Plendil 5mg modified-release tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
06-06-2018
Summary of Product characteristics
(SPC)
06-06-2018
Active ingredient:
Felodipine
Available from:
AstraZeneca UK Ltd
ATC code:
C08CA02
INN (International Name):
Felodipine
Dosage:
5mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02060200; GTIN: 5014162008519
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PLENDIL
2.5 MG PROLONGED-RELEASE TABLETS
PLENDIL
5 MG PROLONGED-RELEASE TABLETS
PLENDIL
10 MG PROLONGED-RELEASE TABLETS
felodipine
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.
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 Plendil is and what it is used for
2.
What you need to know before you take Plendil
3.
How to take Plendil
4.
Possible side effects
5.
How to store Plendil
6.
Contents of the pack and other information
1.
WHAT PLENDIL IS AND WHAT IT IS USED FOR
Plendil contains the active substance felodipine. This belongs to a
group of medicines called
calcium antagonists. It lowers blood pressure by dilating small blood
vessels. It does not
negatively affect the heart function.
Plendil is used in the treatment of high blood pressure (hypertension)
and heart and chest pain
brought on by for example exercise or stress (angina pectoris).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLENDIL
DO NOT TAKE PLENDIL
if you are pregnant. You should tell your doctor as soon as possible
if you become
pregnant while using this medicine.
if you are allergic to felodipine or any of the other ingredients of
this medicine (listed in
section 6).
if you suffer from uncompensated heart failure.
if you have acute myocardial infarction (heart attack).
if you have chest pain of recent onset, or angina pectoris that is
lasting for more than 15
minutes or longer or is more severe than usual.
if you have disease of a heart valve or heart muscle, until you have
talked to your doctor.
WARNINGS AND PRECAUTIONS
Plendil,
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Summary of Product characteristics
OBJECT 1
PLENDIL 2.5MG
Summary of Product Characteristics Updated 17-Nov-2016 | AstraZeneca
UK Limited
1. Name of the medicinal product
Plendil 2.5 mg prolonged-release tablets
Plendil 5 mg prolonged-release tablets
Plendil 10 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each tablet contains 2.5 mg felodipine.
Excipients with known effect:
Each tablet contains 28 mg lactose and 2.5 mg macrogolglycerol
hydroxystearate.
Each tablet contains 5 mg felodipine.
Excipients with known effect:
Each tablet contains 28 mg lactose and 5 mg macrogolglycerol
hydroxystearate.
Each tablet contains 10 mg felodipine.
Excipients with known effect:
Each tablet contains 28 mg lactose and 10 mg macrogolglycerol
hydroxystearate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Plendil 2.5 mg: the tablet is yellow, circular, biconvex, engraved
A/FL on one side and 2.5 on the other
side, with a diameter of 8.5 mm.
Plendil 5 mg: the tablet is pink, circular, biconvex, engraved A/Fm on
one side and 5 on the other side,
with a diameter of 9 mm.
Plendil 10 mg: the tablet is reddish-brown, circular, biconvex,
engraved A/FE on one side and 10 on the
other side, with a diameter of 9 mm.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Stable angina pectoris
4.2 Posology and method of administration
Posology
_Hypertension_
The dose should be adjusted individually. Treatment can be started
with 5 mg once daily. Depending on
the patient's response, the dosage can, where applicable, be decreased
to 2.5 mg or increased to 10 mg
daily. If necessary another antihypertensive agent may be added. The
standard maintenance dose is 5 mg
once daily.
_Angina pectoris_
The dose should be adjusted individually. Treatment should be
initiated with 5 mg once daily and, if
needed, increased to 10 mg once daily.
_Elderly population_
Initial treatment with lowest available dose should be considered.
_Renal impairment_
Dose adjustment is not needed in patients with impaired re
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