TARKA 180 MG/2 MG MODIFIED-RELEASE CAPSULES

Active substance: VERAPAMIL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Tarka® 180 mg/2 mg
modified-release
capsules
Verapamil hydrochloride/
Trandolapril







Read all of this leaflet
carefully before you start
taking 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 get serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Tarka is and what it is used for
2. Before you take Tarka
3. How to take Tarka
4. Possible side effects
5. How to store Tarka
6. Further information
1. WHAT TARKA IS AND WHAT IT IS USED FOR

Medicines to prevent heart problems or high blood
pressure:
• diuretics (also called “water pills”), salt substitutes or
potassium pills.
• any medicines used to control your heartbeat, (such as
beta blockers, digoxin, or other medicines used to
control irregular heartbeats) or your blood pressure.
They may cause your blood pressure to become too low
or may slow your heart beat too much.
Medicines to treat psychological problems:
• any medicines to treat depression, or psychosis such as
imipramine, lithium, midazolam, buspirone, or
tranquilizers.
Medicines to prevent organ transplant rejection:
such as ciclosporin, tacrolimus, everolimus.
Medicines to treat pain or reduce swelling such as:
• steroids (for example, cortisone or prednisone).
• certain anti-inflammatory medicines or pain-killers (for
example, naproxen, ibuprofen or aspirin, or opiods such
as morphine).
Medicines to lower your cholesterol or blood fat
levels: such as “statins” eg. simvastatin, atorvastatin.
Medicines to treat diabetes: such as insulin or tablets
for diabetes.
Medicines to treat epilepsy or seizures: such as
phenytoin, carbamazepine and phenobarbital.
Medicines to treat indigestion or stomach ulcers:
such as antacids and cimetidine.
Other medicines that may react with Tarka:
• Medicines to treat asthma, such as theophylline.
• Medicines to treat infections or tuberculosis, such as
rifampicin, clarithromycin or erythromycin.
• Medicines to treat cancer, such as doxorubicin.
• Medicines to treat or prevent gout, such as allopurinol
and colchicine.
• Medicines used in surgery: tell your surgeon that you
are taking Tarka prior to having surgery as Tarka
may interfere with anaesthetic gases or muscle relaxant
medications or other medicine used during surgical
procedures such as dantrolene.

Tarka 180 mg/2 mg capsules are ‘modified release’ which
means that they release medicine slowly over several
hours.

This is not a complete list of medicines which may interfere
with Tarka. Ask your doctor or pharmacist for advice before
taking any medicine with Tarka.

Tarka is used to treat high blood pressure in patients whose
blood pressure has already been controlled on the
combination of verapamil SR 180 mg and trandolapril
2 mg.
Tarka belongs to the group of blood-pressure lowering
medicines, (also called anti-hypertensives).

Taking Tarka with Food and Drink
It is recommended that Tarka is taken at the same time
each day, before, with or after breakfast.

Tarka contains two different types of medicines:
– a calcium channel blocker (verapamil)
– an Angiotensin Converting Enzyme (ACE)
inhibitor (trandolapril)
2. BEFORE YOU TAKE TARKA
















Do not take Tarka if
• You are allergic (hypersensitive) to trandolapril
or other ACE inhibitors, to verapamil or to any
other ingredients of Tarka capsules (Section
6 contains a list of ingredients).
You (or a member of your family) has ever had a severe
allergic reaction to any other ACE inhibitor such as
swelling in the face, tongue or throat (angioneurotic
oedema).
Your blood pressure is extremely low as a result of severe
heart problems (such as during shock).
You have recently had a severe heart attack.
You have been told by your Doctor that you have heart
failure or second or third degree heart block (impaired
nerve signal in the heart – causing a very slow heart
beat) or an electrical abnormality of the heart causing
periods of very fast heartbeat (Wolff-Parkinson-White
Syndrome).
You have problems with your heart valves or ‘sick sinus
syndrome’ (irregular heartbeat) and you do not wear a
pacemaker.
You have obstructive hypertropic cardiomyopathy
(swelling of the heart muscles).
You have severe liver problems, including a condition
with fluid in the abdomen (ascites).
You have severe kidney disease or require dialysis.
You have a condition where the adrenal gland produces
too many hormones (primary aldosteronism).
You are more than 3 months pregnant (It is also better to
avoid Tarka in early pregnancy – see pregnancy section.)
You are under 18 years of age.
You are being treated with injectable beta-blockers
(except in an intensive care situation).

