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GOPTEN 0.5MG CAPSULES

Active substance(s): TRANDOLAPRIL

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GOPTEN®
0.5, 1, 2 & 4 mg
Capsules
T

1. What is Gopten & what does it do?

GOPTEN®
0.5mg
Capsules
(trandolapril)

IMPORTANT INFORMATION
Read all of this leaflet carefully before you
start taking this medicine
Keep this leaflet as you may need to read it again
This leaflet provides a summary of the
information currently available about Gopten
For further information or advice ask your doctor
or pharmacist
This medicine is for you only and should never
be given to anyone else, even if they appear
to have the same symptoms as you
Tell your doctor or pharmacist if you experience
any side effects

The name of your medicine is Gopten 0.5mg
Capsules but will be referred to as Gopten throughout
the remainder of this leaflet.
This product is also available in other strengths as
hat does
1mg,
2mg iand 4mg capsules.
t do?

Gopten belongs to a group of medicines called angiotensinconverting enzyme (or ACE) inhibitors. They work by relaxing
blood vessels, making it easier for the heart to pump blood
around the body and lowering blood pressure.
Gopten capsules are used to treat high blood pressure
(hypertension).
The capsules may also be prescribed to protect your heart
after a heart attack.

2. What should you know before taking Gopten ?
DO NOT TAKE GOPTEN if you:
Are more than 3 months pregnant. (It is also better
to avoid Gopten in early pregnancy -see pregnancy
section.)
Suffer from any obstruction that slows the flow of
blood in the heart, such as narrowing of the one of
the valves in the heart (aortic stenosis).
Have ever suffered from a severe allergic reaction
called angioedema, involving a skin condition
(urticaria) and swelling mainly affecting the face,
extremities, tongue, mouth and throat.
Are allergic (sensitive) to trandolapril or any of the
ingredients in Gopten capsules.
TELL YOUR DOCTOR BEFORE YOU TAKE GOPTEN
They may need to adjust your dose, if you:
have been taking diuretics (water tablets) for a long time
or have been on a low salt diet.
have recently had severe or prolonged sickness or
diarrhoea.
have been told by a doctor that you have an intolerance to
some sugars. Gopten contains lactose and it may not be
suitable for you if you have a hereditary intolerance to
lactose.

have suffered from an allergic reaction to any other ACE
inhibitor, such as swelling of the face, lips, tongue or
throat with difficulty swallowing or breathing.
Are suffering from any of the following: liver or kidney
problems including dialysis (certain dialysis membranes
should not be used in patients being treated with Gopten
capsules); diabetes mellitus; heart failure or collagen
vascular disease (connective tissue disease).
If you are receiving LDL-apheresis or desensitisation
treatment against animal venoms.
TAKING OTHER MEDICINES
Before taking Gopten it is important to tell your doctor if
you are taking ANY other medicine, even those you may
have bought yourself without a prescription. They may
alter the way Gopten works in your body and/or require
your dose to be adjusted. This is particularly true for:
water tablets (diuretics) and any other medicines for high
blood pressure;
potassium supplements;
anti-inflammatory pain killers (or NSAIDs), such as
ibuprofen or aspirin;
drugs used to treat depression or mood swings (e.g.
lithium, neuroleptic or tricylic antidepressants);
sympathomimetics (found in some decongestants,
cough/cold remedies and asthma medications);
antacids (used to treat indigestion and/or heartburn);
drugs used to lower the body’s immune system
(immunosuppressant agents);
drugs used in the treatment of cancer (cytostatic agents),
gout (e.g. allopurinol), severe asthma (corticosteroids)
and abnormal heart rate (e.g. procainamide);
antidiabetic medicines (e.g. insulin and oral
hypoglycaemics);
injectable gold therapy for arthritis.

OTHER IMPORTANT INFORMATION
If you need to have an operation it is important to tell the
surgeon or dentist, Gopten may affect the anaesthetic or
other treatments used.
If you have a blood or urine test, remember to tell the
doctor or nurse you are taking Gopten as it may affect
the results.
Gopten is NOT suitable for children.
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 Gopten before you become pregnant or as
soon as you know you are pregnant and will advise you
to take another medicine instead of Gopten.
Gopten 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. Gopten 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
MACHINERY
It is NOT advisable to drive
or Operate machinery for
several hours after your first
dose or an increase in the
dose of Gopten.

