SUMMARY CMI

NEOTIGASON^® capsules

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

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?

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.

FULL CMI

NEOTIGASON^® capsules

Active ingredient(s): acitretin

Consumer Medicine Information (CMI)

This leaflet provides important information about using NEOTIGASON. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NEOTIGASON.

Where to find information in this leaflet:

1. Why am I using NEOTIGASON?
2. What should I know before I use NEOTIGASON?
3. What if I am taking other medicines?
4. How do I use NEOTIGASON?
5. What should I know while using NEOTIGASON?
6. Are there any side effects?
7. Product details

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. Vitamin A, which we obtain from food, is important for the normal growth and development of the body, especially the skin.

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.

In severe psoriasis and some other skin disorders, where there is a problem with the normal development of the skin, NEOTIGASON helps return the skin to normal.

There are many different types of medicines used to treat skin conditions.

Your doctor may have prescribed NEOTIGASON for another purpose.

Ask your doctor if you have any questions why NEOTIGASON has been prescribed for you.

2. What should I know before I use NEOTIGASON?

Warnings

Do not use NEOTIGASON if:

• you are allergic to acitretin, vitamin A, other retinoids or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• You are pregnant, or intend to become pregnancy during treatment or in the 3 years after stopping treatment.
• You are a woman of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
• You are taking tetracycline antibiotics (such as doxycycline HCl or Minocycline HCl)
• You are taking vitamin A, or preparation containing vitamin A.
• You have severe liver or kidney disease or abnormally high fat levels in your blood.
• You are also taking methotrexate

Check with your doctor if you:

• have any other medical conditions including:
  - diabetes, or a history of diabetes in your family
  - liver disease
  - high triglycerides or cholesterols levels in the blood, or a history of high blood triglycerides or cholesterol levels in your family
• take any medicines for any other condition
• are allergic to any other medicines, foods, dyes or preservatives

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

NEOTIGASON should not be taken if you are pregnant, or intend to become pregnant during treatment or in the 3 years after stopping treatment.

The possibility that you may be pregnant must be ruled out by you and your doctor before you start taking NEOTIGASON.

A pregnancy test must be negative when performed within one week before beginning of treatment.

NEOTIGASON is highly teratogenic and there is an extremely high risk that a severely deformed baby will result if taken before or during pregnancy, no matter for how long or at what dose.

You must use effective contraception (preferably two complementary forms), without interruption for one month before, during and 3 years after treatment.

A combination hormonal contraceptive product or an intrauterine device should be used. It is recommended that a diaphragm or condom is also used. Low dose minipills (progesterone only) are not recommended.

Breastfeeding must be stopped before treatment begins. Do not breastfeed while taking NEOTIGASON.

Children

NEOTIGASON should only be used in children where alternative therapy cannot be used.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NEOTIGASON and affect how it works. These medicines include:

• tetracycline antibiotics
• phenytoin
• methotrexate
• alcohol containing medicines
• low-dose progestogen oral contraceptive (also called the "mini-pill")
• vitamin A supplements, or preparations containing vitamin A.

Your doctor or pharmacist has a complete list of medicines to avoid while taking NEOTIGASON.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NEOTIGASON.

4. How do I use NEOTIGASON?

How much to take

• Your doctor will tell you how many NEOTIGASON Capsules to take each day.
• This quantity will be especially matched to your needs and whether you develop any side effects.
• Follow the instructions provided and use NEOTIGASON until your doctor tells you to stop.
• The initial dose is usually 25 mg (1 x 25 mg capsule) or 30 mg (3 x 10 mg capsules) per day for 2 to 4 weeks. Your dose will probably then be adjusted.

You may notice the first signs of improvement during the first week but, more often, after 2 or 3 weeks. It may take 2 to 3 months before the full effect is seen.

The affected skin will either peel off or gradually clear. Sometimes there will be more redness or itching at first, but this will normally improve as treatment continues.

When to take NEOTIGASON

• NEOTIGASON is usually taken once daily swallowed whole with meals or with a glass of milk.
• If you are female, you should wait until the 2nd or 3rd day of your next normal menstrual period before you start NEOTIGASON therapy.

If you forget to take NEOTIGASON

NEOTIGASON should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you use too much NEOTIGASON

If you think that you have used too much NEOTIGASON, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (In Australia by calling 13 11 26 and in New Zealand 0800 POISON [0800 764 766]), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

There is no information currently available on the effects of overdose with NEOTIGASON. However, based on experience with excessive vitamin A and other drugs similar to NEOTIGASON, signs of overdosage may include transient headache, vomiting, flushed face, dry itchy skin and lips, pain in the stomach, drowsiness, dizziness and unco-ordination. You should recover without any after effects. You may need some tests to see if your liver has been affected.

