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TRANDOLAPRIL 4MG CAPSULES

Active substance(s): TRANDOLAPRIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TRANDOLAPRIL 0.5 mg, 1 mg,
2 mg & 4 mg CAPSULES
(trandolapril)

Read all of this leaflet carefully before you start
using 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 gets 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 use Trandolapril.
3. How to use Trandolapril.
4. Possible side effects.
5. How to store Trandolapril.
6. Further information.
1. WHAT TRANDOLAPRIL IS AND WHAT IT IS USED FOR
Trandolapril, the active ingredient in Trandolapril belongs
to a group of medicines called angiotensin- converting
enzyme inhibitors (sometimes called ACE inhibitors). ACE
inhibitors work by relaxing the blood vessels which makes
it easier for the heart to pump blood around the body.
This helps to lower the blood pressure.
Trandolapril is used to treat high blood pressure. It may
also be used to protect the heart after a heart attack.
2. BEFORE YOU USE TRANDOLAPRIL
Do not use Trandolapril if:
• you are allergic to trandolapril, other ACE inhibitors
(e.g. perindopril or ramipril) or any of the other
ingredients listed in Section 6
• you have ever had the condition known as angioedema
(an itchy rash such as nettle rash or hives) or Quinke's
oedema (this is a severe allergic skin condition)
associated with administration of an ACE inhibitor
• you are more than 3 months pregnant. (It is also
better to avoid Trandolapril in early pregnancy – see
'Pregnancy' section.)
Take special care with Trandolapril if:
It is possible that you may develop problems with low
blood pressure and reduced kidney function if you are a
patient at risk being treated with Trandolapril. This may
cause you to faint. You must be placed in a side position
and someone in your surroundings must call an
ambulance or the emergency services.
Tell your doctor if:
• you have been taking diuretics ('water' tablets) for a
long time or you have been on a low salt diet
• you recently had severe or prolonged vomiting or
diarrhoea
• you ever had an allergic reaction (named Quincke's
oedema or angioedeme) to any other ACE inhibitors
(e.g. perindopril or ramipril, including swelling in the
face, lips, tongue or throat with difficulty in swallowing
or breathing)
• you suffer from a condition known as collagen vascular
disease (this is sometimes called connective tissue
disease, e.g. lupus or scleroderma)
• you suffer from diabetes mellitus
• you suffer from heart failure
• you are on kidney dialysis (some kinds of dialysis
membrane may not be suitable)
• you have liver or kidney problems including
transplantation
• you are going to be anaesthetised before an operation
• you have a narrowing of one of the valves in the heart
(aorta stenosis) or in the outflow from the left chamber
of the heart
• you are being treated with medicine that lowers your
immune response
• you develop a cough. Your doctor may choose another
medicine for you
• you are to undergo LDL apheresis (which is removal
of cholesterol from your blood by a machine)
• you are going to have desensitisation treatment to

reduce the effects of an allergy to bee or wasp stings
• you must tell your doctor 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).
Using other medicines
Other medication can affect the efficacy and safety of this
medication. On the other hand, Trandolapril can affect to
the efficacy and safety of other medication. Please tell
your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription, herbal products or
natural products. Remember to tell your doctor about
Trandolapril if you receive another medication during
your treatment or shortly after your treatment with
Trandolapril. It is especially important to inform your
doctor if you use:
• other medicines for high blood pressure including
'water' tablets such as Bendroflumethiazide
• diuretics ('water' tablets) that retain potassium such
as Spironolactone, Amiloride and Triamterene or
potassium canrenoate and potassium supplements
• anti-inflammatory pain killers (NSAIDs - e.g. ibuprofen,
diclofenac, indometacin, acetylsalicylic acid and
COX-2 inhibitors)
• lithium or tricyclic antidepressant (e.g. amitriptyline,
dosulepin)
• medicines for diabetes (such as insulin, glibenclamide or
gliclazide)
• antacids
• allopurinol (for gout) or procainamide (for abnormal
heart rhythms)
• immunosuppressants (e.g. ciclosporin), steroid
medication (e.g. prednisolone, hydrocortisone) or
anticancer medication
• antipsychotic drugs such as chlorpromazine,
thioridazine, flupentixol.
If you need to have an operation, it is important that you
tell the surgeon or dentist that you are taking Trandolapril.
It may affect the anaesthetic or other treatments used.
Contact your doctor and inform him if you are taking any
of the above medications. It may be necessary to adjust
the dose.
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
Ask your doctor or pharmacist for advice before taking
any medicine.
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.
Driving and using machines
Trandolapril can make some people feel dizzy or faint
especially when they first start to take the capsules. 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. Wait and see how the capsules
affect you.
Important information about some of the ingredients of
Trandolapril
This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine. This
medicine (in capsules of 0.5 mg, 1 mg and 2 mg) contains
sunset yellow (E110), which may cause allergic reactions.