If you have any questions or are not sure about any of the
above, please talk to your doctor or pharmacist.
Take special care with Tarka
Your doctor may choose to closely monitor your
blood pressure and take blood samples at the start
of treatment and after dose changes if:
• You are elderly (older than 65 years of age).
• You have diabetes.
• You have liver or kidney problems, or have recently had a
kidney transplant.
• You have ever had or are at risk of a heart attack or
stroke.
• You are taking lithium (a medicine used in the treatment
of mania).
• You have been on a salt restricted diet, or have been
vomiting, had diarrhoea or have had diarrhoea recently,
are dehydrated, or are taking diuretic medicines
(sometimes called “water pills”) or other medicines which
may alter your potassium levels.
Tell your doctor if any of the following apply to you:
Heart disease:
• You have a slow or irregular heart beat.
• You have been told by your doctor that you have either
first degree heart block (nerve block in the heart causing
a slow heart beat) or left ventricular dysfunction (the left
side of your heart pumps poorly).
Other conditions:
• You are using Tarka and medicines affecting the immune
system (e.g. ciclosporin), or have an immune system
disease such as systemic lupus erythematosus (a
condition which causes joint pain, skin rashes and fever)
or scleroderma (a condition leading to hardening and
thickening of the skin and possible hair loss) as you may
be at increased risk of low levels of white blood cells.
• You have a neuro-muscular disorder such as myasthenia
gravis (chronic fatigue and muscular weakness),
Lambert-Eaton syndrome or advanced Duchenne
muscular dystrophy.
• You are having injections to prevent allergic reactions to
bee stings (desensitisation therapy)
• You are unable to tolerate some sugars (such as lactose
or galactose).
• You think you are (or might become) pregnant. Tarka 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).
• You are breastfeeding (see section ‘Pregnancy and
Breastfeeding’).
Allergic reactions:
• In rare instances some patients have had severe allergic
reactions after taking ACE inhibitors such as Tarka.
These reactions are more common in black people, and
can result in an itchy rash and/or the swelling of the face,
lips, tongue and throat (angioneurotic oedema). Severe
allergic reactions may also affect the gut and cause belly
pain (with or without nausea and vomiting) (intestinal
angioedema). If any of this occurs, stop taking Tarka
and seek immediate medical assistance.
Taking other medicines
Several medicines can cause unwanted reactions if used
with Tarka. Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription or any herbal
medicines. In particular tell your doctor if you are taking any
of the following medicines:

Alcohol
Avoid alcohol while using Tarka. You may experience
greater blood pressure lowering effects than usual.
Grapefruit juice
Do not drink grapefruit juice while you are taking Tarka.
Grapefruit juice may increase the amount of verapamil
which your body absorbs. This may increase your risk of
side effects from Tarka.
Pregnancy and Breastfeeding
Pregnancy
You must tell your doctor if you think you are (or might
become) pregnant. Your doctor will normally advise you to
stop taking Tarka before you become pregnant or as soon
as you know you are pregnant and will advise you to take
another medicine instead of Tarka. Tarka 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Tarka 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.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using Machines
Your ability to drive safely or to use heavy machines may
be affected. It may make you feel dizziness or fatigue.
Until you are aware how Tarka affects you, you should not
drive a vehicle or operate dangerous tools or large
machinery.
Important information about some of the ingredients
of Tarka
Sodium:
This medicinal product contains 1.12 mmol (or 25.73 mg) of
sodium per capsule. To be taken into consideration by
patients on a controlled sodium diet.
Lactose:
Tarka capsules contain lactose. This medicinal product
contains 54.50 mg of lactose monohydrate per capsule. If
you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. HOW TO TAKE TARKA
Always take your Tarka capsules exactly as your
doctor has instructed. You should check with
your doctor or pharmacist if you are not sure how
to take Tarka. The dose of Tarka has been
selected by your doctor as the most appropriate to control
your blood pressure.
The usual dosage is one Tarka modified-release capsule
taken once every day in the morning before, with or after
breakfast. The capsule should be swallowed whole with a
glass of water, without sucking, chewing or crushing it.
If you take more Tarka than you should
If you believe you have taken too much Tarka you should
immediately contact your doctor or pharmacist, some
situations may require emergency medical treatment.
If you take too much Tarka you may feel sleepy or dizzy,
due to a large drop in your blood pressure and slowing of
your heartbeat. Other symptoms that may occur if you take
too much Tarka are: shock (sudden drop in blood pressure
or heart rate), stupor, kidney failure, fast breathing, fast
heartbeat, irregular heartbeat, anxiety and cough.
If you forget to take Tarka
Take Tarka at the same time every day to avoid forgetting
to take your Tarka dose.
If you do forget to take your Tarka capsule take it as soon
as you remember, but only if you remember on the same
day as the missed dose.
Never take two capsules to make up for the one you have
missed.
If you stop taking Tarka
It is not recommended that you stop treatment with Tarka
unless advised to do so by your doctor.
If you stop taking Tarka you may experience an increase in
your blood pressure.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tarka capsules may cause side effects,
although not everybody gets them. The side effects
reported with Tarka are listed below:
Tell your doctor immediately and stop taking Tarka if
you experience a severe allergic reaction causing an itchy
rash and/or swelling of the face, lips, eyelids, tongue or
throat. Although this is rare you may need urgent medical
assistance.
Common side effects (occur in 1 to 10 users in 100)
• coughing
• dizziness, headache, feeling of spinning
• constipation
• a sudden sensation of warmth with redness over the
body
The following are Uncommon side effects (occur in 1 to 10
users in 1,000)
• allergic reactions (such as rash or itching)
• drowsiness
• shaking/trembling
• awareness of your heartbeat (palpitations)
• fast or slow heart beats (AV-block)










chest pain
stomach and intestine problems
nausea, stomach pain
diarrhoea
sweating
abnormal liver function test
frequent urination
elevated fat lipid levels in the blood (hyperlipidaemia)

The following are Rare side effects (occur in 1 to 10 users in
10,000)
• loss of appetite
• fainting
• hair loss
• increase in the amount of bile pigment in the blood
causing the skin or whites of the eyes to turn yellow
(hyperbilirubinaemia)
• skin problems
• cold sores (herpes simplex)
The following are Very Rare side effects (occur in less than
1 user in 10,000)
• bronchitis (inflammation of the upper airways)
• sinus congestion (blocked or stuffy nose/sinuses)
• shortness of breath/tightness of the chest
• fatigue
• weakness
• aggression, anxiety, depression, agitation
• problems keeping your balance
• sleeping difficulties
• pins-and-needles feeling in your skin, hot/cold sensations
• taste changes
• vision problems (eg. blurred vision)
• yellowing of the skin or the whites of the eyes (jaundice)
• inflammation of the pancreas or liver
• vomiting
• blocked bile ducts
• dry mouth or throat
• severe allergic reaction causing swelling of the face,
eyelids, tongue or throat
• changes in the levels of red or white blood cells which
could lead to bruising, bleeding or reduced resistance to
infection
• 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
• erectile dysfunction
• swelling of breasts (in males)
• severe heart problems/heart attack/fast heartbeat
• stroke
• sudden reduction in kidney function
• swelling caused by accumulation of fluid
• changes in blood potassium levels
• a sudden drop in blood flow through the body that may
be life-threatening
• very low blood pressure
• low blood pressure when you stand or sit up
• changes in blood pressure
The following are side effects with an unknown frequency:
• a life threatening allergic reaction that causes a painful
red or purple rash and blisters on the skin and lining of
the mouth
Some side effects have not been seen with Tarka or its
ingredients but have been seen with other medicines that
are like Tarka:
• changes in numbers of red blood cells
• increased break down of red blood cells, which may
cause fatigue
• confusion
• problem sleeping
• ringing in the ears
• abnormal heartbeat
• heart attack
• a brief disruption in the blood supply to part of the brain,
which may cause a temporary disturbance in seeing,
speaking or moving
• 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
• a temporary narrowing of the airways in the lungs making
it hard to breathe
• severe allergic reaction that affects the gut and causes
belly pain (with or without nausea and vomiting) (intestinal
angioedema)
• indigestion
• abnormal movement in the intestines, which may cause
a swollen belly, stomach pain and constipation
• abnormal bile flow in the liver causing the whites of the
eye to turn yellow
• a life threatening allergic reaction that causes the skin to
blister and peel
• abnormal kidney function tests
• movement disorders such as extreme restlessness and
disturbance of wanted or unwanted movements
• muscle weakness in both arms and both legs that affects
your ability to move
• breasts that leak milk
• gums that spread over the teeth
• worsening of certain nerve and muscle disorders (such
as myasthenia gravis, Lambert-Eaton syndrome,
Duchenne muscular dystrophy)
• painful redness of the skin on the legs and arms
• greater than normal amounts of prolactin (female
hormone) in the blood that causes the breasts to produce
milk
This is not a complete list of side effects. Some effects may
only be found with blood or other medical testing.
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.

5. HOW TO STORE TARKA
Keep out of the reach and sight of children.
Do not take Tarka after the expiry date which is stated on
the carton.
The expiry date refers to the last day of the month.
Do not store above 25 °C.
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
What Tarka contains
The active substances are Verapamil hydrochloride and
Trandolapril.
Each capsule contains:
180 mg of Verapamil hydrocloride
2 mg of Trandolapril
The other ingredients are:
Ingredients of the verapamil film-coated tablet:
Povidone, microcrystalline cellulose, sodium alginate,
hypromellose (hydroxypropylmethylcellulose), magnesium
stearate, hyprolose, macrogol 400, macrogol 6000, talc,
silicia, docusate sodium, titanium dioxide (E171)
Ingredients of the trandolapril granule:
Maize starch, lactose, povidone, sodium stearyl fumarate
Ingredients of the hard gelatine capsule:
Titanium dioxide (E171), iron oxide red (E172), gelatine,
sodium lauryl sulphate
What Tarka looks like and contents of the pack
Tarka is a pale pink opaque coloured, modified-released
capsule.
Tarka 180 mg/2 mg is available in blister strips packs of 14,
20, 28, 30, 50, 56, 98, 100, 280 and 300 modified-released
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Abbott Laboratories Limited
Abbott House,
Vanwall Business Park,
Vanwall Road,
Maidenhead,
Berkshire
SL6 4XE
Manufacturer
Abbott GmbH & Co KG
Knollstrasse
67061 Ludwigshafen
Germany
Tel. 0049 621 589 –0 (switch board)
Fax 0049 621 589 2896
Info.de@abbott.com
This medicinal product is authorised in the UK under the
following name:
United Kingdom: Tarka 180 mg/2 mg modified-release
Capsules
This leaflet was last approved in February 2012

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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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