Coltramyl

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

THIOCOLCHICOSIDE

Dostupno od:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC koda:

M03BX05

INN (International ime):

THIOCOLCHICOSIDE 4 mg

Farmaceutski oblik:

TABLET

Sastav:

THIOCOLCHICOSIDE 4 mg

Tip recepta:

POM

Područje terapije:

MUSCLE RELAXANTS

Status autorizacije:

Withdrawn

Datum autorizacije:

2005-07-15

Uputa o lijeku

Page 1 of 3 

MEDICINE 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
COLTRAMYL® 4 MG tablet        

_Thiocolchicoside _
_ _

IN THIS LEAFLET: 
1. What Coltramyl 4mg tablet is and what it is used for? 
2. What information do you need to know before taking Coltramyl 4mg tablet? 
3. How to take Coltramyl 4mg tablet? 
4. What are the possible side effects? 
5. How to store Coltramyl 4mg tablet? 
6. Further information 

1. WHAT COLTRAMYL 4MG TABLET IS AND WHAT IT IS USED FOR? 
This medicine is a muscle relaxant. It is used in adults
and adolescents from 16 years onwards
as an adjuvant treatment for painful 
muscular contractions. It is to be used for acute conditions
related to spinal column. 

2. WHAT INFORMATION DO YOU NEED TO KNOW BEFORE
TAKING COLTRAMYL 4MG TABLET? 
If your doctor has told you that you have intolerance to certain sugars, contact your doctor before taking this medication

DO NOT TAKE COLTRAMYL 4MG TABLET IF: 


- you are allergic
to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) 


- you are pregnant, might become pregnant or think you may be pregnant 


- you are a woman of childbearing potential not using contraception 


- you are breast feeding 
IN CASE OF DOUBT ALWAYS SEEK THE ADVICE OF YOUR DOCTOR OR
YOUR PHARMACIST.

TAKE SPECIAL CARE WITH COLTRAMYL 4MG TABLET 
SPECIAL WARNINGS 
Use with caution in case of history of epilepsy or seizures.
 You should stop treatment if you have a seizure.

PRECAUTIONS FOR USE  
Inform your doctor in case of diarrhoea so that he can eventually readjust
the dosage. 
Inform your doctor in case of stomach pain, nausea or vomiting 
This medicine must
not be used in patients with intolerance to galactose

Svojstava lijeka

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Coltramyl

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg thiocolchicoside.
For the excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adjuvant treatment of painful muscle contractures in acute spinal
pathology in adults and
adolescents from 16 years onwards.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg
per day). The treatment
duration is limited to 7 consecutive days
Doses exceeding recommended doses or long-term use should be avoided
(see section 4.4).
Paediatric population
Coltramyl should not be used in children and adolescents under 16
years of age because of safety
concerns (see section 5.3).
_ _
_ADULTS ONLY (OVER 16 YEARS OLD): _
Oral administration.
The tablets are taken with a glass of water.
Daily dosage is 4 tablets, taken as two tablets every 12 hours.
4.3 CONTRAINDICATIONS
Thiocolchicoside must not be used
- in patients hypersensitive to the active substance or to any of the
excipients listed in section 6.1
- during the entire pregnancy period
- during lactation
Page 2 of 7
- in women of childbearing potential not using contraception
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
SPECIAL WARNINGS
Thiocolchicoside should be administered with caution to patients with
epilepsy or patients with a
risk of seizures.
The occurrence of seizures requires discontinuation of treatment.
PRECAUTIONS
In the case of diarrhea, the dosage should be reduced.
If necessary, the tablets can be taken with an antacid.
Due to the presence of lactose and sucrose, patients with rare
hereditary conditions of galactose or
fructose intolerance, the Lapp lactase deficiency, glucose-galactose
malabsorption or sucrase-
isomaltase deficiency should not take this medicine.
Preclinical studies showed that one of thiocolcoside metabolites
(SL59.0955) induced aneuploidy
(i.e. unequal number of chromosomes in di