TILDIEM RETARD 90 MG PROLONGED RELEASE TABLETS 90 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DILTIAZEM HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Dosage:

90 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: 
INFORMATION FOR THE USER
TILDIEM® RETARD 90MG AND 
120MG PROLONGED RELEASE 
TABLETS
Diltiazem hydrochloride
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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:
• Angina (chest pain)
• High blood pressure
 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 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, you may  
  feel out

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tildiem Retard 90 mg Prolonged release Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 90 mg diltiazem hydrochloride as the active ingredient.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Off-white biconvex 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 with a little water and not chewed.
Patients should be advised that the tablet membrane may pass through the gastrointestinal tract unchanged.
Adults:
Angina and hypertension:
The usual starting dose is one tablet (90mg or 120mg) twice daily. Patient responses may vary and dosage
requirements can differ significantly between individual patients. Higher divided doses up to 480mg/day have been
used with benefit in some angina patients especially in unstable angina. Doses of 360mg/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 40 beats per minute the dose should not be
increased.
Tildiem Retard 90mg Prolonged Release Tablets should be used with caution in patients with renal or hepatic
impairment (see section 4.4 Special Warnings and Precautions for Use)
Angina:
The recommended starting dose is one Tildiem 60mg tablet twice daily. This dose may be increased to one 90mg or
120mg Tildiem Retard tablet twice daily.
Hypertension:
The starting dose should be one 120mg Tildiem Retard tablet daily. Dose adjustment to one 90mg or one 120mg
Tildiem Retard tablet twice daily may be required.
Children:
Safety and efficacy