TRIAPIN MITE 2.5MG/2.5MG PROLONGED-RELEASE TABLETS

Active substance: RAMIPRIL

View full screen / Print PDF » Download PDF ⇩

Transcript
Triapin® Mite 2.5mg/2.5 mg
prolonged-release tablets
Triapin® 5mg/5mg
prolonged-release tablets

2359 / 2360
09.01.14[5]

(felodipine/ramipril)
PATIENT INFORMATION LEAFLET
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
Your medicine will be referred to as Triapin 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 USED FOR:
Triapin Mite 2.5 mg / 2.5 mg and Triapin mg / 5 mg prolonged-release
tablets 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
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
- 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.
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’.
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 manicdepressive illness
- Phenytoin, carbamazepine and barbiturates. These medicines are usually
used to treat epilepsy, fits and convulsions. Barbiturates are also used for
sleeping problems
- 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
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 Mite 2.5mg/2.5mg tablet or 1 Triapin 5mg/5mg
tablet taken once a day
- Your doctor may start you on Triapin Mite 2.5mg/2.5mg tablets and then
change you to Triapin 5mg/5mg tablet to increase your dose
- The maximum dose is either 2 Triapin Mite 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.
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.
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
- 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
- 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, pharmacist or nurse. 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 out of the sight and reach of children
Do not use your tablets after the expiry date shown on the label. The expiry
date refers to the last day of that month.
o

Do not store above 30 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.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Triapin contains
Triapin Mite and Triapin contain the active ingredients felodipine and ramipril.
Triapin Mite 2.5mg/2.5mg prolonged-release tabletsEach tablet contains 2.5mg felodipine and 2.5mg ramipril.
Triapin 5mg/5mg prolonged-release tabletsEach tablet contains 5mg felodipine and 5mg ramipril.
The tablets also contain the inactive ingredients hydroxypropyl cellulose,
hypromellose 10000 CPS, hypromellose 50 CPS, hypromellose 6 CPS,
hypromellose 5 CPS, lactose anhydrous, pregelatinised maize starch,
microcrystalline cellulose, macrogol 6000, polyoxyl 40 hydrogenated castor
oil, propyl gallate, sodium aluminium silicate, sodium stearyl fumarate, iron
oxide reddish-brown E172, yellow iron oxide E172, titanium dioxide E171
and paraffin.

What Triapin look like and the contents of the pack
Triapin Mite 2.5mg/2.5mg prolonged-release tablets are circular, apricot
coloured, biconvex and engraved 'H OD' on one side and marked '2.5' on
the other side.
Triapin 5mg/5mg prolonged-release tablets are circular, reddish-brown
coloured, biconvex and engraved 'H OE' on one side and marked '5' on the
other side.
Triapin come in blister packs of 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst,
Brüningstrasse 50, D-65926 Frankfurt-am-Main, Germany and is procured
from within the EU by Product Licence holder Tenolol Ltd., 5, Sandridge
Close, Harrow, HA1 1XD Repackaged by Servipharm Ltd.
POM

Triapin Mite 2.5mg/2.5mg prolonged-release tablets PL 30900/2359
Triapin 5mg/5mg prolonged-release tablets PL 30900/2360

This leaflet was last revised on 09.01.14[5]
Triapin is trademark of Sanofi-Aventis Deutschland GmbH.

Expand view ⇕

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
(web1)