3. How should you take GOPTEN?
ALWAYS take Gopten exactly as your doctor has told you.
If you are not sure refer to the label on the carton or check
with your doctor or pharmacist. Your dosage will depend
on what you are being treated for:
Hypertension (high blood pressure)
The usual starting dose is one 0.5mg capsule once a
day. Your doctor will probably increase this dose to one
1mg or 2mg capsule once a day. The maximum dose of
Gopten is 4mg a day.
Following a heart attack
Treatment will normally be started quite soon after a heart
attack, usually at a low dose of 0.5mg each day. Your
doctor will probably increase this dose gradually to a
maximum of 4mg each day.
TAKE YOUR GOPTEN CAPSULES with a glass of water.
You should swallow the capsules whole
without chewing them. They may be taken
with or without food.
IF YOU TAKE MORE GOPTEN THAN
PRESCRIBED
you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your capsules
with you.
IF YOU FORGET TO TAKE YOUR GOPTEN CAPSULES
take them as soon as you remember, unless it is almost
time for your next dose. If it is, do not take the missed
dose at all. Never double up on a dose to make up for the
one you have missed.
IF YOU STOP TAKING GOPTEN your condition may get
worse. It is important that you keep taking these capsules
until your doctor tells you to stop. Do NOT stop just
because you feel better

4. Possible side effects of Gopten Capsules.
INFORMATION ABOUT POSSIBLE
SIDE EFFECTS
As with all medicines, Gopten can cause side effects,
although not everyone will suffer from them. Gopten can
make some people feel dizzy or faint, especially when they
first start to take the capsules.
If any side effects become serious, or if you notice any
side effects that are not listed in this leaflet, please tell
your doctor or pharmacist.
CONTACT YOUR DOCTOR IMMEDIATELY and
STOP taking the capsules if you develop:
harsh or noisy breathing
swelling of your face, extremities, tongue, mouth or
throat (angioedema)
CONTACT A DOCTOR AS SOON AS POSSIBLE if
you develop any of the following symptoms:
yellowing of the eyes and/ or skin
severe sore throat with high fever
severe abdominal pain with bloating and vomiting
In clinical trials in patients with hypertension or in
patients following myocardial infarction the observed
side effects include:
Common (less than 1 per 10 but more than 1 per 100)
Headache
Dizziness
Cough
Weakness
Hypotension (low blood pressure)
Uncommon (less than 1 per 100 but more than 1 per 1000)
Sensation of pounding or fluttering in the chest
(palpitations)

Feeling sick (nausea)
Low blood pressure (hypotension)
Rash, itching
Malaise (a feeling of bodily discomfort)
Heart failure
Increased creatinine
Other side effects that have been reported for
trandolapril or other ACE inhibitors include:
Upper respiratory tract infections
Lack of iron (anaemia)
High level of uric acid in blood
Sleeping problems, depression, lack of sex drive
Mini stroke (transient ischaemic attack)
Drowsiness
Loss of consciousness
Involuntary twitching of a muscle
Migraine
Altered taste
Confusion
Visual disturbance
Ringing in ears (tinnitus)
Balance disorder which makes you feel unsteady, giddy,
woozy, or have a sensation of movement, spinning, or
floating (vertigo)
Heart problems including heart attack, chest pain, heart
failure, irregular heartbeat, fast heart beat and slow
heartbeat
Disruption in the electrical signals of the heart and loss of
heart function (cardiac arrest)
Rupturing of a blood vessel in the brain (cerebral
haemorrhage), hot flush
Narrowing or blockage of arteries mostly in the legs and
arms
Upper respiratory tract inflammation/congestion (e.g
nasal congestion); nose bleed

Contraction of the bands of muscles around your airways
(bronchospasm), sore throat, shortness of breath and
chest infection (bronchitis)
Inflammation of the sinuses (sinusitis), runny nose
(rhinitis), Swelling of the tongue (glossitis)
Vomiting, abdominal pains, diarrhoea, constipation, dry
mouth, indigestion, blockage of small or large intestine
(ileus)
Inflammation (pancreatitis) of the pancreas
Hepatitis (liver inflammation) and cholestatic jaundice
Itching, a rash, or itchy weals (raised skin lumps with
inflammation around them), any kind of skin inflammation
on the outer or inside linings of your body. Patches of
thickened red skin with silvery looking scales, hair loss or
any other very severe skin reactions. These symptoms
may also be accompanied by fever, muscle pain or joint
pain.
Increase sweating
Back pain, muscle spasm and pain in arms and/or legs
Abnormally frequent urination, kidney problems
Impotence
Chest pain, swelling, feeling abnormal and tiredness
Swelling of the tissue in the intestinal tract (Intestinal
Angioedema)
Gopten may cause certain changes in your blood and your
doctor may do blood tests to monitor this. The following
changes have occurred in some patients taking Gopten
An increase in creatinine or blood urea nitrogen
(substances which can tell how well your kidneys are
working).
An increase in liver enzymes and serum bilirubin
(substances which can tell how well your liver is
working).
A lack of certain white blood cells which may lead to
infection, sore throat or fever (Agranulocytosis).
A decrease in the number of all types of blood cells
(pancytopenia).

