TRIAPIN 2.5MG/2.5MG PROLONGED RELEASE TABLETS

Active substance: RAMIPRIL

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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.

• 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.

Package leaflet: information for the user

× 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
Triapin 2.5 mg / 2.5 mg
and tongue, swelling around the eyes and lips, difficulty
and Triapin 5 mg / 5 mg prolonged
breathing and swallowing. Taking this medicine may increase
the risk of having a more serious attack of this condition
release tablets
× You have heart problems such as heart failure, obstructions
ramipril/felodipine
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)
Read all of this leaflet carefully before you start taking × You have a severe kidney problem
this medicine because it contains important information for × You are having dialysis
you.
× You have a severe liver problem
• Keep this leaflet. You may need to read it again.
× You are pregnant, trying to get pregnant or breast-feeding
• If you have any further questions, ask your doctor or
(see ‘Pregnancy and breast-feeding’ below)
pharmacist.
× You are taking a blood pressure medicine containing
• This medicine has been prescribed for you only. Do not pass
aliskiren and you have diabetes
it on to others. It may harm them, even if their signs of
× You are taking a blood pressure medicine containing
illness are the same as yours.
aliskiren and you have kidney problems
• If you get any side effects, talk to your doctor or pharmacist. Do not take this medicine if any of the above apply to you.
This includes any possible side effects not listed in this leaflet. If you are not sure, talk to your doctor or pharmacist before
See section 4.
taking Triapin tablets.

Market Authorisation holder:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturers:
Chinoin Private Co. Ltd
Veresegyhaz
Hungary
This leaflet was last approved in December 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

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

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.

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.

6. Contents of the pack and other information

• 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.

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

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.

• 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

2. What you need to know before you take Triapin

What Triapin looks like and contents of the pack

Do not take Triapin tablets if:

• Triapin 5mg/5mg tablets are reddish-brown and have
“H/OE” marked on one side and “5” on the other side

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• 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

× 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.)

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.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Triapin tablets.

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Pregnancy and breast-feeding
Do not take Triapin tablets if:
Other medicines and Triapin tablets
• You are pregnant, might become pregnant or think you may
Tell your doctor or pharmacist if you are using, have recently
be pregnant. This is because the medicine could harm your
taken or might take any other medicines. This includes
baby
medicines obtained without a prescription, including herbal
• You are breast-feeding or planning to breast-feed. This is
medicines. This is because Triapin tablets can affect the way
because small amounts may pass into the mothers’ milk
some other medicines work. Also some medicines can affect the
If you suspect you have become pregnant while taking Triapin
way Triapin tablets work.
tablets, you should talk to your doctor straight away.
In particular, tell your doctor if you are taking or being treated Ask your doctor or pharmacist for advice before taking any
with any of the following:
medicine.
• Medicines for lowering high blood pressure
(antihypertensives), including those containing aliskiren,
Driving and using machines
and other medicines that lower blood pressure (nitrates,
You may feel dizzy or light-headed after taking this medicine. If
antipsychotics, narcotics and anesthetics)
this happens, do not drive or use any tools or machines.
• Medicines to treat HIV infection
• Procainamide – used for treating heart rhythm disorders
Triapin tablets contain lactose and hydrogenated castor oil
• Water tablets (diuretics) which can cause high blood
This medicine contains lactose, a type of sugar. If you have
potassium such as amiloride, spironolactone, triamterene
been told by your doctor that you cannot tolerate some sugars,
• Heparin – used for thinning the blood
talk to your doctor before taking this medicine. This medicine
• Lithium preparations - used to treat mania, depression and
contains hydrogenated castor oil. It may cause stomach upset
manic-depressive illness
or diarrhea.
• Phenytoin, carbamazepine and barbiturates. These
3. How to take Triapin
medicines are usually used to treat epilepsy, fits and
convulsions. Barbiturates are also used for sleeping problems Always take this medicine exactly as your doctor has told
• Theophylline – used for treating asthma
you. Check with your doctor or pharmacist if you are not
• Sympathomimetics such as adrenaline, noradrenaline or
sure. Triapin tablets are for adults only. Do not give them to
ephedrine (medicines which act on the heart and blood
children.
vessels)
Taking this medicine
• Erythromycin, itraconazole, ketoconazole – used for treating • Take this medicine by mouth
infections
• Take the tablets on an empty stomach or after eating a light
• Rifampicin – used for treatment of tuberculosis
meal
• Allopurinol – used for treating gout
• Swallow the tablets whole with half a glass of water or other
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used to
drink. Do not break, crush or chew the tablets
relieve pain and inflammation
• Do not take your tablets with grapefruit juice or alcohol
• Immunosuppressants – used in rheumatoid arthritis or after How much to take
organ transplants
• The usual dose is 1 Triapin 2.5mg/2.5mg tablet or 1 Triapin
• Tacrolimus which is a medicine given to prevent the body
5mg/5mg tablet taken once a day
from rejecting a transplanted organ, such as a kidney or liver • Your doctor may start you on Triapin 2.5mg/2.5mg tablets
• Cytostatics – used to treat cancer
and then change you to Triapin 5mg/5mg tablet to increase
• Insulin, glibenclamide, metformin, vildagliptin and other
your dose
medicines used for diabetes mellitus
• The maximum dose is either 2 Triapin 2.5mg/2.5mg tablets
• Glucocorticoids (‘steroids’)
once a day or 1 Triapin 5mg/5mg tablet once a day
• Potassium salts
• If you are already taking diuretics (water tablets), your doctor
• St John’s Wort
may stop or reduce the amount of the diuretic you take
If you are not sure if any of the above apply to you, talk to your
before beginning treatment with Triapin
doctor or pharmacist before taking Triapin tablets.
Use in children
Triapin tablets with food and drink
Do not give Triapin to children.
• Taking your tablet with alcohol may increase the effect of
If you take more Triapin than you should
your medicine
If you take more Triapin than you should, tell a doctor or go to
• Taking this medicine with grapefruit juice is not
the nearest hospital casualty department straight away. Take
recommended
the medicine pack with you. This is so the doctor knows what
• Increasing the amount of salt in your diet may lower the
you have taken. You may feel dizzy and light-headed because
effect of this medicine
your blood pressure is too low.
• Take the tablets on an empty stomach or after eating a light
If you forget to take Triapin
meal
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.

