About the shortage of Zactin Tabs (fluoxetine 20 mg dispersible tablets)

The pharmaceutical company Alphapharm has notified the Therapeutic Goods Administration (TGA) about a shortage of Zactin Tabs (fluoxetine 20 mg dispersible tablets) due to manufacturing issues. The shortage of Zactin Tabs is now resolved. 

The information that follows on this page is no longer current. 

To address the ongoing shortage, we have extended the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Instrument 2023 (SSSI) which was due to expire on 31 May 2024. The extended Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Amendment Instrument 2024 will remain in force until 30 September 2024, ensuring timely access for patients using Zactin Tabs (fluoxetine 20 mg dispersible tablets).

This Serious Scarcity Substitution Instrument (SSSI) allows pharmacists to dispense the 20 mg and 10 mg capsule alternatives as needed without first being approved by the prescriber as outlined in the substitution protocol. The pharmacist will then notify the prescriber of the substitution soon after and will include the correct instructions to the patient for the provided fluoxetine product. 

It may be further extended if the shortage continues, or we may revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. This SSSI is in effect in all states and territories. For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).

To help manage the shortage, the TGA has also temporarily approved the supply of overseas fluoxetine 10 mg capsule products under section 19A of the Therapeutic Goods Act 1989. These lower-strength capsule products can be used for patients taking a dose of less than 20 mg or a dose that cannot be made up using multiples of 20 mg. Pharmacists can search for Zactin Tabs on the Section 19A approvals database for details about the companies supplying these products. From 1 February 2024, Medreich fluoxetine 10mg capsules (Link Medical Products) will be subsidised on the Pharmaceutical Benefits Scheme (PBS). Further information about prescribing criteria is on the PBS website.

We have formed a Medicine Shortage Action Group (MSAG) made up of clinical experts in psychiatry, general practice and pharmacy to consider the effects of the shortage of Zactin Tabs on patients, prescribers and pharmacists. The MSAG group gave the following advice:

• Patients should be switched to fluoxetine 20 mg capsules, where possible.
• Where required, fluoxetine capsules may be opened and the contents dispersed.  Advice about safely opening and dispersing the contents of fluoxetine capsule products can be found in the Society of Hospital Pharmacists (SHPA) Don’t Rush to Crush guidelines.
• Patients with swallowing difficulties, dexterity issues, health conditions requiring enteral feeding or other conditions where the capsule dose form is not appropriate will require individualised advice regarding treatment options.
• In the event that a patient cannot receive their prescribed dose, referral to a prescriber would be required.

The Medicine Shortage Reports Database contains the most up-to-date information about this shortage and the steps we have taken to manage its impact. Information about the cause of the shortage is available on the fluoxetine advisory page. 

Information for patients and carers

If you or the person you care for takes Zactin Tabs, you can continue using the tablets that you have until you run out. After this, you will need to switch to a capsule form of the medicine.

If you are receiving capsules in place of tablets, the pharmacist will:

• supply you with the correct number of capsules to make up your prescribed dose of Zactin Tabs.
• explain how many capsules you need to take to make up your daily dose.
• refer you to your prescriber if they determine none of the fluoxetine capsule products available are appropriate for your specific needs.

Where possible, the capsule products are to be swallowed whole. If you or the person you care for cannot swallow capsules, or if you use tablets for another reason, you feel makes capsules unsuitable, please see your pharmacist or doctor for advice before your supply of Zactin Tabs runs out.

If your healthcare professional recommends the 10 mg capsules to you, you will need your doctor to write you a new prescription, dated on or after 1 February 2024, to receive the 10mg capsules as a PBS benefit. Please also keep in mind that excipients (other inactive ingredients that include fillers, sweeteners, flavours and colours) vary between brands and formulations of medicines, so you should tell your pharmacist if you are allergic or intolerant to certain ingredients.

Information for prescribers

Keep in mind that there is a shortage of Zactin Tabs when prescribing to patients, particularly when starting new patients on the medicine. 

You should switch patients to fluoxetine 20 mg capsules where possible. The TGA has advised suppliers of fluoxetine capsules to expect an increase in demand. A patient prescribed a dose of fluoxetine that is less than 20 mg or a dose that cannot be made up using multiples of 20 mg, may be supplied a 10 mg capsule product available through section 19A. To receive fluoxetine 10mg capsules as a PBS benefit, patients must be issued a new prescription dated on or after the PBS listing date of 1 February 2024. Due to the limited supply of overseas fluoxetine 10 mg capsule products, please consider the need for separate prescriptions for fluoxetine 10mg and fluoxetine 20mg for patients taking doses over 20 mg.

With an SSSI in place, the pharmacist may:

• give your patient a fluoxetine capsule product in place of tablets, depending on their daily dose, or refer the patient to you to review their needs. 
• give your patient, or their carer, instructions on how to administer the contents of fluoxetine capsules if they have difficulty swallowing, dexterity issues or health conditions requiring enteral feeding. There are instructions for safely opening and dispersing the contents of fluoxetine capsules in the SHPA’s Don’t Rush to Crush– external site guidelines.
• ask your patient to contact you if they are unable to take any available dosage form of fluoxetine.

Children and patients who take doses of fluoxetine less than 10mg should be assessed for suitable alternative dosage forms.

Information for pharmacists

We are advising prescribers to keep in mind that there is a shortage of Zactin Tabs and to switch patients to fluoxetine 20 mg capsules where possible. We have also advised suppliers of fluoxetine capsules to expect an increase in demand.

We are advising patients and their carers to continue taking the Zactin Tabs they have until they run out, and to talk to their pharmacist about the switch to fluoxetine capsules. 

The SSSI is in effect, allowing you to substitute fluoxetine capsule products without prior approval from the prescriber if the permitted circumstances of the SSSI are met. See both the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI.

If you have a patient who requires a 20 mg dose of fluoxetine, or a dose which can be made up using multiples of 20 mg, you can supply them with a 20 mg capsule product. If you have a patient who requires a dose of fluoxetine that is less than 20 mg or a dose that cannot be made up using multiples of 20 mg, you can supply them with a 10 mg capsule product available through section 19A.

To receive fluoxetine 10mg capsules as a PBS benefit, patients must be issued a new prescription by their doctor, dated on or after the PBS listing date of 1 February 2024.

Additionally, if you supply a 10 mg capsule product using a PBS prescription for fluoxetine     20 mg (new or repeat prescriptions) issued prior to 1 February 2024, this will become a private prescription, as will any subsequent supplies. The patient will need a new PBS prescription from their prescriber if they require a supply of 20 mg capsules to be subsidised under the PBS. 

If you are dispensing an authority approved prescription for fluoxetine 20 mg capsules, the PBS Online warnings (reason code 162 or 163) can be disregarded when using this SSSI.  If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used and the PBS Online warning (reason code 151) can be disregarded. More information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI is available on the PBS website.

When using the SSSI, you should do the following:

• Use your clinical judgement to determine if a substitution is appropriate for the patient.
• Calculate the equivalent quantity of fluoxetine capsules to the number of tablets originally prescribed.
• Do not supply fluoxetine products of differing strengths as part of the same prescription. If your patient requires a 10 mg dosage of fluoxetine as part of their daily dose, only dispense a 10 mg fluoxetine product. 
• Ensure the patient, or their carer, understands how many capsules they are required to take as part of their required daily dose.
• If a patient is being switched to the 10 mg capsules available through section 19A, check that the patient is not allergic or intolerant to any of the excipients in the overseas brand.
• Patients should be advised to swallow capsules whole (where possible) and ensure that their required daily dose is taken in full according to the prescribed dosage.
• Notify the prescriber of the substitution afterwards.

Patients or carers of patients who use Zactin Tabs for their fluoxetine dose because of difficulty swallowing, dexterity issues or health conditions requiring enteral feeding, may ask you for advice about opening fluoxetine capsules and dispersing the contents. You can find information about opening the capsules and dispersing the contents in SHPA’s Don’t Rush to Crush guidelines. You can explain these recommendations to patients and carers where appropriate or refer them to their prescriber if needed.

Children and patients who take doses of fluoxetine less than 10 mg should be referred to their prescriber and assessed for suitable alternative dosage forms.

General information

Please note that while the current shortage is expected to end by 30 June 2024, this date may change and you should check the medicine shortage reports database for updates.

Please also note the TGA can suggest approaches to manage the supply of medicines during shortages but does not regulate the clinical decisions of health professionals. 

The TGA will continue to monitor the supply of Zactin Tabs dispersible tablets and work with the supplier to update this advice as needed.