Adalat (Nifedipine) Australia: Official CMI, PI, PBS, Safety & Shortages 2025
You typed Adalat because you want the right page, not a rabbit hole. Maybe you need the official leaflet, a dosing detail your GP mentioned, PBS status, or to check a shortage. This guide is the shortest, no-fuss path to the exact Australian sources patients and clinicians actually use. Iāll point you to the correct pages, show you what to look for on-screen, and flag the safety bits that matter day to day. Expect zero fluff and practical steps you can do in under five minutes.
What youāll get here: the fastest route to the official Consumer Medicine Information (CMI) and Product Information (PI), how to confirm if your specific strength is PBS-listed, where to check medicine shortages, and how to report a side effect in Australia. Iāll also add quick safety checkpoints (grapefruit, crushing tablets, missed doses), and some clean FAQs.
Jobs to be done today: (1) Get the official Adalat leaflets (CMI/PI) without guessing; (2) Confirm availability and any current shortages; (3) Check PBS coverage and likely out-of-pocket rules; (4) Find practical use tips (how to take, what to avoid); (5) Know how to report side effects or product issues; (6) Troubleshoot brand switches and pharmacy substitutions.
Find the exact Adalat pages you need (Australia)
If your goal is the official Australian leaflets and status, start here. Adalat is the brand name for nifedipine (a calcium channel blocker) originally by Bayer. In Australia, youāll mainly see modified-release/controlled-release tablets (often called OROS, GITS, or MR/CR) used for high blood pressure and angina. The steps below take you to the government-backed pages without guessing links.
Consumer Medicine Information (CMI) for patients (fastest route)
- Open your browser and search: āHealthdirect medicines Adalat OROS CMIā.
- On the result, look for a page that clearly says āMedicine Finderā or āConsumer Medicine Informationā. You should see the active ingredient ānifedipineā.
- On the page, confirm the brand name, strength (e.g., 30 mg, 60 mg), and dosage form (modified-release). The CMI tells you what itās for, how to take it, common side effects, and when to seek help.
- Visual cue: Youāll see āHealthdirectā branding and the familiar Australian government look. If itās not Healthdirect, make sure itās an Australian source and up to date.
Product Information (PI) for clinicians and detailed dosing
- Search: āTGA ARTG nifedipine Adalat Product Informationā.
- Open the Therapeutic Goods Administration (TGA) result that mentions āPublic ARTG summaryā.
- On the ARTG summary page, look for āProduct Informationā (PDF). Thatās the official prescriber document with pharmacology, indications, contraindications, interactions, and dosing guidance.
- Visual cue: Australian Government crest and āTherapeutic Goods Administrationā in the header. The PI link is usually near the top or under āDocumentsā.
PBS listing and expected coāpayment
- Search: āPBS schedule nifedipine modified release 30 mgā.
- Open the result thatās clearly the Pharmaceutical Benefits Scheme (PBS) website.
- Use the PBS search box to find ānifedipine modified releaseā or ānifedipine 30 mg MR / 60 mg MRā.
- On the item page, check brand options, restriction notes (if any), and whether brand premiums apply. The standard PBS coāpayment rules apply (general vs concession). If your pharmacy price looks off, ask about brand premiums or stock sourcing.
Medicine shortages (current status)
- Search: āTGA medicine shortages nifedipineā.
- Open the TGA Medicine Shortages Reports page.
- Filter/search for ānifedipineā and skim by strength and brand. Entries show start/end dates, impact (e.g., low/no supply), and suggested actions for prescribers.
- If your exact strength is affected, speak with your pharmacist or GP about equivalent modified-release nifedipine brands or a dose/formulation switch.
Safety alerts and recalls
- Search: āTGA safety alert nifedipineā or āTGA recall nifedipineā.
- Open TGA safety alerts/recalls and check by brand/active ingredient.
- If you find an alert that matches your batch, follow the instructions. Keep your pack and batch number handy for verification.
Manufacturer medical information
- Search: āBayer Medical Information Australia Adalatā.
- Open the Bayer AU medical information page. You can usually submit a question online (e.g., excipients, lactose content, splitting tablets, brand substitution).
- Tip: Include the exact strength and the batch number if your question is about a specific pack.
