Tritace titration pack tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Mevcut itibaren:

Sanofi

ATC kodu:

C09AA05

Farmasötik formu:

Not applicable

Sınıf:

No Controlled Drug Status

Reçete türü:

Never Valid To Prescribe As A VMP

Ürün özeti:

BNF: 02050501; GTIN: 5000283653165 5000283658238

Bilgilendirme broşürü

89031942. 4/4
89031942 1/4
_PACK. ITEM:_
ARKHÉ S.N.C.
Tel. [phone]
fax [phone]
1 - Prima realizzazione
 REFLEX BLUE
SANOFI S.P.A.
Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
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05-02-2018
IST TRITACE GB I02
ISTRUZIONI
GB: GREAT BRITAIN
89031942
89031227
62C0007 V.1.0
1101100101
167 X 315MM DP
7
-
-
9,5 PT SU 10 PT
2 - Modifica testo reg.
3 - Modifica testo reg.
4 - Modifica testo reg.
5 - Modifica testo reg.
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PACKAGE LEAFLET:
INFORMATION FOR THE USER
TRITACE
® 1.25MG - 2.5MG
5MG - 10MG TABLETS
TRITACE
® TABLETS TITRATION PACK
Ramipril
IS THIS LEAFLET HARD TO SEE
OR READ?
PHONE [phone]
FOR HELP
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 TRITACE is and what it is used for
2. What you need to know before you take TRITACE
3. How to take TRITACE
4. Possible side effects
5. How to store TRITACE
6. Contents of the pack and other information
1. WHAT TRITACE IS AND WHAT
IT IS USED FOR
TRITACE contains a medicine called ramipril. This
belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).
TRITACE works by:
• Decreasing your body’s production of substances
that could raise your blood pressure
• Making your blood vessels relax and widen
• Making it easier for your heart to pump blood
around your body.
TRITACE can be used:
• To treat high blood pressure (hypertension

Ürün özellikleri

OBJECT 1
TRITACE TABLET TITRATION PACK
Summary of Product Characteristics Updated 22-Feb-2018 | SANOFI
1. Name of the medicinal product
Tritace Tablet Titration Pack 2.5 mg, 5 mg, 10 mg tablets
2. Qualitative and quantitative composition
Tablets
Each 2.5 mg tablet contains ramipril 2.5 mg
Each 5 mg tablet contains ramipril 5 mg
Each 10 mg tablet contain ramipril 10 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets 2.5 mg
Yellowish to yellow oblong tablet with dimensions of 8 x 4 mm with
score-line.
Upper stamp: 2.5 & logo (
)
Lower stamp: HMR & 2.5
The tablet can be divided into equal doses.
Tablets 5 mg
Pale red oblong tablet with dimensions of 8 x 4 mm with score-line.
Upper stamp: 5 & logo (
)
Lower stamp: HMP & 5
The tablet can be divided into equal doses.
Tablets 10 mg
White to almost white oblong tablet with dimensions of 7 x 4.5 mm with
score-line.
Upper stamp: HMO/HMO
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
• manifest atherothrombotic cardiovascular disease (history of
coronary heart disease or stroke, or
peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor (see section
5.1).
- Treatment of renal disease:
• Incipient glomerular diabetic nephropathy as defined by the
presence of microalbuminuria,
• Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with at least one
cardiovascular risk factor (see section 5.1),
• Manifest glomerular non diabetic nephropathy as defined by
macroproteinuria ≥ 3 g/day (see section
5.1).
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of
mortality from the acute phase of
myocardial infarction in patients with clinical signs of heart failure
when started > 48 hours following
acute myocardial infarction.
4.2 Posology and metho