidepressants (e.g. dosulepin, amitriptyline)
Any of the group of medicines known as tranquillisers (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.

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” and “Warnings and precautions”).
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.
Trandolapril with food, drink and alcohol
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 recommendeded 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this 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.

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Trandolapril capsules contain lactose
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 1mg Capsules also contain sunset yellow (E110), which may cause allergic
reactions.

3. How to take Trandolapril
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure. The recommended 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 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.
Use in 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

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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. Do not take a double dose to make up for a forgotten capsule. Take the
remaining doses at the correct time.
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.
Stop taking Trandolapril capsules and see a doctor straight away if you notice any of
the following serious side effects:












Allergic reactions have been reported rarely. If you experience any sudden
wheeziness, tightness in the chest, difficulty swallowing, swelling of eyes or eyelids,
face or lips, a skin rash such as red spots or hives (skin lumps) or itching, please talk
to your doctor immediately.
Severe skin reactions including rash, ulcers in your mouth, worsening of a preexisting skin disease, reddening, blistering or detachment of skin
Heart problems such as heart attack (symptoms may include chest pain, tightness of
the chest, shortness of breath or trouble breathing), cessation of heart beat (cardiac
arrest), irregular or strong heartbeat, chest pain, abnormal heart rhythm, irregular or
faster heart rate.
Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg),
loss of coordination, nausea, or difficulty speaking or breathing (sign of brain disorder
e.g. stroke)
Inflammation of the pancreas, which causes severe pain in the abdomen and back
Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your
skin or eyes (jaundice). This may be due to inflammation of the liver or changes in the
way your liver is working.
Severe sore throat with fever.

The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
 Low blood pressure
 Headache
 Dizziness
 Cough

Uncommon (may affect up to 1 in 100 people):

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Nasal congestion (upper respiratory tract infection, inflammation and congestion
runny nose)
Diarrhoea, constipation, stomach problems
Balance disorder which makes you feel unsteady, giddy, woozy, or have a sensation
of dizziness or “spinning”
General feeling of being unwell
Difficulty in sleeping, sleepiness moving towards loss of consciousness
Reduced sex drive or erectile dysfunction
Hot flushes
Back pain, muscle spasms, pain in hands and feet
Swelling
Feeling abnormal

Rare (may affect up to 1 in 1,000 people):
 Urinary tract infection
 Reduction in red blood cells which can make the skin pale and cause weakness or
breathlessness,
 Reduction in the number of white blood cells, which makes infections more likely
 High level of blood sugar
 Low blood levels of sodium which can cause tiredness and confusion, muscle twitching,
fits or coma
 Gout
 An increase in appetite
 Abnormal liver function test
 Seeing and hearing things which are not there (hallucinations)
 Depression, difficulties sleeping, anxiety, agitation, lack of feeling, emotion, interest,
and concern
 Stroke,
 Fainting
 Pins-and-needles feeling in your skin, hot/cold sensations
 Disease of the blood vessels (angiopathy), narrowing of the blood vessels, varicose
veins
 Migraine,
 Migraine without aura (common migraine)
 Taste disturbances
 Blurred vision, eye disorder
 Ringing in the ears
 High blood pressure, disease of the blood vessels, narrowing of the blood vessels
 Swollen and enlarged veins
 Temporary loss of consciousness
 Nose bleed, throat irritation, productive cough, shortness of breath
 Bronchitis (inflammation of the upper airways)
 Vomiting of blood, inflammation of the stomach lining, vomiting, stomach pain,
indigestion, bloating , dry mouth
 Yellowing of the skin or the whites of the eyes (jaundice)
 Skin reactions including allergic reaction causing hives/sores; skin inflammation,
itchy rash, raised red patches, scaly or blistery rash
 Muscle or joint pain, muscle weakness

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Sudden reduction in kidney function
Injury

Not known (frequency cannot be estimated from the available data):
 Increased levels of potassium in the blood
 Bleeding in the brain, muscular paralysis, balance disorder
 Hair loss
 Severe reduction in the number of white blood cells which makes infections more
likely
 Severe reduction in blood cells which can cause weakness, bruising or make
infections more likely,
 Increased break down of red blood cells, which may cause fatigue
 Abnormal heartbeat
 Heart attack
 Difficulty in breathing or wheezing
 Abnormal movement in the intestines, which may cause a swollen belly, stomach pain
and constipation
 Abnormal results of blood tests or other medical examinations
The following side effects have been reported with this class of medicine (ACE inhibitors)
with an unknown frequency:
 Blood disorder with a reduction in red blood cells
 Confusion
 Sinus infection or redness and swelling of the sinuses
 Redness and swelling of the lining of the nose
 Tongue infection or redness and swelling of the tongue
 Severe allergic reaction that affects the gut and causes stomach pain (with or without
nausea and vomiting)

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
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Do not use this medicine after the
expiry date which is stated on the carton. The expiry date refers to the last day of that month.
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 contains
 The active substance is trandolapril
 Each capsule contains 0.5, 1 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 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.
OR**
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company
responsible for manufacture: Pharmachemie B.V., Haarlem, The Netherlands.
PL 00289/0800
PL 00289/0801
PL 00289/0802
This leaflet was last revised in July 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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