5. What should I know while using NEOTIGASON?

Things you should do

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Your doctor may want to do some blood, liver function and other tests from time to time to check on your progress and detect any unwanted side effects.

Your cholesterol and serum triglyceride levels should be monitored when NEOTIGASON is used for a long time.

Tell your doctor if you are taking vitamin supplements that contain greater than 2500 IU of Vitamin A. If you are not sure, check with your doctor or pharmacist.

Avoid alcohol in drinks, food or medicines during treatment.

Alcohol should also be avoided for 2 months after stopping treatment with NEOTIGASON.

FOR FEMALE PATIENTS:

You must use two forms of birth control without interruption for at least 1 month before you start NEOTIGASON and for the whole time you are taking NEOTIGASON and for at least 3 years after you finish taking NEOTIGASON.

Therapy should be started on the second or third day of your next normal menstrual period.

Your doctor may ask you to have a pregnancy test every month during use and every 1-3 months after stopping until 3 years have passed.

Call your doctor straight away if you:

• become pregnant while you are taking NEOTIGASON. Stop taking NEOTIGASON immediately
• become pregnant in the three years following the end of treatment.

Remind any doctor, dentist or pharmacist you visit that you are using NEOTIGASON.

Things you should not do

• Do not stop taking NEOTIGASON or lower the dose without first checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.
• Do not donate blood during treatment or for at least 3 years after stopping treatment.
• Do not use oral contraceptive "Minipills" (progestogen only pills) as contraception during treatment.
• Do not give NEOTIGASON to anyone else even if their symptoms seem similar to yours.
• Do not use NEOTIGASON to treat other complaints unless your doctor says to.
• Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Eyes and Skin

• Wearing contact lenses during treatment and for a little while after treatment with NEOTIGASON may cause discomfort. An eye lubricant, or artificial tears, available from your pharmacist, will assist with this problem. Otherwise, you may temporarily need to wear glasses instead.
• Your skin may be more sensitive to sunburn while on NEOTIGASON.
• Avoid excessive sun exposure and apply a sunscreen while taking NEOTIGASON.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NEOTIGASON affects you.

Normally your ability to drive cars or operate machinery is not affected by NEOTIGASON, however decreased night vision has been reported. Patients may need to be cautious before they drive a car or operate machinery at night.

Drinking alcohol

Tell your doctor if you drink 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

• Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the blister pack they may not keep well.
• Store below 25°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration OR Medsafe online at www.tga.gov.au/reporting-problems OR nzphvc.otago.ac.nz/reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NEOTIGASON contains

Do not take this medicine if you are allergic to any of these ingredients.

What NEOTIGASON looks like

NEOTIGASON 10 mg hard gelatin capsules have a white opaque body and a brown opaque cap with a "10" printed on the body (AUST R 52455).

NEOTIGASON 25 mg hard gelatin capsules have a yellow opaque body and a brown opaque cap with a "25" printed on the body (AUST R 52456).

NEOTIGASON Capsules are gluten free.

NEOTIGASON Capsules are lactose free.

NEOTIGASON Capsules come in cartons of 10, 30, 100*.

*Not all pack sizes may be marketed

Who distributes NEOTIGASON

Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Ph: 1800 288 382

Teva Pharma (New Zealand) Ltd
Auckland, New Zealand

This leaflet was prepared in January 2025.

Published by MIMS March 2025

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

4.1 Therapeutic Indications

Acitretin may be used for the treatment of:
Severe intractable psoriasis in all its forms.
Severe forms of disorders of keratinisation, such as hyperkeratosis palmaris et plantaris, pustulosis palmaris et plantaris, ichthyosis, keratosis follicularis (Darier's disease), lichen planus affecting the skin or the mucosae, pityriasis rubra pilaris.

4.2 Dose and Method of Administration

Neotigason should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy.

Dosage considerations.

Adults.

Children.

Combined treatment.

