Bexarotene Cipla

Package leaflet: Information for the patient

Bexarotene Cipla 75 mg soft capsules

Bexarotene
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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 side 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

The active substance of Bexarotene Cipla, bexarotene, belongs to a group of medicines known as retinoids,
which are similar to vitamin A.
Bexarotene Cipla is used to treat patients with advanced cutaneous T-cell lymphoma (CTCL) who have not responded to other therapies. CTCL is a disease in which certain types of cells of the 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, if you are of childbearing age and are not using an effective contraceptive method.
• if you have or have had pancreatitis, have uncontrolled lipid levels (high fats in the blood) (elevated cholesterol or triglycerides in the blood), have a condition known as hypervitaminosis A, have uncontrolled thyroid disease, have impaired liver function, or have an active systemic infection.

Warnings and precautions
Talk to your doctor before taking Bexarotene Cipla

• if you have a known hypersensitivity to retinoids (substances similar to vitamin A), have liver disease, have high blood lipid levels, or are taking medicines that could increase blood lipids, have uncontrolled diabetes mellitus (sugar diabetes), have or have had gallbladder or biliary tract disorders, or consume excessive amounts of alcohol.
• if you have ever had mental health problems, including depression, aggressive tendencies, or mood changes, as taking Bexarotene Cipla may affect your mood.

Before starting treatment, you may need to undergo fasting blood lipid tests, which will need to be repeated weekly and later monthly throughout the duration of treatment.
Before starting treatment and during treatment, blood tests will be performed to assess liver and thyroid function, and to monitor red and white blood cell counts.
If you experience vision problems during treatment, you will have periodic eye examinations.
Minimize sun exposure and avoid tanning lamps.
Do not take vitamin A supplements in daily doses exceeding 15,000 International Units during treatment.

Mental health problems
You may not notice certain changes in your mood and behavior; therefore, it is very important to inform your friends and family that this medicine may affect mood and behavior. These people may notice changes and help you identify any problems that you should discuss with your doctor.

Children and adolescents
Bexarotene Cipla must not be used in 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 (for fungal infections),
• erythromycin, clarithromycin, and rifampicin (for bacterial infections),
• phenytoin and phenobarbital (for seizure control),
• gemfibrozil (to reduce high blood lipid levels such as cholesterol and triglycerides),
• vitamin A supplements, protease inhibitors (for viral infections),
• tamoxifen (for certain types of cancer),
• dexamethasone (for inflammatory conditions),
• insulin, medicines that stimulate insulin secretion, or medicines that increase insulin sensitivity (used for diabetes mellitus).

This is very important because when multiple medicines are taken together, their effects may be weakened or strengthened depending on the case.

Bexarotene Cipla with food and drink
Bexarotene Cipla should be taken with food (see section 3). If you regularly consume grapefruit or grapefruit juice, you should consult your doctor, as these substances may potentially alter your body's response to Bexarotene Cipla treatment.

Pregnancy and breastfeeding
Bexarotene Cipla may cause harm to the developing fetus. DO NOT take Bexarotene Cipla if you are pregnant or breastfeeding. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
If you are of childbearing potential (i.e., able to become pregnant), you must perform a pregnancy test one week before starting treatment to rule out pregnancy. From one month before starting treatment with Bexarotene Cipla until one month after stopping treatment, you must continuously use effective contraception (birth control). The use of two reliable contraceptive methods together is recommended. If you are using a hormonal contraceptive method (e.g., oral contraceptive pill), you should consult your doctor.
If you are a man and your partner is pregnant or of childbearing age, you must always use a condom during sexual intercourse throughout treatment with bexarotene and for at least one month after taking the last dose.

Driving and using machines
It is not known whether Bexarotene Cipla may affect the ability to drive or operate machinery. If you experience vision disturbances or dizziness, do not drive or operate machinery.

