Dantrium 100mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Dantrolene sodium

Mevcut itibaren:

Lexon (UK) Ltd

ATC kodu:

M03CA01

INN (International Adı):

Dantrolene sodium

Doz:

100mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 10020200

Bilgilendirme broşürü

Page 1 of 2
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DATE:
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Profile
Technical Info
PRE-PRINTED (AS PART OF ARTWORK)
PRINTED ON-LINE
33338301
1
35591
18/02/2020
UK
-
-
PIL
ROTTENDORF
NOR-LFT18-V1
148x280mm
TBC
TBC
N/A
103487273 / 401782890 0020
Black
Dantrium - Capsules
100mg
FONTS USED:
Arial Rounded MT-Bold
Myriad Pro-Bold
Myriad Pro-Regular
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
FONTS USED:
Arial Rounded MT-Bold
Myriad Pro-Bold
Myriad Pro-Regular
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
PACKAGE LEAFLET: INFORMATION FOR
THE USER
DANTRIUM
®
25 MG CAPSULES /
DANTRIUM
®
100 MG CAPSULES
DANTROLENE SODIUM
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, pharmacist or nurse.
-
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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dantrium Capsules are and what they
are used for
2. What you need to know before you take
Dantrium Capsules
3. How to take Dantrium Capsules
4. Possible side effects
5. How to store Dantrium Capsules
6. Contents of the pack and other information
1. WHAT DANTRIUM CAPSULES ARE AND WHAT
THEY ARE USED FOR
Dantrium Capsules contain the active
substance dantrolene sodium – this is a
muscle relaxant which is used to treat severe,
long term muscle stiffness (spasticity) in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DANTRIUM CAPSULES
DO NOT take Dantrium Capsules if:
-
you are allergic to any ingredients in the
product (see section 6 and

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dantrium Capsules 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg dantrolene sodium
Excipient with known effect: 189.0 mg of lactose monohydrate per
capsule.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule
Dantrium Capsules are presented as white-green capsules of size 1.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dantrium Capsules are indicated for the treatment of chronic, severe
spasticity of
skeletal muscle in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage for Use in Spasticity for Adults
For the individual patient the lowest dose compatible with optimal
response is
recommended. A recommended dosage increment scale is shown below:
1st week
One 25 mg capsule daily
2nd week
One 25 mg capsule twice daily
3rd week
Two 25 mg capsules twice daily
4th week
Two 25 mg capsules three times daily
5th week
Three 25 mg capsules three times daily
6th week
Three 25 mg capsules four times daily
7th week
One 100 mg capsule four times daily.
Each dosage level should be maintained for seven days in order to
determine the
patient's response. Therapy with a dose four times daily may offer
maximum benefit
to some patients. Maximum daily dose should not exceed 400 mg. In view
of the
potential for hepatotoxicity with long term use, if no observable
benefit is derived
from the administration of Dantrium after a total of 6-8 weeks,
therapy should be
discontinued.
Elderly
A similar dosage titration schedule should be used with the elderly.
Paediatric population
Dantrium is not recommended for use in children.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Dantrium is contraindicated where spasticity is utilised to sustain
upright posture and
balance in locomotion or whenever spasticity is utilised to obtain or
maintain
increased function.
Dantrium is contraindicated in patients with evidence of hepatic
dysfunction.
Dantrium is not indicated for the treatment of acut