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 75 mg Soft Capsules are and what they are used for
2. What you need to know before you take Bexarotene 75 mg Soft Capsules
3. How to take Bexarotene 75 mg Soft Capsules
4. Possible side effects
5. How to store Bexarotene 75 mg Soft Capsules
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
• if you have uncontrolled lipid (blood fats) elevations (high blood cholesterol or high blood triglycerides)
• if you have a condition known as hypervitaminosis A
• if you have uncontrolled thyroid disease
• if you have insufficient liver function
• if you have an ongoing systemic infection

Talk to your doctor or pharmacist before taking this medicine:

• if you have a known allergy to retinoids (related to vitamin A)
• if you suffer from liver disease
• if you have high blood lipids (fats) or take medicines which may cause high blood lipids (fats)
• if you have uncontrolled diabetes mellitus (sugar diabetes)
• if you have had gall bladder or biliary tract disease
• if you 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 fat (lipid) levels may need to be checked before you start treatment with bexarotene and at weekly intervals afterwards, and then monthly while taking this medicine.
• Blood tests to check the function of your liver and thyroid gland and to check your red and white blood cell counts will be carried out before and during treatment with this medicine.
• Regular eye examinations may be needed if you experience visual difficulties while taking this medicine.
• Bexarotene can make you more sensitive to sunlight. 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 while taking this medicine.
• Do not donate blood while taking this medicine.

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 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 for fungal infections)
• erythromycin, clarithromycin and rifampicin (used for bacterial infections)
• phenytoin and phenobarbital (used for seizures)
• gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol)
• protease inhibitors (used for viral infections)
• tamoxifen (used for some forms of cancer)
• dexamethasone (used for inflammatory conditions)
• insulin, agents enhancing insulin secretion, or insulin-sensitisers (used for diabetes mellitus)
• vitamin A supplements (do not take more than 15,000 International Units of vitamin A supplements per day during treatment with bexarotene)

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

This medicine 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 therapy.

Bexarotene may be harmful to a developing foetus. DO NOT use bexarotene 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 treatment, do not drive or operate machinery.

• This medicine contains 93 mg sorbitol in each capsule. 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 this medicine.
• Butylated hydroxyanisole may cause irritation to the mucous membranes, therefore the capsules must be swallowed whole 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, 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 decide how long you should take bexarotene, and when treatment may be stopped. Do not stop taking your medication until your doctor advises you to do so.

Very common (can occur in more than 1 in 10 patients treated):

• low white blood cell count
• lowering of thyroid hormones level
• increased blood fats (triglycerides and cholesterol)
• skin reactions (itching, redness, irritation, peeling)
• headache, fatigue, pain

Common (can occur in up to 1 in 10 patients treated):

• low red blood cell count, enlarged lymph nodes, worsening of lymphoma
• thyroid disorder
• increased liver enzymes, abnormal liver function tests, impaired kidney function, low protein in blood, weight gain
• difficulty sleeping (insomnia), dizziness, reduced skin sensation
• dry eyes, deafness, abnormal sensations of the eye including irritation and heaviness
• swelling of legs and arms
• feeling sick (nausea), diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excess gas, being sick (vomiting)
• dry skin, skin disorder, loss of hair, skin ulcer, acne, skin thickening, skin nodule, increased sweating
• joint aches, bone pain, muscle aches
• chills, abdominal pain, allergic reaction, infection

Uncommon (can occur in up to 1 in 100 patients treated):

• blood disorders such as raised levels of white blood cells; raised or reduced blood platelets (causing purple spots and patches on the skin and on mucus membranes such as inside the mouth)
• overactive thyroid
• raised bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol
• agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, spinning sensation (vertigo)
• abnormal vision, blurred vision, inflammation of the eye lids, cataract, inflammation of the white part of the eye, lesion of the cornea of the eye, ear disorder, defect in field of vision
• swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels
• gastrointestinal disorder (stomach or digestive problems), liver failure, inflammation of the pancreas
• changes in hair, herpes simplex (cold sores), nail disorder, pustular rash, weeping or oozing wounds, skin discoloration
• muscle weakness
• proteins in urine, abnormal kidney function
• back pain, skin infection, fever, parasitic infection, abnormal laboratory test, disorder of mucous membranes, tumour

Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.

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 Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or 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 macrogol, polysorbate, povidone, butylated hydroxyanisole and purified water.

The capsule shell consists of gelatin, glycerol, sorbitol liquid (partially dehydrated), titanium dioxide and purified water.

Bexarotene 75 mg Soft Capsules are white to off-white, oblong, soft capsules.

They are packed in a white plastic bottle with a child-resistant cap, containing 100 capsules.

If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected]