Pacifen

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Baclofen 10mg

זמין מ:

Viatris Limited

INN (שם בינלאומי):

Baclofen 10 mg

כמות:

10 mg

טופס פרצבטיות:

Tablet

הרכב:

Active: Baclofen 10mg Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

יחידות באריזה:

Bottle, plastic, 50 tablets

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Pharmaceutical Works Polpharma SA

סממני תרפויטית:

Spasticity of the skeletal muscles in multiple sclerosis. Spastic conditions occurring in spinal-cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.

leaflet_short:

Package - Contents - Shelf Life: Bottle, plastic, - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, McDermott Laboratories: 40 mL HDPE bottle 33 mm PP child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 250 tablets - 36 months from date of manufacture stored at or below 25°C

תאריך אישור:

1986-09-18

עלון מידע

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PACIFEN
_BACLOFEN TABLETS 10 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Pacifen.
This leaflet answers some common
questions about Pacifen.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pacifen
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BACLOFEN IS
USED FOR
PACIFEN is used to reduce excess
tension in your muscles which
causes spasms. These spasms
happen in various illnesses such as
multiple sclerosis and diseases or
injuries of the spinal cord.
Because this medicine reduces
spasms and the pain that goes with
them, it helps to make you more
mobile. This can help you to
manage your daily activities more
easily.
Pacifen contains the active
ingredient baclofen It belongs to a
group of medicines called muscle
relaxants.
It works by reducing the excessive
stiffness and/or spasms in your
muscle.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
PACIFEN
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE PACIFEN IF YOU HAVE
AN ALLERGY TO:

any medicine containing
baclofen.

any of the ingredients listed
at the end of this leaflet.

Some of the symptoms of
an allergic reaction may
include: shortness of
breath; wheezing or
difficulty breathing; swelling
of the face, lips, tongue or
other parts of the body;
rash, itching or hives on the
skin.
DO NOT TAKE PACIFEN IF YOU HAVE
PEPTIC ULCERATION, A CONDITION
WHERE THERE ARE PAINFUL SORES OR
ULCERS IN THE LINING OF THE STOMACH
AND/OR SMALL INTESTINES.
DO NOT GIVE PACIFEN TO

מאפייני מוצר

Page 1 of 12
NEW ZEALAND DATA SHEET
PACIFEN
1. PRODUCT NAME
PACIFEN, 10 mg tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of baclofen
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
PACIFEN 10 mg tablets are white, round, flat bevelled edged marked
'BN' | '10' on one side and 'G'
on the other. Each tablet contains 10 mg of baclofen and has a
diameter of 7 mm.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Spasticity of the skeletal muscles in multiple sclerosis. Spastic
conditions occurring in spinal-cord
diseases of infectious, degenerative, traumatic, neoplastic, or
unknown origin: e.g. spastic spinal
paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse
myelitis, traumatic paraplegia or
paraparesis, and compression of the spinal cord; muscle spasm of
cerebral origin, especially where
due to infantile cerebral palsy, as well as following cerebrovascular
accidents or in the presence of
neoplastic or degenerative brain disease.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Treatment should always be initiated with small, gradually increasing
doses of PACIFEN. The
optimum daily dosage should be individually adapted to the patient’s
requirements in such a way
that clonus, flexor and extensor spasms, and spasticity are reduced,
but that adverse effects are as
far as possible avoided.
In order to prevent excessive weakness and falling, PACIFEN should be
used with caution when
spasticity is needed to sustain upright posture and balance in
locomotion or whenever spasticity is
used to maintain function. It may be important to maintain some degree
of muscle tone and allow
occasional spasms to help support circulatory function. PACIFEN should
be taken during meals with
a little liquid.
The daily dosage should be given in divided doses, preferably 3 in
adults and 4 in children.
Page 2 of 12
DOSE
_ADULTS_
Treatment should as a rule be started with a dosage of 5 mg, 3 times
daily, which, fo