Akineton 2mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Biperiden hydrochloride

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

N04AA; N04AA02

INN (International Name):

Biperiden hydrochloride

Dosage:

2 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Tertiary amines; biperiden

Authorization date:

2017-07-28

Patient Information leaflet

AKINETON 2 MG TABLETS
biperiden hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
What Akineton is and what it is used for
What you need to know before you take Akineton
How to take Akineton
Possible side effects
How to store Akineton
Contents of the pack and other information
WHAT AKINETON IS AND WHAT IT IS USED FOR
The name of your tablets is Akineton 2mg tablets - called Akineton in
this
leaflet. The active ingredient in Akineton is biperiden hydrochloride.
Each
tablet contains 2 mg of biperiden hydrochloride.
Akineton belongs to a group of medicines called anticholinergic
agents.
Akineton can be used to treat Parkinson’s disease by relaxing muscle
spasms and controlling muscle twitching. It can also be used to
control
muscle twitching and spasms caused by some medicines.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKINETON
DO NOT TAKE AKINETON:_ _
*
If you are allergic (hypersensitive) to biperiden hydrochloride or any
of the
other ingredients in Akineton (please see section 6).
*
If you suffer from glaucoma.
*
If you have an abnormal heartbeat or any other heart problems..
*
If your doctor has told you that you have a narrowing of your stomach
or
bowels, or any other bowel problem.
*
If you are male, and you have benign tumour of the prostate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Akineton:
*
If you suffer from thyroid problems.
*
Some people may be more sensitive to the effects of Akineton and
may need closer moni

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2022
CRN00CS1H
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Akineton 2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of Biperiden Hydrochloride.
Excipients with known effect:
Each tablet also contains Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Czech Republic._
Circular, biplanar, white tablet with a bisecting score on one
surface.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA1253/001/001
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.
5 PHARMACOLOGICAL PROPERTIES
As per PA1253/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium hydrogen phosphate
Copovidone
Potato starch
Lactose monohydrate
Magnesium stearate
Corn starch
Microcrystalline cellulose
Talc
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
04 February 2022
CRN00CS1H
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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.
Keep blister in the outer carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Supplied in packs of 100 tablets in a blister pack.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/010/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
July 2017
10 DATE OF REVISION OF THE TEXT
October 2021