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Orfadin Capsules


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ORFADIN® Capsules

nitisinone


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ORFADIN hard capsules.

It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ORFADIN against the benefits they expect it will have for you.

If you have any concerns about taking ORFADIN, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ORFADIN is used for

ORFADIN contains a medicine called nitisinone which is used for the treatment of a disease called hereditary tyrosinaemia type 1. In this disease the body is unable to completely break down the amino acid tyrosine. Harmful substances will be formed and accumulated in the body.

ORFADIN blocks the breakdown of tyrosine and by doing so the harmful substances are not formed.

However, tyrosine will remain in the body and therefore a special diet (with low tyrosine and phenylalanine content) must be followed when taking ORFADIN.

Nitisinone belongs to a group of medicines called 'other alimentary and metabolism products'.

Ask your doctor if you have any questions about why ORFADIN has been prescribed for you. Your doctor may have prescribed it for another reason.

ORFADIN is not addictive.

ORFADIN is only available on a doctor's prescription.

Before you take ORFADIN

When you must not take it

You should discuss with your doctor if you:

  • have a history of hypersensitivity (an allergy) to the active substance or any of the other ingredients listed at the end of this leaflet.
    Signs of allergic reactions may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
  • are breast-feeding.

Do not take ORFADIN if the packaging is torn or seems to have been opened.

Do not take ORFADIN after the expiry date printed on the bottle. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take ORFADIN

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant or are breast feeding.

Taking other medicines

Tell your doctor or pharmacist about all other medications that you are taking, even ones that you can buy without a prescription from your pharmacy, supermarket or health food shop. Your doctor or pharmacist can tell you which medicines you can safely take with ORFADIN.

How to take ORFADIN

It is important to follow the directions that your doctor has given to you. They may differ from the information contained in this leaflet.

How much to take

Always take ORFADIN exactly as your doctor has told you. You should check with your doctor if you are not sure.

The usual daily dose is 1 mg/kg body weight divided in morning and evening administrations.

When to take it

Take your first dose in the morning.

Take your second dose in the evening.

How to take it

Take your medicine with food.

Swallow the capsules whole with a full glass of water.

If you have problems with swallowing the capsules, they may be opened and the powder suspended into a small amount of water or formula diet just before intake.

How long to take it

Continue taking ORFADIN for as long as your doctor tells you.

If you forget to take it

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken more than you should. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using ORFADIN

Things you must do

It is very important that you stay on the special diet, with low tyrosine and phenylalanine content, that your doctor recommend. If you do not understand the instructions on your diet, ask your doctor for help.

Make sure that all of your doctors and pharmacists know about your use of ORFADIN. Remind them if any new medicines are about to be started.

If you become pregnant while taking this medicine, tell your doctor immediately.

Be sure to keep all of your doctor’s appointments so your progress can be checked.

  • your doctor will test your blood to check if the amounts of ORFADIN given are enough and to make sure that there are no possible side effects causing blood disorders.
  • your doctor will also check your liver regularly as the disease can affect the liver.
  • your doctor will also check on your general development.

Things you must not do

Do not use ORFADIN to treat any complaint other than that directed by your doctor. It may not be safe to use ORFADIN for another complaint.

Do not give ORFADIN to someone else even if their symptoms are the same. It may not be safe for another person to use ORFADIN.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert until you know how this medicine affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you feel unwell while you are taking ORFADIN.

Like all medicines, ORFADIN may have some side effects. Most side effects are mild and patients often find that these wear off after a few weeks.

Tell your doctor immediately if you notice any of the following:

  • different eye symptoms as listed below:
    – opacity in the cornea
    – inflammation in the cornea
    – inflammation in the eye
    – inflammation in the eyelid
    – sensitivity to light
    – eye pain
  • rash, itching or other skin disorders
  • headache, abdominal pain, constipation

There may be other side effects that your doctor will carefully monitor by taking blood samples. These are:

  • reduced number of platelets and white blood cells
  • shortage of certain white blood cells (granulocytopenia)
  • increased number of white blood cells

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using ORFADIN

Storage

Keep ORFADIN capsules in their bottle until it is time to take your dose. If you take them out of their container, they may not keep well.

Keep ORFADIN in a refrigerator (2°C to 8°C). Do not freeze.

ORFADIN 5 mg and 10 mg capsules can be stored for a single period of 2 months at a temperature below 25°C, after which it must be discarded.

Do not leave it in the car, especially on hot or cold days. Heat and dampness can destroy some medicines.

Keep ORFADIN where children cannot reach it.

Disposal

Return any unused or expired medicine to your doctor or pharmacist.

Product description

What ORFADIN looks like

ORFADIN capsules are white, opaque, hard gelatin capsules, imprinted with "NTBC" and the strength "2 mg", "5 mg" or "10 mg" in black. The capsules contain a white to off-white powder.

Ingredients

Each ORFADIN capsule contains 2 mg, 5 mg or 10 mg nitisinone.

It also contains the following inactive ingredients:

  • pregelatinised maize starch
  • gelatin
  • titanium dioxide
  • printing ink: Capsugel Ink 10A1 Black (Proprietary Ingredient Number 109522) or Capsugel Ink 10A2 Black (Proprietary Ingredient Number 109521)

ORFADIN capsules are available in plastic bottles with child resistant closures.

Each bottle contains 60 capsules.

Supplier

ORFADIN capsules are supplied in Australia by:

A. Menarini Australia Pty Ltd
Level 8, 67 Albert Avenue
Chatswood NSW 2067
Medical Information: 1800 644 542

Australian Registration Numbers:

ORFADIN 2 mg: AUST R 164163

ORFADIN 5 mg: AUST R 164173

ORFADIN 10 mg: AUST R 164174

ORFADIN® is a registered trademark of Swedish Orphan Biovitrum International AB, used under licence by A. Menarini Australia Pty Ltd.

This leaflet was revised in May 2018.

For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi

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Published by MIMS June 2018