Consumer medicine information

1. Why am I using ACTAIR?

ACTAIR contains active ingredients which are a 50% mixture of allergen extracts from 2 species of house dust mite - American House Dust Mite and European House Dust Mite. ACTAIR is used for the treatment of house dust mite allergies that are characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) with or without conjunctivitis (itchy and watery eyes) in adults, adolescents and children 5 years and over
For more information, see Section 1. Why am I using ACTAIR? in the full CMI.

2. What should I know before I use ACTAIR?

Do not use if you have ever had an allergic reaction to any of the ingredients listed at the end of the CMI or if you suffer from severe and/or unstable asthma; your immune system is very weakened; if you suffer from a cancer; if you have any inflammation in your mouth
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. For more information, see Section 2. What should I know before I use ACTAIR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ACTAIR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ACTAIR?

The therapy is composed of an initiation treatment (including a 3-day dose escalation) and a continuation treatment.
The tablets are taken by keeping the tablet under your tongue until it is completely disintegrated (at least 2 minutes) before you swallow. More instructions can be found in Section 4. How do I use ACTAIR? in the full CMI.

5. What should I know while using ACTAIR?

6. Are there any side effects?

Common side effects: Swelling or itching of the mouth, throat irritation and itchy ear.
Serious side effects: Allergic symptoms that affect the whole body, (i.e., rapid onset of an illness associated with involvement of the skin and/or mucosa, difficulties in swallowing, breathing difficulty, voices change, abdominal pain or symptoms related to drop in blood pressure). Serious allergic reaction with swelling of the face and/or mouth or tongue and throat. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Actair initiation treatment sublingual tablets 100 IR and 300 IR. Mixture of American (D. farinae) and European (D. pteronyssinus) house dust mite allergen extracts.
Actair continuation treatment sublingual tablets 300 IR. Mixture of American (D. farinae) and European (D. pteronyssinus) house dust mite allergen extracts.

2 Qualitative and Quantitative Composition

A 50% mixture of house dust mite allergen extracts from: European house dust mites (Dermatophagoides pteronyssinus) and American house dust mites (Dermatophagoides farinae), 100 IR* or 300 IR* per sublingual tablet.
*IR (index of reactivity): the IR unit has been defined to measure the allergenicity of an allergen extract. The allergen extract contains 100 IR/mL when, on a skin prick test using a Stallerpoint, it induces a wheal diameter of 7 mm in 30 patients sensitized to this allergen, (geometric mean). The cutaneous reactivity of these patients is simultaneously demonstrated by a positive skin prick test to either 9% codeine phosphate or 10 mg/mL histamine dihydrochloride. The IR unit of Stallergenes is not comparable to the units used by other allergen manufacturers.
Excipients with known effects. Lactose monohydrate.
One sublingual tablet of 100 IR contains 82.8 - 83.3 mg lactose monohydrate.
One sublingual tablet of 300 IR contains 80.8 - 82.3 mg lactose monohydrate.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sublingual tablet.
Actair is presented as white to beige, brown speckled tablet. The 100 IR tablets are engraved "SAC" on one side and "100" on the other and the 300 IR tablets are engraved "SAC" on one side and "300" on the other.

4 Clinical Particulars

4.9 Overdose

Overdoses of up to 1000 IR for up to 28 days and overdosing of at least 600 IR for up to 324 days were reported in patients receiving Actair. No unexpected safety risk emerged in those patients. Doses up to 2000 IR for 10 days in asthmatic patients have been investigated without any new safety concerns. Higher doses may be associated with reduced tolerability and may potentially increase the risk of serious allergic reactions.
In the event of an overdose, the adverse effects should be treated symptomatically.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: Allergen extract, house dust mites. ATC code: V01AA03.

5.3 Preclinical Safety Data

Genotoxicity. Actair active substances revealed no evidence of mutagenic or clastogenic potential based on the results of in vitro genotoxicity tests (bacterial reverse mutation, mouse lymphoma thymidine kinase and micronucleus assays).
Carcinogenicity. Carcinogenicity studies have not been conducted with Actair.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - S4.

Summary Table of Changes

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