CIPLA-OSELTAMIVIR CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Cipla Medpro (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS OSELTAMIVIR PHOSPHATE EQUIVALENT TO OSELTAMIVIR 75,0 mg

Authorization status:

Registered

Authorization date:

2008-09-12

Patient Information leaflet

Cipla Medpro (Pty) Ltd.
Page 1 of 16
PATIENT INFORMATION LEAFLET FOR
CIPLA OSELTAMIVIR
SCHEDULING STATUS:
CIPLA OSELTAMIVIR (75 MG CAPSULES)
OSELTAMIVIR
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CIPLA
OSELTAMIVIR
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
CIPLA OSELTAMIVIR 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 CIPLA OSELTAMIVIR is and what it is used for
2.
What you need to know before you take CIPLA OSELTAMIVIR
3.
How to take CIPLA OSELTAMIVIR
4.
Possible side effects
5.
How to store CIPLA OSELTAMIVIR
6.
Contents of the pack and other information.
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Cipla Medpro (Pty) Ltd.
Page 2 of 16
1.
WHAT CIPLA OSELTAMIVIR IS AND WHAT IT IS USED FOR
CIPLA OSELTAMIVIR contains oseltamivir which belongs to a group of
medicines called
antivirals. These medicines act by preventing the influenza virus from
spreading inside the
body, thereby helping ease or prevent symptoms of influenza virus
infection.
CIPLA OSELTAMIVIR is indicated for:
•
Treatment of influenza in adults and children ≥ 1 year of age.
•
Pandemic use: CIPLA OSELTAMIVIR is indicated for the treatment of
infants 6 to 12 months
of age during a pandemic influenza outbreak only, and not for endemic
(seasonal) influenza
use.
•
Prophylaxis (prevention) of influenza in adults and children ≥ 1
year of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPLA OSELTAMIVIR
DO NOT TAKE CIPLA OSELTAMIVIR:
•
If you are hypersensitive (allergic) to oseltamivir or any of the
other ingredients of CIPLA
OSELTAMIVIR (listed in section 6).
WARNINGS AND PRECAUTIONS
Take special care with CIPLA OSELTAMIVIR:
•
If you notice changes in your behaviour or mood (neuropsychiatric
events) such as
convulsions (seizures), hallucinations, delirium (disturbed state of
mind) and distu

Summary of Product characteristics

Cipla Medpro (Pty) Ltd.
Page 1 of 23
PROFESSIONAL INFORMATION FOR
CIPLA OSELTAMIVIR
SCHEDULING STATUS
1 NAME OF THE MEDICINE
CIPLA OSELTAMIVIR (75 mg capsules).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains oseltamivir phosphate equivalent to 75 mg
oseltamivir.
Sugar free.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules.
White to off white coloured free flowing powder filled in size ‘2’
capsule having white
body spin printed with ’75 mg’ in black and yellow coloured cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CIPLA OSELTAMIVIR is indicated for:
•
Treatment of influenza in adults and children ≥ 1 year of age (see
section 4.4 and
4.2).
•
Pandemic use: CIPLA OSELTAMIVIR is indicated for the treatment of
infants 6 to
12 months of age during a pandemic influenza outbreak only, and not
for endemic
(seasonal) influenza use (see section 4.4 and 5.2).
•
Prophylaxis of influenza in adults and children ≥ 1 year of age.
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Cipla Medpro (Pty) Ltd.
Page 2 of 23
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
STANDARD DOSAGE
_TREATMENT OF INFLUENZA _
Treatment should be initiated within the first or second day of onset
of influenza
symptoms.
_Adults and adolescents _
In
adults
and
adolescents
≥
13
years
the
recommended
oral
dose
of
CIPLA
OSELTAMIVIR is one 75 mg capsule twice daily for 5 days.
_Children _
Treatment with one 75 mg capsule twice daily may also be administered
to children >
40 kg who are able to swallow capsules.
_Children ≥ 1 year of age_ _who are not able to swallow capsules
_(_refer to METHOD OF _
_ADMINISTRATION below)_
_ _
BODY WEIGHT
RECOMMENDED DOSE FOR 5 DAYS
≤ 15 kg
30 mg twice daily
> 15 to 23 kg
45 mg twice daily
> 23 to 40 kg
60 mg twice daily
> 40 kg
75 mg twice daily
_The recommended oral dose of CIPLA OSELTAMIVIR for children 6 to 12
months of _
_age who are not able to swallow capsules (refer to METHOD OF
ADMINISTRATION below)_
Based on limited pharmacokinetic data currently available, a dosage of
3 mg/kg twi