Pregabalin Adalvo 82.5 mg prolonged-release tablets

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Доступна з:

Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta

Код атс:

N02BF02

ІПН (Міжнародна Ім'я):

PREGABALIN 82.5 mg

Фармацевтична форма:

PROLONGED-RELEASE TABLET

Склад:

PREGABALIN 82.5 mg

Тип рецепту:

POM

Терапевтична области:

ANALGESICS

Статус Авторизація:

Authorised

Дата Авторизація:

2024-03-04

інформаційний буклет

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN ADALVO 82.5 MG PROLONGED-RELEASE TABLETS
PREGABALIN ADALVO 165 MG PROLONGED-RELEASE TABLETS
PREGABALIN ADALVO 330 MG PROLONGED-RELEASE TABLETS
pregabalin
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 Pregabalin Adalvo is and what it is used for
2.
What you need to know before you take Pregabalin Adalvo
3.
How to take Pregabalin Adalvo
4.
Possible side effects
5.
How to store Pregabalin Adalvo
6.
Contents of the pack and other information
1.
WHAT PREGABALIN ADALVO IS AND WHAT IT IS USED FOR
Pregabalin Adalvo belongs to a group of medicines used to treat
neuropathic pain in adults.
Pregabalin Adalvo is used to treat long lasting pain caused by damage
to the nerves. A variety of
diseases can cause peripheral neuropathic pain, such as diabetes or
shingles. Pain sensations may be
described as hot, burning, throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, numbness,
pins and needles. Peripheral and central neuropathic pain may also be
associated with mood changes,
sleep disturbance, fatigue (tiredness), and can have an impact on
physical and social functioning and
overall quality of life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREGABALIN ADALVO
DO NOT TAKE PREGABALIN ADALVO
If you are allergic to pregabalin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pregabalin Adalvo.
-
Some patients taking Pregabalin Adalvo have

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Adalvo 82.5 mg prolonged-release tablets
Pregabalin Adalvo 165 mg prolonged-release tablets
Pregabalin Adalvo 330 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Pregabalin Adalvo 82.5 mg prolonged-release tablets _
Each prolonged-release tablet contains 82.5 mg of pregabalin.
_Pregabalin Adalvo 165 mg prolonged-release tablets _
Each prolonged-release tablet contains 165 mg of pregabalin.
_Pregabalin Adalvo 330 mg prolonged-release tablets _
Each prolonged-release tablet contains 330 mg of pregabalin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
_Pregabalin Adalvo 82.5 mg prolonged-release tablet _
White, oval, unscored tablet, blank on one side and imprinted “ALV
379” in black ink on the other
side with a length of 19 mm, a width of 12 mm and thickness of
approximately 7 mm.
_Pregabalin Adalvo 165 mg prolonged-release tablet _
Yellow, oval, unscored tablet, blank on one side and imprinted “ALV
380” in black ink on the other
side with a length of 19 mm, a width of 12 mm and thickness of
approximately 7 mm.
_ _
_Pregabalin Adalvo 330 mg prolonged-release tablet _
Pink, oval, unscored tablet, blank on one side and imprinted “ALV
381” in black ink on the other side
with a length of 19 mm, a width of 12 mm and thickness of
approximately 8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pregabalin Adalvo is indicated for the treatment of peripheral and
central neuropathic pain in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose range is 165 to 660 mg per day given once daily directly
after an evening meal.
Treatment with pregabalin prolonged release for neuropathic pain can
be started at a dose of 165 mg
per day given once daily directly after an evening meal and can be
increased to 330 mg given once
daily within 1 week based on individual patient response and
tolerability. The maximum
recommended dose of pregabalin prolong