Modafinil 100mg Tablets

País: Reino Unido

Língua: inglês

Origem: myHealthbox

Ingredientes ativos:

modafinil

Disponível em:

Chanelle Medical

Código ATC:

N06BA07

DCI (Denominação Comum Internacional):

modafinil

Dosagem:

100mg

Forma farmacêutica:

Tablets

Via de administração:

Oral use

Unidades em pacote:

Packs containing 30, 50, 60, 90 or 100 tablets

Tipo de prescrição:

POM - Prescription Only Medicine

Fabricado por:

Chanelle Medical

Grupo terapêutico:

Psychoanaleptics, centrally acting sympathomimetics

Indicações terapêuticas:

It is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy. Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.

Status de autorização:

Authorised

Data de autorização:

2015-05-27

Folheto informativo - Bula

 
Page 1 of 6 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MODAFINIL 100 MG TABLETS 
MODAFINIL 200 MG TABLETS 

MODAFINIL  

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 or
pharmacist.  
  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 Modafinil is and what it is used for 
2.  What you need to know before you take Modafinil  
3.  How to take Modafinil  
4.  Possible side effects  
5.  How to store Modafinil  
6.  Contents of the pack and other information 

1.   
WHAT MODAFINIL IS AND WHAT IT IS USED FOR 
The active ingredient in the tablets is modafinil.  

Modafinil can be taken by adults who suffer from narcolepsy to
help them to stay awake. 
Narcolepsy is a condition that causes excessive daytime sleepiness
and a tendency to fall 
asleep suddenly in inappropriate situations (sleep attacks).
Modafinil may improve your 
narcolepsy and reduce the likelihood that you
will have sleep attacks but there may still be 
other ways that you can improve your condition and your doctor
will advise you.  

2.   
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODAFINIL  
DO NOT TAKE MODAFINIL  
  If you are ALLERGIC to modafinil, or to any of the other
ingredients of this medicine 
(listed in section 6).  
  If you have an IRREGULAR HEARTBEAT.  
  If you have UNCONTROLLED, MODERATE TO SEVERE HIGH BLOOD
PRESSURE (h

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Modafinil 100 mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Modafinil 100 mg: Each tablet contains 100 mg of modafinil. 
Excipients with known effect: lactose 101.5 mg.  

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Tablet 

Modafinil 100 mg: white to off-white, 12.65 mm x 5.55 mm capsule
shaped tablet 
embossed with ‘100’. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Modafinil is indicated in adults for the treatment
of excessive sleepiness associated 
with narcolepsy with or without cataplexy.  
Excessive sleepiness is defined
as difficulty maintaining wakefulness and an 
increased likelihood
of falling asleep in inappropriate situations.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Treatment should be initiated by or under the supervision of
a physician with 
appropriate knowledge of indicated disorders (see section 4.1).  

A diagnosis of narcolepsy should be made according to the
International 
Classification of Sleep Disorders (ICSD2) guideline.  

Patient monitoring and clinical assessment of the
need for treatment should be 
performed on a periodic basis.  

Posology  
The recommended starting daily dose is 200 mg. The total
daily dose may be taken as 
a single dose in the morning or as two doses, one in the
morning and one at noon, 
according to physician assessment of the patient and the patient's
response. 

Doses of up to 400mg in one or two divided doses can be
used in patients with 
insufficient response to the initial 200mg modafinil dose.  

Long-term use  
Physicians prescribing modafinil for an extended time should
periodically re-evaluate 
the long-term use for the individual
patients as the long-term efficacy of modafinil 
has not been evaluated (> 9 weeks).  

_Patients