Bexarotene 75 mg soft capsules

• 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.

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

• 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.

Talk to your doctor or pharmacist before taking bexarotene capsule

• 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 bexarotene 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.

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.

Bexarotene capsules should not be used in children or adolescents.

Tell your doctor or pharmacist 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.

Bexarotene capsule 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 bexarotene capsule therapy.

Bexarotene may be harmful to a developing foetus. DO NOT use bexarotene capsule 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 bexarotene. 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.

It is not known whether bexarotene 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

Bexarotene capsule contains sorbitol (a type of sugar). Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.

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

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

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

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.

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects. you can help provide more information on the safety of this medicine.

• The active substance is bexarotene. Each capsule contains 75 mg bexarotene.
• The other ingredients are:
  • Capsule contains: Polyethylene glycol 400, polysorbate 20, povidone and butylated hydroxyanisole.
  • Capsule shell: Gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171).

Bexarotene capsules are white to off-white colored dispersion encapsulated in white to off white colored opaque, oblong shape soft gelatin capsule.

Bexarotene capsule is available as soft gel capsules for oral use in a high-density polyethylene bottle with child-resistant closures containing 100 capsules.

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