Skip to Content

GOPTEN CAPSULES 0.5MG

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

GOPTEN®
0.5, 1, 2 & 4 mg
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

1. What is Gopten & what does it 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 breastfeeding. Gopten is not recommended for mothers who are breastfeeding, 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 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 0.5 mg capsule once a day. Your
doctor will probably increase this dose to one 1 mg or 2 mg
capsule once a day. The maximum dose of Gopten 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 0.5 mg each day. Your doctor will probably
increase this dose gradually to a maximum of 4 mg 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.

FRONT

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).
5. How should you store Gopten?
Your capsules should be stored in a safe place out of
the reach and sight of children.
They should be kept below 25°C and in their original
packaging.
DO NOT use Gopten after the expiry date printed on
the packaging. 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 leftover capsules
carelessly (e.g down the toilet or in with your general rubbish).

erythrosine (E127), yellow iron oxide (E172), black iron oxide
(E172) (in the 4 mg only), and sodium lauryl sulphate.
GOPTEN CALENDAR PACK CONTAINS:
Type of pack
Capsules per pack
Capsule Colour
Gopten 0.5 mg
14
Red & yellow
Gopten 1.0 mg
28
Red & orange
Gopten 2.0 mg
28
Red
Gopten 4.0 mg
28
Red & maroon
Marketing Authorisation Holder:
Abbott Laboratories Ltd.,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire SL6 4XE, United Kingdom
Manufacturer:
Famar Italia S.P.A.,
Via Zambeletti 25, 20021 Baranzate (Milano) Italy
Leaflet was last

6. Further information about Gopten Capsules.
Gopten ingredients:
The active substance(s) is trandolapril.
The capsules are available in different strengths containing either
0.5mg, 1mg, 2mg or 4mg of trandolapril.
The other ingredient(s) are lactose, maize starch, povidone,
sodium stearyl fumarate, gelatin, titanium dioxide (E171),

BACK

1. What is Gopten & what does it do?

GOPTEN®
0.5, 1, 2 & 4 mg
Capsule
Trandolapril

Gopten 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.
• 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:

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

• 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 patients receiving dialysis (as 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).

• are undergoing 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, antipsychotic 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 breastfeeding. Gopten is not recommended for mothers who are breastfeeding, 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 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 0.5 mg capsule once a day. Your doctor
will probably increase this dose to one 1 mg or 2 mg capsule once a
day. The maximum dose of
Gopten 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 0.5 mg each day. Your doctor
will probably increase this dose gradually to a maximum of
4 mg 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.

MKP-01173-2012 · GB · 5232

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

Cyan, Magenta, Yellow, Black

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

N066/N067/N069/P339

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)

000 M 000

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 ischemic 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 heartbeat and slow heartbeat
• Loss of heart function (cardiac arrest)
• Disruption in the electrical signals of the heart and loss of heart
function (cardiac arrest)
• Rupturing of a blood vessel in the brain (cerebral hemorrhage), 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 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)

6. Further information about Gopten?
Gopten ingredients:
The active substance(s) is trandolapril.
The capsules are available in different strengths containing either
0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril.
The other ingredient(s) are lactose, maize starch, povidone, sodium
stearyl fumarate, gelatin, titanium dioxide (E171), erythrosine (E127),
yellow iron oxide (E172), black iron oxide (E172) (in the 4 mg only), and
sodium lauryl sulphate.
GOPTEN CALENDAR PACK CONTAINS:

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).
5. How should you store Gopten?
Your capsules should be stored in a safe place out of
the reach and sight of children.
They should be kept below 25°C and in their original
packaging.
Do NOT use Gopten after the expiry date printed on the
packaging. 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 leftover capsules carelessly (e.g down the toilet or in
with your general rubbish).

Type of pack

Capsules per pack

Gopten 0.5 mg
Gopten 1.0 mg
Gopten 2.0 mg
Gopten 4.0 mg

14
28
28
28

Capsule Colour
Red & yellow
Red & orange
Red
Red & maroon

Marketing Authorisation Holder:
Abbott Laboratories Ltd.,
Abbott House,
Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire SL6 4XE,
United Kingdom
Manufacturer:
Abbott GmbH & Co. KG,
Knollstrasse 50,
67061 Ludwigshafen,
Germany
Leaflet was last revised 04/2012

Expand Transcript

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.

Hide