Not in Australia? Try your regulator: āEMA Adalatā (EU), āMedsafe nifedipineā (NZ), āFDA nifedipine labelā (US). Always match the brand and strength-formulations differ by country.
| Where to go | What youāll find | Best for | Search phrase to use |
|---|---|---|---|
| Healthdirect Medicine Finder | Consumer Medicine Information (plain English) | Patients and carers | Healthdirect medicines Adalat OROS CMI |
| TGA Public ARTG Summary | Product Information PDF (prescriber-level detail) | Clinicians, pharmacists | TGA ARTG nifedipine Adalat Product Information |
| PBS website | PBS listing, brand premiums, restrictions | Cost/coverage checks | PBS nifedipine modified release 30 mg |
| TGA Medicine Shortages | Current/anticipated shortage notices | Stock planning, alternatives | TGA medicine shortages nifedipine |
| TGA Safety Alerts/Recalls | Alerts, recall instructions, batch issues | Safety verification | TGA safety alert nifedipine |
| Bayer Medical Information (AU) | Brand-specific inquiries and excipients | Edge cases, allergies | Bayer Medical Information Australia Adalat |
Quick actions, safety checkpoints, and smart shortcuts
Use this section like a checklist. Itās the āwhat do I do right now?ā piece.
Verify your exact product
- Check your pack for āmodified-releaseā, ācontrolled-releaseā, āMR/CRā, āGITS/OROSā. Donāt assume release type-confirm it.
- Match strength (e.g., 30 mg, 60 mg) to the CMI/PI so the dosing and guidance line up.
- If your pharmacy substituted a different brand of nifedipine MR, confirm the release type is equivalent. Not all controlled-release technologies behave the same; your GP/pharmacist can advise on dose equivalence.
How to take it (common-sense rules)
- Swallow whole with water. Do not crush, chew, or split modified-release tablets. That can dump the dose and drop your blood pressure too fast.
- Take at the same time each day. Morning is common, but consistency is the real goal.
- With or without food is usually fine-just be consistent with your routine. Avoid grapefruit and grapefruit juice (CYP3A4 interaction can boost levels).
- Donāt expect it to fix chest pain the moment it starts. Nifedipine MR is for prevention/management, not for sudden angina relief. Use your prescribed nitroglycerin (glyceryl trinitrate) for acute chest pain and call emergency if pain persists.
- Seeing a āghost tabletā shell in your stool? That can happen with OROS/GITS tablets; the medicine is released and the empty shell passes through.
Missed dose logic (once-daily MR forms)
- If you remember within about 12 hours, take it. If itās closer to your next dose, skip the missed one. Donāt double up.
- Had a near-faint, severe dizziness, or chest pain after a double dose? Seek medical help.
Common side effects to watch
- Headache, flushing, dizziness, palpitations, ankle swelling (peripheral oedema). These are well-known with nifedipine.
- Often they ease after the first week. If swelling or dizziness is bad or getting worse, talk to your GP-dose tweaks or a companion medicine can help.
Red flags-seek urgent care
- Crushing or persistent chest pain not relieved by your usual nitro
- Fainting, severe shortness of breath, sudden swelling of face/lips/tongue
- Severe lightheadedness or a big drop in blood pressure with confusion/weakness
Interactions you shouldnāt ignore
- Strong CYP3A4 inhibitors can raise levels: macrolide antibiotics (e.g., clarithromycin, erythromycin), azole antifungals (e.g., ketoconazole, itraconazole), certain HIV protease inhibitors.
- Strong inducers can lower levels: rifampicin, carbamazepine, phenytoin, St Johnās wort.
- Alcohol can heighten dizziness, especially at start or dose increases.
- Always tell your prescriber about any new antibiotic or antifungal before you start it.
Who needs extra caution
- Severe aortic stenosis, recent unstable angina or heart attack-specialist input helps.
- Liver impairment-dose adjustment may be needed.
- Pregnancy/breastfeeding-nifedipine is sometimes used under specialist care (e.g., in pregnancy). Donāt start/stop without your obstetric team.
- Older adults-go slow on dose changes; monitor dizziness/falls risk.
Shortage plan (what to do if your strength isnāt in stock)
- Check the TGA shortages page for your strength and brand. Note the expected end date.
- Ask your pharmacist about an equivalent modified-release nifedipine brand. If the release technology differs, your GP may adjust the dose.
- If thereās a national shortage, your GP/pharmacist can advise an interim alternative (sometimes another calcium channel blocker). Donāt guess a substitute yourself.
