Chloroquine phosphate 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloroquine phosphate

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CHLOROQUINE PHOSPHATE TABLETS BP 250 MG
Please read this leaflet carefully before you start to take your
medicine. If you have any
questions or are not sure about anything, ask your doctor or
pharmacist. Keep this leaflet
in a safe place, you may need to read it again.
WHAT ARE CHLOROQUINE PHOSPHATE TABLETS BP 250 MG?
These tablets are white, round biconvex tablets with a breakline on
one face. The active
ingredient is Chloroquine Phosphate BP 250 mg. Each tablet also
contains the inactive
ingredients Lactose BP, Starch BP, Sodium Starch Glycollate BP,
Magnesium Stearate
BP and Stearic Acid BP. The tablets are available in blister packs in
a variety of sizes.
MARKETING AUTHORIZATION HOLDER:
Bristol
Laboratories
Limited
Unit-3,
Canalside, Northbridge
Road,
Berkhamsted,
HP4 1EG
MANUFACTURER:
Norbrook Laboratories Limited, Newry, Co. Down, Northern Ireland.
WHAT ARE CHLOROQUINE PHOSPHATE TABLETS BP 250 MG USED FOR?
Chloroquine Phosphate is one of a group of medicines called anti
malarials, which are
used in the prevention and suppression of malaria. (When prescribed by
a doctor it may
also be used to TREAT malaria).
WHEN USED TO PREVENT MALARIA, OFFICIAL GUIDELINES AND LOCAL
INFORMATION ON
PREVALENCE OR RESISTANCE TO ANTI MALARIAL DRUGS SHOULD BE TAKEN INTO
CONSIDERATION.
WHEN MUST CHLOROQUINE PHOSPHATE TABLETS BP 250 MG NOT BE TAKEN?
YOU SHOULD NOT TAKE THESE TABLETS IF:
•
You are allergic to Chloroquine Phosphate or any of the other
ingredients in the tablet.
•
You are pregnant or planning to be.
•
You have a rare hereditary problem of galactose intolerance, the Lapp
lactase
deficiency or glucose-galactase malabsorption.
•
You are currently taking amiodaraone for treatment of irregular heart
beats
YOU SHOULD CONSULT YOUR DOCTOR BEFORE TAKING THESE TABLETS IF:
•
You suffer from Porphyria.
•
You suffer from kidney disorders.
•
You suffer from liver disorders, particularly cirrhosis.
•
You suffer from Psoriasis.
ML-3-
1-APPROVED-LEAFLET-CHLOROQUINE-PHOSPHATE-TABLETS-250MG-P

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloroquine Phosphate 250 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Chloroquine phosphate as an active
ingredient.
Excipient with known effect: also contains Lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
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
Posology
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.
PAEDRIATRIC POPULATION: 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
½Tablet
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.
PAEDRIATRIC POPULATION: 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
Chloroquine phosphate to patients with renal disease or hepatic
disease.
B) PROPHYLAXIS AND SUPPRESSION OF MALARIA
ADULTS: Two tablets t