Bexarotene Cipla 75 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Bexarotene Cipla 75 mg soft capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, inform your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Bexarotene Cipla is and what it is 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 taking Bexarotene Cipla

Do not take Bexarotene Cipla:

• If you are allergic to bexarotene or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding, or if you could become pregnant and are not using effective contraceptive measures.
• If you have had previous episodes of pancreatitis, if you have uncontrolled elevation of lipids (fats in the blood) (high blood cholesterol or high blood triglyceride levels), if you have hypervitaminosis A, uncontrolled thyroid disease, reduced liver function, or persistent systemic infection.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you have known hypersensitivity to retinoids (related to vitamin A), suffer from liver disease, have high blood lipid levels, or are taking medicines that may cause high blood lipid levels; if you have uncontrolled diabetes mellitus, have had gallbladder or biliary tract disease, or consume excessive amounts of alcohol.
• If you have ever had any mental health problems, such as depression, aggressive tendencies, or mood changes. This is because this medicine may affect your mood.

Fasting blood lipid levels should be measured before starting treatment and at weekly intervals, then monthly throughout therapy with this medicine.

Blood tests to assess your liver and thyroid gland function, as well as your white and red blood cell counts, will be performed before and during treatment.

Regular eye examinations may be necessary if you experience visual disturbances while taking this medicine.

Minimize exposure to sunlight and avoid ultraviolet lamps.

You must not ingest 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. It is very important to inform your friends and family that this medicine may affect your mood and behavior. They may notice these changes and help you identify any problems that you need to discuss with your doctor.

Children and adolescents

This medicine must not be given to children or adolescents.

Other medicines and Bexarotene Cipla

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 and other conditions),
• Gemfibrozil (to reduce high blood fat levels such as triglycerides and cholesterol),
• Vitamin A supplements, protease inhibitors (for viral infections),
• Tamoxifen (for 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 may strengthen or weaken the effects of the medicines.

Taking Bexarotene Cipla with food and drink

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

Pregnancy and breastfeeding

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

If you could become pregnant, you must have a pregnancy test one week before starting treatment to confirm you are not pregnant. You must continuously use an effective contraceptive method (birth control) starting one month before beginning treatment and continuing for at least one month after stopping this medicine. The use of two reliable forms of contraception together is recommended. You should consult your doctor if you are taking a hormonal contraceptive (e.g., oral contraceptive pill).

If you are a man and your partner is pregnant or could become pregnant, you must 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 unknown whether this medicine affects your ability to drive a car or operate machinery. If you experience dizziness or visual disturbances during therapy, you must not drive or operate machinery.

Bexarotene Cipla contains sorbitol

This medicine contains 122.198 mg of sorbitol per capsule. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Bexarotene Cipla

Follow exactly the instructions for using this medicine as given by your doctor. If in 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 daily. You should take the prescribed number of capsules at the same time each day with a meal. The capsules may be taken immediately before or after the meal, or during the meal, according to your preference. The capsules must be swallowed whole, without chewing.

Duration of therapy with Bexarotene Cipla

Although some patients experience improvement within the first few weeks of treatment, most patients require prolonged therapy lasting several months before improvement is noticed.

If you take more Bexarotene Cipla than you should

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

If you forget to take Bexarotene Cipla

If you forget to take a dose, take the prescribed dose with the next meal on the same day, and take your normal dose the following day. Do not take a double dose on the same day to make up for a missed dose.

If you stop taking Bexarotene Cipla

Your doctor will decide how long you should take this medicine and when you should stop treatment. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

The following adverse effects have been reported in patients with CLL treated with the recommended starting dose of capsules.

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

• Low white blood cell count.
• Decreased levels of thyroid hormones.
• Increased blood fats (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, lymph node swelling, worsening of lymphoma.
• Thyroid disorder.
• Increased liver enzymes, impaired kidney function, decreased serum proteins, weight gain.
• Insomnia, dizziness, reduced skin sensation.
• Dry eyes, deafness, eye discomfort including irritation and heaviness.
• Swelling of arms and legs.
• Nausea, diarrhea, dry mouth, dry lips, loss of appetite, constipation, excessive gas, abnormalities in 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, higher or lower platelet count.
• Overactive thyroid.
• Elevated blood bilirubin, impaired kidney function, gout, reduced HDL cholesterol.
• Restlessness, difficulty maintaining balance, depression, increased skin sensitivity to touch, abnormal nerve sensations, dizziness.
• Abnormal vision, blurred vision, eyelid swelling, cataracts, inflammation of the white of the eye, corneal eye injury, ear disorders, visual field defects.
• Swelling, bleeding, high blood pressure, rapid heartbeat, visible vein swelling, blood vessel dilation.
• Gastrointestinal disorders, liver failure, pancreatitis.
• Hair disorders, simple herpes, nail disorders, pustular rash, serous discharge, skin discoloration.
• Muscle weakness.
• Protein in urine, abnormal kidney function.
• Back pain, skin infection, fever, parasitic infection, abnormal laboratory tests, mucosal disorders, tumours.

Other rare adverse effects include pancreatitis, cerebral haemorrhage, and liver failure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bexarotene Cipla

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label after 'EXP'. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 components are:

• Capsule contents: macrogol 400, polysorbate 20, povidone, and butylhydroxyanisole (E320).
• Capsule shell: gelatin, special sorbitol and glycerin mixture (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 oblong, opaque white to off-white soft gelatin capsules filled with a white to off-white suspension.

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

Marketing Authorization Holder and Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

Local Representative

Cipla Europe NV

C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Bexaroten Cipla 75 mg Weichkapsel

Spain: Bexaroteno Cipla 75 mg cápsulas blandas EFG

France: Bexarotène Cipla 75 mg, capsule molle

Italy: Bexarotene Cipla

Date of the most recent review of this leaflet: October 2021

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