Pinefeld XL 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Felodipine

Available from:

Tillomed Laboratories Ltd

ATC code:

C08CA02

INN (International Name):

Felodipine

Dosage:

10mg

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: 5024655002382

Patient Information leaflet

Phama-
code
area
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
•
Keep this leaflet. You may want 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Pinefeld is and what it is used for
2.
What you need to know before you take Pinefeld
3.
How to take Pinefeld
4.
Possible side effects
5.
How to store Pinefeld
6.
Contents of the pack and other information
1. WHAT PINEFELD IS AND WHAT IT IS USED FOR
The active ingredient in Pinefeld XL is felodipine which
belongs to a group of medicines called calcium channel
blockers. These work by blocking the effects of calcium on
the blood vessels (narrowing of the blood vessels) which
helps the blood vessels to relax and widen, increasing the
blood flow and supply of oxygen to the heart, reducing the
heart’s workload.
Pinefeld is used to treat the following:
•
High blood pressure (hypertension)
•
To prevent angina (chest pain)
The name of this medicine is Pinefeld XL 10mg Prolonged-
Release Film-Coated Tablets (felodipine) and is referred to
as Pinefeld throughout this leaflet.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE PINEFELD
Do not take Pinefeld if:
•
You are allergic to felodipine, other calcium channel
blockers or any of the other ingredients of this medicine
(listed in section 6)
•
You suffer from an insufficient blood supply to the heart
muscle which can cause chest pain (unstable angina
pectoris)
•
You have had a severe heart attack within the last month
(acute myocardial infarction)
•
You suffer from heart failure or heart disease
•
You are pregnant, think you may be pregnant or are
planning to have a baby (see

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pinefeld XL 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 10mg felodipine
Excipients with known effect: Each prolonged release tablet contains
92mg of lactose
(as lactose monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablet.
Grey-red, round, biconvex tablets with an approximate diameter of 9mm,
with the
imprint F10 on one side.
4.1
THERAPEUTIC INDICATIONS
Essential hypertension and prophylaxis of chronic 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. Dose increases should occur at
intervals of at
least 2 weeks. The standard maintenance dose is 5-10 mg once daily.
Doses higher
than 20 mg daily are not usually required.
_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.
Pinefeld XL can be used in combination with
β
-blockers, ACE inhibitors or diuretics.
Combination therapy will usually enhance the antihypertensive effect.
Care should be
taken to avoid hypotension.
Different prolonged-release preparations do not necessarily have the
same effect.
When changing therapy from different prolonged-release preparations of
felodipine to
Pinefeld
XL,
blood
pressure
should
be
checked
and
the
dosage
changed
as
appropriate (see section 5.2).
_Elderly population _
Initial treatment with lowest available dose should be considered.
_Renal impairment _
Caution should be taken in patients with severe renal impairment (see
section 5.2).
Dose adjustment is not needed in patients with impaired renal
function.
_Hepatic impairment _
Patients with im