FELODUR ER felodipine 10mg extended release tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

felodipine, Quantity: 10 mg

Disponível em:

AstraZeneca Pty Ltd

Forma farmacêutica:

Tablet, modified release

Composição:

Excipient Ingredients: sodium stearylfumarate; Carnauba Wax; hypromellose; aluminium sodium silicate; iron oxide red; titanium dioxide; hyprolose; lactose; iron oxide yellow; PEG-40 hydrogenated castor oil; microcrystalline cellulose; macrogol 6000; propyl gallate

Via de administração:

Oral

Unidades em pacote:

7 (sample), 30

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Hypertension.

Resumo do produto:

Visual Identification: Circular, red-brown, biconvex film-coated tablet with A/FE impressed on one side and 10 on the other side; 9 mm diameter; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Licence status A

Data de autorização:

1997-11-10

Folheto informativo - Bula

FELODUR
® ER
_Felodipine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
FELODUR ER. It does not contain
all the information that is known
about FELODUR ER.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
FELODUR ER 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 need to read it again.
WHAT FELODUR ER IS
FOR
FELODUR ER is used to treat high
blood pressure, also called
hypertension. FELODUR ER lowers
blood pressure by dilating
(expanding) small blood vessels,
letting the blood be pumped around
the body more easily.
Your doctor will have explained why
you are being treated with
FELODUR ER and told you what
dose to take.
The ER in FELODUR ER stands for
Extended Release. This means that
the tablets are designed to work over
a 24 hour period.
FELODUR ER contains felodipine,
which belongs to the family of
medicines known as calcium channel
blockers. These medicines do not
change the way the body takes in
calcium from food.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
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.
FELODUR ER is only available with
a doctor's prescription.
FELODUR ER is not addictive
BEFORE YOU USE
FELODUR ER
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE FELODUR ER IF YOU
HAVE AN ALLERGY TO ANY MEDICINE
CONTAINING FELODIPINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THE
LEAFLET.
Some of the symptoms of an allergic
reaction may include, tightness of the
chest, wheezing, coughing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives.
DO NOT TAK

Características técnicas

1 of 10
AUSTRALIAN PRODUCT INFORMATION
FELODUR
® ER (FELODIPINE) EXTENDED RELEASE TABLETS
1
NAME OF THE MEDICINE
Felodipine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FELODUR ER tablets contain 2.5mg, 5mg or 10mg felodipine.
EXCIPIENT WITH KNOWN EFFECT
Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FELODUR ER TABLETS 2.5MG:
Yellow, circular, biconvex, film-coated, engraved A/FL on one side and
2.5 on the other. Diameter
8.5 mm.
FELODUR ER TABLETS 5MG
Pink, circular, biconvex, film-coated, engraved A/Fm on one side and 5
on the other. Diameter 9
mm.
FELODUR ER TABLETS 10MG:
Red-brown, circular, biconvex, film-coated, engraved A/FE on one side
and 10 on the other.
Diameter 9 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_HYPERTENSION _
The dose should be adjusted individually.
Treatment should be started with 5mg once daily. In elderly patients a
starting dose of 2.5mg once
daily should be considered.
If necessary, the dose can be increased in 2.5 or 5mg/day increments.
The usual maintenance dose
is 5mg to 10mg daily. Doses higher than 20mg daily of FELODUR ER are
not recommended.
2 of 10
SPECIAL PATIENT POPULATIONS
_RENAL IMPAIRMENT _
Impaired renal function does not influence felodipine peak plasma
concentrations or AUC, and a
dosage reduction is not necessary for patients with renal impairment.
_HEPATIC IMPAIRMENT _
The dose of felodipine should be reduced in patients with severely
impaired liver function.
Patients with impaired hepatic function may have elevated plasma
concentrations of felodipine and
may respond to lower doses.
_USE IN THE ELDERLY _
The dose should be adjusted individually, taking patient age into
consideration (see Section 4.4
Special warnings and precautions for use). An initial dose of 2.5mg
once daily should be
considered.
_PAEDIATRIC USE _
Due to limited clinical trial experience, felodipine should not be
used in paediatric patients.
METHOD OF ADMINISTRATION
FELODUR E