• 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,
4. Possible side effects
tingling, pricking, burning or creeping on your skin
(paraesthesia)
Like all medicines, this medicine can cause side effects,
• Loss or change in the way things taste
although not everybody gets them.
• Sleep problems
Stop taking Triapin tablets and see a doctor straight away,
• Feeling depressed, anxious, more nervous than usual or
if you notice any of the following serious side effects - you
restless
may need urgent medical treatment.
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the face, lips or throat which make it difficult
• A swelling in your gut called “intestinal angioedema”
to swallow or breathe, as well as itching and rashes. These
presenting with symptoms like abdominal pain, vomiting
could be signs of a severe allergic reaction to Triapin.
and diarrhoea
• Severe skin reactions including rash, ulcers in your mouth,
• Heartburn, constipation or dry mouth
worsening of a pre-existing skin disease, reddening, blistering • Passing more water (urine) than usual over the day
or detachment of skin, (such as Stevens-Johnson syndrome,
• Sweating more than usual
toxic epidermal necrolysis or erythema multiforme).
• Loss or decrease of appetite (anorexia)
Tell your doctor immediately if you experience:
• Increased or irregular heartbeats
• Faster heart rate, uneven or forceful heartbeat (palpitations), • Blurred vision
chest pain, tightness in your chest or more serious problems • Pain in your joints
including heart attack and stroke
• Fever
• Shortness of breath or a cough. These could be signs of lung • Sexual inability in men, reduced sexual desire in men or
problems
women
• Bruising more easily, bleeding for longer than normal,
• An increased number of certain white blood cells
any sign of bleeding (e.g. bleeding from the gums), purple
(eosinophilia) found during a blood test
spots, blotching on the skin or getting infections more easily • Blood tests showing changes in the way your liver, pancreas
than usual, sore throat and fever, feeling tired, faint, dizzy
or kidneys are working.
or having pale skin. These can be signs of blood or bone
Rare (may affect up to 1 in 1,000 people)
marrow problems
• Feeling shaky or confused
• Severe stomach pain which may reach through to your back. • Red and swollen tongue
This could be a sign of pancreatitis (inflammation of the
• Severe flaking or peeling of the skin, itchy, lumpy rash
pancreas)
• Nail problem (e.g. loosening or separation of a nail from its
• Fever, chills, tiredness, loss of appetite, stomach pain, feeling
bed)
sick, yellowing of your skin or eyes (jaundice). These can be
• Skin rash or bruising
signs of liver problems such as hepatitis (inflammation of the • Blotches on your skin and cold extremities
liver) or liver damage.
• Red, itchy, swollen or watery eyes
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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

• 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.

2

3

KISIR.TRIAPIN FTBL ÖSSZ.A #5
380x240 mm

A1

544563

angol / English

P Reflex Blue

KI-248

CRGB - V1 - 05/2012

KOD-001

Ocean Sans Pro SAN (9 pt) [10,8 pt]
2014. 01. 29.

480800

méret és szöveg változás / size and text change (VISTA folder: 1182108, 2013VERES0097)

2.
MAITZ Adrienn

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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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