Decreased haemoglobin (anaemia).
Haemolytic anaemia (anaemia due to ruptured blood
cells).
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 any 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.

6. Further information about Gopten
Gopten ingredients:
The active substance(s) is trandolapril.
The other ingredient(s) are lactose, maize starch,
povidone, sodium stearyl fumarate, gelatin, titanium
dioxide (E171), erythrosine (E127), yellow iron oxide
(E172) and sodium lauryl sulphate.
GOPTEN CALENDAR PACK CONTAINS:

5. How should you store Gopten?
Type of pack
Keep out of the reach and sight of
children.
Store in a dry place.
Do NOT use Gopten after the
expiry date shown on the carton.
The date refers to the last day of
that month.
If your doctor decides to stop your
treatment, return any left over
capsules to your pharmacist. Only
keep the capsules if your doctor
tells you to. Do NOT dispose of
left over capsules carelessly (e.g.
down the toilet or in with your
general rubbish)
If your capsules become discoloured or show any signs of
deterioration, you should seek the advice of your
pharmacist.

Gopten 0.5mg

Capsules
per pack
28

Capsule
Colour
Red & yellow

The capsules are hard gelatin, opaque capsules with a
red coloured body and a yellow coloured cap.
Manufacturer: Abbott GmbH & Co. KG, Knollstrasse 50,
67061 Ludwigshafen, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Gopten 0.5mg Capsules – PL No: 18799/0863
Gopten is a registered Trademark of Abbott
Leaflet date: 19.09.2014

POM

GOPTEN®
0.5, 1, 2 & 4 mg
Capsules
T

Trandolapril 0.5mg
Capsules

1. What is Trandolapril & what does it do?
Trandolapril belongs to a group of medicines called
angiotensin- converting enzyme (or ACE) inhibitors. They work
by relaxing blood vessels, making it easier for the heart to
pump blood around the body and lowering blood pressure.
Trandolapril capsules are used to treat high blood pressure
(hypertension).
The capsules may also be prescribed to protect your heart
after a heart attack.

IMPORTANT INFORMATION
Read all of this leaflet carefully before you
start taking this medicine
Keep this leaflet as you may need to read it again
This leaflet provides a summary of the
information currently available about Trandolapril
For further information or advice ask your doctor
or pharmacist
This medicine is for you only and should never
be given to anyone else, even if they appear
to have the same symptoms as you
Tell your doctor or pharmacist if you experience
any side effects
The name of your medicine is Trandolapril 0.5mg
Capsules but will be referred to as Trandolapril
throughout the remainder of this leaflet.
This product is also available in other strengths as
1mg,
2mg iand 4mg capsules.
hat does
t do?

2. What should you know before taking
DOTrandolapril ? NOT TAKE TRANDOLAPRIL if you:
DO NOT TAKE TRANDOLAPRIL if you:
Are more than 3 months pregnant. (It is also better
to avoid Trandolapril in early pregnancy -see
pregnancy section.)
Suffer from any obstruction that slows the flow of
blood in the heart, such as narrowing of the one of
the valves in the heart (aortic stenosis).
Have ever suffered from a severe allergic reaction
called angioedema, involving a skin condition
(urticaria) and swelling mainly affecting the face,
extremities, tongue, mouth and throat.
Are allergic (sensitive) to trandolapril or any of the
ingredients in Trandolapril capsules.
TELL YOUR DOCTOR BEFORE YOU TAKE
TRANDOLAPRIL
They may need to adjust your dose, if you:
have been taking diuretics (water tablets) for a long time
or have been on a low salt diet.
have recently had severe or prolonged sickness or
diarrhoea.