3. HOW TO USE TRANDOLAPRIL
Always take Trandolapril exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure. Swallow your capsules whole without
chewing them and take them with a glass of water.
Always take them at the same time of day. The number of
capsules that you will need to take will depend on what
you are treated for. If you are already taking diuretics your
doctor may tell you to reduce the dose of the diuretic or
even tell you to stop taking them, before you start to take
Trandolapril.
Adults
High blood pressure (hypertension)
The usual starting dose is 0.5 mg once a day. Your doctor
will probably increase this dose to 1-2 mg daily. The
maximum dose is 4 mg a day.
Patients with heart failure
The hospital will initiate your treatment. The usual
starting dose is 0.5 mg once a day.
Treatment 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.
The elderly
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.
Children
Trandolapril should not be given to children.
Patients with kidney problems
Your doctor will adjust your dose depending on the
results of your laboratory tests (0.5-1 mg daily).
Patients in kidney dialysis
0.5 mg daily.
Patients with liver problems
The initial dose is 0.5 mg daily. Afterwards your doctor
may adjust your dose as needed.
If you take more Trandolapril than you should
Contact your doctor, hospital or pharmacy, if you have
taken too much of this medicine and you feel
uncomfortable. The symptoms of overdose are severely
reduced blood pressure, shock (swelling in the mouth and
throat which causes difficulty breathing - contact your
doctor), slowing down of thought processes (lethargy),
slow pulse, disturbances in the salt balance and reduced
kidney function.

Common side effects (occur in between 1 and 10 out of
100 treated): • dizziness • headache • weakness • cough.
Uncommon side effects (occur in between 1 and 10 out
of 1,000 treated): • noticeable heartbeats • nausea •
itching and skin rash • feeling sick and/or being sick.
Rare side effects (occur in between 1 and 10 out of
10,000 treated) and very rare side effects (occur in fewer
than 1 out of 10,000 treated): • nervousness • difficulties
sleeping • sleepiness moving towards loss of
consciousness • throat irritation • nosebleed • vomiting •
stomach pain • diarrhoea • constipation • indigestion
• fluid retention (oedema) • tendency to sweat • nettle
rash • muscle pain • hot flushes.
Side effects with unknown frequency: • changes to
blood test parameters such as liver enzymes, creatinine
and urea • allergic reaction such as itching and skin rash •
increased levels of potassium in the blood • bleeding in
the brain • muscular paralysis • temporary loss of
consciousness • shortness of breath • bronchitis • dry
mouth • inflammation in the pancreas • hair loss • severe
skin diseases (including Erythema multiforme and
Stevens-Johnson's syndrome) • fever • blood disorders
such as agranulocytosis (a condition in which there is an
insufficient number of white blood cells and therefore
infections can occur) • leucopenia (reduction in the
number of white blood cells) • pancytopenia (a reduction
of all types of blood cells, including red and white blood
cells as well as platelets) and decreased amount of
oxygen-carrying protein in the blood (haemoglobin) and
haematocrit (the proportion of space red blood cells take
up in the blood).
Other side effects that have been reported with ACE
inhibitors include kidney problems, severe drops in blood
pressure with symptoms such as fainting, chest pain or
stroke.
Allergic reactions have been reported very rarely. If you
experience any sudden wheeziness, tightness in the
chest, difficulty swallowing, swelling of eyelids, face or
lips, a skin rash such as red spots or hives (skin lumps) or
itching, please contact your doctor immediately.
If you suffer from any of these side effects or any other
side effects not mentioned in this leaflet, please talk to
your doctor or pharmacist.
5. HOW TO STORE TRANDOLAPRIL
Keep out of the reach and sight of children. Store in the
original package. Store below 25°C. Do not use after the
expiry date which is stated on the carton. The expiry date
refers to the last day of that month. 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

If you forget to take Trandolapril
Do not take a double dose to make up for a forgotten
dose.

What Trandolapril contains
The active substance is trandolapril 0.5 mg, 1 mg, 2 mg or
4 mg. The other ingredients are: lactose monohydrate,
pregelatinised maize starch, microcrystalline cellulose,
dimeticone, magnesium stearate, colloidal anhydrous
silica, gelatin, titanium dioxide (E171) and erythrosine
(E127). In addition, each strength also contains the
following: 0.5 mg: sunset yellow (E110), quinoline yellow
(E104), 1 mg and 2 mg: sunset yellow (E110), 4 mg: red
iron oxide (E172), black iron oxide (E172), yellow iron
oxide (E172).

If you stop using Trandolapril
It is important that you keep taking the capsules until
your doctor tells you to stop. Do not stop just because
you feel better. If you stop taking the capsules, your
condition may get worse.

What Trandolapril looks like and contents of the pack:
0.5 mg: light scarlet - rich yellow, size 2 oblong capsules
1 mg: light scarlet - light orange, size 2 oblong capsules
2 mg: light scarlet - light scarlet, size 2 oblong capsules
4 mg: swedish orange - light scarlet, size 2 oblong capsules.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Contents:
0.5 mg: 14 capsules. 1 mg, 2 mg and 4 mg: 28 capsules.

4. POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL.

Like all medicines, Trandolapril can cause side effects,
although not everybody gets them.
Very common side effects (occur in more than 1 out of
10 treated) and common side effects (occur in between
1 and 10 out of 100 treated): • reduced blood pressure.

Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

This leaflet was last
revised in: 02/2014

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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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