KEMADRIN TABLETS 5 MG

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

PROCYCLIDINE HYDROCHLORIDE

Доступно од:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

АТЦ код:

N04AA04

Фармацеутски облик:

TABLETS

Састав:

PROCYCLIDINE HYDROCHLORIDE 5 MG

Пут администрације:

PER OS

Тип рецептора:

Required

Произведен од:

ASPEN BAD OLDESLOE GMBH, GERMANY

Терапеутска група:

PROCYCLIDINE

Терапеутска област:

PROCYCLIDINE

Терапеутске индикације:

Indicated in all forms of parkinson's disease: idiopathic (paralysis agitans), post encephalitic and arteriosclerotic.

Датум одобрења:

2023-02-28

Информативни летак

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
Kemadrin Tablets 5 mg
The active ingredient and its quantity:
Each tablet contains: Procyclidine Hydrochloride 5 mg
Inactive ingredients and allergens in the medicine: see
sections 2 “Important information regarding some of the
ingredients of the medicine” and 6 “Further Information” in
the leaflet.
Read this 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. Kemadrin tablets are not intended
for use in children.
This medicine has been prescribed as treatment for you. Do
not pass it on to others. It may harm them even if it seems
to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine Kemadrin is intended for the treatment of
all forms of Parkinson’s disease: idiopathic )of unknown
source), postencephalitic )after a viral inflammation of the
brain) and arteriosclerotic )related to blood vessels).
Therapeutic group:
The active ingredient in Kemadrin is procyclidine, which
belongs to the group of anticholinergic medicines that
prevent the action of the substance acetylcholine in the body.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• You are sensitive )allergic( to the active ingredient
procyclidine or to any of the other ingredients contained
in the medicine )see section 6).
• You have problems passing urine )urinary retention(.
• You suffer from a problem caused by excessive
intraocular pressure called “closed angle glaucoma”.
• You have stomach cramps and pains or constipation.
Do not take the medicine if any of the conditions listed
above apply to you. If you are uncertain, discuss this
with the doctor or pharmacist before starting use of
Kemadrin.
Special warnings regarding use of the medicine
Before starting treatment with Kemadrin, tell the doctor
if

Карактеристике производа

Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE
MEDICINAL PRODUCT
Kemadrin Tablets 5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Procyclidine Hydrochloride BP, 5 mg per tablet
Excipients with known effect: Lactose Monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets, one face with a break-line and coded
KT above the break-line and
05 below the break-line, with a score-line on the other face.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kemadrin is indicated in all forms of Parkinson’s disease:
idiopathic (paralysis agitans),
postencephalitic and arteriosclerotic.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The variation in optimum dosage from one patient to another should be
taken into consideration
by the physician.
_Dosage in adults: _
_ _
_Parkinson's disease: _
_ _
Treatment is usually started at 2.5 mg procyclidine three times per
day, increasing by 2.5 to 5
mg per day at intervals of two or three days until the optimum
clinical response is achieved.
The usual maintenance dose to achieve optimal response is 15 to 30 mg
procyclidine per day.
Addition of a fourth dose before retiring has been seen to be
beneficial in some patients.
Doses up
to 60 mg procyclidine have been well tolerated,
and at the discretion of the attending physician
dosing to this level may be appropriate.
In general, younger patients or those with postencephalitic
parkinsonism may require higher
doses for a therapeutic response than older patients and those with
arteriosclerotic
parkinsonism.
_Paediatric population _
_ _
The use of Kemadrin in this age group is not recommended.
_ _
Page 2 of 6
_Older people _
_ _
Elderly patients may be more susceptible than younger adults to the
anticholinergic effects of
Kemadrin and a reduced dosage may be required (see section 4.4).
_Method of administration _
Oral administration may be better tolerated if associated with a meal.
Tablets can be divided into equal doses.