PROMOZIO 250/100 atovaquone/proguanil hydrochloride 250 mg/100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atovaquone, Quantity: 250 mg; proguanil hydrochloride, Quantity: 100 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Atovaquone,Proguanil hydrochloride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: povidone; microcrystalline cellulose; poloxamer; sodium starch glycollate type A; hyprolose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 8000; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

12, 24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Promozio (250mg atovaquone/100mg proguanil hydrochloride) is indicated for:,? Prophylaxis of Plasmodium falciparum malaria in adults.,? Treatment of Plasmodium falciparum malaria in adults.

Product summary:

Visual Identification: Pinkish brown to brown coloured, circular, biconvex bevelled edged film coated tablets with '404' debossed on one side and 'G' debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-06-27

Patient Information leaflet

PROMOZIO
® 250/100
_(Atovaquone and Proguanil Hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take Promozio 250/100.
This leaflet answers some common
questions about Promozio 250/100. It
does not contain all of 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 expected benefits of you taking
Promozio 250/100 against the risks
this medicine could 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 IS PROMOZIO
250/100 USED FOR?
Promozio 250/100 belongs to a broad
group of medicines called
antimalarials.
It contains in one tablet a mixture of
two antimalarial medicines which
work well when taken together. One
medicine is atovaquone and the other
is proguanil hydrochloride.
Promozio 250/100 is used to prevent
or treat the type of malaria infection
known as Plasmodium falciparum
malaria. Plasmodium falciparum
belongs to one particular family of
malaria parasites. It affects the blood
and liver. Promozio 250/100 works
by killing this parasite.
Promozio 250/100 is not addictive.
BEFORE YOU TAKE
PROMOZIO 250/100
_DO NOT TAKE IT:_
YOU MUST NOT TAKE PROMOZIO
250/100 IF:
•
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO ATOVAQUONE
(WELLVONE™) OR PROGUANIL
HYDROCHLORIDE (PALUDRINE), OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET (SEE
"INGREDIENTS").
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF:_
YOU MUST TELL YOUR DOCTOR IF:
•
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
•
IN THE PAST PROMOZIO 250/100
HAS BEEN INEFFECTIVE FOR YOU.
•
AFTER TAKING PROMOZIO 250/100,
YOUR SYMPTOMS OF MALARIA HAVE
RETURNED AFTER IMPROVING FOR A
TIME.
•
YOU HAVE DIARRHOEA (LOOSE
BOWEL MOTIONS). THIS MAY
INTERFERE WITH THE A

Summary of Product characteristics

PROMOZIO-CCDSV8-PIV2-07JUN19 PAGE 1 OF 19
AUSTRALIAN PRODUCT INFORMATION – PROMOZIO 250/100
(ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET
1
NAME OF THE MEDICINE
atovaquone and proguanil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promozio 250/100 tablet is a fixed combination product containing
atovaquone and proguanil
hydrochloride.
Each tablet contains the active ingredients atovaquone 250 mg and
proguanil hydrochloride
100 mg.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Pinkish brown to brown coloured, circular, biconvex, bevelled-edged,
film-coated tablets with
‘404’ debossed on one side and ‘G’ debossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Promozio 250/100 is indicated for:
•
Prophylaxis of
_Plasmodium falciparum_
malaria in adults
•
Treatment of
_Plasmodium falciparum_
malaria in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
The daily dose should be taken with food or a milky drink at the same
time each day.
In the event of vomiting, within 1 hour of dosing, a repeat dose
should be taken.
Promozio 250/100 should preferably be swallowed whole.
PROMOZIO-CCDSV8-PIV2-07JUN19 PAGE 2 OF 19
PROPHYLAXIS
Prophylaxis should start 1 to 2 days before entering a malaria-endemic
area, and be continued
daily until seven days after leaving the area.
If patients are unable to tolerate food, Promozio 250/100 tablets
should be administered, but
systemic exposure of atovaquone will be reduced.
_DOSAGE IN ADULTS: _
One Promozio 250/100 tablet daily.
TREATMENT
_DOSAGE IN ADULTS: _
Four tablets as a single dose for three consecutive days.
DOSAGE IN THE ELDERLY (PROPHYLAXIS AND TREATMENT):
A pharmacokinetic study indicates that no dosage adjustments are
needed in the elderly (see
SECTION 5.2 PHARMACOKINETIC PROPERTIES
).
DOSAGE IN HEPATIC IMPAIRMENT (PROPHYLAXIS AND TREATMENT):
A pharmacokinetic study indicates that no dosage adjustments are
needed in patients with mild to
moderate hepatic impairment. No studies have been