PLAQUENIL

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

HYDROXYCHLOROQUINE SULFATE

Disponible des:

SANOFI ISRAEL LTD

Codi ATC:

P01BA02

formulario farmacéutico:

FILM COATED TABLETS

Composición:

HYDROXYCHLOROQUINE SULFATE 200 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

SANOFI WINTHROP INDUSTRIE, FRANCE

Grupo terapéutico:

HYDROXYCHLOROQUINE

Área terapéutica:

HYDROXYCHLOROQUINE

indicaciones terapéuticas:

Plaquenil is indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, p. malaria. p. ovale and susceptible strains of p. falciparum it is also indicated for the treatment of discoid and sustemic lupus erythematosus and rheumatoid arthritis.

Data d'autorització:

2020-04-30

Informació per a l'usuari

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
PLAQUENIL
200 mg Film-Coated Tablets
ACTIVE INGREDIENT AND ITS QUANTITY:
Each Plaquenil tablet contains:
Hydroxychloroquine sulfate 200 mg (155 mg base)
INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION: See section
6 “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment and control of symptoms
of malaria attacks, treatment of lupus erythematosus and rheumatoid
arthritis.
THERAPEUTIC GROUP: The active ingredient belongs to the aminoquinoline
group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• YOU ARE SENSITIVE (ALLERGIC) TO HYDROXYCHLOROQUINE, CHLOROQUINE
OR TO ANY OF THE ADDITIONAL INGREDIENTS CONTAINED IN THE
MEDICINE (SEE SECTION 6 “FURTHER INFORMATION”).
IF YOU ARE UNCERTAIN WHETHER YOU ARE SUFFERING FROM AN ALLERGIC
REACTION TO THE MEDICINE, CONSULT THE PHARMACIST OR DOCTOR.
Symptoms of an allergic reaction may include asthma attack, facial
swelling, skin rash or hay fever.
• YOU SUFFER FROM MACULAR DEGENERATION (MACULOPATHY) OR
HAVE SUFFERED IN THE PAST FROM CHANGES IN VISION WHEN TAKING
MEDICINES FOR TREATMENT OF RHEUMATOID ARTHRITIS OR FOR
TREATMENT OF MALARIA.
• YOU HAVE A HEART RHYTHM DISORDER.
• DO NOT USE THE MEDICINE IN CHILDREN UNDER 6 YEARS OF AGE.
• DO NOT USE THE MEDICINE FOR LONG PERIODS OF TIME IN CHILDREN
OVER 6 YEARS OF AGE.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
• Plaquenil can cause severe hypoglycemia (low blood sugar levels),
including los

Fitxa tècnica

1
PLAQ-PO-200-22.0
PRODUCT INFORMATION
1. NAME OF THE MEDICINE
PLAQUENIL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Film coated tablets containing hydroxychloroquine sulfate 200 mg
(equivalent to 155 mg
base).
For full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
White to off-white peanut shaped tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Plaquenil is indicated for the suppressive treatment
and treatment of acute attacks of malaria
due to _Plasmodium vivax, p. malaria. p. ovale_ and susceptible
strains of _p. falciparum. _
It is also indicated for the treatment of discoid and systemic lupus
erythematosus and
rheumatoid arthritis
4.2 DOSAGE AND METHOD OF ADMINISTRATION
RHEUMATOID ARTHRITIS
Plaquenil is cumulative in action and will require several weeks to
exert its beneficial
therapeutic effects, whereas minor side effects may occur relatively
early. Several months of
therapy may be required before maximum effects can be obtained.
Initial dosage: In adults, a suitable initial dosage is from 400 to
600 mg daily, preferably taken
at meal times. In a few patients the side effects may require
temporary reduction of the initial
dosage. Generally, after five to ten days the dose may be gradually
increased to the
optimum response level, frequently without return of side effects.
Maintenance dosage: When a good response is obtained (usually in four
to twelve weeks)
the dose can be reduced to 200 to 400 mg daily (but should not exceed
6 mg/kg per day)
and can be continued as maintenance treatment. The minimum effective
maintenance dose
should be employed. The incidence of retinopathy has been reported to
be higher when the
maintenance dose is exceeded.
If objective improvement (such as reduced joint swelling or increased
mobility) does not
occur within six months the drug should be discontinued.
2
If a relapse occurs after medication is withdrawn, therapy may be
resumed or continued on
an intermittent schedule if there are no ocular contraindications.
Safe use of Plaquen