BEXAROTENE CIPLA 75 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Bexarotene Cipla 75 mg Soft Capsules EFG

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Bexarotene Cipla and what is it used for

Bexarotene, the active substance of this medicine, belongs to a family of medicines known as retinoids, which are related to vitamin A.

This medicine is given to patients with advanced stages of cutaneous T-cell lymphoma (CTCL) whose disease has not responded to other therapies. CTCL is a condition in which certain cells of the body's lymphatic system, called T-lymphocytes, become cancerous and affect the skin.

2. What you need to know before you take Bexarotene Cipla

Do not take Bexarotene Cipla:

• 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 may become pregnant and are not using effective contraception.
• If you have had previous episodes of pancreatitis, if you have uncontrolled high lipid levels (high levels of cholesterol or triglycerides in the blood), if you have hypervitaminosis A, uncontrolled thyroid disease, decreased liver function, or persistent systemic infection.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have a known hypersensitivity to retinoids (related to vitamin A), if you have liver disease, high lipid levels in the blood, or if you are taking medicines that may cause high lipid levels in the blood, if you have uncontrolled diabetes mellitus, if you have had gallbladder or bile duct disease, or if you consume excessive amounts of alcohol.
• if you have ever had any mental health problems, such as depression, aggressive tendencies, or mood changes. The reason is that this medicine may affect your mood.

Fasting lipid level tests should be performed before starting treatment and at weekly intervals, and then at monthly intervals throughout the duration of therapy with this medicine.

Blood tests will be performed before and during treatment to evaluate your liver and thyroid function and to check your white and red blood cell count.

Regular eye exams may be necessary if you experience vision problems while taking this medicine.

Reduce sun exposure as much as possible and avoid ultraviolet lamps.

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

Mental health problems

You may notice some changes in your mood and behavior, so it is very important that you tell your friends and family that this medicine may affect your mood and behavior. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Children and adolescents

This medicine should not be given to children or adolescents.

Other medicines and Bexarotene Cipla

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 epileptic seizures and others),
• gemfibrozil (to reduce high fat levels in the blood, such as triglycerides and cholesterol),
• vitamin A supplements, protease inhibitors (against viral infections),
• tamoxifen (against certain types of cancer),
• dexamethasone (for inflammatory conditions),
• insulin, medicines that increase insulin secretion or insulin sensitivity (used for diabetes mellitus).

This is important because taking more than one medicine at the same time can enhance or weaken the effect of the medicines.

Taking Bexarotene Cipla with food and drinks

This medicine should be taken with food (see section 3). If you regularly consume grapefruit or grapefruit juice, consult your doctor, as they may potentially alter the body's response to this medicine's therapy.

Pregnancy and breast-feeding

This medicine may be harmful to a developing fetus. DO NOT use this medicine if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you can become pregnant, you should have a pregnancy test one week before starting treatment to confirm that you are not pregnant. You should use effective contraception continuously (birth control) that starts one month before starting treatment and continues until one month after stopping this medicine. It is recommended to use two reliable forms of contraception together. You should consult your doctor if you are taking hormonal contraceptives (e.g., birth control pills).

If you are a man and your partner is pregnant or may become pregnant, you should use condoms during sexual intercourse while taking this medicine and for at least one month after the last dose.

Driving and using machines

It is not known whether this medicine affects your ability to drive or use machines. If you experience dizziness or vision problems during therapy, you should not drive vehicles or operate machinery.

Bexarotene Cipla contains sorbitol

This medicine contains 122.198 mg of 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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Bexarotene Cipla

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will prescribe a suitable dose for you.

The recommended dose is generally 4 to 10 capsules taken once a day. You should take the prescribed number of capsules at the same time each day with a meal. The capsules can be taken immediately before, after, or during the meal, as you prefer. The capsules should be swallowed whole, without chewing.

Duration of therapy with Bexarotene Cipla

Although some patients notice improvement after the first few weeks of treatment, most patients need a longer therapy of several months before noticing improvement.

