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TRIAPIN 2.5MG/2.5MG PROLONGED RELEASE TABLETS

Active substance: RAMIPRIL

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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
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 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.

6. Contents of the pack and other information

Package leaflet: information for the user

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
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.

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

Market Authorisation holder:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

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. See section 4.
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

Manufacturers:
Chinoin Private Co. Ltd
Veresegyhaz
Hungary
This leaflet was last approved in February 2015.
This medicinal product is authorised in the Member States
of the EEA under the following names: Triapin, Triapin
Mite, Tazko, Tazko Mite, Triacor, Delmuno

Store the tablets in the pack below 25oC.

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.
• 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

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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.

4

ramipril/felodipine

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.)

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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
• You are black because the medicine may have less effect
on your blood pressure and more side effects
• You are going to have treatment to lower the effect of
an allergy to bee or wasp stings (desensitization)
• You are having treatment where your blood is treated
outside the body, such as ‘low-density lipoprotein
apheresis’.
• You have swelling in your gums which may be a sign of
gingivitis or periodontitis. Careful dental hygiene may
be necessary to avoid additional gum problems, such
as a condition which increases the size of your gums.
• You are taking any of the following medicines used to
treat high blood pressure:
-- an angiotensin II receptor blocker (ARBs)
(also known as sartans-for example valsartan,
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× 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,
obstructions in your heart, 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
× You have a severe liver problem
× You are pregnant, trying to get pregnant or
breast‑feeding (see ‘Pregnancy and breast‑feeding’
below)
× You have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren.
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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telmisartan, irbesartan), in particular if you have
diabetes-related kidney problems.
-- aliskiren
Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g. potassium)
in your blood at regular intervals.
See also information under the heading “Do not take
Triapin tablets”.

headings “Do not take Triapin tablets” and “Warnings
and precautions”).
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
Other medicines and Triapin tablets
the effect of this medicine
Tell your doctor or pharmacist if you are using, have
• Take the tablets on an empty stomach or after eating a
recently taken or might take any other medicines. This
light meal
includes medicines obtained without a prescription,
including herbal medicines. This is because Triapin tablets Pregnancy and breast-feeding
can affect the way some other medicines work. Also some Do not take Triapin tablets if:
medicines can affect the way Triapin tablets work.
• You are pregnant, might become pregnant or think you
may be pregnant. This is because the medicine could
In particular, tell your doctor if you are taking or being
harm your baby
treated with any of the following:
• You are breast-feeding or planning to breast-feed. This
• Medicines for lowering high blood pressure
is because small amounts may pass into the mothers’
(antihypertensives), including those containing aliskiren,
milk
and other medicines that lower blood pressure (nitrates,
If you suspect you have become pregnant while
antipsychotics, narcotics and anesthetics)
taking Triapin tablets, you should talk to your doctor
• Medicines to treat HIV infection
immediately.
• Procainamide – used for treating heart rhythm
Ask your doctor or pharmacist for advice before taking any
disorders
medicine.
• Water tablets (diuretics) which can cause high
blood potassium such as amiloride, spironolactone,
triamterene
Driving and using machines
• Heparin – used for thinning the blood
• Lithium preparations - used to treat mania, depression You may feel dizzy or light-headed after taking this
medicine. If this happens, do not drive or use any tools or
and manic-depressive illness
machines.
• Phenytoin, carbamazepine and barbiturates. These
medicines are usually used to treat epilepsy, fits and
Triapin tablets contain lactose and hydrogenated
convulsions. Barbiturates are also used for sleeping
castor oil
problems
This medicine contains lactose, a type of sugar. If you
• Theophylline – used for treating asthma
have been told by your doctor that you cannot tolerate
• Sympathomimetics such as adrenaline, noradrenaline
some sugars, talk to your doctor before taking this
or ephedrine (medicines which act on the heart and
medicine. This medicine contains hydrogenated castor oil.
blood vessels)
It may cause stomach upset or diarrhea.
• Erythromycin, itraconazole, ketoconazole – used for
treating infections
3. How to take Triapin
• Rifampicin – used for treatment of tuberculosis
Always take this medicine exactly as your doctor has told
• Allopurinol – used for treating gout
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used you. Check with your doctor or pharmacist if you are not
sure. Triapin tablets are for adults only. Do not give them
to relieve pain and inflammation
• Immunosuppressants – used in rheumatoid arthritis or to children.
Taking this medicine
after organ transplants
• Take this medicine by mouth
• Tacrolimus which is a medicine given to prevent the
• Take the tablets on an empty stomach or after eating a
body from rejecting a transplanted organ, such as a
light meal
kidney or liver
• Swallow the tablets whole with half a glass of water or
• Cytostatics – used to treat cancer
other drink. Do not break, crush or chew the tablets
• Insulin, glibenclamide, metformin, vildagliptin and
• Do not take your tablets with grapefruit juice or alcohol
other medicines used for diabetes mellitus
How much to take
• Glucocorticoids (‘steroids’)
• The usual dose is 1 Triapin 2.5mg/2.5mg tablet or 1
• Potassium salts
Triapin 5mg/5mg tablet taken once a day
• St John’s Wort
Your doctor may need to change your dose and/or to take • Your doctor may start you on Triapin 2.5mg/2.5mg
tablets and then change you to Triapin 5mg/5mg tablet
other precautions:
to increase your dose
• If you are taking an angiotensin II receptor blocker
(ARB) or aliskiren (see also information under the

• 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 light-headed 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.
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.
Other side effects include:
Please tell your doctor if any of the following gets serious
or lasts longer than a few days.
Very Common (may affect more than 1 in 10 people)
• Swollen arms and legs. This may be a sign of your body
holding onto more water than usual
Common (may affect up to 1 in 10 people)
• 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
• 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.

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2015. 03. 05.

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Új szöveg / new text - VISTA folder No. 1390054

5.
TÓTH-LESI Ildikó / SZABÓ 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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