TRIAPIN 2.5MG/2.5MG PROLONGED RELEASE TABLETS

Active substance: RAMIPRIL

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Loss or decrease of appetite (anorexia)
Increased or irregular heartbeats
Blurred vision
Pain in your joints
Fever
Sexual inability in men, reduced sexual desire
in men or women
• An increased number of certain white blood
cells (eosinophilia) found during a blood test
• Blood tests showing changes in the way your
liver, pancreas or kidneys are working.
Rare (may affect up to 1 in 1,000 people)
• Feeling shaky or confused
• Red and swollen tongue
• Severe flaking or peeling of the skin, itchy,
lumpy rash
• Nail problem (e.g. loosening or separation of a
nail from its bed)
• Skin rash or bruising
• Blotches on your skin and cold extremities
• Red, itchy, swollen or watery eyes
• Disturbed hearing and ringing in your ears
• Feeling weak
• Blood tests showing a decrease in the number
of red blood cells, white blood cells or platelets
or in the amount of haemoglobin.
• Reduced sexual function in men or women
Very rare (may affect up to 1 in 10,000 people)
• Being more sensitive to the sun than usual
• Slight swelling of your gums or bleeding gums
• Blood tests showing more sugar than usual in
your blood.
Other side effects reported:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.
• Difficulty concentrating
• Swollen mouth
• Blood tests showing too few blood cells in your
blood
• Blood tests showing less sodium than usual in
your blood

Package leaflet: information for the user

Triapin 2.5 mg / 2.5 mg
and Triapin 5 mg / 5 mg
prolonged release tablets
ramipril/felodipine

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours
• If you get any side effects, talk to your doctor
or pharmacist; this includes any possible side
effects not listed in this leaflet
What is in this leaflet:
1. What Triapin is and what it is used for
2. What you need to know before you take Triapin
3. How to take Triapin
4. Possible side effects
5. How to store Triapin
6. Contents of the pack and other information
1. What Triapin is and what it is used for
Triapin 2.5 mg / 2.5 mg and Triapin 5 mg / 5 mg
prolonged release tablets (also called Triapin
tablets in this leaflet) both contain two medicines
called ramipril and felodipine.

• Fingers and toes changing colour when you are
cold and then tingling or feeling painful when
you warm up (Raynaud’s phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Change in the way things smell
• Hair loss.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
5. How to store Triapin
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
Store the tablets in the pack below 25oC.
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.
6. Contents of the pack and other
information
What Triapin contains
• The active ingredients in Triapin tablets are:
ramipril and felodipine.
- Triapin 2.5mg/2.5mg tablets contain 2.5 mg
of ramipril and 2.5 mg of felodipine
- Triapin 5mg/5mg tablets contain 5 mg of
ramipril and 5 mg of felodipine
• The other ingredients are: hydroxypropylcellulose,
hydroxypropylmethylcellulose, lactose
anhydrous, maize starch, microcrystalline
cellulose, polyethylene glycol, polyoxyl 40
hydrogenated castor oil, propyl gallate, sodium
aluminium silicate, sodium stearyl fumarate, iron
oxides E172, titanium dioxide E171 and paraffin

• Ramipril belongs to a group of medicines
called ‘angiotensin converting enzyme
inhibitors’ (ACE inhibitors). It works by stopping
the production of substances that raise blood
pressure and makes your blood vessels relax
and widen.
• Felodipine belongs to a group of medicines
called ‘calcium antagonists’. It makes your
blood vessels relax and widen. This helps to
lower your blood pressure.
Triapin tablets are used to treat high blood
pressure (hypertension). High blood pressure can
mean you are more likely to have problems such
as heart disease, kidney disease and stroke. This
medicine lowers your blood pressure and lowers
the risk of these problems.
2. What you need to know before you take
Triapin
Do not take Triapin tablets if:
× You are allergic to:
- ramipril or any other ACE inhibitor
- felodipine or any other calcium antagonists
- any of the other ingredients of this medicine
(listed in section 6.)
× You have ever had a serious allergic reaction
called “angioedema”. The signs include itching,
hives (urticaria), red marks on the hands,
feet and throat, swelling of the throat and
tongue, swelling around the eyes and lips,
difficulty breathing and swallowing. Taking
this medicine may increase the risk of having a
more serious attack of this condition
× You have heart problems such as heart failure,
angina which is unstable, a heart condition
known as atrioventricular block II or III, have
ever had a heart attack (acute myocardial
infarction) or a stroke (disturbance of the
blood circulation in the brain)
× You have a severe kidney problem
× You are having dialysis

KISIR.TRIAPIN FTBL ÖSSZ.A #4

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Market Authorisation holder:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturers:
Chinoin Private Co. Ltd
Veresegyhaz
Hungary
This leaflet was last approved in March 2013.
This medicinal product is authorised in the
Member States of the EEA under the following
names: Triapin, Triapin Mite, Tazko, Tazko Mite,
Triacor, Delmuno

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× You have a severe liver problem
× You are pregnant, trying to get pregnant
or breast-feeding (see ‘Pregnancy and
breast-feeding’ below)
× You are taking a blood pressure medicine
containing aliskiren and you have diabetes
× You are taking a blood pressure medicine
containing aliskiren and you have kidney
problems
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Triapin
tablets.

