Tagant

Package Leaflet: Information for the User

Tagant, 40 mg, coated tablets

Tagant, 80 mg, coated tablets

Enzalutamide

Read all of this leaflet carefully before 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 get 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 and other information

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

1. What Tagant is and what it is used for

Tagant contains the active substance enzalutamide. Tagant is used in adult men for the treatment of prostate cancer which is:

• no longer responding to hormone therapy or surgical treatment to lower testosterone levels, or
• has spread to other parts of the body and is responding to hormone therapy or surgical treatment to lower testosterone levels, or
• in men who have had their prostate gland removed and have had radiation therapy and have a rapid increase in prostate-specific antigen (PSA) levels but the cancer has not spread to other parts of the body and is responding to hormone therapy to lower testosterone levels.

How Tagant works

Tagant is a medicine that works by blocking the action of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops the growth and spread of prostate cancer cells.

2. What you need to know before taking Tagant

Do not take Tagant:

• if you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breast-feeding (see "Pregnancy, breast-feeding and fertility").

Warnings and precautions

Seizures
Seizures have been reported in 5 out of 1000 people taking Tagant and in less than 3 out of 1000 people taking placebo (see "Tagant and other medicines" below and in section 4 "Possible side effects").
If you are taking medicines that may cause seizures or increase the risk of seizures (see below "Tagant and other medicines").
If you have a seizure while taking Tagant:
You should contact your doctor as soon as possible. Your doctor may decide that you should stop taking Tagant.
Posterior Reversible Encephalopathy Syndrome (PRES)
PRES has been rarely reported in patients treated with Tagant. If you have seizures, worsening headache, confusion, blindness, or other vision problems, you should contact your doctor immediately (see also section 4 "Possible side effects").
Risk of new tumors (second primary malignancies)
There have been reports of new (second) cancers in patients treated with Tagant, including bladder and colon cancer.
If you experience symptoms of gastrointestinal bleeding, blood in urine, or frequent urgent need to urinate while taking Tagant, you should contact your doctor as soon as possible.
Before taking Tagant, you should discuss with your doctor:

• if you have ever had a severe skin rash or peeling after taking Tagant or other medicines
• if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
• if you are receiving chemotherapy, e.g. docetaxel
• if you have liver disease
• if you have kidney disease

You should tell your doctor if you have any of the following conditions:
any heart or blood vessel disease, including irregular heart rhythms (arrhythmia), or if you are being treated for these conditions. The risk of irregular heart rhythms may increase when taking Tagant.
If you are allergic to enzalutamide, you may experience a rash or swelling of the face, tongue, lips, or throat. If you have been told that you are allergic to enzalutamide or any of the other ingredients of this medicine, you should not take Tagant.
Severe skin rash or peeling, blisters, and (or) mouth sores have been reported in patients taking Tagant. If you experience any of these symptoms of severe skin reactions, as described in section 4, you should contact your doctor immediately and stop taking Tagant.

In case of any of the above situations or doubts, you should consult your doctor before taking this medicine.

Children and adolescents

This medicine is not intended for use in children and adolescents.

Tagant and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should know the names of the medicines you are taking. You should have a list of these medicines with you to show your doctor when a new medicine is prescribed. You should not start or stop taking any medicine before talking to the doctor who prescribed Tagant.
You should tell your doctor if you are taking any of the following medicines. These medicines taken with Tagant may increase the risk of seizures:

• certain medicines used to treat asthma and other respiratory diseases (e.g. aminophylline, theophylline)
• medicines used to treat certain mental disorders, such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
• certain medicines used to treat pain (e.g. pethidine)

You should tell your doctor about taking the following medicines. These medicines may affect the action of Tagant or Tagant may affect the action of these medicines.
This applies to medicines used to:

• lower cholesterol levels (e.g. gemfibrozil, atorvastatin, simvastatin)
• treat pain (e.g. fentanyl, tramadol)
• treat cancer (e.g. cabazitaxel)
• treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid)
• treat certain mental disorders, such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
• treat sleep disorders (e.g. zolpidem)
• treat heart disease or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
• treat severe inflammatory diseases (e.g. dexamethasone, prednisolone)
• treat HIV infection (e.g. indinavir, ritonavir)
• treat bacterial infections (e.g. clarithromycin, doxycycline)
• treat thyroid disorders (e.g. levothyroxine)
• treat gout (e.g. colchicine)
• treat stomach disorders (e.g. omeprazole)
• prevent heart disease or stroke (e.g. dabigatran etexilate)
• prevent rejection of a transplanted organ (e.g. tacrolimus)

Tagant may affect the action of certain medicines used to treat irregular heart rhythms (e.g. quinidine, procainamide, amiodarone, and sotalol) or increase the risk of irregular heart rhythms when taken with certain other medicines [e.g. methadone (used to relieve pain and as part of detoxification treatment for drug addiction), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental illness)].
You should tell your doctor about taking any of the above medicines. The dose of Tagant or any other medicine you are taking may need to be changed.

Pregnancy, breast-feeding and fertility

• Tagant is not intended for use in women.This medicine, when taken by women during pregnancy, may harm the unborn child or cause pregnancy loss. This medicine should not be taken by women who are pregnant, may become pregnant, or are breast-feeding.
• This medicine may affect fertility in men.
• If you are having sex with a woman who can become pregnant, you should use a condom and another effective method of birth control during treatment with Tagant and for 3 months after stopping treatment with this medicine. If you are having sex with a pregnant woman, you should use a condom to protect the unborn child during treatment with Tagant and for 3 months after stopping treatment with this medicine.
• Caregivers - see section 3 "How to take Tagant", which describes how to handle the medicine.

