IVEDAL TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ZOLPIDEM 10,0 mg

Authorization status:

Registered

Authorization date:

2004-07-05

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
Zolpidem tartrate 10 mg
_ _
_ _
Film-coated tablets
THIS AMENDMENT: Aligning section 4.6 of Ivedal (clone) PI with section
4.6 of Stilnox (innovator) PI.
DATE OF SUBMISSION: 28 October 2021
DATE OF APPROVAL: 24 December 2021
SIGNED: __________
Page 1 of 12
PATIENT INFORMATION LEAFLET FOR IVEDAL
SCHEDULING STATUS
IVEDAL, 10 MG, FILM-COATED TABLETS
ZOLPIDEM TARTRATE
CONTAINS SUGAR (90,4 MG LACTOSE MONOHYDRATE PER TABLET).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING IVEDAL
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor, pharmacist, nurse or
other health care provider.
•
IVEDAL 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 IVEDAL is and what it is used for
2.
What you need to know before you take IVEDAL
3.
How to take IVEDAL
4.
Possible side effects
5.
How to store IVEDAL
6.
Contents of the pack and other information
1.
WHAT IVEDAL IS AND WHAT IT IS USED FOR
IVEDAL contains a medicine called zolpidem tartrate and belongs to a
group of medicines called
hypnotics. It works by acting on your brain to help you sleep.
S5
sanofi-aventis south africa (pty) ltd
Zolpidem tartrate 10 mg
_ _
_ _
Film-coated tablets
THIS AMENDMENT: Aligning section 4.6 of Ivedal (clone) PI with section
4.6 of Stilnox (innovator) PI.
DATE OF SUBMISSION: 28 October 2021
DATE OF APPROVAL: 24 December 2021
SIGNED: __________
Page 2 of 12
IVEDAL is used to initiate sleep in adults with severe sleeping
difficulties, also called insomnia, for
a short term only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IVEDAL
DO NOT TAKE IVEDAL:
•
If you are hypersensitive (allergic) to zolpidem tartrate or any of
the other ingredients of
IVEDAL (listed in section 6). Signs of an allergic reaction include
rash, swallowing or
breathing problems, swelling of the lips, face, throat or tongue.
•
If you have myasthe

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
Zolpidem tartrate 10 mg
_ _
_ _
Film-coated tablets
THIS AMENDMENT: Aligning section 4.6 of Ivedal (clone) PI with section
4.6 of Stilnox (innovator) PI.
DATE OF SUBMISSION: 28 October 2021
DATE OF APPROVAL: 24 December 2021
_ _
SIGNED: __________
Page 1 of 19
PROFESSIONAL INFORMATION FOR IVEDAL
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
IVEDAL, 10 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg zolpidem tartrate.
Excipients with known effects:
Contains sugar (90,40 mg lactose monohydrate per tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white, film-coated, oblong tablet, scored, engraved “SN
10” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IVEDAL is indicated for the short term treatment of insomnia.
IVEDAL, or a short acting hypnotic, is only indicated when the
disorder is severe, disabling or
subjecting the individual to extreme distress.
S5
sanofi-aventis south africa (pty) ltd
Zolpidem tartrate 10 mg
_ _
_ _
Film-coated tablets
THIS AMENDMENT: Aligning section 4.6 of Ivedal (clone) PI with section
4.6 of Stilnox (innovator) PI.
DATE OF SUBMISSION: 28 October 2021
DATE OF APPROVAL: 24 December 2021
_ _
SIGNED: __________
Page 2 of 19
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Treatment should be as short as possible. Generally, the duration of
treatment varies from a few
days to two weeks with a maximum, including the tapering off process,
of four weeks.
In certain cases, extension beyond the maximum treatment period may be
necessary; if so, it
should not take place without re-evaluation of the patient’s status.
IVEDAL should be taken immediately before going to bed, or in bed.
IVEDAL should be taken in a
single intake and not be readministered during the same night.
_DOSE: _
The recommended daily dose for adults is 10 mg immediately before
bedtime, or in bed. The
lowest effective daily dose of IVEDAL should be