Adizem-SR 180mg capsules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Diltiazem hydrochloride

थमां उपलब्ध:

Mawdsley-Brooks & Company Ltd

ए.टी.सी कोड:

C08DB01

INN (इंटरनेशनल नाम):

Diltiazem hydrochloride

डोज़:

180mg

फार्मास्यूटिकल फॉर्म:

Modified-release capsule

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Caution - AMP level prescribing advised

उत्पाद समीक्षा:

BNF: 02060200

सूचना पत्रक

1109-6
_ADIZEM_
®
_-SR _90 MG, 120 MG AND 180 MG
PROLONGED-RELEASE CAPSULES
Diltiazem hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any get side talk with your doctor.This includes
any possible side effects not listed in this leaflet.See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What
_ADIZEM-SR_
capsules are and what they are
used for
2.
What you need to know before you take
_ADIZEM-SR_
capsules
3.
How to take
_ADIZEM-SR_
capsules
4. Possible side effects
5.
How to store
_ADIZEM-SR_
capsules
6.
Contents of the pack and other information
1.
WHAT _ADIZEM-SR _CAPSULES ARE AND WHAT
THEY ARE USED FOR
These capsules have been prescribed for you to
treat angina (chest pain caused by a reduction of
oxygen to the heart muscle) or high blood pressure
(hypertension). They contain the active ingredient
diltiazem. Diltiazem belongs to a group of medicines
called calcium antagonists. Calcium antagonists
help more blood to reach the heart and reduce
blood pressure. The other ingredients of
_ADIZEM-SR _
capsules are listed in section 6 of this leaflet.
_ADIZEM-SR _CAPSULES ARE DESIGNED TO WORK PROPERLY
OVER 12 HOURS. IF THE CAPSULES ARE CRUSHED OR
CHEWED, THE ENTIRE 12‑HOUR DOSE MAY BE ABSORBED
RAPIDLY INTO YOUR BODY. THIS CAN BE DANGEROUS,
CAUSING SERIOUS PROBLEMS SUCH AS AN OVERDOSE.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
_ADIZEM-SR_ CAPSULES
DO NOT TAKE _ADIZEM-SR _CAPSULES IF YOU:
•
are allergic (hypersensitive) to diltiazem or any of
the other ingredients of the capsules (see section 6
‘Further Information’);
•
have a slow or irregular heart beat;
•
have heart failure (which can cause shortness of
brea

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ADIZEM-SR capsules 180 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 180 mg diltiazem hydrochloride.
Excipients: also contains sucrose 36.53 mg per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release capsules
Capsules with white bodies and pale brown caps marked "180 mg"
containing
prolonged release microgranules.
4.1
THERAPEUTIC INDICATIONS
For the management of angina pectoris.
For the treatment of mild to moderate hypertension.
_ _
_ADIZEM-SR_ capsules are indicated for use in adults only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Angina
Adults:
The usual initial dose is 90 mg twice daily. Dosage may be increased
gradually to
120 mg twice daily or 180 mg twice daily if required. Patients’
responses may vary
and dosage requirements can differ significantly between individual
patients.
Elderly and patients with impaired renal or hepatic function:
In the elderly, dosage should commence at 60 mg diltiazem
hydrochloride twice daily
and the dose carefully titrated as required.
Hypertension:
Adults:
The usual dose is one _ADIZEM-SR_ 120 tablet or capsule twice daily.
Patients may
benefit by titrating from a lower total daily dose.
Elderly and patients with impaired renal or hepatic function:
The starting dose should be 60 mg diltiazem hydrochloride twice daily,
increasing to
one _ADIZEM-SR_ 90 mg capsule twice daily and then to one _ADIZEM-SR_
120 mg
tablet or capsule twice daily if clinically indicated.
Paediatric population:
The _ADIZEM_ preparations are not recommended for children. Safety and
efficacy in
children has not been established.
Method of administration
Oral.
To be taken at 12 hour intervals.
Dosage may be taken with or without food, and should be swallowed
whole and not
chewed.
In order to avoid confusion, it is suggested that patients once
titrated to an effective
dose using either _ADIZEM-SR_ tablets or capsules should remain on
this treatment
and should