Bexarotene Cipla contains Sorbitol and butylated hydroxyanisole
Bexarotene Cipla contains sorbitol (a type of sugar). Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Butylated hydroxyanisole may cause irritation to mucous membranes; therefore, the capsules must be swallowed whole and not chewed.

3. How to take Bexarotene Cipla

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will prescribe the dose suitable for you.
The recommended dose is generally 4 to 10 capsules taken once daily. Take the number of capsules prescribed by your doctor every day at the same time with a meal. The capsules may be taken immediately before, during, or immediately after the meal, depending on your preference. The capsules must be swallowed whole and must not be chewed.

Duration of treatment with Bexarotene Cipla
Although some patients show improvement within the first few weeks, most patients require several months or more of treatment before improvement occurs.

If you take more Bexarotene Cipla than you should
If you have taken more Bexarotene Cipla than prescribed, you must contact your doctor.

If you forget to take Bexarotene Cipla
If you forget to take a dose, take your daily dose at the next meal on the same day, and resume your regular dosing schedule 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 Bexarotene Cipla and when you can stop treatment. Do not stop taking this medicine until your doctor advises you to do so.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any worsening of your health while taking Bexarotene Cipla, consult your doctor as soon as possible. Sometimes it may be necessary to adjust the dose or stop treatment. Your doctor will advise you on what to do.
The following side effects have been reported in patients with CTCL treated with the recommended initial dose.

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

• Low white blood cell count (low number of white blood cells in the blood)
• Decreased thyroid hormone levels
• Increased blood fats (triglycerides and cholesterol)
• Skin reactions (itching, redness, irritation, skin peeling)
• Headache, fatigue, malaise

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

• Low red blood cell count (low number of red blood cells in the blood), enlarged lymph nodes, worsening of lymphoma
• Thyroid disorders
• Increased liver enzymes, impaired kidney function, low blood protein levels, weight gain
• Insomnia, dizziness, reduced skin sensitivity
• Dry eyes, deafness, abnormal eye sensations including irritation and heaviness
• Swelling in arms and legs
• Nausea, diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excessive intestinal gas, abnormal liver function tests, vomiting
• Dry skin, skin disorders, hair loss, skin ulcer, 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 abnormalities, eosinophilia, leukocytosis, lymphocytosis, purpura, increased or decreased platelet count in the blood
• Overactive thyroid gland
• Elevated blood bilirubin levels, impaired kidney function, gout, decreased HDL cholesterol levels
• Restlessness, difficulty maintaining balance, depression, increased skin sensitivity to touch, abnormal nerve sensitivity, vertigo
• Vision disturbances, blurred vision, eyelid inflammation, cataract, corneal conjunctivitis, corneal lesion, hearing disturbance, visual field defect
• Swelling, haemorrhage, hypertension, tachycardia, visible vein dilation, blood vessel dilation
• Gastrointestinal disorders, liver failure, pancreatitis
• Hair or body hair changes, herpes simplex, nail changes, pustular rash, serum leakage, skin colour change
• Muscle weakness
• Protein in urine, altered kidney function
• Back pain, skin infection, fever, parasitic infection, abnormal laboratory tests, mucosal disorder, tumour

Rare events leading to death include acute inflammation of the pancreas, cerebral haemorrhages, and liver failure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Bexarotene Cipla

Keep this medicine out of the 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 that month.
Store below 25°C. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bexarotene Cipla contains

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

Description of the appearance of Bexarotene Cipla and package contents
Bexarotene Cipla consists of a white to off-white dispersion encapsulated in soft gelatin capsules, oblong in shape, opaque, white to off-white in colour.
Bexarotene Cipla is available as soft capsules for oral use, supplied in a high-density polyethylene bottle with child-resistant closure, containing 100 capsules.

Marketing Authorisation Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp
Belgium

This medicinal product 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 cápsulas blandas
France Bexarotène Cipla 75 mg, capsule molles
Italy Bexarotene Cipla