TARGRETIN 75 mg Soft Capsule

Зміст інструкції

1. TARGRETIN 75 mg soft capsules
   1. What is Targretin and what is it used for
   2. What you need to know before you take Targretin
   3. How to take Targretin
   4. Possible side effects
   5. How to store Targretin
   6. Contents of the pack and other information

TARGRETIN 75 mg soft capsules

bexarotene
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Targretin and what is it used for

The active ingredient of Targretin, bexarotene, belongs to a group of drugs called retinoids,
similar to vitamin A. Targretin is indicated for the treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have not responded to at least one prior systemic treatment. Cutaneous T-cell lymphoma 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 you take Targretin

Do not take Targretin:

• if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding, if you are of childbearing potential and not using effective contraception.
• if you suffer from or have suffered from pancreatitis, uncontrolled hyperlipidemia (high cholesterol or triglycerides in the blood), hypervitaminosis A, uncontrolled thyroid disease, liver function insufficiency or an ongoing generalized infection.

Warnings and precautions
Talk to your doctor before taking Targretin

• if you have a known hypersensitivity to retinoids (similar to vitamin A), have a liver disease, have hyperlipidemia (high cholesterol or triglycerides in the blood) or are taking medicines that could cause an increase in blood fats, suffer from uncontrolled diabetes mellitus, suffer from or have suffered from gallbladder or bile duct disorders, or consume excessive amounts of alcohol.
• if you have had mental health problems in the past, including depression, aggressive tendencies or mood changes, because taking Targretin may have effects on mood.

Before starting therapy, it may be necessary to perform tests to determine the fats in the
blood while fasting, to be repeated weekly and then monthly for the entire duration of the
therapy.
Before starting therapy, blood tests will be performed to establish liver and thyroid function and to determine the amount of red blood cells and white blood cells in the blood, and these will then
be monitored during therapy.
If you experience vision problems during therapy, you will be given periodic eye exams.
Expose yourself to the sun as little as possible and avoid exposure to sunlamps.
Do not take vitamin A supplements in daily doses greater than 15,000 International Units
during treatment.
Mental health problems You may not notice some changes in your mood and
behavior, so it is very important that you tell friends and family that this medicine can
have effects on mood and behavior. These people may notice the changes
and help you identify any problems you need to discuss with your doctor.

Children and adolescents
Targretin should not be used by children or adolescents.

Other medicines and Targretin
Tell your doctor 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 seizures),
• gemfibrozil (to reduce high levels of fats in the blood, such as cholesterol and triglycerides),
• vitamin A supplements, protease inhibitors (for viral infections),
• tamoxifen (for some forms of cancer),
• dexamethasone (for inflammatory states), insulin, medicines that promote insulin secretion or increase sensitivity to insulin (used for diabetes mellitus).
• This is very important, because when several medicines are taken at the same time, their effect may be weakened or strengthened depending on the case.

Targretin with food and drink
Targretin must be taken with food (see section 3). If you regularly consume grapefruit or
grapefruit juice, it is advisable to consult your doctor, as these substances are potentially
able to alter the body's response to therapy with Targretin.

Pregnancy and breastfeeding
Targretin can cause harm to the fetus. Do not take Targretin if you are pregnant or if you are breastfeeding.
If you are pregnant or breastfeeding or if you think you may be pregnant or are planning to become pregnant, talk to your doctor before taking this medicine. If you are fertile, i.e. have the ability to
become pregnant, you should take a pregnancy test one week before starting therapy to
rule out pregnancy. Starting one month before the start of therapy with Targretin until
one month after you have finished it, you should always use effective contraception. It is recommended to
use two reliable methods of contraception together. If you are using hormonal contraception
(e.g., the contraceptive pill), it is advisable to consult your doctor.
If you are a man and your partner is pregnant or of childbearing potential, during therapy with bexarotene and
for at least one month after the last dose, you should always use a condom during
sexual intercourse.

Driving and using machines
It is not known whether Targretin may affect the ability to drive vehicles or operate machinery.
If you experience vision problems or dizziness, you should not drive vehicles or use machinery.

Targretin contains Sorbitol and butylated hydroxyanisole
Targretin contains a small amount of sorbitol (a type of sugar). If you have an intolerance to
any sugars, tell your doctor before taking this medicine.
Butylated hydroxyanisole may cause irritation of the mucous membranes. Therefore, Targretin capsules must
be swallowed whole and not chewed.

