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TRANDOLAPRIL 4MG CAPSULES

Active substance(s): TRANDOLAPRIL / TRANDOLAPRIL / TRANDOLAPRIL

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Trandolapril 4mg Capsules
Your medicine is known by the above name but will be referred to as
Trandolapril throughout this leaflet. This medicine is also available in
0.5mg, 1mg and 2mg strengths.
Patient Information Leaflet
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto
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 take Trandolapril.
3) How to take 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 take 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 breastfeed, 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.

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.
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
If you forget to take Trandolapril
Do not take a double dose to make up for a forgotten dose.
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.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4) Possible side effects
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.
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 StevensJohnson'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.






Keep 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 and blister. The expiry date refers to the last day of the 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.
• If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

6) Further Information
What Trandolapril contains:
The active substance is trandolapril. Each capsule contains 4mg of
trandolapril.
The other ingredients are: lactose monohydrate, pregelatinised maize
starch, microcrystalline cellulose, dimeticone, magnesium stearate,
colloidal anhydrous silica, gelatin, titanium dioxide (E171), erythrosine
(E127), red iron oxide (E172), black iron oxide (E172) and yellow iron
oxide (E172).
What Trandolapril looks like and contents of the pack
Trandolapril 4mg capsules are swedish orange - light scarlet, oblong
capsules, containing white powder.
They come in blister packs containing 28 tablets.
PL 10383/2197 Trandolapril 4mg Capsules

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 18.01.2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

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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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