Baclofen (Noumed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Baclofen 10mg

Available from:

Noumed Pharmaceuticals Limited

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Baclofen 10mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose Povidone

Prescription type:

Prescription

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al in outer carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2021-01-29

Patient Information leaflet

New Zealand Consumer Medicine Information
1
BACLOFEN (NOUMED)
_BACLOFEN PH.EUR. _
10 mg uncoated tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Baclofen
(Noumed).
This leaflet answers some common questions about Baclofen (Noumed). 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 using
Baclofen (Noumed) against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT BACLOFEN (NOUMED) IS USED FOR
Baclofen (Noumed) 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.
Baclofen (Noumed) 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
muscles.
Your doctor may have prescribed Baclofen (Noumed) for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BACLOFEN (NOUMED)
HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's prescription.
New Zealand Consumer Medicine Information
2
BEFORE YOU USE BACLOFEN (NOUMED)
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE BACLOFEN (NOUMED) 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 BACLOFEN (NOU

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 14
1
PRODUCT NAME
Baclofen (Noumed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Baclofen
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet, uncoated.
Presentation
Baclofen (Noumed) are white coloured, round shaped, flat tablets,
debossed with ‘B’ and ‘10’
separated by break line on one side and plain on the other side.
The tablets can be divided into equal doses.
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
Treatment should always be initiated with small, gradually increasing
doses of Baclofen
(Noumed). 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, Baclofen (Noumed)
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.
NEW ZEALAND DATA SHEET
Page 2 of 14
Baclofen (Noumed) 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.
Dose
Adults
Treatment should as a rule be started with a dosage