Viazem XL 360mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diltiazem hydrochloride

Available from:

Thornton & Ross Ltd

ATC code:

C08DB01

INN (International Name):

Diltiazem hydrochloride

Dosage:

360mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 02060200; GTIN: 5030451001795

Patient Information leaflet

02500148P00360148L03-M060UWASS
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PACKAGE LEAFLET: INFORMATION FOR THE USER
VIAZEM
® XL
DILTIAZEM HYDROCHLORIDE
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 get serious, or if you notice any
side-effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Viazem
®
XL is and what it is used for
2.
Before you take Viazem
®
XL
3.
How to take Viazem
®
XL
4.
Possible side-effects
5.
How to store Viazem
®
XL
6.
Further information
1. WHAT VIAZEM
® XL IS AND WHAT IT IS USED FOR
The active ingredient in this medicine is called diltiazem. It belongs
to a group of medicines called calcium
antagonists which are used to treat high blood pressure, or to help
control angina.
2. BEFORE YOU TAKE VIAZEM
® XL
DO NOT TAKE VIAZEM
® XL:
•
if you are allergic to diltiazem or any of the other ingredients in
Viazem
®
XL (see list under ‘What Viazem
®
XL contains).
Azorubine can cause allergic reactions including asthma. Allergy is
more common in those people allergic to aspirin
•
if you have serious heart problems, particularly if a doctor has told
you that you have any of the following conditions;
-
Severe bradycardia (a very slow pulse)
-
Heart block or pre-excitation syndrome or sick sinus syndrome
(conditions in which there are problems with the
control of your heart rate)
-
Left ventricular failure
•
if you are already taking a medicine containing invabradine for the
treatment of certain heart diseases
•
if you have unstable angina
•
if the patient is a child
•
if you are pregnant or are breast-feeding.
If you are not sure, talk to your doctor or pharmacist before taking
this medici

Summary of Product characteristics

OBJECT 1
VIAZEM XL 360MG
Summary of Product Characteristics Updated 20-Oct-2015 | Thornton &
Ross Ltd
1. Name of the medicinal product
VIAZEM XL 360mg
2. Qualitative and quantitative composition
Diltiazem hydrochloride: 360 mg capsule.
For excipients see section 6.1
3. Pharmaceutical form
Prolonged release capsule, hard.
Blue-green opaque capsules. Each capsule is printed on the cap and
body, in white ink, with Viazem XL
360.
4. Clinical particulars
4.1 Therapeutic indications
VIAZEM XL is indicated for the management of stable angina pectoris
and the treatment of mild to
moderate hypertension.
4.2 Posology and method of administration
Dosage requirements may differ between patients with angina and
patients with hypertension. In addition
individual patients response may vary, necessitating careful
titration. The range of strengths facilitates
titration to the optimal dose.
One capsule of VIAZEM XL is to be taken before or during a meal. The
dose should be taken at
approximately the same time each day.
The capsule should not be chewed but swallowed whole, with a glass of
water.
Due to the variability of release profile in individual patients, when
changing from one type of sustained
release diltiazem preparation to another, it may be necessary to
adjust the dose.
Adults
Hypertension: The usual starting dose is 180 mg once daily. The dose
may be increased after 2-4 weeks
according to the patient's response and the usual maintenance dose is
240mg-360mg once daily. The
maximum daily dose is 360 mg. However, the single daily doses of 300
mg and 360 mg should only be
administered to patients when no satisfactory therapeutic effect has
been effected with lower doses and
after the benefit risk-ratio has been carefully assessed by the
doctor.
Angina: Care should be taken when titrating patients with stable
angina in order to establish the optimal
dose. The usual starting dose is 180 mg once daily. The dose may be
increased after 2-4 weeks according
to the patient's response. The maximum daily dose is 360 mg. However,
the