Akineton Retard 4 mg prolonged release tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Biperiden hydrochloride

Commercializzato da:

Laboratorio Farmaceutico S.I.T.

Codice ATC:

N04AA; N04AA02

INN (Nome Internazionale):

Biperiden hydrochloride

Dosaggio:

4 milligram(s)

Forma farmaceutica:

Prolonged-release tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Tertiary amines; biperiden

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1979-04-01

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AKINETON RETARD 4 MG PROLONGED RELEASE 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 Retard is and what it is used for
2. What you need to know before you take Akineton Retard
3. How to take Akineton Retard
4. Possible side effects
5. How to store Akineton Retard
6. Contents of the pack and other information
1. WHAT AKINETON RETARD IS AND WHAT IT IS USED FOR
The name of your tablets is Akineton Retard 4 mg prolonged release
tablets called Akineton Retard
tablets in this leaflet. The active ingredient in Akineton Retard is
biperiden hydrochloride in a
prolonged release formulation. The tablets are designed to release
biperiden slowly into your
bloodstream throughout the day.
Akineton Retard belongs to a group of medicines called anticholinergic
agents.
Akineton Retard 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 RETARD TABLETS
_ _
DO NOT TAKE AKINETON RETARD:

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 m

Scheda tecnica

Health Products Regulatory Authority
17 December 2020
CRN009SX3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Akineton Retard 4 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of biperiden hydrochloride.
Excipients with known effect:
Each tablet contains 252 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release, film-coated tablets
Yellowish oblong tablets, scored on both sides.
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Akineton Retard is indicated in adults for 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.
Unless otherwise prescribed by the physician, treatment is normally
initiated with Akineton Tablets, gradually incremented to
determine the most suitable dosage for each individual; patients are
then switched to Akineton Retard 4 mg prolonged release
tablets.
_Adults_
Experience has shown that the average dose for adults is 4-8 mg (one
to two tablets), to a maximum of 12 mg (three tablets)
daily.
The total daily dose should be spread over the day, with the first
tablet always being taken in the morning. The tablets should
be taken whole with some liquid, either with or immediately after
meals.
_Special Populations_
Elderly
Cautious dosing is necessary in elderly patients, especially those
with symptoms of
organic brain disease.
Paediatric population
The safety and efficacy of Akineton Retard in children and adolescents
have not been established.
No data are available.
Health Products Regulatory Authority
17 December 2020
CRN009SX3
Page 2 of 5
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