Triapin 5mg/5mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Felodipine; Ramipril

Available from:

Sanofi

ATC code:

C09BB05

INN (International Name):

Felodipine; Ramipril

Dosage:

5mg ; 5mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5013841202361

Patient Information leaflet

PACKAGE LEAFL ET: 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 LEAFL ET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leafl et. 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 eff ects, talk to your doctor or
pharmacist. This includes any possible side eff ects not
listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET:
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 eff ects
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 leafl et) 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

Summary of Product characteristics

OBJECT 1
TRIAPIN 5MG/5MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 22-Feb-2018 | SANOFI
1. Name of the medicinal product
Triapin 5mg/5mg prolonged release tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of felodipine and 5 mg of ramipril.
Each tablet contains 51.5 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Triapin 5mg/5mg tablets are circular (diameter approx 9 mm),
reddish-brown coloured, biconvex and
engraved
on one side and marked 5 on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension. Triapin fixed dose combination is
indicated in patients whose blood
pressure is not adequately controlled on felodipine or ramipril alone.
4.2 Posology and method of administration
Posology
_Use in adults, including older people:_
One tablet Triapin 5mg/5mg once daily. The maximum dose is one tablet
Triapin 5mg/5mg once daily.
Special populations
_Use in patients with impaired liver function:_
See sections 4.3 and 4.4.
_Use in patients with impaired renal function or patients already on
diuretic treatment: _
See sections 4.3 and 4.4.
Individual dose titration with the components can be recommended and
when clinically appropriate,
direct change from monotherapy to the fixed combination may be
considered.
_Paediatric population:_
Triapin is not recommended for use in children due to a lack of data.
Method of administration
Triapin tablets should be swallowed whole with a sufficient amount of
liquid. The tablets must not be
divided, crushed or chewed.
The tablet can be administered without food or following a light meal
not rich in fat or carbohydrate.
4.3 Contraindications
• hypersensitivity to felodipine (or other dihydropyridines),
ramipril, other angiotensin converting enzyme
(ACE) inhibitors or any of the excipients listed in section 6.1.
• history of angioedema.
• concomitant use with sacubitril/valsartan therapy (see sections
4.4 and 4.5).
• unstable haemod