PROPYL-THIOCIL

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

PROPYLTHIOURACIL

Commercializzato da:

TEVA ISRAEL LTD

Codice ATC:

H03BA

Forma farmaceutica:

TABLETS

Composizione:

PROPYLTHIOURACIL 50 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

TEVA ISRAEL LTD, ISRAEL

Gruppo terapeutico:

THIOURACILS

Indicazioni terapeutiche:

Hyperthyroidism.

Data dell'autorizzazione:

2021-11-30

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
PROPYL-THIOCIL
TABLETS
COMPOSITION
Each tablet contains:
Propylthiouracil 50 mg
For
information
regarding
inactive
ingredients
and
allergens, see section 2 - “Important information about
some of the ingredients of the medicine” and section 6 -
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE.
This
leaflet
contains
concise
information
about the medicine. If you have additional questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for 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 to treat an overactive thyroid
gland (hyperthyroidism).
THERAPEUTIC GROUP
A thiouracil-type medicine which belongs to the antithyroid
group.
An overactive thyroid gland is a condition in which the
thyroid gland produces too much thyroid hormone.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient
propylthiouracil or to any of the other ingredients
this medicine contains (see section 6 - “Additional
information”).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE
TREATMENT
WITH
PROPYL-THIOCIL,
INFORM
THE
DOCTOR IF:
•
You are pregnant, might be pregnant or are breastfeeding
•
You have had any liver or kidney problems in the past
•
You are over 40 years old
CONTACT YOUR DOCTOR IMMEDIATELY BEFORE TAKING THIS
MEDICINE IF THE FOLLOWING CONDITION APPLIES TO YOU:
You develop symptoms of liver disease, such as nausea,
feeling unwell, diarrhea, yellowing of the skin or eyes,
dark urine, pale stools, bleeding easily, itching or chills.
Some cases of severe liver reactions, including cases
with fatal outcome or requiring liver transplant, have
been reported in both children and adults treated with
propylthiouracil.
TE

Scheda tecnica

Propyl-Thiocil Tablets LC 03/2021 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
PROPYL-THIOCIL
1.
NAME OF THE MEDICINAL PRODUCT
Propyl-Thiocil
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Propyl-Thiocil tablet contains 50 mg Propylthiouracil.
Excipients with known effect:
Each Tablet contains 22 mg of lactose monohydrate.
Each Tablet contains 0.06 mg of sodium benzoate (E211).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
White, flat beveled tablet, scored in half on one side of the tablet,
engraved “TEVA” on the other side of
the tablet.
. The tablet can be divided or crushed.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Propyl-Thiocil is indicated for hyperthyroidism.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Propylthiouracil is administered by the oral route.
_ _
_Note: _
The total daily dosage is usually given in 3 equal doses at
approximately 8-hour intervals.
_ _
The tablets can be divided. or crushed.
_ _
ADULTS
_Initial Dosage _
_ _
200-300 mg daily, in divided doses. In patients with severe
hyperthyroidism, very large goiters, or both,
the initial dosage should usually be 400 mg daily. An occasional
patient may require 600-900 mg/day
initially.
_Maintenance Dosage _
_ _
100-150 mg daily. This may be increased according to the degree of
severity of the individual case.
2
Propyl-Thiocil Tablets OKD 01/2023 Notification
CHILDREN 6-10 YEARS OF AGE
_Initial Dosage _
50-150 mg daily.
_Maintenance Dosage _
_ _
The maintenance dosage should be determined according to the response
of the patient.
CHILDREN OVER 10 YEARS OF AGE
_Initial Dosage _
150-300 mg daily.
_Maintenance Dosage _
_ _
The maintenance dosage should be determined according to the response
of the patient.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be made aware that the development of certain adverse
effects (fever, mouth ulcers, rashes,
sore throat) may