Kenzem SR 120mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diltiazem hydrochloride

Available from:

Kent Pharma (UK) 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: 5015201006206

Patient Information leaflet

PATIENT INFORMATION LEAFLET
(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 FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
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 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
PREGNANCY, BREAST-FEEDING AND FERTILITY
DO NOT take this medicine if you:
•
are pregnant or planning to become pregnant
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
STOP TAKING YOUR MEDICINE AND TELL YOUR DOCTOR IMMEDIATELY, OR GO
TO YOUR NEAREST HOSPITAL CASUALTY DEPARTMENT IF YOU EXPERIENCE:
•
an allergic reaction. The symptoms may include a rash, problems with
swallowing or breathing, swelling of the lips, face, throat or tongue
•
severe blistering rash where layers of skin peel off leaving scalded
skin. You may also have a fever. This could be an illness called
‘toxic
epidermal necrolysis’.
•
a skin rash with dark circles and pale centres, red patches,
blistering or
peeling. You may also have a fever. This could be an illness called
‘erythema multiforme’ or ‘Stevens-Johnson syndrome’.
•
heart problems or heart failure. The signs could be shortness of
breath,
flushing, feeling of tiredness along with swollen ankles and legs
•
a severe slowing of the heart (which may cause either fainting or
dizziness)
•
hepatitis (symptoms include high temperature, nausea, muscle aches,
tiredness, loss of appetite and diarrhoea). A disturbance in liver
enzyme
level is often detectable by a blood test.
WHAT KENZEM SR CAPSULES CONTAIN
Kenzem 60mg, 90mg or 120mg SR Capsules contain the active
ingredient diltiazem hydrochloride.
The other inactive ingredients include sugar spheres (sucrose and
maize
starch), povidone, m

Summary of Product characteristics

OBJECT 1
KENZEM 120MG SR CAPSULES
Summary of Product Characteristics Updated 16-Jan-2017 | Kent
Pharmaceuticals Ltd
•
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
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5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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Administrative data
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Kenzem 120mg SR Capsules
2. Qualitative and quantitative composition
Each capsule contains 120mg of diltiazem hydrochloride
Excipients with known effect:
Product contains sucrose.
For full list of excipients, see section 6.1
3. Pharmaceutical form
Modified release capsule
4. Clinical particulars
4.1 Therapeutic indications
The treatment of angina pectoris.
The treatment of mild to moderate hypertension.
4.2 Posology and method of administration
Kenzem (Diltiazem hydrochloride) is available in a range of
presentations to enable dosage to be adjusted
to meet individual requirements of the patient. Careful titration of
the dose should be considered where
appropriate, as individual patient response may vary. When changing
from one type of diltiazem
formulation to another it may be necessary