have been told by a doctor that you have an intolerance to
some sugars. Trandolapril contains lactose and it may not be
suitable for you if you have a hereditary intolerance to
lactose.
have suffered from an allergic reaction to any other ACE
inhibitor, such as swelling of the face, lips, tongue or
throat with difficulty swallowing or breathing.
Are suffering from any of the following: liver or kidney
problems including dialysis (certain dialysis membranes
should not be used in patients being treated with
Trandolapril capsules); diabetes mellitus; heart failure or
collagen vascular disease (connective tissue disease).
If you are receiving LDL-apheresis or desensitisation
treatment against animal venoms.
TAKING OTHER MEDICINES
Before taking Trandolapril it is important to tell your doctor
if you are taking ANY other medicine, even those you may
have bought yourself without a prescription. They may
alter the way Trandolapril works in your body and/or
require your dose to be adjusted. This is particularly true
for:
water tablets (diuretics) and any other medicines for high
blood pressure;
potassium supplements;
anti-inflammatory pain killers (or NSAIDs), such as
ibuprofen or aspirin;
drugs used to treat depression or mood swings (e.g.
lithium, neuroleptic or tricylic antidepressants);
sympathomimetics (found in some decongestants,
cough/cold remedies and asthma medications);
antacids (used to treat indigestion and/or heartburn);
drugs used to lower the body’s immune system
(immunosuppressant agents);
drugs used in the treatment of cancer (cytostatic agents),
gout (e.g. allopurinol), severe asthma (corticosteroids)
and abnormal heart rate (e.g. procainamide);

antidiabetic medicines (e.g. insulin and oral
hypoglycaemics);
injectable gold therapy for arthritis.
3
OTHER IMPORTANT INFORMATION
If you need to have an operation it is important to tell the
surgeon or dentist, Trandolapril may affect the
anaesthetic or other treatments used.
If you have a blood or urine test, remember to tell the
doctor or nurse you are taking Trandolapril as it may
affect the results.
Trandolapril is NOT suitable for children.
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 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
MACHINERY
It is NOT advisable to drive or
operate machinery for
several hours after your first
dose or an increase in the
dose of Trandolapril

3. How should you take TRANDOLAPRIL?
ALWAYS take Trandolapril exactly as your doctor has told
you. If you are not sure refer to the label on the carton or
check with your doctor or pharmacist. Your dosage will
depend on what you are being treated for:
Hypertension (high blood pressure)
The usual starting dose is one 0.5 mg capsule once a day.
Your doctor will probably increase this dose to one 1mg or
2mg capsule once a day. The maximum dose of
Trandolapril is 4 mg a day.
Following a heart attack
Treatment will normally be started quite soon after a heart
attack, usually at a low dose of 0.5mg each day. Your
doctor will probably increase this dose gradually to a
maximum of 4mg each day.
TAKE YOUR TRANDOLAPRIL CAPSULES with a glass
of water. You should swallow the capsules
whole without chewing them. They may be
taken with or without food.
IF YOU TAKE MORE TRANDOLAPRIL
THAN PRESCRIBED
you should contact a doctor or go to the nearest hospital
casualty department IMMEDIATELY taking your capsules
with you.
IF YOU FORGET TO TAKE YOUR TRANDOLAPRIL
CAPSULES
take them as soon as you remember, unless it is almost
time for your next dose. If it is, do not take the missed
dose at all. Never double up on a dose to make up for the
one you have missed.

IF YOU STOP TAKING TRANDOLAPRIL your condition
may get worse. It is important that you keep taking these
capsules until your doctor tells you to stop. Do NOT stop
just because you feel better.

4. Possible side effects of Trandolapril
Capsules.
apsules.
INFORMATION ABOUT POSSIBLE
SIDE EFFECTS

As with all medicines, Trandolapril can cause side effects,
although not everyone will suffer from them. Trandolapril
can make some people feel dizzy or faint, especially when
they first start to take the capsules.
If any side effects become serious, or if you notice any
side effects that are not listed in this leaflet, please tell
your doctor or pharmacist.
CONTACT YOUR DOCTOR IMMEDIATELY and
STOP taking the capsules if you develop:
harsh or noisy breathing
swelling of your face, extremities, tongue, mouth or
throat (angioedema)
CONTACT A DOCTOR AS SOON AS POSSIBLE if
you develop any of the following symptoms:
yellowing of the eyes and/ or skin
severe sore throat with high fever
severe abdominal pain with bloating and vomiting
In clinical trials in patients with hypertension or in
patients following myocardial infarction the observed
side effects include:
Common (less than 1 per 10 but more than 1 per 100)
Headache
Dizziness
Cough

