TRITACE 10 Milligram Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

RAMIPRIL

Disponible depuis:

LTT Pharma Limited

Code ATC:

C09AA05

DCI (Dénomination commune internationale):

RAMIPRIL

Dosage:

10 Milligram

forme pharmaceutique:

Tablets

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

ACE inhibitors, plain

Statut de autorisation:

Authorised

Date de l'autorisation:

2014-07-04

Notice patient

Tell your doctor if you are taking any of the following
medicines. They can
make Tritace work less well:
*
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal 
Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin
and 
aspirin)
*
Medicines used for the treatment of low blood pressure, shock,
cardiac 
failure, asthma or allergies such as ephedrine, noradrenaline or 
adrenaline. Your doctor will need to check your blood pressure.
Tell your doctor if you are taking any of the following medicines.
They can increase the chance of getting side effects if you take them
with
Tritace:
*
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal 
Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and

aspirin)
*
Medicines for cancer (chemotherapy)
*
Medicines to stop the rejection of organs after a transplant such as 
ciclosporin
*
Diuretics (water tablets) such as furosemide
*
Medicines which can increase the amount of potassium in your blood
such  
as spironolactone, triamterene, amiloride, potassium salts and
heparin 
(for thinning blood)
*
Steroid medicines for inflammation such as prednisolone
*
Allopurinol (used to lower the uric acid in your blood)
*
Procainamide (for heart rhythm problems).
*
Temsirolimus (for cancer)
*
Sirolimus, everolimus (for prevention of graft rejection)
*
Vildagliptin (used for treating type 2 diabetes)
*
Your doctor may need to change your dose and/or to take other 
precautions if you are taking an angiotensin II receptor blocker (ARB)
or 
aliskiren (see also information under the headings “Do not
take Tritace” 
and “Warnings and precautions”).  
Tell your doctor if you are taking any of the following medicines. 
They may be affected by Tritace:
*
Medicines for diabetes such as oral glucose lowering medicines and 
insulin. Tritace may lower your blood sugar amounts. Check your blood

sugar amounts closely while taking Tritace
*
Lithium (for mental health problems). Tritace may increase the amount
of  
lit

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRITACE 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each tablet contains ramipril 10 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
_Product imported from the United Kingdom:_
White to almost white oblong tablet with score line, upper stamp HMO/HMO. The tablet can be divided into equal
halves.
4 CLINICAL PARTICULARS
As per PA0540/084/008
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/084/008
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hypromellose
Pregelatinized maize starch
Microcrystalline cellulose
Sodium stearyl fumarate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage conditions.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 26/10/2016_
_CRN 2181079_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Packs of 28, tablets in PVC/Alu blisters
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
Any unused product or waste material should be disposed of in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/118/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4th July 2014
10 DATE OF REVISION OF THE TEX