Tildiem Retard 120mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diltiazem hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

C08DB01

INN (International Name):

Diltiazem hydrochloride

Dosage:

120mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 02060200

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TILDIEM
® RETARD 120MG TABLETS
(diltiazem hydrochloride)
Your medicine is available using the above name but will be
referred to as Tildiem Retard throughout the 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
IN THIS LEAFLET:
1.
What Tildiem Retard is and what it is used for
2.
Before you take Tildiem Retard
3.
How to take Tildiem Retard
4.
Possible side effects
5.
How to store Tildiem Retard
6.
Further information
1.
WHAT TILDIEM RETARD IS AND WHAT IT IS USED
FOR
Tildiem Retard 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 Retard is used for:

High blood pressure

Angina (chest pain)
2.
BEFORE YOU TAKE TILDIEM RETARD
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
Retard (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 breast-feeding or planning to breast-feed (see
Section below: 'Pregnancy and breast-feeding')

You have a very slow heartbeat - less than 50 beats per
minute

You have heart failure and problems with blood flow to
your lungs. With these illnesses, you may feel out of
breath and have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tildiem Retard 120mg Prolonged-Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 120 mg of the active substance diltiazem
hydrochloride.
Also contains: 69.4 mg of sucrose and 17.97 mg of sodium.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, round convex coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate hypertension and angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tildiem Retard tablets should be swallowed whole with a little water
and
not crushed or chewed.
Patients should be advised that the tablet membrane may pass through
the
gastro- intestinal tract unchanged.
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 Retard
90 mg and 120 mg should continue to be prescribed by brand name.
Adults
_Angina and hypertension: _
The usual starting dose is one tablet (90 mg or 120 mg) twice daily.
Patient
responses may vary, and dosage requirements can differ significantly
between
individual patients. Higher divided doses up to 480 mg/day have been
used
with benefit in some angina patients especially in unstable angina.
Doses of
360 mg/day may be required to provide adequate BP control in
hypertensive
patients.
Elderly and patients with impaired hepatic or renal function
Heart rate should be monitored in these patients and if it falls below
50 beats
per minute the dose should not be increased.
_Angina: _
The recommended starting dose is one Tildiem