Weakness
Hypotension (low blood pressure)
Uncommon (less than 1 per 100 but more than 1 per 1000)
Sensation of pounding or fluttering in the chest
(palpitations)
Feeling sick (nausea)
Low blood pressure (hypotension)
Rash, itching
Malaise (a feeling of bodily discomfort)
Heart failure
Increased creatinine
Other side effects that have been reported for
trandolapril or other ACE inhibitors include:
Upper respiratory tract infections
Lack of iron (anaemia)
High level of uric acid in blood
Sleeping problems, depression, lack of sex drive
Mini stroke (transient ischaemic attack)
Drowsiness
Loss of consciousness
Involuntary twitching of a muscle
Migraine
Altered taste
Confusion
Visual disturbance
Ringing in ears (tinnitus)
Balance disorder which makes you feel unsteady, giddy,
woozy, or have a sensation of movement, spinning, or
floating (vertigo)
Heart problems including heart attack, chest pain, heart
failure, irregular heartbeat, fast heart beat and slow
heartbeat
Disruption in the electrical signals of the heart and loss of
heart function (cardiac arrest)
Rupturing of a blood vessel in the brain (cerebral
haemorrhage), hot flush

Narrowing or blockage of arteries mostly in the legs and
arms
Upper respiratory tract inflammation/congestion (e.g
nasal congestion); nose bleed
Contraction of the bands of muscles around your airways
(bronchospasm), sore throat, shortness of breath and
chest infection (bronchitis)
Inflammation of the sinuses (sinusitis), runny nose
(rhinitis), Swelling of the tongue (glossitis)
Vomiting, abdominal pains, diarrhoea, constipation, dry
mouth, indigestion, blockage of small or large intestine
(ileus)
Inflammation (pancreatitis) of the pancreas
Hepatitis (liver inflammation) and cholestatic jaundice
Itching, a rash, or itchy weals (raised skin lumps with
inflammation around them), any kind of skin inflammation
on the outer or inside linings of your body. Patches of
thickened red skin with silvery looking scales, hair loss or
any other very severe skin reactions. These symptoms
may also be accompanied by fever, muscle pain or joint
pain.
Increase sweating
Back pain, muscle spasm and pain in arms and/or legs
Abnormally frequent urination, kidney problems
Impotence
Chest pain, swelling, feeling abnormal and tiredness
Swelling of the tissue in the intestinal tract (Intestinal
Angioedema)
Trandolapril may cause certain changes in your blood and
your doctor may do blood tests to monitor this. The
following changes have occurred in some patients taking
Trandolapril
An increase in creatinine or blood urea nitrogen
(substances which can tell how well your kidneys are
working).

An increase in liver enzymes and serum bilirubin
(substances which can tell how well your liver is
working).
A lack of certain white blood cells which may lead to
infection, sore throat or fever (Agranulocytosis).
A decrease in the number of all types of blood cells
(pancytopenia).
Decreased haemoglobin (anaemia).
Haemolytic anaemia (anaemia due to ruptured blood
cells).
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 any 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 should you store Trandolapril?
Keep out of the reach and sight of
children.
Store in a dry place.
Do NOT use Trandolapril after the
expiry date shown on the carton.
The date refers to the last day of
that month.
If your doctor decides to stop your
treatment, return any left over
capsules to your pharmacist. Only
keep the capsules if your doctor
tells you to. Do NOT dispose of
left over capsules carelessly (e.g.
down the toilet or in with your
general rubbish)

If your capsules become discoloured or show any signs of
deterioration, you should seek the advice of your
pharmacist.

6. Further information about Trandolapril
Trandolapril ingredients:
The active substance(s) is trandolapril.
The other ingredient(s) are lactose, maize starch,
povidone, sodium stearyl fumarate, gelatin, titanium
dioxide (E171), erythrosine (E127), yellow iron oxide
(E172) and sodium lauryl sulphate.
TRANDOLAPRIL CALENDAR PACK CONTAINS:
Type of pack

Trandolapril 0.5mg

Capsules
per pack
28

Capsule
Colour
Red & yellow

The capsules are hard gelatin, opaque capsules with a
red coloured body and a yellow coloured cap.
Manufacturer: Abbott GmbH & Co. KG, Knollstrasse 50,
67061 Ludwigshafen, Germany.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
POM
Trandolapril 0.5mg Capsules – PL No: 18799/0863
Leaflet date: 19.09.2014

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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