Falcistat Tablets 25 mg + 500 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Pyrimethamine , Sulfadoxine

Available from:

Remedica LTD, CYPRUS

INN (International Name):

Pyrimethamine + Sulfadoxine

Dosage:

25 mg + 500 mg

Pharmaceutical form:

Tablets

Manufactured by:

REMEDICA LIMITED, CYPRUS

Product summary:

Physical description: White, round, flat scored tablets, debossed with S/P and Remedica’s logo on one side; Local technical representative: Stanley Tanzania Limited (4885)

Authorization status:

Registered/Compliant

Authorization date:

2020-08-03

Summary of Product characteristics

FALCISTAT TABS-SPC-V1-04-Draft1
Page 1 of 7
Ref: FALCISTAT TABS-SPC-V1-04-Draft1
SUMMARY OF PRODUCT CHARACTERISTICS
_1. NAME OF THE MEDICINAL PRODUCT _
Falcistat Tablets
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Sulfadoxine 500 mg and Pyrimethamine 25 mg
_3. PHARMACEUTICAL FORM _
Tablets
_4. CLINICAL PARTICULARS _
_4.1. THERAPEUTIC INDICATIONS _
Falcistat
is
indicated
for
the
treatment
of
_Plasmodium _
_falciparum _
malaria
and
in
restricted
circumstances can be used for the prophylaxis of _Plasmodium
falciparum_ malaria.
_TREATMENT OF MALARIA_
Falcistat is indicated for the treatment of malaria, particularly when
caused by strains of _Plasmodium _
_falciparum_ resistant to other antimalarials.
_PROPHYLAXIS OF MALARIA_
Falcistat is not routinely recommended for malaria prophylaxis.
Malaria prophylaxis with Falcistat is indicated for travellers to
areas where _ Plasmodium falciparum_
malaria is endemic and sensitive to Falcistat, and when alternative
drugs are not available or contra-
indicated.
Whenever
malaria
prophylaxis
is
prescribed,
the
malaria
situation
and
in
particular,
resistance trends at the traveller's destination and any stop-over
point must be considered. At present,
there
is
no
antimalarial
agent
which
provides
absolute
protection
against
malaria,
but
careful
compliance to drug prophylaxis can usually prevent serious progression
of the disease.
_4.2. POSOLOGY AND METHOD OF ADMINISTRATION _
_ _
The tablets should be swallowed with plenty of fluid after a meal.
_ADULTS AND CHILDREN_
_CURATIVE TREATMENT OF MALARIA _
The appropriate amount of the drug is given in one single dose. This
dose should not be repeated for
at least seven days.
FALCISTAT TABS-SPC-V1-04-Draft1
Page 2 of 7
Adults (higher dose for persons over 60kg)
2 to 3 tablets
Children
10 - 14 years (> 30 - 45kg)
2 tablets
5 - 10 years (> 20 - 30kg)
1½ tablets
2 - 5 years (> 10 - 20kg)
1 tablet
under 2 years (5 - 10kg)
½ tablet
In very severe cases, quinine may be added, preferably parenterally.
An adequate supply of fluids and
electro