Diltam 90 mg Prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diltiazem hydrochloride

Available from:

Rowex Ltd

ATC code:

C08DB; C08DB01

INN (International Name):

Diltiazem hydrochloride

Dosage:

90 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzothiazepine derivatives; diltiazem

Authorization status:

Marketed

Authorization date:

1995-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DILTAM 90MG PROLONGED-RELEASE TABLETS
Diltiazem Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- 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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Diltam is and what it is used for
2. What you need to know before you take Diltam
3. How to take Diltam
4. Possible side effects
5. How to store Diltam
6. Contents of the pack and other information.
1
WHAT DILTAM IS AND WHAT IT IS USED FOR
Diltam contains the active substance diltiazem hydrochloride. It
belongs to a group of medicines
known as calcium channel blockers. It works by relaxing blood vessels
so that blood passes through
them more easily. This helps to lower your blood pressure. It also
works by improving blood supply
to the heart muscle which then receives more oxygen and as a result
chest pain is prevented.
Diltiazem does not provide immediate relief of chest pain from angina.
Diltam is used to treat:
• Mild to moderate high blood pressure
• A certain type of chest pain called angina.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILTAM
DO NOT TAKE DILTAM IF:
- you are allergic to diltiazem or any of the other ingredients of
this medicine (listed in section 6).
Signs of an allergic reaction include: rash, swallowing or breathing
problems, swelling.
- 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 swollen ankles.
- you have any other serious problems with your heart. This includes
having an uneven

Summary of Product characteristics

Health Products Regulatory Authority
07 October 2019
CRN008PGJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diltam 90 mg Prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 90mg diltiazem hydrochloride.
Excipient(s) with known effect: each tablet contains 30.0 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged – release tablet
White, round, biconvex tablets with a score notch on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate hypertension and angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Oral. Diltam 90 mg Prolonged release tablets should be swallowed with
a little water and not chewed.
ADULTS:
_ANGINA AND HYPERTENSION:_
The usual starting dose is one tablet (90 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 diltiazem 60 mg tablet twice
daily. This dose may be increased to one Diltam 90 mg
Prolonged release tablet twice daily.
_HYPERTENSION:_
The starting dose should be one 120 mg diltiazem retard tablet daily.
Dose adjustment to one Diltam 90 mg Prolonged release
tablet twice daily may be required.
PAEDIATRIC POPULATION:
Safety and efficacy in children have not been established. Therefore
diltiazem is not recommended for use in children.
4.3 CONTRAINDICATIONS
Pregnancy, lactation and women of childbearing potential (see section
4.6).
Sick sinus syndrome except in the presence of a functioning
ventricular pac