Targretin Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Targretin is and what it is used for
2. What you need to know before you take Targretin
3. How to take Targretin
4. Possible side effects
5. How to store Targretin
6. Contents of the pack and other information

Do not take Targretin

• if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast feeding or if you can become pregnant and are not using effective birth control measures.
• if you have a history of pancreatitis, have uncontrolled lipid (blood fats) elevations (high blood cholesterol or high blood triglycerides), have a condition known as hypervitaminosis A, have uncontrolled thyroid disease, have insufficient liver function or have an ongoing systemic infection.

Warnings and precautions

Talk to your doctor before taking Targretin

• if you have a known hypersensitivity to retinoids (related to vitamin A), suffer from liver disease, have high blood lipids or take medicines which may cause high blood lipids, have uncontrolled diabetes mellitus (sugar diabetes), have had gall bladder or biliary tract disease, or consume excessive amounts of alcohol.
• if you have ever had any mental health problems including depression, aggressive tendencies or mood changes. This is because taking Targretin may affect your mood.

Your fasting blood lipid determinations may have to be performed before therapy is initiated and at weekly intervals afterwards, and then monthly while taking this medicine.

Blood tests to evaluate the function of your liver and thyroid gland and to monitor your red blood cell and white blood cell counts will be obtained before therapy is started and will be monitored during therapy.

Periodic eye exams may be needed if you experience visual difficulties while taking this medicine.

Minimise exposure to sunlight as much as possible and avoid exposure to sun lamps.

Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.

Mental health problems

You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour. They may notice these changes and help you identify any problems that you need to talk to your doctor about.

Children and adolescents

Targretin capsules should not be used in children or adolescents.

Other medicines and Targretin

Tell your doctor if you are taking, have recently taken or might take any other medicines, such as

• ketoconazole and itraconazole (used against fungal infections),
• erythromycin, clarithromycin and rifampicin (used against bacterial infections),
• phenytoin and phenobarbital (used against seizures),
• gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
• vitamin A supplements, protease inhibitors (used against viral infections),
• tamoxifen (used against some forms of cancer),
• dexamethasone (used for inflammatory conditions),
• insulin, agents enhancing insulin secretion, or insulin-sensitisers (used against diabetes mellitus).

This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.

Targretin with food and drink

Targretin should be taken with food (see section 3). If you regularly consume grapefruit or grapefruit juice, please consult your doctor as these have the potential to alter your body’s response to Targretin therapy.

Pregnancy and breast-feeding

Targretin may be harmful to a developing foetus. DO NOT use Targretin if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start therapy, confirming you are not pregnant. You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin. It is recommended that two reliable forms of contraception be used together. If you are taking a hormonal contraceptive (for example, birth control pills), you should discuss this with your doctor.

If you are male and your partner is pregnant or capable of becoming pregnant, you must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.

Driving and using machines

It is not known whether Targretin has an effect on your ability to drive a car or operate machinery. If you experience dizziness or problems with your vision during therapy, do not drive or operate machinery.

Targretin contains sorbitol and butylated hydroxyanisole

Targretin contains a small amount of sorbitol (a type of sugar). If you have an intolerance to some sugars, speak to your doctor before taking this medicinal product.

Butylated hydroxyanisole may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.

How long you should take Targretin

Although some patients have improvement within the first several weeks, most patients require several months or more of treatment to improve.

If you take more Targretin than you should

If you have taken more than the prescribed dose of Targretin, you must contact your doctor.

If you forget to take Targretin

If you forget to take one dose, take your daily dose with your next meal on the same day, then take your usual dose as normal, the following day. Do not take a double dose in one day to make up for a forgotten dose the previous day.

If you stop taking Targretin

Your doctor should determine how long you should take Targretin, and when treatment may be stopped. Do not stop taking your medication until your doctor advises you to do so.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

By reporting side effects you can help provide more information on the safety of this medicine

What Targretin contains

Each Targretin capsule contains 75 mg of the active substance bexarotene.

The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole.

The capsule shell consists of gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)

What Targretin looks like and contents of the pack

Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.

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