Avloclor 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloroquine phosphate

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

P01BA01

INN (International Name):

Chloroquine phosphate

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040100; GTIN: 5000455004610

Patient Information leaflet

Artwork Information
Product Title:
Avloclor PIL
Date:
12-05-22
Product Size:
420mm x 297mm
Label Number:
21-0419
Version:
2
Colours Used:
Black
Fonts Used:
Helvetica/ Helvetica condensed
Font size (min):
12pt
Blue dotted and solid lines do not print
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVLOCLOR
® 250 MG TABLETS
chloroquine phosphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more
information or advice.
•
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Avloclor is and what it is used for
2. What you need to know before you take Avloclor
3. How to take Avloclor
4. Possible side effects
5. How to store Avloclor
6. Contents of the pack and other information
1.
WHAT AVLOCLOR IS AND WHAT IT IS
USED FOR
Avloclor contains a medicine called chloroquine
phosphate. This belongs to a group of medicines
called ‘anti-malarials’.
‘Anti-malarials’ can be taken in certain parts of the
world to help prevent malaria. This is a serious
disease spread by infected mosquitoes. Avloclor will
give some degree of protection (prophylaxis) against
malaria in certain countries.
Medicines to help prevent malaria (malaria
prophylaxis) are recommended for:
•
People travelling to countries where malaria
occurs.
•
People living in malaria areas who are not
immune to malaria.
These people have little or no immunity to malaria,
so they are at risk of severe attacks.
YOU MUST GET MEDICAL ADVICE ON WHICH
ANTI-MALARIAL MEDICINES TO TAKE. You must ask your
doctor or pharmacist if Avloclor is suitable for the part
of the world that you are visiting. In some countries
you may have to take Avloclor with another medicine
for maximum

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Avloclor 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 250 mg chloroquine phosphate which is equivalent to
155 mg
chloroquine base.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
a)
Treatment of malaria.
b)
Prophylaxis and suppression of malaria.
c)
Treatment of amoebic hepatitis and abscess.
d)
Treatment of discoid and systemic lupus erythematosus.
e)
Treatment of rheumatoid arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be taken after food.
A) TREATMENT OF MALARIA
I) _P. FALCIPARUM_ AND _P. MALARIAE_ INFECTIONS
ADULTS: A single dose of four tablets, followed by two tablets six
hours later
and then two tablets a day for two days.
CHILDREN: A single dose of 10mg base/kg, followed by 5mg base/kg six
hours
later and then 5mg base/kg a day for two days.
AGE (YEARS)
INITIAL DOSE
SECOND DOSE 6
HOURS AFTER FIRST
DOSE ON EACH OF THE
TWO SUBSEQUENT DAYS
1-4
1 Tablet
½ Tablet
½ Tablet
5-8
2 Tablets
1 Tablet
1 Tablet
9-14
3 Tablets
1½ Tablets
1½ Tablets
II) _P. VIVAX_ AND _P. OVALE_ INFECTIONS
ADULTS: A single dose of four tablets, followed by two tablets six
hours later
and then two tablets a day for two days. Follow with a course of
treatment
with primaquine if a radical cure is required.
CHILDREN: A single dose of 10mg base/kg, followed by 5mg base/kg six
hours
later and then 5mg base/kg a day for two days. Follow with a course of
treatment with primaquine if a radical cure is required.
ELDERLY PATIENTS:
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.
HEPATIC OR RENALLY IMPAIRED PATIENTS: Caution is necessary when giving
Avloclor to patients with renal disease or hepatic disease.
B) PROPHYLAXIS AND SUPPRESSION OF MALARIA
ADULTS: Two tablets taken once a week, on the same day each week.
Start one
week