Frisium 10mg Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Clobazam

Inapatikana kutoka:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC kanuni:

N05BA; N05BA09

INN (Jina la Kimataifa):

Clobazam

Kipimo:

10 milligram(s)

Dawa fomu:

Tablet

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Benzodiazepine derivatives; clobazam

Idhini hali ya:

Marketed

Idhini ya tarehe:

1980-08-25

Taarifa za kipeperushi

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Frisium®10 mg Tablets
Clobazam
Is this leaflet hard to see or read? Phone [phone] for help
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You
may need to read it again.
• If you have any further questions, ask you
r doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Frisium is and what it is used for
2. What you need to know before you take Frisium
3. How to take Frisium
4. Possible side effects
5. How to store Frisium
6. Further information
1.
WHAT FRISIUM IS AND WHAT IT IS USED FOR
Frisium contains a medicine called Clobazam. This belongs to a group
of medicines called
benzodiazepines. Frisium can be used for:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRISIUM
Do not take Frisium if:
▪
You are allergic (hypersensitive) to clobazam, other benzodiazepine
medicines or any
of the other ingredients of Frisium (see section 6: Further
Information) Signs of an
allergic reaction include: a rash, swallowing or breathing problems,
swelling of your
lips, face, throat or tongue
▪
You are breast-feeding
▪
You suffer from pre-existing muscle weakness or an illness that causes
muscle
weakness (called ‘myasthenia gravis’)
▪
You have liver problems
▪
You have breathing problems
▪
You stop breathing for short periods during
sleep (called ‘sleep apnoea syndrome’)
▪
You suffer from depression, as this may lead to suicidal thoughts.
▪
The patient is under 6 years old
Do not take if any of the above apply to you. If you are not sure,
talk to your doctor or
pharmacist before taking Frisium. Use of Frisium may lead to a
physical addiction. Stopping
Frisium suddenly m

Tabia za bidhaa

Health Products Regulatory Authority
10 May 2023
CRN009K16
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Frisium 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg clobazam.
Excipients: each tablet contains 72.3mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white, circular, biconvex tablet having the monogram ‘Hoechst’
engraved on one face and the identifying codes ‘B’ and ‘GL’
and a single score-line on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Anxiety
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
In patients with depression or anxiety associated with depression,
Frisium must be used only in conjunction with adequate
concomitant treatment.
Before treatment of anxiety states associated with emotional
instability, it must first be determined whether the patient suffers
from a depressive disorder requiring adjunctive or different
treatment.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazipines is recommended only for adjunctive, i.e. not
for primary treatment.
• As adjunctive therapy in epilepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Anxiety
Treatment should be as short as possible. The patient must be
re-assessed after a period not exceeding 4 weeks and regularly
thereafter in order to evaluate the need for continued treatment,
especially where the patient is free of symptoms. Generally
the overall duration of treatment (i.e. including tapering-off
process) must not exceed 8 to 12 weeks.
In certain cases extension beyond the maximum treatment period may be
necessary; if so it should not take place without
re-evaluation of the patient’s status with special expertise. It is
strongly recommended that prolonged periods of uninterrupted
treatment be avoided, since they may lead to dependance.
_Adults: _Th