If you take more Bexarotene Cipla than you should

If you have taken more than the prescribed dose of this medicine, you should contact your doctor.

If you forget to take Bexarotene Cipla

If you forget to take a dose, take the daily dose with the next meal on the same day, and take the normal dose the next day. Do not take a double dose in one day to make up for the missed doses the previous day.

If you stop taking Bexarotene Cipla

Your doctor will determine how long you should take this medicine and when you should stop treatment. Do not stop taking the medicine until your doctor tells you to.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any worsening of your condition while taking this medicine, tell your doctor. Sometimes it is necessary to modify the dose or stop treatment. Your doctor will advise you what to do.

The following side effects were reported in patients with CTCL treated with the recommended initial dose of capsules.

Very common (may affect more than 1 in 10 people):

• Low white blood cell count.
• Decreased thyroid hormone levels.
• Increased fat levels in the blood (triglycerides and cholesterol).
• Skin reactions (itching, redness, irritation, skin peeling).
• Headache, fatigue, pain.

Common (may affect up to 1 in 10 people):

• Low red blood cell count, thickening of lymph nodes, worsening of lymphoma.
• Thyroid disorders.
• Increased liver enzymes, affected kidney function, decreased serum proteins, weight gain.
• Insomnia, dizziness, decreased skin sensation.
• Dry eyes, hearing loss, eye discomfort, including irritation and heaviness.
• Swelling of arms and legs.
• Nausea, diarrhea, dry mouth, dry lips, loss of appetite, constipation, gas, abnormal liver function tests, vomiting.
• Dry skin, skin disorders, hair loss, skin ulcers, acne, skin thickening, skin nodules, increased sweating.
• Joint pain, bone pain, muscle pain.
• Chills, abdominal pain, allergic reaction, infection.

Uncommon (may affect up to 1 in 100 people):

• Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, increased or decreased platelet count.
• Overactive thyroid.
• Increased bilirubin in the blood, affected kidney function, gout, decreased HDL cholesterol.
• Agitation, difficulty maintaining balance, depression, increased skin sensation, abnormal nerve sensations, vertigo.
• Abnormal vision, blurred vision, eyelid inflammation, cataracts, inflammation of the white of the eye, corneal injury, ear disorders, visual field defects.
• Swelling, bleeding, high blood pressure, rapid heartbeat, visible swelling of veins, dilation of blood vessels.
• Gastrointestinal disorders, liver failure, pancreatitis.
• Hair disorders, herpes simplex, nail disorders, pustular eruption, serous discharge, skin discoloration.
• Muscle weakness.
• Protein in urine, abnormal kidney function.
• Back pain, skin infection, fever, parasitic infection, abnormal laboratory tests, mucosal disorders, tumors.

Other rare side effects are pancreatitis, cerebral hemorrhage, and liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bexarotene Cipla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiry date is the last day of the month shown.

Store below 25 ?C. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bexarotene Cipla

The active substance is bexarotene. Each capsule contains 75 mg of bexarotene.

The other ingredients are:

• Contents of the capsules: macrogol 400, polysorbate 20, povidone, and butylhydroxyanisole (E320).
• Cap capsule:gelatin, a mixture of sorbitol and special glycerin (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol, and water), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Bexarotene Cipla 75 mg soft capsules EFG are soft gelatin capsules of oblong shape, opaque, white to off-white, and filled with a white to off-white suspension.

Bexarotene Cipla 75 mg soft capsules EFG are presented in soft capsules for oral use in a high-density polyethylene bottle with a child-resistant closure, containing 100 capsules.

Marketing authorisation holder and manufacturer

Cipla Europe NV

De Keyserlei 58-60, Box 19,

2018, Antwerp

Belgium

Local representative

Cipla Europe NV C/Guzmán el Bueno, 133 Edif Britannia-

28003- Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Bexaroten Cipla 75 mg Weichkapsel

Spain: Bexaroteno Cipla 75 mg soft capsules EFG

France: Bexarotène Cipla 75 mg, capsule molle

Italy: Bexarotene Cipla

Date of last revision of this leaflet: October 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).