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Warnings and precautions
Talk to your doctor or pharmacist before
taking Triapin tablets if:
You have kidney problems, diabetes mellitus
or are taking medicines which increase
potassium. Your doctor may carry out regular
blood tests, particularly for checking the levels
of potassium in your blood
You are taking medicines or have conditions
which may decrease sodium levels in your
blood. Your doctor may carry out regular
blood tests, particularly for checking the levels
of sodium in your blood especially if you are
elderly.
You have kidney artery problems
You have narrowing of the main blood
vessel leading from the heart (aortic stenosis)
or heart muscle disease (hypertrophic
cardiomyopathy)
You have any other heart problem
You have systemic lupus erythmatosus or
scleroderma
You suffer from liver problems
You are going to have an anesthestic or surgery
You are taking medicines which lower the
number of certain blood cells

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angol / English

330 x 210 mm

What Triapin looks like and contents of the
pack
• Triapin 2.5mg/2.5mg tablets are apricot
coloured and have “H/OD” marked on one side
and “2.5” marked on the other side
• Triapin 5mg/5mg tablets are reddish-brown
and have
“H/OE” marked on one side and “5” on the
other side
• Both strengths of Triapin come in blister packs
containing 10, 14, 15, 21, 28, 30, 50, 98 and
100 tablets or in bottles containing 56, 250 and
280 tablets
Not all pack sizes may be marketed.

CRGB - V1 - 05/2012

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2013. 04. 03.

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szövegváltozás / text change (VISTA folder: 928103)

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TÓTH-LESI Ildikó

p You are black because the medicine may have

less effect on your blood pressure and more
side effects
p You are going to have treatment to lower
the effect of an allergy to bee or wasp stings
(desensitization)
p You are having treatment where your blood is
treated outside the body, such as ‘low-density
lipoprotein apheresis’.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Triapin tablets.
Other medicines and Triapin tablets
Tell your doctor or pharmacist if you are using,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription, including herbal
medicines. This is because Triapin tablets can
affect the way some other medicines work. Also
some medicines can affect the way Triapin tablets
work.
In particular, tell your doctor if you are taking or
being treated with any of the following:
• Medicines for lowering high blood pressure
(antihypertensives), including those containing
aliskiren, and other medicines that lower blood
pressure (nitrates, antipsychotics, narcotics and
anesthetics)
• Medicines to treat HIV infection
• Procainamide – used for treating heart rhythm
disorders
• Water tablets (diuretics) which can cause
high blood potassium such as amiloride,
spironolactone, triamterene
• Heparin – used for thinning the blood
• Lithium preparations - used to treat mania,
depression and manic-depressive illness
• Phenytoin, carbamazepine and barbiturates.
These medicines are usually used to treat
epilepsy, fits and convulsions. Barbiturates are
also used for sleeping problems

• The maximum dose is either 2 Triapin
2.5mg/2.5mg tablets once a day or 1 Triapin
5mg/5mg tablet once a day
• If you are already taking diuretics (water
tablets), your doctor may stop or reduce
the amount of the diuretic you take before
beginning treatment with Triapin
Use in children
Do not give Triapin to children.
If you take more Triapin than you should
If you take more Triapin than you should, tell
a doctor or go to the nearest hospital casualty
department straight away. Take the medicine
pack with you. This is so the doctor knows what
you have taken. You may feel dizzy and lightheaded because your blood pressure is too low.
If you forget to take Triapin
If you forget to take a dose and remember on the
same day:
• Take it as soon as you remember
• On the next day, take your usual dose of
Triapin
If you forget to take a dose and remember this
the next day:
• Take only your usual dose of Triapin
• Do not take a double dose to make up for a
forgotten dose
If you stop taking Triapin
Keep taking treatment until your doctor tells you
to stop. Do not stop taking this medicine just
because you feel better. If you stop, your blood
pressure may rise again.

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

• Theophylline – used for treating asthma
• Sympathomimetics such as adrenaline,
noradrenaline or ephedrine (medicines which
act on the heart and blood vessels)
• Erythromycin, itraconazole, ketoconazole –
used for treating infections
• Rifampicin – used for treatment of tuberculosis
• Allopurinol – used for treating gout
• Non-steroidal anti-inflammatory drugs
(NSAIDs) – used to relieve pain and
inflammation
• Immunosuppressants – used in rheumatoid
arthritis or after organ transplants
• Tacrolimus which is a medicine given to
prevent the body from rejecting a transplanted
organ, such as a kidney or liver
• Cytostatics – used to treat cancer
• Insulin, glibenclamide, metformin and other
medicines used for diabetes mellitus
• Glucocorticoids (‘steroids’)
• Potassium salts
• St John’s Wort
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Triapin tablets.
Triapin tablets with food and drink
• Taking your tablet with alcohol may increase
the effect of your medicine
• Taking this medicine with grapefruit juice is
not recommended
• Increasing the amount of salt in your diet may
lower the effect of this medicine
• Take the tablets on an empty stomach or after
eating a light meal
Pregnancy and breast-feeding
Do not take Triapin tablets if:
• You are pregnant, might become pregnant or
think you may be pregnant. This is because the
medicine could harm your baby
• You are breast-feeding or planning to breastfeed. This is because small amounts may pass
into the mothers’ milk

