Nifedipine: Supply issues

Supply issue Discontinuation Active

There is a supply issue with the 20 mg tablets (Nyefax Retard). In January 2021 we notified that Adalat brand of nifedipine was being discontinued.

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Supply issue: 20 mg tablets

Stocks of Nyefax Retard brand nifedipine 20 mg (pharmacode: 529435) are running low. This is due to a manufacturing issue. The supplier (Douglas) anticipates the registered product to be available again by the end of the year.

We listed an alternative brand on 1 May 2021.

  • Brand: Mylan nifedipine
  • Presentation: 20 mg
  • Listed: 1 May 2021
  • Available: We are advised stock will be available in late April.
  • Pharmacode: 2607220

The Mylan product is not Medsafe approved. It will need to be prescribed and supplied in line with section 29 of the Medicines Act. 

Dosing regimen 

The dosing regimen of Mylan brand nifedipine 20mg long-acting remains twice a day, the same as Nyefax Retard 20mg.

Read the nifedipine monograph - NZ Formulary(external link)

Discontinuation of Adalat brand 10, 30, 60 mg tablets

As communicated in January 2021, the supplier of the Adalat brand of nifedipine tab long acting 10mg, 30 mg and 60 mg has discontinued the Adalat brand. The stock was exhausted in January 2021. It was delisted on 1 August 2021.

Alternative brands of nifedipine, Tensipine MR 10 and Mylan nifedipine have been sourced and supplied since January 2021.

Alternative brands of nifedipine

PHARMAC has sourced alternative supply of nifedipine 10 mg, 30 mg, and 60 mg.

30 mg and 60 mg presentations

  • Brand: Mylan nifedipine
  • Pharmacodes: 30 mg 2602911 | 60 mg 2602938

Dosing regimen

 The dosing regimen of Mylan brand nifedipine 30mg and 60mg long-acting remains once per day, the same as Adalat Oros 30mg and 60mg.

10 mg presentation

  • Brand: Tensipine nifedipine
  • Pharmacode: 2603217

The Mylan and Tensipine brands are unapproved medicines in New Zealand so they must be prescribed and supplied in line with section 29 of the Medicines Act 1981.

Information for people taking nifedipine

You will still be able to access nifedipine. We have made alternative brands available. They are Mylan nifedipine and Tensipine nifedipine. 

You should talk to your health care professional about what the change in brands means for you.

Check with your pharmacist about whether you should be taking nifedipine once or twice a day.

Please note, these alternatives are not approved by Medsafe. 

Learn more about taking an unapproved medicine – Health Navigator website(external link)

Key dates for prescribers and pharmacists

  • 1 January 2021: two alternative brands of nifedipine listed on the Pharmaceutical Schedule
    • Mylan nifedipine 30 mg and 60 mg long-acting tablets
    • Tensipine nifedipine 10 mg long-acting tablets
  • 1 May 2021: Mylan nifedipine 20 mg long-acting tablets listed in the Schedule
    • Stock expected late April 2021
  • 1 August 2021: Delisted for the following brands and presentations
    • Adalat 10 – long-acting tab 10 mg
    • Adefin – long-acting tab 10 mg
    • Adalat Oros – long-acting tab 30 mg
    • Adalat Oros – long-acting tab 60 mg
    • Adefin XL – long-acting tab 60 mg
  • End 2021: Nyefax Retard brand nifedipine 20 mg tablets expected to be available again.

Information for prescribers and pharmacists

We have listed alternative brands for all presentations of nifedipine. None of these brands are Medsafe-approved. 

Nifedipine is available as:

  • twice daily long-acting tablets (10 mg and 20 mg)
  • once daily long-acting tablets (30 mg and 60 mg).

Dosing regimen

The change in brand has not changed the dosing regimen. 

  • the Mylan brand 20 mg is a twice daily dose, the same as the Nyefax Retard brand
  • he Mylan brand 30 mg and 60 mg are a once a day dose, the same as the Adalat brand.

Read more about prescribing nifedipine on New Zealand Formulary(external link)

The Mylan and Tensipine brands are not registered in New Zealand. They must be prescribed and supplied in line with section 29 of the Medicines Act 1981. 

We know a section 29 medicine is not ideal because only medical practitioners can prescribe it. Section 29 supply was the only option. Using these unapproved brands ensures patients can continue to access funded nifedipine.

Read the Medsafe website for more information about your obligations under section 29.

Information for prescribers and pharmacists about section 29 on Medsafe’s website(external link)

Information for consumers about section 29 on Health Navigator website(external link)

Who to contact

If you take nifedipine, talk to your prescriber or pharmacist. PHARMAC can't advise on anyone's personal clinical circumstances.

If you have questions about the listing or funding, email enquiry@pharmac.govt.nz