Driving and using machines

Tagant may have a moderate effect on your ability to drive and use machines. Seizures have been reported in patients taking Tagant.
If you are at increased risk of seizures, you should consult your doctor.

Tagant contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per coated tablet, which is essentially "sodium-free".

3. How to take Tagant

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose is 160 mg (four 40 mg coated tablets or two 80 mg coated tablets), taken at the same time once a day.

Taking Tagant

• Swallow the tablets whole with water.
• Do not cut, crush, or chew the tablets before swallowing.
• Tagant can be taken with or without food.
• People other than the patient or their caregivers should not handle Tagant. Women who are pregnant or may become pregnant should not touch damaged or broken Tagant tablets without protective gloves.

Your doctor may also prescribe other medicines while you are taking Tagant.

If you take more Tagant than you should

If you have taken more tablets than prescribed, you should stop taking Tagant and contact your doctor. The risk of seizures or other side effects may increase.

If you forget to take Tagant

If you miss a dose, you should take the usual dose as soon as possible.

• If you miss a dose, you should take the usual dose the next day.
• If you miss a dose for more than one day, you should contact your doctor immediately.
• Do not take a double doseto make up for a forgotten dose.

Stopping treatment with Tagant

You should not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

Seizures

Seizures have been reported in 5 out of 1000 people taking Tagant and in less than 3 out of 1000 people taking placebo.
Seizures are more likely to occur when taking more than the recommended dose of this medicine, taking certain other medicines, and when there is a higher than usual risk of seizures.
If you have a seizure, you should contact your doctor as soon as possible.
Your doctor will decide whether to stop taking Tagant.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES has been rarely reported in patients treated with Tagant (may occur in less than 1 in 1000 people); it is a rare, reversible condition of the brain. If you have seizures, worsening headache, confusion, blindness, or other vision problems, you should contact your doctor immediately (see also section 4 "Possible side effects").

Other side effects include:

Very common(may affect more than 1 in 10 people)
Fatigue, falls, bone fractures, hot flushes, high blood pressure.
Common(may affect up to 1 in 10 people)
Headache, feeling anxious, dry skin, itching, memory problems, coronary artery disease, breast enlargement in men (gynaecomastia), restless legs syndrome (an uncontrollable urge to move a part of the body, usually the legs), decreased concentration, forgetfulness, changes in taste.
Uncommon(may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, low white blood cell count, increased liver enzyme levels in blood tests (indicating liver problems).
Frequency not known(frequency cannot be estimated from the available data)
Muscle pain, muscle spasms, muscle weakness, back pain, changes in ECG (prolonged QT interval), stomach upset, including nausea, skin rash causing red spots or patches on the skin that may look like targets or "bull's eye" with a dark red center surrounded by lighter red rings (erythema multiforme), or other severe skin reactions characterized by red, non-raised, target-like or round patches on the trunk, often with central blisters, skin peeling, mouth sores, throat, nose, genitals, and eyes, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, rash, vomiting, swelling of the face, lips, tongue, and (or) throat, decreased platelet count (which increases the risk of bleeding or bruising), diarrhea.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tagant

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 blister, bottle, and outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tagant contains

• The active substance is enzalutamide.
• Each Tagant 40 mg coated tablet contains 40 mg of enzalutamide.
• Each Tagant 80 mg coated tablet contains 80 mg of enzalutamide.
• The other ingredients are:
• Tablet core: copolymer of methacrylic acid and ethyl acrylate (1:1), colloidal silicon dioxide (E551), microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate.
• Tablet coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), yellow iron oxide (E172), talc (E553b).

What Tagant looks like and contents of the pack

Tagant 40 mg coated tablets are yellow, round, coated tablets (tablets) with a diameter of 10.1 mm ± 5% with "40" embossed on one side.
Each carton contains 112 coated tablets in blisters of aluminum-OPA/Aluminum/PVC or blisters of aluminum-OPA/Aluminum/PVC with perforations containing single doses of 112 x 1 coated tablets, in a cardboard box.
Tagant is also available in high-density polyethylene (HDPE) bottles with a polypropylene (PP) container containing an oxygen absorber and a PP cap with a child-resistant closure, containing 112 coated tablets, in a cardboard box.
Tagant 80 mg coated tablets are yellow, oval, coated tablets (tablets) with dimensions of 17.1 mm x 9.1 mm ± 5% with "80" embossed on one side.
Each carton contains 56 coated tablets in blisters of aluminum-OPA/Aluminum/PVC or blisters of aluminum-OPA/Aluminum/PVC with perforations containing single doses of 56 x 1 coated tablets.
Tagant is also available in high-density polyethylene (HDPE) bottles with a polypropylene (PP) container containing an oxygen absorber and a PP cap with a child-resistant closure, containing 56 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38,
1106 Budapest
Hungary

Manufacturer:

Pharos MT Limited
Hf62x
Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta
For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

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

Netherlands: Tagant 40 mg, filmomhulde tabletten, Tagant 80 mg, filmomhulde tabletten
Czech Republic: Tagant
Hungary: Tagant 40 mg, filmtabletta, Tagant 80 mg, filmtabletta
Poland: Tagant
Romania: Tagant, 40 mg, comprimate filmate, Tagant, 80 mg, comprimate filmate
Slovakia: Tagant, 40 mg, Tagant, 80 mg

Date of last revision of the leaflet