Mysoline 250 mg Tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Primidone

Предлага се от:

IMED Healthcare Ltd.

АТС код:

N03AA; N03AA03

INN (Международно Name):

Primidone

дозиране:

250 milligram(s)

Лекарствена форма:

Tablet

Терапевтична област:

Barbiturates and derivatives; primidone

Дата Оторизация:

2021-12-17

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
MYSOLINE 250 MG TABLETS
primidone
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 of the 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 Mysoline is and what it is used for
2. What you need to know before you take Mysoline
3. How to take Mysoline
4. Possible side effects
5. How to store Mysoline
6. Contents of the pack and other information
1. WHAT MYSOLINE IS AND WHAT IT IS USED FOR
Mysoline contains primidone as the active ingredient. It belongs to a
group of medicines used
to treat seizures.
Mysoline is used for the treatment of certain types of epilepsy,
seizures (fits) or shaking
attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYSOLINE
DO NOT TAKE MYSOLINE:

If you are allergic to primidone, phenobarbital, or to any of the
other ingredients of this
medicine (listed in section
6).

If you or anyone in your family has porphyria (a rare inherited
metabolism disorder).

If you are also taking:
-
cholic acid (used to treat congenital bile acid deficiency),
-
St. John’s wort (herb used to treat depression),
-
isavuconazole or voriconazole (antifungal medicines),
-
cobicistat, nelfinavir or rilpivirine (used to treat HIV infection),
-
delamanid (used to treat tuberculosis),
-
telaprevir, daclatasvir, dasabuvir, ombitasvir/paritaprevir,
ledipasvir (used to treat
hepatitis),
-
lurasidone (used to treat schizophrenia),
-
sofosbuvir (used to treat hepatitis C virus infection).
WARNINGS AND PRECAUTIONS
This medicine is not effective for certain forms of epilepsy. Your
doctor will assess wheth

Данни за продукта

Health Products Regulatory Authority
17 December 2021
CRN00CDRH
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mysoline 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg primidone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Portugal_
Round, white, biconvex tablet intagliated on one face with an "M" on
either side of a scoreline and plain on the other face.
The scoreline allows the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA1777/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1777/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Povidone
Gelatin
Carmellose calcium
Magnesium stearate
Stearic acid
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container 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.
Store in the original package in order to protect from light and
moisture.
Keep the outer carton tightly closed.
6.5 NATURE AND CONTENTS OF CONTAINER
Box of 100 tablets contained in 10 PVC/aluminum blisters, each
containing 10 tablets.
Health Products Regulatory Authority
17 December 2021
CRN00CDRH
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue,
Northwest Business Park,
Ballycoolin,
Dublin 15,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/179/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17
th
December 2021
10 DATE OF REVISION OF THE TEXT
December 2021