PBS and out-of-pocket tips
- On PBS, nifedipine MR usually falls under standard coāpayment rules (general vs concession). If your cost is higher than expected, ask about brand premiums or supply issues.
- For a long-term script, consider getting repeats filled a few days early so shortages donāt leave you without medicine.
Side effect or quality concern? Report it
- Search āReport a problem or side effect TGAā. Fill in the online form with the brand, strength, batch number, when the issue started, and any other meds youāre on.
- Keep the pack until youāre told you can discard it, in case more info is needed.
FAQs and troubleshooting for common Adalat tasks
Is Adalat the same as nifedipine?
Yes. Adalat is a brand of the active ingredient nifedipine. In Australia, youāll often see modified-release formulations for once-daily dosing.
Adalat OROS vs generic nifedipine MR-are they interchangeable?
Theyāre designed to release nifedipine slowly, but the release mechanisms can differ (e.g., OROS/GITS osmotic pump vs other MR matrices). Many patients can switch brands at the same milligram dose, but some notice differences. If youāre told ābrand substitutedā, confirm with your pharmacist and watch your blood pressure and symptoms for a couple of weeks. If anything feels off, call your GP.
Can I split or crush the tablets?
No for modified-release. Splitting/crushing can dump the dose and cause a sharp blood pressure drop. If swallowing is an issue, ask your doctor about alternatives or a different formulation.
How quickly does it start working?
Modified-release nifedipine starts lowering blood pressure the first day, but you usually see the steady effect after several days. For angina prevention, your doctor will review symptom control over 1-2 weeks and adjust dose as needed.
Can I stop suddenly?
Donāt stop without a plan. Stopping a calcium channel blocker abruptly can let blood pressure rebound or angina worsen. Your GP can taper or switch safely.
What about grapefruit?
Avoid grapefruit and its juice-they can raise nifedipine levels and increase side effects. Oranges and other citrus are fine.
Is it safe in pregnancy or breastfeeding?
Nifedipine is sometimes used in pregnancy under specialist guidance. If youāre pregnant, planning, or breastfeeding, talk to your obstetric team before any change. Donāt start or stop on your own.
What if my ankles swell?
Ankle swelling is common with dihydropyridine calcium channel blockers. Elevating legs, dose adjustments, or combining with another blood pressure med can help. Check with your GP; donāt just add a diuretic without advice.
Any special storage tips for Australian summers?
Keep it below the temperature on the pack (often 25°C). Donāt store in the car or bathroom. Keep in the original blister and carton to protect from heat and moisture.
What should I bring to my GP review?
- Your actual pack (for brand, strength, batch).
- Home blood pressure log (time of day, readings for the last 1-2 weeks).
- A list of all medicines, vitamins, and herbal products.
How do I verify Iām reading the latest leaflet?
On CMI/PI PDFs, check the āDate of revisionā. If itās more than a couple of years old and your pack looks newer, search again via TGA ARTG to make sure you have the latest document.
Can I use it for sudden chest pain?
No. Use your prescribed fast-acting nitrate for acute chest pain and call emergency if pain doesnāt resolve quickly. Nifedipine MR is a background controller, not a rescue medicine.
Is there lactose or sodium in it?
Excipients vary by brand and strength. Check the PI āList of excipientsā or ask Bayer Medical Information (for Adalat) or your pharmacist for the exact formulation you have.
Next steps and quick troubleshooting by persona
- Patient who just got a new brand at the pharmacy: Compare the release type on the new box to your old one; confirm with the pharmacist itās an equivalent MR; monitor your BP for 1-2 weeks; book a GP check if symptoms change.
- Carer managing meds for an older adult: Set a daily reminder; avoid pill cutters with MR tablets; keep a simple side-effect diary (dizziness, swelling, headaches) to share at the next review.
- Clinician needing exact wording: Go straight to the TGA ARTG page and download the PI; check TGA shortages before switching brands; document any dose conversion if the release tech differs.
- Pharmacist under shortage pressure: Check TGA shortages and PBS for alternative brands; counsel on ghost tablet shells and grapefruit; add a shelf sticker to remind staff āDo not crush-MRā.
If you only do one thing after this page, do this: grab the CMI from Healthdirect for your exact strength, then bookmark the TGA ARTG PI. Those two pages answer 90% of daily Adalat questions with the most current, Australian-approved info.
Caroline Marchetta
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