Adizem-SR 90mg 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:

90mg

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: 5012854010802

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADIZEM_
_®_
_-SR _90 MG, 120 MG AND 180 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 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’);
•
are pregnant, likely to become pregnant or are breastfeeding;
•
have a very slow (

Summary of Product characteristics

OBJECT 1
ADIZEM-SR CAPSULES 90 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-SR_ capsules 90 mg, 120 mg, 180 mg
2. Qualitative and quantitative composition
Each capsule contains 90 mg, 120 mg or 180 mg diltiazem hydrochloride.
Excipients: also contains sucrose 18.26 mg per capsule. (90 mg only)
Excipients: also contains sucrose 24.35 mg per capsule. (120 mg only)
Excipients: also contains sucrose 36.53 mg per capsule. (180 mg only)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged release capsule
_ADIZEM-SR_ capsules 90 mg are white capsules marked “90 mg”
_ADIZEM-SR_ capsules 120 mg are white capsules marked “120 mg”
_ADIZEM-SR_ capsules 180 mg are white capsules marked “180 mg”
The capsules contain prolonged release microgranules.
4. Clinical particulars
4.1 Therapeutic indications
For the management of angina pectoris.
For the