3. How to take Targretin

Take this medicine following exactly the instructions of your doctor.
If you have any doubts, consult your doctor or pharmacist. The dose that your doctor has prescribed is the one suitable for
you. The recommended dose is generally from 4 to 10 capsules to be taken once a day.
Take the number of capsules that your doctor has prescribed every day at the same time together with a meal.
The capsules can be taken either immediately before, during or immediately after the meal, depending on
your preferences. The capsules must be swallowed whole and not chewed.

Duration of treatment with Targretin
Although some patients experience improvement within the first few weeks, most need
several months of treatment or more to improve.

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

If you forget to take Targretin
If you forget to take a dose, take your daily dose at the next meal, and resume the
next day with the usual dose. Do not take a double dose on the same day to make up for the
forgotten dose from the previous day.

If you stop taking Targretin
Your doctor must decide how long you should take Targretin and when you can stop the
treatment. Do not stop taking the medicine until your doctor advises you to do so.
If you have any doubts 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 experience any worsening of your health condition while taking Targretin, consult your doctor as
soon as possible. Sometimes it is necessary to adjust the dose or stop therapy. Your doctor will advise
you what to do.
The following are side effects reported by patients with cutaneous T-cell lymphoma treated with the
recommended starting dose.
Very common (may affect more than 1 in 10 people treated):
Low white blood cell count (low number of white blood cells in the blood)
Lowering of thyroid hormone levels
Increased fats in the blood (triglycerides and cholesterol)
Skin reactions (itching, redness, irritation, scaling of the skin)
Headache, fatigue, malaise
Common (may affect up to 1 in 10 people treated):
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, kidney dysfunction, low blood protein levels, weight gain
Insomnia, dizziness, reduced skin sensitivity
Dry eye, hearing loss, abnormal eye sensitivity, including irritation and heaviness
Swelling of legs and arms
Nausea, diarrhea, dry mouth, dry lips, loss of appetite, constipation, excess gas in the
intestines, abnormal liver function tests, vomiting
Dry skin, skin disorders, hair loss, sores, acne, thickening of the skin, skin nodules, increased
sweating
Joint pain, bone pain, muscle pain
Chills, abdominal pain, allergic reactions, infection
Uncommon (may affect up to 1 in 100 people treated):
Blood abnormalities: eosinophilia, leukocytosis, lymphocytosis, purpura, increase or decrease in
blood platelets
Excessive thyroid activity
Elevated bilirubin levels in the blood, worsening of kidney function, gout, decreased HDL
cholesterol
Agitation, difficulty maintaining balance, depression, increased skin sensitivity to touch, abnormal
nerve sensitivity, vertigo
Visual impairment, blurred vision, eyelid inflammation, cataract, corneal conjunctivitis
inflammation, corneal injury, hearing impairment, visual field defect
Swelling, bleeding, hypertension, tachycardia, visible dilation of veins, dilation of blood
vessels
Gastrointestinal disorders, liver failure, pancreatitis
Alteration of hair and body hair (trichosis), herpes (herpes simplex), alteration of nails
(onychosis), pustular erythema, serum collection, skin color change
Muscle weakness
Protein in urine, kidney dysfunction
Back pain, skin infection, fever, parasitic infection, laboratory parameter abnormalities, mucous
membrane affection, tumor
Rare, life-threatening side effects are acute pancreatitis, cerebral hemorrhages and severe liver
failure.

Reporting of side effects
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 through the national reporting system
indicated in Annex V. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Targretin

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. The expiry date
refers to the last day of that month.
Do not store at a temperature above 30  C. Keep the container tightly closed.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Targretin contains
Each Targretin capsule contains 75 mg of bexarotene, the active substance. The capsules also contain
the following excipients: macrogol, polysorbate, povidone and butylated hydroxyanisole.
The capsule shell consists of gelatin, a special mixture of sorbitol and glycerin
(glycerin, sorbitol, sorbitan anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and
ink for the lettering (SDA 35A alcohol (ethanol and ethyl acetate), propylene glycol (E1520),
black iron oxide (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400,
28% ammonium hydroxide).

Description of the appearance of Targretin and contents of the pack
Targretin is available in soft capsules for oral use in a white plastic bottle containing 100 capsules.

Marketing authorisation holder
H.A.C. Pharma
Péricentre 2
43 Avenue de la Côte de Nacre
14000 Caen
France

Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.