Paludrine 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Proguanil hydrochloride

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

P01BB01

INN (International Name):

Proguanil hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040100; GTIN: 5000455006515

Patient Information leaflet

Artwork Information
Product Title:
Paludrine 100mg tabs leaflet
Date:
18-05-15
Product Size:
340mm x 296mm
Label Number:
15-073
Colours Used:
Black
Fonts Used:
N. Helvetica, N. Helvetica bold
Font size:
10.5pt
Version 5
ADULTS AND CHILDREN OVER 14 YEARS
•
Take two tablets daily.
CHILDREN
•
UNDER 1 YEAR (INCLUDING BABIES WHO ARE BEING BREAST-FED): Take a
quarter of a
Paludrine tablet daily.
•
AGES 1 TO 4 YEARS: Take half a Paludrine tablet daily.
•
AGES 5 TO 8 YEARS: Take one Paludrine tablet daily.
•
AGES 9 TO 14 YEARS: Take one and a half Paludrine tablets daily.
HOW TO TAKE YOUR TABLETS
•
Take the tablet(s) at the same time each day.
•
Take the tablet(s) after food.
•
Swallow the tablet(s), or part tablets, whole with a drink of water.
•
For a young child, the tablet(s) may be given crushed in milk, honey
or jam.
IF YOU TAKE MORE PALUDRINE TABLETS THAN YOU SHOULD
If you take more Paludrine tablets than you should, talk to a doctor
or go to a hospital
straight away. Show any left-over medicines or the empty packet to the
doctor.
IF YOU FORGET TO TAKE YOUR PALUDRINE TABLETS
•
If you forget to take a dose of Paludrine, take it as soon as you
remember. However,
if it is nearly time for the next dose of Paludrine, skip the missed
dose.
•
Do not take a double dose (two doses at the same time) to make up for
a forgotten dose.
STOPPING PALUDRINE
Only stop taking Paludrine four weeks after leaving the malaria area
or if your doctor tells
you to.
If you have any further questions on the use of this product, ask your
doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS
Like all medicines, Paludrine can cause side effects, although not
everybody gets them.
ALLERGIC REACTIONS
If you have an allergic reaction, STOP TAKING PALUDRINE AND GET
MEDICAL HELP OR
CONTACT YOUR DOCTOR STRAIGHT AWAY. The signs may include:
•
Difficulty in breathing.
•
Swelling of the face, lips, tongue or throat which may cause
difficulty in swallowing.
•
An itchy rash (similar to nettle rash or hives).
OTHER POSSIBLE SIDE EFFECTS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paludrine 100 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Proguanil hydrochloride 100 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Scored, uncoated white tablet.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Paludrine’ is an effective antimalarial agent.
It is recommended for the prevention and suppression of malaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Non-immune subjects entering a malarious area are advised to begin
treatment
with Paludrine 1 week before, or if this is not possible, then at
least 2 days
before entering the malarious area. The daily dose of Paludrine should
be
continued throughout exposure to risk and for 4 weeks after leaving
the area.
ADULTS:
Two tablets (200 mg) daily.
PAEDIATRIC POPULATION:
Under 1 year:
1/4 tablet (25 mg) daily
1 to 4 years:
1/2 tablet (50 mg) daily
5 to 8 years:
1 tablet (100 mg) daily
9 to 14 years:
1 1/2 tablets (150 mg) daily
Over 14 years:
Adult dose daily
The daily dose is best taken with water, after food, at the same time
each day.
Provided the tablet fragment gives the minimum amount specified,
precise
accuracy in children's dosage is not essential since the drug
possesses a wide
safety margin.
For a young child, the dose may be administered crushed and mixed with
milk,
honey or jam.
OLDER PEOPLE: There are no special dosage recommendations for the
elderly,
but it may be advisable to monitor elderly patients so that optimum
dosage can
be individually determined.
RENAL IMPAIRMENT: Based on a theoretical model derived from a single
dose
pharmacokinetic study, the following guidance is given for adults with
renal
impairment. (See also Sections 4.3 and 4.4)
CREATININE CLEARANCE
(ML/MIN 1.73 M
2
)
DOSAGE
> 60
200 mg once daily (standard dose)
20 to 59
100 mg once daily
10 to 19
50 mg every second day
< 10
50 mg once weekly
The grade of renal impairment and/or the serum creatinine
concentr