Adalat LA 60 mg Prolonged-release Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Nifedipine

Dostępny od:

PCO Manufacturing Ltd.

Kod ATC:

C08CA; C08CA05

INN (International Nazwa):

Nifedipine

Dawkowanie:

60 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Dihydropyridine derivatives; nifedipine

Status autoryzacji:

Authorised

Data autoryzacji:

2001-12-14

Ulotka dla pacjenta

_ _
PACKAGE LEAFLET – INFORMATION FOR THE USER
ADALAT
® LA 60MG PROLONGED
RELEASE TABLET
Nifedipine
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 more questions, ask your doctor or 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 any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
WHAT ADALAT LA IS
2.
BEFORE YOU TAKE ADALAT LA
3.
HOW YOU TAKE ADALAT LA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ADALAT LA
6.
FURTHER INFORMATION
1.
WHAT ADALAT LA IS
Adalat LA contains nifedipine, which belongs to a group of medicines
called _calcium_ _antagonists._
ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA _(chest _
_pain)._
For high blood pressure: Adalat LA works by relaxing and expanding the
blood vessels.
This makes the blood flow more easily and lowers blood pressure.
Lower blood pressure reduces the strain on your heart.
For angina: Adalat LA works by relaxing and expanding the arteries
supplying the heart. This allows more blood and oxygen to reach the
heart and decreases the strain on it. Your angina attacks will be less
severe and less frequent if there is less strain on the heart.
2.
BEFORE YOU TAKE ADALAT LA
DO NOT TAKE ADALAT LA:

IF YOU HAVE HAD A HEART ATTACK within the last month.

IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA will not help relieve
symptoms of angina quickly.

IF YOU HAVE UNSTABLE ANGINA.

IF YOU ARE ALLERGIC to the active ingredient (nifedipine), to any
other
similar medicines (known as _dihydropyridines) _or to any of the other
ingredients. The ingredients of Adalat LA are listed in section 6.

IF YOU ARE TAKING RIFAMPICIN, an antibiotic.

IF YOU HAVE A LIVER DISEASE that prevents your liver from working
properly.

IF YOU HAVE INFLAMMATION OF THE BOWEL OR INTESTINES, suc

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat LA 60 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 60 mg of nifedipine.
Excipients: Sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet
_Product imported from The Netherlands, Greece and Spain;_
Pink, lacquered tablets printed ‘Adalat 60’ in black on one side,
plain on the other side.
4 CLINICAL PARTICULARS
As per PA 1410/025/007
5 PHARMACOLOGICAL PROPERTIES
As per PA 1410/025/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Excipients present in the product imported from The Netherlands:
Polyethylene oxide
Hypromellose
Magnesium stearate
Sodium chloride
Iron oxide red (E172)
Cellulose acetate
Macrogol
Hyprolose
Propylene glycol
Titanium dioxide (E171)
Printing ink (shellac, iron oxide black (E172))
Excipients present in the product imported from Greece:
Polyethylene oxide
Hypromellose
Magnesium stearate
Sodium chloride
Iron oxide red (E172)
Cellulose acetate
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_9_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_5_
_8_
_3_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
Macrogol 4000
Propylene glycol
Titanium dioxide (E171)
Excipients present in the product imported from Spain:
Polyethylene oxide
Hypromellose
Magnesium stearate
Sodium chloride
Iron oxide red (E172)
Cellulose acetate
Macrogol
Hyprolose
Propylene glycol