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Triapin tablets and see a doctor
straight away, if you notice any of the
following serious side effects - you may need
urgent medical treatment.
• Swelling of the face, lips or throat which make
it difficult to swallow or breathe, as well as
itching and rashes. These could be signs of a
severe allergic reaction to Triapin.
• Severe skin reactions including rash, ulcers in
your mouth, worsening of a pre-existing skin
disease, reddening, blistering or detachment of
skin, (such as Stevens-Johnson syndrome, toxic
epidermal necrolysis or erythema multiforme).
Tell your doctor immediately if you
experience:
• Faster heart rate, uneven or forceful heartbeat
(palpitations), chest pain, tightness in your
chest or more serious problems including heart
attack and stroke
• Shortness of breath or a cough. These could be
signs of lung problems
• Bruising more easily, bleeding for longer than
normal, any sign of bleeding (e.g. bleeding
from the gums), purple spots, blotching on
the skin or getting infections more easily than
usual, sore throat and fever, feeling tired, faint,
dizzy or having pale skin. These can be signs of
blood or bone marrow problems
• Severe stomach pain which may reach
through to your back. This could be a sign of
pancreatitis (inflammation of the pancreas)
• Fever, chills, tiredness, loss of appetite,
stomach pain, feeling sick, yellowing of your
skin or eyes (jaundice). These can be signs of
liver problems such as hepatitis (inflammation
of the liver) or liver damage.

If you suspect you have become pregnant while
taking Triapin tablets, you should talk to your
doctor straight away.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
You may feel dizzy or light-headed after taking
this medicine. If this happens, do not drive or use
any tools or machines.
Triapin tablets contain lactose and
hydrogenated castor oil
This medicine contains lactose, a type of sugar. If
you have been told by your doctor that you cannot
tolerate some sugars, talk to your doctor before
taking this medicine. This medicine contains
hydrogenated castor oil. It may cause stomach
upset or diarrhea.
3. How to take Triapin
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. Triapin tablets are
for adults only. Do not give them to children.
Taking this medicine
• Take this medicine by mouth
• Take the tablets on an empty stomach or after
eating a light meal
• Swallow the tablets whole with half a glass of
water or other drink. Do not break, crush or
chew the tablets
• Do not take your tablets with grapefruit juice
or alcohol
How much to take
• The usual dose is 1 Triapin 2.5mg/2.5mg tablet
or 1 Triapin 5mg/5mg tablet taken once a day
• Your doctor may start you on Triapin
2.5mg/2.5mg tablets and then change you to
Triapin 5mg/5mg tablet to increase your dose
2

Other side effects include:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.
Common (may affect up to 1 in 10 people)
• Swollen arms and legs. This may be a sign of
your body holding onto more water than usual
• Headache or feeling tired
• Feeling dizzy. This is more likely to happen
when you start taking Triapin tablets or start
taking a higher dose
• Fainting, hypotension (abnormally low blood
pressure), especially when you stand or sit up
quickly
• Flushing
• Dry tickly cough, inflammation of your sinuses
(sinusitis) or bronchitis, shortness of breath
• Stomach or gut pain, diarrhoea, indigestion,
feeling or being sick
• Skin rash with or without raised area
• Chest pain
• Cramps or pain in your muscles
• Blood tests showing more potassium than
usual in your blood.
Uncommon (may affect up to 1 in 100 people)
• Balance problems (vertigo)
• Itching and unusual skin sensations such
as numbness, tingling, pricking, burning or
creeping on your skin (paraesthesia)
• Loss or change in the way things taste
• Sleep problems
• Feeling depressed, anxious, more nervous than
usual or restless
• Blocked nose, difficulty breathing or worsening
of asthma
• A swelling in your gut called “intestinal
angioedema” presenting with symptoms like
abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Passing more water (urine) than usual over the
day
• Sweating more than usual
3

KISIR.TRIAPIN FTBL ÖSSZ.A #4
330 x 210 mm

A1

480800

angol / English

P Reflex Blue

KI-171

CRGB - V1 - 05/2012

KOD-001

Ocean Sans Pro SAN Book, Bold, Italic
(9 pt) [9 pt]
2013. 04. 03.

366645

szövegváltozás / text change (VISTA folder: 928103)

5
TÓTH-LESI Ildikó

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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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