Arcalion 200mg Coated Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-06-2021
Summary of Product characteristics
(SPC)
24-06-2021
Active ingredient:
SULBUTIAMINE
Available from:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC code:
A11DA02
INN (International Name):
SULBUTIAMINE 200 mg
Pharmaceutical form:
COATED TABLET
Composition:
SULBUTIAMINE 200 mg
Prescription type:
OTC
Therapeutic area:
VITAMINS
Authorization status:
Authorised
Authorization date:
2005-11-17
Patient Information leaflet
1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCALION 200 MG, COATED TABLET
Sulbutiamine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you
.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after.
WHAT IS IN THIS LEAFLET
:
1.
What Arcalion is and what it is used for
2.
What you need to know before you take Arcalion
3.
How to take Arcalion
4.
Possible side effects
5.
How to store Arcalion
6.
Contents of the pack and other information
1.
WHAT ARCALION IS AND WHAT IS USED FOR
Arcalion is used to treat certain states of transient fatigue in
adults.
You must talk to your doctor if you do not feel better or if you feel
worse after 4 weeks.
2.
WHAT YOU NEED TO KNOW BEFOR YOU TAKE ARCALION
DO NOT TAKE ARCALION
If you are allergic) to sulbutiamine, or any of the other ingredients
of this medicine listed in section 6.
WARNINGS AND PRECAUTIONS
If you are pregnant or breastfeeding, please talk to your doctor
before taking Arcalion.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children and adolescents.
OTHER MEDICINES AND ARCALION
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Arcalion may interact with the following medicines :
-
Diuretics (used for blood pressure) which may increase the thiamine
excretion (vitamin B1)
-
Neuromuscular blocking agents (used in genereal anesthesia) whose
effects may be increased with
thiamine (vitamin B1).
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding , think you may be pregnant or
Read the complete document
Summary of Product characteristics
1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ARCALION 200 MG
, coated tablet
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Sulbutiamine
............................................................................................
200 mg per coated tablet.
Excipients with known effect : glucose anhydrous, lactose monohydrate,
sucrose and sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of certain physical or mental inhibition states involving
reduced activity and apathy. In confirmed
depressive states, this medicine does not eliminate the need for
specific antidepressant treatment.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULT USE ONLY.
2 to 3 tablets daily.
Duration of treatment is limited to 4 weeks.
_Paediatric population:_
This medicinal product is intended only for adults.
Method of administration
Tablets should be swallowed whole with a large glass of water,
dividing the doses between the morning and
midday meals.
4.3.
CONTRAINDICATIONS
Hypersensitivity the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
This medicinal product contains glucose, lactose and sucrose.
Patients with rare hereditary problems of fructose or galactose
intolerance, total lactase deficiency, glucose-
galactose malabsorption or sucrase-isomaltase insufficiencyshould not
take this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially ‘sodium-free’.
2
This medicinal product contains Sunset Yellow FCF (E110), and may
cause allergic reactions, even delayed
(see section 4.8).
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No specific interaction studies have been performed with sulbutiamine.
_Concomitant use to be taken into consideration _
−
Diuretics: the urinary excretion of thiamine (metabolite of
Read the complete document
