INTAL FORTE CFC-FREE INHALER sodium cromoglycate 5mg/actuation inhalation metered dose aerosol can

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium cromoglycate, Quantity: 5 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: povidone; macrogol 600; apaflurane

Administration route:

Inhalation

Units in package:

112 actuations

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The prophylactic treatment of bronchial asthma, including the prevention of exercise induced bronchospasm.

Product summary:

Visual Identification: A suspension of sodium cromoglycate in a volatile propellant contained in an aluminium can fitted with a metering valve.; Container Type: Aerosol Can - Metered Dose; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-04-15

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING INTAL FORTE CFC-FREE INHALER?
Intal Forte CFC-Free Inhaler contains the active ingredient sodium
cromoglycate. Intal Forte CFC-Free Inhaler is used to treat
asthma and can be used before exercise.
For more information, see Section 1. Why am I using Intal Forte
CFC-Free Inhaler? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INTAL FORTE CFC-FREE INHALER?
Do not use if you have ever had an allergic reaction to Intal Forte
CFC-Free Forte Inhaler or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT, OR ARE BREASTFEEDING OR PLAN TO BREASTFEED.
For more information, see Section 2. What should I know before I use
Intal Forte CFC-Free Inhaler? in the full CMI.
3.
WHAT IF I AM TAKING OR USING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy
without a prescription from your pharmacy, supermarket or health food
shop.
More information can be found in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE INTAL FORTE CFC-FREE INHALER?
The usual starting dose is two puffs four times each day.
More instructions can be found in Section 4. How do I use Intal Forte
CFC-Free Inhaler? in the full CMI. Instructions on how to use
and clean the inhaler can be found in Section 4. How do I use Intal
Forte CFC-Free Inhaler? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INTAL FORTE CFC-FREE INHALER?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
INTAL FORTE CFC-FREE
INHALER.
•
IF YOU HAVE AN ASTHMA ACTION PLAN THAT YOU HAVE AGREED WITH YOUR
DOCTOR, ALWAY

Summary of Product characteristics

intal-ccdsv4-piv8-14jul20
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION – INTAL CFC FREE
INHALER AND INTAL FORTE CFC FREE INHALER
(SODIUM CROMOGLYCATE)
1
NAME OF THE MEDICINE
Sodium cromoglycate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INTAL (1 MG) CFC-FREE:
Each actuation contains sodium cromoglycate 1.0 mg.
INTAL FORTE (5 MG)
CFC-FREE
: Each actuation contains sodium cromoglycate 5.0 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pressurised oral inhalation
INTAL is a metered dose inhaler containing sodium cromoglycate as a
suspension in the
propellant, apaflurane, a non CFC (chlorofluorocarbon) propellant.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prophylactic treatment of bronchial asthma, including the
prevention of exercise induced
bronchospasm.
4.2
DOSE AND METHOD OF ADMINISTRATION
Patients vary in their response to INTAL CFC-Free formulations.
INTAL (1 MG) CFC-FREE
: Adults and Children: two inhalations of the aerosol four times
daily.
The suggested dosage regimen is two inhalations on retiring at night
and on waking in the
morning and at intervals of 4 to 6 hours. Additional doses before
exercise may be taken.
INTAL FORTE (5 MG) CFC-FREE:
The recommended initial dosage of INTAL FORTE (5 mg)
CFC-Free is two inhalations twice daily. In some patients with more
severe asthma, or
during periods of severe challenge, an increased dosage of up to four
inhalations four times
daily may be required to achieve optimal control. To prevent asthmatic
symptoms associated
with exercise, a dose of two to four inhalations 5-10 minutes prior to
exercise is
recommended.
intal-ccdsv4-piv8-14jul20
Page 2 of 9
MAINTENANCE TREATMENT
Maintenance dosage should be individually assessed. Patients should be
warned against
suddenly discontinuing therapy when symptoms have been partially or
completely controlled
by INTAL CFC-Free formulations.
Since the therapy is essentially prophylactic it is important to
continue therapy in those
patients who benefit. If it is necessary t