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TRANDOLAPRIL 1 MG CAPSULES

Active substance(s): TRANDOLAPRIL

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TEVA UK Ref:

Version:

231-30 -63913-Y LEA TRANDOLAPRIL A/S CAPS TUK
4

17 July 2014

Trandolapril / UK
190 x 380 mm Side A

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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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
• 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
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)
• 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 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.

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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.
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 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.

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TRANDOLAPRIL
0.5, 1 AND 2 MG CAPSULES

TEVA UK Ref:

Version:

231-30 -63913-Y LEA TRANDOLAPRIL A/S CAPS TUK
4

17 July 2014

Trandolapril / UK
190 x 380 mm Side B

Possible side effects

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 pre-existing 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:

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Common (may affect up to 1 in 10 people):
• Low blood pressure
• Headache
• Dizziness
• Cough
Uncommon (may affect up to 1 in 100 people):
• 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
• 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

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Version 1.8

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.

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.
PL 00289/0800
PL 00289/0801
PL 00289/0802
This leaflet was last revised in July 2015

Approved

63913-Y
322K101950115

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820

4

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

Expand view ⇕

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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