APO-TELMISARTAN/AMLODIPINE 40/5 telmisartan/amlodipine (as besilate) 40/5 mg tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 6.94 mg; telmisartan, Quantity: 40 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amlodipine besilate,Telmisartan

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; croscarmellose sodium; brilliant blue FCF aluminium lake; mannitol; magnesium stearate; microcrystalline cellulose; povidone; silicon dioxide; iron oxide yellow; sodium hydroxide; meglumine; iron oxide black; isomalt

Administration route:

Oral

Units in package:

28's pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Product summary:

Visual Identification: White and Blue colored, two-layered, modified capsule-shaped, biconvex uncoated tablets with"APO" engraved on one side and "40/5" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-07-26

Patient Information leaflet

APO-TELMISARTAN/
AMLODIPINE TABLETS
_Telmisartan/Amlodipine_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about telmisartan/
amlodipine. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Telmisartan/amlodipine is used to
lower high blood pressure
(hypertension).
Telmisartan belongs to a group of
medicines called angiotensin II
receptor antagonists.
Amlodipine belongs to a group of
medicines called calcium channel
blockers.
_HOW IT WORKS_
Telmisartan and amlodipine work
together to help stop your blood
vessels tightening. As a result, the
blood vessels relax, and blood
pressure is lowered.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
telmisartan
•
amlodipine
•
dihydropyridine medicines
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing, difficulty breathing or
tightness in chest
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
biliary obstructio

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-TELMISARTAN/AMLODIPINE
(TELMISARTAN AND AMLODIPINE (AS THE BESILATE
SALT)) TABLETS
1
NAME OF THE MEDICINE
Telmisartan and Amlodipine (as the besilate salt)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg or 80 mg telmisartan and 5 mg or 10 mg
amlodipine (as besilate)
as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
40/5 MG TABLETS:
White and Blue coloured, two-Iayered. Modified capsule shaped,
biconvex, uncoated tablets
with “APO” engraved on one side and “40/5" on the other side.
White layer may contain blue
specks and blue layer may contain white specks.
40/10 MG TABLETS:
White and Blue coloured, two-Iayered. Modified capsule shaped,
biconvex, uncoated tablets
with “APO” engraved on one side and “40/10" on the other side.
White layer may contain blue
specks and blue layer may contain white specks.
80/5 MG TABLETS:
White and Blue coloured, two-Iayered. Modified capsule shaped,
biconvex, uncoated tablets
with “APO” engraved on one side and “80/5" on the other side.
White layer may contain blue
specks and blue layer may contain white specks.
80/10 MG TABLETS:
White and Blue coloured, two-Iayered. Modified capsule shaped,
biconvex, uncoated tablets
with “APO” engraved on one side and “80/10" on the other side.
White layer may contain blue
specks and blue layer may contain white specks.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
fixed-dose combination.
(see section 4.2 DOSE AND METHOD OF ADMINISTRATION)
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Telmisartan/Amlodipine tablets are intended for oral
administration.
DOSAGE
Telmisartan/Amlodipine should be taken once daily.
Telmisartan/Amlodipine may be taken with or without food.
Telmisartan/Amlodipine can be administered with other antihypertensive
drugs.
Replacement therapy
Patients receiving telmisartan and amlod