PROTOCIDE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TINIDAZOLE

Available from:

UNIPHARM LTD, ISRAEL

ATC code:

P01AB02

Pharmaceutical form:

TABLETS

Composition:

TINIDAZOLE 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

UNIPHARM LTD, ISRAEL

Therapeutic area:

TINIDAZOLE

Therapeutic indications:

For the oral treatment of Trichomonas Vaginals infections of the genito urinary tract in both female and male. For the prevention of anerobic infections after gynocological operations and stomach operations.

Authorization date:

2019-03-03

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS)
– 1986
The medicine is dispensed with a
doctor’s prescription only
PROTOCIDE
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet contains:
Tinidazole 500 mg
For the list of inactive and allergenic
ingredients in the preparation, see
section 6: ”Further information“ and
section 2: ”Before using the medicine“.
READ THE LEAFLET CAREFULLY IN ITS
ENTIRETY BEFORE USING THE MEDICINE.
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
to yours.
1. WHAT
IS
THE
MEDICINE
INTENDED FOR?
For treatment of infections in the
genitals and in the urinary tracts in
both women and men, caused by
trichomonas vaginalis.
For prevention of
infections by
anaerobic bacteria after gynecological
and abdominal surgeries.
THERAPEUTIC GROUP: Azole antibiotics.
119148010
12C21
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to
tinidazole, to similar medicines, or
to any of the additional ingredients
contained in the medicine )see
section 6: ”Further information“(.
An allergic reaction can cause
itching, skin rash or breathing
difficulties with wheezing.
• You are in the first trimester of
pregnancy )the first 13 weeks of
pregnancy(, are trying to become
pregnant or are breastfeeding.
• You suffer from a central nervous
system
disease,
including
epilepsy.
• You suffer, or have suffered in the
past, from an impairment in the
blood system )blood dyscrasia(.
SPECIAL WARNINGS REGARDING USE OF
THE MEDICINE:
Inform the doctor or pharmacist if
you develop abnormal neurological
signs )such as: dizziness, vertigo,
difficulty in controlling movements(
during treatment with PROTOCIDE, as
you may be asked to stop treatment
with the medicine.
IF YOU ARE TAKING, OR IF YOU HAVE
RECE

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
PROTOCIDE 500mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PROTOCIDE 500mg Tablet contains 500mg of Tinidazole.
3. PHARMACEUTICAL FORM
Orange, round, film-coated biconvex tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOR THE ORAL TREATMENT OF TRICHOMONAS VAGINALIS INFECTIONS OF THE
GENITOURINARY TRACT IN
BOTH FEMALE AND MALE. FOR THE PREVENTION OF ANAEROBIC INFECTIONS AFTER
GYNECOLOGICAL
OPERATIONS AND STOMACH OPERATIONS.4.2 POSOLOGY AND METHOD OF
ADMINISTRATION
It is recommended that PROTOCIDE be taken during or after a meal
_PREVENTION OF POSTOPERATIVE INFECTIONS: _
ADULT
Oral: A single oral dose of 2 g approximately 12 hours before surgery.
CHILDREN LESS THAN 12 YEARS
Data are not available to permit dosage recommendations for
prophylaxis of anaerobic
infections in children below the age of 12 years.
UROGENITAL TRICHOMONIASIS:
When infection with Trichomonas vaginalis is confirmed, simultaneous
treatment of the
consort is recommended.
ADULT PREFERRED REGIMEN
A single oral dose of 2 g.
ADULT ALTERNATIVE REGIMEN
One 150 mg tablet orally three times daily for 5 days, or one 150 mg
tablet orally twice daily
for 7 days.
CHILDREN
A single dose of 50 to 75 mg/kg of body weight. It may be necessary to
repeat this dose
once in some cases.
_ _
_USE IN RENAL IMPAIRMENT _
Dosage adjustments in patients with impaired renal function are
generally not necessary.
However, because tinidazole is easily removed by haemodialysis,
patients may require
additional doses of tinidazole to compensate.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
As with other drugs of similar structure, tinidazole is
contraindicated in patients having, or with a
history of, blood dyscrasia, although no persistent haematological
abnormalities have been noted
in clinical or animal studies.
Tinidazole should be avoided in patients with organic neurological
disorders.
Tinidazole, other 5-nitroimidazole derivatives or any of the
c