Amlodipine Pinewood 10 mg tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Amlodipine besylate

Inapatikana kutoka:

Pinewood Laboratories Ltd

ATC kanuni:

C08CA; C08CA01

INN (Jina la Kimataifa):

Amlodipine besylate

Kipimo:

10 milligram(s)

Dawa fomu:

Tablet

Eneo la matibabu:

Dihydropyridine derivatives; amlodipine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2013-02-22

Taarifa za kipeperushi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE PINEWOOD 5 MG TABLETS
AMLODIPINE PINEWOOD 10 MG TABLETS
Amlodipine
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Amlodipine Pinewood is and what it is used for
2.
What you need to know before you take Amlodipine Pinewood
3.
How to take Amlodipine Pinewood
4.
Possible side effects
5.
How to store Amlodipine Pinewood
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE PINEWOOD IS AND WHAT IT IS USED FOR
Amlodipine Pinewood tablets contain the active substance amlodipine
which belongs to a group of
medicines called calcium antagonists.
Amlodipine
Pinewood is used to treat high blood pressure (hypertension) or a
certain type of chest pain
called angina, a rare form of which is Prinzmetal’s or variant
angina.
In patients with high blood pressure your medicine works by relaxing
blood vessels, so that blood passes
through them more easily. In patients with angina Amlodipine Pinewood
works by improving blood
supply to the heart muscle which then receives more oxygen and as a
result chest pain is prevented. Your
medicine does not provide immediate relief of chest pain from angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE PINEWOOD
DO NOT TAKE AMLODIPINE PINEWOOD:
-
if you are allergic to amlodipine or any of the other ingredients of
this medicine (listed in section
6), or to any other calcium antagonists. This may be itching,
reddening of the skin or difficulty in
breathing.
-
if you have severe low blood pre

Tabia za bidhaa

Health Products Regulatory Authority
07 July 2022
CRN00CZSD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Pinewood 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of amlodipine (as amlodipine besilate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat faced, bevelled edged tablets with
‘UH’ debossed on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal’s) angina
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
For both hypertension and angina, the usual initial dose is 5 mg
amlodipine once daily which may be increased to a maximum
dose of 10 mg depending on the individual patient’s response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide diuretic, alpha blocker, beta blocker, or an
angiotensin converting enzyme inhibitor. For angina, Amlodipine may be
used as monotherapy or in combination with other
antianginal medicinal products in patients with angina that is
refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of amlodipine is required upon concomitant
administration of thiazide diuretics, beta blockers and
angiotensin-converting enzyme inhibitors.
Special populations
_Elderly _
Amlodipine used at similar doses in elderly or younger patients is
equally well tolerated. Normal dosage regimens are
recommended in the elderly, but increase of the dosage should take
place with care (see sections 4.4 and 5.2).
_Hepatic impairment_
Dosage recommendations have not been established in patients with mild
to moderate hepatic impairment; therefore dose
selection should be cautious and should start at the lower end of the
dosing range (see sections 4.4 and 5.2).
Health Products Regulatory Authority
07 July 2022
CRN00CZSD
Page 2 of 9
The pharmacokinetics of amlodipine have not been studied in seve