4.3 Contraindications

Neotigason (acitretin) is strictly contraindicated in:
pregnant women;
women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
Neotigason is highly teratogenic, inducing a high frequency of severe and life threatening birth defects. Neotigason must not be used by patients who are pregnant or who intend to become pregnant during therapy or for 3 years after cessation of therapy.
Neotigason is also contraindicated in people who are hypersensitive to acitretin or other ingredients in Neotigason capsules, or to other retinoids.
Women of childbearing potential must not receive blood from patients being treated with Neotigason. Donation of blood by a patient being treated with Neotigason is prohibited during and for three years after completion of treatment with Neotigason.
Neotigason is contraindicated while breastfeeding.
Neotigason is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values.
Since both Neotigason and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated.
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with Neotigason is also contraindicated.
Concomitant administration of Neotigason and vitamin A or other retinoids is contraindicated due to the risk of hypervitaminosis A.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Pregnancy prevention programme.

Prior to starting therapy.

Follow-up visits.

End of treatment.

Psychiatric disorders.

Pseudotumour cerebri.

Hyperostosis.

Use in diabetes.

General.

High risk patients.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Lipids.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Preliminary studies indicated that acitretin does not interfere with the actions of oestrogen/ progesterone oral contraceptives. In a study of ten healthy male volunteers, acitretin did not interfere with the hypoprothrombinaemic effect of the coumarin type anticoagulant phenprocoumon. Progestogen only oral contraceptives ('Minipills') should be avoided as a contraceptive measure because their efficacy may be reduced by retinoid treatment.
Concomitant administration of vitamin A and other retinoids must be avoided because of the risk of hypervitaminosis A. (See Section 4.3 Contraindications.)
Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
Methotrexate, tetracyclines (see Section 4.3 Contraindications).
In a study of twelve healthy male subjects, the concomitant administration of digoxin and acitretin did not alter the pharmacokinetics of either drug. In a study of ten healthy men, the concomitant administration of cimetidine and acitretin did not alter the pharmacokinetics of either drug.
Further interactions between acitretin and other substances (e.g. digoxin, cimetidine, combined estrogen/ progestogen oral contraceptives) have not been observed so far.
In concurrent treatment with phenytoin, it must be remembered that Neotigason partially reduces the protein binding of phenytoin.
Concomitant administration of alcohol may cause increased levels of etretinate, which is much slower than acitretin to be eliminated from the body. Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol. In a 2-way crossover study, all 10 subjects formed etretinate with concurrent ingestion of a single 100 mg oral dose of acitretin during a 3 hour period of ethanol ingestion (total ethanol ~ 1.4 g/kg bodyweight). A mean peak etretinate concentration of 59 nanogram/mL (range: 22-105 nanogram/mL) was observed and extrapolation of AUC values indicated that the formation of etretinate in this study was comparable to a single 5 mg oral dose of etretinate. Ethanol must not be ingested during treatment with Neotigason by women of childbearing age, as clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol. This result was also observed in vitro. The mechanism of this metabolic process has not been defined, so it is not clear whether other interacting agents are also possible. Ethanol should be avoided for two months after cessation of acitretin therapy.

Note.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Decreased night vision has been reported with Neotigason therapy. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects are seen in most patients receiving Neotigason. However, they usually disappear when the dosage is reduced or the drug withdrawn. An initial worsening of the disease symptoms is sometimes seen.
Most of the adverse effects occurring in association with systemic retinoids including Neotigason resemble those of excessive vitamin A intake.
During treatment with high doses of acitretin, reversible elevation of serum triglycerides and serum cholesterol has occurred especially in high risk patients (disturbances of lipid metabolism, diabetes mellitus, obesity, alcoholism). An associated risk of atherogenesis cannot be ruled out if these conditions persist.

Children.

Diabetics.

Eye disorders.

Summary of the safety profile.

Post market.

Reporting suspected adverse effects.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Special populations.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 10 mg Neotigason capsule contains 10 mg of acitretin.
It also contains Cellulose - microcrystalline, Gelatin, Glucose - spray-dried liquid, Iron oxide black, Iron oxide red, Iron oxide yellow, Opacode monogramming ink S-1-17822 Black (PI), Opacode monogramming ink S-1-17823 Black (PI), Sodium ascorbate and Titanium dioxide.
Each 25 mg Neotigason capsule contains 25 mg of acitretin.
It also contains Cellulose - microcrystalline, Gelatin, Glucose - spray-dried liquid, Iron oxide black, Iron oxide red, Iron oxide yellow, Opacode monogramming ink S-1-17822 Black (PI), Opacode monogramming ink S-1-17823 Black (PI), Sodium ascorbate and Titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
The product is sensitive to moisture, therefore, store in the original package.

6.5 Nature and Contents of Container

Capsules 10 mg.

Capsules 25 mg.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes