Consumer medicine information

Neotigason 25 mg Capsules

Acitretin

BRAND INFORMATION

Brand name

Neotigason

Active ingredient

Acitretin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Neotigason 25 mg Capsules.

1. Why am I using NEOTIGASON?


NEOTIGASON contains the active ingredient acitretin. NEOTIGASON belongs to a group of medicines called retinoids, which are very similar to Vitamin A. NEOTIGASON is used to treat severe psoriasis (skin disease with thickened patches of red skin, often with silvery scales) and other severe disorders of the skin.
For more information, see Section 1. Why am I using NEOTIGASON? in the full CMI.

2. What should I know before I use NEOTIGASON?


Do not use if you have ever had an allergic reaction to NEOTIGASON, retinoids or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines. NEOTIGASON should not be used if you are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use NEOTIGASON? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with NEOTIGASON 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 NEOTIGASON?

  • NEOTIGASON is usually taken once daily swallowed whole with meals or with a glass of milk

More instructions can be found in Section 4. How do I use NEOTIGASON? in the full CMI.

5. What should I know while using NEOTIGASON?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using NEOTIGASON.
  • Your doctor may want to do some blood, liver function and other tests from time to time.
  • Your cholesterol and serum triglyceride levels should be monitored when NEOTIGASON is used for a long time.
Things you should not do
  • Do not stop taking NEOTIGASON or lower the dose without first checking with your doctor.
  • Do not donate blood during treatment or for at least 3 years after stopping treatment.
  • Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Driving or using machines
  • Decreased night vision has been reported. Patients may need to be cautious before they drive a car or operate machinery at night.
Drinking alcohol
  • Avoid alcohol in drinks, food or medicines during treatment.
  • Alcohol should also be avoided for 2 months after stopping treatment with NEOTIGASON.
Looking after your medicine
  • Store below 25°C
  • Store in original package to protect from moisture

For more information, see Section 5. What should I know while using NEOTIGASON? in the full CMI.

6. Are there any side effects?


Common side effects can include dryness of the lips, mouth, nose, eyes and skin, thinning or peeling of the skin, thirst, flushing, rash, redness of the skin or itchiness.
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.

BRAND INFORMATION

Brand name

Neotigason

Active ingredient

Acitretin

Schedule

S4

 

1 Name of Medicine

Acitretin.

2 Qualitative and Quantitative Composition

Neotigason (acitretin) is a retinoid for the oral treatment of severe cases of psoriasis and disorders of keratinisation. It is available as 10 and 25 mg capsules.
The chemical name of acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl- 2,4,6,8-nonatetranoic acid. Its empirical formula is C21H26O3 with a molecular weight of 326.44.
Each 10 mg Neotigason capsule contains 10 mg of acitretin.
Each 25 mg Neotigason capsule contains 25 mg of acitretin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Acitretin is a metabolite of etretinate and is related to both retinoic acid and retinol (Vitamin A). Acitretin is a green-yellow crystalline powder. It is virtually insoluble in water (< 0.1 mg/100 mL). The pKa is approximately 5. It is present in the capsules as a spray-dried powder.
The hard gelatin capsules have a white opaque body and a brown opaque cap with the number "10" printed in black ink on the body.
The hard gelatin capsules have a yellow opaque body and a brown opaque cap with the number "25" printed in black ink on the body.

4 Clinical Particulars

4.9 Overdose

In the event of acute overdose, Neotigason must be withdrawn at once. Symptoms of overdose are identical to an acute hypervitaminosis A, i.e. headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. The acute oral toxicity (LD50) of acitretin in both mice and rats was greater than 4,000 mg/kg.
Treatment of overdose should consist of general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Acitretin has been shown to be embryotoxic and/or teratogenic in mice, rats and rabbits at doses approximately 3, 15 and 0.5 times the maximum recommended therapeutic dose, respectively.
Carcinogenicity. Carcinogenicity studies carried out with acitretin showed an increase in the frequency of blood vessel tumours (haemangiomas and haemangiosarcomas) in male mice.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSACITRE.gif CAS number. CAS Registry Number: 55079-83-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NEOTIGST.gif