TILDIEM LA 300 Milligram Prolonged Release Capsules

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

DILTIAZEM HYDROCHLORIDE

Доступно од:

LTT Pharma Limited

INN (Међународно име):

DILTIAZEM HYDROCHLORIDE

Дозирање:

300 Milligram

Фармацеутски облик:

Prolonged Release Capsules

Тип рецептора:

Product subject to prescription which may be renewed (B)

Статус ауторизације:

Authorised

Датум одобрења:

0000-00-00

Информативни летак

TILDIEM  LA 300MG PROLONGED-RELEASE HARD CAPSULES
(diltiazem hydrochloride)
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Tildiem LA 300mg Prolonged-Release Hard
Capsules but will be referred to as Tildiem LA throughout the
leaflet.
IN THIS LEAFLET:
What Tildiem LA is and what it is used for
Before you take Tildiem LA
How to take Tildiem LA
Possible side effects
How to store Tildiem LA
Further information
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)
BEFORE YOU TAKE TILDIEM LA
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
* 
You are allergic (hypersensitive) to diltiazem hydrochloride or any of
the 
other ingredients of Tildiem LA (listed in Section 6 below) Signs of
an  
allergic reaction include: a rash, swallowing or breathing problems,

swelling of your lips, face, throat or tongue.
* 
You are having a medicine called dantrolene used for severe muscle  
spasms or severe fever (see Section below: ‘Taking other
medicines’).
* 
You have a very slow heartbeat - less than 40 beats per minute.
* 
You have heart failure and problems with blood flow to your 
lungs. With these illnesses, yo

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tildiem LA 300 mg Prolonged-Release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg 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, hard capsules.
_Product imported from Greece_
Opaque capsules with a white body and a yellow cap.
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.
Tildiem LA 300 has been used following an acute myocardial infarction initially treated with thrombolysis, in the
absence of congestive heart failure (see section 5.1 Pharmacodynamics).
Adults:
Angina and hype