Nicotinell Step 1 Patch 21mg 24 Hours 28 Day Supply
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Nicotinell Step 1 Patch 21mg 24 Hours 28 Day Supply
- Product type: Medicine — Registered (AUST R)
- Used for: a 24-hour transdermal nicotine patch used as an aid to smoking cessation in adults
- ARTG listing: AUST R 42626
- Australian sponsor: Perrigo Australia Pty Ltd
- Schedule: Unscheduled (general sale through pharmacy)
- Pack size: 28 patches (28-day supply)
- Last reviewed: 29 May 2026
Product specification
| ARTG ID | 42626 |
|---|---|
| Listing / registration number | AUST R 42626 |
| Product type | Medicine — Registered (AUST R) |
| Australian sponsor | Perrigo Australia Pty Ltd |
| ARTG start date | 23 April 1993 |
| Dosage form | Transdermal patch |
| Route of administration | Transdermal |
| Pack size | 28 patches (28-day supply) |
| Active ingredients | Nicotine 52.5 mg per patch, delivering 21 mg over 24 hours |
| Schedule | Unscheduled (general sale through pharmacy) |
| Storage | Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children. |
About this product
Nicotinell Step 1 Patch 21mg 24 Hours 28 Day Supply is a 24-hour transdermal nicotine patch used as an aid to smoking cessation in adults. Supplied in Australia by Perrigo Australia Pty Ltd. Use it in accordance with the carton instructions and your healthcare professional's advice.
About the active
Nicotine (Transdermal)
Nicotine is a naturally occurring alkaloid from the tobacco plant (Nicotiana tabacum), a member of the Solanaceae family. In therapeutic use it is delivered as a controlled-release pharmaceutical-grade compound through the skin via a rate-controlled patch matrix.
The patch is designed to release nicotine at a steady, predictable rate over a 24-hour wear period, replacing the nicotine the user would otherwise obtain from cigarettes and so reducing the withdrawal symptoms associated with stopping smoking.
The Step 1 patch is the highest-strength patch in the three-step Nicotinell programme. It is intended as the starting strength for adults who smoke 20 or more cigarettes per day; users typically step down to Step 2 (14 mg over 24 hours) and Step 3 (7 mg over 24 hours) over subsequent weeks.
Safety: not recommended during pregnancy or breastfeeding without professional advice. Discuss with a pharmacist or doctor before use if you have had a recent heart attack, unstable angina, severe arrhythmias, or are taking medicines that may interact with nicotine. Used patches still contain significant nicotine and must be folded inwards on the adhesive side and discarded out of reach of children and pets.
Indications
The following indications are recorded on this product's ARTG entry:
- Aid in the treatment of nicotine dependence as an aid to smoking cessation
- Step 1 (highest strength) is the starting strength for adults who smoke 20 or more cigarettes per day; users typically step down to Step 2 (14 mg) and Step 3 (7 mg) over subsequent weeks
Directions for use
Apply one patch daily to a clean, dry, hairless area of skin on the upper arm, chest or hip. Remove and replace at the same time each day. Rotate sites to reduce skin irritation. Follow the stepped programme on the carton — step down to lower strengths over the recommended weeks.
Warnings and important information
- Always read the label and follow the directions for use.
- If symptoms persist, talk to your healthcare professional.
- Discuss with your pharmacist or doctor before use during pregnancy or breastfeeding.
- Keep out of reach of children.
- Do not use after the expiry date printed on the pack.
- Stop use and seek advice if any unexpected reaction occurs.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep the original packaging closed. Keep out of reach of children. Do not use after the expiry date printed on the pack.
Frequently asked questions
What is Nicotinell Step 1 Patch used for?
Nicotinell Step 1 Patch is a 24-hour transdermal nicotine patch used as an aid to smoking cessation in adults. It is supplied in Australia by Perrigo Australia Pty Ltd. Refer to your pharmacist or doctor for advice on whether the product is suitable for you.
How does Nicotinell Step 1 Patch work?
The active in Nicotinell Step 1 Patch is described in detail under 'About the active' above. The mechanism of action is summarised there in plain English.
What are the active ingredients in Nicotinell Step 1 Patch?
Nicotinell Step 1 Patch contains Nicotine 52.5 mg per patch, delivering 21 mg over 24 hours. The full active panel is shown in the Product Specification table above.
How do I apply Nicotinell Step 1 Patch?
Apply one patch daily to a clean, dry, hairless area of skin on the upper arm, chest or hip. Remove and replace at the same time each day. Rotate sites to reduce skin irritation. Follow the stepped programme on the carton — step down to lower strengths over the recommended weeks.
What are the possible side effects?
Refer to the Consumer Medicine Information leaflet supplied with the pack and to your pharmacist for the full side-effect profile. Stop use and seek advice if any unexpected reaction occurs.
Can I take this with my other prescription medicines?
Several common medicines interact with Nicotinell Step 1 Patch. Bring the pack to your pharmacist and ask them to check it against your current medicines list before starting.
Is this suitable during pregnancy or breastfeeding?
Use during pregnancy or breastfeeding is not recommended without professional advice. Refer to the carton and confirm with your pharmacist or doctor.
What should I do if I miss a dose?
If you miss a dose of Nicotinell Step 1 Patch, take it as soon as you remember unless it is nearly time for your next dose — in that case, skip the missed dose and continue with your usual schedule. If you have taken more than the directed amount, call the Poisons Information Centre on 13 11 26 (Australia) for advice.
Is this medicine TGA approved?
Yes. Nicotinell Step 1 Patch is a Registered (AUST R) medicine on the Australian Register of Therapeutic Goods, individually evaluated by the TGA for safety, quality and efficacy. The AUST R number is 42626 — you can verify the entry at tga.gov.au/resources/artg/42626.
Where is it manufactured?
Nicotinell Step 1 Patch is supplied in Australia by Perrigo Australia Pty Ltd.
This information is general in nature and is not a substitute for professional medical advice. If you have questions about whether Nicotinell Step 1 Patch is right for you, speak with your pharmacist or doctor. For 24-hour health advice in Australia, call Healthdirect on 1800 022 222. For poisoning enquiries, call the Poisons Information Centre on 13 11 26.
Sources
- Australian Register of Therapeutic Goods (ARTG) — entry for this product. tga.gov.au/resources/artg
- Therapeutic Goods Administration — Permissible Indications Determination and Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. tga.gov.au
- Healthdirect Australia — general consumer health information. healthdirect.gov.au
- Manufacturer carton and Consumer Medicine Information (where supplied).
ALWAYS READ THE LABEL ON THE PRODUCT AND FOLLOW THE DIRECTIONS FOR USE UNLESS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL.
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(Product SKU 109045)
| SKU | 109045 |
| Barcode # | 9305000600276 |
| Shipping Cubic | 0.000385000m3 |
| Assembled Length | 0.110m |
| Assembled Height | 0.037m |
| Assembled Width | 0.100m |
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