DOMILO CAPSULES

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Adcock Ingram Limited

Annus:

See ingredients

Ravimvorm:

CAPSULES

Koostis:

EACH CAPSULE CONTAINS FINGOLIMOD 0,5 mg

Volitamisolek:

Registered

Infovoldik

Adcock Ingram Limited
Proposed Patient Information Leaflet
Domilo 0,5 mg hard capsule
Each capsule contains fingolimod 0,5 mg (as
hydrochloride)
Date: 25 July 2022
Module 1.3.2 Patient Information Leaflet
Page
1
of
22
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
DOMILO, 0,5 MG (HARD CAPSULES)
FINGOLIMOD HYDROCHLORIDE
DOMILO IS SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DOMILO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor, pharmacist nurse or
other healthcare provider.
•
Domilo has been prescribed for you personally and you should not share
your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What Domilo is and what it is used for
2.
What you need to know before you take Domilo
3.
How to take Domilo
4.
Possible side effects
5.
How to store Domilo
Adcock Ingram Limited
Proposed Patient Information Leaflet
Domilo 0,5 mg hard capsule
Each capsule contains fingolimod 0,5 mg (as
hydrochloride)
Date: 25 July 2022
Module 1.3.2 Patient Information Leaflet
Page
2
of
22
6.
Contents of the pack and other information
1. WHAT DOMILO IS AND WHAT IT IS USED FOR
Domilo contains the active substance fingolimod. Fingolimod is a
selective immunosuppressant and is
used in adults to treat relapsing multiple sclerosis (MS)
characterised by repeated attacks (relapses) of
nervous system symptoms that reflect inflammation within the central
nervous system.
Domilo does not cure MS, but it helps to reduce the number of relapses
and to slow down the progression
of physical disabilities due to MS.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMILO
DO NOT TAKE DOMILO:
•
if you are hypersensitive (allergic) to fingolimod or any of the other
ingredients of Domilo (listed
in section 6).
•
if you are taking or have recently taken medicine for irregular
heartbeat such as quinidine,
disopyramide, amiodarone or sotalol.
•
if you are pregnant or breastfeeding your baby.
•
if you have a

Toote omadused

Adcock Ingram Limited
Professional Information
Domilo 0,5 mg hard capsule
Each capsule contains fingolimod 0,5 mg (as
hydrochloride)
Date: 25 July 2021
Module 1.3.1.1 Professional Information
Page
1
of
46
DOMILO SHOULD BE USED ONLY BY NEUROLOGISTS EXPERIENCED IN THE
TREATMENT OF
MULTIPLE SCLEROSIS. DOMILO INDUCES A REDUCTION IN HEART RATE UPON
TREATMENT
INITIATION, WHICH CAN LEAD TO BRADYDYSRHYTHMIA. THE EFFECT IS USUALLY
MAXIMAL ON
DAY 1, WITHIN THE FIRST 6 HOURS AND HEART RATE USUALLY NORMALISES BY 1
MONTH.
HOWEVER, THESE EVENTS MAY OCCUR AT ANY TIME. HOURLY MONITORING FOR AT
LEAST 6
HOURS (ECG, HEART RATE AND BLOOD PRESSURE) ON DAY 1 IS MANDATORY FOR
ALL
PATIENTS, IN ORDER TO DETERMINE INDIVIDUAL RESPONSE TO TREATMENT
INITIATION.
PATIENTS WHO EXPERIENCE THESE EVENTS OR PATIENTS WITH RISK FACTORS
(SEE SECTION 4.4)
SHOULD HAVE EXTENDED MONITORING (AT LEAST OVERNIGHT). IF PATIENTS
DEVELOP SIGNS OR
SYMPTOMS RELATED TO HEART RATE REDUCTION, THE MONITORING SHOULD BE
EXTENDED
UNTIL RESOLUTION OF THE EVENT.
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
Domilo, 0,5 mg (hard capsules)
Adcock Ingram Limited
Professional Information
Domilo 0,5 mg hard capsule
Each capsule contains fingolimod 0,5 mg (as
hydrochloride)
Date: 25 July 2021
Module 1.3.1.1 Professional Information
Page
2
of
46
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0,5 mg fingolimod (as hydrochloride).
Domilo is sugar free.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules.
Hard gelatine capsule of 16 mm (size 3), with a white body and yellow
coloured cap.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Domilo is indicated as a disease modifying therapy for the treatment
of patients with relapsing multiple
sclerosis to reduce the frequency of relapses and to delay the
progression of disability.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Do not exceed the recommended dosage.
Adcock Ingram Limited
Professional Information
Domilo 0,5 mg hard capsule
Each capsule contains fingolimod 0,5 mg (