Kemadrin 5 mg tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Procyclidine hydrochloride

Verfügbar ab:

PCO Manufacturing Ltd.

ATC-Code:

N04AA; N04AA04

INN (Internationale Bezeichnung):

Procyclidine hydrochloride

Darreichungsform:

Tablet

Therapiebereich:

Tertiary amines; procyclidine

Berechtigungsdatum:

2022-09-09

Gebrauchsinformation

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
KEMADRIN
®
5 MG
TABLETS
procyclidine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kemadrin is and what it is used for
2.
What you need to know before you take Kemadrin
3.
How to take Kemadrin
4.
Possible side effects
5.
How to store Kemadrin
6.
Contents of the pack and other information
1 s and what it is used for
1.
WHAT KEMADRIN IS AND WHAT IT IS USED FOR
Kemadrin contains a medicine called procyclidine. This belongs
to a group of medicines called anticholinergics. They stop a
substance called acetylcholine working in your body.
You must talk to a doctor if you do not feel better or if you feel
worse.
Kemadrin is used to:
•
treat and relieve the signs of Parkinson’s disease such as:
-
stiff muscles, paralysis, and tremor (shaking of hands)
-
problems talking, writing and walking
-
producing too much saliva and dribbling
-
sweating and uncontrolled eye movements
-
depression
•
stop side effects called ‘extrapyramidal effects’, which are
caused by some medicines. These may include signs
similar to Parkinson’s disease or restlessness and unusual
head and body movements.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KEMADRIN
DO NOT TAKE KEMADRIN IF:
•
you are allergic to procyclidine or any of the other
ingredients of this medicine (listed in section 6).
•
you experience uncontrolled movements of the head or
tongue (tardive dyskinesia)
Do not take if the above applies to you. If you are not sure, talk
to your do

Fachinformation

Health Products Regulatory Authority
19 December 2022
CRN00D9GV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kemadrin 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains procyclidine hydrochloride 5 mg.
Excipient(s) with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
_Product imported from Belgium:_
White, round, biconvex tablets, one face with a break-line and coded
KT above the breakline 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
As per PA1691/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose monohydrate
sodium carboxymethyl starch type A
povidone
magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
bottle and outer package of the product on the market in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottles with polyethylene snap-fit closure containing 100
tablets.
Health Products Regulatory Authority
19 December 2022
CRN00D9GV
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/494/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 9
th
September 2022
10 DATE OF REVISION OF THE TEXT
December 2022