Adizem-XL 120mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diltiazem hydrochloride

Available from:

Napp Pharmaceuticals Ltd

ATC code:

C08DB01

INN (International Name):

Diltiazem hydrochloride

Dosage:

120mg

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: 5012854010116

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADIZEM_
_®_
_-XL _120 MG, 180 MG, 200 MG, 240 MG AND 300 MG PROLONGED RELEASE
CAPSULES
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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_ADIZEM-XL _
capsules are and what they are used for
2.
What you need to know before you take
_ADIZEM-XL_
capsules
3.
How to take
_ADIZEM-XL_
capsules
4.
Possible side effects
5.
How to store
_ADIZEM-XL _
capsules
6.
Contents of the pack and other information
1.
WHAT _ADIZEM-XL_ 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-XL_
capsules are listed in
section 6 of this leaflet.
_ADIZEM-XL_
CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 24 HOURS. IF THE CAPSULES
ARE CRUSHED OR CHEWED,
THE ENTIRE 24-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-XL_ CAPSULES
DO NOT TAKE _ADIZEM-XL _CAPSULES IF YOU:
•
are allergic (hypersensitive) to diltiazem or any of the other
ingredients of the capsules (see section 6
‘Further Information’);
•
are pregnant, likely to become pregnant or are breastfeeding;
•
hav

Summary of Product characteristics

OBJECT 1
ADIZEM-XL CAPSULES 120 MG
Summary of Product Characteristics Updated 16-Nov-2020 | Napp
Pharmaceuticals Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
_ADIZEM-XL_ Capsules 120, 180, 200, 240 and 300 mg
2. Qualitative and quantitative composition
Each capsule contains 120, 180, 200, 240 or 300 mg diltiazem
hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsule
_ADIZEM-XL_ capsules 120 mg are approximately 16mm long with a pale
pink body and a navy blue cap,
marked DCR 120.
_ADIZEM-XL_ capsules 180 mg are approximately 18mm long with a dark
pink body and a royal blue cap,
marked DCR 180.
_ADIZEM-XL_ capsules 200 mg are approximately 19mm long with a light
brown body and a light brown
cap, marked DCR 200.
_ADIZEM-XL_ capsules 240 mg are approximately 19mm long with a dark
red body and a blue cap, marked
DCR 240.
_ADIZEM-XL_ capsules 300 mg are approximately 22mm long with a dark
maroon body and a p