Akineton 2 mg tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Biperiden hydrochloride

Beszerezhető a:

Laboratorio Farmaceutico S.I.T.

ATC-kód:

N04AA; N04AA02

INN (nemzetközi neve):

Biperiden hydrochloride

Adagolás:

2 milligram(s)

Gyógyszerészeti forma:

Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Tertiary amines; biperiden

Engedélyezési státusz:

Marketed

Engedély dátuma:

1979-04-01

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AKINETON 2 MG TABLETS
BIPERIDEN 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 Akineton is and what it is used for
2. What you need to know before you take Akineton
3. How to take Akineton
4. Possible side effects
5. How to store Akineton
6. Contents of the pack and other information
1. WHAT AKINETON IS AND WHAT IT IS USED FOR
The name of your tablets is Akineton 2 mg tablets.
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.
2. 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 of this
medicine (listed in 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 senstitive to the effects of Akineton and may
need

Termékjellemzők

Health Products Regulatory Authority
17 December 2020
CRN009SX3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Akineton 2 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of biperiden hydrochloride.
Excipients with known effect: Each tablet contains 38mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Circular, biplanar, white tablet with a bisecting score on one
surface.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Akineton is indicated in the management of:
- Parkinsonian syndromes, especially to counteract muscular rigidity
and tremor;
- Extrapyramidal symptoms such as early dyskinesia, akathisia and
parkinsonism provoked by neuroleptics and similarly acting
drugs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Akineton is normally initiated with small incremental
doses, depending on the therapeutic effect and side
effects.
_Adults_
Parkinsonism:
Treatment is initiated with an oral dose of 1 mg (½ tablet) twice
daily. The dose can be increased by 2 mg (1 tablet) per day up
to a maximum of 16 mg (8 tablets) daily. The total daily dose should
be spread evenly throughout the day.
Drug-induced movement disorders:
1 to 4 mg (½ - 2 tablets) one to four times daily as oral concomitant
medication to the neuroleptic, depending upon the
severity of the symptoms.
_Special populations_
_Elderly_
Cautious dosing is necessary in elderly patients, especially those
with symptoms of organic brain disease.
_Paediatric population_
Experience with Akineton 2mg Tablets in paediatric use is limited and
relates mainly to short-term treatment of drug-induced
dystonia (e.g. by neuroleptics or metoclopramide and congener
compounds).
Health Products Regulatory Authority
17 December 2020
CRN009SX3
Page 2 of 5
Drug-induced movement disorders:
Children aged 3-15 years:
1 to 2 mg (½ - 1 tablet) one to three times daily.
Method of administration
Oral use.