TILDIEM LA 200 MG PROLONGED-RELEASE CAPSULES, HARD 200 Milligram Prolonged Release Capsules

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

DILTIAZEM HYDROCHLORIDE

Beszerezhető a:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (nemzetközi neve):

DILTIAZEM HYDROCHLORIDE

Adagolás:

200 Milligram

Gyógyszerészeti forma:

Prolonged Release Capsules

Recept típusa:

Product subject to prescription which may be renewed (B)

Engedélyezési státusz:

Authorised

Engedély dátuma:

0000-00-00

Betegtájékoztató

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IR
LANDE NOTICE TILDIEM 200/300 MG
26-06-13 V5
484399
210X148 MM
OCEAN SANS
9 PT
247900
1
NOIR
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Plan N° :
E 84
Site de Quetign
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Type :
ROULEAU DOUBLE
Vista modifica
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om the 18/06/13
PACKAGE LEAFLET:
INFORMATION FOR THE USER
TILDIEM LA 200MG AND 
300MG PROLONGED RELEASE 
CAPSULES, HARD
Diltiazem hydrochloride 
IS THIS LEAFLET HARD TO 
SEE OR READ?
PHONE [phone]
FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE.
•  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.
Do not pass it on to others. It may harm them, 
even if their symptoms are the same as yours
•  If any of the side effects gets serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist
IN THIS LEAFLET: 
1. What Tildiem LA is and what it is used for
2. Before you take Tildiem LA 
3. How to take Tildiem LA 
4. Possible side effects
5. How to store Tildiem LA 
6. Further information

 1.  WHAT TILDIEM LA IS AND WHAT IT IS USED FOR
Tildiem LA contains a medicine called diltiazem 
hydrochloride. This belongs to a group of 
medicines called ‘calcium-channel blockers’.
It works by making your blood vessels wider. 
This helps to lower your blood pressure. It also 
makes it easier for your heart to pump blood 
around the body. This helps to prevent the chest 
pain caused by angina.
Tildiem LA is used for:
•  High blood pressure 
•  Angina (chest pain)

 2.  BEFORE YOU TAKE TILDIEM LA 
DO NOT TAKE THIS MEDICINE AND T

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tildiem LA 200 mg Prolonged-Release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg of diltiazem hydrochloride as the active ingredient in a combination of immediate-
release and coated prolonged-release pellets.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release Capsule, Hard.
Opaque capsules with a grey body and a pink cap containing white immediate release and prolonged-release pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a calcium antagonist for use in the management of angina pectoris and mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage and administration:_
Tildiem LA 200 and Tildiem LA 300 are sustained release products for once daily dosing. The capsules should not be
crushed or chewed but swallowed whole with water, ideally before or during a meal. The dosage requirements may
differ in patients with angina or hypertension.
Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the
individual requirements of the patient. Careful titration of the dose should be considered where appropriate, as
individual patient response may vary. When changing from one type of Tildiem formulation to another, it may be
necessary to adjust the dosage until a satisfactory response is obtained. To ensure consistency of response once
established, particularly in the sustained release formulations, Tildiem LA 200 and Tildiem LA 300 should continue to
be prescribed by brand name.
_Adults:_
Angina and hypertension:
The usual starting dose is Tildiem LA 200, one capsule once daily. This dose may be increased to Tildiem LA 300 once
daily, or 2 ca