PREGABALIN DEXCEL 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PREGABALIN

Available from:

DEXCEL LTD, ISRAEL

ATC code:

N03AX16

Pharmaceutical form:

CAPSULES

Composition:

PREGABALIN 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic area:

PREGABALIN

Therapeutic indications:

For the treatment of peripheral and central neuropathic pain in adults.Management of FibromyalgiaTreatment of Generalised Anxiety Disorder (GAD) in adults

Authorization date:

2022-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATION
S (PREPARATIONS)-1986
This
medicine can be sold with a physician’s prescription only
PREGABALIN DEXCEL 25, 50, 75, 100, 150, 200, 225, 300 MG, CAPSULES
ACTIVE INGREDIENT: Each capsule contains Pregabalin at a dose of 25,
50, 75, 100, 150, 200, 225,
300 mg, respectively.
Inactive ingredients and allergens in the medicine
–
see section 6 “Additional
information
”
and in
section 2
“
Important information about some of the ingredients of the medicine
”
.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise
information about the medicine. If you have any further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
This medicine is not intended for treatment of children and
adolescents under 18 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of neuropathic pain in adults
,
for the treatment of Fibromyalgia and for the
treatment of Generalised Anxiety Disorder (GAD) in adults.
THERAPEUTIC GROUP: A gamma-aminobutyric acid analog.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:

You are hypersensitive (allergic) to the active ingredient (Pregablin)
or to any of the other
ingredients this medicine contains (see section 6).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
REFER TO YOUR DOCTOR BEFORE TAKING PREGABALIN.

Some patients taking Pregabalin have reported allergic effects. These
effects include
swelling of the face, lips, tongue and throat, as well as diffuse skin
rash. If you experience
one or more of these effects, refer to a doctor immediately.

Serious skin rashes such Stevens-Johnson syndrome and toxic epidermal
necrolysis have
been reported in association with Pregabalin using. Stop using the
medicine and refer to
doctor immediately if you experience any of the symptoms related to
serious skin reactions